Toelatingsnummer 10568 N

Agrichem Ethofumesaat (2)  

 

10568 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 VEREENVOUDIGDE UITBREIDING

 

Gelet op de aanvraag d.d. 20 maart 2009 (20090239 VUG) van

 

Agrichem B.V.

Koopvaardijweg 9

4906 CV  OOSTERHOUT NB

 

 

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 (2)

 

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

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Uitbreiding

Het gebruiksgebied van het middel Agrichem Ethofumesaat (2) wordt met ingang van datum dezes  uitgebreid met de toepassing in de zaad- en zodenteelt van diverse soorten gras. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

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: vloeistof

werkzame stof:

gehalte:

ethofumesaat

200 g/l

 

letterlijk en zonder enige aanvulling:

andere zeer giftige, giftige, bijtende of schadelijke stof: xyleen

 

gevaarsymbool:

aanduiding:

Xn

Schadelijk

 

Waarschuwingszinnen:    

R10                 -Ontvlambaar.

R38                 -Irriterend voor de huid.

R52/53            -Schadelijk voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

R65                 -Schadelijk: kan longschade veroorzaken na verslikken.

 

 

Veiligheidsaanbevelingen: 

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

S62                 -Bij inslikken niet het braken opwekken, direct een arts raadplegen en de verpakking of het etiket tonen.

 

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:

 

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

 

§         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
.

 

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

 

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 uitbreiding van het gebruiksgebied van het middel Agrichem Ethofumesaat (2) (10568 N), een middel op basis van de werkzame stof ethofumesaat. Het middel is bij besluit van 30 september 1994 reeds toegelaten als onkruidbestrijdingsmiddel in de teelt van suiker- en voederbieten. Met onderliggende aanvraag wordt toelating als onkruidbestrijdingsmiddel in de zaadteelt van diverse soorten graszaad gevraagd.

Het middel is toegelaten tot 28 februari 2013.

Ten aanzien van de volgende aspecten is verzocht de vereenvoudigde uitbreidingsprocedure  te volgen:

-Fysisch chemische eigenschappen en analysemethoden

-Werkzaamheid

 

2.2 Informatie met betrekking tot de stof

De 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.

 

2.3 Karakterisering van het middel

Agrichem Ethofumesaat (2) 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 23 maart 2009 ontvangen; op 26 maart 2009 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 15 februari 2010 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 versie 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 (zie Hoofdstuk 2, Physical and Chemical Properties, in Bijlage II bij dit besluit).

 

3.2  Analysemethoden

Gelet op de aard van het verzoek is dit aspect niet beoordeeld (zie Hoofdstuk 3, Analytical Methods, 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 hier 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 (2) 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).

 

 

 

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, 5 november 2010

 

 

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. 5 november 2010 tot vereenvoudigde uitbreiding van de toelating van het middel Agrichem Ethofumesaat (2), toelatingnummer 10568 N

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als onkruidbestrijdingsmiddel in de teelt van:

  1. suiker- en voederbieten
  2. graszaad
  3. graszoden

 

Om niet tot de doelsoorten behorende planten te beschermen is toepassing in de graszaadteelt en graszodenteelt 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 (2) 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 (2) 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 op basis van een “vereenvoudigde uitbreiding”. Er is voor deze uitbreiding geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel gebruikt wordt.

 

Toepassingen

Suiker- en voederbieten

Agrichem Ethofumesaat (2) 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:
1,5 liter Agrichem Ethofumesaat (2) + 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:
2,5 liter Agrichem Ethofumesaat (2) + 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.

 

Mengvoorschriften

Agrichem Ethofumesaat (2) toegepast in combinatie met middelen op basis van fenmedifam:

-           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 (2) 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 graszodenteelt

Agrichem Ethofumesaat (2) 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 (2) 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:

-   7,5 liter per hectare, indien duist en windhalm kleiner zijn dan 3 spruiten

-   10,0 liter per hectare, indien reeds 3-5 spruiten zijn gevormd.

Grotere duist of windhalm wordt niet meer bestreden.

 

Zaadteelt van overige grassen

Dosering:

Maximaal 10,0 liter per hectare.

Aangezien voor deze toepassing geen gegevens over fytotoxiciteit zijn beoordeeld, is het gebruik van Agrichem Ethofumesaat (2) 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 10,0 liter per hectare.

