Toelatingsnummer 13853 N

Betanal Power  

 

13853 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 WEDERZIJDSE ERKENNING

 

Gelet op de aanvraag d.d. 14 oktober 2011 (20110886 NLWERG) van

 

Bayer CropScience SA-N.V.

Energieweg 1

3641 RT  MIJDRECHT

 

 

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

 

Betanal Power

 

gelet op artikel 36, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Toelating

1.      Het middel Betanal Power is toegelaten voor de in bijlage I genoemde toepassingen onder nummer 13853 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 28 februari 2015.

 

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 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: Emulgeerbaar concentraat

 

werkzame stof:

gehalte:

fenmedifam

160 g/l

desmedifam

160 g/l

 

letterlijk en zonder enige aanvulling:

 

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

 

gevaarsymbool:

aanduiding:

N

Milieugevaarlijk

 

Waarschuwingszinnen: 

 

R51/53            -Vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

 

Veiligheidsaanbevelingen:

 

S49                 -Uitsluitend in de oorspronkelijke verpakking bewaren.

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

V31-NL            -Kan bij (langdurig) contact corrosie veroorzaken bij metalen.

 

 

Specifieke vermeldingen:

 

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

 

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

 

a.      letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I..

 

 

2 DETAILS VAN DE AANVRAAG

 

Het betreft een aanvraag tot verkrijging van een toelating van het middel Betanal Power (13853 N), een middel op basis van de werkzame stof desmedifam en fenmedifam.  Het middel wordt aangevraagd als onkruidbestrijdingsmiddel door middel van een na opkomst behandeling in suikerbiet.

 


2.1 Informatie met betrekking tot de stof

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

 

Desmedifam is per 1 maart 2005 geplaatst op Annex I van richtlijn 91/414  (Richtlijn 2004/58/EG, 23 april 2004).

 

Desmedifam is goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011) en geplaatst als stof 86 in de bijlage.

 

Fenmedifam is per 1 maart 2005 geplaatst op Annex I van richtlijn 91/414 (Richtlijn 2004/58/EG, 23 april 2004).

 

Fenmedifam is goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011) en geplaatst als stof 88 in de bijlage.

 

2.2 Karakterisering van het middel

Betanal Power is een herbicide, op basis van de werkzame stoffen desmedifam 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 transport naar

de apoplasten. Desmedifam en fenmedifam remmen de fotosynthese door onderbreking van

het elektronentransport. De middelen hebben geen bodemwerking en met name

breedbladige onkruiden worden bestreden.

 

2.3 Voorgeschiedenis

De aanvraag is op 20 oktober 2011 ontvangen; op 17 oktober 2011 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 20 juli 2012 is de aanvraag in behandeling genomen.

 

3  RISICOBEOORDELINGEN

Conform RGB (H2) en de Evaluation Manual 1.

 

3.1  Inleiding

De onderhavige aanvraag betreft een verzoek tot wederzijdse erkenning van de toelating in het Verenigd Koninkrijk van het gewasbeschermingsmiddel Betanal Power. 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 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 Betanal Power op basis van de werkzame stoffen desmedifam 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 119, eerste lid, Wet gewasbeschermingsmiddelen en biociden en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

 

 

Wageningen, 2 november 2012

 

 

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. 2 november 2012 tot toelating van het middel Betanal Power, toelatingnummer 13853 N

 

 

 

WETTELIJK GEBRUIKSVOORSCHRIFT

 

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

 

Toepassings-

gebied

Te bestrijden organisme

Dosering (middel) per toepassing

Maximaal aantal toepassingen per teeltcyclus

Minimum interval tussen toepassingen in dagen

Suikerbiet

Eenjarige onkruiden

1 L/ha

3

7

 

 

Om in het water levende organismen te beschermen is toepassing uitsluitend toegestaan wanneer in percelen die grenzen aan oppervlaktewater gebruik wordt gemaakt van minimaal 75% drift reducerende spuitdoppen.

 

                                                                                                          

 

Toepassingsvoorwaarden

 

Betanal Power dient toegepast te worden in een spuitvolume van 80 tot 100 liter per hectare.

