Toelatingsnummer 14293 N

Betasana Trio SC  

 

14293 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 WEDERZIJDSE ERKENNING

 

Gelet op de aanvraag d.d. 4 augustus 2009 (20090643 WERG) van

 

United Phosphorus Limited

Chadwick H,Birchwood Prk

WARRINGTON, CHESHIRE WA3 6AE

GROOT-BRITTANNIË

 

 

tot verkrijging van een wederzijdse erkenning van de toelating in het Verenigd Koninkrijk van het middel op basis van de werkzame stoffen desmedifam, ethofumesaat en fenmedifam en desmedifam,

 

Betasana Trio SC

 

gelet op artikel 41, lid 1 van de Verordening (EG) 1107/2009,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Toelating

1.      Het middel Betasana Trio SC is toegelaten voor de in bijlage I genoemde toepassingen onder nummer 14293 N met ingang van datum dezes. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

 

2.      De toelating geldt tot 31 juli 2017.

 

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 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 29, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden,

 

1.    De aanduidingen, welke ingevolge artikelen 9.2.3.1 en 9.2.3.2 van de Wet milieubeheer en artikelen 14, 15a, 15b, 15c en 15e van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld, worden hierbij vastgesteld als volgt:

 

aard van het preparaat: Suspensie concentraat

 

werkzame stof:

gehalte:

Ethofumesaat

115 g/l

Fenmedifam

75 g/l

Desmedifam

15 g/l

 

letterlijk en zonder enige aanvulling:

 

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

-

 

gevaarsymbool:

aanduiding:

Xi

Irriterend

N

Milieugevaarlijk

 

 

Waarschuwingszinnen: 

 

R36                 -Irriterend voor de ogen.

R50/53            -Zeer vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

 

 

Veiligheidsaanbevelingen:

 

S46                 -In geval van inslikken onmiddellijk een arts raadplegen en verpakking of etiket tonen.

S60                 -Deze stof en de verpakking als gevaarlijk afval afvoeren.

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

 

 

Specifieke vermeldingen:

 

 

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

 

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

 

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

 

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

 

 


2 DETAILS VAN DE AANVRAAG

 

Het betreft een aanvraag tot verkrijging van een toelating van het middel Betasana Trio SC (14293 N), een middel op basis van de werkzame stof desmedifam, ethofumesaat en fenmedifam.  Het middel wordt aangevraagd als onkruidbestrijdingsmiddel in bieten.

 

2.2 Informatie met betrekking tot de stof

Er zijn in Nederland reeds andere middelen op basis van de werkzame stoffen desmedifam,  ethofumesaat en fenmedifam toegelaten.

 

Desmedifam is per 1 maart 2005 opgenomen in Bijlage I van Richtlijn  91/414/EEC

De stof is goedgekeurd onder Verordening  1107/2009 (nummer 86).

 

Ethofumesaat is 1 maart 2003 opgenomen in Bijlage I van Richtlijn  91/414/EEC

De stof is goedgekeurd onder Verordening  107/2009 (nummer 29).

 

Fenmedifam is per 1 maart 2005 opgenomen in Bijlage I van Richtlijn  91/414/EEC

De stof is goedgekeurd onder Verordening  1107/2009 (nummer 88).

 

2.3 Karakterisering van het middel

Betasana Trio SC is een onkruidbestrijdingsmiddel op basis van de werkzame stoffen desmedifam, ethofumesaat en fenmedifam.

Desmedifam en fenmedifam behoren tot de groep van de fenylcarbamaten. Dit zijn selectief systemisch werkende herbiciden die worden opgenomen door het blad, met een primaire verplaatsing naar de apoplasten. Desmedifam en fenmedifam remmen de fotosynthese door onderbreking van het elektronentransport. De middelen hebben geen bodemwerking.  Met name breedbladige onkruiden worden bestreden.

Ethofumesaat behoort tot de groep van benzofuranen. Het is een selectief werkend herbicide, dat opgenomen wordt door uitlopers (grassen) en wortels (breedbladige onkruiden). Ethofumesaat remt de groei van meristemen, vertraagt de celdeling en beperkt de opbouw van de wasachtige cuticula.

Deze werkzame stoffen zijn in Nederland al geruime tijd toegelaten. Desmedifam, ethofumesaat en fenmedifam hebben een toelating in deze combinatie en in combinatie met metamitron. Er zijn ook middelen toegelaten op basis van alleen ethofumesaat of fenmedifam.

 

2.4 Voorgeschiedenis

De aanvraag is op 5 augustus 2009 ontvangen; op 28 september 2009 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 2 juli 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  Inleiding

De onderhavige aanvraag betreft een verzoek tot wederzijdse erkenning van de toelating in het Verenigd Koninkrijk van het gewasbeschermingsmiddel Betasana Trio SC. Gezien de aard van de wederzijdse erkenning wordt ervan uitgegaan dat de beoordeling door het Verenigd Koninkrijk  is uitgevoerd conform de Uniforme Beginselen (annex VI bij richtlijn 91/414/EEG).

 

Voor de beoordeling van de aspecten fysische en chemische eigenschappen, analysemethoden, werkzaamheid en delen van de aspecten risico voor de mens en risico voor het milieu refereert het Ctgb aan het toelatingsbesluit in het Verenigd Koninkrijk  Op een aantal hieronder weergegeven voor de Nederlandse situatie specifieke punten, toetst het Ctgb zelf inhoudelijk.

 

3.2  Risico voor de mens

De volgende aspecten worden nationaal ingevuld:

·          Arbeidsomstandigheden - nationale modellen en arbeidshygiënische strategie

·          Volksgezondheid - de criteria voor residuen in volggewassen

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 beoordeling van het risico voor de toepasser staat beschreven in Hoofdstuk 4 Mammalian Toxicology, van Bijlage II bij dit besluit.

De beoordeling van het risico voor de volksgezondheid met betrekking tot residuen in volggewassen staat beschreven in Hoofdstuk 5, Residues van bijlage II behorende bij dit besluit.

 

3.3  Risico voor het milieu

De volgende aspecten worden nationaal ingevuld:

·         Uitspoeling naar grondwater

·         Drift naar oppervlaktewater; van toepassing op : Waterorganismen, vogels, zoogdieren, niet-doelwitplanten, niet-doelwitarthropoden en oppervlaktewater bestemd voor de bereiding van drinkwater

·         Drinkwatercriterium oppervlaktewater

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.

 

3.4  Eindconclusie

Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Betasana Trio SC basis van de werkzame stoffen desmedifam, ethofumesaat en fenmedifam. 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 4 van Bijlage 2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

 

Wageningen, 6 december 2013

 

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,

 


ir. J.F. de Leeuw

voorzitter



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 6 december 2013 tot wederzijdse erkenning het middel Betasana Trio SC, toelatingnummer 14293 N

 

 

Wettelijk Gebruiksvoorschrift

Toegestaan is uitsluitend het professionele gebruik als onkruidbestrijdingsmiddel door middel van een na opkomst toepassing in het volgende toepassingsgebied (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden

 

Toepassingsgebied

Te bestrijden organisme

Dosering (middel) per toepassing

Maximaal aantal toepassingen per teeltcyclus

Maximaal aantal liter middel per ha per teeltcyclus

Minimum interval tussen toepassingen in dagen

Bieten

Eenjarige breedbladige onkruiden

2 - 2,5 l/ha

3

7 l/ha

5

 

Betasana Trio Sc dient te worden toegepast in 100-300 liter water per ha.

 

Om niet tot de doelsoorten behorende planten te beschermen is toepassing op percelen die niet grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruikt wordt gemaakt van driftarme spuitdoppen

 

Toepassingsvoorwaarden

Er zijn geen aanvullende toepassingsvoorwaarden.

 

.


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 6 december 2013 tot toelating van het middel Betasana Trio SC, toelatingnummer 14293 N

 

Contents

                                                                                                                                              Page

1.     Identity of the plant protection product 3

2.     Physical and chemical properties. 4

3.     Methods of analysis. 4

4.     Mammalian toxicology. 5

5.     Residues. 10

6.     Environmental fate and behaviour 11

7.     Ecotoxicology. 39

8.     Efficacy. 65

9.     Conclusion. 66

10.       Classification and labelling. 67

Appendix 1  Table of authorised uses. 1

Appendix 2  Reference list 4

 

 


1.      Identity of the plant protection product

 

1.1       Applicant

United Phosphorus Ltd.

Chadwick House, Birchwood Park

Warrington, Cheshire WA3 6AE

 

1.2       Identity of the active substance

ISO Common name

Desmedipham

Name in Dutch

Desmedifam

Chemical name

ethyl 3-phenylcarbamoyloxyphenylcarbamate [IUPAC]

CAS no

13684-56-5

EEC no

EINECS: 237-198-5

 

The active substance desmedipham was included in Annex I of Directive 91/414/EEC on March 1st , 2005.

 

From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance is approved under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC (Number 86).

 

ISO Common name

Ethofumesate

Name in Dutch

Ethofumesaat

Chemical name

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

CAS no

26225-79-6

EEC no

247-525-3

 

The active substance ethofumesate was included in Annex I of Directive 91/414/EEC on March 1st , 2003.

 

From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance is approved under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC (Number 29).

 

Common name

Phenmedipham

Name in Dutch

Fenmedifam

Chemical name

methyl 3-(3-methylcarbaniloyloxy)carbanilate;
3-methoxycarbonylaminophenyl 3´-methylcarbanilate [IUPAC]

CAS no

13684-63-4

EEC no

237-199-0

 

The active substance phenmedipham was included in Annex I of Directive 91/414/EEC on March 1st , 2005.

