Toelatingsnummer 12942 N

 

ADMIRE O-TEQ

 

12942 N

 

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

BESTRIJDINGSMIDDELEN

 

1 TOELATING

 

Gelet op de aanvraag d.d. 7 oktober 2005 (20050313 TG) van

 

Bayer CropScience B.V.

Energieweg 1

3641 RT MIJDRECHT

 

 

tot verkrijging van een toelating als bedoeld in artikel 2, eerste lid, van de Bestrijdingsmiddelenwet 1962 (Stb. 288) voor het insectenbestrijdingsmiddel, op basis van de werkzame stof imidacloprid

 

ADMIRE O-TEQ

 

gelet op de artikelen 3 en 4 van de Bestrijdingsmiddelenwet 1962,

 

BESLUIT HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN als volgt:

 

I Toelating

1.      Het bestrijdingsmiddel ADMIRE O-TEQ wordt toegelaten in de zin van artikel 2, eerste lid, van de Bestrijdingsmiddelenwet 1962, onder nummer en datum dezes. Voor de gronden waarop dit besluit berust wordt verwezen naar bijlage II dezes.

2.      De toelating geldt tot 1 januari 2010

 

II Samenstelling, vorm en afwerking

Onverminderd hetgeen omtrent de samenstelling, vorm en afwerking van een bestrijdingsmiddel is bepaald in de Regeling samenstelling bestrijdingsmiddelen, moeten de samenstelling, vorm en fysische toestand van het middel alsmede de chemische en fysische eigenschappen daarvan overeenkomen met de bij de aanvraag tot toelating ingediende gegevens op basis waarvan de toelating is verstrekt.

 

III Gebruik

Het bestrijdingsmiddel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I dezes onder A. is voorgeschreven.

 


IV Classificatie en etikettering

 

  1. De aanduidingen, welke ingevolge artikel 36 van de Wet milieugevaarlijke stoffen en artikelen 14, 15a, 15b, 15c en 15e van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld, worden hierbij vastgesteld als volgt:

 

Overeenkomstig artikel 15c, lid 1, onder b van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten:

 

-          aard van het preparaat: Olie dispersie

 

Overeenkomstig artikel 15e, onder b van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten:

 

- Werkzame stof:

- Gehalte:

 

 

imidacloprid

350 g/l

 

 

 

Overeenkomstig artikel 14, leden 1, 2 en 3 van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten:

 

-          andere zeer giftige, giftige, bijtende of schadelijke stof(fen):

-

 

  1. Behalve de onder 1. bedoelde en de overige bij de Wet Milieugevaarlijke Stoffen en Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten voorgeschreven aanduidingen en vermeldingen moeten op de verpakking voorkomen:

 

a.      letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A.

 

b.      hetzij letterlijk, hetzij naar zakelijke inhoud:
de gebruiksaanwijzing
De tekst van de gebruiksaanwijzing is opgenomen in Bijlage I, onder B.
De tekst mag worden aangevuld met technische aanwijzingen voor een goede bestrijding mits deze niet met die tekst in strijd zijn
.

 

c.      overeenkomstig artikel 14, lid 4 tot en met lid 13 van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten, letterlijk en zonder enige aanvulling, tenzij bij de veiligheidsaanbeveling anders is vermeld:

- Gevaarsymbool:

- Aanduiding:

 

 

Xn

Schadelijk

 

 

N

Milieugevaarlijk

 

 

-          Waarschuwingszinnen:

Schadelijk bij opname door de mond.

Irriterend voor de ogen en de huid.

Kan overgevoeligheid veroorzaken bij contact met de huid.

Zeer vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

 

-          Veiligheidsaanbevelingen:

Niet roken tijdens gebruik.

Draag geschikte handschoenen en beschermende kleding.

In geval van inslikken onmiddellijk een arts raadplegen en verpakking of etiket tonen.

Deze stof en de verpakking als gevaarlijk afval afvoeren. (Deze zin hoeft niet te worden vermeld op het etiket indien u deelneemt aan het verpakkingenconvenant, en op het etiket het STORL-vignet voert, en ingevolge dit convenant de toepasselijke zin uit de volgende verwijderingszinnen op het etiket vermeldt:

1)      Deze verpakking is bedrijfsafval, mits deze is schoongespoeld, zoals wettelijk is voorgeschreven.

2)      Deze verpakking is bedrijfsafval, nadat deze volledig is geleegd.

3)      Deze verpakking dient nadat deze volledig is geleegd te worden ingeleverd bij een KCA-depot. Informeer bij uw gemeente.)

Voorkom lozing in het milieu. Vraag om speciale instructies / veiligheidsgegevenskaart.

 

d.      overeenkomstig artikel 14, lid 13 en lid 14 van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten, letterlijk en zonder enige aanvulling:

 

-          Specifieke vermeldingen:

-

 

e. n.v.t.

 

f.        overeenkomstig artikel 15e, onder a van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten, letterlijk en zonder enige aanvulling:

 

'Volg de gebruiksaanwijzing om gevaar voor mens en milieu te voorkomen.'

 

g.      Ingevolge artikel 15c van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten moet uitsluitend op die verpakkingen van bestrijdingsmiddelen die (mede) voor huishoudelijk gebruik zijn bestemd het logo voor klein chemisch afval (kca-logo) worden aangebracht, bestaand uit een afvalbak met een kruis erdoor zoals aangegeven in bijlage III bij deze regeling.

 

h. n.v.t.

 

2 DETAILS VAN DE AANVRAAG

 

2.1 Aanvraag

Het betreft een aanvraag tot toelating van het middel ADMIRE O-TEQ (12942 N), een middel op basis van de werkzame stof imidacloprid. Het middel wordt aangevraagd als insectenbestrijdingsmiddel voor toepassing in de teelt van appels en peren, in de bedekte teelt van aubergine, augurk, courgette, komkommer, tomaat, Spaanse peper en paprika, in de bedekte teelt van bloemisterijgewassen, in de bedekte teelt van gerbera en chrysant, in de onbedekte teelt van bloemisterijgewassen, in de teelt van bloembol- en bloemknolgewassen, in de teelt van bolbloem- en knolbloemgewassen, in de teelt van boomkwekerijgewassen en vaste planten, in de onbedekte teelt van hop en in de pennenteelt van witlof.

 


2.2 Informatie met betrekking tot de stof

Er zijn in Nederland reeds andere middelen op basis van de werkzame stof imidacloprid toegelaten.

De werkzame stof is genotificeerd en wordt door Duitsland beoordeeld. Er is per 31 januari 2006 een concept van de Europese beoordeling beschikbaar, welke gebruikt is voor de beoordeling van deze aanvraag.

Er is nog geen besluit genomen tot plaatsing van de werkzame stof op bijlage 1 van de gewas-beschermingsmiddelenrichtlijn 91/414/EEG.

 

2.3 Karakterisering van het middel

ADMIRE O-TEQ is een insecticide op basis van imidacloprid. Imidacloprid behoort tot de groep van neonicotinoiden. Het werkingsmechanisme is gebaseerd op verstoring van het centrale zenuwstelsel van de insecten.

Imidacloprid is een systemisch insecticide met een translaminaire werking en heeft een contact en maag werking. Het product wordt door de wortels opgenomen en door de plant heen getransporteerd. Insecten die aan planten zuigen of eten komen in contact met het product. De werkingsduur van het middel is enkele weken tot enkele maanden.

 

2.4 Voorgeschiedenis

De aanvraag is op 7 oktober 2005 ontvangen; op 7 oktober 2005 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 19 januari 2006 is de aanvraag in behandeling genomen. De verschuldigde kosten zijn op 23 januari 2006 ontvangen. In de vergadering van 11 oktober 2006 heeft het College aanvullende vragen gesteld voor het aspect milieu. Op 9 maart 2007 zijn de aanvullende gegevens ontvangen. Na op volledigheid te zijn beoordeeld zijn deze gegevens op 17 april 2007 in behandeling genomen. Op 18 april 2007 werden de verschuldigde beoordelingskosten ontvangen.

 

3 RISICOBEOORDELINGEN 

 

3.1 Fysische en chemische eigenschappen

De geleverde gegevens geven in voldoende mate de mogelijkheid om op basis daarvan de identiteit van het middel vast te stellen, te specificeren en te karakteriseren. Er is vastgesteld dat de standaardgegevens voor milieu, toxicologische aspecten en risicos met betrekking tot de fysisch-chemische eigenschappen beschikbaar zijn (artikel 3, lid 1, sub d Bmw 1962).

De beoordeling van de evaluatie van het middel en de stof staat beschreven in Bijlage II, Hoofdstuk 2. Physical and chemical properties behorende bij dit besluit.

 

3.2 Analysemethoden

De geleverde analysemethoden voldoen aan de vereisten. De residuanalysemethoden zijn specifiek en gevoelig genoeg om te kunnen worden gebruikt voor het controleren van de betreffende plantaardige en dierlijke producten op het maximaal toegestane gehalte, en het monitoren van de verspreiding van de residuen in het milieu (artikel 3, lid 1, sub b en c Bmw 1962).

De beoordeling van de evaluatie van de analysemethoden staat beschreven in Bijlage II, Hoofdstuk 3. Methods of analysis behorende bij dit besluit.

 


3.3 Humane Toxicologie

Er is vastgesteld dat het middel en zijn omzettingsproducten, wanneer het overeenkomstig het bepaalde bij of krachtens de Bestrijdingsmiddelenwet 1962 wordt gebruikt:

-        de gezondheid niet schaadt of de veiligheid niet in gevaar brengt van degene die het middel toepast, en

-        de gezondheid niet schaadt of de veiligheid niet in gevaar brengt van diegenen, die na toepassing van het middel door verrichten van werkzaamheden daarmee of met de residuen daarvan in aanraking komen (artikel 3, lid 1, sub a, onderdelen 5 en 6 Bmw 1962).

Het profiel humane toxicologie inclusief de beoordeling van het risico voor de toepasser staat beschreven in Bijlage II, Hoofdstuk 4. Mammalian toxicology behorende bij dit besluit.

 

3.4 Residuen en risico voor de volksgezondheid

Er is vastgesteld dat het middel en zijn omzettingsproducten, wanneer het overeenkomstig het bepaalde bij of krachtens de Bestrijdingsmiddelenwet 1962 wordt gebruikt geen schadelijke uitwerking heeft op de gezondheid van de mens (artikel 3, lid 1, sub a, onderdeel 3 Bmw 1962).

De vastgestelde maximum residuniveaus en de beoordeling van het risico voor de volksgezondheid staan beschreven in Bijlage II, Hoofdstuk 5. Residues behorende bij dit besluit.

 

3.5 Gedrag in bodem, water en lucht

Er is vastgesteld dat het middel en zijn omzettingsproducten, wanneer het overeenkomstig het bepaalde bij of krachtens de Bestrijdingsmiddelenwet 1962 wordt gebruikt

-        geen schadelijke uitwerking heeft op het grondwater en)

-        geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt gehouden met:

       de plaats waar het bestrijdingsmiddel in het milieu terecht komt en wordt verspreid, met name voor wat betreft besmetting van het water, met inbegrip van drink- en grondwater en belasting van de bodem;

       de gevolgen voor niet doel-soorten

(artikel 3, lid 1, sub a, onderdelen 9 en 10 Bmw 1962).

Het profiel milieu inclusief de beoordeling van het risico voor het milieu staat beschreven in Bijlage II, Hoofdstuk 6. Environmental fate and behaviour behorende bij dit besluit.

 

3.6 Ecotoxicologie

Er is vastgesteld dat het middel en zijn omzettingsproducten, wanneer het overeenkomstig het bepaalde bij of krachtens de Bestrijdingsmiddelenwet 1962 wordt gebruikt

-        geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt gehouden met:

       de plaats waar het bestrijdingsmiddel in het milieu terecht komt en wordt verspreid, met name voor wat betreft besmetting van het water, met inbegrip van drink- en grondwater en belasting van de bodem;

       de gevolgen voor niet doel-soorten (artikel 3, lid 1, sub a, onderdeel 10 Bmw 1962).

Het profiel ecotoxicologie inclusief de beoordeling van het risico voor niet-doelwit soorten staat beschreven in Bijlage II, Hoofdstuk 7. Ecotoxicology behorende bij dit besluit.

 

3.7 Werkzaamheid

Er is vastgesteld dat het middel en zijn omzettingsproducten, wanneer het overeenkomstig het bepaalde bij of krachtens de Bestrijdingsmiddelenwet 1962 wordt gebruikt:

-        voldoende werkzaam is en

-        geen onaanvaardbare uitwerking heeft op planten of plantaardige producten (artikel 3, lid 1, sub a, onderdelen 1 en 2 Bmw 1962).

De beoordeling van het aspect werkzaamheid staat beschreven in Bijlage II, Hoofddstuk 8. Efficacy behorende bij dit besluit.

 

3.8 Eindconclusie

Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel
ADMIRE O-TEQ op basis van de werkzame stof imidacloprid voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 3 Bestrijdingsmiddelenwet 1962).

 

 

 

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 8 van de Bestrijdingsmiddelenwet 1962 en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de Toelating van Bestrijdingsmiddelen (Ctb), Postbus 217, 6700 AE WAGENINGEN. Het Ctb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

 

 

Wageningen, 27 juli 2007

 

 

HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN,





(voorzitter)

 

 



HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN

 

BIJLAGE I bij het besluit d.d. 27 juli 2007 tot toelating van het middel ADMIRE O-TEQ, toelatingnummer 12942 N

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

Toegestaan is uitsluitend het gebruik als insectenbestrijdingsmiddel:

a) in de teelt van appels en peren door middel van een gewasbehandeling met een maximum aantal behandelingen van totaal twee keer per seizoen, met dien verstande dat toepassing alleen is toegestaan vr de bloei tot en met het muizenoorstadium alsmede na de bloei van appel en peer;

b) in de teelt onder glas van aubergine, augurk, courgette, komkommer, tomaat, Spaanse peper en paprika, met dien verstande dat het middel slechts centraal met de voedingsoplossing c.q. door middel van directe kraanvak-injectie mag worden meegegeven, met dien verstande dat het middel op de dag van de oogst niet vr de oogst mag worden toegepast; deze toepassingen zijn enkel toegestaan in kassen met een volledig gesloten recirculatiesysteem;

c) in de bedekte teelt van bloemisterijgewassen door middel van een druppelbehandeling. Deze toepassingen zijn enkel toegestaan in kassen met een volledig gesloten recirculatiesysteem;

d) in de bedekte teelt van gerbera en chrysant door middel van een gewasbehandeling.

e) In de onbedekte teelt van bloemisterijgewassen door middel van een gewasbehandeling, met dien verstande dat toepassing alleen is toegestaan voor de bloei tot het zichtbaar worden van de eerste bloemknoppen alsmede na de bloei;

f) in de teelt van en ten behoeve van de teelt van bloembol- en bloemknolgewassen door middel van een dompelbehandeling, met dien verstande dat bloei moet worden voorkomen;

g) in de teelt van en ten behoeve van de teelt van bloembol en bloemknolgewassen door middel van een gewasbehandeling, met dien verstande dat toepassing alleen is toegestaan vr de bloei tot het zichtbaar worden van de eerste bloemknoppen alsmede na de bloei;

h) in de teelt van en ten behoeve van de teelt van bolbloem- en knolbloem gewassen door middel van een gewasbehandeling en een dompelbehandeling;

i) in de teelt van boomkwekerijgewassen en vaste planten door middel van een gewasbehandeling, met dien verstande dat toepassing alleen is toegestaan vr de bloei tot het zichtbaar worden van de eerste bloemknoppen alsmede na de bloei.

j) In de onbedekte teelt van hop door middel van een aanstrijkbehandeling, met dien verstande dat niet meer dan 360 gram middel per ha wordt toegediend.

k) In de pennenteelt van witlof door middel van een behandeling in de zaaivoor.

