Toelatingsnummer 10319 N

Agrichem Ethofumesaat Flowable  

 

10319 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 WIJZIGING TOELATING

 

Gelet op het verzoek d.d. 12 mei 2009 (20090441 WGGAG) van

 

Agrichem B.V.

Koopvaardijweg 9

4906 CV  OOSTERHOUT NB

 

 

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

 

Agrichem Ethofumesaat Flowable

 

gelet op artikel 41, tweede lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Wijziging toelating

Het middel Agrichem Ethofumesaat Flowable is laatstelijk bij besluit d.d. 23 februari 2007 toegelaten tot 28 februari 2013. De toelating van het middel Agrichem Ethofumesaat Flowable wordt gewijzigd en is met ingang van datum dezes toegelaten voor de in bijlage I genoemde toepassingen.Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

 

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 (SC)

 

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:

 

S37d-NL         -Draag geschikte handschoenen tijdens het mengen en laden.

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.

 

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
.

 

c)     bij het toelatingsnummer een cirkel met daarin de aanduiding W.6.

 

1.5  Aflever- en/of opgebruiktermijn 

Het gewijzigde WGGA dient bij de eerstvolgende aanmaak gebruikt te worden. Oude verpakkingen mogen worden opgemaakt (artikel 17:2 Besluit bestuursregelement regeling toelating gewasbeschermingsmiddelen en biociden Ctgb 2007).

 

2 DETAILS VAN HET VERZOEK EN DE TOELATING

 

2.1 Verzoek

Het betreft een verzoek tot wijziging van de toelating van het middel Agrichem Ethofumesaat Flowable  (10319 N), een middel op basis van de werkzame stof ethofumesaat. Het middel is toegelaten als onkruidbestrijdingsmiddel in de teelt van suiker- en voederbieten en in de teelt van graszaad en graszoden. Het middel is toegelaten tot 28 februari 2013.

 

De gevraagde wijziging betreft:

In het Wettelijk Gebruiksvoorschrift wordt LDS-systeem in bieten opgenomen.

 

2.2 Informatie met betrekking tot de stof

De bestaande werkzame stof Ethofumesaat is per 1 maart 2003 geplaatst op Annex I (Richtlijn 2002/37/EG d.d. 3 mei 2002) 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 14 mei 2009 ontvangen; op 15 mei 2009 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 7 september 2009 is de aanvraag in behandeling genomen.

 

3  RISICOBEOORDELINGEN

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is weergegeven in de RGB (Hoofdstuk 2); te weten de werkinstructies RGB (voor toxicologie en milieu) en in de RGB aangeduide (delen van de) toepasselijke versie van de HTB ( in dit geval versie1.0)

 

3.1  Fysische en chemische eigenschappen

Niet beoordeeld in het kader van deze aanvraag.

 

3.2  Analysemethoden

Niet beoordeeld in het kader van deze aanvraag.

 

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 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 gewijzigde Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Agrichem Ethofumesaat Flowable op basis van de werkzame stof(fen) ethofumesaat 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, 2 september 2011

 

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,




dr. D. K. J. Tommel

voorzitter

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 2 september 2011 tot wijziging 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 voederbieten en in de zaadteelt van Engels en Italiaans raaigras.

 

Om niet tot de doelsoorten behorende planten te beschermen is toepassing in de zaadteelt van Engels en Italiaans raaigras uitsluitend toegestaan indien gebruikt wordt gemaakt van driftarme spuitdoppen.

   

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

 

Na gebruik in de graszaadteelt, het gras/hooi niet vervoederen.

 

Toepassing met een luchtvaartuig is niet toegestaan.

 

Dit middel is uitsluitend bestemd voor professioneel gebruik.

 

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.

 

Toepassingen

Suiker-en voederbieten

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.


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.

 

Zaadteelt van Engels en Italiaans raaigras

Agrichem Ethofumesaat flowable bestrijdt duist, windhalm, straatgras, muur en herderstasje in de zaadteelt van Engels en Italiaans raaigras. 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 raaigras 2 spruiten heeft gevormd. Bij toepassing na de oogst van de dekvrucht dient het raaigras afgehard te zijn. Behandeling niet herhalen. Spuit op een gezond gewas.

Dosering:

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

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

Grotere duist of windhalm wordt niet meer bestreden.

 

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, maďs, 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. 2 september 2011 tot wijziging van de toelating van het middel Agrichem Ethofumesaat Flowable, toelatingnummer 10319 N

 

RISKMANAGEMENT

 

 

 

Contents

                                                                                                                                              Page

1.         Identity of the plant protection product 3

2.         Physical and chemical properties. 3

3.         Methods of analysis. 3

4.         Mammalian toxicology. 3

5.         Residues. 9

6.         Environmental fate and behaviour. 14

7.         Ecotoxicology. 28

8.         Efficacy. 57

9.         Conclusion. 57

10.       Classification and labelling. 57

 

Appendix 1      Table of authorised uses. 1

Appendix 2      Reference list 2

 


1.                  Identity of the plant protection product

 

1.1       Applicant

Agrichem B.V.