 

From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance is approved under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC (Number 88).

 

1.3       Identity of the plant protection product

Name

Betasana Trio SC

Formulation type

SC

Content active substance

15 g/L desmedipham

115 g/L ethofumesate

75 g/L Phenmedipham

 

For the assessment of the formulation and its proposed use we refer to the member state of the original authorisation (United Kingdom).

 

1.4       Function

Herbicide.

 

1.5       Uses applied for

See GAP (Appendix I).

 

1.6       Background to the application

Application for mutual recognition of an authorisation of a plant protection product. The application for Betasana Trio SC is based on the authorisation for Betasana Trio SC in  the United Kingdom (MAPP 15551).

  

1.7       Packaging details

 

1.7.1    Packaging description

Material:

HDPE screw top ‘jerry can’

Capacity:

5 L

Type of closure and size of opening:

Container neck: 63 mm, type of closure not specified

Other information

ADR compliant and UN certified.

 

1.7.2    Detailed instructions for safe disposal

See application form and MSDS.

 

 

2.      Physical and chemical properties

 

For the assessment of the physical and chemical properties of Betasana Trio SC we refer to the member state of the original authorisation (United Kingdom).

 

3.      Methods of analysis

 

For the assessment of the methods of analysis required for  Betasana Trio SC we refer to the member state of the original authorisation (United Kingdom).

 


3.4       Physical-chemical classification and labelling

 

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

Professional use, packaging > 125mL

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

-

Symbol:

-

Indication of danger:

-

R phrases

-

-

S phrases

-

-

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

Proposed shelf life of the formulation: 2 years (shelf-life study ongoing)

 

 

4.      Mammalian toxicology

 

4.1       Toxicity of the formulated product (IIIA 7.1)

For the evaluation of the toxicity of the formulated product Betasana Trio SC, we refer to the member state of the original authorisation (United Kingdom).

 

4.2       Dermal absorption (IIIA 7.3)

 

Desmedipham

UK used a value of 10% for desmedipham for dermal absorption (both the product concentrate and dilution) in the risk assessment and since this application is a request for mutual recognition the value of 10% is also used in this risk assessment.

 

Ethofumesate

UK used a value of 1% for ethofumesate for dermal absorption (both the product concentrate and dilution) in the risk assessment and since this application is a request for mutual recognition the value of 1% is also used in this risk assessment.

 

Phenmedipham

UK used a value of 1% for phenmedipham for dermal absorption (both the product concentrate and dilution) in the risk assessment and since this application is a request for mutual recognition the value of 1% is also used in this risk assessment.

 

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

For toxicological data relating to non-active substances we refer to the registration report written by the United Kingdom.

 


4.4       Exposure/risk assessments (Dutch specific aspect)

 

Overview of the intended uses

An application (request for mutual recognition) has been submitted for the authorisation of the plant protection product Betasana Trio SC, a herbicide based on the active substances desmedipham, ethofumesate and phenmedipham.

 

Betasana Trio is a SC formulation and contains 15 g/L desmedipham, 115 g/L ethofumesate and 75 g/L phenmedipham.

 

The formulation Betasana Trio SC is applied by mechanical downward spraying in sugar and fodder beets. The formulation is applied maximally 3 times during the period April – May with a maximum dose of 2.5 L formulation / ha. Therefore, a semi-chronic exposure duration is applicable for the operator (including contract workers).

 

4.4.1    Operator exposure/risk

 

Desmedipham

 

Tier 1

 

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

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

Since desmedipham is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 0.04 mg/kg bw/day (= 2.8 mg/day for a 70-kg operator), based on the 90 day study in dogs, is applied.

 

Exposure/risk

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

 

Table T.1 Internal operator exposure to desmedipham and risk assessment for the use of Betasana Trio SC

 

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/

Loadingc

Respiratory

<0.01

2.8

<0.01

Dermal

0.75

2.8

0.27

Applicationc

Respiratory

<0.01

2.8

<0.01

Dermal

0.11

2.8

0.04

 

Total

0.87

2.8

0.31

a    Internal exposure was calculated with:

·       biological availability via the dermal route: 10% (concentrate) and 10% (spray dilution) (see 4.2)

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

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

c    External exposure is estimated with EUROPOEM

 

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

 

Ethofumesate

 

Tier 1

 

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

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

Since 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.

 

Exposure/risk

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

 

Table T.2 Internal operator exposure to ethofumesate and risk assessment for the use of Betasana Trio

 

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/

Loadingc

Respiratory

0.01

175

<0.01

Dermal

0.58

175

<0.01

Applicationc

Respiratory

0.02

175

<0.01

Dermal

0.09

175

<0.01

 

Total

0.70

175

<0.01

a    Internal exposure was calculated with:

·       biological availability via the dermal route: 1% (concentrate) and 1% (spray dilution) (see 4.2)

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

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

c    External exposure is estimated with EUROPOEM

 

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

 

Phenmedipham

 

Tier 1

 

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

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

Since phenmedipham is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 0.13 mg/kg bw/day (= 9.1 mg/day for a 70-kg operator), based on the 90-d study in rats is used for the risk assessment.

 


Exposure/risk

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

 

Table T.3 Internal operator exposure to phenmedipham and risk assessment for the use of Betasana Trio SC

 

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/

Loadingc

Respiratory

0.01

9.1

<0.01

Dermal

0.38

9.1

0.04

Applicationc

Respiratory

0.02

9.1

<0.01

Dermal

0.06

9.1

0.01

 

Total

0.46

9.1

0.05

a    Internal exposure was calculated with:

·       biological availability via the dermal route: 1% (concentrate) and 1% (spray dilution) (see 4.2)

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

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

c    External exposure is estimated with EUROPOEM

 

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

 

4.4.2    Bystander exposure/risk

Desmedipham, ethofumesate and phenmedipham

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

Desmedipham, ethofumesate and phenmedipham

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

Desmedipham, ethofumesate and phenmedipham

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 desmedipham, ethofumesate and phenmedipham as a result of the application of Betasana Trio SC in sugar and fodder beets.

 

Bystander exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected bystander due to exposure to desmedipham, ethofumesate and phenmedipham during application of Betasana Trio SC in sugar and fodder beets.

 

Worker exposure and re-entry

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 and adverse health effects are expected.

 

No additional risk is expected for the simultaneous exposure to desmedipham, ethofumesate, phenmedipham (see 4.7).

 

4.5       Appropriate mammalian toxicology and operator exposure end-points 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

The formulation Betasana Trio SC is a mixture of three active substances.

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 profiles based on the individual substances.

 

Ethofumesate induces effects on the liver. The critical effect of phenmedipham and desmedipham is haemolytic anaemia. Based on the differences in toxicological profile, no additional risk is expected for the combined exposure to ethofumesate and phenmedipham/desmedipham.

 

Phenmedipham and desmedipham both induce haemolytic anaemia. Since these substances have a comparable toxicological profile, it is likely that the effects are additive. The combined exposure to phenmedipham and desmedipham results in a risk-index of 0.05+0.31=0.36. Therefore, no risk is expected for the combined exposure to phenmedipham and desmedipham.

 

4.8       Mammalian toxicology classification and labelling

 

Proposal for the classification and labelling of the formulation concerning health

 

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

 

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

 

Symbol:

Xi

Indication of danger:

Irritant

R phrases

R36

Irritating to eyes.

 

 

 

S phrases

S46

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

Special provisions:
DPD-phrases

-

-

Plant protection products phrase:
DPD-phrase

DPD01

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

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

 

Risk phrases:

 

Safety phrases:

S46 is invariably assigned to formulations assigned with the mentioned R-phrase(s), intended for professional use only when this does not lead to more than six safety-phrases.

Other:

 

 

 

5.      Residues

 

For the aspect ‘Residues’, and risk for consumers we refer to the member state of the original authorisation (United Kingdom), except for the aspect ‘residues in succeeding crops’.

 

5.1       Summary of residue data

 

5.1.6    Residues in succeeding crops (Dutch specific aspect)

 

Desmedipham

The uptake of residues into rotational crops studied (lettuce, radish and wheat) was low at all time points, with residue levels declining rapidly as the planting interval increased.

 

Ethofumesate

Due to persistence of ethofumesate for Annex I inclusion the following restriction was set: the dose level of ethofumesate must not exceed 1.0 kg ai/ha every 3 years. With the current application request and normal crop rotation (beets are grown in rotation with other crops by default), this restriction will be honoured and no detectable residue levels are expected in rotational crops.

 

Phenmedipham

Due to fast degradation and strong adsorption in soil, no detectable residues are expected in succeeding crops.

 

Conclusion

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

 

5.2.1        Data requirements

No data requirements were identified.

 


6.      Environmental fate and behaviour

 

The underlying risk assessment is based on the final list of endpoints for active substances desmedipham, ethofumesate and phenmedipham and on the UK authorisation for Betasana Trio SC. For the Dutch specific aspects data from previous assessments is used.  

 

Desmedipham is an existing substance, placed on Annex I. For the risk assessment the List of Endpoints (24/11/2003) from the final review report (13/02/2004) is used.

 

Ethofumesate is an existing substance, placed on Annex I. For the risk assessment the final List of Endpoints (26/02/2002) from the final review report (15/05/2002) is used.