 

Gevaarlijk voor bijen en hommels, om de bijen te beschermen mag u dit product niet gebruiken op in bloei staande gewassen. Gebruik dit product niet op plaatsen waar bijen actief naar voedsel zoeken, gebruik dit product niet in de buurt van in bloei staand onkruid. Verwijder onkruid voordat het bloeit.

 

Dit middel is schadelijk voor niet-doelwit arthropoden. Vermijd onnodige blootstelling

 

Om in het water levende organismen te beschermen is toepassing in de teelt van appel en peer als insecticiden uitsluitend toegestaan wanneer in percelen die grenzen aan oppervlaktewater in de periode voor of na 1 mei gebruik wordt gemaakt van n van de onderstaande drift reducerende maatregelen:

Vr 1 mei (kaal)

- Venturidop + nzijdige bespuiting laatste bomenrij; ventilatorstand uit

Na 1 mei (volblad)

- Tunnelspuit

- Combinatie windhaag op de rand van het rijpad en nzijdige bespuiting van de laatste bomenrij

- Venturidop + nzijdige bespuiting laatste bomenrij; ventilator aan

 

Dit middel is uitsluitend bestemd voor beroepsmatig gebruik.

 

Veiligheidstermijn

De termijn tussen de laatste toepassing en de oogst mag niet korter zijn dan:

14 dagen voor appels en peren

35 dagen voor hop

 

 

 

B.

GEBRUIKSAANWIJZING

 

Attentie
Bijen kunnen actief vliegen op niet-bloeiende gewassen, bijvoorbeeld om honingdauw te verzamelen die door luizen is afgescheiden.

 

Algemeen
ADMIRE O-TEQ is een systemisch middel op basis van imidacloprid. Het middel wordt bij de druppelbehandeling door de wortels opgenomen en bij de gewasbehandeling door de bladeren en vervolgens in de plant verspreid. De werkingssnelheid wordt mede bepaald door de activiteit van het gewas. Laat in geval van substraatteelt, voordat u het middel toepast, het gewas de matten wat droogtrekken. Dit bevordert de opname. Het middel dient met de voedingsoplossing te worden meegedruppeld.

Het verdient aanbeveling bij gebruik in siergewassen eerst door een proefbespuiting vast te stellen of de in aanmerking komende variteiten het middel goed verdragen.

 

Toepassingen

 

Appel en peer, ter bestrijding van de groene appelwants

Bij aanwezigheid van larven van de groene appelwants, indien noodzakelijk, een bestrijding uitvoeren.
Dosering: 0,02%

 

Appel, ter bestrijding van bladluizen, o.a. roze appelluis, appelgrasluis, groene appeltakluis, fluitenkruidluis, bloedvlekkenluis.
Bij aanwezigheid van de stammoeders van de roze appelluis of zodra aantasting van n van de overige bladluizen wordt waargenomen een bespuiting uitvoeren. Ingekrulde luizen worden goed bestreden.

Dosering: 0,02%

 

Appel, ter bestrijding van de appelzaagwesp.

Bij het vinden van de prikken van de appelzaagwesp gedurende de bloei van appel, direct na de bloei een bespuiting uitvoeren.

Dosering: 0,02%

 

Peer, ter bestrijding van bladluizen, o.a. roze pereluis, vouwgalluis, zwarte pereluis, zwarte boneluis

Zodra aantasting wordt waargenomen een bespuiting uitvoeren.

Dosering: 0,02%

 

Peer, ter bestrijding van de perezaagwesp.

Bij het vinden van de prikken van de perezaagwesp gedurende de bloei van peer, direct na de bloei een bespuiting uitvoeren.

Dosering: 0,02%

 

Het middel toepassen met ruim water. Toevoeging van uitvloeier kan de effectiviteit verbeteren.

 

Bedekte teelt van aubergine, augurk, courgette, komkommer, tomaat, Spaanse peper en paprika op kunstmatig substraat, ter bestrijding van boterbloemluis, groene en rode perzikluis, katoenluis en zwarte boneluis.
Zodra een aantasting wordt waargenomen een behandeling uitvoeren. Laat voordat het middel wordt toegepast, het gewas de matten wat droogtrekken. Dit bevordert de opname. Het middel dient met de voedingsoplossing te worden meegedruppeld.
Dosering: 7 ml per 1000 planten

 

Bedekte teelt van aubergine, augurk, courgette, komkommer, tomaat, Spaanse peper en paprika op kunstmatig substraat, ter bestrijding van larven van kaswittevlieg.

Zodra een aantasting wordt waargenomen een behandeling uitvoeren. Laat voordat het middel wordt toegepast, het gewas de matten wat droogtrekken. Dit bevordert de opname. Het middel dient met de voedingsoplossing te worden meegedruppeld
Dosering: 28 ml middel per 1000 planten

Het verdient aanbeveling middels een proefbehandeling vast te stellen of het gewas de behandeling verdraagt.

 

Bedekte teelt van bloemisterijgewassen op kunstmatig substraat, ter bestrijding van boterbloemluis, groene en rode perzikluis, katoenluis en zwarte boneluis.
Zodra een aantasting wordt waargenomen een behandeling uitvoeren. Laat voordat het middel wordt toegepast, het gewas de matten wat droogtrekken. Dit bevordert de opname. Het middel dient met de voedingsoplossing te worden meegedruppeld.
Dosering: 7 ml per 1000 planten

 

Bedekte teelt van bloemisterijgewassen op kunstmatig substraat, ter bestrijding van kaswittevlieg.

Zodra een aantasting wordt waargenomen, een behandeling uitvoeren. Laat voordat het middel wordt toegepast, het gewas de matten wat droogtrekken. Dit bevordert de opname. Het middel dient met de voedingsoplossing te worden meegedruppeld.
Dosering: 28 ml per 1000 planten

 

Bedekte teelt van gerbera en chrysant, ter bestrijding van bladluizen: boterbloemluis, groene en rode perzikluis, katoenluis en zwarte boneluis en ter bestrijding van kaswittevlieg.
Zodra aantasting wordt waargenomen het middel door een gewasbehandeling toepassen. Zonodig de bespuiting met een interval van 7-10 dagen herhalen.
Dosering: 0,02% (20 ml per 100 liter water)

 

Onbedekte teelt van bloemisterijgewassen, ter bestrijding van bladluizen: boterbloemluis, groene perzikluis (incl. de rode variant), katoenluis, zwarte boneluis en ter bestrijding van kaswittevlieg.
Zodra een aantasting wordt waargenomen het middel door een gewasbehandeling toepassen.
Zonodig de bespuiting met een interval van 7-10 dagen herhalen. Bij kaswittevlieg kunnen meer dan twee bespuitingen noodzakelijk zijn.
Dosering: 0,02% (20 ml per 100 liter water)

 

De teelt van bloembol-, bloemknol, knolbloem en bolbloemgewassen (gewasbehandeling), ter bestrijding van groene perzikluis, katoenluis en zwarte bonenluis.
Zodra aantasting wordt waargenomen een gewasbehandeling uitvoeren. De behandeling indien nodig herhalen.
Dosering: 200 ml per ha of 0,02% (20 ml per 100 liter water)

 

De teelt van gladiolen (gewasbehandeling), ter bestrijding van gladiolentrips.

Bij het verschijnen van het derde blad starten met de bestrijding. De behandeling daarna nog twee keer herhalen met intervallen van 7-10 dagen.

Dosering: 200 ml per ha of 0,02% (20 ml per 100 liter water)

 

Dompelbehandeling van bloembollen, bloemknollen, knolbloemen en bolbloemen

In deze gebruiksaanwijzing is voor de toepassingen voor bloembollenplantgoed steeds uitgegaan van een standaardontsmettingswijze waarbij gestreefd dient te worden naar minimale restanten door opgebruik. Voor de toegestane wijze van verwerken van restanten ontsmettingsvloeistof wordt verwezen naar de "Beschikking verwijdering dompelvloeistof bloembollen en -knollen".

 

Voor andere toepassingstechnieken (kort dompelen, schuimen e.d.) zullen afgeleide doseringen nodig zijn. Raadpleeg hiervoor de betreffende voorlichtingspublicaties waarin tevens is aangegeven hoe, overeenkomstig voornoemde Beschikking, de restanten kunnen worden verwerkt.

 

Bloembol-, bloemknol, knolbloem en bolbloemgewassen (dompelbehandeling), ter bestrijding van groene perzikluis, katoenluis en zwarte bonenluis.
Het plantgoed vr het planten gedurende 15 minuten dompelen. Het plantgoed dient op het moment van behandeling in rust te zijn. Bij gewassen die in het najaar geplant worden of gewassen die op het dompeltijdstip geen wortels hebben, kan tegen het einde van de teelt een aanvullende bestrijding met een insecticide noodzakelijk zijn. Dompelbehandeling indien mogelijk kort voor het planten uitvoeren. Menging met fungiciden is mogelijk.
Dosering: 0,08% (80 ml per 100 liter water) en maximaal 750 liter dompelvloeistof per ha toepassen. Bij gewassen die in het najaar geplant worden en bijgewassen met weinig wortels op het dompeltijdstip, de dosering verhogen tot 0,1% (100 ml per 100 ml dompelvloeistof) en maximaal 600 liter dompelvloeistof per ha toepassen.

 

Gladiolen (dompelbehandeling), ter bestrijding van gladiolentrips tijdens de bewaring van de knollen.

Na het pellen en voor de bewaring de knollen dompelen. Menging met fungiciden is mogelijk.

Dosering: 0,08% (80 ml per 100 ml dompelvloeistof) en maximaal 750 liter dompelvloeistof per ha toepassen

 

Bedekte teelt van boomkwekerijgewassen en vaste planten, ter bestrijding van bladluizen: boterbloemluis, groene en rode perzikluis, katoenluis, zwarte boneluis, gewone rozeluis, sjalotteluis en groene kortstaartluis.
Zodra een aantasting wordt waargenomen het middel door een gewasbehandeling toepassen.
Zonodig de bespuiting met een interval van 7-10 dagen herhalen.
Dosering: 0,02% (20 ml per 100 liter water)

 

Onbedekte teelt van boomkwekerijgewassen en vaste planten, ter bestrijding van bladluizen: boterbloemluis, groene en rode perzikluis, zwarte boneluis, gewone rozeluis, sjalotteluis, groene kortstaartluis, aardappeltopluis, zwarte kerseluis, groene appeltakluis, groene sparreluis, vogelkersluis en beukebladluis.
Zodra een aantasting wordt waargenomen het middel door een gewasbehandeling toepassen.
Zonodig de bespuiting met een interval van 7-10 dagen herhalen.
Dosering: 0,02% (20 ml per 100 liter water)

 

Onbedekte teelt van boomkwekerijgewassen en vaste planten, ter bestrijding van de buxusbladvlo.

Toepassen zodra de larven uit de wintereieren komen.

Dosering: 0,02% (20 ml per 100 liter water)

 

Onbedekte teelt van hop, ter bestrijding van de hopluis.
Zodra aantasting wordt waargenomen een behandeling uitvoeren waarbij het middel door middel van aanstrijken op de stengel wordt gebracht.
Per groeiseizoen n behandeling uitvoeren.
Dosering: per 1000 scheuten 90 ml middel in 1,5 liter water oplossen. Maximaal 360 gram middel per hectare toepassen.

Pennenteelt van witlof in de vollegrond, ter bestrijding van de wollige slawortelluis. Toepassen via een spray-toepassing in de zaaivoor. De spray na het zaaien voor het dichtstrijken van de zaaivoor richten. Doordat de kieming door de toepassing wat achter kan blijven wordt geadviseerd 5% extra zaad te gebruiken.

Dosering: 500 ml middel per ha

 



HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN

 

BIJLAGE II bij het besluit d.d. 27 juli 2007 tot toelating van het middel ADMIRE O-TEQ, toelatingnummer 12942 N

 

Contents Page

 

 

1. Identity of the plant protection product 2

 

2. Physical and chemical properties 5

 

3. Methods of analysis 10

 

4. Mammalian toxicology 12

 

5. Residues 21

 

6. Environmental fate and behaviour 25

 

7. Ecotoxicology 44

 

8. Efficacy 70

 

9. Conclusion 72

 

10. Classification and labelling 72

 


1. Identity of the plant protection product

 

1.1 Applicant

Bayer Crop Science B.V.

Energieweg 1

3641 RT Mijdrecht

 

1.2 Identity of the active substance

Common name

Imidacloprid

Name in Dutch

Imidacloprid

Chemical name

1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine

CAS nr

138261-41-3

EEG nr

-

 

The active substance is not included in the Annex 1 list of directive 91/414/EC. A draft assessment report (DAR) of the active substance is available (RMS: Germany).

 

1.3 Identity of the plant protection product

Name

ADMIRE O-TEQ

Formulation type

OD (Oil Dispersion)

Content active substance

350 g/L

 

The formulation is not part of the assessment of the active substance for inclusion in the Annex 1 list of 91/414/EC.

 

1.4 Function

Insecticide.

 

1.5 Uses applied for

Intended uses of ADMIRE O-TEQ are listed in Table 1.

 

Table 1: Intended uses ADMIRE O-TEQ

Uses

Dose a.s.