 

Resistentiemanagement

Dit middel bevat de werkzame stoffen desmedifam en fenmedifam. Desmedifam en fenmedifam en behoren tot de fenylcarbamaten. De Hrac code is 5. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.

 


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 2 november 2012 tot toelating van het middel Betanal Power, toelatingnummer 13853 N

 

Contents

                                                                                                                                              Page

1.    Identity of the plant protection product 7

2.    Physical and chemical properties. 8

3.    Methods of analysis. 8

4.    Mammalian toxicology. 9

5.    Residues. 15

6.    Environmental fate and behaviour. 15

7.    Ecotoxicology. 36

8.    Efficacy. 60

9.    Conclusion. 60

10.      Classification and labelling. 61

Appendix 1      Table of authorised uses. 1

Appendix 2      Reference list 3


 

1.      Identity of the plant protection product

 

1.1       Applicant

Bayer CropScience B.V

Energieweg 1

Mijdrecht

3641 RT

Nederland

 

1.2       Identity of the active substance

Common name

Desmedipham

Name in Dutch

Desmedifam

Chemical name

Ethyl-3-phenylcarbamoyloxyphenylcarbamate

CAS no

13684-56-5

EC no

237-198-5

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

 

Common name

Phenmedipham

Name in Dutch

Fenmedifam

Chemical name

3-[(Methoxycarbonyl)amino]phenyl-(3-methyl-phenyl)carbamate

CAS no

13684-63-4

EC no

237-199-0

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

 

1.3       Identity of the plant protection product

Name

Betanal Power

Formulation type

EC

Content active substance

160 g/L phenmedipham; 160 g/L desmedipham pure active substance

 

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

 

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 authorization of a plant protection product.

The application for Betanal Power is based on the authorization for Betanal Maxxim (MAPP 14186) in the United Kingdom.

 


1.7       Packaging details

 

1.7.1    Packaging description

Material:

HDPE/PA

Capacity:

5-10L

Type of closure and size of opening:

Screw cap

Other information

-

 

1.7.2    Detailed instructions for safe disposal

See application form and MSDS (no particular recommendations)

 

 

2.      Physical and chemical properties

 

For the assessment of the physical and chemical properties of Betanal Power we refer to the member state of the original authorisation (UK).

 

 

3.      Methods of analysis

 

For the assessment of the methods of analysis required for Betanal Power we refer to the member state of the original authorisation (UK).

 

3.4       Physical-chemical classification and labelling

 

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

 

Professional use.

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

S49

V31-NL

Keep only in the original container.

May cause corrosion in (prolonged) contact with metals.

Special provisions:
DPD-phrases

 

 

 

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

 


4.      Mammalian toxicology

 

 

4.1       Toxicity of the formulated product (IIIA 7.1)

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

 

4.2       Dermal absorption (IIIA 7.3)

The United Kingdom used a value of 1% for both the concentrate and spray dilution for dermal absorption in the risk assessment of desmedipham and since this application is a request for mutual recognition the value of 1% for both the concentrate and spray dilution is also used in this risk assessment of desmedipham.

 

The United Kingdom used a value of 10% for both the concentrate and spray dilution for dermal absorption in the risk assessment of phenmedipham and since this application is a request for mutual recognition the value of 10% for both the concentrate and spray dilution is also used in this risk assessment of phenmedipham.

 

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 , a herbicide based on the active substances desmedipham and phenmedipham.

 

is an EC (emulsifiable concentrate) formulation and contains 160 g/L desmedipham and 160 g/L phenmedipham.

 

The formulation is applied by mechanical downward spraying in sugar beets. The formulation is applied up to three times during the period March – June with a maximum dose of 1 L formulation / ha. Therefore, a semi-chronic exposure duration is applicable for the operator (including contract workers).

 

4.4.1    Operator exposure/risk

 

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

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

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

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

Tier 4: Prescription of PPE

 


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 a NOAEL of 4.3 mg/kg bw/day derived in the 90-day oral dog study and using a safety factor of 100, is used for the risk assessment.