Koopvaardijweg 9

4906 CV Oosterhout

The Netherlands

 

1.2       Identity of the active substance

ISO name

Ethofumesate

Name in Dutch

Ethofumesaat

Chemical name

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

ylmethanesulfonate (IUPAC)

CAS no

26225-79-6

EEC no

247 525-3

 

The active substance ethofumesate was included on 1 March 2003 in Annex I of Directive 91/414/EEC. The active substance has been approved by Regulation (EC) No 1107/2009 since 14 June 2011 according to Regulation (EU) No 540/2011 of 25 May 2011.

 

1.3       Identity of the plant protection product

Name

Agrichem Ethofumesaat Flowable

Formulation type

SC, Suspension Concentrate

Content active substance

500 g/l pure active substance

 

1.4       Function

Herbicide.

 

1.5       Uses applied for

See GAP (Appendix I).

 

1.6       Background to the application

It concerns an application for revision of the label in the cultivation of sugar and fodder beet. This revision of the cGAP concerns the use of a Low Dose System (LDS) for beets.

 

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

 

The methods of analysis of the plant protection product remain unchanged.

 

 

4.                  Mammalian toxicology

 

List of Endpoints

Ethofumesate is an existing 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. 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 skin 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.

 

The formulation Agrichem Ethofumesaat Flowable is applied by mechanical downward spraying in sugar- and fodder beet by low dosing system (LDS). The formulation is applied up to four times in the period March-June with a maximum dose of 0.4 L formulation / ha. Therefore, a semi-chronic exposure duration is applicable for the operator (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. The exposure is only estimated with the highest dose.

 

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 sugar- and fodder beet (uncovered)

Mixing/

Loading

Respiratory

0.01

175

<0.01

Dermal

40

175

0.23

Application

Respiratory

0.02

175

<0.01

Dermal

6.0

175

0.03

 

Total

46

175

0.26

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

·       biological availability via the dermal route:   100% (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.

 

Since the EU-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 sugar- and fodder beet.

 

Bystander exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected bystander after dermal and respiratory exposure to ethofumesate as a result of the application of Agrichem Ethofumesaat Flowable in sugar- and fodder beet.

 

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 sugar- and fodder beet due to exposure to ethofumesate after application of Agrichem Ethofumesaat Flowable.

 

These conclusions are also valid for the simultaneous exposure to  ethofumesate, metamitron and phenmedipham (see 4.7).

 

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

See List of Endpoints.

 

4.6       Data requirements

Based on this evaluation, no additional data requirements are identified.

 

4.7       Combination toxicology

Agrichem Ethofumesaat Flowable contains only one active substance. However, it should be used in combination with maximally 0.7 kg/ha metamitron and 0.16 kg/ha phenmedipham when applied in a low dosing system to sugar- and fodder beet.

 

The combined toxicological effect of these 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(s) based on the individual substances.

 

Metamitron and ethofumesate both induce effects on the liver. These effects could possibly be correlated to the induction of biotransformation enzymes. In that case, these substances could in principle influence the toxicological effects on each other (induce or deduce). Phenmedipham has a different toxicological profile: the target organ for phenmedipham is the red blood cell system (haemolytic anaemia).

 

The NL-AOEL of ethofumesate is 681 mg/day and the NL-AOEL of metamitron is 20 mg/day.

 

Table T.2 Internal exposure to ethofumesate (0.2 kg/ha) and metamitron (0.7 kg/ha)

and risk assessment

 

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on sugar- and fodder beet (uncovered)

Ethofumesate

46

681

0.07

Metamitron

5.7

20

0.28

Total

 

 

0.35

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

·       biological availability via the dermal route:

ethofumesate: 100% (concentrate) and 100% (spray dilution)

metamitron: 1% (concentrate) and 20% (spray dilution)

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

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

 

Since the estimated exposures to these substances is a fraction of the AOEL and the sum of the risk indices of the individual substances is <1.0, no risks are expected even if an additive effect is induced by the simultaneous exposure to the substances.

 

It is therefore not expected that combined exposure to (residues of) these active substances will result in an additional risk above the estimated risks based on the individual substances, when used in accordance with Good Agricultural Practice.

 

4.8       Mammalian toxicology classification and labelling

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

 

Symbol:

-

Indication of danger: -

 

Risk phrases

-

-

 

Proposal for the classification and labelling of the formulation concerning health

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

 

The current classification and labelling, which is prepared in conformity with Directive 1999/45/EC, can be maintained.

 

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

S37d-NL

Wear suitable gloves during mixing and loading

 

 

 

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.

 

 

5.                  Residues

 

An application for revision of the label of the plant protection product Agrichem Ethofumesaat Flowable, a herbicide based on the active substance ethofumesate, in the cultivation of sugar and fodder beet and perennial an Italian ryegrass, was submitted. 

