Toelatingsnummer 10319 N

Agrichem Ethofumesaat Flowable  

 

10319 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 VEREENVOUDIGDE UITBREIDING

 

Gelet op de aanvraag d.d. 13 mei 2011 (20110507 VUG) van

 

 

Agrichem BV

Koopvaardijweg 9

4906 CV Oosterhout

 

 

tot uitbreiding van de gebruiksdoeleinden van de toelating van als bedoeld in artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden het gewasbeschermingsmiddel, op basis van de werkzame stof ethofumesaat

 

Agrichem Ethofumesaat Flowable

 

gelet op artikel 31, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Uitbreiding

1. Het gebruiksgebied van het middel Agrichem Ethofumesaat Flowable wordt met ingang van

    datum dezes uitgebreid met de toepassing als onkruidbestrijdingsmiddel in de graszaadteelt

    en in de graszodenteelt. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit

    besluit.

2.  De toelating geldt tot 28 februari 2013.

 

1.2  Samenstelling, vorm en verpakking

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

 

1.3  Gebruik

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

 


1.4 Classificatie en etikettering

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

 

1.    De aanduidingen, welke ingevolge artikelen 9.2.3.1 en 9.2.3.2 van de Wet milieubeheer 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: suspensie concentraat

 

werkzame stof:

gehalte:

ethofumesaat

500 g/l

 

letterlijk en zonder enige aanvulling:

 

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

-

 

gevaarsymbool:

aanduiding:

-

-

 

Waarschuwingszinnen:

 

                        R52/53            -Schadelijk voor in het water levende organismen; kan in het

 aquatisch milieu op lange termijn schadelijke effecten

 veroorzaken

 

Veiligheidsaanbevelingen:

S61                 -Voorkom lozing in het milieu. Vraag om speciale instructies / veiligheidsgegevenskaart.

 

 

Specifieke vermeldingen:

 

DPD01            -Volg de gebruiksaanwijzing om gevaar voor mens en milieu te voorkomen.

 

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

 

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

 

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

 

c.      bij het toelatingsnummer een cirkel met daarin de aanduiding W.7.

 


1.5 Aflever- en opgebruiktermijn

De nieuwe etikettering dient bij de eerstvolgende aanmaak op de verpakking te worden aangebracht.

Oude verpakkingen mogen worden opgemaakt (artikel 17:2 Besluit bestuursreglement regeling toelating gewasbeschermingsmiddelen en biociden Ctgb 2007).

 

 

2 DETAILS VAN DE AANVRAAG EN TOELATING

 

2.1 Aanvraag

Het betreft een aanvraag tot vereenvoudigde uitbreiding van het gebruiksgebied van het middel Agrichem Ethofumesaat Flowable (10319 N), een middel op basis van de werkzame stof ethofumesaat. De aanvraag is gedaan door Agrichem B.V.  

 

Het middel is toegelaten tot 28 februari 2013. Met onderliggende aanvraag wordt toelating als onkruidbestrijdingsmiddel in de graszaadteelt en in de graszodenteelt gevraagd.

 

Er is verzocht de vereenvoudigde uitbreidingsprocedure te volgen aangezien de graszaadteelt en de graszodenteelt worden aangemerkt als kleine toepassing. Dit betekent dat voor de aspecten fysische en chemische eigenschappen en werkzaamheid geen beoordeling is uitgevoerd. Voor het aspect analysemethoden is een beperkte beoordeling uitgevoerd (residu-analysemethoden voor plantaardige en dierlijke producten).

 

2.2 Informatie met betrekking tot de stof

De werkzame stof is per 1 maart 2003 geplaatst op Annex I van gewasbeschermingsrichtlijn 91/414/EEG. De stof is goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011).

 

2.3 Karakterisering van het middel

Agrichem Ethofumesaat Flowable is een herbicide op basis van ethofumesaat. Er zijn middelen toegelaten op basis van alleen ethofumesaat als werkzame stof, maar ook in diverse combinaties met desmedifam, fenmedifam en metamitron. Ethofumesaat behoort tot de groep van benzofuran. Het werkingsmechanisme is gebaseerd op de remming van de vetzuursynthese, waardoor onder meer de vorming van een celmembraan wordt belemmerd. De groei van de meristemen wordt geremd en de celdeling vertraagt. Deze stof heeft een systemische werking in de plant en wordt opgenomen door het wortelstelsel en het blad. De opname door het blad (incl. opnamesnelheid) neemt af naarmate de onkruiden groter zijn. Ethofumesaat werkt op éénjarige grassen en éénjarige tweezaadlobbige onkruiden.

 

2.4 Voorgeschiedenis

De aanvraag is op 16 mei 2011ontvangen; op 17 mei 2011zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 24 november 2011 is de aanvraag in behandeling genomen.

 

 

3  RISICOBEOORDELINGEN

 

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is weergegeven in de RGB (Hoofdstuk 2) en de Evaluation Manual 1.0.

 

3.1  Fysische en chemische eigenschappen

Gelet op de aard van het verzoek is dit aspect niet beoordeeld. De fysische en chemische eigenschappen wijzigen niet.

 

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 voor de mens

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 4 en 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.

 

3.5  Werkzaamheid

Het aspect werkzaamheid is niet beoordeeld omdat het een vereenvoudigde uitbreiding betreft.

 

3.6  Eindconclusie

Bij gebruik volgens het gewijzigde Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is de uitbreiding voor de gevraagde doeleinden van het middel Agrichem Ethofumesaat Flowable op basis van de werkzame stof ethofumesaat voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden).

 

4 AFLEVER- EN/OF OPGEBRUIKTERMIJN 

 

De nieuwe etikettering dient bij de eerstvolgende aanmaak op de verpakking te worden aangebracht.

Oude verpakkingen mogen worden opgemaakt (artikel 17:2 Besluit bestuursreglement regeling toelating gewasbeschermingsmiddelen en biociden Ctgb 2007).

 

 

 


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, 6 april 2012

 

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,





ir. J. de Leeuw

voorzitter

 

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 6 april 2012 tot vereenvoudigde uitbreiding van de toelating van het middel Agrichem Ethofumesaat Flowable, toelatingnummer 10319 N

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als onkruidbestrijdingsmiddel :

-in de teelt van suiker- en voederbiet

-in de graszaadteelt

-in de graszodenteelt

 

Bij de interpretatie van wat valt onder bovengenoemde teelten is uitgegaan van de definitielijst toepassingsgebieden gewasbeschermingsmiddelen, versie 2.0, Ctgb juni 2011.

 

De totale dosering in één seizoen mag niet hoger zijn dan 2 kg ethofumesaat (als werkzame stof) per hectare.

 

Na gebruik in de teelt van graszaad en graszoden, het gras niet vervoederen.

 

Het middel is uitsluitend bestemd voor professioneel gebruik.

 

Om niet tot de doelsoorten behorende planten te beschermen is de toepassing in de teelt van graszaad en graszoden uitsluitend toegestaan indien er gebruik wordt gemaakt van driftarme spuitdoppen.

 

 

 

B.

GEBRUIKSAANWIJZING

Algemeen

Agrichem Ethofumesaat Flowable is een bodemherbicide met systemische werking via de ondergrondse delen van de onkruiden. Vochtige grond op het moment van toepassen en enige neerslag nadien bevorderen de werking. De gewassen moeten echter bij behandeling droog zijn. Met uitzondering van kamille bestrijdt Agrichem Ethofumesaat Flowable een breed spectrum éénjarige onkruiden waaronder kleefkruid. Waterhoeveelheid: 200-300 liter per ha.

 

Het gebruik in de graszaadteelt (met uitzondering van Engels- en Italiaans raaigras) en de graszodenteelt,is beoordeeld conform de “vereenvoudigde uitbreidingsprocedure”. Er is voor deze toepassingen geen werkzaamheids- en fytotoxiciteitsonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel gebruikt wordt.

Gebruik van dit middel in deze toepassingsgebieden, komt voor risico en verantwoordelijkheid van de gebruiker.

 

Suiker- en voederbiet

Agrichem Ethofumesaat Flowable is na-opkomst alleen werkzaam in combinatie met middelen op basis van fenmedifam. Deze tankmenging geeft een goede bestrijding tot in het 4-6 bladstadium van de meeste tweezaadlobbige zaadonkruiden.

Deze combinatie komt vooral in aanmerking voor toepassing op zand- en dalgronden en specifiek voor de bestrijding van veelknopigen en kleefkruid op alle grondsoorten.


Dosering:

Vanaf het 2 bladstadium (BBCH 12) van de biet:
0,6 liter Agrichem Ethofumesaat Flowable + 560 gram fenmedifam (actieve stof) per hectare (
bijvoorbeeld 3,5 liter per hectare van een product o.b.v. 160 g fenmedifam/l).
Zonodig na 10-14 dagen een tweede bespuiting uitvoeren met 0,6 liter Agrichem Ethofumesaat Flowable + 560 gram fenmedifam (actieve stof) per hectare (
bijvoorbeeld 3,5 liter per hectare van een product o.b.v. 160 g fenmedifam/l).