Aangezien voor deze toepassing geen gegevens over fytotoxiciteit zijn beoordeeld, is het gebruik van Agrichem Ethofumesaat (2) 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 (2) werd toegepast kunnen de volgende gewassen na kerend ploegen gezaaid of geplant worden: suiker- en voederbieten, maïs, 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. 5 november 2010 tot vereenvoudigde uitbreiding van de toelating van het middel Agrichem Ethofumesaat (2), toelatingnummer 10568 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                                      4

 

5.   Residues                                                            9

 

6.   Environmental fate and behaviour                9

 

7.   Ecotoxicology                                                    21

 

8.   Efficacy                                                               38

 

9.   Conclusion                                                        38

 

10. Classification and labelling                             38


1.         Identity of the plant protection product

 

1.1       Applicant

AgrChem 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.

 

1.3       Identity of the plant protection product

Name

Agrichem Ethofumesate (2)

Formulation type

EC, Emulsifiable concentrate

Content active substance

200 g/l pure active substance

 

1.4       Function

Herbicide.

 

1.5       Uses applied for

See GAP (Appendix I).

 

1.6       Background to the application

The application is intended for simplified extension to the use in production of all species of grass seed and grass sods.

 

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 simplified extension of Agrichem Ethofumesate (2) in grass seed and grass sods does not involve application on crops for human consumption or application on crops for animal consumption (use of grass as well as the straws after harvest of the seeds is prohibited as livestock feed). Therefore, no additional data concerning residue analytical methods for food/feed of plant origin or of animal origin are required.

 

 

4.                  Mammalian toxicology

 

List of Endpoints

Ethofumesate

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. 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 (2) does not need to be classified on the basis of its acute oral, dermal, and inhalation toxicology (no study available, not required).

The formulation Agrichem Ethofumesaat (2) is considered irritating to skin and needs to be classified as R38 ‘Irritating to skin’.

The formulation Agrichem Ethofumesaat (2) does not need to be classified for eye irritation.

The formulation Agrichem Ethofumesaat (2) does not need to be classified for 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 (2) is applied by mechanical downward spraying in grass seed crops and grass sods. The formulation is applied once round emergence with a maximum dose of 10 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 (2) 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 (2)

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on grass seed crops and grass sods (uncovered)

Mixing/

Loading

Respiratory

0.1

175

<0.01

Dermal

400

175

2.29

Application

Respiratory

0.16

175

<0.01

Dermal

60

175

0.34

 

Total

460

175

2.63

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 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 multigeneration 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 (2)

 

Route

Estimated internal exposure a (mg /day)

Systemic

NL-AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on grass seed crops and grass sods (uncovered)

Mixing/

Loadingc

Respiratory

0.100

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.

Grass seen crops and grass sods are not expected to be entered by the general public.

 

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 (2) in grass seed crops and grass sods.

 

The following restrictions need to be included in the directions of use:

-

 

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 (2) in grass seed crops and grass sods.

 

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 to ethofumesate as a result of the application of Agrichem Ethofumesaat (2) in grass seed crops and grass sods.

 

The following restrictions need to be included in the directions of use:

-

 

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 (2) contains only one active substance and it is not described that it should be used in combination with other formulations whem applied in grass seed crops and grass sods.

 

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 (Xn, R38), which is prepared in conformity with Directive 1999/45/EC, can be maintained. S37d-NL, however, can be removed since the extension is assessed according to the RGB. Explanation: In the second tier no dermal protection of the hands is required (based on NL-AOEL) for use in grass (RGB). For sugar and beetroots, no dermal protection of the hands is required.

 

 

5.                  Residues

 

The application for authorisation of the plant protection product Agrichem Ethofumesaat (2) in the production of grass seed of various species and grass sods does not concern crops used for food or feed (use of grass as well as the straws 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

 

List of Endpoints Fate/behaviour 

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, 40-60ºN)

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 (2) with a.s. 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 degradate or related compounds.

 

Com-pound name

Code num-ber(s)

IUPAC name

Structural formula

Structure

Mole-cular Weight

[g/mol]

Observed in study (% of occurrence/ formation)

Ethofu-mesate

-

(±)-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].