This revision of the cGAP concerns the use of a Low Dose System (LDS) and the cumulative dose is higher than the (cumulative) authorised dose

Ethofumesate is an existing active substances, included in Annex I of 91/414/EEC. The Lists of Endpoints presented below is the most recent available.

 

List of Endpoints (January 25th, 2002)

 

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

Plant groups covered

Sugar beet (root crops), rye grass (cereals), onion (root crops), tobacco (leafy vegetables), wheat (cereals), radish (root crops) and cabbage (leafy vegetables).

Rotational crops

Root and tuber vegetables (radish, carrots, cabbage), leaf vegetables (spinach, cabbage) and cereals (wheat, grain, corn)

Plant residue definition for monitoring

Ethofumesate and the metabolites 2,3-dihydro-3,3-dimethyl-2-oxo-benzofuran-5-yl methane sulphonate (AE C509607) and 2-(2-hydroxy-5-methane sulphonyloxyphenyl)-2-methyl-propionic acid (AE C520645; free and conjugated)

 

Plant residue definition for risk assessment

Ethofumesate and the metabolites 2,3-dihydro-3,3-dimethyl-2-oxo-benzofuran-5-yl methane sulphonate (AE C509607) and 2-(2-hydroxy-5-methane sulphonyloxyphenyl)-2-methyl-propionic acid (AE C520645; free and conjugated).

Conversion factor (monitoring to risk assessment)

None

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

 

 

Root and tuber vegetables (radish, carrots, cabbage), leaf vegetables (spinach) and cereals (wheat, grain, corn)

 

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

Animals covered

Cow and hen (parent compound only)

Animal residue definition for monitoring

Ethofumesate (2-Ethoxy-2,3-dihydro-3,3-dimethyl-benzofuran-5-yl-methane sulphonate) and the metabolites 2,3-dihydro-3,3-dimethyl-2-oxo-benzofuran-5-yl methane sulphonate ( AE C509607) and 2-(2-hydroxy-5-methane sulphonyloxyphenyl)-2-methylpropionic acid (AE C520645; in free form only).

 

Animal residue definition for risk assessment

Ethofumesate (2-Ethoxy-2,3-dihydro-3,3-dimethyl-benzofuran-5-yl-methane sulphonate) and the metabolites 2,3-dihydro-3,3-dimethyl-2-oxo-benzofuran-5-yl methane sulphonate ( AE C509607) and 2-(2-hydroxy-5-methane sulphonyloxyphenyl)-2-methylpropionic acid (AE C520645; in free form only).

 

Conversion factor (monitoring to risk assessment)

-

Metabolism in rat and ruminant similar (yes/no)

Yes

Fat soluble residue: (yes/no)

Log Pow parent compound: 2.7

Log Pow NC 20 645: Data not available.

 

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

 

 

Root and tuber vegetables (radish, carrots, cabbage), leaf vegetables (spinach) and cereals (wheat, grain, corn)

 

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

 

 

Ethofumesate and the two conjugated metabolites NC 9607 and conjugated NC 8493 were not degraded during prolonged storage (maximum 54 weeks) of frozen samples of sugar beet plants.

Ethofumesate and NC 9607 residues in fortified samples of sugar beet tops, and ethofumesate residues in fortified samples of sugar beet roots did not significantly decline after storage at -20 °C for up to 24 months. But, NC 9607 residues in fortified samples of sugar beet roots gave a mean recovery of 77 % after 24 months storage at -20 °C.
Studies on cereals, leafy vegetables and root crops will not be evaluated for the time being.

 

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

 

Not required as the notifier has announced that there is no intended use in grassland. According to extrapolation from a new metabolism study (C 003362) all residues in a dairy cow, all tissues (including liver and kidney) and milk would be below LOQ. A new estimation of ethofumesate intake (1x) via fodder crops by RMS (17 December 1999) resulted in a total intake of 0.91 ppm in dairy cows and 0.89 ppm in beef cows (will be included in the addendum to the monograph). According to 7031/VI/95 rev 4, livestock feeding studies are however, only required when total diet is: ł0.1 ppm and metabolism studies indicate that significant residues (0.01 ppm or above the LOQ) may occur in edible animal tissue when taking account of the potential 1x dose rate. If current uses in fodder crops (sugar beet tops and roots (molasses), fodder beet tops, mangold tops and roots and pulses) also are the only intended uses, there seems to be no need for a new livestock feeding study.

 

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

Crop/processed crop

 

Number of studies

Transfer factor

% Transference

Sugarbeet/Sugar

 

4

0.1-0.3

Not possible to calculate

Sugarbeet/Molasses

 

4

6-24

Not possible to calculate

Sugarbeet/Wet pulp

 

3*

0.2-0.4

Not possible to calculate

Sugarbeet/Thick juice

 

5

4-5

Not possible to calculate

Sugarbeet/Thin (raw) juice

 

5

0.5-1.9

Not possible to calculate

* Substrates in studies R19 and R41 were not analysed

 

Comments on/additions to List of Endpoints

In the evaluation table (Doc. 6487/VI/99 rev. 6 (05.02.2001)), a data requirement to be dealt with at member state level was identified. As this data requirement concerned the use on beans with pods in Southern Europe, it is not of importance for this revision of the label.