(g a.s./ha)

Number of appli-cations

Interval between applications

Application time (growth stage and season)

Apple against common green capsid bug (Lygus pabulinus), European apple sawfly (Hoplocampa testudinea)

Young crop 0.07
Adult crop 0.105

2

7-14 days

April-July

Apple against rosy apple aphid (Dysaphis plantaginea), apple aphid (Aphis pomi), rosy leaf-curling aphid (Dysaphid devecta, Dysaphis anthrisci), apple-grass aphid (Rhopalosiphum insertum

Young crop 0.07
Adult crop 0.105

2

7-14 days

April-Sept

Pear against common green capsid bug (Lygus pabulinus), pear sawfly (Hoplocampa brevis)

Young crop 0.07
Adult crop 0.084

2

7-14 days

April-July

Pear against pear aphid (Dysaphis pyri), pear coltsfoot aphid (Anuraphis farfarae), Melanaphis pyaria, black bean aphid (Aphis fabae)

Young crop 0.07
Adult crop 0.084

2

7-14 days

April-Sept

Aubergine, gherkins, courgettes, cucumber, tomato, red pepper, and sweet pepper on artificial substrate (protected culture) against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae)

2.45 g a.s./1000 plants

2

1 day

March-Nov

Aubergine, gherkins, courgettes, cucumber, tomato, red pepper, and sweet pepper on artificial substrate (protected culture) against greenhouse whitefly (Trialeurodes vaporariorum)

28 ml/1000 plants

2

1 day

March-Nov

Floriculture crops on artificial substrate (protected culture) against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae)

2.45 g a.s./1000 plants

2

1 day

March-Nov

Floriculture crops on artificial substrate (protected culture) against greenhouse whitefly (Trialeurodes vaporariorum)

9.8 g a.s /1000 plants

2

1 day

March-Nov

Floriculture crops in the open ground (protected culture) against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae)

0.084

2

7-10 days

Jan-Dec

Gerbera and chrysanthemum (protected culture) against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae), greenhouse whitefly (Trialeurodes vaporariorum)

0.084

2

7-10 days

Jan-Dec

Perennial floriculture crops in the open ground against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), black bean aphid (Aphis fabae), greenhouse whitefly (Trialeurodes vaporariorum)

0.084

2

7-10 days

Jan-Dec

Flower bulb- and bulb flower crops (open field) against green peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae)

0.07

2

7-10 days

March-Sept

Flower bulb- and bulb flower crops (protected culture) against green peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae)

0.07

2

7-10 days

March-Sept

Flower bulb- and bulb flower crops (dip treatment) against green peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae)

0.08%

1

-

Jan-Dec

Gladiolus against gladiolus thrips (Taeniothrips simplex)

0.07

3

7-10

May-Sept

Gladiolus against gladiolus thrips (Taeniothrips simplex)

0.07

3

7-10

Jan-Dec

Gladiolus (dip treatment) against gladiolus thrips (Taeniothrips simplex)

0.08%

1

-

Jan-Dec

Tree nursery crops and perennials (protected culture) against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae), rose aphid (Macrosiphum rosae), shallot aphid (Myzus ascolonicus), plum leaf-curling aphid (Brachycaudys helichrysi)

0.07

2

7-10 days

Jan-Dec

Tree nursery crops and perennials in the open ground against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), black bean aphid (Aphis fabae), rose aphid (Macrosiphum rosae), shallot aphid (Myzus ascolonicus), plum leaf-curling aphid (Brachycaudys helichrysi), potato aphid (Macrosiphum euphorbiae), black cherry aphid (Myzus cerasi), apple aphid (Aphis pomi), green spruce aphid (Elatobium abietinum), bird cherry aphid (Rhopalosiphum padi), woolly beech aphid (Phyllaphis fagi)

0.084

2

7-10 days

March-Sept

Tree nursery crops and perennials in the open ground against Boxwood psyllids (Psylla buxi)

0.084

1

-

April-May

Hop against hop vine aphid (Phorodon humuli)

0.032 g a.s./1000 shouts

1

-

May-June

Root growing culture of witloof chicory against lettuce root aphid (Pemphigus bursarius)

0.0875

1

-

April-May

 

 

1.6 Background to the application

ADMIRE O-TEQ is a new formulation.

As a consequence of the European assessment of the active substance in the light of the decision whether it can be placed upon Annex I of Directive 91/414/EEG or not, a concept for a monograph has been conceived. The CTB has evaluated this concept-monograph and has given comments upon its contents. With full consideration of these comments, the CTB has made the contents of the concept-monograph her own and applies them in the handling of the present application. In the List of Endpoints underneath, the Dutch comments are typed in italics.

 

1.7 Packaging details

 

1.7.1 Packaging description

Material:

High Density Polyethylene (HDPE) or Ethylvinylalcohol (EVOH) or Polyamide + HDPE

Capacity:

1 L

Type of closure and size of opening:

White cap, liner-less or induction seal, 50 mm

Other information

-

 

1.7.2 Detailed instructions for safe disposal

See application form and MSDS.

 

 

2.                  Physical and chemical properties

 

2.1              Active substance: Imidacloprid

Data about the identity and the physical and chemical properties are taken from the List of Endpoints (DAR, December 2005). Changes and/or additions are made in italics.

 

Identity

Active substance (ISO Common Name)

Imidacloprid

Chemical name (IUPAC)

1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine

Chemical name (CA)

1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine

CIPAC No

582

CAS No

138261-41-3

EEC No (EINECS or ELINCS)

Not available

FAO Specification (including year of publication)

Not available

Minimum purity of the active substance as manufactured (g/kg)

970

Identity of relevant impurities (of toxicological, environmental and/or other significance) in the active substance as manufactured (g/kg)

None identified

Molecular formula

C9H10ClN5O2

Molecular mass

255.7

Structural formula

 

 

 

Physical-chemical properties

 

Melting point (state purity)

144 C (99.9 %)

Boiling point (state purity)

Temperature of decomposition

>200 C

Appearance (state purity)

Colourless crystals (99.8 %) or cream coloured powder (98.5 %)

Relative density (state purity)

= 1.54 g/cm3 (pycnometer with air)

= 1.41 g/cm3 (pycnometer with n‑heptane)

Surface tension

72.20 mN/m (458.91 mg/L) at 20 C

Vapour pressure (in Pa, state temperature)

20 C: 4 x 10-10 Pa

25 C: 9 x 10-10 Pa

extrapolated from measurement between 50 to 70 C

Henrys law constant (in Pam3mol-1)

1.7 * 10-10 Pa m3 mol-1 (20 C)

Solubility in water (in g/l or mg/l, state temperature)

610 mg/L (demineralised water, 20 C), independent of the pH in the range between 4 and 9.

Solubility in organic solvents (in g/l or

mg/l, state temperature)

Solvent Solubility (20 C)

n-Hexane < 0.1 g/L

Toluene 0.69 g/L

Dichloromethane 67 g/L

2-Propanol 2.3 g/L

Acetone 50 g/L

Ethylacetate 6.7 g/L

 

Acetonitrile 50 g/L

Dimethylsulfoxide > 200 g/L

Dimethylformamide > 200 g/L

Partition co-efficient (log Pow) (state pH and temperature)

log Po/w = 0.57, demineralised water, 21 C

Hydrolytic stability (DT50) (state pH and temperature)

No degradation at pH 5 and at 25 C during 30 d.

Slightly degradation at pH 9 at 25 C during 30 d, calculated DT50 ≈ 1 a.

Dissociation constant

No pka in aqueous systems

UV/VIS absorption (max.) (if absorption >290 nm state ε at wavelength)

lmax [nm] e

212 13346

270 22054

Photostability (DT50) (aqueous, sunlight, state pH)

pH 7, 23 24.5 C: DT50 = 57 min

environmental: DT50 = 4.2 h (calculated)

Quantum yield of direct photo-

transformation in water at λ > 290 nm

Φ = 0.014 (highly pure water, 25 C)

Photochemical oxidative degradation in air

DT50 0.85 hours (calculation according to Atkinson 1987, 12 h daytime, 1.5 x 106 OH-radicals/cm)

24 h time period, 5 x 105 OH-radicals/cm DT50 2.54 h

Flammability

Not highly flammable. No gases were liberated.

Auto-flammability

>144C (melting point)

Oxidative properties

Oxidising

Explosive properties

Not explosive.

 

2.2              Plant protection product: ADMIRE O-TEQ

Data about the plant protection product are based on information provided by the applicant.

 

The range of the application concentration of the plant protection product is 0.02-0.2 %.

 

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

GLP: no

Method: visual

suspension

acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

GLP: no

Method: visual

beige

acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

GLP: no

Method: olfactory

weak chemical

acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

GLP: yes

Method: EEC A.14

not sensitive to shock, not explosive when heated

acceptable

B.2.2.5 (IIIA 2.2)

Oxidising properties

GLP: yes

Method: EEC A.21

no oxidizing properties

acceptable

B.2.2.6 (IIIA 2.3)

Flammability

 

not applicable for an oil dispersion

acceptable

B.2.2.7 (IIIA 2.3)

Auto-flammability

GLP: yes

Method: EEC A.15

auto-ignition temperature 335C

acceptable

B.2.2.8 (IIIA 2.3)

Flash point

GLP: yes

Method: EEC A.9

no flash point up to 110C

acceptable

B.2.2.9 (IIIA 2.4)

Acidity/

alkalinity

 

not applicable (4 pH 10)

acceptable

B.2.2.10 (IIIA 2.4)

pH

GLP: yes

Method: CIPAC MT 75.3

1% in CIPAC D water under N2 atmosphere at room temperature: pH = 8.9

acceptable

B.2.2.11 (IIIA 2.5)

Surface tension

GLP: yes

Method: OECD 115

At 25C, undiluted product:

29 mN/m

acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: yes

Method: OECD 114

dynamic viscosity

shear rate

(s-1)

viscosity at 20C

(mPa.s)

viscosity at 40C

(mPa.s)

100

423

45.3

acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: yes

Method: OECD 114

dynamic viscosity

shear rate

(s-1)

viscosity at 20C

(mPa.s)

viscosity at 40C

(mPa.s)

20

499

528

100

403

296

acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: yes

Method: OECD 114, calculated from dynamic viscosity and density

kinematic viscosity

shear rate

(s-1)

viscosity at 20C

(m2.s-1)

viscosity at 40C

(m2.s-1)

100

3.88E-04

4.21E-05

acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: yes

Method: OECD 114, calculated from dynamic viscosity and density

kinematic viscosity

shear rate

(s-1)

viscosity at 20C

(m2.s-1)

viscosity at 40C

(m2.s-1)

20

4.59E-04

4.90E-04

100

3.71E-04

2.75E-04

acceptable

B.2.2.13 (IIIA 2.6)

Relative density

GLP: yes

Method: OECD 109

D420 = 1.090

D440 = 1.077

acceptable

B.2.2.13 (IIIA 2.6)

Relative density

GLP: yes

Method: OECD 109

D420 = 1.086

D440 = 1.077

acceptable

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

 

not relevant for an oil dispersion

acceptable

B.2.2.14 (IIIA 2.7)

Storage stability

GLP: no

Method: CIPAC MT 46.3

In HDPE, COEX/E-VAL & COEX/PA pack:

Physically and chemically stable for 14 days at 54C. In HDPE pourability after storage was just outside acceptable limits (5.13% residue, 0.30% rinsed residue).

acceptable; the applicant states that the residue will be negligible under practical conditions with the use of an injection hopper, which is well established in Northern Europe.

B.2.2.14 (IIIA 2.7)

Storage stability

GLP: no

Method: CIPAC MT 39.3

In HDPE, COEX/E-VAL & COEX /PA pack:

Stable for 7 days at 0C.

acceptable

B.2.2.15 (IIIA 2.7)

Shelf life

 

study ongoing, results except in 2007

acceptable provided that results are submitted in 2007.

B.2.2.16

(IIIA 2.8)

Wettability

 

not relevant for an oil dispersion

acceptable

B.2.2.17 (IIIA 2.8)

Persistent foaming

GLP: no

Method: CIPAC MT 47.2

0.26%, CIPAC D water:

20.5/15/12/8.5 mL after 10 s/1 min/3 min/12 min.

6.4%, CIPAC D water:

71/31/12/7 mL after 10 s/1 min/3 min/12 min.

acceptable

B.2.2.18

(IIIA 2.8)

Suspensibility

 

not relevant for an oil dispersion

acceptable

B.2.2.19

(IIIA 2.8)

Spontaneity of dispersion

 

not relevant for an oil dispersion

acceptable

B.2.2.20

(IIIA 2.8)

Dilution stability

 

not relevant for an oil dispersion

acceptable

B.2.2.21

(IIIA 2.8)

Dry sieve test

 

not relevant for an oil dispersion

acceptable

B.2.2.22

(IIIA 2.8)

Wet sieve test

GLP: no

Method: CIPAC MT 185

<0.01% residue on 75 m sieve

acceptable

B.2.2.23

(IIIA 2.8)

Particle size distribution

 

not relevant for an oil dispersion

acceptable

B.2.2.24

(IIIA 2.8)

Content of dust/fines

 

not relevant for an oil dispersion

acceptable

B.2.2.25

(IIIA 2.8)

Attrition and friability

 

not relevant for an oil dispersion

acceptable

B.2.2.26 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

GLP: no

Method: CIPAC MT 180

0.02%, 0.26% and 6.4% of the preparation in CIPAC A and D water: initial dispersion complete; after 30 min 0.8 mL cream, 0.0 mL oil; after 24 h redispersibility complete; after 24.5 h 0.9 mL cream, 0.0 mL oil.

acceptable

B.2.2.27

(IIIA 2.8)

Stability of dilute emulsion

 

not relevant for an oil dispersion

acceptable

B.2.2.28

(IIIA 2.8)

Flowability

 

not relevant for an oil dispersion

acceptable

B.2.2.29

(IIIA 2.8)

Pourability (rinsibility)

GLP: no

Method: CIPAC MT 148

residue 2.46%, rinsed residue 0.10%

acceptable

B.2.2.30

(IIIA 2.8)

Dustability

 

not relevant for an oil dispersion

acceptable

B.2.2.31

(IIIA 2.8)

Adherence and distribution to seeds

 

not relevant for an oil dispersion

acceptable

2.9.1

Physical compatibility with other products

 

not applicable

 

2.9.2

Chemical compatibility with other products

 

not applicable

 

 

No mixing with other plant protection products or adjuvants is proposed. No information is available on the behaviour of this product when mixed with other products. Mixing with another product or adjuvant can therefore result in unexpected behaviour.

 


Conclusion

The physical and chemical properties of the active substance and the plant protection product are sufficiently described by the available data. Neither the active substance nor the product has any physical or chemical properties, which would adversely affect the use according to the proposed use and label instructions. The claimed shelf life of 2 years is supported by the results of accelerated storage stability testing (14 days, 54C). The shelf-life study is still in progress (report expected in May 2007) and the report should be submitted as soon as it becomes available.

 

2.3 Data requirements

The report of the shelf-life study should be submitted as soon as it becomes available.

 

 

3.                  Methods of analysis

Description and data about the analytical methods are taken from the List of Endpoints (DAR, December 2005), except where noted. Changes and/or additions are made in italics.

 

3.1. Analytical methods in technical material and plant protection product

Technical as (principle of method)

HPLC-UV

Impurities in technical as (principle of method)

HPLC-UV

Preparation (principle of method)

HPLC-UV(A)

(A) Report with validation for ADMIRE O-TEQ was not included in DAR but submitted to CTB along with the application for registration.

 

Conclusion

 

The analytical methods for the technical active substance and the impurities have been assessed in the monograph and are considered to be acceptable. The method for the determination of the active substance in the preparation was evaluated by CTB and found to be acceptable.

 

 

3.2 Residue analytical methods

Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes)

LC-MS/MS 0.02 mg/kg for each separately(A) (a.s., metabolite M01, M06); apple, cotton seed, potato
GC/MS 0,05 mg/kg(B) (total residue(C)); all crop categories

LC-MS/MS(D) 0.01 mg/kg (a.s.); wheat grain, green material & straw, olive fruit, oil & pomace, cocoa bean, chocolate & cocoa powder

LC-MS/MS(D) 0.05 mg/kg (total residue(C)); apple, bean, citrus fruit & peel, olive fruit, pepper, tomato

Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes)

GC/MS 0.02 mg/kg (total residue)(E)

LC-MS/MS 0.02 mg/kg (total residue)

Soil (principle of method and LOQ)

LC-MS/MS 0.005 mg/kg (as)

HPLC/UV 0.01 mg/kg (as)

Water (principle of method and LOQ)

HPLC/UV 0.05 g/L (as)
HPLC-MS/MS 0,10 g/L (as)

Air (principle of method and LOQ)

HPLC-UV 5 g/m

Body fluids and tissues (principle of method and LOQ)

Not required, non toxic compound

(A) The List of Endpoints of the DAR stated 0.02 mg/kg for the sum of a.s., M01 and M06, but the text in vol. 1, point 2.2.3 confirmed that 0.02 mg/kg was the LOQ for the individual compounds.

