Toelatingsnummer 13004 N

Chrysal Plus  

 

13004 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 TOELATING

 

Gelet op de aanvraag d.d. 11 december 2006 (20060794 TG) van

 

Bayer CropScience B.V.

Energieweg 1

3641 RT  MIJDRECHT

 

 

 

tot verkrijging van een toelating als bedoeld in artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden (Stb. 2007, 125) voor de groeiregulator, op basis van de stof ethefon,

 

Chrysal Plus

 

gelet op artikel 23, eerste lid, Wet gewasbeschermingsmiddelen en biociden (Stb. 2007, 125),

 

 

BESLUIT HET COLLEGE als volgt:

 

§ I  Toelating

1.      Het middel Chrysal Plus is toegelaten voor de in bijlage 1 genoemde toepassingen onder nummer 13004 N met ingang van datum dezes. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

 

2.      De toelating geldt tot 1 januari 2018.

 

§ II  Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.

 

§ III  Gebruik

Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I onder A bij dit besluit is voorgeschreven.

 

§ IV Classificatie en etikettering

 

Gelet op artikel 29, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden,

 

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:

 

aard van het preparaat: Met water mengbaar concentraat

 

werkzame stof:

gehalte:

ethefon

480 g/l

 

 

op verpakkingen die (mede)  bestemd zijn voor huishoudelijk gebruik: het kca-logo

(het kca-logo is het logo voor klein chemisch afval bestaande uit een afvalbak met een kruis erdoor als opgenomen in bijlage III bij de genoemde Nadere regels)         

 

letterlijk en zonder enige aanvulling:

 

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

-

 

gevaarsymbool:

aanduiding:

Xi

Irriterend

N

Milieugevaarlijk

 

 

Waarschuwingszinnen: 

 

Gevaar voor ernstig oogletsel.

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

 

 

Veiligheidsaanbevelingen:

 

Niet roken tijdens gebruik.

Bij aanraking met de ogen onmiddellijk met overvloedig water afspoelen en deskundig medisch advies inwinnen.

Een bescherming voor ogen dragen.

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

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

Middel en/of oplossingen ervan niet met metaal in aanraking brengen.

 

Specifieke vermeldingen:

 

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

 

2.    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
.

 

 - 

 

2 DETAILS VAN DE AANVRAAG

 

2.1 Aanvraag

Het betreft een aanvraag tot toelating van het middel Chrysal Plus (13004 N), een middel op basis van de werkzame stof ethefon. Het middel wordt aangevraagd als groeiregulator na de oogst bij Tulipa.

 

2.2 Informatie met betrekking tot de stof

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

De stof ethefon is geplaatst op Bijlage I van Richtlijn 91/414/EEG (Richtlijn 2006/85/EG van de Commissie van 23 oktober 2006). De Europese einddatum van ethefon is 31 juli 2017.

 

2.3 Karakterisering van het middel

Chrysal Plus is een groeiregulator op basis van ethefon. De werking berust op de omzetting van ethefon naar ethyleen. Het vrijgekomen ethyleen is een plantenhormoon, dat een rol speelt bij verouderingsprocessen en afrijpingsprocessen in planten; het remt de groei en ontwikkeling. Daarnaast is uit recent onderzoek gebleken dat ethyleen ook een cruciale rol speelt in de plant bij de afweer tegen microbiologische aantasters.

 

2.4 Voorgeschiedenis

De aanvraag is ontvangen op 11 december 2006 en op die datum zijn ook de verschuldigde aanvraagkosten ontvangen. Op 12 februari 2007, 22 februari 2007, 3 april 2007 en 31 mei 2007 zijn gegevens ontvangen. De aanvraag is inhoudelijk onvolledig bevonden op 26 juli 2007. Op 6 augustus 2007 zijn de ontbrekende gegevens ontvangen. De aanvraag is op 20 september 2007 in behandeling genomen. Op 26 september 2007 werden de verschuldigde beoordelingskosten ontvangen.

 

3  RISICOBEOORDELINGEN

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is de Handleiding toelating bestrijdingsmiddelen (HTB) versie 1.0.

 

3.1  Fysische en chemische eigenschappen

De aard en de hoeveelheid van de werkzame stoffen en de in toxicologisch en ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar geacht (artikel 28, eerste lid, sub c en e, Wet gewasbeschermingsmiddelen en biociden).

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

 

3.2  Analysemethoden

De geleverde analysemethoden voldoen aan de vereisten. De residuen die het gevolg zijn van geoorloofd gebruik die in toxicologisch opzicht of vanuit milieu oogpunt van belang zijn, kunnen worden bepaald met algemeen gebruikte passende methoden (artikel 28, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden).

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

 

3.3  Risico volksgezondheid

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen directe of indirecte schadelijke uitwerking heeft op de gezondheid van de mens. De voorlopige vastgestelde maximum residugehalten op landbouwproducten zijn aanvaardbaar (artikel 28, eerste lid, sub b, onderdeel 4 en sub f, Wet gewasbeschermingsmiddelen en biociden.
Het profiel humane toxicologie inclusief de beoordeling van het risico voor de toepasser staat beschreven in Hoofdstuk 4 Mammalian Toxicology, in Bijlage II bij dit besluit.

Het residuprofiel, de vastgestelde maximum residugehalten en de beoordeling van het risico voor de volksgezondheid staan beschreven in Hoofdstuk 5, Residues in bijlage II behorende bij dit besluit.

 

3.4  Risico voor het milieu

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt gehouden met de volgende aspecten:

-          de plaats waar het middel in het milieu terechtkomt en wordt verspreid, met name voor wat betreft besmetting van het water, waaronder drinkwater en grondwater,

-          de gevolgen voor niet-doelsoorten.

(artikel 28, eerste lid, sub b, onderdeel 5, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van het risico voor het milieu staat beschreven in Hoofdstuk 6, Environmental Fate and Behaviour, en Hoofdstuk 7, Ecotoxicology, in Bijlage II bij dit besluit.

Het profiel gedrag en lotgevallen staat beschreven in Hoofdstuk 6 in Bijlage II bij dit besluit. Het profiel Ecotoxicology staat beschreven in Hoofdstuk 7 in Bijlage II bij dit besluit.

 

3.5  Werkzaamheid

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, voldoende werkzaam is en geen onaanvaardbare uitwerking heeft op planten of plantaardige producten (artikel 28, eerste lid, sub b, onderdelen 1 en 2, Wet gewasbeschermingsmiddelen en biociden).

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

 

3.6  Eindconclusie

Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel
Chrysal Plus op basis van de werkzame stof ethefon voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 28, Wet gewasbeschermingsmiddelen en biociden).

 

 


 

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 119, eerste lid, Wet gewasbeschermingsmiddelen en biociden 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 gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

 

 

Wageningen, 21 december 2007

 

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,





(voorzitter)

 

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 21 december 2007 tot toelating van het middel Chrysal Plus, toelatingnummer 13004 N

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is het gebruik als groeiregulerend middel na de oogst bij Tulipa.

 

Dit middel is uitsluitend bedoeld voor beroepsmatig gebruik.

 

Om de werking van de rioolwaterzuiveringsinstallatie te beschermen is het niet toegestaan restanten van de gebruiksoplossing te lozen op het riool. Deze restanten dienen afgevoerd te worden als chemisch afval.

 

B.

GEBRUIKSAANWIJZING

 

Bij Tulipa kan steelgroei en het kromgroeien van stelen tegengegaan worden door ChrysaI Plus. Afhankelijk van de dosering kan de gewenste remming worden verkregen. ChrysaI Plus moet altijd worden gebruikt in combinatie met een gibberelline en benzyladenine.

Toepassing

ChrysaI Plus verbetert de steelkwaliteit bij Tulipa.

Oplossen van ChrysaI Plus in de pre-mix oplossing

15 ml ChrysaI Plus en 1 liter ChrysaI BVB

Matige remming

30 ml ChrysaI Plus en 1 liter ChrysaI BVB

Sterke remming

Na het toevoegen van ChrysaI Plus aan de ChrysaI BVB, de oplossing goed schudden. Hierna is het concentraat gereed voor gebruik.

Oplossen ChrysaI Plus pre-mix

2-10 ml per liter water. De dosering is afhankelijk van de behandelingsduur en de omgevingstemperatuur:

Behandelingsduur in uren (minimum-maximum)

Omgevingstemperatuur in°C

Dosering in ml per liter

0.1-2 (kort)

15-20

10

2-10

0-5

5

10-72 (overnacht)

0-5

2

 

De kant-en-klare oplossing kan maximaal 1 dag gebruikt worden, daarna de oplossing nieuw aanmaken.

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 21 december 2007 tot toelating van het middel Chrysal Plus, toelatingnummer 13004 N

 

Contents                                                                  Page

 

 

1.   Identity of the plant protection product          2

 

2.   Physical and chemical properties                    3

 

3.   Methods of analysis                                           8

 

4.   Mammalian toxicology                                       11

 

5.   Residues                                                             19

 

6.   Environmental fate and behaviour                  19

 

7.   Ecotoxicology                                                     30

 

8.   Efficacy                                                                43

 

9.   Conclusion                                                          45

 

10. Classification and labelling                              45

 


1.         Identity of the plant protection product

 

1.1       Applicant

Bayer CropScience B.V.

Energieweg 1

3641 RT Mijdrecht

 

1.2       Identity of the active substance

Common name

Ethephon

Name in Dutch

Ethefon

Chemical name

2-chloroethylphosphonic acid [IUPAC]

CAS no

16672-87-0

EEG no

240-718-3

 

1.3       Identity of the plant protection product

Name

Chrysal Plus

Formulation type

SL

Content active substance

Pure ethephon: 480 g/L

 

The formulation was not part of the assessment of the active substance for inclusion in the Annex I list of Directive 91/414/EEC.

 

1.4       Function

The product Chrysal Plus is a growth regulator.

 

1.5       Uses applied for

The use is claimed in Tulip, in combination with  a product based on plant hormones (gibberellins and benzyladenine), to prevent growth of the stems and curling of the stems after cutting, resulting in a longer period that the flowers will remain upright. 

 

Uses

Dose a.s.

(kg a.s./hL)

Number of applications

Interval between applications

Application time (growth stage and season)

tulip

0.0144

1

-

Jan-Dec, directly after cutting the flowers.

 

1.6       Background to the application

It concerns an application for registration of the product Chrysal Plus (20060794 TG). The active substance is ethephon. Ethephon is included in Annex I of Directive 91/414/EEC (Commission Directive 2006/85/EC dated 23.10.2006). The expiration of the inclusion is 31 July 2017.

 


1.7       Packaging details

 

1.7.1    Packaging description

Material:

HDPE

Capacity:

30 ml

Type of closure and size of opening:

unspecified size, not relevant for risk assessment

Other information

UN/ADR compliant

 

1.7.2    Detailed instructions for safe disposal

See application form and MSDS.

 

 

2.      Physical and chemical properties

 

2.1              Active substance: ethephon

The final list of endpoints presented below is taken from the List of Endpoints (EFSA Review Report, April 2006), also taking into account the Commission final review report on ethephon (SANCO/10037/2006 – rev. 2, d.d. 14 June 2006). Where relevant, some additional remarks/information are given in italics.

 

Identity

Active substance (ISO Common Name)

Ethephon (No ISO common name is available, the name “ethephon” is approved by the American National Standards Institute, and the name “chlorethephon” is used in New Zealand.)

Chemical name (IUPAC)

2-chloroethylphosphonic acid

Chemical name (CA)

(2-chloroethyl)phosphonic acid

CIPAC No

373

CAS No

16672-87-0

EEC No (EINECS or ELINCS)

240-718-3

FAO Specification (including year of                                publication)

Ethephon technical: > 910 g/kg

MEPHA: Mono 2-chloroethyl ester, 2-chloroethyl phosphonic acid: maximum 20 g/kg

1,2-Dichloroethane: maximum 0.5 g/kg

(Specification 373/TC/S/F (2000))

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

910 g/kg (technical dry material - TC)

692 g/kg (technical concentrate - TK)

MEPHA: Mono 2-chloroethyl ester, 2-chloroethyl phosphonic acid : Maximum 2 % of the ethephon declared content

1,2-Dichloroethane: Maximum 0.04% of the ethephon declared content

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

See FAO Specification

Molecular formula

C2H6ClO3P

Molecular mass

144.5

Structural formula

 

 

Physical-chemical properties

Melting point (state purity)

73.3°C (98.5%)

Boiling point (state purity)

not relevant (thermal decomposition)

Temperature of decomposition

250-400°C (under nitrogen) (98.5%)

Appearance (state purity)

white crystalline powder (98.5%)

TK: colourless viscous liquid with no characteristic odour

Relative density (state purity)

Density: 1.65  kg/m3 at 20°C (98.5%)

TK: D420 = 1.404

Surface tension

68.5 mN/m at 20°C (98.5%) (1 g/L)

Vapour pressure (in Pa, state temperature)

<1.0 x 10-3 Pa (from 18 to 80°C) (98.5%)

Henry’s law constant (in Pa·m3·mol-1)

 <1.45 x 10-7 Pa m3mol-1solids or liquids

determined or calculated from water solubility and vp (units Pa m3 mol-1)

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

at pH <0.2: ................................................... >1000 g/L

at pH 4:           800 g/L.