 

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. 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:

 

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 (5 cm)

Use

Substance

Rate

[kg a.s./ha]

Freq.

Fraction on soil *

PIECsoil

5 cm

[mg a.s./kg]

Grass seed crops and grass sods

ethofumesate

2.0

1

0.4

1.07

* fraction on soil is detemined 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 3.3.3 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 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

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

1/n: 0.9 (default)

 

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

Solubility in water: 50 mg/L (25 ºC)

Molecular mass: 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]

Frequency

Interval [days]

Fraction

Intercepted *

PEC

groundwater [mg/L]

 

 

 

 

 

 

spring

Grass seed crops and grass sods

ethofumesate

2.0

1

-

0.6

3.631

  * 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 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 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. 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 exceedance 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 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

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

Grass seed crops and grass sods

ethofumesate

3.631

23396.5

1

4513

<0.001

 

From Table M.2b it reads that the expected leaching for the a.s. 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

In earlier assessments of Agrichem Ethofumesate (2), monitoring data from groundwater monitoring from five locations in Denmark and from a regional survey in the Netherlands are described. Notifier 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 be able to use the monitoring data in the assessment. Therefore, these are considered supplemental information.

 

Conclusions

The proposed application of the product complies 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

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:

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: 207.7 L/kg

Arithmetic mean Kom for sediment: 207.7 L/kg

1/n: 0.9 (default)

 

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

Solubility in water: 0.05 g/L (25 ºC)

Molecular mass: 286.3 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.

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.

Inter-val

Drift

[%]

PIEC

[mg/L] *

PEC21

[mg/L] *

PEC28

[mg/L] *

Grass seed crops and grass sods

ethofumesate

2.0

1

-

1

9.51

8.21

7.88

* calculated according to TOXSWA

 

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

 

Monitoring data

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 2008). 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

(2008)

n > authorisation threshold

 

n > indicative/ad hoc MPC threshold

 

n > MPC-INS threshold *

376**

0

0

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 1856 in 30.

 

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

 

Drinking water criterion

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

 

Ethofumesate

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. 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 2004 – 2008

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]

Amsterdam-Rijn kanaal (Nieuwersluis)

No measurements

Nieuwegein

 

 

 

Andijk

0/3

0/3

0.005

Brakel

7/59

0/59

0.030

Heel

0/3

0/3

0.025

Petrusplaat/Keizersveer

15/104

3/104

0.050

Scheelhoek/Stellendam

4/34

0/34

0.027

Drentsche Aa (De Punt)

No measurements

Total

26/219

3/219

0.040

 

The relevant monitoring data (data set VEWIN, 2004-2008) indicate that the 90-percentile of all measurements together and of all individual abstraction points do not exceed the threshold of 0.1 µg/L. Therefore, the application of Agrichem Ethofumesate (2) 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 (25 ºC). 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:

-

 

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

-

 

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

 

List of Endpoints Ecotoxicology

The ethofumesate beta taskforce (including Agrichem) submitted new studies, which are equivalent to the studies from the DAR. Since the endpoints of the new studies are comparable with the endpoints from the DAR, the final List of Endpoints from the DAR is used for the risk assessment. Comments and additions are given in italic. Some studies and statements submitted for re-registration (Decision of the Board on 23rd of February 2007) are used. Also a new study with the formulated product was submitted by the applicant (see endpoints formulation).

 

List of Endpoints Ecotoxicology

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to mammals

LD50>8000 mg/kg bw, rat and mouse

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

Reproduction toxicity to mammals

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

Reproduction toxicity to birds

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

*Ctgb:  ‘>’ should be ‘

 


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

(Annex IIA, point 8.2, Annex IIIA, point 10.2)

Group

Test substance

Time-scale

Endpoint

Toxicity

(mg as/l)

Laboratory tests

Fish

ethofumesate

96 hours

Mortality

LC50 11

Daphnia

ethofumesate

48 hours

Immobilisation

EC50 14

Green algae

ethofumesate

96 hours

Biomass

EC50 3.9

Fish

Tramat 500

96 hours

Mortality

LC50 ca 13

Daphnia

Tramat 500

48 hours

Immobilisation

EC50 ca 30

Algae

Ethofumesate 50SC

96 hours

Biomass

EC50 3.2

Lemna sp

ethofumesate

14 days

Biomass

IC50 >50

NOEC 4.3

Fish

ethofumesate

21 days

Sublethal effects

NOEC 0.8

Daphnia

ethofumesate

21 days

Reproduction

NOEC 0.32

Chironomus sp

ethofumesate

28 days

Reproduction

NOEC>5.0

Microcosm or mesocosm tests

no data

 