 

Phenmedipham is an existing substance, placed on Annex I since April 2004. For the risk assessment the final List of Endpoints (24/11/2003) from the final review report (13/02/2004) is used.

 

Additional data or evaluations are included in the LoEP in italics.

 

List of Endpoints Fate/behaviour

 

Desmedipham (LoEP November 2003)

Fate and behaviour in the environment

 

Fate and behaviour in soil

Route of degradation

 

Aerobic:

 

Mineralization after 100 days:

21.4-37.8 % (5 soils; after 100 days; both labels)

7.5-46.4 % (2 soils; after 112 days; both labels)

14-19 % (1 soil, after 90 days; AP-label)

Non-extractable residues after 100 days:

55.8-67.2 % (5 soils; after 100 days; both labels)

21.5-55.0 % (2 soils; after 112 days; both labels)

64 % (1 soil, after 90 days; AP-label)

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

EHPC; max 13.8 % after 3 days

-in the field study in N. Dakota max 87 % after 28 days

 

 

Supplemental studies

 

Anaerobic:

Mineralisation: phenyl label    1.2 % at day 120

                        aniline label     1.0 % at day 120

Non-extractable residues:

                        phenyl label  90.4 % at d 120

                        aniline label  67.6 % at d 120

Metabolites

EHCP: max 78 % after day 1

Aniline: max 69 % after day 1

 

 

Soil photolysis:

Stable

 

 

Remarks:

None

 

Rate of degradation

 

Laboratory studies

 

DT50lab (20 °C, aerobic):

range 3.2 – 175 days, n=12, median 17 days

 

EHPC 0.34d, 0.25d and 0.38d (20ºC) average/geomean 0.32 days (taken from addendum)

DT90lab (20 °C, aerobic):

18 – 714 days, n=11;

average 142 days, median 73 days; r2 values not given

DT50lab (10 °C, aerobic):

no study

DT50lab (20 °C, anaerobic):

phenyl label: 0.34 days in water phase

                      0.57 days in water phase

aniline label: 0.30 days in water phase

                      0.41 days in water phase

Field studies (country or region)

 

DT50f from soil dissipation studies:

 

DT50f:

Germany, bare soil, three sites:

 4.8 days at pH 6.2,

 8.8 days at pH 7.1,

 9.0 days at pH 6.9

mean 7.5 days (1st order,  r2= 0.94-0.98)

geomean 7.2 days

 

USA California, one site, 12.2 days, r2=0.95

(USA, N.Dakota, one site, 41.5 days, r2=0.53)

 

(In USA, N.Dakota: EHPC detected at max. 87 % of applied DMP at day 28)

(DT50 of 9 days has been used in the PECsoil calculation)

DT90f from soil dissipation studies:

DT90f:

Germany (sites described above):

18.5, 29.2 and 29.8 days, mean 25.8 days, n=3

USA, California:  40 days

 

(DT90 of 30 days has been used in the PECsoil calculation)

Soil accumulation studies:

no study submitted nor required

Soil residue studies:

no study submitted nor required

 

 

Remarks:

e.g. effect of soil pH on degradation rate

no clear pH dependence

 

 


Adsorption/desorption

 

Kf / Koc:

Kd:






pH dependence:

DMP: Koc values not possible to obtain due to high hydrolysis rate –  no new study submitted


Rf values of 0.02 - 0.07 in 4 soils, corresponding the Koc values of 13898, 5927, 10389 and 11952 L/kg


EHPC: Koc 124-335; 4 soils

No pH dependence

 

 

Mobility

 

Laboratory studies:

 

Column leaching:

Guideline: BBA

Precipitation: 200 mm in 2 days

Soils: 3 German standard soils

Use rate: 1.5 kg /ha as Betanal AM 21 formulation, corresponding to 0.5 kg 14C-DMP/ha

Leachate: total residue <0.5 % of AR in all soils, not characterised further

Soil columns: total residue ~95 % of AR, mainly in top 5 cm, not characterised further

Aged residue leaching:

Guideline:  BBA IV 4-2

Soils: German standard soil 2.1

Use rate: 14C-AP-labelled DMP 250 g/ha

Aged for: 5 days

Precipitation: 200 mm in 2 days

Leachate: total residue  3.3 % of AR in leachate, EHPC 0.3 % of AR, m-aminophenol 1.65 % of AR, unknown 1.4 % of AR, no DMP could be found (LOD = 0.04 % of AR)

Soil column: Over 85 % of AR in the top 10 cm of soil, mainly as EHPC, only traces of DMP could be found

Volatiles: during ageing about 3 % of AR volatilised

 

 

Field studies:

 

Lysimeter/Field leaching studies:

Location: Switzerland, Itingen

Study type: lysimeter, 3 years

Soil: 1 sandy soil with low content of organic C

Number of applications: 1 X 480 g/ha (highest field use rate) in first year or in two successive years, no applications in the third year

Crops: fodder beet 2 years + winter wheat + barley

Average annual rainfall: 1043 mm

Average annual leachate volume: 440 mm

% radioactivity in leachate (max/year): totally 0.31 % of AR (1st year application) or 0.46 % of AR (1st + 2nd year applications) was found in leachates

Yearly mean concentrations: total radioactivity 0.09 – 0.1, 0.10 – 0.32, 0.10 – 0.39 µg/l for year 1, 2, and 3 respectively. No DMP or EHPC was found in leachates (LOD for parent and parent equivalents was 0.05 µg/l), m-aminophenol was not analysed

 

 

Remarks:

No groundwater contamination expected

 

Fate and behaviour in water

Abiotic degradation

 

Hydrolytic degradation:

 

pH 5, 22 °C : 70 days

          25 °C: 39 days

 

 

pH 7, 22 °C:  19.6 h

          25 °C:  12 h

 

 

pH 9, 22 °C:  0.17 h

           25 °C:  7 min

Major metabolites:

EHPC: stable at pH 4, 5, 7 and 9 at 50 °C

 

Photolytic degradation:

stable

Major metabolites:

stable

 

 

Biological degradation

 

Readily biodegradable:

 

no

Water/sediment study:

DT50 water:
DT90 water:
DT50 whole system:
DT90 whole system:

Distribution in water / sediment systems
(active substance)

Distribution in water / sediment systems
(metabolites)

2 systems; phenyl- and aniline labelled DMP;

First order kinetic model
0.1-3.1 days
0.3-10.4 days
2.2-4.0  days
7.3-13.3 days

Phenyl label: Max 9 % in sediment at day 14

Aniline label: Max  5 % in sediment at day 21

Water (two systems):

EHPC: max 96 % at day 1 and 22.7 % at day 100

Aniline: max 72 % at day 0 and 14.9 % at day 100

Sediment (two systems):

EHPC: max 13 % at day 100

Aniline: not found in sediment

 

Information from addendum 3:

EHPC DT50 whole system: 62.5 days (single value from kinetic model)

Aniline DT50 whole system: 35.4 days (single value from kinetic model)

Kom: for aniline no sorption data was available and a conservative Kom estimate of 10 l/kg was used as suggested in Aquatic Guidance Document

Accumulation in water and/or sediment:

due to quite rapid dissipation no accumulation is expected

 

 

 

Degradation in the saturated zone

no study submitted nor required

 

 

Remarks:

None

Fate and behaviour in air

Volatility

 

Vapour pressure:

4·10 –8 Pa  at 25 °C,  extrapolated  (99.6 % pure)

Henry's law constant:

4.3 · 10 -7 Pa · m3 ·  mol –1

 

 

Photolytic degradation

 

Direct photolysis in air:

Not studied, no data required

Photochemical oxidative degradation in air

DT50:

10.8 hours (Atkinson method)

Volatilisation:

from plant surfaces: after 24 h less than 3 % was volatilised

 

 

from soil: after 24 h no volatilisation

Remarks:

PECair considered negligible

 

Ethofumesate (LoEP dd February 2002)

Fate and behaviour in the environment

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

 

Three additional studies are submitted to Ctgb;

Annex

point

 

Author

Year

Title

Source (where different from company)

Company, Report No.

GLP or GEP status (where relevant)

Published or Unpublished

7.3

Mc Laughlin S.P

2012

14 C Ethofumesate Aerobic Rate of Degradation in Soil

 

 

7.4.7

 

 

 

 

7.3

 

 

Diehl M.

 

 

 

 

Staffa C. and Hein W

 

 

 

2005

 

 

 

 

2012

 

 

Ethofumesate : Mobility and degradation in soil in outdoor lysimeters

 

 

14 C Ethofumesate- Aerobic degradation in nine European Soils at 200 C in the dark

 

A lysimeter study of Diehl (2005) was submitted earlier and was not accepted. Two soil transformation studies (total 13 soils) are evaluated an summarised by Ctgb. Characteristics and conclusion are given below: 

 

Characteristics

Reference

:

Mc Laughlin S.P.

 

Incubation time

:

62 days

Year of execution

:

2012

 

Nominal concentration

:

1 kg/ha

GLP statement

:

Yes

 

Temperature

:

20 ± 2 °C

Guideline

:

OECD 307

 

DT50

:

See evaluation

Test substance

:

Ethofumesate

 

Metabolites

:

None

Test system

:

Soil (laboratory)

 

Acceptability

:

Acceptable

 

Conclusion

In general, study is well performed and all soils can be included in the results.  Modelling was according to FOCUS guidance; all 4 fits were visually good or very good; χ2 – values were below 7%, and P-value was << 0.05 for all SFO fits. For all fits the SFO fit showed a lower χ2 value, and visual fit was good. Therefore, presented DFOP fit was not necessary according to FOCUS. Ctgb agrees with the use of the results as presented below as trigger and modelling endpoints.