Tijdelijk kan enige gewasbeschadiging optreden, vooral van kleine bietenplantjes. De eerste 2 echte blaadjes moeten daarom bij alle bieten min. 1 cm groot zijn alvorens een behandeling wordt uitgevoerd en de onderstaande restricties dienen opgevolgd te worden.

 Vanaf het 4 bladstadium (BBCH 14) van de biet:
1,0 liter Agrichem Ethofumesaat Flowable + 800 gram fenmedifam (actieve stof) per hectare (
bijvoorbeeld 5 liter per hectare van een product o.b.v. 160 g fenmedifam/l) als enkelvoudige behandeling.

 

Ook kan gekozen worden voor toepassing in een tankmix in een Lage-Dosering-Systeem, op onkruiden in het kiembladstadium.

 

Dosering:

0,2 liter Agrichem Ethofumesaat Flowable + 350 gram metamitron (actieve stof) per hectare (bijvoorbeeld 0,5 liter per hectare van een product o.b.v. 700 g metamitron/l)) + 80 gram fenmedifam (actieve stof) per hectare (bijvoorbeeld 0,5 liter per hectare van een product o.b.v. 160 g fenmedifam/l).

Indien gewenst kan 0,5 l/ha olie (voor deze toepassing geschikt) worden toegevoegd.

De toepassing herhalen als nieuwe onkruiden aanwezig zijn. Als de onkruiden 1-2 echte blaadjes hebben of als minder gevoelige onkruiden voorkomen kunnen de doseringen verhoogd worden tot 0,4 liter Agrichem Ethofumesaat Flowable + 700 gram metamitron (actieve stof) per hectare (bijvoorbeeld 1 liter per hectare van een product o.b.v. 700 g metamitron/l) + 160 gram fenmedifam (actieve stof) per hectare (bijvoorbeeld 1 liter per hectare van een product o.b.v. 160 g fenmedifam/l).

 

Mengvoorschriften

Agrichem Ethofumesaat Flowable toegepast in combinatie met middelen op basis van fenmedifam en eventueel metamitron:

-           Giet 20-50 liter water in de tank

-           Voeg fenmedifam toe en zet het roersysteem in werking

-           Voeg water toe tot de helft van de benodigde hoeveelheid

-           Voeg Agrichem Ethofumesaat Flowable en eventueel metamitron toe

-           Vul verder aan met water

 

Laat de roerinrichting in werking, zowel bij het vullen van de tank als tijdens het spuiten.

 

Restricties:

-        Spuit op een afgehard en gezond bietengewas, dat niet verzwakt is door insecten, stuifschade, nachtvorst of herbiciden.

-        Spuit niet bij maximale dagtemperatuur boven 18 °C en niet bij scherp zonnig weer. In deze gevallen bij voorkeur ‘s avonds spuiten.

 

Graszaadteelt en de graszodenteelt

Agrichem Ethofumesaat Flowable bestrijdt duist, windhalm, straatgras, muur en herderstasje in de graszaad- en graszodenteelt. Het effect op graanopslag is wisselvallig. Toepassing vindt bij voorkeur in het najaar plaats, op kleine onkruiden.

Agrichem Ethofumesaat Flowable kan worden gespoten vanaf het moment dat het gras
2 spruiten heeft gevormd. Bij toepassing na de oogst van de dekvrucht dient het gras afgehard te zijn. Behandeling niet herhalen. Spuit op een gezond gewas.

 

Zaadteelt van Engels en Italiaans raaigras

Dosering:

-   3,0 liter middel per hectare, indien duist en windhalm kleiner zijn dan 3 spruiten

-   4,0 liter middel per hectare, indien reeds 3-5 spruiten zijn gevormd.

Grotere duist of windhalm wordt niet meer bestreden.

 

Zaadteelt van overige grassen

Dosering:

Maximaal 4 liter middel per hectare.

Aangezien voor deze toepassing geen gegevens over fytotoxiciteit zijn beoordeeld, is het gebruik van Agrichem Ethofumesaat Flowable in deze teelt voor eigen risico van de teler. Het verdient aanbeveling vooraf advies te vragen bij de teeltadviseur over de gevoeligheid van de betreffende soort en de te gebruiken dosering.

 

Graszodenteelt

Dosering:

Maximaal 4 liter middel per hectare.

Aangezien voor deze toepassing geen gegevens over fytotoxiciteit zijn beoordeeld, is het gebruik van Agrichem Ethofumesaat Flowable in deze teelt voor eigen risico van de teler. Het verdient aanbeveling vooraf advies te vragen bij de teeltadviseur over de gevoeligheid van de grassoorten die voorkomen in de zode en de te gebruiken dosering.

 

Opvolgende gewassen:
Om schade te voorkomen als gevolg van eventuele residuen van ethofumesaat in de grond moet voor het zaaien of planten eerst kerend worden geploegd, bijvoorbeeld bij een nateelt van wintergranen of bij een mislukte teelt. Bij mislukken van een gewas waarin Agrichem Ethofumesaat Flowable werd toegepast kunnen de volgende gewassen na kerend ploegen gezaaid of geplant worden: suiker- en voederbieten, maļs, bruine bonen, tuinbonen, raaigrassen, erwten, spinazie, knolselderij, wortelen, zaai- en plantuien.

 

 

 

 


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 6 april 2012 tot vereenvoudigde uitbreiding van de toelating van het middel Agrichem Ethofumesaat Flowable, toelatingnummer 10319 N

 

 

 

 

RISKMANAGEMENT

 

 

 

Contents                                                                  Page

 

 

1.    Identity of the plant protection product          10

 

2.   Physical and chemical properties                   10       

 

3.   Methods of analysis                                         10                              

 

4.   Mammalian toxicology                                      11                   

 

5.   Residues                                                           17                              

 

6.   Environmental fate and behaviour                17                   

 

7.   Ecotoxicology                                                    30                                          

 

8.   Efficacy                                                               48                                                      

 

9.   Conclusion                                                        48                                          

 

10. Classification and labelling                              48                   

 

 

 

Appendix 1    Table of authorised uses

Appendix 2    Reference list
1.         Identity of the plant protection product

 

1.1       Applicant

Agrichem BV

Koopvaardijweg 9

4906 CV Oosterhout

 

1.2              Identity of the active substance

ISO Common name

ethofumesate

Name in Dutch

ethofumesaat

Chemical name

(±)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-ylmethanesulfonate

CAS no.

26225-79-6

EEC no.

247-525-3

 

The active substance was included in Annex I of Directive 91/414/EEC on March 1st 2003. The applicant has its own manufacturing site for ethofumesate. This source (minimum purity 970 g/kg) is considered to be equivalent with the source evaluated for the inclusion of ethofumesate in Annex I of Directive 91/414/EEC.

 

1.3              Identity of the plant protection product

Name

Agrichem Ethofumesaat Flowable

Formulation type

SC

Content active substance

ethofumesate (pure): 500 g/L (~44.2% w/w)

 

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

 

1.4       Function

Agrichem Ethofumusaat Flowable is an herbicide.

 

1.5              Overview of uses applied for

See GAP (appendix 1).

 

1.6              Background to the application

It concerns a simplyfied extension of the authorisation.

 

1.7              Packaging details

Packaging details do not change.

 

2.                  Physical and chemical properties

 

The physical and chemical properties of the plant protection product remain unchanged.

 

3.                  Methods of analysis

 

For this simplified extension only the residue analytical methods for food/feed of plant and animal origin are assessed. Based on the proposed use of the plant protection product (production of grass seed and grass sods), analytical methods for determination of residues in food/feed of plant and animal origin are not required.

 

3.2.3    Conclusion

Based on the proposed use of the plant protection product (production of grass seed and grass sods), analytical methods for determination of residues in food/feed of plant and animal origin are not required.

 

3.3       Data requirements

None.

 

3.4       Physical-chemical classification and labelling

 

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

 

Symbol(s):

-

Indication(s) of danger: -

 

Risk phrase(s)

-

-

 

Proposal for the classification and labelling of the formulation concerning physical chemical properties

 

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

-

-

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

not applicable

Tactile warning of danger obligatory?

not applicable

                

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

 

4.         Mammalian toxicology

 

List of Endpoints

Ethofumesate is a new active substance, included in Annex I of 91/414/EEC. The final List of Endpoints presented below is taken from the final review report on ethofumesate (SANCO/6503/VI/99-final, 15 May 2002). Where relevant, some additional remarks/information are given in italics.