Bioconcentration

Bioconcentration factor (BCF)

144, based on total radioactivity

Annex VI Trigger:for the bioconcentration factor

100

Clearance time           (CT50)

                                    (CT90)

< 1 day

< 3 days

 

Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4)

Acute oral toxicity

>50 µg/bee

Acute contact toxicity

>50 µg/bee

 

Field or semi-field tests

No significant effects of Betanal Progress (formulation with co-actives) at treatment with 6% solution (200 l/ha, 1.5 kg ethofumesate/ha) in semi-field test.

 

Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5)

Species

Stage

Test

Substance

Dose

(kg/ha)

Endpoint

Adverse effect1

Annex VI

Trigger

Laboratory tests

Aleochora bilineata

adult

Tramat 500

1.25

kg as/ha

Mortality, egg production and viability

no effects

30%

Poecilus cupreus

adult

Tramat 500

2.0 kg as/ha

Mortality

no effects

30%

Chrysoperla carnea

larvae

Tramat 500

2% solution

ca 2.0 kg as/ha

Mortality, egg production and viability

no adverse effects

30%

Chrysoperla carnea

larvae

Betanal Progress

3% solution

0.8 kg etho-fumesate/ha

Mortality, egg production and viability

slight reduction

30%

Coccinella septempunctata

larvae

Betanal Progress

3% solution

0.8 kg etho-fumesate/ha

Mortality

no effects

30%

Syrphus corollae

larvae

Betanal Progress

2% solution

 

Mortality, pupation, hatching, viable offspring

slightly reduced performance of treated larvae

30%

Poecilus cupreus

 

adult

Betanal Progress

1.5%solution

0.8 kg etho-fumesate/ha

Mortality, number of pupae fed

no effects

30%

Aleochora bilineata

adult

Betanal Progress

1% solution

0.4 kg etho-fumesate/ha

Parasitic efficiency

no effects

 

 

Aleochora bilineata

adult

Ethosat

1 kg as /ha

Parasitic efficiency

no effects

30%

 

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 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 effect percentages (i.e. increase of e.g. reproduction) and a – sign for mortality effect percentages (i.e. decrease of mortality).

 

Field or semi-field tests

no data

 

Effects on earthworms (Annex IIA, point 8.4, Annex IIIA, point 10.6)

Acute toxicity

14 days LC50 134 mg/kg soil (Eisenia andrei)

Reproductive toxicity

56 day NOEL>25 mg as/kg soil (Eisenia foetida)

 

Effects on other soil non-target macro-organisms

No data available

-

 

Effects on soil micro-organisms (Annex IIA, point 8.5, Annex IIIA, point 10.7)

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 as/ha) in one study. No treatment related effects in majority of studies.

 

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 residue 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

 

 

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

Several studies with the formulated product Agrichem Ethofumesaat (2) are available. The studies are evaluated by the RIVM (report 10255A00, 03/2006 and 11586a00; 03/2008). An additional study was submitted by the applicant. This was summarized and evaluated by the Ctgb (02/2008). 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

(sprayed bean leaves)

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

Sub-stance

Soil type

Dose

product

[mg/kg]

Dose

a.s

[mg/kg]

Dura-tion

 

[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 (summarized and evaluated by the RIVM (11586a00, 03/2007)

 

Seedling emergence

Substance

Species

Criterion

Endpoint

Value

product

 

[L/ha]

Value

ethofu-mesate

[kg as/ha]

200 EC

Allium cepa

ER50

emergence

> 64

> 12.9

 

(onion)

ER50

survival

> 64

> 12.9

 

 

ER50

biomass

61

12.3

200 EC

Triticum

aestivum

ER50

emergence

> 6.25

> 1.26

 

ER50

survival

> 6.25

> 1.26

 

(wheat)

ER50

biomass

1.03

0.207

200 EC

Brassica napus

ER50

emergence

> 64

> 12.9

 