 

Characteristics

Reference

:

Staffa, C., Hein, W.

 

Incubation time

:

84/77 d. ; 1 soil: 120 days

Year of execution

:

2010b

 

Nominal concentration

:

50 µg/ 100g dry soil  =  500 mg a.i./ha

GLP statement

:

Yes

 

Temperature

:

20 +/- 2°C

Guideline

:

OECD 307

 

DT50

:

See evaluation

Test substance

:

Ethofumesate

 

Metabolites

:

None

Test system

:

Soil (laboratory)

 

Acceptability

:

Acceptable

Conclusion

In general, study is well performed and all soils can be included in the results.  Modelling was according to FOCUS guidance; all 9 fits were visually good or very good; χ2 – values were below 10%, and P-value was << 0.05 for all soils. Ctgb agrees with the use of the results as presented below for modelling.

(Note: according to FOCUS Kinetics guidelines, it is not agreed to use these endpoints as trigger endpoints; for use as trigger endpoints, a FOMC fit to the data should be included).

 

Normalisation of endpoints from above studies and studies from DAR resulted in the following endpoints:

 

Study

Location

Soil type

DT50act

DT50normalised

McLaughlin (2012)

Fislis

Silt Loam

16

12.8

Horn

Loam

9.4

7.6

Montesquieu

Clay

20.4

15.5

Sevelen

Sandy loam

11.7

8.7

 

 

 

 

 

Staffa & Hein (2012)

Mussbach (DE)

Loam

17.7

12.8

Speyer 5M (DE)

Sandy loam

15.4

10.8

Speyer 2.2 (DE)

Loamy sand

12.8

12.8

Lockington (UK)

clay loam

25.5

19.4

Lockington (UK)

sandy loam

23.3

22.3

Village Neuf (FR)

Loam

13.6

10.08

Gemeinlebarn (AU)

Silt loam

12.5

8.7

Carlet, Valancia (SP)

Silt loam

17.3

12.0

Regalbuto, Enna (IT)

Loam

11.1

9.7

 

 

 

 

 

Waring (1992)

 

Sandy Loam

122

125.8

 

Silt Loam

83

86.9

Waring (1993)

 

Loamy sand

211

162.0

Adcock et al. (1975)

 

Sandy Loam

51

48.3

Colorado

Sandy loam

47

44.6

Hall et al. (1991)

Speyer

Silty Sand

61

46.8

Speyer

Sandy Loam

99

66.7

Speyer

Silty Clay Loam

113

65.0

Speyer

Clay Loam

84

48.6

Fisher (1994)

German soil 2.2

Sandy Loam

54

46.2

 

 

 

 

 

 

 

 

Median

19.4

 

 

 

Geomean

25.2

 

The median DT50 of 19.4 days (n=23) will be used in the risk assessment.

 

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
ºN)
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.

 

The applicant submitted a lysimeter study by Parsons (2003; 14C-ethofumesate and 2,-oxo-ethofumesate: mobility and degradation in soil in field lysimeters) and the analytical report (Final Analytical Report 14C-ethofumesate and 2,-oxo-ethofumesate: mobility and degradation in soil in field lysimeters).The assessment of the lysimeter study according to Verschoor et al. 2001 showed that the used soil profile is more vulnerable than the standard Dutch scenario. The amount of rain and irrigation are both comparable. However, the temperature is higher and the amount of leachate is very low resulting in a less vulnerable lysimeter study. No degradation and adsorption/desorption characteristics for the soils used are available. Based on these findings the lysimeter study has to be standardized according to Verschoor et al. (2001).

 

Aim of the standardization study is to calculate the simulation error for the lysimeter study and to calibrate the half-life in soil to the results of this study. This was done by calculations with the FOCUS_PEARL v3.3.3 model. The standardization was described by HJM Verhaar, Environ, 2009 (Calibration of a lysimeter study (Parsons, ACE01-012) ENVIRON, UP-LYS-20090082) and resulted in simulation error 4.4 x 10-8. This simulation error is too low to be relevant for risk  assessment.

 

Ctgb also evaluated this study and a 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 (Evaluation Alterra WUR 2006).

 

The applicant submitted data on an additional lysimeter study, ‘Ethofumesate: mobility and degradation in soil in outdoor lysimeters’ written by M. Diehl (RCC Ltd, Itingen), RCC Study Nr 836695, 2005. This study with two lysimeters was summarized and evaluated in a report by Alterra. The amount of percolated water was 650 mm in the first year and about 400 mm in the second year. In the lysimeters 34.44% and 36.67% of the applied radioactivity was found in total. 0.63 and 0.79% in the leachate in the first year and 0.49 and 0.42% in the second year.

The lysimeters are performed and reported correctly and the result will be used for further assessment.

 

The results of the two lysimeters were used to calibrate the study. The applicant submitted a calibration study of two lysimeters; ‘Ethofumesate; calibration of a lysimeter study (Diehl, 836695)’ by HJM Verhaar, Environ, 2009.’ This study was summarised and evaluated in Alterra report 20110301 (Boesten J.).

 

Aim of the study was to calculate the simulation error for the lysimeter study and to calibrate the half-life in soil to the results of this study. This was done by calculations with the FOCUS_PEARL v3.3.3 model. From the calibration study no meaningful simulation error could be calculated. The simulated results of the total material balance show that that the total aeric mass leached corresponds with a fraction of the dose less than 10-6. The results of the study for the calibration of the lysimeter cannot be used for risk assessment.

 

Phenmedipham (LoEP dd November 2003)

 

Fate and behaviour in the environment

 


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

PMP: Mineralization after 100 days

 

CO2 evolved:

13.3 – 16.5 %  of AR within 120 days, AP 14C-labelled, low temperature/low moisture (n=1)

9.7 – 11.3 %  of AR within 120 days, phenoxy ring –U-14C labelled (n=3)

PMP: Non-extractable residues after 100 days

 

63.6 – 64.1 % of AR within 120 days, AP 14C-labelled, low temperature/low moisture (n=1)

71.3 – 73.8 % of AR within 120 days

phenoxy ring –U-14C labeled (n=3)

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

MHPC max 14 % of AR at day 14 (n=1)

APMP max  4 % of AR after 56 days (n=1)

(label position AP)

MHPC max 54 % at day 5 (n=1, ring-U-labelled)

MHPC: Mineralization after 100 days

From MHPC: ca. 10 % CO2 within 7 days (n=3)

MHPC: Non-extractable residues after 100 days

From MHPC: 80-83 % within 7 days (n=3)

 

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

Anaerobic degradation

 

CO2 evolved 6.6 % of AR,

NER 74.3 % of AR after 97 days,

MHPC max 19 % of AR after 32 days

(label position AP, n=1)

Soil photolysis

 

DT50 79 hours on irradiated soil

photochemical products:

3-aminophenol and 3-methoxycarbonylaminophenol

max 17.8 % of AR (sum of all polar products)

after 105 hours of irradiation

(n=1)

           

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

Method of calculation

laboratory: 1st order kinetics

computer program by Timme

 

Laboratory studies (range or median, with n value,

with r2 value)

 

PMP

DT50lab (22ºC, aerobic):  14.1 days (n=1, r2 = 0.934)

Normalised to 20 °C by using Q10 of 2.2: 16.4 days

DT50lab (20ºC, aerobic):  26, 42, 43 d, mean=37 days (n=3, r2 = 0.932 - 0.953)

 

DT90lab (22ºC, aerobic):  47 days (n=1, r2  = 0.934)

Normalised to 20 °C by using Q10 of 2.2: 55 days

DT90lab (20ºC, aerobic):  85, 138, 143 days (n=3, r2  = 0.932 – 0.953)

 

DT50lab (11ºC, aerobic): 25 days,

DT90lab (11ºC, aerobic): 105 days

 

PMP

DT50lab (22ºC, anaerobic): 12.5 days (n=1, r2 = 0.934)

DT90lab (22ºC, anaerobic): 42 days (n=1, r2 = 0.934)

Metabolites:

MHPC

 

DT50lab (22ºC, aerobic): 12 days (n=1, r2 = 0.748) Ctgb: value is according to SFO using TopFit (in fact the value is 11.6 d, see Addendum 1 Vol 3, using Arrhenius a DT50 of 13.6 d is derived for 20 ºC)

DT90lab (22ºC, aerobic):  38 days (n=1, r2 = 0.748)

DT50lab (20ºC, aerobic): 0.1, 0.2, 0.3 days (n=3,

r2 = 0.992 - 0.999) NB square root kinetics

DT90lab (20ºC, aerobic):  1.2, 2.3, 2.9 days (n=3,

r2 = 0.992 - 0.999)

MHPC

DT50lab (20ºC, anaerobic): 49 days (n=1, r2  = 0.930)

DT90lab (20ºC, anaerobic): 161 days (n=1, r2  = 0.930)

APMP

DT50lab (22ºC, aerobic): 16.7 days (n=1, r2 = 0.993)

DT90lab (22ºC, aerobic):  55.5 days (n=1, r2  = 0.993)

APMP

DT50lab (20ºC, anaerobic): 70 days (n=1, r2 = 0.982)

DT90lab (20ºC, anaerobic): 231 days (n=1, r2 =0.982)

degradation in the saturated zone

 no data submitted nor required

Field studies (state location, range or median with

n value)

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)

Ctgb: geomean 13.5 days

 

USA, California, one site:

sandy loam, on red beet  stage 4-6 leaf:

13.3 days at pH 7.0 (n=1, r2 not available, 1st order)

 

metabolites:  no DT50 values calculated in the field studies

 

DT90f: Germany, sites described above:

range 30 - 133 days, mean 82 days (n=4 , r2  not available, 1st order)

 

For PECsoil calculation the median DT50f of 15.5 days from the German field studies was used.