Agrichem cannot refer to the protected studies from the DAR. The ethofumesate beta taskforce (including Agrichem) has submitted new studies, which are equivalent to the studies evaluated in the DAR (see Board meeting C-179.3.2, d.d. March 14, 2007). Since the endpoints of the new studies are comparable with the endpoints from the studies in the DAR, the final EU List of Endpoints based on the DAR is used for the risk assessment.

 

Absorption, distribution, excretion and metabolism in mammals

Rate and extent of absorption:

Up to 100 % absorbed. Value based on oral and iv. dosing.

Distribution:

Widely distributed.

Potential for accumulation:

No evidence of accumulation

Rate and extent of excretion:

Rapid and almost complete within 24 h. Mainly via urine (approximately 90 %)

Toxicologically significant compounds:

Parent compound and metabolites

Metabolism in animals:

Extensively metabolised. Hydrolysis, oxidation and ring opening.

 

 

Acute toxicity

Rat LD50 oral:

> 5 000 mg/kg bw

Rat LD50 dermal:

> 2 000 mg/kg bw

Rat LC50 inhalation:

> 0.3 mg/l (whole-body exposure, dust aerosol) 1

Skin irritation:

Non-irritant.

Eye irritation:

Non-irritant.

Skin sensitization (test method used and result):

Non-sensitising (M&K, Buehler).

1 In the DAR for ethofumesate another acute inhalation study is summarized with an LC50 of > 3.97 mg/L (4 h nose only, highest attainable concentration). Based on this study ethofumesate does not classify for acute inhalation toxicity.

 

Short term toxicity

Target / critical effect:

Increased liver and kidney weights

Lowest relevant oral NOAEL / NOEL:

250 mg/kg bw/d (90-day oral study in dog)

Lowest relevant dermal NOAEL / NOEL:

1000 mg/kg bw/d (21-day dermal study in rabbit)

Lowest relevant inhalation NOAEL / NOEL:

Data not required.

 

 

Genotoxicity

No genotoxic potential. One test was positive but was not done according to OECD Guidelines. All other tests were negative (15 tests).

 

 

Long term toxicity and carcinogenicity

Target / critical effect:

Liver

Lowest relevant NOAEL:

7 mg/kg bw/d; 2-year feeding study in rat

Carcinogenicity:

No carcinogenic potential

 

Reproductive toxicity

Target / critical effect - Reproduction:

Decreased pup weight at parental toxic dose levels

Lowest relevant reproductive NOAEL / NOEL:

78 mg/kg bw/d; multigeneration study in rat (Tesh-1980) 2

Target / critical effect - Developmental toxicity:

Foetotoxicity.
Increased incidences of resorption at maternal toxic dose levels.
Increase in the delayed ossification is not significant at litter toxic dose levels.

Lowest relevant developmental NOAEL / NOEL:

300 mg/kg bw/d (developmental study in rabbit) 3

2 Also parental NOAEL

3 Also maternal NOAEL

 

Delayed neurotoxicity

Data not required. No indication from other studies.

 

 

Other toxicological studies

Data not required.

 

 

Medical data

General survey of accessible literature: no adverse effects in humans exposed.

 

Summary

 

 

Value

Study

Safety factor

ADI:

0.07 mg/kg bw/d

2-y rat (Suresh‑95)

100

AOEL systemic:

2.5 mg/kg bw/d

90-d dog (Brownlie-94)

100

ARfD (acute reference dose):

Not required

 

 

 

 

Dermal absorption

No data. Default value of 10% is used for calculations. 4

4 See 4.2 for comment on dermal absorption

 

Local effects

Ethofumesate does not produce local effects, neither after a single nor repeated exposure.

 

Data requirements active substance

No additional data requirements are identified.

 

4.1       Toxicity of the formulated product (IIIA 7.1)

The formulation Agrichem Ethofumesaat Flowable does not need to be classified on the basis of its acute oral and dermal toxicology (based on the calculation rules described in Directive 1999/45/EG).

The formulation Agrichem Ethofumesaat Flowable does not need to be classified on the basis of its acute inhalation toxicology (no study available, not required).

The formulation Agrichem Ethofumesaat Flowable does not need to be classified for dermal irritation.

The formulation Agrichem Ethofumesaat Flowable does not need to be classified for eye irritation or skin sensitisation (based on the calculation rules described in Directive 1999/45/EG).

 

4.1.1    Data requirements formulated product

No additional data requirements are identified.

 

4.2       Dermal absorption (IIIA 7.3)

NL commented on dermal absorption for ECCO76, WG-Evaluation and WG-Legislation. Based on physical chemical parameters (Mol. Weight 286, log Pow 2.7) and the almost complete oral absorption, the value for dermal absorption might be much higher. In the absence of data, a default value of 100% should be used according to the EU Guidance document on Dermal Absorption (Rev. 7). Since the dermal absorption is a formulation related property, NL can deviate from the value in the List of Endpoints. For risk assessment a value of 100% will be used.

 

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

The available toxicological data relating to non-active substances will be taken into account in the classification and labelling of the formulated product.

 

4.4       Exposure/risk assessments

 

4.4.1    Operator exposure/risk

According to the Dutch Plant Protection Products and Biocides Regulations the risk assessment is performed according to a tiered approach. There are four possible tiers:

Tier 1: Risk assessment using the EU-AOEL without the use of PPE

Tier 2: Risk assessment using the NL-AOEL without the use of PPE

Tier 3: Refinement of the risk assessment using new dermal absorption data

Tier 4: Prescription of PPE

 

Tier 1

 

Calculation of the EU-AOEL / Tolerable Limit Value (TLV)

For ethofumesate no TLV has been set. The AOEL will be used for the risk assessment.

Since the formulation is applied once in perennial and Italian ryegrass (seed production) during the period of March - November, a semi-chronic AOEL is applicable (including contract workers).

Since ethofumesate is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 2.5 mg/kg bw/day (= 175 mg/day for a 70-kg operator), based on the 90 day study in dogs, is applied (see List of Endpoints).

 

Exposure/risk

Exposure to ethofumesate during mixing and loading and application of Agrichem Ethofumesaat Flowable is estimated with models. The exposure is estimated for the unprotected operator. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and application have to be combined.

In the Table below the estimated internal exposure is compared with the systemic EU-AOEL.

 

Table T.1 Internal operator exposure to ethofumesate and risk assessment for the use of Agrichem Ethofumesaat Flowable

 

Route

Estimated internal exposure a (mg /day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on grass seed crops and turf (4 L/ha) (uncovered)

Mixing/

Loadingc

Respiratory

0.10

175

<0.01

Dermal

400

175

2.3

Applicationc

Respiratory

0.16

175

<0.01

Dermal

60.0

175

0.3

 

Total

460

175

2.6

a    Internal exposure was calculated with:

·       biological availability via the dermal route:   100% (concentrate and spray dilution) (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    External exposure is estimated with EUROPOEM.

 

Since the EU-AOEL is exceeded without the use of PPE, a tier 2 assessment has to be performed using the NL-AOEL.

 

Tier 2

 

Calculation of the NL-AOEL

The risk index calculated with the EU-AOEL is >1. Therefore, the Plant Protection Products and Biocides Regulations (NL: Rgb) prescribes the calculation of the risk with an AOEL based on allometric extrapolation (known as the NL-AOEL). This method takes into account the caloric demand of the species studied and results in a more specific value than the EU-AOEL for which a standard factor of 100 is applied.

 

The calculation of the systemic AOEL for semi-chronic exposure is based on the overall NOAEL of 350 mg/kg bw/day in the short term studies with the rat (including the multigeneratition studies). Calculations from other studies result in higher AOELs.

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

 

Used factors are:

·       extrapolation rat® human on basis of caloric demand                                      4

·       other interspecies differences:                                                                            3

·       intraspecies differences: (professional use)                                                       3

·       biological availability via oral route:                                                                      100%*

·       weight of professional operator/worker:                                                              70 kg

* If the absorbed dose is significantly lower (<80%) than the administered dose, this is adjusted by a correction factor equal to the percentage absorption.

 

AOELsystemic: 350 x 70 / (4 x 3 x 3) =681 mg/day

 

Table T.2 Internal operator exposure to ethofumesate and risk assessment for the use of Agrichem Ethofumesaat Flowable

 

Route

Estimated internal exposure a (mg /day)

Systemic

NL-AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on grass seed crops and turf (4 L/ha) (uncovered)

Mixing/

Loadingc

Respiratory

0.10

681

<0.01

Dermal

400

681

0.6

Applicationc

Respiratory

0.16

681

<0.01

Dermal

60.0

681

0.09

 

Total

460

681

0.7

a    Internal exposure was calculated with:

·       biological availability via the dermal route:   100% (concentrate and spray dilution) (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    External exposure is estimated with EUROPOEM.

 

Since the NL-AOEL is not exceeded without the use of PPE, a higher tier assessment is not required.