Above pH 5: decomposition and no solubility could be determined

Solubility in organic solvents (in g/l or

 mg/l, state temperature)

purity 98.5%:

n-heptane                  <0.3 mg/L at 20°C

p-xylene                    82.5 mg/L at 20°C

1,2-dichloroethane    832 mg/L at 20°C

methanol                   >600 g/L at 20°C

acetone                     >600 g/L at 20°C

ethyl acetate             >600 g/L at 20°C

acetonitrile                >600 g/L at 20°C

dimethylsulfoxide      >600 g/L. at 20°C

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

purity 98.5%:

Log Pow = -0.63 at pH 2, room temperature

Log Pow = -1.89 at pH 7, room temperature

Log Pow = -1.81 at pH 10, room temperature

Hydrolytic stability (DT50) (state pH and temperature)

97.5% radio chem. pure:

Half life at 25°C:

at pH 5                        73.5 days

at pH 7                        2.4 days

at pH 9                        1.0 day

(linear-regression)

Dissociation constant

purity 98.5%:

pK1 = 2.82 at 21°C

pK2 = 7.21 at 21°C

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

At 195 nm: ε = 33

At 295 nm: ε = 0.4

No absorption above 290 nm.

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

Ethephon (at 25°C and pH 5):

rate constant  k2 under irradiated conditions
9.39E-04 h-1 (DT50 61 days of 12 hr irradiation/day).

rate constant  k1 under non-irradiated conditions 5.22E-04 h-1 (DT50 111 days of 12 hr darkness/day).

Net rate constant k3 (DT50) due to irradiation alone:

k3 = k2 – k1 = 4.17E-04 h-1 (Net half-life 139 days of 12 hr irradiation/day).

(Linear-regression)

 

Only degradation product is ethylene, max. 15.3 and 23.1% in non-irradiated and irradiated samples, respectively.

Quantum yield of direct photo-

transformation in water at λ > 290 nm

no data required since photolysis is insignificant (see above)

Photochemical oxidative degradation in air

Half-life in air @ 25 °C: 10.160 days (12 hours sunlight/day) and 5.080 days (24 hours sunlight/day)

Flashpoint

Purity 71.4% (TK): no flash point up to 111°C (boiling temp.)

Auto-flammability

Purity 70.2% (TK): self ignition temperature: 490°C

Oxidative properties

Not oxidising (theoretical assessment)

Explosive properties

purity 70.2% (TK): not explosive

 

 

2.2              Plant protection product: Chrysal Plus

The maximum final concentration of the plant protection product is 0.03%.

 

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

GLP

Visual

Liquid

Acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

GLP

Visual

Colourless

Acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

 

Not determined

Acceptable; non-essential information.

B.2.2.4 (IIIA 2.2)

Explosive properties

GLP

EC A14

Not explosive

Acceptable

B.2.2.5 (IIIA 2.2)

Oxidising properties

Theoretical assessment

Not oxidising

Acceptable

B.2.2.6 (IIIA 2.3)

Flammability

 

Not applicable for SL formulations.

 

B.2.2.7 (IIIA 2.3)

Auto-flammability

GLP

DIN 51794

600 oC

Acceptable; comparable with EC method.

B.2.2.8 (IIIA 2.3)

Flash point

Theoretical assessment

The formulation does not contain flammable components.

Acceptable

B.2.2.9 (IIIA 2.4)

Acidity / alkalinity

GLP

CIPAC MT31.2.3

27.20% as H2SO4

Acceptable

B.2.2.10 (IIIA 2.4)

pH

GLP

CIPAC MT75.2

1%: 1.79

 

Acceptable

 

The undiluted formulation was not tested, but is not deemed required because the pH of a 1% solution is < 4.

B.2.2.11 (IIIA 2.5)

Surface tension

GLP

EEC A5

1% v/v in distilled water: 55 mN/m at 20 oC.

Acceptable; the formulation does not contain hydrocarbons and therefore Xn/R65 is not triggered.

B.2.2.12 (IIIA 2.5)

Viscosity

 

Not determined

Acceptable; the formulation does not contain hydrocarbons and therefore Xn/R65 is not triggered.

B.2.2.13 (IIIA 2.6)

Relative density

GLP

CIPAC MT3.2.1

Density: 1.2062 g/cm3

Acceptable

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

 

Not applicable for SL formulations.

 

B.2.2.14 (IIIA 2.7)

Storage stability

GLP

CIPAC MT46

Stable for 2 weeks at 54 oC in HDPE.

 

Properties determined before and after storage: a.i. content, appearance, packaging stability, acidity, pH of a 1% solution, density, foam persistence, dilution stability.

Acceptable

 

 

GLP

CIPAC MT39.1

Stable for 7 days at 0 oC

Acceptable

B.2.2.15 (IIIA 2.7)

Shelf life

GLP

Stable for 2 years at ambient temperatures (20 oC) in HDPE.

 

Properties determined before and after storage: a.i. content, appearance, packaging stability, acidity, pH of a 1% solution, density, foam persistence, dilution stability.

Acceptable

 

The shelf-life study did not include analysis of formation of relevant impurities. Based on the results of the hydrolysis study and the low pH of the formulation, it is considered unlikely relevant impurities will be formed during storage (the low pH of the formulation stabilises ethephon; no other degradation products than ethylene were detected in the hydrolysis study).

B.2.2.16

(IIIA 2.8)

Wettability

 

Not applicable for SL formulations.

 

B.2.2.17 (IIIA 2.8)

Persistent foaming

GLP

CIPAC MT47.1

CIPAC D, 10g/L (1%): no foam was observed after 10s, 1, 3 and 12 minutes.

Acceptable

B.2.2.18

(IIIA 2.8)

Suspensibility

 

Not applicable for SL formulations.

 

B.2.2.19

(IIIA 2.8)

Spontaneity of dispersion

 

Not applicable for SL formulations.

 

B.2.2.20

(IIIA 2.8)

Dilution stability

GLP

CIPAC MT41

20g/L in CIPAC D: no material retained on a 45 μm sieve; solution remained clear and homogeneous.

Acceptable

B.2.2.21

(IIIA 2.8)

Dry sieve test

 

Not applicable for SL formulations.

 

B.2.2.22

(IIIA 2.8)

Wet sieve test

 

Not applicable for SL formulations.

 

B.2.2.23

(IIIA 2.8)

Particle size distribution

 

Not applicable for SL formulations.

 

B.2.2.24

(IIIA 2.8)

Content of dust/fines

 

Not applicable for SL formulations.

 

B.2.2.25

(IIIA 2.8)

Attrition and friability

 

Not applicable for SL formulations.

 

B.2.2.26 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

 

Not applicable for SL formulations.

 

B.2.2.27

(IIIA 2.8)

Stability of dilute emulsion

 

Not applicable for SL formulations.

 

B.2.2.28

(IIIA 2.8)

Flowability

 

Not applicable for SL formulations.

 

B.2.2.29

(IIIA 2.8)

Pourability (rinsibility)

 

Not applicable for SL formulations.

 

B.2.2.30

(IIIA 2.8)

Dustability

 

Not applicable for SL formulations.

 

B.2.2.31

(IIIA 2.8)

Adherence and distribution to seeds

 

Not applicable for SL formulations.

 

2.9.1

Physical compatibility with other products

 

 

See explanation below the table.

2.9.2

Chemical compatibility with other products

 

 

See 2.9.1

 

The label instructions indicate that the product Chrysal Plus should always be used in combination with benzyladenine and gibberellins containing products. Therefore, physical and chemical compatibility of these products with Chrysal Plus should be investigated. No specific studies were submitted, but since the efficacy tests were performed using a product comparable to the only authorised product in the Netherlands based on these active substances, physical and chemical compatibility is considered addressed, in this specific case, by the efficacy dossier.

 

No information is available on the behaviour of this product when mixed. 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 shelf-life of Chrysal Plus is 24 months in the proposed commercial packaging (HDPE).

 

2.3       Data requirements

None.

 

 

3.                  Methods of analysis

The final list of endpoints presented below is taken from the List of Endpoints (EFSA Review Report, April 2006), also taking into account the Commission final review report on ethephon (SANCO/10037/2006 – rev. 2, d.d. 14 June 2006). Where relevant, some additional remarks/information are given in italics.

 

3.1.            Analytical methods in technical material and plant protection product

Technical as (principle of method)

Titration (CIPAC method 373)

Impurities in technical as (principle of  method)

GC-FID; CG-ECD; karl Fisher; Chloride titration, ion-chromatography-conductivity

Preparation (principle of method)

Titration (CIPAC method 373)

or

GC-FID method LM033/01-0 for the determination of ethephon in Chrysal Plus

 


Conclusion

The analytical methods regarding the technical active ingredient have been assessed in the monograph and are considered to be acceptable. The analytical method for the preparation was provided by the applicant and is sufficiently validated.

 

 

3.2       Residue analytical methods

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

Not applicable; proposed use only includes application on ornamentals.

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

Not applicable; proposed use only includes application on ornamentals.

Soil (principle of method and LOQ)

HPLC-MS/MS
Extraction with weak phosphorous acid solution. Mobile phases: water/formic acid and acetonitrile. Column: Aqua 3µ C18 125A.

LOQ = 5 µg/kg

Water (principle of method and LOQ)

Empore disk extraction, followed by dissolution with a mixture of methanol and hydrochloric acid. Evaporation to aqueous residue and solvent transfer into acetonitrile and silylation of extract with MTBSTFA. Quantification by GC-MS. LOQ (mineral, tap and surface water) 0.1 µg/L

 

HPLC-MS/MS method 00975 for the determination of ethephon residues in surface and drinking water.

Confirmatory method: not required for tandem MS

LOQ = 0.05 µg/L

Air (principle of method and LOQ)

Air is trapped in cartridges with silica gel, which is desorbed with a concentrated alkaline solution, liberating ethylene. Ethylene is transferred to the headspace by sonication and quantified by GC-FID. LOQ 2  µg/m3 (> 50 L air sample)

or

Air is trapped in adsorption tubes with XAD which is extracted with a mixture of methanol and formic acid Quantification by LC-MS/MS.

LOQ 1.4  µg/m3

Body fluids and tissues (principle of method and LOQ)

Not required, non toxic compound

 

The proposed use only involves application on ornamentals. No residue analytical methodology is required to support the authorisation of Chrysal Plus.

 

Definition of the residue and MRL’s for ethephon

Matrix

Definition of the residue for monitoring

MRL

Food/feed of plant origin

No definition of the residue is proposed. The product is not used on or near edible crops.

Food/feed of animal origin

No definition of the residue is proposed. No relevant residues are expected to occur in food/feed of animal origin.

 

Required LOQ

Soil

Ethephon

0.05 mg/kg (default)

Drinking water

Ethephon

0.1 µg/L (Dutch drinking water guideline)

Surface water

Ethephon

0.1 µg/L

Air

Ethylene, ethephon

0.009 mg/m3 (derived from the AOEL (0.03 mg/kg bw/day) 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.

 

The residue analytical methods for water, soil and air, 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 MRL’s 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 ethephon (symbols and R phrases)
(EU classification) concerning physical chemical properties

 

Symbol(s):

-

Indication(s) of danger: -

 

Risk phrase(s)

-

-

 

Proposal for the classification and labelling of Chrysal Plus concerning physical chemical properties

 

Regarding the physical and chemical properties of the formulation, the method of application and the further information on the plant protection product, 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:

-

Indication of danger:

-

R phrases

-

-

 

 

 

S phrases

21

V31-NL

When using do not smoke.