 

5.1       Summary of residue data

Only points that are not covered by the List of Endpoints (LoEP) or that need clarification are discussed below.

 

5.1.1    Metabolism in plants

See LoEP Residues.

 

5.1.2    Metabolism in livestock

For sugar beets an EU-MRL of 0.5 mg/kg is established. Currently no MRL is established for fodder beet. The proposed ‘MRLs’ for risk assessment in the DAR were 0.3 and 0.1 mg/kg for beet tops and beet root, respectively.  For peas, an MRL of 0.05* mg/kg is established. With these residue levels, a dietary burden of 0.87, 0.91 and 0.22 mg/kg dry feed was calculated for dairy cattle, beef cattle and poultry, respectively (addendum to the draft assessment report, d.d. December 2000).

 

Metabolism in ruminants was investigated in sheep (single dose of ca. 4 mg/kg dry feed) and cow (7 daily doses of 13 mg/kg dry feed, 15N). Metabolism in hens was investigated (14 daily doses of 10 mg/kg dry feed, 400N). Metabolism in ruminant and rat are similar, so no studies with pigs are required.

 

No significant residues were detected in animal tissues; and it is concluded that no residues are expected above the LOQ from the proposed GAP on sugar and fodder beet.

 

5.1.3    Residue definition (plant and animal)

The residue definition for monitoring and risk assessment of plant and animal products is ethofumesate (sum of ethofumesate and the metabolite 2,3-dihydro-3,3-dimethyl-2-oxobenzofuran-5-yl methane sulphonate expressed as ethofumesate)

 

This residue definition is different from the residue definition in the List of Endpoints, which also contains metabolite 2-(2-hydroxy-5-methane sulphonyloxyphenyl)-2-methyl-propionic acid. During MRL harmonisation it was concluded that due to analytical difficulties, this metabolite could not be measured. A conversion factor for risk assessment to include this metabolite was not considered necessary.

 

5.1.4    Stability of residues

See LoEP Residues.

 

5.1.5    Supervised residue trials

Sugar and fodder beet root

The cGAP-NL for Agrichem Ethofumesaat Flowable is the requested LDS dose regime of four applications between BBCH 10-12 at 0.2 kg as/ha, with a spray interval of 7 days. A PHI is not required because of the early applications. One hundred and forty five studies are described in the draft assessment report with sugar- or fodder beet. Studies were performed with 1-4 applications of about 300 g ai/ha or 1 application of 1-1.5 kg/ha. In most of the studies, residues decreased to < LOQ at harvest. Only at the highest dose level residues above 0.05 but below 0.1 mg/kg were detected. For the intended use of Agrichem Ethofumesaat Flowable residues of < 0.05 mg/kg are expected in sugar beet, which is covered by the EU-MRL of 0.5 mg/kg. Processing factors were calculated, being 0.4 for crystallised sugar and up to 5 for thick juice.

 

Sugar and fodder beet tops

Residues were determined in sugar beet and fodder beet tops. Residues were somewhat higher in fodder beet tops, up to 0.18 mg/kg at an application rate of 2.0 kg ai/ha/season.

 

Data for calculation of livestock dietary burden

During the EU-evaluation an ‘MRL’ for risk assessment of 0.3 mg/kg was calculated for beet tops. An ‘MRL’ for risk assessment of 0.1 mg/kg was calculated for fodder beetroots. These values of 0.3 and 0.1 mg/kg for beet tops and beetroot, respectively, were used for calculating the livestock dietary burden, see 5.1.2. metabolism in livestock.

 

5.1.6    Residues in succeeding crops

See LoEP Residues. No detectable residue levels are expected in rotational crops.

 

5.1.7    Residues from livestock feeding studies

Covered by livestock metabolism studies.

 

5.1.8    Processing factors

See LoEP Residues.

 

5.1.9    Calculation of the ADI and the ARfD

Calculation of the ADI

The ADI was taken from the final List of Endpoints of human toxicology. The ADI was calculated from the NOAEL of 7 mg/kg bw/d from the 2y oral rat study, based on body weight gain at the near highest dose group of 70 mg/kg bw/d. A default safety factor of 100 was assumed to be appropriate to account for these adverse effects and an ADI of 0.07 mg/kg bw/d was set.

 

Calculation of the ARfD

No ARfD is derived, since ethofumesate has no acute toxic properties.

 

5.2       Maximum Residue Levels

EU-MRLs have been harmonised by directives 2003/60/EC (animal products, cereals) and 2006/74/EC (fruits and vegetables). These MRLs have been included in Regulation (EC) 396/2005, Annexes II and IIIb. In the risk assessment, a worst case MRL for risk assessment for sugar of 0.1 mg/kg will be applied. The product complies with this MRL Directives.