(B) The List of Endpoints of the DAR stated that the LOQ was 0.05 0.10 mg/kg, which was the range for LOQs from the various validation reports.

(C) Sum of residues containing the 6-chloro-nicotinic acid unit.

(D) Report with validation for ADMIRE O-TEQ was not included in DAR but submitted to CTB along with the application for registration; an ILV was not submitted but is not required since the methods evaluated in the DAR are suitable for monitoring of the proposed MRLs.

(E) The List of Endpoints of the DAR stated that the LOQ was 0.02 0.08 mg/kg. The initial validated level was 0.02 mg/kg, the level of 0.08 mg/kg pertained to the LOQ of the ILV.

 

Based on the proposed use of the plant protection product, analytical methods for determination of residues in food/feed of plant origin are required for watery matrices (apple, pear, egg plant, gherkin, courgette, cucumber, tomato, chilli pepper, sweet pepper and chicory root).

 

 

Definition of the residue and proposed MRLs for imidacloprid

Matrix

Proposed definition of the residue for monitoring

Proposed MRL

Food/feed of plant origin

Sum of imidacloprid and its metabolites imidacloprid-5-hydroxy (M1) and imidacloprid-olefine (M6), expressed as imidacloprid

watery crops: 0.2-1 mg/kg

Food/feed of animal origin

Sum of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as imidacloprid

0.05*

 

Required LOQ

Soil

Imidacloprid

0.05 mg/kg (default)

Drinking water

Imidacloprid

0.1 g/L (Dutch drinking water guideline)

Surface water

Imidacloprid

2.2 g/L (NOEC for C. riparius)

Air

Imidacloprid

45 g/m3 (derived from the AOEL according to SANCO/825/00)

Body fluids and tissues

The active substance is not classified as (very) toxic thus no definition of the residue is proposed.

not applicable

 

The residue analytical methods, included in the above List of Endpoints, are suitable for monitoring of the proposed MRLs.

 

The residue analytical methods for water, soil and air, evaluated in the monograph, are acceptable and suitable for monitoring of residues in the environment.

 

Conclusion

The submitted analytical methods meet the requirements. The methods are specific and sufficiently sensitive to enable their use for enforcement of the MRLs and for monitoring of residues in the environment.

 

3.3 Data requirements

None.

 

3.4 Physical-chemical classification and Labelling

 

Proposal for the classification of the active ingredient (symbols and R phrases)
(EU classification) concerning physical chemical properties

 

Symbol(s):

oxidising

Indication(s) of danger: O

 

Risk phrase(s)

R8

Contact with combustible material may cause fire

 

This labeling is in accordance with the proposal in the DAR (2005).

 

Proposal for the classification and labeling of the formulation concerning physical chemical properties for professional use:

 

Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application, the following labeling of the preparation is proposed:

 

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

-

Indication of danger:

-

R phrases

-

-

S phrases

21

When using do not smoke

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

N.a.

Tactile warning of danger obligatory?

N.a.

 

Explanation:

Hazard symbol:

 

Risk phrases:

 

Safety phrases:

 

Other:

 

 

 

4.                  Mammalian toxicology

List of End-points

Imidacloprid is an existing active substance. The toxicological profile presented below is based on the Draft Assessment Report (DAR) prepared by the RMS Germany. The Dutch comments on the DAR and some additional information, when relevant, are also presented (in italic). Since the active substance is still in the process of evaluation/discussion, the toxicological profile below should be regarded as provisional (comments from the Member States are received; subsequently the substance has to be discussed in the first WG evaluation meeting). The list of endpoints presented below is copied from the DAR (d.d. 30 December 2005).

 



Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1)

Rate and extent of absorption

High bioavailability (> 92 %) based on urinary (56 %) and biliary (35 %) excretion in biliary excretion study, within 48 h

Distribution

Uniformly and rapidly distributed, highest residues in the liver, kidney, lung and skin; plasma Cmax = 0.85 (10.8) mg/mL within 1 h after administration of 1 (20) mg/kg bw

Potential for accumulation

No evidence for accumulation

Rate and extent of excretion

Rapidly and completely (21 % in faeces, 75 % in urine within 48 h); evidence for enterohepatic circulation

Metabolism in animals

Extensive (85 - 90 %); oxidative cleavage and conjugation, hydroxylation of the imidazolidine ring giving rise to at least 16 metabolites

Toxicologically significant compounds
(animals, plants and environment)

Parent compound and animal metabolites

 

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral

~ 500 mg/kg bw/d Xn, R 22

Rat LD50 dermal

> 5000 mg/kg bw/d

Rat LC50 inhalation

> 0.69 mg/L air/4 hr (aerosol, maximum technically attainable concentration, head-nose-exposure)

Skin irritation

Non-irritant

Eye irritation

Non-irritant

Skin sensitisation (test method used and result)

Not sensitising (M & K)

 

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect

Body weight gain (rat, dog), liver (clinical chemistry and histopathological findings: rat, dog), trembling/tremor (dog)

Lowest relevant oral NOAEL / NOEL

90-d rat: 14 mg/kg bw/d

1-yr dog: 15 mg/kg bw/d

Lowest relevant dermal NOAEL / NOEL

15-d, rabbit: 1000 mg/kg bw/d

Lowest relevant inhalation NOAEL / NOEL

4-wk, rat: 0.0055 mg/L air

 

Genotoxicity (Annex IIA, point 5.4)

 

No evidence for genotoxicity 1

1 In vitro tests for point‑mutation effects (Salmonella/microsome reverse‑mutation and CHO‑HGPRT tests) gave negative results. In vitro tests for DNA-damaging properties (yeast mitotic recombination assay, B. subtilis rec‑assay, rat hepatocyte UDS test) were also negative. A weak indication of sister chromatid exchange (SCE) induction in CHO cells was found in an in vitro test. However, this was not confirmed by the in vivo SCE test in bone marrow of Chinese hamsters. In the cytogenetic study with human lymphocyte cultures, a slight, reproducible increase in the aberration rate was observed in the cytotoxic concentration range without metabolic activation; an equivocal result was obtained with metabolic activation. All in vivo tests for chromosome damage (micronucleus test, bone marrow cytogenetics and spermatogonia cytogenetics) were negative, however, so that a clastogenic potential of imidacloprid in vivo can be excluded. The overall conclusion is that imidacloprid exhibits no genotoxic potential in vivo.

 

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target / critical effect

Body weight gain (rat, mouse), liver (blood chemistry: rat, mouse; organ weight decrease: mouse ); thyroid (mineralisation in the follicular colloid: rat)

Lowest relevant NOAEL / NOEL

2-yr rat: 5.7 mg/kg bw/d

2-yr mouse: 65.6 mg/kg bw/d

Carcinogenicity

No evidence for carcinogenicity

 

Reproductive toxicity (Annex IIA, point 5.6)

Reproduction target / critical effect

Parental bw gain decreased; fertility parameters unaffected; pup weight gain reduction at parentally toxic doses

Lowest relevant NOAEL

Rat, 2-generation:

parental: 20 mg/kg bw/d

reproduction: 50 mg/kg bw/d

offspring: 40 mg/kg bw/d

Developmental target / critical effect

Rat: maternal bw gain and food consuption decreased; developmental toxicity indicated by increase in skeletal variant (wavy rib)

Rabbit: maternal bw gain and food consumption decreased, mortality; increased prenatal litter loss, reduced fetal weight, delayed ossification and skeletal anomalies at maternally toxic doses

Lowest relevant NOAEL / NOEL

Rat, maternal: 30 mg/kg bw/d

Rat, developmental: 30 mg/kg bw/d

Rabbit, maternal: 8 mg/kg bw/d

Rabbit, developmental: 24 mg/kg bw/d

 

Neurotoxicity / Delayed neurotoxicity (Annex IIA, point 5.7)

 

Clinical signs and neurobehavorial effects ascribed to acute cholinergic toxicity; subchronic effects related to the general toxicity.

NOAEL (acute neurotoxicity study)

42 mg/kg bw 2

NOEL (subacute neurotoxicity study)

9.3 mg/kg bw/d

NOEL (developmental neurotoxicity study)

30 mg/kg bw/d

2 The RMS considers the decreases in motor and locomotor activity at 42 mg/kg bw not test substance-related. However, the real question probably is whether the decreases at this dose level are adverse or not, because the decreases might be dose-related. Based on the results in this study, an additional study was performed with females with a dose level of 20 mg/kg bw. 20 mg/kg bw may also be regarded as the NOAEL for acute neurotoxicity.

 

Other toxicological studies (Annex IIA, point 5.8)

 

NTN 33893-nitrosimine (WAK 3839; metabolite) and nitroguanidine (impurity) tested for kinetics and metabolism, acute toxicity, subchronic effects, reproduction toxicity (nitroguanidine only) and mutagenicity revealing no evidence of a special risk

 

Medical data (Annex IIA, point 5.9)

 

No evidence of adverse effects, some formulations sensitising to humans

 

Summary (Annex IIA, point 5.10)

 

Value

Study

Safety factor

ADI

0.06 mg/kg bw

Rat, 2-yr

100

AOEL systemic

0.15 mg/kg bw/d

Dog, 1-yr

100

ARfD (acute reference dose)

0.4 mg/kg bw/d 3

dog 90-day study (acute effects), rat acute neurotoxicity study,

100

3 NL commented on the NOAEL in the 90-day dog study and on the NOAEL in the acute neurotoxicity study. This might change the calculation of the ARfD.

 

Dermal absorption (Annex IIIA, point 7.3)

 

100 % (default value, based on physicochemical data)

 

Classification and proposed labelling (Annex IIA, point 10)

with regard to toxicological data

Xn, R 22 (Harmful if swallowed)

 

 

Data requirements active substance

Data requirements identified in the EU-assessment are also applicable to the Dutch assessment.

 

4.1 Toxicity of the formulated product (IIIA 7.1)

The formulation ADMIRE O-TEQ needs to be classified as R22 Harmful if swallowed, based on the acute oral toxicity (LD50 rat = 2000 mg/kg bw).

The formulation ADMIRE O-TEQ does not need to be classified on the basis of its acute dermal (LD50 rat >4000 mg/kg bw), and inhalation toxicology (no study available; not necessary for this formulation).

The formulation is considered irritating to skin and needs to be classified as R38 Irritating to skin.

The formulation is considered irritating to eyes and needs to be classified as R36 Irritating to eyes.

The formulation ADMIRE O-TEQ is positive in an LLNA test for skin sensitisation and needs to be classified as R43 May cause sensitisation by skin contact.

 

4.1.1 Data requirements formulated product

No additional data requirements are identified.

 

4.2 Dermal absorption (IIIA 7.3)

The dermal absorption in the list of endpoints is 100% (default based on physico-chemical properties). For the current registration request, an in vitro dermal absorption study was submitted. The dermal absorption of imidacloprid formulated as OD 200 was investigated in vitro in human and rat skin (ADMIRE O-TEQ is an OD 350 formulation; the results of the in vitro study can be used for the current risk assessment).

The results show that dermal absorption for human skin is 0.3% for the concentrate and 8% for the spray dilution.

 

4.3 Available toxicological data relating to non-active substances (IIIA 7.4)

Other formulants: no reason for toxicological concern.

 

4.4 Exposure/risk assessments

 

Overview of the intended uses

An application was submitted for the authorisation of the plant protection product
ADMIRE O-TEQ, an insecticide based on the active substance imidacloprid.

ADMIRE O-TEQ is an OD formulation (oil dispersion) and contains 350 g/L imidacloprid.

The formulation is applied by:

- mechanical upwards spraying (apple/pear)

- drip treatment (eggplant, gherkins, courgettes, cucumber, tomato, red pepper, sweet pepper, floriculture crops): only exposure during mixing/loading

- downwards spraying in the greenhouse (floriculture crops, flower bulbs and bulb flowers, tree nursery crops and perennials; this is however calculated with the Dutch greenhouse model for up- and downwards spraying)

- mechanical downwards spraying (open field culture of floriculture crops, flower bulbs and bulb flowers, tree nursery crops and perennials). For the culture of chicory, the application is by spray treatment in the seed drill. As a worst-case, the exposure is estimated with the model for mechanical downwards spraying open field.

- dip treatment (flower bulbs and bulb flower crops). The dipping fluid contains 80 ml formulation per 100 L water. Dipping of the bulbs occurs shortly before planting of the bulbs or before storage of the bulbs. Planting of the flower bulbs occurs automatically. The operator can only be exposed to ADMIRE O-TEQ during mixing/loading of the dipping fluid (the packing cases with bulbs are placed in and out the dipping unit with a lift truck). Therefore, a risk assessment is performed for the operator during mixing/loading. A realistic estimate is that per day a maximum amount of 1200 L dipping fluid is prepared by the operator.

- brush application (hop). No exposure model available. Most relevant model is the biocide model 2 (for dermal exposure) and model 3 (for respiratory exposure) of the section consumer product painting, a model for the painting of sheds and fences. Since this model is worst-case for the brush application in hop and since the exposure during mixing and loading (90 ml formulation in 1.5 L water) will be low, no exposure calculation is performed for mixing/loading.

 

The formulation is applied 1-3 times per year with a spray interval of at least 7 days. Therefore, a semi-chronic exposure duration is applicable for the operator (contract workers included).

 

AOEL for the worker:

ADMIRE O-TEQ is applied only 1-3 times per year. Imidacloprid is taken up by the crop very fast. Furthermore, Admire is rapidly absorbed, distributed and excreted in the rat. Therefore, also for the worker a semi-chronic AOEL is applicable.

 

Calculation of the AOEL

Imidacloprid is not yet included in Annex I of 91/414/EEC. This means that The Netherlands may calculate the AOEL according to the Dutch method. This method takes into account the caloric need of the studied species and results in a more specific value than the EU-AOEL for which a standard factor of 100 is applied.

 

The calculation of the systemic AOEL for semi-chronic exposure is based on the overall NOAEL of 15 mg/kg bw/day in the short-term studies in rats and dogs (taking into account the dose-spacing in the short-term studies, this is the most relevant NOAEL).

Safety factors are used to compensate for the uncertainties, which arise from for example extrapolation from the tested species to humans and the differences between experimental circumstances, and to ensure that at the acceptable exposure level no adverse health effects will occur.

 

Used factors are:

extrapolation rat man on basis of caloric need: 4

other interspecies differences: 3

intraspecies differences: (professional use) 3

biological availability via oral route: 92%

weight of professional operator/worker: 70 kg

 

AOELsystemic: 15 x 0.92 x 70 / (4 x 3 x 3) = 27 mg/day

 

 

4.4.1 Operator exposure/risk

Exposure to imidacloprid during mixing and loading and application of ADMIRE O-TEQ is estimated with models. The exposure is estimated for the unprotected operator. In the Table below the estimated internal exposure is compared with the systemic AOEL. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and application have to be combined.