 

Exposure/risk

Exposure to desmedipham during mixing and loading and application of 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

 

Route

Estimated internal exposure a (mg/day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on sugar beets (1 L/ha, uncovered)

Mixing/

Loadingc

Respiratory

0.01

2.80

< 0.01

Dermal

0.32

2.80

0.11

Applicationc

Respiratory

0.01

2.80

< 0.01

Dermal

0.05

2.80

0.02

 

Total

0.39

2.80

0.14

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 lowest relevant NOAEL of 13 mg/kg bw/day derived in the 90-day oral feeding study in rat and a using the conventional safety factor of 100, is used for the risk assessment.

 

 

Exposure/risk

Exposure to phenmedipham during mixing and loading and application of 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 phenmedipham and risk assessment for the use of

 

Route

Estimated internal exposure a (mg/day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on sugar beets (1 L/ha, uncovered)

Mixing/

Loadingc

Respiratory

0.01

9.10

< 0.01

Dermal

3.20

9.10

0.35

Applicationc

Respiratory

0.01

9.10

< 0.01

Dermal

0.48

9.10

0.05

 

Total

3.70

9.10

0.41

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.

 

4.4.2    Bystander exposure/risk

 

Desmedipham

 

The exposure is estimated for the unprotected bystander. In Table T.3 the estimated internal exposure is compared with the systemic EU-AOEL.

 

Table T.3 Internal bystander exposure to desmedipham and risk assessment during application of

 

Route

Estimated internal exposure a (mg/day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Bystander exposure during application in sugar beets

 

Respiratory

0.08

2.80

0.03

Dermal

< 0.01

2.80

< 0.01

 

Total

0.08

2.80

0.03

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

·       biological availability via the dermal route: 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.

 


Phenmedipham

 

The exposure is estimated for the unprotected bystander. In Table T.4 the estimated internal exposure is compared with the systemic EU-AOEL.

 

Table T.4 Internal bystander exposure to phenmedipham and risk assessment during application of

 

Route

Estimated internal exposure a (mg/day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Bystander exposure during application in sugar beets

 

Respiratory

0.08

9.10

0.01

Dermal

0.02

9.10

< 0.01

 

Total

0.09

9.10

0.01

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

·       biological availability via the dermal route: 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.

 

 

 

4.4.3    Worker exposure/risk

 

Desmedipham

 

Tier 1

 

Crop inspection tasks may occur shortly after application of Betanal Power on sugar beets. The exposure is estimated for the unprotected worker. In Table T.5 the estimated internal exposure is compared with the systemic EU-AOEL. A work period of 2 hours/day is considered appropriate. Regarding the transfer coefficient (EUROPOEM II), the TC value of 0.25 for hand harvesting field vegetables can used as a suitable surrogate for inspection activities in sugar beets.

 

Table T.5 Internal worker exposure to desmedipham and risk assessment after application of Betanal Power

 

Route

Estimated internal exposure a (mg/day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Re-entry activities in sugar beets

 

Respiratory

-c

2.80

-c

Dermal

0.02

2.80

0.01

 

Total

0.02

2.80

0.01

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

·       biological availability via the dermal route: 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    No model is available to calculate the respiratory internal exposure. However, the respiratory internal exposure

      can be considered negligible in view of the fact that the use concerns field activities (outdoors) and no spraying

      of the product occurs during re-entry activities.

 


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

 

Phenmedipham

 

Tier 1

 

Crop inspection tasks may occur shortly after application of Betanal Power on sugar beets. The exposure is estimated for the unprotected worker. In Table T.6 the estimated internal exposure is compared with the systemic EU-AOEL. A work period of 2 hours/day is considered appropriate. Regarding the transfer coefficient (EUROPOEM II), the TC value of 0.25 for hand harvesting field vegetables can used as a suitable surrogate for inspection activities in sugar beets.

 

Table T.6 Internal worker exposure to phenmedipham and risk assessment after application of Betanal Power

 

Route

Estimated internal exposure a (mg/day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Re-entry activities in sugar beets

 

Respiratory

-c

9.10

-c

Dermal

0.24

9.10

0.03

 

Total

0.24

9.10

0.03

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

·       biological availability via the dermal route: 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    No model is available to calculate the respiratory internal exposure. However, the respiratory internal exposure

      can be considered negligible in view of the fact that the use concerns field activities (outdoors) and no spraying

      of the product occurs during re-entry activities.