(oilseed rape)

ER50

survival

> 64

> 12.9

 

 

ER50

biomass

23.5

4.73

200 EC

Glycine max

ER50

emergence

> 64

> 12.9

 

(soybean)

ER50

survival

> 64

> 12.9

 

 

ER50

biomass

> 64

> 12.9

200 EC

Linum

usitatissimum

ER50

emergence

> 6.25

> 1.26

 

ER50

survival

> 6.25

> 1.26

 

(flax)

ER50

biomass

3.34

0.627

200 EC

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]

200 EC

Allium cepa

ER50

biomass

36.1

7.27

 

(onion)

 

 

 

 

200 EC

Triticum aestivum

ER50

biomass

1.16

0.234

 

(wheat)

 

 

 

 

200 EC

Brassica napus

ER50

biomass

15.9

3.2

 

(oilseed rape)

 

 

 

 

200 EC

Glycine max

ER50

biomass

2.91

0.586

 

(soybean)

 

 

 

 

200 EC

Linum usitatissimum

ER50

biomass

2.36

0.475

 

(flax)

 

 

 

 

200 EC

Lycopersicon esculentum

ER50

biomass

1.24

0.250

 

(tomato)

 

 

 

 

 

7.1       Effects on birds

Birds can be exposed to the active substance ethofumesate via natural food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning.

 

The threshold value for acute and short-term exposure for birds is set at 0.1 times the LD50 and LC50 value, and the threshold value for chronic exposure is set at 0.2 times the NOEC value. This means that TERs (Toxicity-Exposure Ratio’s) for acute and short-term exposure should be ³ 10 and TER for chronic exposure should be ³ 5.

Table E.1 presents an overview of toxicity data.

 

Table E.1 Overview of toxicity data for birds for substance ethofumesate

 

Endpoint

Value

Acute toxicity to birds:

LD50

>2000 mg a.s./kg bw

Dietary toxicity to birds:

LC50

>5200ppm ~ >1820 mg a.s./kg bw/d 1

Reproductive toxicity to birds:

NOEL

406 mg a.s./kg bw/d

1 Endpoints should be expressed in daily dose. Since no data on food intake rate and body weight of the tested birds in the dietary study is available, the endpoint is recalculated to daily dose based on the default value as recommended in the EFSA PPR-opinion on azinphos-methyl (factor 0.35 for the dietary LC50 value).

 

7.1.1    Natural food and drinking water

Sprayed products

Procedures for risk assessment for birds comply with the recommendations in the Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (Sanco/4145/2000).

For the current application, uses can be categorized as grassland. Depending on the crop category, different indicator species are chosen. Table E.2 shows which indicator species are relevant for which uses.

 

Table E.2. Indicator species per use

Use

Crop

Indicator species

Grass seed crops and grass sods

grassland

large herbivorous and insectivorous

 

Table E.3a-c show the TER values for birds. The estimated daily uptake values (ETE, Estimated Theoretical Exposure) for acute, short-term and long-term exposure are calculated using the Food Intake Rate of the indicator species (FIR) divided by the body weight of the indicator species (bw), the Residue per Unit Dose (RUD), a time-weighted-average factor (fTWA, only for long term) and the application rate. For uses with frequency > 1, a MAF (Multiple Application Factor) may be applicable. The ETE is calculated as application rate * (FIR/bw) * RUD * MAF [* fTWA, only for long term]. The ETE is compared to the relevant toxicity figure. TER should be above the trigger for an acceptable risk.

 

Table E.3a Acute risk for birds

Substance

FIR / bw

RUD

Applica-tion rate

 

(kg a.s./ha)

MAF

Acute ETE

LD50 (mg/kg bw/d)

TER

(mg/kg bw/d)

(trigger 10)

Large herbivorous bird

ethofumesate

0.44

142

2.0

-

125

>2000

>16.0

 

Insectivorous bird

 

 

 

 

 

 

ethofumesate

1.04

52

2.0

-

108

>2000

>18.5

 

Table E.3b Short-term risk for birds

Substance

FIR / bw

RUD

Applica-tion rate

 

(kg a.s./ha)

MAF

Short-term ETE

LC50 (mg/kg bw/d)