Do not bring (diluted) product into contact with metal.

 

 

 

Special provisions:
DPD-phrases

-

-

 

 

 

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 


 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

S21 is assigned to product that contain halogenated compounds based on the possibility of formation of toxic fumes when the product is incinerated or burned.

V31-NL is assigned to products that have a pH of 4 or lower.

Other:

-

 

 

4.      Mammalian toxicology

The final list of endpoints presented below is taken from the List of Endpoints (EFSA Review Report, April 2006), also taking into account the Commission final review report on ethephon (SANCO/10037/2006 – rev. 2, d.d. 14 June 2006). Where relevant, some additional remarks/information are given in italics.

 

Chapter 2.3     Impact on Human and Animal Health

 

Many of the toxicity studies have been conducted with Ethephon Base 250 (a liquid concentrate of c.70% ethephon in water) but all dose levels quoted here refer to ethephon.

 



Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 6.1)

Rate and extent of absorption:

78-84% based on radiolabel recovered in urine, tissues, cage wash, expired air/volatiles and residual carcass within 120 h.

Distribution:

Widely; highest residues in liver, blood and kidney at 50 mg/kg bodyweight.

Potential for accumulation:

No potential for accumulation

Rate and extent of excretion:

Extensively excreted - urinary: 50-60% in 120 h; faecal 4.0-6.5% in 120 h; and exhaled 20%

Metabolism in animals

Extensively metabolised to disodium salt of ethephon, and HEPA was found in the liver

Toxicologically significant compounds (animals, plants and environment)

Ethephon and HEPA (toxicologically relevant)

 

Acute toxicity (Annex IIA, point 6.2)

Rat LD50 oral

1564 mg/kg bw; R22

Rat LD50 dermal

983 mg/kg bw; R21

Rat LC50 inhalation

3.26 mg/L air/4h (whole body); R20

Skin irritation

Causes burns; R34

Eye irritation

No data available, not considered necessary due to pH and effects (R34) of substance

Skin sensitization (test method used and result)

Evidence of skin sensitization – inconclusive due to corrosive properties (LLNA and Maximisation test); R43?*

* From EFSA Scientific Report:

Ethephon needs to be classified as “harmful” based on the results of the acute oral (LD50 1564 mg/kg bw), dermal (LD50 983 mg/kg bw) and inhalation (LC50 3.26 mg/L) toxicity studies. Ethephon should be classified as “causes burns” based on the results of the skin irritation study. No eye irritation study with ethephon was performed, due to the pH of 1.6. Ethephon does not have sensitising properties in a Buehler test or in an LLNA test. However, both tests were of limited value since the Buehler test was performed with far too less animals, and the experience of the LLNA test was insufficient to assess the effect of altering the pH before the test, and the influence on the results is unclear. In the Maximisation test 5 test animals revealed discrete/patchy erythema, some of them with dryness of the skin, and an additional 3 test animals showed dryness of the skin, none of these effects were observed in control animals. In the meeting, no conclusion was reached in relation to the sensitising potential of ethephon. It was decided that due to the corrosive properties of ethephon, the evidence of skin sensitization is inconclusive. It was noted that ethephon was classified as [R34] ‘Causes burns’, and thus classification as [R43] would not impact on the requirement for PPE, as this would be triggered by the corrosive nature of the material.

Ethephon is classified as ‘CORROSIVE’ with the associated risk phrases [R20/21/22] ‘Harmful by inhalation, in contact with skin and if swallowed’ and [R34] ‘Causes burns’. The applicability of [R43] ‘May cause sensitisation by skin contact’ was forwarded to ECB.

 

Short term toxicity (Annex IIA, point 6.3)

Target / critical effect

Inhibition of cholinesterase (ChE) activity in erythrocytes

Lowest relevant oral NOAEL / NOEL

28-day mouse: 22 mg/kg bw/day

1 year dog: 27 mg/kg bw/day  based on decreased body weight and spleen and thyroid weight (ChE activity in plasma, erythrocytes and brain was not investigated in dogs)

Lowest relevant dermal NOAEL / NOEL

no good study available (not required)

Lowest relevant inhalation NOAEL / NOEL

No data – not required

 

Genotoxicity (Annex IIA, point 6.4)

No genotoxic potential*

*In vitro: Ames test (positive in one tester strain, negative in 4 tester strains), genmutation in CHO cells (HGPRT, negative), chromosome aberration in CHO cells (negative), UDS rat hepatocytes (negative); in vivo: rat liver UDS (negative).

 

Long term toxicity and carcinogenicity (Annex IIA, point 6.5)

Target/critical effect

Inhibition of ChE activity in erythrocytes

Lowest relevant NOAEL / NOEL

2 years rat: 13 mg/kg bw/day

Carcinogenicity

No carcinogenic potential

 

Reproductive toxicity (Annex IIA, point 6.6)

Reproduction target / critical effect

Decreased pup weight (F1 and F2), decreased survival of F1B and F2B pups, at parental toxic doses (decreased body weight (gain) and food consumption).

Lowest relevant reproductive NOAEL / NOEL

Parental and offdpring:231 mg/kg bw/day.

Reproductive: > 2444 mg/kg bw/day

Developmental target / critical effect

Increased pre-and post-implantation loss, reduced number of live foetuses, reduced foetal weight at maternally toxic doses (19 out of 22 deaths).

Lowest relevant developmental NOAEL / NOEL

Parental and developmental: 125 mg/kg bw/day (rabbit).

 

Neurotoxicity / Delayed neurotoxicity (Annex IIA, point 6.7)

Acute neurotoxicity (rat)

reduced motor activity and myosis (NOAEL < 500 mg/kg bw/day)

Acute delayed neurotoxicity (hen)

No sign of delayed neurotoxicity (NOAEL > 1428 mg/kg bw/d)

Semichronic oral neurotoxicity (rat)

inhibition of ChE activity (NOAEL 75 mg/kg bw/day)

 

 

Other toxicological studies (Annex IIA, point 6.8)

Studies with a plant metabolite (2-hydroxyethylphosphonic acid, HEPA)

- LD50, oral rat: > 2000 mg/kg bw

- 28d oral toxicity rat: mortality, clinical signs, decreased body weight (NOAEL 350 mg/kg bw/d)

ChE activity in plasma, erythrocytes and brain was not investigated.

- no genotoxic potential

Human volunteer studies

three subacute studies (capsule) were submitted. Individual studies were of limited quality. An overall NOAEL of 0.5 mg/kg bw/day was established based on clinical observations (urination, diarrhoea, bowel movements) at 1.5 mg/kg bw/day.

 

Medical data (Annex IIA, point 6.9)

No relevant data

 

Summary (Annex IIA, point 6.10)

Value

Study

Safety factor

ADI

0.03 mg/kg bw/day

1-y oral dog, supported by human data

1000*

AOEL short-term, internal

0.03 mg/kg bw/day

1-y oral dog, supported by human data

1000*

ARfD (acute reference dose)

0.03 mg/kg bw/day

1-y oral dog, supported by human data

1000*

* an extra factor of 10 was considered since ChE activity was not measured in the study

 

Dermal absorption (Annex IIIA, point 7.3)

 

3% for concentrate

1.5% for spray dilution

based on in vitro human and rat and in vivo rat data

 

Acceptable exposure scenarios (including method of calculation)

Operator

Without PPE exposure is 48% of AOEL ( (DE-GM model)

Workers

No risk estimated, for cereals exposure with intensive crop contact is not expected.

Bystanders

Estimates 5% of AOEL

 

Classification and proposed labelling (Annex IIA, point 10)

with regard to toxicological data

 

 

Symbol            -  C

Risk phrase     -  R20, R21, R22, R34, R43?

Safety phrase  -  S26, S36/37/39, S45

 

Data requirements active substance

No additional data requirements are identified in the review report.

 

4.1       Toxicity of the formulated product (IIIA 7.1)

The formulation Chrysal Plus does not need to be classified on the basis of its acute oral (LD50 rat >2000 mg/kg bw), dermal (LD50 rat >2000 mg/kg bw), and inhalation toxicology (no study performed, not required).

The formulation Chrysal Plus does not need to be classified for dermal irritation.

The formulation Chrysal Plus is considered severely irritating to eyes and needs to be classified as R41 ‘Risk of serious damage to eyes’.

The formulation is negative in a modified Buehler test for skin sensitisation. At the moment Chrysal Plus does not require labelling with R43 ‘May cause sensitisation by skin contact’, however this may change depending on the ECB conclusion about the sensitising properties of ethephon.

 

4.1.1    Data requirements formulated product

No additional data requirements are identified.

 

4.2       Dermal absorption (IIIA 7.3)

See List of endpoints. The in vitro and in vivo dermal absorption studies were performed with the formulation Cerone. The composition of Cerone is comparable to the composition of Chrysal Plus. Therefore, the values of 3.0% for the concentrate and 1.5% for the dilution can be used for the risk assessment of Chrysal Plus.

 

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 has been submitted for the authorisation of the plant protection product Chrysal Plus, a growth regulator based on the active substance ethephon in tulips. Chrysal Plus has to be used in combination with a formulation containing gibberellin and benzyladenine.

Chrysal Plus is a SL formulation and contains 480 g/L ethephon.

 

The formulation Chrysal Plus is applied by mixing it with a formulation based on gibberellin and benzyladenine. Small amounts of the resulting pre-mix solution are added to buckets with water (2 – 10 ml pre-mix / liter water). After harvesting, the cut flowers are placed in the buckets. Operators and workers can be the same persons. Exposure can occur during a large period of the year and therefore, a chronic exposure duration is applicable for the operator and worker.

For the current risk assessment, the following assumptions are made:

The product is generally added in greenhouses where tulips are cut. The tulips are placed in buckets filled with the diluted solution. Subsequently, sorting and packaging of the tulips is done manually by the workers.

 

Calculation of the AOEL

Since ethephon is included in Annex I of 91/414/EEC, the EU-AOEL of 0.03 mg/kg bw/day (= 2.1 mg/day for a 70-kg operator), based on the 1 year study in dogs is applied (see List of Endpoints). Since this is a 1 year study the AOEL is applicable for the relatively large period of the year (> 3 months) during which occupational exposure is possible.

 

 

4.4.1    Operator exposure/risk

Operator exposure can occur during mixing of Chrysal Plus with the formulation based on gibberellin en benzyladenine and adding this mixture to the buckets.

In a larger company, mixing and loading is performed once in a large storage vessel. A standard amount of water is mechanically added to the buckets and a standard volume of the mixture is mechanically added to the water.

In a small company, mixing and loading might be done manually for each bucket separately.

In any case, the operator exposure is estimated to be substantially lower than the worker exposure, since the worker is actually handling the wet flowers treated with Chrysal Plus. See 4.4.3a for the worker exposure/risk.

 

4.4.2    Bystander exposure/risk

It is assumed that bystanders will not be present during the activities.

 

4.4.3    Worker exposure/risk

Worker exposure can occur during sorting and bundling of the flowers. The applicant submitted an exposure study with a product that is handled during sorting and bundling of the flowers in a way comparable to Chrysal Plus. The report describes a study in which the actual dermal exposure to (aminooxy) acetic acid hemihydrochloride (40.1 g/L) during handling of flowers treated with Chrysal EVBTM was measured. The measurements took place in October 1999 in a greenhouse where carnations were handled. The study is considered well performed and the population is of sufficient size. However, the study only represents the situation in one company with one kind of flowers. Therefore, the 90-percentile values were used for estimating the dermal exposure.

Workers picked up flowers from buckets filled with a Chrysal EVBTM solution and placed them on a table, sorted and arranged them by colour on the conveyor belt, mechanically cut the flowers to a new length and placed them in buckets with a fresh solution of Chrysal EVBTM. Work activities varied between one worker performing all activities like transport of buckets, removing carnations from buckets, sorting carnations on the conveyor belt and emptying the buckets all by himself, to the situation where work activities were performed by two workers. In that situation generally one worker was standing at the conveyor belt sorting carnations, while the other worker performed the transport of carnations to the work tables and emptying the buckets filled with the Chrysal EVB dilution.

 

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

Depending on the treatment period of the flowers, the amount of the pre-mix solution can vary from 2 – 10 ml per liter water, resulting in 28 –140 mg ethephon/L dilution. The calculation is done for the maximum amount used.