 

For FOCUS gw modelling the DT50lab of 25 days was used for PMP, and 7 days for MHPC.

Soil accumulation and plateau concentration

no data submitted nor required

 

Soil adsorption/desorption (Annex IIA, point 7.1.2)

Kf /Koc

PMP

 

 

 

 

 

 

 

MHPC

 

 

 

 

 

 

 

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

dependence)

Koc:

PMP:

657, 934, 1072, mean = 888, 1/n = 0.821, 0.865, 0.854

(soil samples, n = 3, equilibrium time 2.5 hours)

 

469, 728, mean = 599, 1/n = 0.82, 0.84

(sediments, n=2, equilibrium time 3 hours)

 

Koc:

MHPC: 212, 138, 58, 470, mean = 220, 1/n  = 0.515, 0.699, 0.949, 0.805 (n = 4, one outlier excluded)

 

Kd:

MHPC: 0.57 - 4.8

 

Yes, due to the hydrolysis processes which indirect affect the adsorption of parent. No dependence for the metabolites.

 

For FOCUS gw modelling with FOCUS_PEARL v. 1.1.1  following median Kom values were used:

PMP: 422, 1/n = 0.84

MHPC: 101, 1/n = 0.752

 

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

Column leaching

PMP: 

 

 

 

 

 

 

 

 

 

 

 

 

PMP:

 

 

 

 

 

 

 

 

 

 

 

PMP:

 

 

 

 

 

 

 

 

MHPC:

 

 

1) Guideline: US EPA subdiv. N, para 163.1

Precipitation:  920 ml corresponding to 50.8 cm rainfall in 10 days (92 ml/d)

Soils: 2 soils, label  positions AP and T

Use rate: 0.825 kg/ha (AP) and 1.1 kg/ha (T)

Leachate: total residue 0.33 - 0.45 % of AR in leachates, not characterized further

Soil columns: total residue 88.1 – 92.6 % of AR in soil columns (mainly in the top 5 cm),  NER 43.1 – 53.1 % and 34.9 – 60.4 % extractable of it

Volatiles 3.72 – 7.27 % of AR during the leaching period.

 

2) Guideline: US EPA subdiv. N, para 163.1

 Precipitation:  560 mm in 5 days

Soil: 2 soils, label positions AP and T

Use rate 1.65 kg/ha

Leachate: total residue 0.6 - 2.3 % of AR in leachates, not characterized further

Soil columns: total residue 89.5 – 95.4 % of AR in soil columns (mainly in the top 10 cm), extractable 26 – 64 % of it, mainly unchanged parent

Volatiles not trapped.

 

 

3) Guideline:  BBA

Precipitation: 200 ml/day for 2 days

Soils: 3 soils, label position AP

Use rate: 1.5 kg/ha

Leachate: total residue <0.5 % of AR in leachates, not characterized further

Soil columns: total residue  > 93 % of AR, mainly in the top 5 cm.

 

Guideline:  TNO in-house method

Precipitation: 140 ml/day for 3 days, corresponding to 30 cm of rainfall in 3 days

Soils: 2 soils, humic sand and loam

Use rate: 0.5 mg MHPC/column

 Leachate: 47.2 - 47.7 % of AR in leachates in the loam soil, not detected in the humic sand soil

Soil columns: In the humic sand the main part of the activity remained in the soil layers 12-24 cm, in the loam soil the activity was evenly distributed to the layers 6-30 cm, and only traces were located in the top 5 cm.

Aged residues leaching

 

1) Guideline:  BBA

Soils: 1 soil, German standard soil 2.1

Use rate:  960 g/ha, label position T

Aged at 20 degrees C, 40 % MWHC, for 33 days

Precipitation:  2 days irrigation of 200 mm

Leachate: 0.48 % of AR was found in the leachate, not characterized further

Soil column: 96.2 % of AR remained in soil, mainly in the top 10 cm

Volatiles: 5.7 % of AR.

 

2) Guideline:  EPA Vol 40, No 123, Part II, 1975

Soils: 2 soils, German standard soils 2.2 and 2.3

Use rate:  1.25 kg/ha, label position AP

Aged at 25-30 degrees C, 70 % MWHC, for 30 days

Precipitation:  45 days irrigation of 125 mm/day

Leachate:  0.58 and 1.66 % of AR was found in the leachates, not characterized further

Soil column: 99.1 – 112.9 % of AR remained  in the soil, mainly in the top 6 cm. The aged soil was not analysed further for the metabolites.

 

3) Guideline:   EPA Vol 40, No 123, Part II, 1975

Soils: 2 soils, German standard soils 2.2 and 2.3

Use rate: 1.65 kg/ha on soil 2.2 and 1.25 kg/ha on soil 2.3, label position T

Aged at 25-30 degrees C, 75 % MWHC, for 30 days

Precipitation:  45 days irrigation of 125 mm/day

Leachate:   1.37 - 1.83 % of AR was found in the leachates, not characterized further

Soil column: 72.9 – 88.7 % of AR remained in the soil, mainly in the top 5 cm. The aged soil was not characterized further for the metabolites.

Lysimeter/ field leaching studies

 

1) Location: UK

Study type: lysimeter

Soils: loamy sand, low content of organic matter

Number of applications: one single application of 0.942 kg/ha  in the first year, study continued over 2 years

Crops: sugar beet + wheat

Average annual rainfall: 757 mm (1st year), 948 mm (2nd year)

Average annual leachate volume: 200 mm/ first year (25 % of the precipitation), 445 mm/ second year (47 % of the precipitation)

% radioactivity in the leachate (max/year): after 2 years totally 0.8 - 1.1 % of AR was leached

Peak annual average concentrations: total radioactive residues 1.28 – 1.9 mg/l in the first year, 1.1 – 1.33 mg/l in the second year  (40 % of AR in leachate attributed to humic acid type fragments and up to 27 % incorporated with naturally occurring compounds),  MHPC 0.006 mg/l, PMP could not be detected in any of the samples (LOD = 0.03 mg/l as a.s.equivalents).

 

2) Location: Germany

Study type: lysimeter

Soils: loamy sand with low organic matter content

Number of applications:  1.0 kg/ha either once or in two successive years, study continued for up to 3 years

Crops: sugar beet (1 or 2 successive years) + wheat

Average annual rainfall: 860 mm/year (cumulative sum of 2582 mm within 3 years)

Average annual leachate volume: 428 mm

% radioactivity in the leachate (max/year): after 2 years totally 0.22 - 0.32 % of AR was leached

Peak annual average concentrations: total radioactive residues 0.314 – 0.805 mg/l (water soluble humic acid-type components, due to the low radioactivity the further characterization was not possible). MHPC was calculated as <0.01 mg as equivalents/l. (LOQ = 0.017 mg/l for PMP and 0.010 mg/l for MHPC).

 

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

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

            DT50                    DT90                   r2

pH 4:   259 d                   861 d                -0.9726

pH 5:     47 d                   156 d                -0.9958

pH 7:     12 h                     39 h                -0.9922

pH 9:       7 min                  24 min           -0.9860

(25 oC, 1st order kinetics)

Hydrolysis products:

MHPC formed:

pH 4: max 8.0 % of AR after 672 h

pH 5: max 38.0 % of AR after 720 h

pH 7: completely after 72 h

pH 9: completely after 30 min

 

MHPC is hydrolytically stable at pH 4, 5, 7, 9 under sterile conditions and at 50 oC over 120 h.

Photolytic degradation of active substance and

relevant metabolites

no degradation (artificial light source, λ > 290 nm)

Readily biodegradable (yes/no)

no

Degradation in    - DT50 water

water/sediment    - DT90 water

 

                            - DT50 whole system

                          

                            - DT90 whole system

 

 

MHPC:               - DT50 water

 - DT90 water

                          

                            - DT50 whole system

                          

                            - DT90 whole system

 

 

Mineralisation

NER in sediment

 

 

 

 

Distribution in water / sediment systems (active

substance)

 

 

 

 

 

 

Distribution in water / sediment systems

(metabolites)

0.1 – 0.3 days (Öt/1st order, r2 = 0.989, 0.544, n=2)       

0.6 – 3.4 days (Öt/1st order, r2 = 0.989, 0.544, n=2)

 

0.11, 0.12, 0.18 days (1st order kinetics, r2 = 0.942 – 0.978, n=3) geomean 0.133 d

0.38, 0.40, 0.60 days  (1st order kinetics, r2 = 0.942 – 0.978, n=3)

 

10-21 days (apparent DT50 determined visually)

not available

 

10.6, 23.9, 24.9 days (1st order kinetics, r2 = 0.942 – 0.978, n=3) geomean = 18.5 d

35.3, 79.4, 82.8 days (1st order kinetics, r2 = 0.942 – 0.978, n=3)

 

CO2: 14 - 30 % of AR at study end after 126 days (n=2)

NER in sediment: max.55 - 78 % of AR after 70/35 days,

50 % at study end after 126 days, n=2)

 

1 - 2 % of AR in water phase and

51 - 55 % in sediment after 126 days

(non-sterilised samples, 2 label positions, 2 systems),

44 - 51 % of AR in water and

39 - 44 % in sediment after 126 days (sterilised samples, 1 label position, 2 systems).