 

5.3       Consumer risk assessment

Risk assessment for chronic exposure through diet

A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA PRIMo rev. 2.0, containing all available Member State diets, and the harmonised EU-MRLs. The maximum TMDI is 18.3% of the ADI for UK toddlers. The TMDI is 1.3% and 2.8% of the ADI for the Dutch general population and Dutch children ages 1-6, respectively.

 

Risk assessment for acute exposure through diet

As no ARfD was derived for ethofumesate, a risk assessment for acute exposure was not performed.

 

Conclusion

Based on the assessment for residues, no risk for the consumer due to the exposure to ethofumesate is currently expected. The product complies with the Uniform Principles.

 

5.4       Data requirements

No data requirements were identified.

 

 

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 update of 20 October 2009, which came into effect on 1 January 2010.

 

Ethofumesate

Ethofumesate is an existing active substance, listed on Annex I of Guideline 91/414/EC per 1st March 2003 (directive 2002/37/EEC, d.d. 3rd May 2002). For the risk assessment the final list of endpoints (dated 26th February 2002) is used.

 

List of Endpoints Fate/behaviour 

 

Fate and behaviour in soil

Route of degradation

 

Aerobic:

 

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

Major metabolites above 10 % of applied active substance: name and/or code
% of applied rate (range and maximum)

All less than 6%

 

 

Supplemental studies

 

Anaerobic:

Not relevant because of very slow transformation

 

 

Soil photolysis:

DT50  two studies :

14 d; =290nm, 24 h light, 1.5 kg a.s./ha

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

 

 

Remarks:

None

 

Rate of degradation

 

Laboratory studies

 

DT50lab (20 °C, aerobic):

40 - 75% WHC:

range 47 – 211 d; mean 97 d; median 84 d; n=10

DT90lab (20 °C, aerobic):

40 - 75% WHC:

range 210 – 701 d; median 331 d; n=10

DT50lab (10 °C, aerobic):

No study.

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

Result: DT50, (10°C, aerobic) (calc.) = 198 d

DT50lab (20 °C, anaerobic):

Very slow transformation: 90-100% unaltered

after 60 d; n=2

 

Field studies (country or region)

 

DT50f from soil dissipation studies:

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

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

California, USA: 2.1 kg as/ha: 75 d. n=1

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

n=13

DT90f from soil dissipation studies:

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 studies:

No relevant data.

Calculated based on a field DT50 = 119 days

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.

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

Soil residue studies:

Data not required.

 

 

Remarks:
e.g. effect of soil pH on degradation rate

 

None.

 


Adsorption/desorption

 

Kf / Koc:

 

Kd

 

pH 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.

 

Mobility

 

Laboratory studies:

 

Column leaching:

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

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

Aged residue leaching:

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

 

 

Field studies:

 

Lysimeter/Field leaching studies:

Two studies according to BBA guideline:

 

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

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

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

 

 

Remarks:

None.

 

Fate and behaviour in water

Abiotic degradation

 

Hydrolytic degradation:

pH 5.0, 7.0, 9.2: Negligible

Major metabolites:

None.

Photolytic degradation:

Artificial light: (greatly variable results)
37-62 d (summer, 40-60
şN)
4.6 d  (on a year basis) / 2.6 d (for month May)

Major metabolites:

None identified.

 

 

Biological degradation

 

Readily biodegradable:

Not readily biodegradable; n=3

Water/sediment study:

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

DT50 water:

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

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

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

DT90 water:

Study 1:   -

Study 2: 121 and 212 days, n=2

Study 3: -

DT50 whole system:

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

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

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

geomean value: 114.6 d, calculated by Ctgb, based on only simple first order kinetics, n=2, ind. values 125 and 105 d)

DT90 whole system:

Study 1: -

Study 2: 507 and 550 days, n=2

Study 3: -

Distribution in water / sediment systems
(active substance)

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

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. No DT50 calculated for the sediment.

Distribution in water / sediment systems
(metabolites)

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

Accumulation in water and/or sediment:

Considered not relevant since active substance is applied every third year.

Rate of mineralisation

Non-extractable residues

6-9%

27%

Degradation in the saturated zone

Degradation in the saturated zone: No study.  Not required.

 

 

Remarks:

None.

 

Fate and behaviour in air

Volatility

 

Vapour pressure:

6.5 x 10-4 Pa (25 °C)

Henry's law constant:

6.8 x 10-4 Pa×m3×mol -1 (25 °C)

 

 

Photolytic degradation

 

Direct photolysis in air:

Data 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

 

 

Remarks:

No remarks.

 

Metamitron

Metamitron is an existing substance listed on Annex I. The following data originating from the LoEP from the EFSA conclusion of September 2008 is used for risk assessment.

 

Data metamitron

Since the newly proposed applications are only applied as a tank mix with metamitron, combination toxicology with metamitron has to be considered. Metamitron is an existing active substance, decided to be listed on Annex I of Guideline 91/414/EC per  1st September 2009 (directive 2008/125/EC d.d. 19th December 2008). For the risk assessment data from the final List of endpoints (dated September 2008) is used.