 

4.4.2    Bystander exposure/risk

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

 

4.4.3    Worker exposure/risk

Shortly after application it is not necessary to perform any re-entry activities during which intensive contact with the treated crop will occur. Therefore no worker exposure is calculated.

 

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 ethofumesate as a result of the application of Agrichem Ethofumesaat Flowable in grass seed crops and turf.

 

Bystander exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected bystander due to exposure to ethofumesate during application of Agrichem Ethofumesaat Flowable in grass seed crops and turf.

 

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 in grass seed crops and turf due to exposure to ethofumesate after application of Agrichem Ethofumesaat Flowable.

 

4.5       Appropriate mammalian toxicology and operator exposure endpoints relating to
the product and approved uses

See List of Endpoints.

 

4.6       Data requirements

None.

 

4.7       Combination toxicology

Agrichem Ethofumesaat Flowable contains only one active substance and it is not described that it should be used in combination with other formulations.

 

4.8       Mammalian toxicology classification and labelling

 

Proposal for the classification and labelling of the formulation concerning health

 

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

 

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

-

Symbol:

-

Indication of danger:

 

R phrases

-

-

S phrases

-

-

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?

n.a.

Tactile warning of danger obligatory?

n.a.

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

Based on the tier 2 risk assessment using NL-AOEL as prescribed in the Plant Protection Products and Biocides Regulations (NL: Rgb) S37d-NL is no longer warranted.

Other:

-

 

5.         Residues

 

The application for authorisation of the plant protection product Agrichem Ethofumesaat Flowable in grass seed crops and turf does not concern crops used for food or feed (use of grass as well as the hay after harvest of the seeds is prohibited as livestock feed). Therefore, a further assessment of the residual behaviour of ethofumesate is not necessary. The additional risk for consumers is considered to be negligible.

 

6          Environmental fate and behaviour

 

Risk assessment is done in accordance with Chapter 2 of the RGB published in the Government Gazette (Staatscourant) 188 of 28 September 2007, including the updates of 20 October 2009 (which came into effect on 1 January 2010) and 18 April 2011 (which came into effect on 23 April 2011).

 

Agrichem is not the owner of the EU dossier but has an equivalent dossier. Therefore the assessment is done based on the List of Endpoints presented in the Review report (15/05/2002). Comments by the Ctgb are included in italics.

 

List of Endpoints Fate/behaviour  (review report, May 2002)

 

Fate and Behaviour in the Environment

 


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

Mineralization after 100 days

Range 6 - 13%; median 8.7%; n=5

Non-extractable residues after 100 days

Range 16 - 34%; median 31%; n=5

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

All less than 6%

 

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

Anaerobic degradation

Not relevant because of very slow transformation

Soil photolysis

In one study: maximum conc. of NC8493 30%

 

           

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

Method of calculation

9 of 10 calculated according to 1st order kinetics,

1 of 10 calculated according to 1.5 order kinetics

Laboratory studies (range or median, with n value,

with r2 value)

DT50lab (20°C, aerobic, 40 - 75% WHC):

Range 47 – 211 days; mean 97 days;

median 84 d n=10

 

DT90lab (20°C, aerobic, 40 - 75% WHC):

Range 210 – 701 days; median 331 days; n=10

 

DT50lab (10°C, aerobic): No study

Calculation of DT50 at 10°C carried out on eight DT50 laboratory tests (20-21°C, aerobic) using Q10=2.2.

Results: DT50, (10°C, aerobic): 198 days.

 

DT50lab (20°C, anaerobic):

Very slow transformation: 90-100% unaltered after 60d.

 

Degradation in the saturated zone: No study

Soil photolysis

DT50, two studies:

14 d; ³290 nm, 24 h light 1.5 kg as/ha.

 65 days; 300-800 nm, light 12 h per day, 15 mg as/kg.

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

DT50f:

Germany: One dose range 0.8 - 6.5 kg as/ha: range 15 - 250 days; median 65 days; n=10. Not dose related

 

UK:  One dose 1.5 kg as/ha: 36 and 56 days; mean 46 days; n=2

 

California, USA: 2.1 kg as/ha: 75 days; n=1

Calculated mean of all = 77 d; median = 56 d; n=13

 

DT90f:

Germany: One dose range 0.8 - 6.5 kg as/ha: range 3 months - >3 years; median ca.11 months; n=11

 

UK:  One dose 1.5 kg as/ha: 4 and 4.6 months, mean 4.3 months; n=2

Soil accumulation and plateau concentration

No relevant data.

Accumulation calculated based on a field DT50 = 119 days assuming 5.0 cm incorporation

a)      Application of 1.0 kg as/ha and year, a plateau concentration of 114% of maximum PECsoil reached after 3 years. Plateau concentration 1.5 mg as/kg soil.

 

Application 1.0 kg as/ha each third year new GAP dec. 1999). There was no significant accumulation. Three years after applic. 0.1% of dose remained.

 


Soil adsorption/desorption (Annex IIA, point 7.1.2)

Kf /Koc

Kd

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

dependence)

Koc = range 97 - 245; mean = 147; median 132; n=11

 

Kd = range 0.73 – 6.2; mean = 2.7; median 2.3; n=11

Not pH dependent

Koc sediment

Koc = 267 and 449; mean 358, n=2

Kd  = 6.1 and 19.4; mean 12.8, n=2

 

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

Column leaching

 

According to BBA Guideline: 200 mm over 2 days: n.d.-2.9% as; n=9

Other method, 508 mm over 15-20 d.: 4.2-67% of applied radioactivity; n=4

Aged residues leaching

 

Three different methods: n.d.-4.2% of applied initial radioactivity; n=5

Lysimeter/ field leaching studies

 

Two studies according to BBA guideline:

 

Two lysimeters per study:

1.      Three lysimeters with loamy sand soil. Lysimeter surface area 0.5 m2 and 1.0 m depth. One dose of 1.25 kg as/ha applied pre-emergence to sugar beet in April 1992. Rainfall of ca. 857 mm/year. Terminated after 2 years.
LOD = 0.1 µg/L

 

2.      Two lysimeters with a sandy soil.Lysimeter surface area 1.0 m2 and 1.2m depth. One dose of 1.5 kg as/ha applied to fodder beet on both lysimeters in May year 1 and additionally to one lysimeter in May year 2. Total rainfall (4 years) 3280 mm. Terminated after 3 years. LOD = 0.01 µg/L

 

Results: No detectable amount active substance or metabolite in leachate in any of the lysimeters.

 

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

Hydrolysis of active substance and relevant metabolites (DT50) (20°C)

pH___5.0___: Negligible

 

pH___7.0___: Negligible

 

pH___9.2___: Negligible

 

Photolytic degradation of active substance and

relevant metabolites

Artificial light: (greatly variable results)

37-62d (summer, 40-60ŗN)

4.6 d  (on a year basis) / 2.6 d (for month May)

 

 

Readily biodegradable (yes/no)

Not readily biodegradable; n=3

Degradation in water/sediment

 

-DT50 water

 

 

 

 

- DT90 water

                           

 

- DT50 whole system

 

 

 

                           

- DT90 whole system

 

 

 

Calculations: 3 out of 5 according to first order kinetics, 2 out of 5 according to 1.5th order kinetics

Study 1: 13 days, n=1 (1st order)

Study 2: 11 and 19 days, n=2 (1st and 1.5th order, resp.)

Study 3: 7 and 50 days, n=2 (root of 1st order)

Study 1:   -

Study 2: 121 and 212 days, n=2

Study 3: -

Study 1: 125 days, n=1, (1st order)

Study 2: 105 and 153 days, n=2 (1st and 1.5th order, resp.)

Study 3: 242 and 285 days, n=2 (root of 1st order

Study 1: -

Study 2: 507 and 550 days, n=2

Study 3: -

 

Ctgb: only SFO fits are taken into account in the assessment.

Distribution in water / sediment systems (as)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Metabolites

Study 1: After 84 days, 14% of applied radioactivity as parent compound in water/51% of in sediment, n=1. Maximum 53% parent compound in the sediment after 63 days of incubation. No DT50 could be calculated.

 

Study 2: After 103 days, 13-18% of applied radioactivity as parent compound in water / 37-41% in sediment. Maximum 48 – 49 % of applied as parent compound in the sediment after 30 days of incubation. Thereafter DT50 in the sediment 170 – 270 days.

 

Study 3: After 225 and 234 days, 21 and 1.5% of applied radioactivity as parent compound in water / 30 and 53% in sediment.

 

Maximum of 4 unknown metabolites, altogether up to 17% of applied radioactivity.

 

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

Direct photolysis in air

 

No study. Not required.