 

MHPC: 60 - 70 % of AR within 1 - 2 days

              1 % of AR after 126 days

 

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

Direct photolysis in air

not studied, no data required

Photochemical oxidative degradation in air (DT50)

6.7 hours derived by the Atkinson method of calculation

Volatilization

from plant surfaces: no data

 

from soil: no data

 

Major Components of the Environmental Residue (Annex IIA, point 7.3)

Relevant to the environment

 

 

Soil: phenmedipham, MHPC

Water: phenmedipham, MHPC

Air: phenmedipham

 

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

Soil (indicate location and type of study)

no data submitted nor required

Surface water (indicate location and type of study)

no data submitted nor required

Ground water (indicate location and type of study)

no data submitted nor required

Air (indicate location and type of study)

no data submitted nor required

 

Appendix A: Metabolite names, codes and other relevant information of the pesticide Betasana Trio SC with active substances desmedipham, ethofumesate and phenmedipham.

 

The compounds shown below were found in one or more studies involving the metabolism and/or environmental fate of active substances desmedipham, ethofumesate and phenmedipham. The parent compound structure of desmedipham, ethofumesate and phenmedipham is shown first in this list and followed by degradate or related compounds.

 

Compound name

Code number(s)

IUPAC name

Structural formula

Structure

Molecular Weight

[g/mol]

Observed in study (% of occurrence/ formation)

Desmedipham

13684-56-5 (CASnr)

ethyl 3´-phenylcarbamoyloxycarbanilate

C16H16N2O4

300.3

 

EHPC

7159-96-8 (CASnr)

ethyl N-(3-hydroxyphenyl)carbamate

C9H11NO3

181.2

Soil (lab degradation): 13.8 %

Water: 96 %

Sediment: 13%

Aniline

62-543-3 (CASnr)

aminobenzeen

C6H7N

Bestand:Anilin.svg

93.13

Water: 72 %

 

Ethofumesate

26225-79-6 (CASnr)

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

C13H18O5S

286.3

 

Phenmedipham

13684-63-4 (CAS nr)

methyl 3-(3-methylcarbaniloyloxy)carbanilate

C16H16N2O4

300.3

 

MHPC

13683-89-1 (CASnr)

Methyl N-(3-hydroxyphenyl)carbamate

 

C8H9NO3

167.2

Soil (lab degradation): 14 %

Water/ sediment: 60-70 %

 


6.1       Fate and behaviour in soil

 

6.1.1    Persistence in soil (Dutch specific aspect)

The higher tier risk assessment on persistence in soil is a Dutch national specific aspect. For the current application for mutual recognition this means that if for the evaluation of the product a higher tier risk assessment is necessary for persistence, the UK risk assessment cannot be used for mutual recognition and a national risk assessment has to be performed.

 

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:

 

Active substance desmedipham

The following laboratory DT50 values are available for the active substance desmedipham: 3.2-175 days (n = 12, median 17 days, (individual values could not be traced in the DAR). 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. In field studies, performed in Germany, the DT50 ranged from 4.8-9.0 days (geomean 7.2 days).

 

For the metabolite EHPC the DT50-values are 0.34, 0.25 and 0.38 days (n = 3, geomean 0.32).

 

In this way, the standards for persistence for the active substance desmedipham and metabolite EHPC as laid down in the RGB are met.

 

Active substance ethofumesate

The following laboratory DT50 values are available for the active substance ethofumesate: range: 47 – 211 days (mean 97 days, median value is 84 days). The mean DT50-value of the active substance 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 is 77 days, range 15 – 250 days, median DT50 is 56 days (n= 10).

 

From the results it is shown that the average field DT50 is < 90 days. Therefore, the standards for persistence for the active substance ethofumesate as laid down in the RGB are met.

 

Active substance 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.

 

For the metabolite MHPC (maximum observed 54 %) the following DT50-values are available: 12 (SFO), 0.1, 0.2, 0.3 (best fit all square root kinetics) days. The value of 12 days (11.6 d) was derived at 22 ºC, Ctgb recalculated to 20 ºC using Arrhenius yielding a value of 13.6 days. The geomean is 0.53 d.

 

In the photolysis study described in the DAR and LoEP, 2 major metabolites were observed, total AR was 18.5 %. Major metabolites were 3-aminophenol and MHPC. The last one is listed in the LoEP as 3-methoxycarbonylaminophenol, while in the DAR (top of B.8) it is defined as methyl-(3-hydroxy phenyl)carbamate. This appears to be a nomenclature issue, which is backed up by the remark in the summary on degradation in soil section: MHPC was the main product of the photolysis, too.

 

The amount of MHPC formed by photolysis is covered by the higher % formed in the standard aerobic test. It is unknown what part of the 18.5 % AR is caused by 3-aminophenol. However, as it was stated that MHPC was the main product of the photolysis (interpreted as more than half which means that the % AR 3-aminophenol would be < 10 %), the metabolite 3-aminophenol is not addressed further.

 

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

 

6.1.2    Leaching to shallow groundwater (Dutch specific aspect)

Leaching to shallow ground water is a Dutch specific aspect. For the current application for mutual recognition this means that the UK risk assessment for leaching to ground water cannot be used for mutual recognition and a national risk assessment has to be performed.

 

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 and metabolites 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, the crop sugar beets, and an interception value appropriate to the crop of 0.2. First date of yearly application is May 25th.

 

For metabolites all available data concerning substance properties are regarded. Metabolites EHPC and MHPC are included in the calculations. No other metabolites occurred above > 10 % of AR, > 5 % of AR at two consecutive sample points or had an increasing tendency. The following input data are used for the calculation:


 



PEARL:

 

Active substance desmedipham:

Median DT50 for degradation in soil (20°C): 17 days (n = 12)

Arithmetic mean Kom (pH-independent): 6201 L/kg

1/n: 0.9 (default)

 

Saturated vapour pressure: 4 x 10-8 Pa (25°C)

Solubility in water: 0.007 g/L (25°C)

Molecular weight: 300.3 g/mol

 

Metabolite EHPC:

Geometric mean DT50 for degradation in soil (20°C): 0.32 days (n=3)

Arithmetic mean Kom (pH-independent): 144 L/kg;

1/n: 1.0 (default value for metabolites)

Maximum fraction of occurrence: 0.87

 

Saturated vapour pressure: 4 x 10-8 Pa (parent value)

Solubility in water: 0.007 g/L (parent value)

Molecular weight: 181.2 g/mol

 

Active substance ethofumesate:

Median DT50 for degradation in soil (20°C):  19.4 days (n= 23)

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

1/n: 0.9 (default)

 

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

Solubility in water: 0.05 g/L (25 °C)

Molecular weight: 286.3 g/mol

 

Plant uptake factor: 0 (worst case)

Q10: 2.2

 

Active substance phenmedipham:

Geometric mean DT50 for degradation in soil (20°C): 29.6 days (n=4)

Arithmetic mean Kom (pH-independent): 515.1 L/kg

Arithmetic mean 1/n: 0.85

 

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

Solubility in water: 0.0018 g/L (20°C at pH 3.4, decomposes at neutral/basic pH)

Molecular weight: 300.3 g/mol

 

Metabolite MHPC:

DT50 for degradation in soil (20°C): 13.6 d (only 1 SFO value)

Arithmetic mean Kom (pH-independent): 127.6 L/kg

Arithmetic mean 1/n: 0.74

Maximum fraction of occurrence: 0.54

 

Saturated vapour pressure: 7.0 x 10-10 Pa (parent value)

Solubility in water: 0.0018 g/L (parent value)

Molecular weight: 167.2 g/mol

Other parameters: standard settings of PEARL 3.3.3

The following concentrations are predicted for the active substances desmedipham, ethofumesate and phenmedipham and the metabolites EPHC and MHPC following the realistic worst case GAP, see Table M.1a.

 

Table M.1a Leaching of active substances desmedipham, ethofumesate and phenmedipham and metabolites EHPC and MHPC as predicted by PEARL 3.3.3

Use

Substance

Rate substance [kg/ha]

Frequency / Interval [days]

Fraction

Intercepted*

PEC

groundwater [mg/L]

 

 

 

 

 

spring

Beets

desmedipham

EHPC

ethofumesate  phenmedipham

MHPC

0.0375

***

0.2875

0.1875

***

3** / 4

0.2

<0.001

<0.001

<0.001

<0.001

<0.001

* fraction on soil is determined as 0.8 for post emergence application on sugar beets – interception value derived from Table 1.6 in “generic guidance for FOCUS groundwater scenarios”.

** first application is with a slightly lower dose (2 l/ha vs. 2.5 L/ha), but for the risk assessment the higher application rate is used (3 x 2.5 l/ha) in line with ecotoxicological risk assessment.

*** calculated via metabolisation scheme in PEARL.

 

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.1a it reads that the expected leaching based on the PEARL-model calculations for the active substances desmedipham, ethofumesate and phenmedipham and metabolites EHPC and MHPC is smaller than 0.01 µg/L for all proposed applications.

 

Lysimeter/field leaching studies

Active substance desmedipham

A lysimeter study is available in the monograph. In this studies the application rates was 450 g a.s./ha. The concentrations of desmedipham and EHPC could not be detected (LOD = 0.05 µg/L). This lysimeter study is not standardised to the Dutch conditions. Since no leaching is expected, this is not necessary.