Table T.1  Internal worker exposure to ethephon and risk assessment after application of Chrysal Plus

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

Sorting and bundling of cut flowers

 

Respiratory c

-

-

-

Dermal

0.034

2.1

0.02

 

Total

0.034

2.1

0.02

a       External exposure was estimated on the basis of a field study. Internal exposure was calculated with:

·       ·       biological availability via the dermal route:   1.5% (see 4.2)

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

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

c       Based on the water solubility, vapour pressure , log Pow  and Henry’s law constant for ethephon, respiratory exposure will be negligible.

 

 

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 ethephon as a result of the application of Chrysal Plus in cut flowers (tulips).

Based on the risk assessment it can also be concluded that no adverse health effects are expected for the unprotected operator after dermal and respiratory exposure to ethephon as a result of the application of Chrysal Plus in cut flowers (tulips) in combination with a formulation based on gibberellin and benzyladenine (see 4.7)

 

Bystander exposure

It is assumed that bystanders will not be present during the activities.

 

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 cut flowers due to exposure to ethephon after application of Chrysal Plus.

Based on the risk assessment it can also be concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure to ethephon as a result of the application of Chrysal Plus in cut flowers (tulips) in combination with a formulation based on gibberellin and benzyladenine (see 4.7).

 

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

Chrysal Plus has to be applied in combination with gibberellin and benzyladenine (Chrysal BVB).  Chrysal BVB is a derivative of VBC-476. VBC-476 is authorised since 15 December 2006. The following information is copied from Dutch authorisation report for the formulation VBC-476.

 

The formulation VBC-476 is a mixture of two active substances. The combined toxicological effect of these two active substances has not been investigated with regard to repeated dose toxicity.

Possibly, the combined exposure to these active substances may lead to a different toxicological profile than the profile that is based on the individual substances.

The main target organ of gibberellin A4+A7 is the kidney and to a lesser extend the liver. In the animals exposed to the highest dose in the 13-week rat study, chronic inflammation was observed in the kidneys and vacuolisation and degeneration in the liver. The critical effects of benzyl(purin-6-yl)amine are decreased body weight and food consumption and increased kidney and liver weights. In the kidney, mineralization was observed in the pelvis and in the liver no pathology was observed with microscopy.

Although the target organs are the same (kidney and liver), a more detailed evaluation shows that the effects are different. Therefore, it is not expected that the combined toxicological effect of gibberellin A4+A7 and benzyl(purin-6-yl)amine is different than the profile that is based on the individual substances.

 

The toxicological profile of ethephon is different from that of the other substances, since ethephon is primarily a cholinesterase inhibitor. Furthermore, the risk index for ethephon in this application is very low (0.02). Therefore, it is not expected that the combined toxicological effect of exposure to ethephon, gibberellin A4+A7 and benzyladenine in the current intended use is different than the profile that is based on the individual substances.

 

4.8       Mammalian toxicology classification and labelling

 

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

 

Symbol:

C

Indication of danger: corrosive

 

Risk phrases

R20/21

 

R34

 

Harmful by inhalation and in contact with skin

Causes burns

 

* N.B.: Based on EU evaluation R22 is additionally proposed. Furthermore the applicability of R43 is forwarded to the ECB

 

 

Proposal for the classification and labeling 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:

Xi

Indication of danger:

Irritant

R phrases

41

Risk of serious damage to eyes.

S phrases

26

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

 

39

Wear eye protection.

 

46

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

Special provisions:
DPD-phrases

-

-

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?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 


 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

The Ctgb only assigns S35 to preparations with hazard-symbol T+, T, or C with respect to the toxicological aspect of the preparation in question. S46 is invariably assigned to formulations assigned with the mentioned R-phrase(s), intended for professional use only when this does not lead to more than six safety-phrases.

Other:

-

 

 

5.      Residues

Not applicable. The product is not used on or near edible crops.

 

 

6.                  Environmental fate and behaviour

The final list of endpoints presented below is taken from the List of Endpoints (EFSA Review Report, April 2006), also taking into account the Commission final review report on ethephon (SANCO/10037/2006 – rev. 2, d.d. 14 June 2006). Where relevant, some additional remarks/information are given in italics.

 

Risk assessment is done in accordance with HTB 1.0 for plant protection products based on 1) active substances which have already been placed on Annex I of Directive 91/414/EEC and 2) “new” active substances. For other plant protection products HTB 0.2 applies.

This means that for the current application of Chrysal Plus, risk assessment is done in accordance with HTB 1.0.

 

Ethephon is listed on Annex I of Directive 91/414/EEC since 1 August 2007. Chrysal Plus is used to prolong after harvest life of cut flowers. To achieve this Chrysal Plus is mixed with Chrysal BVB based on gibberellin A4/A7 and benzyladenine. Because of this prescribed treatment mix, also combination toxicology has to be taken into account.

The treatment is indoors at the Dutch flower auctions. As a result of that the only environmental exposure is on surface water via sewer and sewage treatment plant (STP) and via drinking water and secondary poisoning of birds and mammals as a result of eating fish.

For this assessment the monograph of ethephon is used,  as is the assessment of VBC-476, a plant protection product which is authorised in the Netherlands. Chrysal BVB is a derivative of VBC-476. VBC-476 is authorised since 15 December 2006. The applicant submitted a estimation for PEC surface water, which is also taken into account.

 

List of Endpoints

 

Ethephon

Chapter 2.5     Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil

Mineralisation after 100 days

< 1% a.r. after 180 d (14C-Ethephon, 4 soils)

22.3% a.r. after 44 d (14C-Ethephon, 1 soil)

Non-extractable residues after 100 days

11-53.4% a.r. after 100-102 d (14C-Ethephon, 4 soils, incubated at 20°C)

27% a.r. after 44 d (end study) (14C-Ethephon, clay loam soil, incubated at 20 ºC)

34.9% a.r. after 180d (14C-Ethephon, Clay loam soil, incubated at 10°C)

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

Ethylene
0.0 – 62.1% a.r. after 1 – 180d (4 soils, from volatile traps)

54.6% a.r. after 44 d (1 soil, from volatile traps)

 

Route of degradation in soil - Supplemental studies

Anaerobic degradation

DT50lab (20°C, anaerobic; Clay loam soil) 2.2 d

Mineralisation after 100 days

0.03% a.r. after 30d (14C-Ethephon, Clay loam soil)

Non-extractable residues after 100 days

2.1% a.r. after 30d (14C-Ethephon, Clay loam soil)

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

Ethylene
94.1% a.r. after 30d (14C-Ethephon, Clay loam soil)

Soil photolysis

Clay loam soil: degradation of Ethephon enhanced by irradiation; no photo-products > 10% a.r.

 

Rate of degradation in soil

Method of calculation

first-order kinetics

Laboratory studies (range or median, with n value)

DT50lab (20ºC, aerobic; 4 soils)
22.2d (pH 6.9); 14.2d (pH 6.8); 37.6d (pH 5.9); 2.7d (pH 7.6); r2 0.87 ; 0.96 ; 0.91 ; 0.99 resp.

DT50lab (20ºC, aerobic ; 1 soil) ; 6.5d (pH 8.2). r2: 0.99

average DT50 value: 16.5 d

 

DT90 lab (20ºC, aerobic; 4 soils)
160d ; 60.7d ; 173d ; 12.5d

DT90lab (20ºC, aerobic, 1 soil) ; 63 d

average DT90 value: 93.8d

 

DT50lab  (10ºC, aerobic; Clay loam soil)
51.4d

 

degradation in the saturated zone:

not available and not required

Field studies (state location, range or median with n value)

DT50 field  1st order non- linear r2 0.96-0.99

6.8-20 d. 3 sites in USA (California, North Carolina, Washington) studies considered relevant for use          conditions

DT90 field

22-66 d

Soil accumulation and plateau concentration

not relevant

 

Rate of degradation in soil - Supplemental studies

Anaerobic degradation

DT50lab (20ºC, anaerobic; Clay loam soil)
2.2 d

Soil photolysis

Clay loam soil: degradation of Ethephon enhanced by irradiation.

Irradiated treatment: DT50 16.5 d, DT90 57.8d

Non-irradiated treatment: DT50 20.7 d, DT90 74.4 d

 

Soil adsorption/desorption

KF / KOC / KS/L

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

KF, Koc and 1/n values are listed in corresponding order of soils

Ethephon (4 soils and 1 sediment)

 

soiltype            pH          1/n              Koc [L/kg]

clay                  5.2         0.987          3220

Loamy sand    5.2         1.007          3117

Silt loam          5.3         1.017          608

Sandy loam     4.6         0.977          4078

sediment         6.0        0.987          1676

 

Average Koc 2540 L/kg

 

no pH dependence

 

2-hydroxyethylphosphonic acid (2-HEPA), (4 soils and 1 sediment)
 

 

Soiltype           pH          1/n              Koc [L/kg]

Silt loam          6.0         0.891          1499

Sandy loam     6.3         0.98            2313

Loamy sand    7.1         0.899          1464

Clay                 6.3         0.972          5656

Sediment         5.9         0.974          12055

 

average Koc 4597 L/kg

 

no pH dependence

 

Mobility in soil

Column leaching

not available, not required

Aged residues leaching

not available, not required

Lysimeter/ field leaching studies

not available, not required

 

Route and rate of degradation in water

Hydrolysis of active substance and relevant metabolites

pH 5, 25°C: 26.4% hydrolysed after 30 d, extrapolated DT50: 66.4 d (DT50 at 20°C: 99.1d; Non-linear regression)
pH 7, 25°C: 86.6% hydrolysed after 7 d, DT50: 1.7d (DT50 at 20°C: 2.5d Non-linear regression)

pH 9, 25°C: 75.4% hydrolysed after 2d, DT50 0.93d (DT50 at 20°C: 1.4d Non-linear regression)

Major hydrolysis product: Ethylene gas (not quantified)

Photolytic degradation of active substance and relevant metabolites

Buffer pH 5 with acetate, 25°C, Xenon light > 290 nm. Test duration 15 days. Extrapolated DT50 under continuous illumination: 29.4d.

Non-irradiated control: extrapolated DT50: 51.4 d

Readily biodegradable (yes/no)

not ready biodegradable (study available)

Degradation in water/sediment (range or median, with n value,  state temperature)

from Manningtree (UK) and Ongar (UK) was

Aerobic study with 2 water/sediment systems (from Manningtree and from Ongar), 20°C:


DT50 water: 2.6d and 2.2d

DT50 total water/sediment system,: 3.0d and 2.7d


DT90 water: 8.5d and 7.2d

DT90 total water/sediment system: 9.9d and 8.6d

Mineralisation

Aerobic study with 14C-Ethephon (2 systems), 20°C:

not relevant

Non-extractable residues

Aerobic study with 14C-Ethephon (2 systems), 20°C:

max. 3.5% and 3.6% after 30d (end)

 

Distribution in water / sediment systems (active substance)

Aerobic study (2 systems), 20°C:

Rapid dissipation of Ethephon from water mainly due to degradation with Ethylene as the major degradation product. Max. 98.72 % a.r. at the start and < 1% a.r. after 30 days.

Low amount of residues (extracted + unextracted), bound to the sediment phase (< 5% after 30 days).

Maximal amount of extractable Ethephon in sediment:  6.02 % a.r. (in the Ongar system after 4 days).

Distribution in water / sediment systems (metabolites)

Metabolites > 10% a.r.:

 

Aerobic study (2 systems), 20°C:

Respectively 95% and 99% a.r. was recovered from the volatile traps as trapped ethylene gas.

 

Fate and behaviour in air

Direct photolysis in air

not available, not required

Quantum yield of direct phototransformation

not available, not required

Photochemical oxidative degradation in air

DT50 10.2 h (Atkinson method, 12h. day)

Volatilisation

Henry's Law constant: < 1.45 * 10-7 Pa/mol.m3

 

PECA (air)

Method of calculation

Photochemical oxidative degradation half life of Ethephon is 10.2 days (12 hour day). It has low volatility (Henry’s Law constant is < 1.45 * 10-7 Pa/mol.m3), suggesting that the concentrations of Ethephon in air are likely to be negligible.

 

PECA

Maximum concentration

No data; not calculated

 

Definition of the Residue

Relevant to the environment

soil
Ethephon

 

groundwater

Ethephon

 

surface water and sediment
Ethephon

 

Air
Ethylene, ethephon

 

Monitoring data, if available

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)

not available

Air (indicate location and type of study)

not available

 

Classification and proposed labelling

with regard to the submitted data

 

 

Potential for R53

 

 

 


Gibberellin A4/A7

 

Fate and behaviour in soil

The proposed use of VBC-476 does not result in exposure of the soil compartment by gibberellin A4/A7. Therefore no data on fate and behaviour in soil are required neither is a risk assessment for soil.