Photochemical oxidative degradation in air (DT50)

 

2.1 h, calc. according to Meyland and Howard (AOP)

4.1 h, calc. According to Atkinson

Volatilisation

From plant surfaces:

22% lost from plant surface during 24 hours

 

From soil:

15% lost from soil surface during the first 24 hours

 

Definition of the Residue (Annex IIA, point 7.3)

Relevant to the environment

Soil, water and sediment: Ethofumesate

 



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

Soil (indicate location and type of study)

No data

Surface water (indicate location and type of study)

 

 

1) Monitoring area: Vemmenhög a drained catchment area with intensive agriculture, Scania, south of  Sweden :

 Samples collected during growing season, usually May to September in 1992-1998 in an open ditch receiving drainage water, 1991-1992 and at the outlet of culvert in 1992-1996.

 

Range of applied dose 1991-1996 is 0.17 to 0.30 kg as/ha in cultivation of sugar beet, covering 10 to 19% of catchment area during the period. LOD = 0.1-0.2 µg/l.

 

Reported TWMC(Time Weighted Mean Conc):

a) 1991and 1992 (open ditch): No of samples 34 and 30; frequency of detection 53 and 37%; TWMC  = 0.06 and 0.21 µg as/l, resp.

b) 1992, 1993, 1994, 1995 and 1996 (outlet of culvert): No of samples 29, 25, 18, 22 and 22; frequency of detection 97, 87, 78, 77, and 68%; TWMC  = 1.08, 0.39, 0.63, 0.14 and 0.10 µg as/l, resp.

c) 1998: Low frequency of detection and low concentration.

 

Decrease in frequency and concentrations during the sampling period has been explained by measures taken to minimise effects from bad management and surface run-off.

 

2) Monitoring area: East Anglia UK (Sugar beet growing area. A total number of 792 samples over a 5 years period.

Results: 16 samples ³0.1 µg/l; 42 samples <0.1µg/l but >LOD; LOD = 0.02-0,05 µg/l.

Remark: No details on use of as regarding dose and frequency.

 

Ground water (indicate location and type of study)

 

 

1) East Anglia, UK. A sugar beet growing region. A tot. number of 78 samples from 43 different groundwater wells over a 5 year period.

Results: 1 sample = 0.2 µg/l; 6 samples <0.1 µg/l >LOD; LOD = 0.02-0,05 µg/l.

Remark: No details on use of as regarding dose and frequency.

Air (indicate location and type of study)

No data

 

Appendix A: Metabolite names, codes and other relevant information of the pesticide Agrichem Ethofumesate Flowable with active substance ethofumesate.

 

The compounds shown below were found in one or more studies involving the metabolism and/or environmental fate of ethofumesate. The parent compound structure of ethofumesate

is shown first in this list and followed by degradation or related compounds.

 

Compound name

Code number(s)

IUPAC name

Structural formula

Structure

Molecular Weight

[g/mol]

Observed in study (% of occurrence/ formation)

Ethofumesate

-

(±)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-ylmethanesulfonate

C13H18O5S

286.3

parent

 

 

6.1       Fate and behaviour in soil

 

6.1.1    Persistence in soil

Article 2.8 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion persistence. If for the evaluation of the product a higher tier risk assessment is necessary, a standard is to be set according to the MPC-INS[1] method. Currently this method equals the method described in the Technical Guidance Document (TGD). Additional guidance is presented in RIVM[2]-report 601782001/2007[3].

 

Preceding the harmonisation of the persistence assessment in The Netherlands with regulation 1107/2009/EG, the EU approach for persistence assessment is followed.

 

For the current application this means the following:

 

Active substance ethofumesate

The following laboratory DT50 values are available for the active substance ethofumesate: range: 47 – 211 days (average 97 days, median value 84 days). The mean DT50-value of the a.i. can thus be established to be > 90 days. It can be excluded that after 100 days there will be more than 70% bound (non-extractable) residues of the initial dose together with the formation of less than 5% CO2 of the initial dose.

 

Due to the exceeding of the threshold value of 60 days for the mean DT50 (lab) for the active substance, it has to be demonstrated by means of field dissipation studies that the field DT50 is < 90 days. There are field data provided: mean DT50 = 77 days, range 15 – 250 days, median DT50 = 56 days. From the results it is shown that the average field DT50 is < 90 days.

 

There are no major metabolites.

 

Based on the above, the standards of persistence as laid down in the RGB are met.

 

PECsoil

The concentration of ethofumesate in soil is needed to assess the risk for soil organisms (earthworms, micro-organisms). The PECsoil is calculated for the upper 5 cm of soil using a soil bulk density of 1500 kg/m3.

Since the log Kow of ethofumesate is < 3 (2.7), no risk assessment for secondary poisoning is necessary.

 

The following input data are used for the calculation:

 

PEC soil:

 

Active substance ethofumesate:

Maximum field DT50 for degradation in soil:  250 days

 

Molecular mass: 286.3 g/mol

 

See Table M.1 for other input values and results.

 

Table M.1 PECsoil calculations for active substance ethofumesate (5 cm)

Use

Substance

Rate

 

[kg a.s./ha]

Freq. /interval

[days]

Fraction on soil *

PIECsoil

(5 cm)

[mg a.s./kg]

Grass seed crops and turf

ethofumesate

2.0

1 / n.a.

0.4

1.07

* fraction on soil is determined as 1 – interception value; interception values derived from Table 1.6 in “generic guidance for FOCUS groundwater scenarios”. An interception of 60 % is appropriate for grass at BBCH 20-39.

 

These exposure concentrations are examined against ecotoxicological threshold values in section 7.5.

 

6.1.2        Leaching to shallow groundwater

Article 2.9 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion leaching to groundwater.

 

The leaching potential of the active substance is calculated in the first tier using Pearl 4.4.4 and the FOCUS Kremsmünster scenario. Input variables are the actual worst-case application rate of 2 kg/ha, the crop (grass) and an interception value appropriate to the crop stage of 0.6. Date of yearly spring application is May 25th (default) and for autumn application is November 1st.

 

The following input data are used for the calculation:

 

PEARL:

 

Active substance ethofumesate:

median lab DT50 for degradation in soil (20°C): 84 days

median Kom (pH-independent): 78 L/kg

1/n: 0.9 (default)

 

Saturated vapour pressure: 6.5 x 10-4 Pa (25°C)

Solubility in water: 50 mg/L (25°C)

Molecular mass: 286.3 g/mol

 

Plant uptake factor: 0.5 (systemic active substance)

Q10: 2.2

 

Other parameters: standard settings of PEARL 4.4.4

 

The following concentrations are predicted for the active substance ethofumesate following the realistic worst case GAP, see Table M.2a.

 

Table M.2a Leaching of a.s. ethofumesate as predicted by PEARL 4.4.4

Use

Substance

Rate substance [kg/ha]

Frequency/ Interval [days]

Fraction

Intercepted *

PEC

groundwater [mg/L]

 

 

 

 

 

spring

autumn

Grass seed crops and turf

Ethofumesate

2.0

1 / -

0.6

2.931

3.608

* interception values derived from Table 1.6 in “generic guidance for FOCUS groundwater scenarios”. An interception of 60 % is appropriate for grass at BBCH 20-39.

 

Results of Pearl 4.4.4 using the Kremsmünster scenario are examined against the standard of 0.01 µg/L. This is the standard of 0.1 µg/L with an additional safety factor of 10 for vulnerable groundwater protection areas (NL-specific situation).

 

From Table M.2a it reads that the expected leaching based on the PEARL-model calculations for the active substance ethofumesate larger than 0.1 µg/L. Therefore, further study into the leaching behaviour is necessary.

 

Lysimeter/field leaching studies

An extensive assessment for leaching was made in decision of the Board d.d. 7th of March 2008 (C.190.3.13, for the same formulation). The main findings from that assessment are included here.

 

A lysimeter study in sugar beets has been submitted. In this lysimeter no ethofumesate was found in the leachate. A vulnerability assessment according to the report by Verschoor et al. 2001 showed a more vulnerable soil profile compared with the Dutch standard scenario. The precipitation and irrigation is comparable. The soil temperature is higher and by that less vulnerable. No parallel studies on DT50 and Kom with the lysimeter soil are available. Nevertheless standardisation according to Verschoor was carried out. The result was a simulation error (SE) of 2 x 10-12. This value is not relevant for risk assessment because this value is too low.

 

A second lysimeter study has been submitted together with a standardisation according to Verschoor (2001). Also in this lysimeter no ethofumesate was found in the leachate. However the same argumentation with regard to vulnerability as above is true. Furthermore, according to the report by Verschoor a quantitative vulnerability assessment can only be sufficient if a lysimeter study was triggered by a slight exceeding of the trigger concentration by the model calculations. Standardisation of the lysimeters on the basis of the standard dossier data according to Verschoor revealed a simulation error of 0.75.

For the lysimeter soil a preliminary sorption test was performed that resulted in a Kom value of 106 L/kg. This value can be used for the standardisation calculation. If the value is used together with the worst case DT50 value of 47 days a simulation error of 262 is calculated.