 

Active substance ethofumesate

Two lysimeter studies in sugar beets has been submitted. In both lysimeter studies no ethofumesate was found in the leachate.

 

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.

 

Also for the second lysimeter standardisation according to Verschoor was carried out. From the calibration study no meaningful simulation error could be calculated. The simulated results of the total material balance show that that the total aeric mass leached corresponds with a fraction of the dose less than 10-6. The results of the study for the calibration of the lysimeter cannot be used for risk assessment.

 


Active substance phenmedipham

Two lysimeter studies are available in the monograph. In both studies, the concentrations of phenmedipham and MHPC could not be detected or were < 0.01 µg/L. These lysimeter studies are not standardised to the Dutch conditions. Since no leaching is expected, this is

 

Monitoring data

There are no data available regarding the presence of the active substances desmedipham, ethofumesate and phenmedipham in groundwater.

 

Conclusions

The proposed application 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 (Dutch specific aspect)

Since the Netherlands has its own national drift values, the exposure concentrations of the active substances desmedipham, ethofumesate , phenmedipham and metabolites EHPC (max. formation 0.96 from desmedipham), aniline (max formation 0.72 from desmedipham) and MHPC (maximum observed 70 % of 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. Concentrations in surface water are calculated using the model TOXSWA. The following input data are used for the calculation:

 

TOXSWA:

Active substance desmedipham

Geometric mean DT50 for degradation in water at 20°C: 3.0 days

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

 

Arithmetic mean Kom for suspended organic matter: 6201 L/kg

Arithmetic mean Kom for sediment: 6201 L/kg

1/n = 0.9 (default)

 

Saturated vapour pressure: 4 x 10-8 Pa (25°C)

Solubility in water: 0.007 g/L (25°C)

Molecular weight: 300.3 g/mol

 

Metabolite EHPC

DT50 for degradation in water at 20°C: 62.5 days (n=1)

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

 

Arithmetic mean Kom for suspended organic matter: 144 L/kg

Arithmetic mean Kom for sediment: 144 L/kg

1/n = 1.0 (default for metabolites)

 

Saturated vapour pressure: 4 x 10-8 Pa (parent value)

Solubility in water: 0.007 g/L (parent value)

Molecular weight: 181.2 g/mol

Correction factor: 0.96 (formation fraction metabolite) x 0.60 (relative molar ratio = M metabolite/ M parent) = 0.58

 

Metabolite aniline (see input parameters Addendum 3)

DT50 for degradation in water at 20°C: 35.4 days (n=1)

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

 

Kom for suspended organic matter: 10 L/kg

Kom for sediment: 10 L/kg

1/n = 1.0 (default for metabolites)

 

Saturated vapour pressure: 4 x 10-8 Pa (parent value)

Solubility in water: 0.007 g/L (parent value)

Molecular weight: 93.13 g/mol

Correction factor: 0.72 (formation fraction metabolite) x 0.31 (relative molar ratio = M metabolite/ M parent) = 0.22

 

Active substance ethofumesate

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

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

 

Median Kom for suspended organic matter: 78 L/kg

Median mean Kom for sediment: 78 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 weight: 286.3 g/mol

 

Active substatnce phenmedipham

Geometric mean DT50 for degradation in water at 20°C: 0.133 days

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

 

Kom for suspended organic matter: 347.5 L/kg (derived from sediment studies)

Kom for sediment: 347.5 L/kg

Arithmetic mean 1/n: 0.83

 

Saturated vapour pressure: 7 x 10-10 Pa (25 ºC)

Solubility in water: 0.0018 g/L (20°C at pH 3.4, decomposes at neutral/basic pH)

Molecular weight: 300.3 g/mol

 

Metabolite MHPC:

Geometric mean DT50 for degradation in water at 20°C: 18.5 days

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

 

Arithmetic mean Kom for suspended organic matter: 127.6 L/kg

Arithmetic mean Kom for sediment: 127.6 L/kg

Arithmetic mean 1/n: 0.74

 

Saturated vapour pressure: 7 x 10-10 Pa (parent value)

Solubility in water: 0.0018 g/L (parent value)

Molecular weight: 167.2 g/mol

Formation fraction: 70% formation x 0.56 (g/mol MHPC/g/mol parent) = 0.39

 

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.

 

For metabolites, the level M-I values are used (system DegT50 value) only, since level M-II criteria have not been fully developed under FOCUS Degradation Kinetics.

 

In Table M.3a, the drift percentages and calculated surface water concentrations for the active substances desmedipham, ethofumesate, phenmedipham and metabolites EHPC, aniline and MHPC for each intended use are presented. Aircraft applications are not allowed.

 

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

Use

Substance

Rate a.s.

[kg/ha]

Freq. / Interval [days]

Drift

[%]

PIEC

[mg/L] *

PEC21

[mg/L] *

PEC28

[mg/L] *

 

 

 

 

 

spring

spring

spring

Beets

desmedipham

EHPC

aniline

ethofumesate  phenmedipham

MHPC

0.0375

0.02175

0.00825

0.2875

0.1875

0.07313

3** / 4

1

0.2982

0.2877

0.1105

3.876

0.8912

0.9242

0.1418

0.2515

0.0962

3.500

0.0538

0.7285

0.1198

0.2358

0.0899

3.274

0.0404

0.6784

* calculated according to TOXSWA

** first application is with a slightly lower dose (2 l/ha vs. 2.5 L/ha), but for the risk assessment the higher application rate is used (3 x 2.5 l/ha) in line with ecotoxicological risk assessment.

 

PEC-WFD water body

Since an ecotoxicological risk for desmedipham cannot be excluded in the first tier of the edge-of-field ditch assessment, a second tier assessment has to be performed. By decree of the Ministry of Agriculture, Nature and Food Quality, the Ministry  of Housing, Spatial Planning and the Environment and the Ministry  of Transport, Public Works and Water Management, Ctgb has to assess from September 2009 onwards –based on an interim assessment methodology, see C-212.6-  whether an ecotoxicological risk in the Water Framework Directive (WFD) water bodies might occur. This is implemented by examining the MPC-INS (both acute and chronic values) against a calculated exposure concentration in the WFD water body.

 

In the interim period, only the maximum PEC in the WFD water body is considered (since more knowledge and consensus is needed before implementing a time-weighted average concentration).

 

The calculation of the PEC at the WFD water body accounts for dilution (dilution factor depending on the frequency of application) and degradation during the travel time from ditch to WFD water body. The formula to arrive at this PEC-WFD is:

 

PECmax, WFD = PECmax, edge-of-field ditch* e(-residence time*k) / dilution factor

 

With k=ln2/DT50system. In this case, the DT50 used is 3.0 days.

 

For predicted concentrations in the WFD water body see Table M.3b

 

Table M.3b Maximum concentration for active substances desmedipham following spring application in the WFD water body

Use

Substance

Rate a.s.

[kg/ha]

Drift

[%]

PIECditch

[µg/L] *

Dilution factor

PECmax, WFD [µg/L]

Beets

desmedipham

0.0375

1

0.2982

3

0.031

* TOXSWA output 

 

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.

Active substance desmedipham

The active substance desmedipham was observed in the surface water (most recent data from 2009). In Table M.4a the number of observations in the surface water are presented.

In the pesticide atlas, surface water concentrations are compared to the authorisation threshold value 1.0 µg/L (dated 04/04/05, 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 Maximum Permissible Concentration (MPC) as established in the Fourth National Policy Document on Water Management (value 1.0 µg/L, May 2007).

 

For substance desmedipham, an MPC-INS value is available. This value is a factor 7.7 lower than the value presented in the Pesticide Atlas. Since only spatially aggregated values are presented in the Pesticide Atlas, no exact information on threshold exceeding can be generated. It can be expected that the exceeding factors will be higher than the exceeding factors presented now. However, no definite conclusions can be drawn.

 

Table M.4a Monitoring data desmedipham in Dutch surface water

Total no of observations

(2009)

n > authorisation threshold

 

n > MPC threshold

4th Document water management

n > MPC-INS threshold *

351 **

0

0

> 

* n.a.: no MPC-INS available. < : exceeding expected to be lower than with 4th Document MPC value; > : exceeding expected to be higher than with 4th Document MPC value.

** the number of observations at each location varies between 1 and 30, total number of measurements is 204 in 2009.

 

No exceeding of the threshold values occurred.

 

Active substance ethofumesate

The active substance ethofumesate was observed in the surface water (most recent data from 2009). In Table M.4b the number of observations in the surface water are presented.

In the pesticide atlas, surface water concentrations are compared to the authorisation threshold value 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 Maximum Permissible Concentration (MPC) as established in the Fourth National Policy Document on Water Management (value 6.4 µg/L, May 2007).

 

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.4b Monitoring data ethofumesate in Dutch surface water

Total no of observations

(2009)

n > authorisation threshold

 

n > MPC threshold

4th Document water management

n > MPC-INS threshold *

373 **          

1

1

n.a.

* n.a.: no MPC-INS available. < : exceeding expected to be lower than with 4th Document MPC value; > : exceeding expected to be higher than with 4th Document MPC value.

** the number of observations at each location varies between 1 and 30, total number of measurements is 1760 in 2009.

 

As there is no exceeding of thresholds, the monitoring data have no consequences for the proposed use(s) of the product. The correlation of exceeding 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. There are not enough observations in this version of the Pesticide Atlas to calculate the correlation with land use.