 

Fate and behaviour in water

 

Rate and route of degradation in surface water

 

Water/sediment systems

There is no information about the degradation of gibberellin A4 + A7 in water/sediment systems available.

 

Hydrolyse

Substance

Water type

T

 

[°C]

pH

Duration

 

[d]

Transformation

at end

[%]

DT50

hydrolysis, 20 °C

[d]

Gibberellins A4

buffer

22.4-25.9

5/7/9

30

0-0.5

hydrolytically stable

Gibberellins A7

buffer

22.4-25.9

5

30

84.4

16

Gibberellins A7

buffer

22.4-25.9

7

30

86.0

15

Gibberellins A7

buffer

22.4-25.9

9

30

100

7

 

Gibberellin A4 is hydrolytically stable, and the DT50’s for hydrolysis.  Gibberellin A7 has DT50 values of 16, 15, and 7 days at 20 °C at pH 5, 7, and 9, respectively.

 

Fotolyse

Substance

Water type

T

 

[°C]

pH

Light

source

Wavelength

 

[nm]

Duration

 

[d]

Transformation

at end

[%]

DT50

photo

[d]

Gibberellins A4

Gibberellins A4

Gibberellins A4

buffer

buffer

buffer

22.4-25.9

22.4-25.9

22.4-25.9

5

7

9

Xenon

Xenon

Xenon

290-800

290-800

290-800

30

30

30

17.8

14.4

9.7

101

102

163

Gibberellins A7

Gibberellins A7

Gibberellins A7

buffer

buffer

buffer

22.4-25.9

22.4-25.9

22.4-25.9

5

7

9

Xenon

Xenon

Xenon

290-800

290-800

290-800

30

30

30

15.6

14.0

15.8 (after 14 d)

114

145

56.6

 

Recovery of the Gibberellins was 98.82 ± 1.49%. Temperature ranged from 22.4-25.9 ºC, light intensity was 1.16x10-2 W/cm2, which can be compared to 1.67x10-2 W/cm2 from the natural sunlight outside the lab.

No light absorption was observed for Gibberellins A4 and A7 combined (5.0 mg/L) at wavelengths > 290 nm.  Gibberellins A4 and A7 combined were found to undergo <20% photolysis after 30 days in artificial sunlight at pH 5, 7 and 9. This decline was noticed under both light and dark conditions, making hydrolysis the most likely process. Photolysis was calculated by subtracting the loss due to hydrolysis (taken from the dark samples) from the total loss under light conditions. The A4 and A7 components of Gibberellin also showed <20% photolysis after 30 days. The A7 component, however, did undergo hydrolysis during the test and was hydrolysed for 84.4, 86.0 and 100% at pH 5, 7 and 9, respectively.

 

Impact of water treatment procedures

 

Activated sludge biodegradation

Substance

Sludge

source/type

Contact

time

[h]

T

 

[°C]

Process

Criterion

Value

 

[mg/L]

Gibberellins A4 and A7

municipal sewage treatment plant

3

20-21

BOD

EC50

>55.4

 

The EC50 was > 100 mg test substance/L.Which equals 55.4 mg technical grade material /L.  

 

 

Fate and behaviour in air

 

Route and rate of degradation in air

The vapour pressure of Gibberellin A4 is 0.1598 Pa at 22 oC and for Gibberellin A7 0.0667 Pa at 22 oC.  The Henry’s law constant (in Pa·m3·mol-1) is 0.155 for Gibberellin A4 and

0.065 for Gibberellin A7. Photochemical oxidative degradation in air: for Gibberellin A4 a

half-life of 1.67 hours (hydroxyl) / 22.90 hours (ozone) was calculated and for Gibberellin A7 a

half-lifeof  0.99 hours (hydroxyl) / 11.8 hours (ozone).

 

 

6-Benzyladenine

 

Fate and behaviour in soil

The proposed use of VBC-476 does not result in exposure of the soil compartment by benzyladenine. Therefore no data on fate and behaviour in soil are required, neither is a risk assessment for soil.

 

Fate and behaviour in water

 

Rate and route of degradation in surface water

 

Biodegradability

Substance

Water type

T

 

[°C]

pH

Duration

 

[d]

Transformation

at end

[%]

Classification

6-benzyladenine

activated sludge 

19.8-20.6

6.8-7.5

28

77

readily biodegradable

 

Total biodegradation expressed as ThOD% was 41%. According to the OECD Guideline, this indicates that the test substance was not toxic to the inoculum and did not inhibit the degradation of sodium acetate at the highest concentration tested.

 

Results

 

1.64 mg/L

 

3.28 mg/L

 

time

[days]

BOD

[mg O2/mg]

% biodegradation

[ThODNO3]

BOD

[mg O2/mg]

% biodegradation

[ThODNO3]

7

0.14 (-0.15-0.44)

5 (-5-15)

-0.07

-2

14

0.92 (0.85-1.02)

31 (29-34)

1.15 (1.10-1.30)

39 (37-44)

21

2.11

71

1.99

67

28

2.30

77

1.99

67

 

The observed high oxygen depletion in the inoculum blank when compared to the guideline validation criteria (2.36 vs. 1.5 mg O2/L) is not considered to have influenced the outcome of the test. Therefore, the conclusion is that 6-benzyladenine is readily biodegradable.

 

Sediment adsorption

Substance

Soil type

OM

 

[%]

Clay

 

[%]

CEC

 

[mmol/kg]

T

 

[°C]

KF

adsorption

[L/kg]

[1/n]

KOM

 

[L/kg]

KOC

 

[L/kg]

[8-14C]-N-6-benzyladenine

Clay loam

5.0

27.6

211

20±2

36.7

0.807

734

1266

 

Sandy clay loam

16.6

27.3

534

 

184.6

0.885

1112

1923

 

The test substance easily adsorbed to the sediment (especially in the sandy clay loam with high %OM).

 

Degradation in water-sediment systems

Substance

Soil type

Sediment

 

[%]

T

 

[°C]

pH1

 

[KCl]

OM

 

[%]

Duration

 

[d]

Degradation

at end

[%]

DT50

water

[d]

DT50

system

[d]

14C-6-benzyladenine

sandy clay loam

9.1

20

7.5

16.6

107

93.5

2.4

18.8

14C-6-benzyladenine

clay loam

13.0

20

7.4

5.0

107

98.7

4.2

8.3

 

From a study with two water sediment systems (TNO and Kromme Rijn system) DT50 values were calculated using first order kinetics. For the system TNO a dissipation half life of 2.4 days was calculated and a DT50 in the total system of 18.8 days. For the Kromme Rijn system the dissipation half life for the water phase was 4.2 days the DT50 for the system was 8.3 days.

No metabolites >10% were detected in the systems. CO2 production was 45.2 and 53.1% after 107 days respectively. Non extractable residue amounts for 25.6% and 24.7% respectively after 3 days for the one system and 6 days for the other.

 

Hydrolyse

Substance

Water type

T

 

[°C]

pH

Duration

 

[d]

Transformation

at end

[%]

DT50

Hydrolysis 20 ºC

[d]

6-benzyladenine

buffer

46.9-50.2

4

5

-1.77

hydrolytically stable

 

 

 

7

 

-1.65

hydrolytically stable

 

 

 

9

 

-0.439

hydrolytically stable

 

6-Benzyladenine is hydrolytically stable, and the DT50’s for hydrolysis. 

 

Fotolyse

Substance

Water type

T

 

[°C]

pH

Light

source

Wavelength

 

[nm]

Duration

 

[d]

Transformation

at end

[%]

DT50

photo

[d]

6-benzyladenine

buffer

22.7-25.5

5

7

9

Xenon

 

290-800

 

30

33.3

66.9

9.0

50.6

19.2

244

 

Recovery of the 6-benzyladenine was 104.7 ± 2.66%. Temperature ranged from 22.4-25.9 ºC, light intensity 8.02x10-3 W/cm2, which can be compared to 1.67x10-2 W/cm2 from the natural sunlight outside the lab.

The DT50’s of 50.6 and 19.2 days for 6-benzyladenine at pH 5 and 7, respectively, are considered acceptable. According to the OECD Draft Guideline[1], if the loss of the test substance is 20% after 30 days, Tier 3 (determination of the quantum yield and estimations of direct photolysis rates) and/or 4 (kinetics study on the test chemical and (if applicable) major transformation products) of the guideline should be performed. Since the loss of test substance after 30 days was 33.3 and 66.9% at pH 5 and 7, respectively, the applicant should perform tier 3 and/or 4. The chromatograms for pH 5 and 7 show the formation of a metabolite (retention time approx. 9 minutes). The applicant is requested to submit information concerning the identity of this metabolite. The DT50 of 244 days at pH 9 was not considered acceptable due to the low r2-value (0.592).

However, 6-benzyladenine is not the active substance of the Chrysal Plus, the product for which a registration is applied for but an active substance of Chrysal BVB, the product with which Chrysal Plus is mixed. The questions above will be dealt with when Chrysal BVB will be re-registered. Furthermore, there will be no risk as the following sentence will be stated on the label: “To protect the proper functioning of the sewage treatment plant it is not allowed to discharge the excess used solution into the sewer sytem. This excess used solution has to be disposed as chemical waste” (see chapter 7.5.4).

 

Impact of water treatment procedures

 

Activated sludge biodegradation

Substance

Sludge

source/type

Contact

time

[h]

T

 

[°C]

Process

Criterion

Value

 

[mg/L]

6-benzyladenine

oxidation ditch treating domestic sewage

3

20

BOD

EC50

>1000

 

Reported solubility of 6-benzyladenine is 60 mg/L. The highest test concentration of 1000 mg as/L was almost 17 times higher. No report has been made of visible problems in the solution.  Actual concentrations have not been verified.

 

 

Fate and behaviour in air

 

Route and rate of degradation in air

The vapour pressure of 6-benzyladenine is < 6 x 10 –7 Pa (49 oC).  The Henry’s law constant (in Pa·m3·mol-1) is 1.48 x 10-5 (25 oC). Information on degradation in air is not submitted.

 

 

6.1       Fate and behaviour in soil

 

6.1.1    Persistence in soil

Due to the nature of the application (indoors on impermeable floors) there is no exposure of soil. Therefore the assessment for the aspect persistence in soil is regarded not relevant.

 

6.1.2    Leaching to shallow groundwater

Due to the nature of the application (indoors on impermeable floors) there is no exposure of soil. Therefore the assessment for the aspect leaching to shallow groundwater is regarded not relevant.

 

Conclusions

The proposed application(s) of the product complies with the requirements concerning persistence and leaching in soil.

 

 

6.2       Fate and behaviour in water

 

6.2.1    Rate and route of degradation in surface water

 

Due to the nature of the application (indoors on impermeable floors), exposure of surface water for the proposed use is considered via STP.

The exposure concentrations of the active substances ethephon, gibberellin A4 + A7 and benzyladenine in the surface water are estimated with the model EUSES. All flowers for which a use is requested are summed. This is considered to be a worst case estimate. The applicant provided data on the number of stems processed, the number of containers used etc. These figures are considered realistic and therefore used for calculation of PEC surface water.

 

Table M.1: Discharge of used solution per year

Flower

# stems

# stems/

# containers

L/container

L/year

 

 

container

 

 

 

 

per year

 

per year

 

 

Tulipa

1,303,534,000

200

6,517,670

0.5

3,258,835

 

Table M.2: Discharge of active substance per day

Active

a.i./L

a.i. without

a.i. without

Uptake

a.i. with

substance

 

uptake

uptake

by plants

uptake

 

[g/L rtu]

[kg/year]

[kg/day]

[%]

[kg/day]

Gibberellin A4/A7

0.19

619

3.096

90

0.310

6-benzyladenine

0.19

619

3.096

90

0.310

Ethephon

0.144

469

2.346

90

0.235

 

Assumptions on the size of STP:

Number of auctions

 

4

 locations

 

Discharge volume per year:

3258.835

m3

 

Total number of discharge days:

200

 

 

Discharge per auction per day:

4.1

m3/day

 

 

 

 

 

 

Process volume STP Aalsmeer:

6200

m3/day

= worst case

Process volume STP De Nieuwe Waterweg:

18600

m3/day

 

 

 

 

 

 

STP Aalsmeer

 

Influent

Surface water

 

Process flow

a.i. without

Conc.