In the lysimeters during the experiment the concentration ethofumesate was measured in the top layers of the soil. There are 3 time points available. From these measurements a half-life in the lysimeter topsoil can be estimated. From these calculations a lysimeter half-life of 29.4 days was derived. Standardisation using the lysimeter specific DT50 and Kom value revealed a simulation error of 14.5.

From the final degradation and sorption studies with the lysimeter soil a lysimeter half-life of 58.8 days and a Kom value 108.4 L/kg were derived. Standardisation using the lysimeter specific DT50 and Kom value revealed a simulation error of 4513, which is the correct value to use for further assessment.

 

Standardisation using the third lysimeter (grass) specific DT50 and Kom value revealed a simulation error of > 42280. Simulation errors for ethofumesate were calculated for the two soil types of the three lysimeter soils. In principle the simulation errors of all lysimeters can be used for the risk assessment for deriving the adjustment factor. Nevertheless the very low simulation error is excluded because this value is not relevant for risk assessment. Calculated values and conclusions for leaching including lysimeter data are given in Table M.2b. According to Van der Linden et al., the adjustment factor for leaching estimations in the authorisation procedure is 4513 (2 experiments, 1 number of lysimeter soils).

 


Table M.2b Expected leaching for the active substance ethofumesate including correction based on lysimeter studies

Use

Substance

Computed target

 

 

[mg/L]

Simulation Error (mean)

No. of lysimeter soils

fadjustment

Adjusted PEC

groundwater

spring (modelled target conc./fadj.) [mg/L]

Grass seed crops and turf

Ethofumesate

2.931

(spring)

3.608

(autumn)

23396.5

1

4513

< 0.001

 

< 0.001

 

From Table M.2b it reads that the expected leaching for the active substance ethofumesate based on the PEARL-model calculations including correction is smaller than 0.01 µg/L for all proposed applications. Hence, the applications meet the standards for leaching.

 

Monitoring data

Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90th percentile.

 

In earlier assessments of Agrichem Ethofumesate Flowable, monitoring data from groundwater monitoring from five locations in Denmark and from a regional survey in the Netherlands are described. The applicant submitted statements that at greater depths in none of the samples ethofumesate was detected. The original reports were not submitted. In the Danish study for most of the locations the filter depth is missing. For the Dutch survey also essential information is missing to enable use of the monitoring data in the assessment. Therefore, these are considered supplemental information.

 

Conclusions

The active substance ethofumesate complies with the standards for persistence in soil laid down in the RGB.

 

The proposed application of the product complies with the requirements laid down in the RGB concerning leaching in soil.

 

6.2       Fate and behaviour in water

 

6.2.1    Rate and route of degradation in surface water

Article 2.10c of the Plant Protection Products and Biocides Regulations (RGB) prescribes the use of Dutch specific drift percentages.

 

The exposure concentrations of the active substance ethofumesate in surface water have been estimated for the various proposed uses using calculations of surface water concentrations (in a ditch of 30 cm depth), which originate from spray drift during application of the active substance. The spray drift percen­tage depends on the use.

 

Concentrations in surface water are calculated using the model TOXSWA. The following input data are used for the calculation:

 

TOXSWA:

Active substance ethofumesate:

Geometric mean DT50 for degradation in water at 20°C: 114.6 days (only SFO fits taken into account)

DT50 for degradation in sediment at 20°C: 1000 days (default).

 

Arithmetic mean Kom for suspended organic matter: 78 L/kg

Arithmetic mean Kom for sediment: 78 L/kg

1/n: 0.9 (default)

 

Saturated vapour pressure: 6.5 x 10-4 Pa (25°C)

Solubility in water: 0.05 g/L (25°C)

Molecular mass: 286.3 g/mol

Q10: 2.2

 

Other parameters: standard settings TOXSWA

 

When no separate degradation half-lives (DegT50 values) are available for the water and sediment compartment (accepted level P-II values), the system degradation half-life (DegT50-system, level P-I) is used as input for the degrading compartment and a default value of 1000 days is to be used for the compartment in which no degradation is assumed. This is in line with the recommendations in the FOCUS Guidance Document on Degradation Kinetics. Only spring scenarios are calculated as these provide worst case exposure concentrations. See Table M.3a for results.

 

Table M.3a Overview of surface water concentrations for active substance ethofumesate in the edge-of-field ditch following spring application

Use

Substance

Rate a.s.

[kg/ha]

Freq./ Interval [days]

Drift

 

[%]

PIEC

 

[mg/L] *

PEC21

 

[mg/L] *

PEC28

 

[mg/L] *

Grass seed crops and turf

Ethofumesate

2.0

1

1

9.519

8.475

8.162

* calculated according to TOXSWA

 

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

 

Monitoring data

Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90th percentile.

 

The Pesticide Atlas on internet (www.pesticidesatlas.nl, www.bestrijdingsmiddelenatlas.nl) is used to evaluate measured concentrations of pesticides in Dutch surface water, and to assess whether the observed concentrations exceed threshold values. Dutch water boards have a well-established programme for monitoring pesticide contamination of surface waters. In the Pesticide Atlas, these monitoring data are processed into a graphic format accessible on-line and aiming to provide an insight into measured pesticide contamination of Dutch surface waters against environmental standards. Recently, the new version 2.0 was released. This new version of the Pesticide Atlas does not contain the land use correlation analysis needed to draw relevant conclusions for the authorisation procedure. Instead a link to the land use analysis performed in version 1.0 is made, in which the analysis is made on the basis of data aggregation based on grid cells of either 5 x 5 km or 1 x 1 km.

 

Data from the Pesticide Atlas are used to evaluate potential exceeding of the authorisation threshold and the MPC (ad-hoc or according to INS) threshold. For examination against the drinking water criterion, another database (VEWIN) is used, since the drinking water criterion is only examined at drinking water abstraction points. For the assessment of the proposed applications regarding the drinking water criterion, see next section.


Active substance ethofumesate

The active substance ethofumesate was observed in the surface water (most recent data from 2010). In Table M.4 the number of observations in the surface water are presented.

In the Pesticide Atlas, surface water concentrations are compared to the authorisation threshold value of 32.0 µg/L (4/9/2009, C-200.3.8, consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case 0.1*NOEC Daphnia) and to the indicative Maximum Permissible Concentration (MPC) of 6.4 µg/L as presented in the Pesticide Atlas (data source for the MPC: Zoeksysteem normen voor het waterbeheer, http://www.helpdeskwater.nl/normen_zoeksysteem/normen.php).

 

Currently, this MPC value is not harmonised, which means that not all available ecotoxicological data for this substance are included in the threshold value. In the near future and in the framework of the Water Framework Directive, new quality criteria will be developed which will include both MPC data as well as authorisation data. The currently available MPC value is reported here for information purposes. Pending this policy development (finalisation for all substances expected in 2009-2010), however, no consequences can be drawn for the proposed application.

 

Table M.4 Monitoring data in Dutch surface water (from www.pesticidesatlas.nl, version 2.0)

Total no of locations

(2010)

n > authorisation threshold

n > indicative/ad hoc MPC threshold

n > MPC-INS threshold *

417**

0

0

n.a.

* n.a.: no MPC-INS available

** the number of observations at each location varies between 1 and 30, total number of measurements is 2114 in 2010.

 

As there are no exceedings of thresholds, the monitoring data have no consequences for the proposed use of the product.

 

Drinking water criterion

Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90th percentile.

 

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’. The assessment methodology followed is developed by the WG implementation drinking water criterion and outlined in Alterra report 1635[4].

 

Substances are categorized as new substances on the Dutch market (less than 3 years authorisation) or existing substances on the Dutch market (authorised for more than 3 years).

-          For new substances, a preregistration calculation is performed.

-          For existing substances, the assessment is based on monitoring data of VEWIN (drinking water board).

o        If for an existing substance based on monitoring data no problems are expected by VEWIN, Ctgb follows this VEWIN assessment.

o        If for an existing substance based on monitoring data a potential problem is identified by VEWIN, Ctgb assesses whether the 90th percentile of the monitoring data meet the drinking water criterion at each individual drinking water abstraction point.

 

Active substance ethofumesate

Active substance ethofumesate has been on the Dutch market for > 3 years (authorised since 25/06/1999). This period is sufficiently large to consider the market share to be established. The existing active substance ethofumesate is included in the list of substances of concern due to its presence in surface water at drinking water abstraction points as established by VEWIN/Ctgb. Therefore, an adequate risk assessment is needed based on the highest tier data. There are monitoring data concerning the presence of ethofumesate at drinking water abstraction points. See Table M.5.