 

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

 

Active substance phenmedipham

The active substance phenmedipham was observed in the surface water (most recent data from 2009). In Table M.4c the number of observations in the surface water are presented.

In the pesticide atlas, surface water concentrations are compared to the authorisation threshold value 4.1 µg/L (dated 05/03/07, C-179.3.7) consisting of first or higher tier acute or chronic ecotoxicological threshold value used for risk assessment (in this case 0.01*EC50 Daphnia) and to the Maximum Permissible Concentration (MPC) as established in the Fourth National Policy Document on Water Management (value 0.5 µg/L, May 2007).

 

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(s).

 

Table M.4c Monitoring data phenmedipham in Dutch surface water

Total no of observations

(2009)

n > authorisation threshold

 

n > MPC threshold

4th Document water management

n > MPC-INS threshold *

227**

0

0

n.a.

* n.a.: no MPC-INS available. < : exceeding expected to be lower than with 4th Document MPC value; > : exceeding expected to be higher than with 4th Document MPC value.

** the number of observations at each location varies between 1 and 30, total number of measurements is 253 in 2009.

 

No exceeding of the threshold values occurred.

 

Drinking water criterion

Assessment of the drinking water criterion is in principle not a Dutch national specific criterion however the interpretation is done in a Dutch specific way.

 

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.

 

Active substance desmedipham

Desmedipham has been on the Dutch market for > 3 years (authorised since 03/03/1995). This period is sufficiently large to consider the market share to be established. From the general scientific knowledge collected by the Ctgb about the product and its active substance, the Ctgb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. The Ctgb does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water as laid down in the RGB are met.

 

Active substance 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 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, 2005-2008) indicate that that the measurements do not exceed the drinking water criterion. Therefore, the application of ethofumesate 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.

 

Active substance phenmedipham

Phenmedipham has been on the Dutch market for > 3 years (authorised since 04/04/1996). This period is sufficiently large to consider the market share to be established. From the general scientific knowledge collected by the Ctgb about the product and its active substance, the Ctgb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. The Ctgb does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water as laid down in the RGB are met. The standards for surface water destined for the production of drinking water as laid down in the RGB are met.

 

Conclusion drinking water criterion

The original registration in UK was not assessed against the drinking water criterion. Conclusion risk assessment according to EM 1.0: the proposed application

n of the product  complies with the RGB.

 

6.3       Fate and behaviour in air

 

Route and rate of degradation in air

Assessment of fate and behaviour in air is not a Dutch specific aspect. For the current application for mutual recognition this means that the UK risk assessment should be used. At present there is no framework to assess fate and behaviour in air of plant protection products.

 

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

 

6.6       Overall conclusions fate and behaviour

It can be concluded that:

  1. the active substances desmedipham, ethofumesate and phenmedipham meets the standards for per­sis­tence in soil as laid down in the RGB.
  2. metabolites EHPC of desmedipham and MHPC of phenmedipham meet the standards for per­sis­tence in soil as laid down in the RGB.
  3. the proposed application of the active substances desmedipham, ethofumesate and phenmedipham meets the standards for leaching to the shallow groundwater as laid down in the RGB.
  4. the proposed application of metabolite EHPC of desmedipham and MHPC of phenmedipham meets the standards for leaching to shallow groundwater as laid down in the RGB.
  5. the application for mutual recognition of the product does not comply with the RGB with regard to the standards for surface water destined for the production of drinking water. According to EM 1.0, the proposed application of the product comply with the RGB with regard to the standards for surface water destined for the production of drinking water.

 

 

7.      Ecotoxicology

 

The underlying risk assessment is based on the final list of endpoints for desmedipham, ethofumesate and phenmedipham and on the UK authorisation for Betasana Trio SC.

For desmedipham an MPC was derived (RIVM report 12813, 01/2011).

 

Studies on the formulation were included in the UK risk assessment and are copied below the other LoEPs

 

List of Endpoints Ecotoxicology

Desmedipham

Desmedipham is an existing substance, placed on Annex I since 2005. Since Annex I inclusion is over 5 years ago, the final LoEP can be used for the risk assessment (d.d. 24/11/2003, Review report d.d. 13/02/2004). Furthermore, the applicant has a LoA for the Annex II dossier. Comments and additions are given in italic.

 

List of Endpoints Ecotoxicology

 

Terrestrial Vertebrates

Acute toxicity to mammals:

rat: LD50 > 5000 mg a.i./kg bw (formulations: Betanal AM 11 >5000 mg/kg bw, Betanal Progress >2000 mg/kg bw, Kemifam Pro FL >2000 mg/kg bw)

Acute toxicity to birds:

bobwhite quail: LD50 > 2000 mg/kg bw, NOEL 500 mg/kg

mallard duck: LD50 >2000 mg/kg bw, NOEL 2000 mg/kg

Dietary toxicity to birds:

mallard duck: LC50 > 5000 mg/kg feed; LC50 >5200 mg/kg feed, NOEC 1300 mg/kg feed

bobwhite quail: LC50 >5000 mg/kg feed, NOEC 5000 mg/kg feed; LC50 >5620 mg/kg feed, NOEC  1000 mg/kg feed; LC50 > 5200 mg/kg feed, NOEC 1300 mg/kg feed

Reproductive toxicity to birds:

bobwhite quail: NOEC 450 mg/kg feed

mallard duck: NOEC 90 mg/kg feed (= 11 mg/kg bw/d, taken from DAR)

Reproductive toxicity to mammals:

2-year rat study: NOAEL 50 ppm

 

corresponding to 3 mg/kg bw/day (this should be 4 mg/kg bw/d, see DAR)

 

Aquatic Organisms

DMP

 

Species

Time scale

End-point

Toxicity (mg/ l) for DMP if not mentioned differently

Acute toxicity fish:

Bluegill sunfish

96 hours

LC50

0.25

 

Rainbow trout

96 hours

LC50

8.6 (formulation)

1.38

Long term toxicity fish:

Rainbow trout

28 days

 

NOEC

0.20

Bioaccumulation fish:

Rainbow trout

 7 days

BCF

157

Acute toxicity invertebrate:

Daphnia magna

48 hours

EC50

0.45

 

Daphnia magna

48 hours

EC50

3.7 (formulation)

0.59

Chronic toxicity invertebrate:

Daphnia magna

21 days

NOEC

0.01

Acute toxicity algae:

Selenastrum capricornutum

green alga

96 hours

EbC50

 

0.01

 

Pseudokirchneriella subcapitata

green alga

72 hours

EbC50

 

0.95 (formulation)

0.15

 

Chronic toxicity sediment dwelling organism:

Chironomids

28 days

NOEC

1.0

Acute toxicity aquatic plants:

Lemna minor

7 days

EC50

> 5.2

Bold values are used in the TER calculations.

 

EHPC

 

Species

Time scale

End-point

T

oxicity (mg/ l)

Acute toxicity fish:

Rainbow trout

96 hours

LC50

42

Acute toxicity invertebrate:

Daphnia magna

48 hours

EC50

12

Acute toxicity algae:

Selenastrum capricornutum

green alga

96 hours

EbC50

 

23

Chronic toxicity sediment dwelling organism:

Chironomids

28 days

NOEC

0.47

Bold values are used in the TER calculations.

 

Aniline

 

Species

Time scale

End-point

Toxicity (mg/ l)

Acute toxicity fish:

Rainbow trout

96 hours

LC50

10.6

Chronic toxicity fish:

Fathead minnow

32 days

NOEC

0.42

Acute toxicity invertebrate:

Daphnia pulex

48 hours

EC50

0.1

Chronic toxicity invertebrate:

Ceriodaphnia dubia

7 days

NOEC

0.0081

Acute toxicity algae:

Selenastrum capricornutum

green alga

96 hours

EbC50

 

19

Bold values are used in the TER calculations.

 

Honeybees

 

Acute oral toxicity:

> 50 mg/bee (technical DMP);

> 48.6 mg/bee or >7.8 µg DMP/bee (Betanal AM 11)

Acute contact toxicity:

> 50 mg/bee (technical DMP);

> 25 mg/bee (technical DMP);

339 mg/bee or 54.2 µg DMP/bee (Betanal AM 11)

 

 

Other arthropod species

 

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

 

Species

 

Stage

 

Test

Sub-stance1

 

Dose

(kg as/ha)

 

Endpoint

 

Effect2

 

Annex VI

Trigger

 

 

Laboratory tests

Syrphus corollae

larvae

Betanal Progress EC

2 % corresp. to DMP:

0.064

deve-lopment

54 %

30 %

 

Poecilus cupreus

adult

Betanal Progress EC

6 l/ha ->

DMP: 0.096

mortality

0 %

30 %

 

Poecilus

adult

DMP 160 g/l + PMP 160 g/l EC formu-lation

3l/ha ->

DMP:

0.480

mortality

feeding activity

0 %

27 %

 

30 %

 

 

Aleochara

bilineata

 

adult

 

Betanal Progress EC

 

3 l/ha->

DMP:

0.048

 

parasiting behaviour

 

+15 %

 

30 %

 

Aleochara bilineata

adult

Kemifam Pro FL

6 l/ha ->

DMP:

0.090

hatching

parasiting behaviour

9.8 %

 

30 %

 

 

Pardosa spp.

 

adult

 

Betanal Progress OF

 

0.2, 2.5 and 4 l/ha -> DMP:

0.005, 0.063 and

0.1

 

mortality

feeding behaviour

 

0 - -3 %

15 –  21 %