 

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

 

4.4.4    Re-entry

See 4.4.3 Worker exposure/risk.

 

Overall conclusion of the exposure/risk assessments of operator, bystander, and worker

The product complies with the Uniform Principles.

 

Operator exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected operator after respiratory and dermal exposure to desmedipham and phenmedipham as a result of the application of Betanal Power in sugar 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 and phenmedipham during application of Betanal Power in sugar beets.

 


Worker exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected worker after respiratory and dermal exposure during re-entry activities in sugar beets due to exposure to desmedipham and phenmedipham after application of Betanal Power.

 

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 Betanal Power is a mixture of two active substances. The combined toxicological effect of desmedipham and phenmedipham has not been investigated with regard to repeated dose toxicity.

 

Desmedipham causes effects on red blood cells (methemoglobinemia and hemolytic anemia), related effects (hemosiderin deposition in spleen, liver and kidneys) and thyroidal effects in rat and dog (T3+T4 decreased, hypertrophy and hyperplasia).

Phenmedipham causes effects on red blood cells (methemoglobinemia and hemolytic anemia) and related histopathological effects in spleen, liver and kidneys (increased weight, hemosiderosis, extramedullar hematopoiesis).

As the substances both cause effects on red blood cells and related effects, a combined exposure to these substances could induce an additive effect.

However, for operators, bystanders and workers, the combined risk index for desmedipham and phenmedipham is lower than 1 and therefore no risks are expected even if an additive effect is induced by the simultaneous exposure to both substances.

 

4.8       Mammalian toxicology classification and labelling

 

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

 

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

 

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

-

Symbol:

-

Indication of danger:

-

R phrases

-

-

S phrases

-

-

Special provisions:
DPD-phrases

DPD14

Safety data sheet available for professional user on request.

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:

-

Other:

The phrase DPD14 should be assigned to preparations not classified for physico-chemical properties, health or environmental hazards, but containing at least one substance posing health or environmental hazards.

 

 

5.      Residues

 

For the aspect ‘Residues’ and risk for consumers we refer to the member state of the original authorisation (United Kingdom). The Guidelines for the generation of data concerning residue data Appendix C 7524/VI/95 rev.2 require that the residue situation in rotational crops must always be considered if, after the treated crop has been harvested (or in the event of early ploughing), it is possible to sow or plant a crop which can be used as a foodstuff and/or feed. Since the product was assessed according to the Uniform Principles by the member state of the original authorisation, residues in succeeding crops need no further consideration.

 

 

6.      Environmental fate and behaviour

 

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

 

The underlying risk assessment is based on the final List of Endpoints for active substances desmedipham and phenmedipham and on the UK authorisation for Betanal Power (registered under the trade name Betanal Maxxim). For the Dutch specific aspects data from the assessment of Betanal Expert and other previous assessments are used.

 

List of Endpoints Fate/behaviour 

Desmedipham is an existing substance, placed on Annex I per 1 March 2005. For the risk assessment the List of Endpoints (LoEP d.d. 24 November 2003) as presented in the Review Report (13 February 2004) is used.

 

Phenmedipham is an existing substance, placed on Annex I per 1 March 2005. For the risk assessment the List of Endpoints (LoEP d.d. 24 November 2003) as presented in the Review Report (13 February 2004) is used.

 

Additional information is given in italics.

 


LoEP Desmedipham

 

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 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)

 

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 (mean 244 L/Kg)

1/n 0.843, 0.688, 0.779, 0.775 (mean 0.77)

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

EHPC DT50whole system : 62.5 days

AnilineDT50 whole system: 35.4 days

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

 


LoEP Phenmedipham

 

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 labelled (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)

(Addendum 3) Ctgb: 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) (Addendum 1) 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 mean = 0.85

(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

 

For the re-registration of Betanal Expert the applicant supplied a statement (Garside et al. (2010) Response to Ctgb: evaluation of the re-registration application of Betanal

Expert (application nr: 20070199 THG) - Environmental Fate Data and Exposure Assessment. Document number MEF-10/253) which contained recalculated DT50 values for metabolite MHPC. However, this statement was not included in the dossier submitted for the registration of Betanal Power. The applicant confirmed per e-mail d.d. 27/08/2012 that this statement should also be used in the assessment of Betanal Power.