 

Table T.1 Internal operator exposure to imidacloprid and risk assessment for the use of ADMIRE O-TEQ

 

Route

Estimated internal exposure (mg /day)

Systemic

AOEL

(mg/day)

Risk-index a

Mechanical upward spraying on apple and pear b

Mixing/

Loading

Respiratory

<0.01

27

<0.01

Dermal

0.04

27

<0.01

Application

Respiratory

0.02

27

<0.01

Dermal

3.83

27

0.1

 

Total

3.9

27

0.1

Drip treatment in the protected culture of eggplant, gherkins, courgettes, cucumber, tomato, red pepper, sweet pepper and floriculture crops (only exposure during mixing/loading) b

Mixing/

Loading

Respiratory

<0.01

27

<0.01

Dermal

0.02

27

<0.01

 

Total

0.02

27

<0.01

Manual up-and downward spraying in the protected culture of gerbera and chrysanthemum, flower bulbs and bulb flowers, tree nursery crops and perennials c

Mixing/

Loading/

Application

Respiratory

0.08

27

<0.01

Dermal

1.34

27

0.05

 

Total

1.4

27

0.05

 

 

Mechanical downward spraying (open field) on floriculture crops, flower bulbs and bulb flowers, tree nursery crops and perennials, and chicory b

Mixing/

Loading

Respiratory

<0.01

27

<0.01

Dermal

0.05

27

<0.01

Application

Respiratory

<0.01

27

<0.01

Dermal

0.2

27

0.01

 

Total

0.25

27

0.01

Dipping of flower bulbs b

Mixing/

Loading

Respiratory

<0.01

27

<0.01

Dermal

0.02

27

<0.01

 

Total

0.02

27

<0.01

Brush application in hop e

Application

Respiratory

0.4

27

0.01

Dermal

8.1

27

0.3

 

Total

8.5

27

0.3

a The risk-index is calculated by dividing the internal exposure by the systemic AOEL.

b External exposure was estimated by EUROPOEM. Internal exposure was calculated with:

biological availability via the dermal route: 0.3% for the concentrate; 8% for the spray dilution (see 4.2)

biological availability via the respiratory route: 100% (worst case)

c External exposure was estimated by the Dutch greenhouse model.

d External exposure was estimated by the Dutch model.

e External exposure was estimated by the biocide model 2 and 3 of the section consumer product painting

 

4.4.2 Bystander exposure/risk

The bystander exposure is only a fraction of the operator exposure. Based on the low risk-index for the operator, no exposure calculations are performed for bystanders.

 

4.4.3 Worker exposure/risk

Since imidacloprid is taken up by the crops very fast and a negligible amount will be present on the crops, the exposure estimates below for the worker can be regarded as worst-case.

 

Re-entry activities with intensive contact with the treated crop can be expected in the culture of apple, pear, and floriculture crops.

 

The exposure is estimated for the unprotected worker. In the Table below the estimated internal exposure is compared with the systemic AOEL.


Table T.2 Internal worker exposure to imidacloprid and risk assessment after application of ADMIRE O-TEQ

 

Route

Estimated internal exposure (mg /day)

Systemic

AOEL

(mg/day)

Risk-index c

Re-entry activities in apple and pear a

 

Respiratory

-

27

-

Dermal

1.13

27

0.04

 

Total

1.13

27

0.04

Re-entry activities in floriculture crops b

 

Respiratory

0.03

27

<0.01

Dermal

0.6

27

0.02

 

Total

0.63

27

0.02

a External dermal exposure was estimated by EUROPOEM II (DFR module). There is no model available for exposure by the respiratory route. Internal exposure was calculated with:

biological availability via the dermal route: 8% (see 4.2)

b External exposure was estimated by Dutch greenhouse model. Internal exposure was calculated with:

biological availability via the dermal route: 8% (see 4.2)

biological availability via the respiratory route: 100% (worst case)

c The risk-index is calculated by dividing the internal exposure by the systemic AOEL.

 

4.4.4 Re-entry

See 4.4.3 Worker exposure/risk.

 

Overall conclusion of the exposure/risk assessments of operator, bystander, and worker

The product complies with the Uniform Principles.

 

Operator exposure

Based on the risk assessment it can be concluded that no adverse health effects are expected for the unprotected operator after dermal and respiratory exposure to imidacloprid as a result of the application of ADMIRE O-TEQ in apple, pear, eggplant, gherkins, courgettes, cucumber, tomato, red pepper, sweet pepper, floriculture crops, flower bulbs and bulb flowers, tree nursery crops, perennials, hop, and chicory.

 

Bystander exposure

Based on the risk assessment it can be concluded that no adverse health effects are expected for the unprotected bystander due to exposure to imidacloprid during application of Admire
O-Teq
in apple, pear, eggplant, gherkins, courgettes, cucumber, tomato, red pepper, sweet pepper, floriculture crops, flower bulbs and bulb flowers, tree nursery crops, perennials, hop, and chicory.

 

Worker exposure

Based on the risk assessment it can be concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure during re-entry activities in apple, pear and floriculture crops due to exposure to imidacloprid after application of Admire
O-Teq
.


 

4.5 Appropriate mammalian toxicology and operator exposure end-points relating to
the product and approved uses

See List of end-points.

 

4.6 Data requirements

Based on this evaluation no additional data requirements are identified.

 

4.7 Combination toxicology

ADMIRE O-TEQ contains only one active substance and it is not described that it should be used in combination with other formulations.

 

4.8 Mammalian toxicology classification and labelling

 

Proposal for the classification of the active ingredient (symbols and R phrases)
(EU classification)

 

Symbol:

Xn

Indication of danger: harmful

 

Risk phrases

R22

Harmful if swallowed

 

 

Proposal for the classification and labelling of the formulation concerning health

 

Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labelling of the preparation is proposed:

 

 

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

Xn

Indication of danger:

Harmful

R phrases

22

Harmful if swallowed.

 

36/38

Irritating to eyes and skin.

 

43

May cause sensitisation by skin contact.

S phrases

36/37

Wear suitable protective clothing and gloves.

 

46

If swallowed, seek medical advice immediately and show this container or label.

Special provisions:
DPD-phrases3

-

-

 

 

 

Plant protection products phrase:
DPD-phrase

DPD01

To avoid risk for man and the environment, comply with the instructions for use

Child-resistant fastening obligatory?

n.a.

Tactile warning of danger obligatory?

n.a.

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

S24 is not assigned as this safety-phrase is not obligatory in combination with the risk-phrases assigned

S46 is assigned by the CTB to formulations classified with R22 and R36/38 when this does not lead to more than six safety-phrases.

S36 is concomitantly assigned by the CTB to formulations classified with R43.

Other:

-

 

5.                  Residues

 

List of End-points

 

Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)

Plant groups covered

Apple, corn cotton, eggplant, potato, tomato, tobacco, rice, sugar beet

Rotational crops

Chard, wheat, red beet

Plant residue definition for monitoring

Sum of imidacloprid and its metabolites imidacloprid-5-hydroxy (M1) and imidacloprid-olefine (M6), expressed as imidacloprid

Plant residue definition for risk assessment

Sum of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as imidacloprid

Conversion factor (monitoring to risk assessment)

None.

The residue definition for monitoring covers more than 80 % of the total residue. A conversion factor is therefore not considered neccessary.

 

Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)

Animals covered

Lactating goat, laying hen

Animal residue definition for monitoring

Sum of imidacloprid and its metabolites imidacloprid-5-hydroxy (M1) and imidacloprid-olefine (M6), expressed as imidacloprid

Animal residue definition for risk assessment

Sum of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as imidacloprid

Conversion factor (monitoring to risk assessment)

None.

The residue definition for monitoring covers more than 80 % of the total residue. A conversion factor is therefore not considered neccessary.

Metabolism in rat and ruminant similar (yes/no)

yes

Fat soluble residue: (yes/no)

no

 

Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)

 

 

Residues in succeeding crops do not exceed 0.01 mg/kg

 

Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)

 

 

Wheat grain, wheat forage, wheat straw, cotton seed, tomato, cauliflower, lettuce, orange whole fruit, orange dried pulp, orange juice, orange oil, sugar beet root, sugar beet leaf, barley grain, barley forage, barley straw, sunflower seed, hops green cone, hops dried cone >24 months


Milk, fat (bovine), kidney (bovine), egg, liver (poultry), muscle (poultry) >12 months

Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)

Intakes by livestock 0.1 mg/kg diet/day:

Ruminant:

yes

Poultry:

yes

Pig:

no

Muscle

0.001

0.00014

-

Liver

0.0053

0.001

-

Kidney

0.0032

-

-

Fat

0.0006

0.00005

-

Milk

0.0015

-

-

Eggs

-

0.00035

-

 

Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)

Crop/processed crop

Number of studies

Transfer factor imidacloprid total

% Transference

Apple/washed

Apple/juiced

Apple/sauce

Apple/dried

Apple/pomace, wet

Apple/pomace, dry

Tomato/washed

Tomato/preserve

Tomato/juice

Tomato/ketchup

Tomato/puree

Tomato/paste

Tomato/pomace, wet

Tomato/pomace, dry

Citrus fruit/pulp

Citrus fruit/peel

Citrus fruit/juice

Citrus fruit/marmalade

Citrus fruit/oil

Citrus fruit/molasses

Citrus fruit/pulp, dried

Grape bunches/must

Grape bunches/wine

Grape bunches/washed berries

Grape bunches/juice

Grape bunches/retentate

Grape bunches/pomace, wet

Grape bunches/pomace, dry

Grape bunches/raisin

3

5

4

2

1

3

1

1

3

2

2

3

2

2

3

3

4

2

1

1

1

4

4

2

3

2

5

1

2

0.9

0.656

0.75

0.865

1.6

5.2

2.09

0.91

1.37

1.8

2.3

5.73

1.54

4.3

0.31

2.78

0.28

0.625

0.26

6.47

7.47

1.53

1.17

<0.5

0.73

<0.5

2.23

4.3

1.05

90

56

 

46

60

 

 

 

 

 

 

 

 

 

 

<1

 

<1

21

49

 

 

 

94

 

1

9

12

* Calculated on the basis of distribution in the different portions, parts or products as determined through balance studies

 

Comments on/additions to List of End-points

NL provided comments to the draft assessment report of imidacloprid and its list of end points. Since it was observed in the metabolism studies that parent + M01 + M06 varies from 30-60% of total extractable residues, and most of the metabolites contain the 6-chloropyridinyl moiety, a conversion factor is proposed for the residue definition for risk assessment. However, at the moment in the current residue trials the total residue containing the 6-chloropyridinyl moiety is still determined, so a conversion factor is not necessary for these residue data.

 

5.1 Summary of residue data

 

5.1.1 Metabolism in plants

Metabolism was investigated in apple, corn, cotton, eggplant, potato, tomato, tobacco, rice, and sugar beet in seed/soil treatment or foliar application. Metabolism was found to be identical in the different crop groups with parent imidacloprid, metabolite M01 and metabolite M06 being the main residue.

 

5.1.2 Metabolism in livestock

Metabolism was investigated dairy goat and laying hen. Metabolism was found to be similar in both species and in rat, so no pig study is required.

 

5.1.3 Residue definition (plant and animal)

The proposed residue definition is parent imidacloprid + metabolite M01 + metabolite M06, expressed as imidacloprid (monitoring, all crops). In the Netherlands all metabolites containing the 6-chloropyridinyl moiety are included in the residue definition for risk assessment.

 

The proposed residue definition is parent imidacloprid + metabolite M01 + metabolite M06, expressed as imidacloprid (monitoring, all animal products). In the Netherlands all metabolites containing the 6-chloropyridinyl moiety are included in the residue definition for risk assessment.

 

 

5.1.4 Stability of residues

Potato is a watery matrix. Storage stability was proven for at least 24 months is watery matrices. For animal products, storage stability was proven for 12 months. See List of End points.

 

5.1.5 Residue data

For this national authorisation request, trials were provided already evaluated for the authorisation of Admire and Gaucho Tuinbouw.

 

apple and pear (pome fruit)

Twelve trials were provided performed with apple: 9 trials are acceptable, 6 of them since they were performed according to cGAP-NL and 3 since they were performed with an overdose, however, their residue levels overlapped with the 6 other trials. Residues were determined from 1-30 DAT. The highest residue values were used to calculate the MRL:

2x<0.05, 0.06, 2x0.07, 0.08, 0.09, 0.11 mg/kg. Trials with apple can be used for extrapolation to pear.

MRL = 0.2 mg/kg, STMR = 0.07 mg/kg and HR = 0.11 mg/kg.  

 


cucumber, courgette, gherkin

Twelve trials were provided performed with cucumber: 6 with drip irrigation and 6 with plant sticks. Eight of the trials were according to cGAP-NL. Residues were determined from
1-30 DAT. The highest residue values were used to calculate the MRL:

0.16; 0.18; 0.20; 0.23; 0.25; 0.31 en 2x0.39 mg/kg.

Trials with cucumber can be used for extrapolation to gherkin and courgette.

MRL = 0.5 mg/kg, STMR = 0.24 mg/kg and HR = 0.39 mg/kg.  

 

tomato and eggplant

Twelve trials were provided performed with tomato: 6 with drip irrigation and 6 with plant sticks. Trials were 50-100% overdosed compared to cGAP-NL when expressed in g ai/ha. However, expressed in mg ai/plant, trials fitted tot the cGAP-NL (the plant density was somewhat higher than usual). Residues were determined from 1-30 DAT. The highest residue values were used to calculate the MRL:

2x0.05; 0.07; 2x0.07; 0.08; 2x0.11; 2x0.14; 0.15 en 0.16 mg/kg.

Trials with tomato can be used for extrapolation to eggplant.

MRL = 0.3 mg/kg, STMR = 0.08 mg/kg and HR = 0.16 mg/kg.  

 

sweet pepper and spanish pepper

Six trials were provided performed with sweet pepper: 4 with drip irrigation and 2 with plant sticks. Trials were according to cGAP-NL. Residues were determined from 1-63 DAT.

The highest residue values were used to calculate the MRL:

0.15; 0.16; 2x0.17; 0.24 en 0.27 mg/kg.

Trials with sweet pepper can be used for extrapolation to spanish pepper.

MRL= 0.5 mg/kg, STMR = 0.17 mg/kg, HR = 0.27 mg/kg

 

hops

Four trials were evaluated before. It was concluded that the trials were not performed with the right application method (brushing in stead of rubbing). However, the trials were performed with 0.14 kg/ha with a plant density of 4000 plants/ha. This is considered to be an overdose compared the application request (0.027 kg/1000 shoots, applied only locally).

Selected residue data:

4x<0.05 mg/kg (fresh, 4x<0.2 mg/kg (dry).

MRL= 0.2* mg/kg, STMR = 0.2 mg/kg, HR = 0.2 mg/kg

 

5.1.7 Residues from livestock feeding studies

Livestock feeding was evaluated in the draft assessment report. For the Dutch authorisation of AMIGO, the intake of residues via intake of potato was already included in the total livestock dietary burden of imidacloprid. MRLs were already set and are therefore still valid.

 

5.1.9 Calculation of the ADI and the ARfD

The ADI and ARfD were taken from the most recent list of end points on Human Toxicology, d.d. December 2005.

 

The ADI was based on the NOAEL of 6 mg/kg bw/d from de 2-y dietary study with rats giving rise to effects on increased incidence of follicular colloid mineralisation in the thyroid at the near higher dose group of 17 mg/kg bw/d. Using a safety factor of 100, the ADI was established at 0.06 mg/kg bw/d.