 

Compartment

endpoint

Metamitron

soil

Non-normalised Field DT50 (days)

6.6, 9.6, 10.7 and 22.0 (mean 12.2, geometric mean 11.1, median 10.2)

 

Komsoil (L/kg)

50.1 (median of 15 soils)

 

Komsediment (L/kg)

50.1 (median of 15 soils)

Water (whole system)

DT50 (days)

10.8 and 11.4 (geometric mean 11.1)

General

Vapour pressure

7.44 × 10-7 Pa at  25°C

 

Solubility in water

1.68 g/L at 25 °C (pH 7)

 

Molecular mass

202.2 g/mol

 

phenmedipham

Phenmedipham is an existing substance listed on Annex I.  The following data originating from the LoEP from the final review report (February 2004) is used for risk assessment.

 

Data phenmedipham

Since the proposed applications are applied as a tank mix with phenmedipham, combination toxicology with phenmedipham has to be considered. phenmedipham is an existing active substance, listed on Annex I of Guideline 91/414/EC since April 2004. For the risk assessment data from the final List of endpoints (dated 24th November 2003) is used.

 

Compartment

endpoint

Fenmedifam

soil

Non-normalised Field DT50 (days)

first order kinetics, DT50f:

Germany, bare soil, four sites:

5.8 days at pH 5.0,  9.0 days at pH 6.9, 15.7 days at pH 7.1, 39.9 days at pH 6.0,  mean 17.6 days (n=4, r2  not available, 1st order)

 

Komsoil (L/kg)

522 (mean of 3 soils)

 

Komsediment (L/kg)

352 (mean of 2 sediments)

Water (whole system)

DT50 (days)

0.14 (mean of 3 water/sediment systems)

 

Vapour pressure

7.0x 10-10 Pa (25°C)

 

Solubility in water

0.0018 g/L (20°C)

 

Molar mass

300.3 g/mol

 

Appendix A: Metabolite names, codes and other relevant information of the pesticide Agrichem Ethofumesaat Flowable with a.s. ethofumesate.

 

The compounds shown below were found in one or more studies involving the metabolism and/or environmental fate of a.s. ethofmesate. The parent compound structure of ethofumesate is shown first in this list and followed by degradate or related compounds. As ethofumesate is applied in tank-mix with metamitron and phenmedipham for completeness these structures are included as well.

 

Compound name

Code number (CAS)

IUPAC name

Structural formula

Structure

Molecular Weight

[g/mol]

Observed in study (% of occurrence/ formation)

ethofumesate

26225-79-6

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

C13H18O5S

286.3

 

phenmedipham

13684-63-4

methyl 3-(3-methylcarbaniloyloxy) carbanilate

C16H16N2O4

300.3

 

metamitron

41394-05-2

4-Amino-4,5-dihydro-3-methyl-6-phenyl-1,2,4-triazin-5-one

C10H10N4O

202.2

 

 

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].

 

For the current application this means the following:

 

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.

In this way, the standards for persistence as laid down in the RGB are met.

 

metamitron

Based on the data from the list of endpoints a laboratory geometric mean DT50 value is available for the active substance metamitron of 19 days. The mean DT50-value of the a.s. can thus be established to be <90 days. Furthermore it can be excluded that after 100 days there will be more than 70% of the initial dose present as bound (non-extractable) residues together with the formation of less than 5% of the initial dose as CO2.

 

Although field studies were not triggered the following field DT50 values are available for the active substance metamitron: 10.7; 6.6; 22.0 and 9.6 days (geometric mean 11.1 days).

 

Phenmedipham

The following laboratory DT50 values are available for the active substance phenmedipham: 42, 26 and 43 days (average 37 days, geomean 29.6 d). The mean DT50-value of the active substance can thus be established to be <90 days. Furthermore it can be excluded that after 100 days there will be more than 70% of the initial dose present as bound (non-extractable) residues together with the formation of less than 5% of the initial dose as CO2.

 

Available field studies show first order kinetics DT50f values of 5.8, 9.0, 15.7 and

39.9 days (Germany, bare soil, n=4) with a geomean of 13.5 days.

 

PECsoil

The concentration of the a.s. ethofumesaat, phenmedipham and metamitron 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.

 

The following input data are used for the calculation:

 

PEC soil:

 

Ethofumesate:

Worst case non-normalised field DT50 for degradation in soil:  250 days

Molecular weight: 286.3 g/mol

 

Metamitron:

Worst case non-normalised field DT50 for degradation in soil:  22 days

Molecular weight: 202.2 g/mol

 

Phenmedipham:

Worst case non-normalised field DT50 for degradation in soil:  39.9 days

Molecular weight: 300.3 g/mol

 

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

 

Table M.1 PECsoil calculations (5 cm)

Use

Substance

Rate

[kg a.s./ha]

Freq.