TER

(mg/kg bw/d)

(trigger 10)

Large herbivorous bird

ethofumesate

0.44

76

2.0

-

66.9

>1820

>27.2

 

Insectivorous bird

 

 

 

 

 

 

ethofumesate

1.04

29

2.0

-

60.3

>1820

>30.2

 

Table E.3c Long-term risk for birds

Substance

FIR / bw

RUD

Applica-tion rate

 

(kg a.s./ha)

MAF

ftwa

Long-term ETE

NOEL (mg/kg bw/d)

TER

 

(mg/kg bw/d)

(trigger 5)

Large herbivorous bird

ethofumesate

0.44

76

2.0

-

0.53

35.4

406

11.5

 

Insectivorous bird

 

 

 

 

 

 

 

ethofumesate

1.04

29

2.0

-

-

60.3

406

6.7

 

Taking the results in Table E. into account, it appears that all proposed uses meet the standards laid down in the RGB.

 

drinking water

The risk from exposure through drinking surface water is calculated for a small bird with body weight 10 g and a DWI (daily water intake) of 2.7 g/d. Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In the first instance, acute exposure is taken into account. The highest PIECwater is 9.51 mg/L. It follows that the risk of drinking water is (LD50 * bw) / (PIEC*DWI) = (>2000* 0.010) / (0.00951 * 0.0027) = >100000

Since TER ³ 10, the risk is acceptable. 

 

7.1.2    Secondary poisoning

The risk as a result of secondary poisoning is assessed based on bioconcentration in fish and worms.

Since the log Kow of ethofumesate < 3 (2.7) the potential for bioaccumulation is considered low and no further assessment is deemed necessary.

 

Hence, the proposed uses meet the standards for secondary poisoning.

 

Conclusions birds

The product complies with the RGB.

 

7.2       Effects on aquatic organisms

7.2.1    Aquatic organisms

The risk for aquatic organisms for the various uses of the active substance ethofumesate is assessed by comparing toxicity values with surface water exposure concentrations from section 6.2. Risk assessment is based on toxicity-exposure ratio’s (TERs).

Toxicity data for aquatic organisms are presented in Table E.5 for the active substance ethofumesate. Because the application for authorisation concerns a herbicide, also the effects on macrophytes (aquatic plants) are evaluated.

 

See Table E.4 for the acute and chronic toxicity values to be used in the risk assessment.

 

Table E.4 Overview toxicity endpoints for the active substance

Substance

Organism

Lowest

Toxicity value

 

 

L(E)C50 [mg a.s./L]

NOEC

[mg a.s./L]

[mg a.s./L]

ethofumesate

Acute

 

 

 

 

Algae

3.9

 

3900

 

Daphnids

14

 

14000

 

Fish

11

 

11000

 

Macrophytes

> 50

 

>50000

 

Chronic

 

 

 

 

Daphnids

 

0.32

320

 

Fish

 

0.8

800

Agrichem Ethofumesate (2)

Acute

 

 

 

 

Algae

8.4

 

8400

 

Daphnids

11.5

 

11500

 

Fish

3.8

 

3800

 

These toxicity values are compared to the surface water concentrations calculated in section 6.2. Trigger values for acute exposure are 100 for daphnids and fish (0.01 times the lowest L(E)C50-value) and 10 for algae and macrophytes (0.1 times the lowest EC50-value). Trigger values for chronic exposure are 10 for daphnids and fish (0.1 times the lowest NOEC-values).

For acute and chronic risk, the initial concentration is used (PIEC).  

In table E.5aTER values for aquatic organisms are shown.

 

Table E.5a TER values for active substance ethofumesate: acute

use

 

Substance

TERst

(trigger 10)

TERst

(trigger 100)

TERst

(trigger 100)

TERst

(trigger 10)

 

 

Algae

Daphnid

Fish

Macrophytes

ryegrass

ethofumesate

410

1470

1160

>5250

 

Agrichem Ethofumesaat (2)

882

1208

399

 

 

Table E.5b TER values for active substance ethofumesate: chronic

use

 

Substance

TERlt

(trigger 10)

TERlt

(trigger 10)

 

 

Daphnid

Fish

ryegrass

ethofumesate

33.6

84.0

 

Taking the results in Table E.5a and b into account, the acute TERs for fish and Daphnia magna are above the relevant Annex VI triggers of 100 and the acute TERs for algae and Lemna are above the relevant Annex VI triggers of 10. The chronic TERs for fish and Daphnia magna are above the relevant Annex VI triggers of 10. Thus, it appears that for the active substance ethofumesate the proposed use meets the standards for aquatic organisms.