 

The ARfD was based on the NOAEL of 40 mg/kg bw/d from the acute neurotoxicity study with rats and the 28-d, 90-d and 1-y dietary study with dogs, based on tremors at the near higher dose group of 70 mg/kg bw/d. Using a safety factor of 100, the ARfD was established at
0.4 mg/kg bw/d.

 

 

5.2 Maximum Residue Levels

Imidacloprid is an existing active substance with national MRLs. The crop groups for which authorisation is requested are already assessed before for the formulation Admire and Gaucho Tuinbouw. The product complies with the national MRL directive, except for hops. An MRL off 0.2 mg/kg should be adopted for the Regeling Residuen for the product hops.

Notification of the MRL is not necessary, awaiting the harmonisation of MRLs after Annex I inclusion.

 

 

5.3 Consumer risk assessment

Risk assessment for chronic exposure through diet

Based on the proposed residue tolerances, a calculation of the National Theoretical Maximum Daily Intake (NTMDI) was carried out using the National Dutch diet and the Dutch MRLs. Calculation of the NTMDI shows that 6.5% and 14.6% of the ADI is used for the general population and for children, respectively.

 

Risk assessment for acute exposure through diet

A calculation of the National Estimated Short Term Intake (NESTI) was carried out using the National Dutch diet (large portion sizes; 97,5 percentile from dietary data), the UK unit weights and previously mentioned MRLs. Calculation of the NESTI shows that 7.9% and 17.1% of the ADI is used for table grapes for the general population and for for oranges for children of 1-6y, respectively.

 

 

Conclusion

Authorisation of ADMIRE O-TEQ on the requested crops will not result in any unacceptable risk from intake of imidacloprid to consumers. ADMIRE O-TEQ can be authorised for the requested claims.

 

5.4 Data requirements

-

 

 

6.                  Environmental fate and behaviour

In the Dutch Pesticide Law the Uniform Principles are implemented in the Regulation of Uniform Principles for Plant protection products (BUBG). This Regulation is also the legal basis for the Dutch specific criteria.

 

List of Endpoints Fate/behaviour

Fate and Behaviour in the Environment of imidacloprid

 


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Mineralisation after 100 days

Investigated: pyridinyl-14C-methylene labelled imidacloprid

Loamy sand: 10 % after 100 days (study end)
Silt loam 6.4 % after 100 days (study end)

Sandy loam: 3.3 % after 100 days
7.4 % after 366 days (study end)

Sandy loam: 2.7 % after 100 days
4.9 % after 366 days (study end)

Sandy loam: 16.6 % after 91 days

20.3 % after 126 days (study end)

Non-extractable residues after 100 days

Investigated: pyridinyl-14C-methylene labelled imidacloprid

Loamy sand: 21.6 % after 100 days (study end)
Silt loam 21.5 % after 100 days (study end)

Sandy loam: 16.6 % after 100 days
23.0 % after 366 days (study end)

Sandy loam: 25.0 % after 100 days
39.5 % after 366 days (study end)

Sandy loam: 26.9 % after 91 days

28.1 % after 126 days (study end)

Relevant metabolites - name and/or code, % of applied (range and maximum)

Investigated: pyridinyl-14C-methylene labelled imidacloprid

In all studies (soils see above): 7 metabolites
NTN33893-olefin (1.8 % TAR after 100 d), NTN33893-ring-open-nitroguanidine (max. 3.4 % TAR after 77 d) and NTN33893-desnitro (1.6 % TAR after 201 d).

 

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Anaerobic degradation

no study conducted, reference to anaerobic water/sediment study (see saturated zone)

Soil photolysis

Investigated: pyridinyl-14C-methylene labelled imidacloprid in sandy silt loam/sandy loam. Continuous irradiation 15 d, Xenon lamp, 3,24x1017 photon/sec., 25 C:
DT50:38.9 d, best fit according to Timme and Frehse, formal 2nd order; normalised to sun light, and natural conditions , 40N: 171 days.

Recoveries in % of total applied radioactivity:

active substance: 58.5-103 % at all sampling dates; 61.5 % after 15 days (study end)

metabolites: max. 6.3 % after 15 days (NTN33893-5-hydroxy), other metabolites < 5 %, 2 unknown 2,2 %; 1.3 % TAR

 

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Method of calculation

Lab. DT50 aerob:
Imidacloprid, best fit and 1st order, and standardised to field capacity according to FOCUS

Laboratory studies (range or median, with n value,

with r2 value)

DT50lab (20 C, aerobic): measured at 40 % WHC

best fit 1st order

Loamy sand 188 d (2nd order) 154

Silt loam 248 d (2nd order) 193

Sandy loam 341 d (sqrt 1st order) 186

Sandy loam 77 d (sqrt 1st order) 106

geometric mean: 187 d 156 d

1st order fit standardised to field capacity (according to FOCUS):

Loamy sand 128.4 d

Silt loam 129.3 d

Sandy loam 117.0 d

Sandy loam 98.9 d

geometric mean DT50lab: 117.7 d

 

DT90lab (20 C, aerobic): not determined

 

DT50lab (10 C, aerobic): calculated from 1st order 20 C values using Q10 of 2.2
Loamy sand 339 d

Silt loam 425 d

Sandy loam 409 d

Sandy loam 233 d

geometric mean DT50lab: 343 d

 

DT50lab (20C, anaerobic):

not determined, reference to anaerobic water/sediment study (saturated zone)

Degradation in the saturated zone

Degradation in the saturated zone:

Investigated: pyridinyl-14C-methylene imidacloprid
anaerobic water/sediment-study

DT50lab (20C, anaerobic): 36 days total system

DT90lab (20C, anaerobic, calc. by RMS): 89 days total system, water 107 d /best fit, 1st order, Timme & Frehse)

parent: water: 11.8 % TAR after 120 days, < 0.1 % after 358 days (study end)
sediment: 16.8 % after 14 d, 1.4 % after 120 d, < 0.1 % after 358 days (study end)

metabolite NTN33893-desnitro:
water: 20 % TAR after 60 days, 14.3 % after 358 days (study end)
sediment: 2.2 % after 120 days, 1.5 % after 358 days (study end).

non-extracted: 16 % after 120 d, 22.6 % after 358 d.

Field studies (state location, range or median with

n value)

DT50f

DT50f (in days)
Investigated: imidacloprid 1st

Germany soil best fit order r

Swisttal Hohn silt loam 173 208 0.92

Swisttal Hohn silt loam 140 185 0.88

Burscheid-Hfchen silt loam 62 104 0.88

Burscheid-Hfchen silt loam 79 131 0.61

Kirchlauter sandy loam 142 178 0.82

Kirchlauter sandy loam 180 216 0.85

Worms loam 151 197 0.50

Worms loam 196 228 0.74

Laacher Hof sandy loam 119 152 0.81

Laacher Hof sandy loam 160 186 0.86

median (d) 147 186

Investigated: Confidor 200 SL

soil best fit 1st order

France silty loam 63 d 1 111

Italy silty clay 183 d 2 288

Italy loamy sand 28 d 1 40

Spain silty clay loam 77 d 1 116

geometric mean 71 d 110 d

1 square root 1st order

square root 1.5st order

 

normalised values according to FOCUS

 

location DT50 (d)

Kirchlauter-Pettstadt 85.8

Swisstal-Hohn 89.8

Hfchen 50.6

Worms-Heppenheim 94.3

Laacher Hof 86.0

Kirchlauter-Pettstadt 70.8

Swisstal-Hohn 98.2

Hfchen 41.0

Worms-Heppenheim 82.0

Laacher Hof 71.6

Bagnolo di Nogarole Rocca 179.8

St. Etienne du Gres 65.7

Ca Degli Oppi, Italy 27.0

Castellarnau 58.5

median 76.8

geometric mean 71.9

DT90f

DT90f : investigated: Confidor 200 SL

NE soil 1st order

sandy loam 717*)

sandy loam 591*)

silt loam 614*)

silt loam 690*)

silt loam 435*)

silt loam 345

loam 757*)

loam 654*)

sandy loam 618*)

sandy loam 504*)

geometric mean 578 d

 

SE soil 1st order

France silty loam 956*)

Italy silty clay 368

Italy loamy sand 133

Spain silty clay loam 385

geometric mean 366 d

*) extrapolated value, longer than study duration

Soil accumulation and plateau concentration

Study 1: Germany, apple orchards, 3 test sites, duration 6 years, silt loam (1)/ silty clay (2)/sandy loam (3), annual application rate nearly 105 g as/ha directly onto ground.

measured (g as/kg) residue after last application (6 years) 0-10 cm soil layer:

max min after ~1 year

site 1 55.4 (day 0) 23.2 (day 180) 23.3 (364 d)
site 2 77.1 (day 0) 20.0 (day 80) 34.5 (356 d)

site 3 44.6 (day 0) 20.5 (day 175) 23.1 (357 d)

soil layer 20-30 cm: generally < 6 g as/kg (LOQ)

 

Study 2, Great Britain, seed dressing of winter barley. 2 study sites, sandy loam, duration 6 years, application rate 56/133 g product (Zelmone 350FS)/ha, soil was cultivated to a depth of 19cm

measured (g as/kg) residue after last harvest (6 years appl.) 0-10 cm soil layer 10-20 cm soil layer

site 1 31.4/49.4 18.5/38.2
site 2 17.8/36.3 16.2/29.8

soil layers 20-50 cm: 2 g as/kg soil (LOD)

Soil adsorption/desorption (Annex IIA, point 7.1.2)

Kf /Koc

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Imidacloprid: Koc 109 411, arithmetic mean 225 (n=10)

soil pH Koc Kf 1/n

Sand 5.1 411 0.956 0.783

(98.7 % sand, 0.3 % silt, 1.0 % clay, 0.23 % org .C.)

Sandy soil, low humus 5.6 157 1.17 0.77

(87.8 % sand, 8.7 % silt, 3.5 % clay, 0.75 % org. C.)

Sandy loam 5.2 256 3.59 0.744

(67 % sand, 27 % silt, 6 % clay, 1.4 % org. C.)

Sandy loam 5.7 153 1.83 0.888

(68.3% sand, 24.5 % silt, 7.2 % clay, 1.2 % org. C.)

Sandy loam 6.4 235 3.17 0.782

(72.4% sand, 22.6 % silt, 5.0 % clay, 1.35 % org. C.)

Sandy loam 6.4 109 1.52 0.783

(72.4% sand, 22.6 % silt, 5.0 % clay, 1.4 % org. C.)

Sandy loam 5.6 165 2.14 0.786

(71.6% sand, 21.5 % silt, 6.9 % clay, 1.3 % org. C.)

Loamy sand 4.5 292 1.02 0.878

(79.3 % sand, 15.5 % silt, 5.5 % clay, 0.35 % org.C.)

Silt loam 5.8 277 4.18 0.775

(29.3 % sand, 51.3 % silt, 19.5 % clay, 1.51 % org.C.)

Silt soil 5.3 132 2.38 0.827

(2 % sand, 89 % silt, 9 % clay, 1.8 % org.C.)

Silty clay 7.4 212 1.36 0.851

(15 % sand, 42.3 % silt, 42.7 % clay, 0.64 % org.C.)

Loam 6.5 296 3.45 0.755

(29.3 % sand, 47.2 % silt, 23.5 % clay, 1.16 % org.C.)

arithmetic mean, n=12 22587 0.80

median 212

 

Kd

pH dependence (yes / no) (if yes type of

dependence)

-

 

no

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching

 

Studies regarded as not valid, not relevant for the assessment. Lysimeter studies are of higher relevance.

Aged residues leaching

 

Guideline: BBA IV 4-2, pyridinyl-14C-methylene imidacloprid. 30 and 90 day ageing in the dark, 22 C, 40 % WHC, Application rate 200 g as/ha. Height 14.5 cm.

Soil: Monheim I, sandy loam soil (1.27 % Corg, pH 5.2, biomass 264 mg microbial carbon/kg soil at test start).

and BBA 2.1 (slightly humous sand, 0.75 % Corg, pH 5.6, 146 - 264 mg microbial carbon/kg soil at test start

Percolation 393 mL/48 h.

30 d ageing: < 3 % of applied radioactivity in eluate

90 d ageing: < 2 % of applied radioactivity in eluate

Imidacloprid remained mainly in upper column segment: Monheim I, 90 d: 98.3 % of applied radioactivity
BBA 2.1, 30 d: 71.4 % segment 1, 28.6 % segment 2

BBA 2.1, 90 d: 70.6 % segment 1, 20.7 % segment 2.

 

Guideline EPA 163-1

Pyridinyl-14C-methylene imidacloprid. 4 different soils

30 day ageing in the dark, 22 C, 40 % WHC, Application rate 250 g as/ha. Height 30 cm.

Soils:

sandy loam #411 (75 % sand, 9 % clay, 0.93 % Corg, pH 6.2), fine sand #396 (98.7 % sand, 1 % clay, 0.12 % Corg, pH 5.1); silty clay loam Illinois #413 (22.7 % sand, 51 % silt, 26 % clay, pH 6.2, Corg 1.92); silty clay loam Kansas #414 (17 % sand, 41 % silt, 42 % clay, pH 5.6, Corg 1.22). Percolation 1200 mL/55 h.
Percent of applied radioactivity in leachates:

sand #396: 64 %

sandy loam #411: 0.8 %

silty clay loam #413: 0.4 %

silty clay loam #414 dry packed: 9.3 %

silty clay loam #414 moist packed: 3.6 %

 

Mobility depends on the soil type.

Imidacloprid remained mainly in upper column segments (0-15 cm) of soils containing loam. In soils with high sand content, distribution through column:
Percent of applied radioactivity in aged soil layer and per 5 cm segment:

sandy loam #411: 16.5/24.1/25.5/19.0/3.2 %

silty clay loam #413: 22.6/43.9/18.4/2.7 %

silty clay loam #414 dry packed:
21.6/14.4/17.2/12.6/ 8.5/6.9 %

silty clay loam #414 moist packed:
18.7/34.6 segment 1+2) /19.0/11.9/4.8 %

sand #396: 13.1 % aged layer, 10.6 % (10-15 cm)/ 11.9 % (20-25 cm)

Lysimeter/ field leaching studies

 

3 lysimeter studies, Germany, soil: Laacherhof Monheim, sandy soil, lysimeter surface: 100 x 100 cm, depth 110 cm. 14C-methylene imidacloprid.

 

1. study: 2 lysimeters; application: 500 g as/ha on potato tubers already lying in their planting holes.
Cultural practice: potatoes/winter wheat/winter barley

Precipitation: 800 mm/year. Soil Monheim (72-78.3 % sand, 5.0-9.5 % clay. 0.18-1.35 % Corg, pH 6.9-7.1)

Leachate: distribution of radioactivity:

as-equivalents (g/L) eluate (L)

1st year 0.036/0.047 95.5/95.5

1st+2nd year 0.069/0.081 175.2/213.7

Neither parent compound nor any relevant metabolite was detected (LOQ 0.01 g/L).

In soil: after 2 years 54.6/57.5 % of applied radioactivity;
93 % of that in 0-20 cm soil layer. Extractable residues mainly as: 0.04 mg as/kg 0-20 cm layer; 0.0036 mg as/kg 20-30 cm layer. Below 30 cm as < LOD (0.5 g/kg).

 

2. study: 2 lysimeters, study duration 5 years, 2 application as seed treatment: 117 g as/ha (1991); 126 g as/ha (1994). Cultural practice: sugar beet/ winter wheat/ winter barley/ intermediate crop Phacelia/ sugar beet/ winter wheat/ winter barley.