Interval

[days]

Fraction on soil *

PIECsoil

5 cm

[mg a.s./kg]

beets

Ethofumesate

phenmedipham

0.3

0.56

2

10

0.8

0.63

1.10

beets

Ethofumesate

phenmedipham

0.5

0.8

1

-

0.8

0.53

0.84

Rye grass

ethofumesate

2.0

1

-

0.4

1.07

Beets LDS

Ethofumesate

Phenmedipham

Metamitron

 0.2

 0.160

 0.700

4

7

0.8

0.829

0.574

2.21

* fraction on soil is detemined as 1 – interception value; interception values derived from Table 1.6 in “generic guidance for FOCUS groundwater scenarios”. For beets in an early leaf stage a fraction to soil of 0.8 is considered

 

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 ethofumesate is calculated in the first tier using Pearl 3.3.3 and the FOCUS Kremsmünster scenario. Input variables are the actual worst-case application rate for the crop, the crop (grass and beets) and an interception value appropriate to the crop of 0.6 for grass and 0.2 for beets. First date of yearly application is May 25th (default).

The following input data are used for the calculation:

 

PEARL:

 

Ethofumesate:

Median lab DT50 for degradation in soil (20°C):  84 days (n=10)

Median Kom (pH-independent): 76.5 L/kg

Arithmetic mean 1/n: 0.89

Plant uptake factor: 0.5 (ethofumesate is systemic herbicide)

 

Saturated vapour pressure: 6,5 x 10-4 Pa (25 °C)

Solubility in water: 0.05 g/L (25 °C)

Molecular weight: 286.3 g/mol

 

Other parameters: standard settings of PEARL 3.3.3

 

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

 

Table M.2a Leaching of a.s. ethofumesate as predicted by PEARL 3.3.3

Use

Substance

Rate substance [kg/ha]

Freq

Interval [days]

Fraction

Intercepted *

PEC groundwater [mg/L]

 

 

 

 

 

 

spring

Rye grass

 

ethofumesate

2

1

-

0.6

3.38

beets

Ethofumesate

0.3

2

10

0.2

1.61

beets

Ethofumesate

0.5

1

-

0.2

1.25

Beets LDS

Ethofumesate

 

0.2

4

7

0.2

2.42

  * interception values derived from Table 1.6 in “generic guidance for FOCUS groundwater scenarios”. An interception of 60 % for grass, BBCH stage 20-39, is taken from FOCUS groundwater report. An interception of 20% is considered relevant for beets in early growth stage with weeds present.

 

Results of Pearl 3.3.3 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 a.s. ethofumesate is equal to or larger than 0.1 µg/L. Therefore, further study into the leaching behaviour is necessary.

 

Lysimeter/field leaching studies

Ethofumesate

A lysimeter study in sugar beets has been submitted a.o. for the original registration of Oblix 200 EC. 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. Precipitation and irrigation were comparable and the soil temperature higher and by that less vulnerable. No parallel studies on DT50 and Kom with the lysimeter soil were 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.

 

Later 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 exceedance of the trigger concentration by the model calculations.

Standardisation of the lysimeters on the basis of the standard dossier data on DT50 and Kom according to Verschoor revealed a simulation error of 0.75.

After different discussions and dossier development,  final degradation and sorption studies with the lysimeter soil became available resulting in a lysimeter half-life of 58.8 days and a Kom value of 108.4 L/kg. Standardisation using this lysimeter specific DT50 and Kom value revealed a simulation error of 4513.

 

Standardisation of the third lysimeter (grass) using the same lysimeter 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 of 2 x 10-12 is excluded because this value is not relevant for risk assessment. Therefore the results of 2 lysimeters both with the same soil (2 and 3) are used for RA.

 

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 lysimeter soil, degrees of freedom = 1, tprob=1).

 

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

Use

Substance

Computed target [mg/L]

Simulation Error (mean)

No. of lysimeter soils

fadjustment

Adjusted PEC

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

 

 

spring

 

 

 

spring

Rye grass

 

ethofumesate

3.38

23396.5

1

4513

<0.001

beets

Ethofumesate

1.61

23396.5

1

4513

<0.001

beets

Ethofumesate

1.25

23396.5

1

4513

<0.001

Beets LDS

Ethofumesate

 

2.42

23396.5

1

4513

<0.001

 

From Table M.2b it reads that the expected leaching based on the PEARL-model calculations for the a.s. ethofumesate and the results of lysimeter studies is smaller than 0.01 µg/L for all proposed applications. Hence, the risk for leaching is considered acceptable. The proposed applications meet the standards for leaching to groundwater.

 

Monitoring data

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

There are no data available regarding the presence of the substance ethofumesate in groundwater.

 

Conclusions

The proposed applications of the product comply with the requirements laid down in the RGB concerning persistence and 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 substances ethofumesate, metamitron and phenmedipham 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.

The applicant proposed the following restriction with respect to surface water:

Toepassing met een luchtvaartuig is niet toegestaan.

 

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

 

TOXSWA:

Ethofumesate

Geomean 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).