In the statement, DT50 values for metabolite MHPC were conservatively back calculated from the DT90 values which were derived from square root kinetics modelling. The resulting DT50 values are 0.9 days, 0.4 days and 0.7 days. Ctgb agreed with the applicant to use the conservative and recalculated DT50 values (DT90 values divided by 3.32) for modelling purposes. Together with the DT50 value of 13.6 days (SFO-fit; normalised) for one soil, this results in a geometric mean DT50 of 1.3 days.

 


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

 

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

 

Compound name

Code number

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)

Aminobenzene

C6H7N

Bestand:Anilin.svg

93.13

Water: 72 %

 

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

The risk assessment of persistence in soil is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorization (UK).

 

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 0.160 kg/ha, the crop sugar beet and an interception value appropriate to the crop stage of 0.2. First possible date of yearly application is March 1st according to the GAP. 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. As no sufficient data was available to fill in the complete transformation scheme, all metabolites were assumed to be formed directly from the parent. 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): 6115 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

 

Plant uptake factor: 0.5

Q10: 2.2

 

Metabolite EHPC:

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

Arithmetic mean Kom (pH-independent): 142 L/kg;

Arithmetic mean 1/n: 0.77

 

Maximum fraction of occurrence: 0.87

 

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

Solubility in water: 0.007 g/L (25°C; parent value)

Molecular weight: 181.2 g/mol

 

Plant uptake factor: 0.0

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): 514.9 L/kg (n = 3)

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

 

Plant uptake factor: 0.5

Q10: 2.2

 

Metabolite MHPC:

Geometric mean DT50 for degradation in soil (20°C): 1.3 days (n=4)

Arithmetic mean Kom (pH-independent): 127.3 L/kg

Arithmetic mean 1/n: 0.74

 

Maximum fraction of occurrence: 0.54

 

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

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

Molecular weight: 167.2 g/mol

 

Plant uptake factor: 0.0

Q10: 2.2

 

Other parameters: standard settings of PEARL 3.3.3

 

The following concentrations are predicted for the active substances desmedipham (and metabolite EHPC) and phenmedipham (and metabolite MHPC), following the realistic worst case GAP, see Table M.2.

 

Table M.2 Leaching of active substances active substances desmedipham (and metabolite EHPC) and phenmedipham (and metabolite MHPC) as predicted by PEARL 3.3.3 following spring application

Use

Substance

Rate substance [kg/ha]

Frequency

Interval [days]

Fraction

intercepted

PEC

groundwater [mg/L]

Sugar beet

Desmedipham

EHPC

Phenmedipham

MHPC

0.160

-**

0.160

-**

3

7

0.2

<0.001

<0.001

<0.001

<0.001

* interception values derived from Table 1.6 in “generic guidance for FOCUS groundwater scenarios”, based on the worst case BBCH code as presented in the GAP.

 ** calculated by transformation scheme.

 

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.2 it reads that the expected leaching based on the PEARL-model calculations, for the active substance desmedipham and its metabolite EHPC as well as for the active substance phenmedipham and its metabolite MHPC, is smaller than 0.01 µg/L for the proposed application. Hence, the application meets the standards for leaching as laid down in the RGB.

 

Lysimeter/field leaching studies

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.

 

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 not necessary.

 

Monitoring data

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

 

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

 

Conclusions

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

 

6.2       Fate and behaviour in water

 

6.2.1    Rate and route of degradation in surface water (Dutch specific aspect)

The exposure concentrations of the active substance desmedipham and its metabolites EHPC and aniline, and active substance phenmedipham and its metabolite MHPC, have been estimated in surface water 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 substances. The spray drift percen­tage depends on the use.