Precipitation: 800 mm/year. Soil Monheim (71.8-79.4 % sand, 11.0-16.5 % silt, 9.7-11.8 % clay. 0.19-1.41 % Corg, pH 6.9-7.1): 0-60 cm sandy loam, 60-115 cm loamy sand.

Leachate: distribution of radioactivity:

as-equivalents

(g/L) mean eluate(L) mean

1st year 0.012/0.020 0.02 94.4/102.6 98

2nd year 0.040/0.091 0.07 231.5/218.0 225

3rd year 0.045/0.104 0.07 281.7/320.2 301

4th year 0.070/0.108 0.09 378.6/334.7 357

5th year 0.062/0.114 0.09 114.4/89.3 102

Neither parent compound nor any relevant metabolite was detected throughout the 5 years (LOQ 0.01 g/L).

In soil: after 5 years in 0-10, 10-20, 20-30 cm:
in lysimeter 1. 22.6/15.6/4.22 %TAR (0-30 cm 42.4 %)

in lysimeter 2. 21.7/14.0/4.26 %TAR (0-30 cm 39.96 %)

Extracted parent compound:
in % TAR: g as/kg fresh weight soil

0-10 cm 7.685/6.408 13.2/11.0

10-20 cm 5.590/5.611 9.5/9.6

20-30 cm 1.698/1.921 2.7/3.1

30-40 cm 0.323/0.501 0.5/0.8

40-50 cm 0.034/0.162 0.1/0.3

50-60 cm 0.005/0.094 < LOQ/0.1

60-70 cm < LOQ/0.019 < LOQ

< 70 cm < LOQ < LOQ

 

Residues in plants (total): 2.46 %/1.97 % TAR

Residues in leachates (total) 0.23 %/0.42 % TAR

Total recovery 47.01 %/46.22 % TAR

Loss (CO2 etc.) 52.99 %/53.78 % TAR

 

3. study: 2 lysimeters, study duration 2.5 years, 2 application as seed treatment: 90 g as/unit= 117 g as/ha (1996); 140 g as/ha (1997). Cultural practice: sugar beet/ winter wheat/ winter barley.

Precipitation: 841 mm/year. Soil Monheim (71.8-79.4 % sand, 11.0-16.6 % silt, 9.7-11.8 % clay. 0.19-1.41 % Corg, pH 6.05-6.42): 0-60 cm sandy loam, 60-100 cm loamy sand. 100-115 cm loamy sand.

Distribution of total recovered radioact. (TRR):

as-equivalents/ CO2

leachate (g/L) leachate (L) % TRR

1st year 0.018/0.026 133.3/146.7 43/31

2nd year 0.025/0.038 119.8/132.8 32/17

last 6 months 0.38/0.057 28.5/38.5 19/12

total 281.6/318.0

Imidacloprid and metabolites not analysed, since equivalent-conc. < 0.1 g/L.

 

In soil: predominant portion 86 %/89 % of total recovered radioactivity. (TRR) in 0-30 cm soil layer after 2.5 years:

TAR: 0-30 cm 47.6 %/ 45.53 %; 30-60 cm 6.75 %/ 4.6 %; < 60 cm 1.09 %/0.83 %

Besides as metabolites NTN33893-ring open nitro guanidine (Z1) and NTN33893-desnitro (Z2).

Extractable residues g/kg soil

as equivalents Z1 Z2

0-10 cm 15.2/13.3 3.3/2.8 1.6/1.2

10-20 cm 16.4/15.0 2.7/2.5 0.4/0.3

20-30 cm 4.7/4.3 0.3/0.3 <LOQ

30-40 cm 1.8/1.1 0.270.2 <LOQ

40-50 cm 0.9/0.4 0.1/0.1 <LOQ

50-60 cm 0.6/0.4 0.1/0.1 <LOQ

60-70 cm 0.2/< LOQ 0.1/<LOQ <LOQ

< 70 cm < LOQ/<LOQ <LOQ <LOQ

Residues in soil (total) 55.46 %/50.77 % TAR

Residues in plants (sum all crop): 3.67 %/3.95 % TAR

Residues in leachate (total) 0.02 %/0.04 % TAR

Total recovery 59.16 %/54.77 % TAR

Loss (CO2 etc.) 38.48 %/43.26 % TAR

 

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Hydrolysis of active substance and relevant metabolites (DT50) (state pH and temperature)

pH 5: stable at 25 , DT50 > 1 year

 

pH 7: stable at 25 , DT50 > 1 year

 

pH 9: slow hydrolysis at 25 , DT50 approximately 1 year

Photolytic degradation of active substance and

relevant metabolites

(1) Photolysis artificial light: in sterile water up to 120 min, pH 7, natural sunlight mimic, cut off 290 nm (SUN-TEST apparatus). Conc. 6.31 and 5.18 mg as/L

Tested: [pyridinyl-14C-methylene]-imidacloprid

Results:

- Imidacloprid: absorption coefficient e = 5714 L/Mole x cm at 295 nm and e = 20 L/Mole x cm at 363 nm, quantum yield 0.0142

- Imidacloprid: 28.7 % TAR after 120 min.

- DT50 57 minutes under test conditions
- Environmental DT50, latitude 50 (GC-solar)
spring 0.24 d
summer 0.17 d

- 10 longitude, 50 latitude (Frank & Klpffer)
April-summer 0.4 - 0.28 d
November-December 3.1 - 6.73 d

 

(2a) Photolysis artificial light: in sterile buffer solution pH 7 up to 120 min, natural sunlight mimic, cut off 290 nm (SUN-TEST apparatus). Conc. 5.4 mg as/L

Tested: [pyridinyl-14C-methylene]-imidacloprid

Results:

- Imidacloprid: 28.7 % TAR after 2 h

- Photo-transformation products after 2 h:
NTN33893-desnitro 17.2 % TAR
NTN33893- desnitro olefine 12.6 %
NTN33893-urea 9.8 %
others unknown 8.4 %
volatile degradates none

Photolysis natural sunlight: 4 and 7 h (greenhouse, Yuki, Japan). Conc. 10 mg as/L

Tested: [pyridinyl-14C-methylene]-imidacloprid

Results:

- Imidacloprid: 60 % was degraded after 4 hours

 

(2b) Photolysis artificial light, study for identification of metabolites, 21 h natural sunlight mimic, cut off 290 nm (SUN-TEST apparatus). Conc. 100 mg as/L:

Tested: [pyridinyl-14C-methylene]-imidacloprid

Results:

- 46.2 % of TAR assigned to parent and degradates
NTN33893- ring open guanidine 14.9 % in fraction
NTN33893-desnitro 11.0 % in fraction
NTN33893-urea minor amounts
6-chloro-nicotinic acid minor amounts

 

(2b) Photolysis artificial light, study for identification of metabolites, 21 h natural sunlight mimic, cut off 290 nm (SUN-TEST apparatus). Conc. 100 mg as/L:

Tested: [pyridinyl-14C-methylene]-imidacloprid

Results:

- 46.2 % of TAR assigned to parent and degradates
NTN33893- ring open guanidine 14.9 % in fraction
NTN33893-desnitro 11.0 % in fraction
NTN33893-urea minor amounts
6-chloro-nicotinic acid minor amounts

 

Readily biodegradable (yes/no)

Study not performed, thus considered not readily biodegradable

Dissipation in water/sediment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Dissipation in - DT50 water

water/sediment - DT90 water

 

- DT50 whole system

- DT90 whole system

 

- DT50 sediment

- DT90 sediment

 

 

 

 

- DT50 water (only degradation)

(1) Tested: [pyridinyl-14C-methylene]-imidacloprid,

application rate 2x335 g as/ha (=0.67 mg as/L 10 cm water body); 1 sediment type (Stillwell, Kansas, silty clay, 2.2 % sand, 50 % silt, 47.9 % clay, pH 7.62)

Water: hardness 9 DH=90 mg CaO equivalents.

EPA Guideline 162-4 1982

 

(2) Tested: [pyridinyl-14C-methylene]-imidacloprid,

application rate 1x200 g as/ha (=0.2 mg as/L 10 cm water body); 2 sediment types, 2 replicates (Ijzendoorn NL, loamy silt, 15.3 % sand, 69.7 % silt, 14.9 % clay, Corg 4.09, water pH 8.1-804; Lienden NL, loamy sand, 73.9 % sand, 16.8 % silt, 9.2 % clay, Corg 0.89,Water pH 8.1-8.9). EPA Guideline 162-4 1982

 

Imidacloprid as: (1st order), Standard tests (- no data)

Stillwell IJzendoorn Lienden

DT50,water > 30 d - -

DT90,water - - -

r - - -

DT50,system 129 d 32 d 142 d

DT90,system - - -

r - - -

DT50,sediment - - -

DT90,sediment - - -

r - - -

 

ModelMaker 4.0 (evaluation by RMS)

IJzendoorn Lienden

DT50,water as no degradation 138.8 d

DT50 sedimnet as 13.7 d no degradation

r 0.998 0.998

DT50,water no degradation no degradation
DT50,sediment no degradation no degradation

 

 

Model ecosystem with light

(3) Tested: [pyridinyl-14C-methylene]-imidacloprid,

application rate 2x335 g as/ha (1x=0.67 mg as/L 10 cm water body); 1 sediment type (Stillwell, Kansas, silty clay, 2.2 % sand, 50 % silt, 47.9 % clay, pH 7.62). Water: hardness 9 DH=90 mg CaO equivalents.).
Irradiation with sunlight 21 d, natural cycle; Xenon light 95 h in 21 d test duration, 141 h in 30 d test duration

Imidacloprid as: (1st order)

Stillwell/Light

Xenon light DT50,water < 5 d

Mineralisation rate 5.8 % at day 21 d

Natural sun light Mineralisation rate 9.8 % at day 21 d

 

Outdoor pond system

(4) Tested: Confidor SL200, 198 g as/L. Application rate 6 g as/L. Mesocosm: latitude N 51,Germany, Monheim. test duration 70 d. Sediment type Nespen Wiehltalsperre: silt loam, 23.4 % sand, 62.3 % silt, 14.2 % clay, Corg 4.1.

 

Natural light DT50,water approximately 7 d

Monheim (FRG) DT50,total system approximately 14 d

 

(5) Tested: Imidacloprid. Concentrations 0, 2, 6, 20, 180 g/L. Mesocosm: Denton, North Texas USA. Test duration 70 d. Sediment type: sandy loam, sandy clay loam, 62-78 % sand, 7-15 % silt, 8-24 % clay, Corg 0.6-1.4 %).

 

Natural light DT50,water 1.4 d

Texas (USA) DT50,sediment 14 d

 

(6) Tested: Confidor SL200 (17.3 % as). 2 spray application, resulting in nominal concentrations of 0.6, 1.5, 3.8, 9.4, 23.5 g as/L. Mesocosm: at Aachen, Germany. Test duration 70 d. Sediment type: Nespen Wiehltalsperre: silt loam, 24.3 % sand, 62.3 % silt, 12.4 % clay, Corg 3.4 %, pH 6.5).

 

Natural light DT50,water, after 2nd appl. 13 d

Aachen (FRG) DT50,total system 30 d

Mineralisation

Water/sediment studies

Study (1) after 30 d (study end) in % TAR: 0.7 %

Study (2) after 92 d (study end) in % TAR:
IJzendoorn 1.3/1.4 %; Lienden 1.4/2.5 %

 

 

Non-extractable residues

Water/sediment studies

Study (1) after 30 d (study end) in % TAR: 8.2 %

Study (2) after 92 d (study end) in % TAR:
IJzendoorn 66.4/66.1 %; Lienden 17.4/13.4 %

Distribution in water / sediment systems
(active substance)

 

Maximum values in sediment: (as in % TAR)

Study (1) after 7 d: 23.5 %

Study (2) IJzendoorn (IJ) after 14 d: 31.9 %

Study (2) Lienden (L) after 60 d : 13.6 %

 

Imidacloprid % total applied radioactivity (TAR)

days after ([pyridinyl-14C-methylene]-imidacloprid l)

applicat. (1) water (2)IJ/L (1) sediment (2)IJ/L

0 90.7 78.5/90.3 7.6 13.5/5.5

3 77.2 19.3

7 69.4 23.5

14 67.8 41.2/76.7 22.1 31.9/9.0

21 66.0 19.0

30/29(2) 64.0 26.8/68.1 20.4 22.8/9.4

60 9.8/64.8 13.6/10.3

92 5.1/52.8 6.6/8.9

 

Distribution in water / sediment systems (metabolites)

Maximum values: NTN33893-desnitro (in % TAR)

Study (1) after 7 d: water 2.4 %

after 7, 21, 30 d sediment 0.4 %

Study (2) IJzendoorn (IJ) after 92 d: water 6.0 %

after 92 d: sediment 6.3 %

Study (2) Lienden (L) after 92 d: water 4.5 %

after 92 d: sediment 4.3 %

 

NTN33893-desnitro % total applied radioactivity (TAR)

days after (as [pyridinyl-14C-methylene]-imidacloprid l)

applicat. (1) water (2)IJ/L (1) sediment (2)IJ/L

0 <0-1 < 0.1/<0.1 <0.1 < 0.1/<0.1

3 <0.1 0.1

7 2.4 0.4

14 0.9 0.8/0.7 0.3 1.1/1.2

21 1.4 0.4

30/29(2) 1.4 2.3/1.9 0.4 3.0/1.7

60 4.4/1.7 5.6/2.4

92 6.0/4.5 6.3/4.3

 

other metabolites in lower concentrations, max 3.8 % in water, 0.7 in sediment for 6-chloro-nicotinic acid:

NTN33893-PEDA; NTN33893-nitrosimine; NTN33893-urea; 6-chloro-nicotinic acid; 6-hydroxy-nicotinic acid

 

PEC (ground water) (Annex IIIA, point 9.2.1)

Method of calculation and type of study (e.g.

modelling, monitoring, lysimeter )

FOCUS-PELMO 3.3.2 modelling. Soil DT50 standardised 20 C, geometric mean from 4 laboratory studies 118 d; Koc 225 mL/g, 1/n = 0.8

Application rate

Annual rate: sugar beet seeds 117 g as/ha; apples 1st 70 g (BBCH 10) and 2nd 105 g as/ha (BBCH69/71), tomatoes 2 x 100 g as/ha, 14 d interval Apples and tomatoes: spraying (Confidor SL200), sugar beets: seed treatment (Gaucho FS600)

 


 

Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)

Direct photolysis in air

Study not performed - not measurable, due to low vapour pressure.

Quantum yield of direct phototransformation

criteria for the determination not reached
(A > 10 L/mol x cm), determination is not necessary.