 

Table M.5 Monitoring data for ethofumesate at drinking water abstraction points from surface water in the period 2006 – 2010

Abstraction point

Number of measurements above detection limit/ Number of measurements

[n/N]

Number of measurements above drinking water limit/ Number of measurements

[n/N]

Overall

90-percentile

 

 

 

[μg/L]

Andijk

0/26

0/26

0.010

Nieuwegein

0/39

0/39

0.010

Amsterdam-Rijn kanaal (Nieuwersluis)

0/26

0/26

0.010

Brakel

2/65

0/65

0.010

Heel

0/5

0/5

0.021

Petrusplaat/Keizersveer

16/65

1/65

0.050

Scheelhoek/Stellendam

6/55

0/45

0.016

Drentsche Aa (De Punt)*

1/~170

1/~170

n.c.

* for Drentsche Aa, only one sample (in 2009, the 2010 data are not yet available for the Drentsche Aa) was reported above the detection limit and also above the drinking water limit. About 170 sample points are indicated in the data set, however no detection limit is provided. It is considered that the 90-percentile is below 0.1 µg/L.

 

The relevant monitoring data (data set VEWIN, 2006 -2010) indicate that the 90-percentile conentrations of each individual abstraction point do not exceed the threshold of 0.1 µg/L. Therefore, the application of Agrichem Ethofumesate Flowable is not expected to exceed the drinking water criterion. The standards for surface water destined for the production of drinking water as laid down in the RGB are met.

 

6.3       Fate and behaviour in air

 

Route and rate of degradation in air

Active substance ethofumesate

The vapour pressure is 6.5 x 10-4 Pa (25ŗC). The Henry constant is 6.8 x 10-4 Pa×m3×mol -1, at 25°C. The half-life in air is 2.1-4.1 hours.

 

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 endpoints relating to the product and approved uses

See List of Endpoints.

 

6.5              Data requirements

None.

 

The following restriction sentences were proposed by the applicant:

Toepassing door middel van een luchtvaartuig is niet toegestaan.

 

Om niet tot de doelsoorten behorende planten te beschermen is de toepassing in de teelt van graszaad en graszoden uitsluitend toegestaan indien er gebruik wordt gemaakt van driftarme spuitdoppen.

 

De totale dosering in één seizoen mag niet hoger zijn dan 2 kg ethofumesaat (als werkzame stof) per hectare.

 

Based on the current assessment, the following has to be stated in the GAP/legal instructions for use:

De totale dosering in één seizoen mag niet hoger zijn dan 2 kg ethofumesaat (als werkzame stof) per hectare.

 

6.6       Overall conclusions fate and behaviour

It can be concluded that:

  1. the active substance ethofumesate meets the standards for persistence in soil as laid down in the RGB.
  2. all proposed applications of the active substance ethofumesate meet the standards for leaching to the shallow groundwater as laid down in the RGB.
  3. all proposed applications of the active substance ethofumesate meet the standards for surface water destined for the production of drinking water as laid down in the RGB.

 

7          Ecotoxicology

 

Risk assessment is done in accordance with Chapter 2 of the RGB for products based on
- active substances which have already been placed on Annex I of directive 91/414/EEC

- “new” active substances

 

This means that for the current application of Agrichem Ethofumesaat Flowable, risk assessment is done in accordance with Chapter 2 of the RGB.

 

List of Endpoints Ecotoxicology ethofumesate

Ethofumesate is an existing substance included in Annex I. Agrichem cannot refer to the protected studies from the monograph. The ethofumesate beta taskforce (including Agrichem) has submitted new studies, which are equivalent to the studies from the monograph. Since the endpoints of the new studies are comparable with the endpoints from the monograph, the definitive List of Endpoints from the monograph is used for the risk assessment (26/02/2002; review report d.d.05/2002). Comments and additions are given in italic.

 

Terrestrial Vertebrates

Acute toxicity to mammals:

LD50 > 5000 mg/kg bw (rat)

Acute toxicity to birds:

LD50 > 2000 mg/kg bw (mallard duck, quail)

Dietary toxicity to birds:

LC50 > 5200 mg/kg feed (mallard duck, quail)

NOEC = 2600 mg/kg feed

Reproductive toxicity to birds:

NOEL >406 mg/kg bw per day (>3000 mg/kg feed)

Reproductive toxicity to mammals:

NOAEL 300 mg as/kg bw, rabbit, teratogenicity, foetal

 

Aquatic Organisms

Acute toxicity fish:

LC50 = 11 mg as/l (96 h; Cyprinus carpio)

LC50 »13 mg as/l (Betanal Progress; 96 h; Cyprinus carpio)

LC50 »26 mg as/l, based on mean measured concentration (Tramat 500; 96 h; Cyprinus carpio)

Long term toxicity fish:

NOEC = 0.8 mg as/l (21 d; Oncorhynchus mykiss)

Bioaccumulation fish:

144 (based on total radioactivity)

Acute toxicity invertebrate:

EC50 = 14 mg as/l (48 h; Daphnia magna)

EC50 » 30 mg as/l (Tramat 500; 48 h; Daphnia magna)

Chronic toxicity invertebrate:

NOEC = 0.32 mg as/l (21 d; Daphnia magna)

Acute toxicity algae:

EC50 = 3.9 mg as/l (96 h; Scenedesmus subspicatus)

EC50 = 6.7 mg as/l (Ethofumesate 50SC; 96 h; Scenedesmus subspicatus)

Chronic toxicity sediment dwelling organism:

NOEC > 5.0 mg as/l (28 d; Chironomus riparius)

Acute toxicity aquatic plants:

EC50 > 50 mg as/l (14 d; Lemna minor)

NOEC = 4.3 mg as/l (14 d; Lemna minor)

 

 

Remarks

* Betanal Progress is a formulation containing ethofumesate plus two other active substances

 

Honeybees

Acute oral toxicity:

>50 µg/bee

Acute contact toxicity:

>50 µg/bee

 

Other arthropod species

 

% Adverse Effect1

Aleochora bilineata

No effects
(
adult; mortality, egg production and viability; Tramat 500; 1.25 kg as/ha)

Poecilus cupreus

No effects
(
adult; mortality; Tramat 500; 2.0 kg as/ha)

Chrysoperla carnea

No adverse effects
(larvae; mortality, egg production and viability; Tramat 500; 2 % solution, ca 2.0 kg as/ha)

Chrysoperla carnea

Slight reduction
(
larvae; mortality, egg production and viability; * Betanal Progress; 3 % solution, 0.8 kg etho­fumesate/ha)

Coccinella septempunctata

No effects
(
larvae; mortality; *Betanal Progress; 3% solution, 0.8 kg ethofumesate/ha)

Syrphus corollae

Slightly reduced performance of treated larvae
(
larvae; mortality, pupation, hatching, viable offspring; *Betanal Progress; 2 % solution)

Poecilus cupreus

No effects
(adult; mortality, number of pupae fed; *Betanal Progress; 1.5 %solution, 0.8 kg ethofumesate/ha)

Aleochora bilineata

No effects
(adult; parasitic efficiency; *Betanal Progress; 1% solution, 0.4 kg ethofumesate/ha)

Aleochora bilineata

No effects
(adult; parasitic efficiency; Ethosat; 1 % solution, 1 kg as/ha)

 

 

Remarks

* Betanal Progress is a formulation containing ethofumesate plus two other active substances

 

1 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).

 

Earthworms

Acute toxicity:

LC50 = 134 mg/kg soil (Eisenia andrei; 14 d)

Reproductive toxicity:

NOEL > 25 mg/kg soil (Eisenia foetida; 56 d)

 

Soil micro-organisms

Nitrogen mineralization:

Max 28% inhibition 14 days after treatment with Betanal Progress at normal field rate (6.5 mg/kg) in a 60 days study. No treatment related effects in majority of studies at 4 – 20 kg as/ha.

Carbon mineralization:

Slight effect at maximum recommended field rate (2.0 mg kg soil) in one study. No treatment related effects in majority of studies.

 

Taken from LoEP d.d. 01/2002:

Effects on non-target flora and fauna

Effects of three co-formulations with desmedipham and phenmedipham. Weight reduction.

EC50 9 – 29 g ethofumesate/ha. Stellaria media the most sensitive species.

Effects of ethofumesate on growth of 28 species; weed and crop species, grasses and broadleaved.

Approximately half of the species were affected by more than 25% at the lowest treatment rate (63 g as/ha)

Effects of ethofumesate on non-target fauna including insects, diseases, molluscs, endoparasites, bacteria and nematodes.

No serious effects were identified for any of the tested species.

 

Additional information provided by Agrichem (summarized and evaluated by the Ctgb, 04/2008))

Based on residue data from grass crops, included in the DAR of ethofumesate (non-protected data). Based on these residu trials, eleven studies were considered suitable for residue decline calculation and initial residual values on crop. All studies were preformed  in N-EU, with a single application of 2.0 kg a.s./ha.