 

7.2.2    Risk assessment for bioconcentration

For the active substance a BCF-value of 144 L/kg is available. 

Since the BCF is above 100 L/kg and the substance ethofumesate is not ready biodegradable, there is a risk for bioconcentration.

According to the guidance document on aquatic ecotoxicology the following points should be checked:

1)      Direct long-term effects in fish due to bioconcentration;

2)      Secondary poisoning for birds and mammals;

3)      Biomagnification in aquatic food chains

Ad 1) An ELS study should be available if 100 < BCF < 1000 and EC50 a.s. < 0.1 mg/L. A FLS should be available if BCF > 1000. These triggers are not exceeded for ethofumesate. 

Ad 2) From the assessment of birds and mammals it appears that there is no risk on secondary poisoning through fish.

Ad 3) Required if the BCF > 1000 and the elimination in the BCF study within 14 days < 95% and the DT90 water > 100 days). These triggers are not exceeded.

 

Hence, the active substance ethofumesate meets the standards for bioconcentration.

 

7.2.3    Risk assessment for sediment organisms

The NOEC value for Chironomus is 5000 µg/L. When this value is examined against the PIEC in water of 9.51, the TER value is 525 and the trigger value of 10 is exceeded. Therefore, the active substance ethofumesate meets the standards for sediment organisms.

 

Conclusions aquatic organisms

The proposed application of the product meets the standards.

 

7.3       Effects on terrestrial vertebrates other than birds

Mammals can be exposed to the active substance ethofumesate via natural food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning.

 

The threshold value for acute exposure for mammals is set at 0.1 times the LD50 value, and the threshold value for chronic exposure is set at 0.2 times the NOEC value. This means that TER (Toxicity-Exposure Ratio) for acute exposure should be ³ 10 and TER for chronic exposure should be ³ 5. Dietary toxicity is not taken into account for mammals.

Table E.6 presents an overview of toxicity data.

 

Table E.6 Overview of toxicity data for mammals for substance ethofumesate

 

Endpoint

Value

Acute toxicity to mammals:

LD50

>8000 mg a.s./kg bw

Reproductive toxicity to mammals:

NOEL

300 mg a.s./kg bw/d

 

7.3.1    Natural food and drinking water

Sprayed products

Procedures for risk assessment for mammals comply with the recommendations in the Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (Sanco/4145/2000).

For the current application, uses can be categorized as grassland. Depending on the crop category different indicator species are chosen. Table E.7 shows which indicator species are relevant for which uses.

 

Table E.7 Indicator species per use

 

Use

Crop

Indicator species

 

Grass seed crops and grass sods

Grassland

small herbivorous 

 

Table E.8a-b show the estimated daily uptake values (ETE, Estimated Theoretical Exposure) and TER’s of ethofumesate for acute and long-term exposure, using the Food Intake Rate of the indicator species (FIR) divided by the body weight of the indicator species (bw), the Residue per Unit Dose (RUD), a time-weighted-average factor (fTWA, only for long term) and the application rate. For uses with frequency of > 1, a MAF (Multiple Application Factor) may be applicable. TER should be above the trigger for an acceptable risk.

 

Table E.8a Acute risk for mammals

Substance

FIR / bw

RUD

Applica-tion rate

 

(kg a.s./ha)

MAF

Acute ETE

LD50 (mg/kg bw/d)

TER

(mg/kg bw/d)

(trigger 10)

Small herbivorous mammal

 

ethofumesate

1.39

142

2

-

395

>8000

>20

 

Table E.8b Long-term risk for mammals

Substance

FIR / bw

RUD

Applica-tion rate

 

(kg a.s./ha)

MAF

ftwa

Long-term ETE

NOEL (mg/kg bw/d)

TER

 

(mg/kg bw/d)

(trigger 5)

Small herbivorous mammal

 

ethofumesate

1.39

76

2

-

0.53

112

300

2.7

 

Taking the results in Table E.10 into account, it appears that a long-term risk to mammals for the proposed uses cannot be excluded.