Photochemical oxidative degradation in air

DT50 ..0.85 hours.
(calculation according to Atkinson 1987, 12 h daytime, 1.5 x 106 OH-radicals/cm)

24 h time period, 5 x 105 OH-radicals/cm DT50..2.54 h

Volatilisation

(field experiment in container arrangement, 1 m, apple seedlings). Methylene-14C labelled and formulated imidacloprid.

from plant surfaces:

No as evaporated from plant and soil surfaces within 24 h after application

 

from soil: no evaporation within 24 h

 

Definition of the Residue (Annex IIA, point 7.3)

Relevant to the environment

Relevant for quantitation (> 5 % at 2 sequential measurements during the soil and water/sediment study)

 

Soil : parent compound

Water: parent compound

Sediment parent compound

Ground water: parent compound

Air: parent compound

 

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study)

not available

Surface water (indicate location and type of study)

not available

Ground water (indicate location and type of study)

Germany, groundwater monitoring programme
Data from 4 Federal States

number

total <LOQ 0.1 >0.1-1.0 >1.0 g/L

2000 9 9 0 0 0

2001 23 22 1 0 0

2002 279 278 1 0 0

total 627 625 2 0 0

 

Air (indicate location and type of study)

not available

 

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data

R 53

 

Additional study: Spray drift and required crop-free buffer zones when applying Admire in nursery tree and plant, flower and bulb flower crops in the Netherlands (Zande, J.C. van de, Michielsen, J.M.G.P. and Stallinga, H.)

 

This study was summarised and evaluated by the CTB (05/2007)

 

Bufferzones were calculated in order to meet the standards for aquatic organisms. With these bufferzones, drift is reduced to 0.76% for nursery trees and plants, and flowers, and to 0.65% for Flowerbulbs. With these bufferzones, the expected concentration should be below 0.6 g/L (NOEC for aquatic organisms).

 

Substance

Application technique

Crop

Required minimum crop-free buffer zone [m]

 

 

 

Conventional*

Air-assisted*

Admire

Field sprayer with nozzle XR110-04

Nursery trees and plants

4.3

<1.5

Admire

Field sprayer with nozzle DG110-04

Nursery trees and plants

1.7

<1.0

Admire

Field sprayer with nozzle XLTD02-110/!D120-02

Nursery trees and plants

<1.5

<1.0

Admire

Field sprayer with nozzle XLTD04-110/!D120-04

Nursery trees and plants

<1.0

<1.0

Admire

Field sprayer with low boom height

Nursery trees and plants

2.0

<1.0

Admire

Field sprayer with low boom height

Nursery trees and plants

<1.0

<0.5

Admire

Field sprayer with Slpduk system

Nursery trees and plants

<1.0

x

Admire

Field sprayer with Slpduk system

Nursery trees and plants

<1.0

x

Admire

Field sprayer with nozzle XR110-04

Flowers

3.9

<0.5

Admire

Field sprayer with nozzle DG110-04

Flowers

1.3

<0.5

Admire

Field sprayer with nozzle XLTD02-110/!D120-02

Flowers

<0.5

<0.5

Admire

Field sprayer with nozzle XLTD04-110/!D120-04

Flowers

<0.5

<0.5

Admire

Field sprayer with low boom height

Flowers

1.55

<0.5

Admire

Field sprayer with low boom height

Flowers

<0.5

<0.5

Admire

Field sprayer with Slpduk system

Flowers

<0.5

x

Admire

Field sprayer with Slpduk system

Flowers

<0.5

x

Admire

Field sprayer with nozzle XR110-04

Flower bulbs

5.5

<1.5

Admire

Field sprayer with nozzle DG110-04

Flower bulbs

2.2

<1.0

Admire

Field sprayer with nozzle XLTD02-110/!D120-02

Flower bulbs

<1.5

<1.0

Admire

Field sprayer with nozzle XLTD04-110/!D120-04

Flower bulbs

<1.0

<1.0

Admire

Field sprayer with low boom height

Flower bulbs

2.5

<1.0

Admire

Field sprayer with low boom height

Flower bulbs

<1.0

<0.5

Admire

Field sprayer with Slpduk system

Flower bulbs

<1.0

x

Admire

Field sprayer with Slpduk system

Flower bulbs

<1.0

x

Admire

Tunnel sprayer for bed grown crops

Flower bulbs

<1.0

x

* If a value is indicated with <, it means that the calculated bufferzones are within the standard crop free zones applicable to the crop.

 

 

6.1 Fate and behaviour in soil

 

6.1.1 Persistence in soil

 

imidacloprid

The following laboratory DT50 values are available for the active substance(s) imidacloprid: 128, 129, 117 and 99 days (geomean 117.7 days). It can be excluded that after 100 days there will be more than 70% of the initial dose present as bound (non-extractable) residues together with the formation of less than 5% of the initial dose as CO2.

 

Due to the exceeding of the threshold value of 60 days for the mean DT50 (lab) for imidacloprid, it has to be demonstrated by means of field dissipation studies that the field DT50 is < 90 days. The following field data are provided: normalised values; 85.8, 89.8, 50.6, 94.3, 86, 70.8, 98.3, 41, 82, 71.6, 179.8, 65.7, 27 and, 58.5 days (geometric mean: 71.9/ median: 76.8).

 

From the results it is shown that the average field DT50 is < 90 days. Therefore, the standards for persistence as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG) are met.

 

PECsoil

The concentration of the a.s. in soil is needed to assess the risk for soil organisms (earthworms, micro-organisms). The PECsoil is calculated for the upper 5 cm of soil using a soil bulk density of 1500 kg/m3 and the normalised field DT50 value. See Table M.1 for input values and results.

 

 

Table M.1 PECsoil calculations (5 cm (and HotSpot))

Use

Substance

Rate

[kg a.s./ha]

Frequency

Fraction on soil

PECsoil

5 cm

[mg a.s./kg]

PECsoil

Hot spot

[mg a.s./kg]

Apples and pears

imidacloprid

0.105

2

0.2

0.054

 

Gerbera and chrysanthemum (greenhouse)

item

0.084

3

0.8

0.252

 

Floriculture (field)

item

0.084

2

0.8

0.173

 

Flowerbulbs and bulbflowers, (field)

item

0.07

3

0.8

0.210

 

Flowerbulbs and bulbflowers (protected)

item

0.07

3

0.8

0.210

 

Flowerbulbs and bulbflowers (dipping)

item

0.210

1

1

0.1401

 

Tree nursery and perennial (field)

item

0.084

2

0.8

0.173

 

Tree nursery and perennial (protected)

item

0.07

2

0.8

0.144

 

Chicory (spray treatment in seed drill)

item

0.0875

1

1

0.117

 

1 value assuming equal distribution over the top 10 cm of the total dose

2 value assuming no degradation in soil during cultivation phase and no transport into plants

3 concentration calculated assuming the total dose is equally distributed over the top 5 cm.

 

These exposure concentrations are examined against ecotoxicological threshold values in section 7.5.2. For applications on artificial soil and the application in hop no exposure of soil is expected.

6.1.2 Leaching to shallow groundwater

 

The leaching potential of the a.s. (and metabolites) is calculated in the first tier according to the RUUBG, using Pearl 2.2.2. and the FOCUS Kremsmnster scenario. The methodology as described in the report "The new decision tree for the evaluation of pesticide leaching from soils", A.M.A van der Linden, J.J.T.I. Boesten, A.A. Cornelese, R. Kruijne, M. Leistra, J.B.H.J Linders, J.W. Pol, A. Tiktak and A.J Verschoor, RIVM report 601450019/2004, RIVM, Bilthoven (2004) has to be used. Input variables are the actual worst-case application rate 0.175 kg/ha for different crops, the crop and an interception value appropriate to the crop (or no interception). The following input data are used for the calculation:

 

PEARL:

 

Active substance imidacloprid:

Mean DT50 for degradation in soil (20C): 117.7 days

Mean Kom (pH-independent): 130.5 L/kg

 

Saturated vapour pressure: 410-10 Pa (20C)

Solubility in water: 610 g/L (20C)

Molecular weight: 255.7 g/mol

Other parameters: standard settings of PEARL 2.2.2

 

Proposed use to artificial soil and the application to hop (nr. 2, 4 and 12) have no exposure to soil and therefore no leaching potential has to be calculated.

The following concentrations are predicted for the a.s. imidacloprid following spring and autumn applications for the other proposed uses, see Table M.2.

 

 

Table M.2(a) Leaching of a.s. imidacloprid as predicted by PEARL 2.2.2

 

Use

Rate substance

Freq

Interval

Fraction

intercepted

PEC

groundwater

PEC groundwater

 

[kg/ha]

 

[days]

 

spring

[mg/L]

autumn [mg/L]

Apples and pears

0.105

2

7

0.7

0.09

-

Gerbera and chrysanthemum; greenhouse use

0.084

3

7

0.7

0.048

0.053

Floriculture crops; field use

0.084

2

7

0.7

0.026

0.029

Flower bulbs & bulb flowers; field use

0.07

3

7

0.4

0.102

-

Flower bulbs & bulb flowers; protected use

0.07

3

7

0.4

0.102

0.113

Flower bulbs, bulb flowers (dipping)

0.336

1

 

-

0.446

0.535

Tree nursery crops; field

0.084

2

7

0.7

0.026

-

Tree nursery crops; protected

0.07

2

7

0.7

0.02

0.022

Chicory (spray treatment in seed drill)

0.0875

1

 

-

0.128

 

Results of Pearl 2.2.2. using the Kremsmnster scenario are examined against the standard of 0.01 g/l. This is the BUBG standard of 0.1 g/L with an additional safety factor of 10 for vulnerable groundwater protection areas (NL-specific situation).

 

From Table M.2(a) it reads that the expected leaching based on the PEARL-model calculations for the a.s. imidacloprid larger than 0.01 g/L but smaller than 0.1 g/L, except for the proposed use in flowerbulbs and bulbflowers, and chicory where concentration are >0.1 mg/L. As the predicted concentration for imidacloprid is larger than 0.01 g/L, a restriction on the use in groundwater protection areas should be placed on the label. Or further study into the leaching behaviour is necessary as is required for the use in flowerbulbs and bulbflowers, and chicory.

 

PEARL refined risk assessment

 

From field degradation studies normalised DegT50 values could be derived which can be used for groundwater modelling (checklist appendix 3 HTB 0.2). From the large dataset on sorption behaviour an arrhythmic mean value for Koc and 1/n can be used.

 

PEARL:

 

Active substance imidacloprid:

Geometric mean DegT50 for degradation in soil (normalised field value): 71.9 days

Mean Kom (pH-independent): 130.5 L/kg; 1/n: 0.8.

 

Saturated vapour pressure: 410-10 Pa (20C)

Solubility in water: 610 g/L (20C)

Molecular weight: 255.7 g/mol

Other parameters: standard settings of PEARL 2.2.2

 

Table M.2(b) Leaching of a.s. imidacloprid as predicted by PEARL 2.2.2

Use

Rate substance

Freq

Interval

Fraction

intercepted

PEC

groundwater

PEC groundwater

 

[kg/ha]

 

[days]

 

spring

[mg/L]

autumn [mg/L]

Apples and pears

0.105

2

7

0.7

<0.001

-

Gerbera and chrysanthemum; greenhouse use

0.084

3

7

0.7

<0.001

<0.001

Floriculture crops; field use

0.084

2

7

0.7

<0.001

<0.001

Flower bulbs & bulb flowers; field use

0.07

3

7

0.4

<0.001

-

Flower bulbs & bulb flowers; protected use

0.07

3

7

0.4

<0.001

<0.001

Flower bulbs, bulb flowers (dipping)

0.210

1

 

-

<0.001

<0.001

Tree nursery crops; field

0.084

2

7

0.7

<0.001

-

Tree nursery crops; protected

0.07

2

7

0.7

<0.001

<0.001

Chicory (spray treatment in seed drill)

0.0875

1

 

-

<0.001

-

From Table M.2(b) it reads that the expected leaching based on the refined PEARL-model calculations for imidacloprid is smaller than 0.01 g/L for all proposed applications. Hence, the applications meet the standards for leaching.

 

Lysimeter/field leaching studies

 

For the admission of the product Admire is in March 1997 a lysimeter study was submitted with an imidacloprid seed treatment. This study was evaluated under number 97/0469 by the RIVM and included in the RIVM reportnumber 0865a01. The concentration imidacloprid in the yearly leachate was <0.01 mg/L. A standardisation calculation of the study revealed a concentration of 0.0013 mg/L. A simulation error however could not be calculated correctly. Therefore extrapolation to the Dutch standard situation according to Verschoor et al. could not be done.

The lysimeter conditions however, were classified as vulnerable for soil and comparable to the Dutch situation for climatologic conditions. Because the amount of leachate in the first year was small there could have been enhanced biodegradation. This was however included in the simulation of the lysimeter. It must be considered here that the way of application in the lysimeter study is less representative for the proposed applications of ADMIRE O-TEQ.

 

Monitoring data

 

The active substance imidacloprid was observed in the groundwater [DAR]. In Table M.3 observed concentrations in the shallow groundwater are presented.

 

Table M.3 Monitoring data in groundwater

Location/year

Detection limit [mg/L]

a/n*

Mean conc. [mg/L]

Maximum conc. [mg/L]

Germany 2000

?

0/9

 

<LOQ

Germany 2001

?

1/23

 

0.1

Germany 2002

?

1/279

 

0.1

* number of observations above detection limit (a)/total number observations (n).

 

Monitoring results indicate that the substance imidacloprid was detected on some occasions. Concentrations do not exceed the limit for drinking water. Hence, the monitoring data confirm the predicted concentrations.

Conclusions

The proposed application of the product complies with the requirements laid down in the Regulation of Uniform Principles for Plant protection products (BUBG) concerning persistence and leaching in soil.

 

6.2 Fate and behaviour in water

 

6.2.1 Rate and route of degradation in surface water

The exposure concentrations of the active substance imidacloprid in the surface water are estimated for the various proposed uses using calculations of surface water concentrations (in a ditch of 30 cm depth), which originate from spray drift during application of the active substance. The spray drift percentage depends on the use. Concentrations in surface water are calculated using the model TOXSWA. For the active substance the following input is required (all on the basis of mean values):

 


 

TOXSWA:

Active substance:

DT50 for degradation in water at 20C: 113 days

DT50 for degradation in sediment at 20C: 10000 days (default).

 

Kom for suspended organic matter: 130.5 L/kg

Kom for sediment: 130.5 L/kg

 

Saturated vapour pressure: 410-10 Pa (temperature dependent)

Solubility in water: 610 mg/L (temperature dependent)

Molecular weight: 255.7 g/mol

 

Other parameters: standard settings TOXSWA

 

Because there is no standard method to determine separate degradation rates in water and sediment from the water/sediment study, the DT50 system is used for the water phase and degradation in the sediment is assumed to be zero, which is simulated using a DT50 value of 10000 days.

 

The proposed uses in drip treatment (2 and 4), dipping of flowerbulbs (9), hops (12), and chicory (14) are considered to have no potential for exposure of surface water.

In Table M.4, the drift percentages and calculated surface water concentrations for the active substance imidacloprid for each intended use are presented.

 

 

Table M.4 Overview of surface water concentrations for active substance and metabolite(s) following spring and autumn application

Use

Rate a.s.

[kg/ha]

Freq

Drift

[%]

PIEC

[mg/L] *

PEC21

[mg/L] *

PEC28

[mg/L] *

 

 

 

Spring

autumn

spring

autumn

spring

autumn

Apple & pear

0.105

2

7

6.7

-

6.0

-

5.5

-

Apple & pear**

0.105

2

1.5

1.42

-

1.26

-

1.06

 

Gerbera and chrysanthemum; greenhouse use

0.084

3

0.1

0.11

0.04

0.09

0.017

0.09

0.013

Floriculture crops; field use

0.084

2

1

0.76

0.40

0.78

0.11

0.73

0.08

Flowerbulbs, bulb flowers; field

0.07

3

1<