 

 

trial

Residue (t = 0)

[mg a.s./kg plant]

DT50

[days]

RUD

[(mg a.s.*ha)/

(kg a.s.plant*kg a.s.)

1

159

6.52

79.6

2

257

4.31

129

3

43.6

3.57

21.8

4

205

1.93

103

5

107

10.82

53.7

6

107

2.75

83.3

7

240

3.49

120

8

121

2.16

60.5

9

168

3.51

84.3

10

223

2.05

112

11

224

3.44

112

Mean

174

4.05

87.7

Geomean

 

3.53

 

 

Agrichem Ethofumesate Flowable (500 g/L SC)

Several studies with the formulated product are available.

 

For toxicity of the formulation to bees, non-target arthropods, earthworms and microorganisms, the applicant refers to the data for Agrichem Ethofumesate (2). From the available data it appears that the 200 EC formulation is more toxic than the 500 SC formulation, especially for non-target arthropods (see T. pyri). The data of Agrichem Ethofumesate (2) can be used as worst-case formulation for present risk assessment.

 

Toxicity aquatic organisms

Algae

Substance

Species

Method

Duration

 

[h]

Criterion

Value

 

[mg product/L]

Value

 

[mg a.s./L]

Agrichem Ethofumesaat Flowable

Pseudokirchneriella subcapitata

static

72

ErC50

28.2

12.0

 

 

72

NOErC

1.90

0.81

 

 

72

EbC50

10.7

4.55

 

 

 

72

NOEbC

<1.90

<0.81

 

Invertebrates

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

[mg/L]

Value

a.s.

[mg/L]

Agrichem Ethofumesaat Flowable

Daphnia

magna

static

48

EC50

38.3

16.3

 

Fish

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

mg/L]

Value

a.s.

[mg/L]

Agrichem Ethofumesaat Flowable

Oncorhynchus

mykiss

static

96

LC50

38.8

16.5

 

Toxicity terrestrial organisms

 

Non-target arthropods

Form.1

Species

Method

Dose

 

[L/ha]

Dose

[kg a.s. /ha]

Parameter

Adverse effects2

[%]

LR50

[kg as/ha]

Agrichem Ethofumesaat Flowable

Typhlodromus pyri

Lab.test

4

2.0

Mortality

Reproduction

0

1.0

>2.0

 

1 Formulation Agrichem Ethofumesaat Flowable = 500 g ethofumesate/L SC

2 Adverse effect means:

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

y % effect on a sublethal parameter = y % decrease of sublethal parameter 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 effectpercentages (i.e. increase compared to control) and a – sign for mortality effectspercentages (i.e. decrease compared to control).

 

Earthworms sublethal toxicity

Substance

Species

OM

 

[%]

Criterion

Dose

product

[mg/kg]

Dose

a.s.

[mg/kg]

Agrichem Ethofumesaat Flowable

Eisenia

fetida

10

NOEC

223.6

100

 

Formulation Agrichem Ethofumesaat (2) (Ethofumesate 200 g/L EC).

Several studies with the formulated product Agrichem ethofumesaat (2) are available. An additional study was submitted by the applicant. This study is indicated with *.

 

Toxicity aquatic organisms

Algae

Substance

Species

Method

Duration

 

[h]

Criterion

Value

 

[mg product/L]

Value

 

[mg a.s./L]

Agrichem ethofumesaat (2)

Desmodesmus subspicatus

static

72

ErC50

39.1

8.4

 

 

 

72

NOErC

3.1

0.67

 

 

 

 

72

EbC50

41.5

8.9

 

 

 

72

NOEbC

6.25

1.34

 

Invertebrates

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

[mg/L]

Value

a.s.

[mg/L]

Agrichem ethofumesaat (2)

Daphnia

magna

static

48

EC50

53.4

11.5

 

Fish

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

mg/L]

Value

a.s.

[mg/L]

Agrichem ethofumesaat (2)

Oncorhynchus

mykiss

static

96

LC50

NOEC

17.7

12.5

3.8

2.7

 

Toxicity terrestrial organisms

 

(Bumble)bees

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

[μg/bee]

Value

a.s.

[μg/bee]

Agrichem ethofumesaat (2)

Apis mellifera

oral

48

LD50

>488

>105

 

 

contact

96

LD50

442

95

 

Non-target arthropods

Form.1

Species

Method

Dose

 

[L/ha]

Dose

[kg a.s. /ha]

Parameter

Adverse effects2

[%]

LR50

[kg as/ha]

Agrichem ethofumesaat (2)

Typhlodromus pyri

Lab.test

10

2.0

Mortality

Reproduction

96

100

 

Agrichem ethofumesaat (2)

Typhlodromus pyri

Lab.test

0.74-3.8

0.15-0.75

Mortality

 

 

0.4

Agrichem ethofumesaat (2)

Aphidius rhopalosiphi

Lab.test

10

2.0

Mortality

Reproduction

88

65

 

Agrichem ethofumesaat (2)

Aphidius rhopalosiphi

Lab.test

1.3-13

0.25-2.6

Mortality

 

2.0

Agrichem ethofumesaat (2)

Chrysoperla carnea

Lab.test

10

2.0

Mortality

Reproduction

17.9

+7

 

Agrichem ethofumesaat (2)

Poecilus cupreus

Lab.test

5.0

1.0

Mortality

Consumption

0

16

 

Extended lab test*

 

 

 

 

 

Agrichem ethofumesaat (2)

Typhlodromus pyri

Ext.Lab.test

5.0-20

1.0-4.0

Mortality

Reproduction

 

6.5

2.41

>4.0

 

1 Formulation Agrichem ethofumesaat (2) = 200 g ethofumesate/L EC

2 Adverse effect means:

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

y % effect on a sublethal parameter = y % decrease of sublethal parameter 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 effectpercentages (i.e. increase compared to control) and a – sign for mortality effectspercentages (i.e. decrease compared to control).

*Summarized and evaluated by the Ctgb (02/2008)

 

Earthworms acute toxicity

Substance

Species

OM

 

[%]

Criterion

Dose

product

[mg/kg]

Dose

a.s.

[mg/kg]

Agrichem ethofumesaat (2)

Eisenia fetida

5

LC50

366.1

71.8

 

 

 

NOEC

131

25.7

 

Earthworms sublethal toxicity

Substance

Species

OM

 

[%]

Criterion

Dose

product

[mg/kg]

Dose

a.s.

[mg/kg]

Agrichem ethofumesaat (2)

Eisenia fetida

5

NOECrep

90.7

17.8

 

Micro-organisms

Substance

Soil type

Dose

product

[mg/kg]

Dose

a.s

[mg/kg]

Duration

 

[d]

Process

Maximal

effect

[%]

After

...

[d]

Effect

at end

> 25%

at day 28

[Y/N]

Agrichem ethofumesaat (2)

sandy loam

2.7

13.4

9.38

46.88

28

respiration

7.0

7.4

8

1-28

N

N

Nitrification test was considered not reliable, since variation coefficient in the control was > 15% at day 7 and nitrate formation decreased after 7 and 14 days.

 

Non target plants

 

Seedling emergence

Substance

Species

Criterion

Endpoint

Value

product

 

[L/ha]

Value

ethofu-mesate

[kg as/ha]

Agrichem ethofumesaat (2)

Allium cepa

ER50

emergence

> 64

> 12.9

 

(onion)

ER50

survival

> 64

> 12.9

 

 

ER50

biomass

61

12.3

 

Triticum

aestivum

ER50

emergence

> 6.25

> 1.26

 

ER50

survival

> 6.25

> 1.26

 

(wheat)

ER50

biomass

1.03

0.207

 

Brassica napus

ER50

emergence

> 64

> 12.9

 

(oilseed rape)

ER50

survival

> 64

> 12.9

 

 

ER50

biomass

23.5

4.73

 

Glycine max

ER50

emergence

> 64

> 12.9

 

(soybean)

ER50

survival

> 64

> 12.9

 

 

ER50

biomass

> 64

> 12.9

 

Linum

usitatissimum

ER50

emergence

> 6.25

> 1.26

 

ER50

survival

> 6.25

> 1.26

 

(flax)

ER50

biomass

3.34

0.627

 

Lycopersicon esculentum

ER50

emergence

> 6.25

> 1.26

 

ER50

survival

> 6.25

> 1.26

 

(tomato)

ER50

biomass

5.86

1.18

 

Vegetative vigour

Substance

Species

Criterion

Endpoint

Value

product

 

[L/ha]

Value

ethofu-mesate

[kg as/ha]

Agrichem ethofumesaat (2)

Allium cepa

ER50

biomass

36.1

7.27

 

(onion)

 

 

 

 

 

Triticum aestivum

ER50

biomass

1.16

0.234

 

(wheat)

 

 

 

 

 

Brassica napus

ER50

biomass

15.9

3.2

 

(oilseed rape)

 

 

 

 

 

Glycine max

ER50