Conc.

 

m3/day

uptake

a.I.

a.I.

 

 

[kg/day]

mg//L

mg//L

 

6200.00

3.10

0.50

0.0142

 

 

3.10

0.50

0.0210

 

 

2.35

0.38

0.0894

 

 

In table M.3 the calculated surface water concentrations for the active substance [a.i.] for each intended use are presented.

Tabel M.3 Overview of waste water concentrations for active substances gibberellin A4/A7, 6-benzyladenine and ethephon following spring and autumn application

Flower use

Dose rate

Substance

Concentration in waste water [mg/L]

 

 

 

 

Tulipa

10 ml/L

 

Gibberellin A4 + A7

6-benzyladenine

Ethephon

1.66

0.21

1.18

 

PECsediment

Due to the fact that for gibberellin A4/A7, 6-benzyladenine and ethephon the toxicity value for aquatic invertebrates is >0.1 mg/L for each individual substance, assessment of the risk for sediment organisms is not required and therefore no PEC sediment was calculated.

The exposure concentrations in surface water are compared to the ecotoxicological threshold values in section 7.2.

 

Monitoring data

There are no data available regarding the presence of the substances gibberellin A4 + A7 and 6-benzyladenine in surface water.

 

Drinking water criterion

It follows from the decision of the Court of Appeal on Trade and Industry of 19 August 2005 (Awb 04/37 (General Administrative Law Act)) that when considering an application, the Ctgb should, on the basis of the scientific and technical knowledge and taking into account the data submitted with the application, also judge the application according to the drinking water criterion ‘surface water intended for drinking water production’. No mathematical model for this aspect is available. This means that any data that is available cannot be adequately taken into account. It is therefore not possible to arrive at a scientifically well-founded assessment according to this criterion. The Ctgb has not been given the instruments for testing surface water from which drinking water is produced according to the drinking water criterion. In order to comply with the Court’s decision, however - from which it can be concluded that the Ctgb should make an effort to give an opinion on this point – and as provisional measure, to avoid a situation where no authorisation at all can be granted during the development of a model generation of the data necessary, the Ctgb has investigated whether the product under consideration and the active substance could give cause for concern about the drinking water criterion.

 

From the general scientific knowledge collected by the Ctgb about the product and its active substances, the Ctgb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. The Ctgb does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water are met.

 

The standards for surface water destined for the production of drinking water are met.

 

 

6.3       Fate and behaviour in air

 

Route and rate of degradation in air

 

The active substance ethephon is little volatile.  The Henry’s law constant (in Pa·m3·mol-1) is < 1.45 * 10-7 Pa/mol.m3 (25 oC). Information on degradation in air is not submitted.

 

The active substances gibberellin A4 and A7 are highly volatile. The vapour pressure is

0.1598 Pa at 22 oC for gibberellin A4 and 0.0667 Pa at 22 oC for Gibberellin A7. The Henry constant is 0.155 for gibberellin A4 and 0.065 for gibberellin A7 both at 20°C. The half-life in air is 1.67 and 0.99 hours for gibberellin A4 and A7 respectively.

 

The active substance 6-benzyladenine is little volatile. The vapour pressure is < 6 x 10 –7 Pa (49 oC).  The Henry’s law constant (in Pa·m3·mol-1) is 1.48 x 10-5 (25 oC). Information on degradation in air is not submitted.

 

Since at present there is no framework to assess fate and behaviour in air of plant protection products, for the time being this issue is not taken into consideration.

 

 

6.4      Appropriate fate and behaviour end-points relating to the product and approved uses

See list of endpoints.

 

 

6.5       Data requirements

-

 

6.6       Overall conclusions fate and behaviour

It can be concluded that:

·                under the proposed use there is no exposure of the soil compartment. No risk assessment for persistence is required;

·                under the proposed use there is no exposure of the soil compartment. No risk assessment for leaching to shallow groundwater is required;

·                all proposed applications of the active substances ethephon, gibberellin A4/A7 and 6-benzyladenine meet the standards for surface water destined for the production of drinking water.

 

 

7.      Ecotoxicology

The final list of endpoints presented below is taken from the List of Endpoints (EFSA Review Report, April 2006), also taking into account the Commission final review report on ethephon (SANCO/10037/2006 – rev. 2, d.d. 14 June 2006). Where relevant, some additional remarks/information are given in italics.

 

Risk assessment is done in accordance with HTB 1.0 for plant protection products based on 1) active substances which have already been placed on Annex I of Directive 91/414/EEC and 2) “new” active substances. For other plant protection products HTB 0.2 applies.

This means that for the current application of Chrysal Plus, risk assessment is done in accordance with HTB 1.0.

 

Ethephon is listed on Annex I of Directive 91/414/EC since 1 August 2007. Chrysal Plus is used to prolong after harvest life of cut flowers. To achieve this Chrysal Plus is mixed with Chrysal BVB based on gibberellin A4/A7 and benzyladenine. Because of this prescribed treatment mix, also combination toxicology has to be taken into account.

The treatment is indoors at the Dutch flower auctions. As a result of that the only environmental exposure is on surface water via sewer and sewage treatment plant (STP) and via drinking water and secondary poisoning of birds and mammals as a result of eating fish.

For this assessment the monograph of ethephon is used,  as is the assessment of VBC-476, a plant protection product which is authorised in the Netherlands. Chrysal BVB is a derivative of VBC-476. VBC-476 is authorised since 15 December 2006. The applicant submitted a estimation for PEC surface water, which is also taken into account.

List of Endpoints

 

Ethephon

Chapter 2.6     Effects on Non-target Species

 

Effects on terrestrial vertebrates

Acute toxicity to mammals

LD50 = 1564mg/kg bw

Reproductive toxicity to mammals

Overall NOAEL:

22.8 mg as/kg bw/d

Ecotoxicologically relevant NOEC:

22.8 mg as/kg bw/d

Acute toxicity to birds

LD50 = 764 mg/kg bw (Bobwhite quail)

LD50 = 1425 mg/kg bw (Mallard duck)

NOEL = 450 mg a.s./kg bw (Mallard duck)

Dietary toxicity to birds

8d-LC50 > 450mg a.s./kg bw (Bobwhite quail)

8d-NOEL > 530 mg a.s./kg bw (bobwhite quail)

Reproductive toxicity to birds

6w-NOEL = 159 mg a.s./kg bw (Japanese quail)

 

Toxicity data for aquatic species (most sensitive species of each group)

Purity

Species

Endpoint

Toxicity value

Test Guideline

Reference no.

Acute fish

 

 

 

 

 

 

98%

Carp

Cyprinus carpio)

96h-LC50

> 100 mg a.s./L

OECD 203

EC C.1

8.2.1.2

484 g Ethephon/L (EXP03725A)

Rainbow trout

(Oncorhynchus mykiss)

96h-LC50

 

> 100 mg product/L

 

OECD 203 en EC1

10.2.1.2/01

Chronic toxicity to fish

71.4%

Fathead minnow

Pimephales promelas

34d-NOEC

34d-LOEC

(reproduction)

43 mg a.s./L

86 mg a.s./L

OECD 210

FIFRA 72-4

8.2.2.2

Acute toxicity to invertebrates

72.1%

Daphnia magna

48h-NOEC

(mobility)

not valid

OECD 202

8.2.4.1

Chronic toxicity to invertebrates

72.1%

Daphnia magna

21d-NOEC

21d-LOEC(reproduction)

21d-LC50

67 mg a.s./L

160 mg a.s./L

 

> 160 mg a.s./L

FIFRA 72-1

8.2.5.1

Toxicity algae

72.1%

Chlorella vulgaris

72h-EC50

20.9 mg a.s./L

OECD 201

8.2.6.1

71.9%

Selenastrum capricornutum

120h-EC50

> 1.4 mg a.s./L

FIFRA 122-2 en 122-3

8.2.6.2

71.9%

Anabaena flos aquae

120h-EC50

> 1.8 mg a.s./L

FIFRA 122-2 en 122-3

8.2.6.3

 

Navicula pelliculosa

120h- EC50

> 1.5 mg a.s./L

FIFRA 122-2 en 122-3

8.2.6.4

71.4%

Pseudokirchneriella subcapitata

72h-EC50

7.1 mg a.s./L

OECD 201

8.2.6

71.9%

Lemna gibba

14d-EC50

14d NOEC

> 1.6 mg a.s./L

< 0.10 mg a.s./L

FIFRA 122-2 en 122-3

8.2.8.1

484 g Ethephon/L (EXP03725A)

Scenedesmus subspicatus

72h-EC50

 

56 mg product/L

 

OECD 201 en EC C.3

10.2.1.2/02

Toxicity sediment-dwelling organisms

Not provided and not required (21d-NOEC Daphnia magna > 0.1 mg a.s./L)

Microcosm or mesocosm tests

not provided

 

Bioconcentration

Bioconcentration factor (BCF)

Log Pow < 3

 

Effects on honeybees

Acute oral toxicity bees

LD50 > 116.5 µg a.s./bee

Acute contact toxicity bees

LD50 > 100 µg a.s./bee

Acute oral toxicity bumblebees

not available

Acute contact toxicity bumblebees

not available

 

Ethephon does not reveal an IGR-related mode of action. Hence, this compound is not expected to pose a risk to honey bee brood. Data on the effects of Ethephon on bee brood is therefore not required.

 

Effects on other arthropod species*

Species

Test type,

substrate

Max. recommended test dose

(g a.s./ha)

Actual dose tested

(g a.s./ha)

Overall effect at respective dose in test

Parasitoids

Aphidius

rhopalosiphi

laboratory,

glass plate

480 (cereals)

 

726

87.2% (mortality)

-5.4% (slight increase of parasitation efficiency)

Foliage dwelling predators

Chrysoperla

carnea

laboratory,

glass plate

480(cereals)

 

726

-3.4% (less mortality than in the control)

60.1% reduction in reproduction activity

Ground dwelling predatory species

Poecilus

cupreus

laboratory,

sand

480(cereals)

 

726

0% (mortality)
0% (reproduction)

Predatory mites

Typhlodromus pyri

laboratory,

glass plate

480 (cereals)

 

726

17.7 % (mortality)

No significant adverse effects on reproduction (R=0.67)

 

Extended laboratory studies

Aphidius

rhopalosiphi

extended laboratory,

barley seedlings

480 (cereals)

 

1440

0% (mortality)

7.1% (reproduction)

Chrysoperla

carnea

extended laboratory,

maize leaves

480 (cereals)

 

726

-4.1% (less mortality than in the control)

1.33% (reproduction)

Typhlodromus pyri

extended laboratory,

480 (cereals)

836

-0.2% (mortality)

17% (reproduction)

* all studies are performed with formulation EXP03725A which is considered comparable to the lead formulation, except the extended laboratory study with Aphidius rhopalosiphi, which was conducted with a different formulation likely to be worst case

 

Effects on earthworms

Acute toxicity

14d-LC50 >  60 kg a.s./ha

Reproductive toxicity

8w-NOEC for reproduction > 200 mg a.s./kg

                                                                        

Effects on soil micro-organisms

 < 25 % effect at day 28 at 2.56 mg a.s./kg d.w.soil (1920 g a.s/ha)

 

Effects on other non-target organisms

Non-target plants

Carrot: ER50 = 2.35 kg a.i/ha.

Corn: NOEC = 2.58 kg a.i./ha.

Cucumber: ER50 = 3.58 kg a.i./ha.

Onion: NOEC = 2.35 kg a.i./ha.

Ryegrass: NOEC = 2.35 kg a.i/ha.

Oats: NOEC = 2.58 kg a.i/ha.

Soybean: ER50 = 5.04 kg a.i./ha.

Cabbage: ER50 = 5.15 kg a.i./ha.

Lettuce: ER50 = 1.46 kg a.i./ha.

Tomato: ER50 = 3.25 kg a.i./ha.

Collembola

According to the Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2 final, 17 October 2002), laboratory tests on Collembola reproduction are required for persistent substances (DT90 >100 days). Ethephon is non persistent (DT90 values derived from field test <66 days, see Section B.8.1.3). A study on the reproduction toxicity of Ethephon to Collembola is therefore not required.