 

Refined risk assessment,

The applicant refers to residue data from established grasslands. From these studies it appears that the mean RUD is 88, and the geometric mean DT50 is 3.53 days. Based on this DT50 a refined Ftwa of 0.24 is  calculated. A new long-term ETE calculation and risk assessment is given in Table E.9.

 

Table E.9 Long-term risk for mammals – refined risk assessment

Substance

FIR / bw

RUD

Applica-tion rate

 

(kg a.s./ha)

MAF

ftwa

Long-term ETE

NOEL (mg/kg bw/d)

TER

 

(mg/kg bw/d)

(trigger 5)

Small herbivorous mammal

 

ethofumesate

1.39

88

2

-

0.24

58.7

300

5.1

 

Based on this refined risk assessment, an acceptable risk is expected for mammals.

 

drinking water

The risk from exposure through drinking from surface water is calculated for a small mammal with body weight 10 g and a DWI (daily water intake) of 1.57 g/d. Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In the first instance, acute exposure is taken into account. The highest PIECwater is 9.51 mg/L. It follows that the risk of drinking water is (LD50 * bw) / (PIEC*DWI) = (>8000 * 0.010) / (9.52 * 0.00157) = >100000

Since TER >> 10, the risk is acceptable. 

 

7.3.2    Secondary poisoning

The risk as a result of secondary poisoning is assessed based on bioconcentration in fish and worms.

Since the log Kow of ethofumesate < 3 (2.7), the potential for bioaccumulation is considered low and no further assessment is deemed necessary.

 

Conclusions mammals

The product meets the standards for mammals.

 

7.4       Effects on bees

The risk assessment for bees is based on the ratio between the highest single application rate and toxicity endpoint (LD50 value). An overview of the risk at the proposed uses is given in Table E.10.

 

Table E.10 Risk for bees

Use

Substance

Application rate

LD50

Rate/LD50

Trigger value

 

 

[g a.s./ha]

[µg a.s./bee]

 

 

Grass seed crops and grass sods

ethofumesate

Agrichem Ethofumesate (2)

2000

2000

>50

95

<40

21

50

 

Since the ratio rate/LD50 is below 50, the risk for bees is considered to be low. Hence, all proposed uses meet the standards for bees.

 

Conclusions bees

The product meets the standards.

 

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

7.5.1    Effects on non-target arthropods

The risk for non-target arthopods is assessed by calculating Hazard Quotients. For  this, Lethal Rate values (LR50) are needed. Based on LR50-values from studies with Agrichem Ethofumesaat (2) with the two standard species Aphidius rhopalosiphi (LR50 = 2.0 kg a.s./ha) and Typhlodromus pyri (LR50 =0.4 kg a.s./ha) an in-field and an off-field Hazard Quotient (HQ) can be calculated according to the assessment method established in the SETAC/ESCORT 2 workshop and described in the HTB (v 1.0). Hazard Quotients should be below the trigger value of 2 to meet the standards. The resulting Hazard Quotients are presented in Table E.11.

 

Table E.11 HQ-values for A. rhopalosiphi and T. pyri 

 

Application rate

(kg a.s./ha)

MAF1

Drift factor/

Vegetation factor2

Safety

factor2

LR50

(kg a.s./ha)

HQ

In-field

 

 

 

 

 

 

A. rhopalosiphi

2.0

1

-

-

2.0

1.0

T. pyri

2.0

1

-

-

0.4

5.0

Off-field

 

 

 

 

 

 

A. rhopalosiphi

2.0

1

0.01

10

2.0

0.10

T. pyri

2.0

1

0.01

10

0.4

0.50

1: Multiple Application Factor

2: off-field: drift factor = 10%, vegetation dilution factor = 10, safety factor = 10 (default values)

 

As the above table shows, both in- and off-field HQ values are below the trigger value of 2 for A. rhopalosiphi. For T.pyri the off-field HQ is below the relevant trigger of 2. However, the in-field HQ is above the relevant trigger of 2. Therefore a second tier risk assessment is required, showing an acceptable in-field risk for T. pyri. Since an in-field risk is expected based on the first tier, one additional species should be tested.