 

Median Kom for suspended organic matter: 76.5 L/kg

Median Kom for sediment: 7 6.5L/kg

1/n: 0.9 (default)

 

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

Solubility in water: 0.05 g/L (25 şC)

Molecular weight: 286.3 g/mol

 

metamitron:

Geometric mean DT50 for degradation in water at 20°C:  11.1 days

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

 

Arithmetic mean Kom for suspended organic matter: 50.1 L/kg

Arithmetic mean Kom for sediment: 50.1 L/kg

median 1/n: 0.78

 

Saturated vapour pressure: 7.44 x 10-7 Pa (25°C)

Solubility in water: 1.77 g/L (25°C)

Molecular mass: 202.2 g/mol

 

phenmedipham:

mean DT50 for degradation in water at 20°C:  0.14 days

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

 

Arithmetic mean Kom for suspended organic matter: 522 L/kg

Arithmetic mean Kom for sediment: 352 L/kg

1/n: 0.9 (default)

 

Saturated vapour pressure: 7.0x 10-10 Pa (25°C)

Solubility in water: 0.0018 g/L (20°C)

Molecular weight: 300.3 g/mol

 

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.

 

In Table M.3, the drift percentages and calculated surface water concentrations for the active substances ethofumesate, metamitron and phenmedipham for each intended use are presented.

 

Table M.3 Overview of surface water concentrations for active substances ethofumesate, metamitron and phenmedipham in the edge-of-field ditch following spring application

Use

Substance

Rate a.s.

[kg/ha]

Freq.

Inter-val

Drift

[%]

PIEC [mg/L] *

PEC21 [mg/L] *

PEC28 [mg/L] *

 

 

 

 

 

 

Spring

spring

spring

beets

Ethofumesate

phenmedipham

0.3

0.56

2

10

1

2.70

2.66

2.40

0.11

2.16

0.08

 

combination

 

 

 

 

5.36

2.51

2.24

beets

Ethofumesate

phenmedipham

0.5

0.8

1

-

1

2.38

3.80

2.13

0.08

2.06

0.06

 

combination

 

 

 

 

6.16

2.21

2.12

Seed cultivation of ryegrass

ethofumesate

2

1

-

1

9.51

8.21

7.88

Beets LDS

Ethofumesate

metamitron

Phenmedipham

0.2

0.7

0.16

4

7

1

3.41

9.67

0.76

2.83

7.28

0.05

2.61

6.77

0.05

 

combination

 

 

 

 

13.84

10.16

9.43

*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.

ethofumesate

The active substance ethofumesate was observed in the surface water (most recent data from 2009). 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 µg/L (dated 01-04-05, C-156.3.10) consisting of first or higher tier acute or chronic ecotoxicological threshold value 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, however, no consequences can be drawn for the proposed applications.

 

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

Total no of locations

(2009)

n > authorisation threshold

 

n > indicative/ad hoc MPC threshold

 

n > MPC-INS threshold *

373**

0

1

n.a.

* n.a.: no MPC-INS available. < : exceeding expected to be lower than with indicative/ad hoc MPC value; > : exceeding expected to be higher than with indicative/ad hoc MPC value

** the number of observations at each location varies between 1 and 30, total number of measurements is 1872 in 2009.

 

The correlation of exceedings with land use is derived from the 1.0 version of the Pesticide Atlas. Hence, the correlation is not based on the exact same monitoring data. However, this is the best available information and therefore it is used in this assessment.

 

In version 1.0 of the Pesticide Atlas there are too few measurements of exceeding of the indicative/ad hoc MPC threshold to draw conclusions.

Therefore, no consequences can be drawn from the observed exceeding.

 

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’. 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.

 

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 2005 – 2009

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

0/16

0/16

0.010

Nieuwegein

0/29

0/29

0.010

Amsterdam-Rijn kanaal (Nieuwersluis)

0/13

0/13

0.010

Brakel

9/72

0/72

0.030

Heel

0/4

0/4

0.0425

Petrusplaat/Keizersveer

23/128

3/128

0.0465

Scheelhoek/Stellendam

5/47

0/47

0.020

Drentsche Aa (De Punt)*

1/~170

1/~170

n.c.

* for Drentsche Aa, only one sample 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, 2005-2009) indicate that the overall 90th percentile concentration at drinking water abstraction points is <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

ethofumesate

The vapour pressure is 6.5 x 10-4 Pa at 25 °C. The Henry constant is 6.8 x 10-4 Pa×m3×mol -1 (25 °C). Therefore, the active substance ethofumesate exceeds the criteria written down in FOCUS AIR guidance for the potential for volatilisation from soil and plants. However, the half-life in air is 4.1 hours (Atkinson calculation) and therefore there is no potential risk for long range transport of ethofumesate to more remote areas.

 

Since at present there is no clear 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 End-points.

 

6.5       Data requirements

None

 

The following restriction sentences were proposed by the applicant:

Toepassing met een luchtvaartuig is niet toegestaan.

 

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

Toepassing met een luchtvaartuig is niet toegestaan.

 

6.6       Overall conclusions fate and behaviour

It can be concluded that:

  1. the active substances ethofumesate, metamitron and phenmedipham meet 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

 

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, placed on 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