 

 

Classification and proposed labelling

with regard to the submitted data

R51, R53

 

Gibberellins A4 + A7

 

Toxicity for aquatic organisms

algae:

 

Tabel M.2 Overview toxicity for algae

Substance

Species

Criterion

96h NOEC

Value

 

[mg A4 + A7/L]

Gibberellins A4 + A7

Pseudokirchneriella subcapitata

NOErC

100

 

 

NOEbC

100

 

Actual concentrations (% of 100 mg A4 + A7/L) were 105% for gibberellin A4 and 103% for gibberellin A7 at test initiation and 98% for A4 and 71% for A7 at test termination, expressed as percentage of nominal. Validity criteria were met. No significant differences were found for biomass and growth rate. Therefore, the NOEC was considered to be 100 mg/L.

 

athropods:

 

Tabel M.3 Overview acute toxicity to aquatic athropods

substance

Organism

48-uurs EC50 [mg/L]

remarks

Gibberellins A4 + A7

Daphnia magna

>97

none

 

Mean actual concentrations were 5.6, 11, 23, 48 and 97 mg/L in the treatments 6.3, 13, 25, 50 and 100 mg/L, representing 89, 83, 94, 95 and 97% of nominal, respectively.

Mean percentage of immobilisation after 48 hours was 5% in the control and no mortality in any of the treatments. Therefore, the EC50-value was determined to be >97 mg/L.

 

fish:

 

Tabel M.4 Overview acute toxicity for fish

Substance

Organism

96-hours LC50 [mg/L]

remarks

Gibberellins A4 + A7

Oncorhynchus mykiss

>96

None

Gibberellins A4 + A7

Lepois macrchirua

14.6

Old study (1975)

 

Mean actual concentrations in study 1 were 5.7, 12, 25, 47 and 96 mg/L corresponding with 90, 91, 100, 95 and 96% of nominal in the 6.3, 13, 25, 50 and 100 mg/L treatments, respectively. There was no mortality in the controls and in any of the treatments after 96 hours of exposure.

Since no treatment resulted in > 50% mortality, the LC50-value was empirically estimated to be > 96 mg/L on basis of mean measured concentrations. Results from old study deried from ‘Milieufiche’ 1989.

 

sedimentorganisms:

There are no data regarding the toxicity of gibberellin for sediment organism.

 

Bioconcentration

There are no data regarding the bio accumulation of Giberelline A4 and A7 submitted. The logkow values are gibberellin A4: 2.34 and gibberellin A7: 2.25, therefore an experimental BCF is not required.

 

Toxiciteit voor terrestrial organisms

Some data for a product comparable to VBC-476 are available from old studies (1975)

 

Mammals:

gibberellins have a low acute oral toxicity for mammals: LD50: >3600 mg/kg b.w. (rat).

The NOAEL is 170 mg/kg b.w. (rat, 90 d. semi-chronic).

 

Bees and bumblebees:

There are no data available regarding the risk of gibberellins A4 + A7 for bees. Regarding the proposed use exposure of bees is highly unlikely. Therefore no data are required.

 

Non target arthropods:

There are data available regarding the risk of gibberellins A4 + A7 for Aphidius rhopalosiphi and Typhlodromus pyri.

In Tabel M.5 the results of the effects of gibberellin A4 + A7 are reported.

 

 


Tabel M.5 Overview on the reduction percentages for non-target arthropods

Test substance

Organism

Dose

Endpoint

Adverse effect 3

Gibberellin A4 + A7

Aphidius rhopalosiphi

Lab. studie

 

40 g a.i./ha

Mortality

reproduction

 0%

+13%

Gibberellin A4 + A7

Typhlodromus pyri

Laboratory test

40 g a.i./ha

Corr. Mortality

beneficial capacity 4

reproduction

-1.1%

13.2%

-14%

3 Adverse effect means:

x % effect on mortality = x % increase of mortality compared to control

y % effect on a sublethal parameter = y % decrease of sublethal paramether compared to control

(sublethal parameters are e.g. reproduction, parasitism, food consumption)

 

When effects are favourable for the test organisms, a + sign is used for the sublethal effect percentages (i.e. increase of e.g. reproduction) and a – sign for mortality effect percentages (i.e. decrease of mortality).

 

4 Beneficial capacity = parasitism 

 

 

6-benzyladenine

 

Toxiciteit for aquatic organisms

algae:

 

Tabel M.6 Overview toxicity for algae

Substance

Species

Method

T

 

[°C]

pH

Duration

 

[h]

Criterion

Value

 

[mg/L]

6-benzyladenine

Pseudokirchneriella subcapitata

static

23

8.0

72

NOErC

1.0

 

 

 

 

 

 

ErC50

45.1

 

 

 

 

 

 

NOEbC

10.0

 

 

 

 

 

 

EbC50

36

 

Measured concentrations in the 1.0 and 10.0 mg/L treatments were 92 – 104% of nominal at start and end of the test. Actual concentration in the 101 mg/L treatment was measured to be 54 – 59% of nominal at start and end of the test. It was concluded that test substance solubility is approximately 57 mg/L and that test concentrations were stable during the test. Therefore, for further calculations nominal concentrations are used except for the highest tested concentration for which the mean measured concentration is chosen (i.e. 57.2 mg/L). Validity criteria were met.

 

arthropods:

 

Tabel M.7 Overview acute toxicity to aquatic athropods

 

substance

Organism

48-uurs EC50 [mg/L]

remarks

6-benzyladenine

Daphnia magna

28

none

 

Mean actual concentrations were 5.1, 16 and 52 mg/L in the treatments 5.6, 18 and 56 mg/L, representing 91, 89 and 93% of nominal, respectively.

Mean percentage of mortality after 48 hours was 0% in the control, solvent control and the treatments with 5.6 and 10 mg/L. Mortality was 5, 75 and 100% in the 18, 32 and 56 mg/L, respectively. The EC50-value was determined to be 28 mg/L.

 

fish:

 

Tabel M.8 Overview acute toxicity for fish

Substance

Organism

96-hours LC50 [mg/L]

remarks

6-benzyladenine

Barchydanio rerio

42

none

 

There was no mortality in the controls and in any of the treatments except for the highest treatment of 56 mg/L after 96 hours of exposure. After 96 hours exposure, 40% of the fish had died in the highest treatment. Validity criteria were met. Maximum mortality was 40% at 56 mg/L, the highest concentration tested. A dose-response curve could not be fitted accurately. Therefore, as a conservative estimation, the geometric mean of 32 and 56 mg/L is chosen as a conservative LC50.

 

sedimentorganisms:

There are no data regarding the toxicity of 6-benzyladenine for sediment organism.

 

aquatic plants:

From open literature data on the effect of 6-benzyladenine on Lemna gibba are available. Tassron-de Jong (1971) found that a concentration of 10­-4 M had an inhibitory effect on lemna growth whereas 10-6 M was found to stimulate growth. Berube et al. (1981) reported that dose of 0.002 to 2 ppm of 6-BA increased the water content and esterified fatty acid content in 15 day old plants of Lemna minor whereas high concentrations (5 ppm) decreased the water and fatty acid content. Al-Shalan and Kandeler (1978) showed daylight dependence of the effect of 6-BA on growth of L.gibba. Freshweight was inhibited by benzyladenine (1 ppm) under long day conditions whereas freshweight increased under short day conditions. Therefore it seems there is no clear dose related effect of 6-BA on aquatic plants.

 

Bioconcentration

There are no data regarding the bio accumulation of 6-benzyladenine submitted. The logkow value is 2.16, therefore no experimental BCF is required.

 

Toxicity for terrestrial organisms

birds:

There are studies available regarding the toxicity of 6-benzyladenine for birds. In tables M 9 to M 10 an overview of the toxicity data is presented.

 

Tabel M.9 Overzicht acuut orale toxiciteit voor vogels

substance

Organism

LD50 [mg/kg b.w.]

remarks

6-benzyladenine

Colinus virginianus

1599

none

 

In a 8-day dietary study at six concetrations (5-days substance administration and 3 days normal diet a LC50 of >5620 mg/kg food was derived.

 

Tabel M.10 Overzicht subacuut orale toxiciteit voor vogels

substacne

Organism

LC50 [mg/kg food]

remarks

6-benzyladenine

Colinus virginianus

>5620

none

 

mammals:

benzyladenine  has a low acute oral toxicity for mammals: LD50: 1300 mg/kg b.w. (rat).

 

bees and bumblebees:

For 6-benzyladenine oral en acute contact toxicity data for Apis mellifera are available at 4 dose rates. In table 11 an overview of the acute oral and acute contact toxicity for bees is presented.

 

Tabel M.11 Overview acute oral and acute contact toxicity for bees

substance

Organism

 LD50 [mg a.s./bee]

remarks

6-benzyladenine

Apis mellifera

  >25 (oral)

none

 

 

>25 (contact)

none

 

non-target arthropods:

There are data available regarding the risk of 6-benzyladenine for Aphidius rhopalosiphi and Typhlodromus pyri.

In Tabel M.12 the results of the effects of 6-benzyladenine are reported.

 

Tabel M.12 Overview on the reductionpercentage for non-target arthropods

Test substance

Organism

Dose

[g a.i./ha]

LR­50

[g a.i./ha]

endpoint

Adverse effect 3

6-benzyladenine

Aphidius rhopalosiphi

Lab. studie

 

5 - 80

 36.2

 

 

6-benzyladenine

Typhlodromus pyri

Laboratory test

12.75 - 80

>80

 

 

6-benzyladenine

Chrysoperla carnea

12.75

 

40

 

80

 

Mortality

Reproduction

Mortality

Reproduction

Mortality

reproduction

8.8

9.2

17.7

3.7

0

10.7

3 Adverse effect means:

x % effect on mortality = x % increase of mortality compared to control

y % effect on a sublethal parameter = y % decrease of sublethal paramether compared to control

(sublethal parameters are e.g. reproduction, parasitism, food consumption)

 

When effects are favourable for the test organisms, a + sign is used for the sublethal effect percentages (i.e. increase of e.g. reproduction) and a – sign for mortality effect percentages (i.e. decrease of mortality).

 

4 Beneficial capacity = parasitism 

 

Combination toxicology

Combination toxicology is assessed for formulations containing more than one active substance, and for combinations of products, which are made according to the Instructions for Use as a tank mixture. Based on the precautionary principle, concentration-addition is assumed.

For pesticides the TER (Toxicity-Exposure Ratio) is used as a standard in the risk assessment (except for bees and other non-target arthropods, where HQ-values are calculated). The TER must be higher than a trigger value to comply with the standards.

For the combination risk assessment of formulations containing more than one active substance and for tank mixtures the following formula is used:

   triggersubstance 1 /TERsubstance 1 + triggersubstance 2 /TERsubstance 2 + triggersubstance i/TERsubstance i .

 

When for each substance the trigger values are equal, the combined TER value can be calculated according to:

TERcombi = trigger/((trigger/TERsubstance 1)+(trigger/TERsubstance 2)+( trigger/TERsubstance 3))

 

An acceptable risk is expected when TERcombi > trigger.

 

In case of unequal triggers, the combined TER value can be calculated using the following formula:

 

Triggercombi = triggersubstance 1/triggersubstance 2/triggersubstance i

TERcombi = triggercombi /((triggersubstance 1 /TERsubstance 1)+(triggersubstance 2 /TERsubstance 2)+( triggersubstance i /TERsubstance i))

 

An acceptable risk is expected when TERcombi > triggercombi.

 

In this formula, ‘triggers’ are the trigger values as mentioned in the corresponding chapter of the HTB (v1.0).

In case toxicity of the formulation has been measured, the TER-value of the formulation is calculated with the PEC of the formulation and the toxicity value of the formulation. The PEC of the formulation is the sum of the PECs of the individual active substances. The toxicity value of the formulation is expressed in total amount active substance. Trigger/TER must be smaller than 1.

In the risk assessment, the risk of combination toxicology is assessed using the highest trigger/TER-value from the one based on the sum of the individual substances and the one based on formulation studies. When the standard of 1 is breached, the product is not permissable, unless an adequate risk assessment shows that there are no unacceptable effects under field conditions after application of the product according to the proposed GAP.

 

 

7.1       Effects on birds

Due to the nature of the application (indoors on impermeable floors) birds can be exposed to the active substance ethephon, gibberellin A4/A7 and 6-benzyladenine via drinking water and as a result of secondary poisoning via consumption of contaminated fish only.

However, based on the risk assessment for activated sludge (see section 7.5.4), which leads to the restriction that excess used solution has to be disposed as chemical waste, there is no exposure of surface water. Therefore the assessment for birds is regarded not relevant.

 

Conclusions birds

The product complies.

 

 

7.2       Effects on aquatic organisms

 

7.2.1    Aquatic organisms

Due to the nature of the application (indoors on impermeable floors) exposure of surface water occurs via sewage treatment plants only.

However, based on the risk assessment for activated sludge (see section 7.5.4), which leads to the restriction that excess used solution has to be disposed as chemical waste, there is no exposure of surface water. Therefore the assessment for aquatic organisms is regarded not relevant.

 

Hence, the standards for aquatic organisms are met. 

 

7.2.2    Risk assessment for bioconcentration

Due to the nature of the application (indoors on impermeable floors) exposure of surface water occurs via sewage treatment plants only.

However, based on the risk assessment for activated sludge (see section 7.5.4), which leads to the restriction that excess used solution has to be disposed as chemical waste, there is no exposure of surface water. Therefore the assessment for bioconcentration is regarded not relevant.

 

Hence, the standards for bioconcentration are met. 

 

7.2.3    Risk assessment for sediment organisms

Due to the nature of the application (indoors on impermeable floors) exposure of surface water occurs via sewage treatment plants only.

However, based on the risk assessment for activated sludge (see section 7.5.4), which leads to the restriction that excess used solution has to be disposed as chemical waste, there is no exposure of surface water. Therefore the assessment for sediment organisms is regarded not relevant.

 

Therefore, the active substances gibberellin A4/A7, 6-benzyladenine and ethephon meet the standards for sediment organisms.

 

Conclusions aquatic organisms

The proposed application of the product complies.

 

 

7.3       Effects on terrestrial vertebrates other than birds

Due to the nature of the application (indoors on impermeable floors) mammals can be exposed to the active substance ethephon, gibberellin A4/A7 and 6-benzyladenine via drinking water and as a result of secondary poisoning via consumption of contaminated fish only.

However, based on the risk assessment for activated sludge (see section 7.5.4), which leads to the restriction that excess used solution has to be disposed as chemical waste, there is no exposure of surface water. Therefore the assessment for mammals is regarded not relevant.

 

Conclusions mammals

The product complies.

 

 

7.4       Effects on bees

Due to the nature of the application (indoors)  there is no exposure of bees. Therefore the assessment for bees is regarded not relevant.

 

Conclusions bees

The product meets the standards.

 

 

7.5       Effects on any other organisms (see annex IIIA 10.5-10.8)

 

7.5.1    Effects on non-target arthropods

Due to the nature of the application (indoors)  there is no exposure of non-target arthropods. Therefore the assessment for non-target arthropods is regarded not relevant.

 

Hence, the standards for non-target arthropods are met. 

 

7.5.2    Earthworms

Due to the nature of the application (indoors on impermeable floors) there is no exposure of soil. Therefore the assessment for earthworms is regarded not relevant.

 

Hence, the standards for earthworms are met. 

 

7.5.3    Effects on soil micro-organisms

Due to the nature of the application (indoors on impermeable floors) there is no exposure of soil. Therefore the assessment for soil micro-organisms is regarded not relevant.

 

Hence, the standards for soil micro-organisms are met. 

 

7.5.4    Effects on activated sludge

Due to the nature of the application (indoors on impermeable floors) exposure of activated sludge via the sewer system occurs. Therefore the assessment for activated sludge is relevant.

An EC50 value of 55.4 mg/L is available for gibberellin A4+A7,  >1000 mg/L for 6-benzyladenine. For ethephon no EC50 value is available. The trigger is set to 0,01* EC50, corresponding to 554 µg/L and 10000 mg/L. The concentration in the influent of the sewage treatment plant (STP) is examined against this trigger using the model application EUSES. The PECmax for micro-organisms in the STP as calculated with EUSES is 1660 mg/L for gibberellin A4+A7, 210 mg/L for 6-benzyladenine and 897 mg/L for ethephon. The PEC/trigger value of 1 is exceeded for gibberellin A4/A7; PEC/trigger = 3. For ethephon no PEC/trigger value could be calculated.

Therefore, for the active substance ethephon data on the toxicity for activated sludge must be provided.

 

However, Chrysal Plus has to be used in a prescribed mixed solution with Chrysal BVB, which is an authorised formulation based on gibberellin A4/A7 and 6-benzyladenine. For these formulations there is a risk for activated sludge and the following restriction is included on the label:

Om de werking van de rioolwaterzuiveringsinstallatie te beschermen is het niet toegestaan restanten van de gebruiksoplossing te lozen op het riool. Deze restanten dienen afgevoerd te worden als chemisch afval (To protect the proper functioning of the sewage treatment plant it is not allowed to discharge the excess used solution into the sewer sytem. This excess used solution has to be disposed as chemical waste).

 

With the restriction sentence,  the proposed application meets the standard for activated sludge.

 

7.5.5    Effects on non target-plants

Due to the nature of the application (indoors)  there is no exposure of non-target plants. Therefore the assessment for non-target plants is regarded not relevant.

 

Hence, the standards for non-target plants are met. 

 

Conclusions any other organisms

The product complies for the aspects non-target arthropods, earthworms, soil micro-organisms and non-target plants.

The product only complies for the aspect activated sludge when a restriction sentence is included on the label

 

 

7.6       Appropriate ecotoxicological end-points relating tot the product and approved uses

See list of endpoints.

 

 

7.7       Data requirements

-

 

7.8       Classification and Labelling

 

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

Symbol:

N

Indication of danger: Dangerous to the environment

 

Risk phrases

R51/53

Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

 

Proposal for the classification and labelling of the formulation concerning the environment

 

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

 

Symbol:

N

Indication of danger:

Dangerous for the environment.

R phrases

R51/53

Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

 

 

 

S phrases

S61

Avoid release to the environment. Refer to special instructions/safety data sheets.

 

 

 

 

Explanation:

Hazard symbol:

N is assigned based on the toxicity to aquatic plants

Risk phrases:

51/53 is assigned based on the toxicity to aquatic plants

Safety phrases:

-

Other:

-

 

 

In the GAP/instructions for use the following has to be stated:

Om de werking van de rioolwaterzuiveringsinstallatie te beschermen is het niet toegestaan restanten van de gebruiksoplossing te lozen op het riool. Deze restanten dienen afgevoerd te worden als chemisch afval (To protect the proper functioning of the sewage treatment plant it is not allowed to discharge the excess used solution into the sewer sytem. This excess used solution has to be disposed as chemical waste).

 

 

7.9       Overall conclusions regarding the environment

It can be concluded that:

1.             all proposed applications of the active substances gibberellin A4/A7, 6-benzyladenine and ethephon meet the standards for birds;

2.             all proposed applications of the active substances gibberellin A4/A7, 6-benzyladenine and ethephon meet the standards for aquatic organisms;

3.             the active substances gibberellin A4/A7, 6-benzyladenine and ethephon meet the standards for bioconcentration;

4.             all proposed applications of the active substances gibberellin A4/A7, 6-benzyladenine and ethephon meet the standards for mammals;

5.             all proposed applications of the active substances gibberellin A4/A7, 6-benzyladenine and ethephon meet the standards for bees;

6.             all proposed applications of the active substances gibberellin A4/A7, 6-benzyladenine and ethephon meet the standards for non-target arthropods;

7.             all proposed applications of the active substances gibberellin A4/A7, 6-benzyladenine and ethephon meet the standards for earthworms;

8.             all proposed applications of the active substances gibberellin A4/A7, 6-benzyladenine and ethephon meet the standards for soil micro-organisms;

9.             all proposed applications of the active substances gibberellin A4/A7, 6-benzyladenine and ethephon only meet the standards for activated sludge with the following restriction on the label: To protect the proper functioning of the sewage treatment plant it is not allowed to discharge the excess used solution into the sewer sytem. This excess used solution has to be disposed as chemical waste;

10.         all proposed applications of the active substances gibberellin A4/A7, 6-benzyladenine and ethephon meet the standards for non-target plants.

 

 

8.                  Efficacy

The evaluation is partially based on the summary and evaluation prepared by the Plant Protection Service on behalf of the applicant (report: ds1chrysal01) and the data presented by the applicant.

Chrysal Plus is claimed to be used in combination with a product based on gibberellins and benzyladenine (Chrysal BVB).

 

8.1       Efficacy evaluation

Dose justification

The product is claimed to be used in combination with Chrysal BVB, based on gibberellin and 6-benzyladenine, and the dose justification was obtained from studies were both products were used together. No specific studies with the solo product were provided, and are, because of the nature of the use, not necessary.

 

Efficacy evaluation.

Studies were provided in order to evaluate the efficacy of the combination of ethefon and the plant hormones, gibberellins and benzyladenine. In a large number of tulip varieties the effect of ethephon on stem growth and curling was assessed. Up till 15 ml of ethephon no clear effects were seen. At a dose of 15 ml for half the number of stems a growth reduction was observed. There was a clear effect that the higher the dose, the lesser the growth and curling. Above 30 ml Chrysal Plus per litre the effects of an increase in dose became less significant.

Therefore it can be concluded that at a dose of 15 ml for the premix the growth and curling is inhibited reasonably, whereas a strong growth and stem curling reductions was observed at dosages of 30 ml product in the premix.

 

Conclusion

The product complies with the Uniform Principles because in accordance with article 2.1, it controls the growth of the tulip stems to the required level of control resulting in a longer period that the stems can remain on the vase.

 


8.2       Harmful effects

 

8.2.1    Phytotoxicity

No phytotoxicity was observed. The tulips could be kept on the vase longer and bending of the stems was reduced or prevented.

 

8.2.2    Yield

Due to its nature Chrysal Plus will not have any negative effects on the yield of the tulips in terms of number of stems harvested or quality of the stems. Only positive effects on the quality of the yield is expected.

 

8.2.3    Effects on succeeding crops or substitution crops

Due to its use Chrysal Plus as a post harvest products and the way it is used, no harmful effects on succeeding or substitution crops are expected. This point is not relevant.

 

8.2.4    Effects on plants or plant products to be used for propagation

Due to its use Chrysal Plus as a post harvest products and the way it is used, no harmful effects on plants or plant products to be used for propagation are expected. This point is not relevant.

 

8.2.5    Effects on adjacent crops

Due to its use Chrysal Plus as a post harvest products and the way it is used, no harmful effects on adjacent crops are expected, as adjacent crops are not exposed to the product. This point is not relevant

 

Conclusion

The product complies with the Uniform Principles because it does not, in accordance with article 2.2., induce any unacceptable side effects on plants or plant products, when used and applied in accordance with the proposed label.

 

8.3       Resistance

Ethylene is a natural gas with plant hormone properties, that is produced by plants or part of plants (ripening fruit and aging plant parts). Recently it was found that ethylene is vital for plant resistance against micro-organisms. It plays a key role in the activation of resistance mechanisms against infectious micro-organisms (B.P.J. Geraats, Ph.D.-thesis, 2003: The role of ethylene perception in plant disease resistance ). It is not expected that resistance against ethylene will occur. Nor has there been any records of resistance against ethylene. 

 

Conclusion

The product complies with the Uniform Principles, article 2.1.3 as the level of control on the long term is not influenced by the use of this product because of the possible build up of resistance.

 

8.4       For vertebrate control agents: impact on target vertebrates

Because no vertebrates are controlled, this point is not relevant.

 

8.5       Any other relevant data / information

No other relevant data was used.

 


 

9.                  Conclusion

The product complies with the Uniform Principles.

 

The evaluation is in accordance with the Uniform Principles laid down in appendix VI of Directive 91/414/EC. The evaluation has been carried out on basis of a dossier that meets the criteria of appendix III of the Directive.

 

 

10.      Classification and labelling

 

Proposal for the classification and labelling of the formulation

 

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 assessments, 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:

Xi

Indication of danger:

Irritant

 

N

 

Dangerous for the environment.

R phrases

41

Risk of serious damage to eyes.

 

51/53

Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

S phrases

21

When using do not smoke.

 

26

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

 

39

Wear eye protection.

 

46

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

 

61

Avoid release to the environment. Refer to special instructions/safety data sheets.

 

V31-NL

Do not bring (diluted) product into contact with metal.

Special provisions:
DPD-phrases

-

-

 

 

 

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?

Not applicable

Tactile warning of danger obligatory?

Not applicable