 

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

 

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: 6115 L/kg

Arithmetic mean Kom for sediment: 6115 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

Q10: 2.2

 

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: 142 L/kg

Arithmetic mean Kom for sediment: 142 L/kg

Arithmetic mean 1/n = 0.77

 

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

Solubility in water: 0.007 g/L (25°C; 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

Q10: 2.2

 

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: 5.8 L/kg (default according to Aquatic Guidance Document)

Kom for sediment: 5.8 L/kg

1/n = 1.0 (default for metabolites)

 

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

Solubility in water: 0.007 g/L (25°C; 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

Q10: 2.2

 

Active substance 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).

Arithmetic mean Kom for suspended organic matter: 347.2 L/kg (n=2; sediment study)

Arithmetic mean Kom for sediment: 347.2 L/kg (n=2; sediment study)

Arithmetic mean 1/n: 0.83 (n=2; sediment study)

 

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

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

Molecular weight: 300.3 g/mol

Q10: 2.2

 

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: 127.3 L/kg

Arithmetic mean Kom for sediment: 127.3 L/kg

Arithmetic mean 1/n: 0.74

Saturated vapour pressure: 7 x 10-10 Pa (25°C; parent value)

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

Molecular weight: 167.2 g/mol

Correction factor: 0.70 (maximum formation metabolite) x 0.56 (relative molar ratio = M metabolite/ M parent) = 0.39

Q10: 2.2

 

Other parameters: standard settings TOXSWA

 

When no separate degradation half-lives (DegT50 values) are available for the water and sediment compartment (accepted level P-II values), the system degradation half-life (DegT50-system, level P-I) is used as input for the degrading compartment and a default value of 1000 days is to be used for the compartment in which no degradation is assumed. This is in line with the recommendations in the FOCUS Guidance Document on Degradation Kinetics.

 

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. Metabolites are modelled as parent.

 

In Table M.3, the drift percentages and calculated surface water concentrations for the active substances desmedipham (and metabolite aniline and EHPC) and phenmedipham (and metabolite MHPC), for each intended use are presented.

 

Table M.3 Overview of surface water concentrations for active substances desmedipham (and metabolite aniline and EHPC) and phenmedipham (and metabolite MHPC) in the edge-of-field ditch following spring application

Use

Substance

Rate a.s.

[kg/ha]

Freq./ Inter-val [days]

Drift

[%]

PIEC

[mg/L] *

PEC21

[mg/L] *

PEC28

[mg/L] *

Sugar beet

Desmedipham

EHPC

Aniline

Phenmedipham

MHPC

0.160

0.093

0.035

0.160

0.062

3/7

1

1.095

1.187

0.454

0.760

0.736

0.552

0.994

0.379

0.046

0.573

0.495

0.936

0.356

0.034

0.534

* calculated according to TOXSWA

 

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

 

Monitoring data

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

 

The Pesticide Atlas on internet (www.pesticidesatlas.nl, www.bestrijdingsmiddelenatlas.nl) is used to evaluate measured concentrations of pesticides in Dutch surface water, and to assess whether the observed concentrations exceed threshold values. Dutch water boards have a well-established programme for monitoring pesticide contamination of surface waters. In the Pesticide Atlas, these monitoring data are processed into a graphic format accessible on-line and aiming to provide an insight into measured pesticide contamination of Dutch surface waters against environmental standards.


The current version 2.0 of the Pesticide Atlas does not contain a land use correlation analysis, which may indicate probable or causal relationships with land use. 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 application regarding the drinking water criterion, see next section.

desmedipham

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

In the Pesticide Atlas, surface water concentrations are compared to the authorisation threshold value of 1.0 µg/L (04/04/2005, consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case 0.1*NOEC Daphnia) and to the indicative Maximum Permissible Concentration (MPC) of 1.0 µg/L as presented in the Pesticide Atlas.

 

For substance desmedipham, an MPC-INS value of 0.13 µg/L is available (RIVM report 12813A00, 19/01/2011). This value is a factor 7.7 lower than the value presented in the Pesticide Atlas. It can be expected that the exceeding factors will be higher than the exceeding factors presented now. However, no definite conclusions can be drawn on the number of exceeding of the MPC-INS since exceeding is only indicated in classes and not real values. As the MPC-INS is the same as the AA-EQS it was checked whether this threshold was already included in the Pesticide Atlas. This is not the case. As an indication it was checked whether the monitoring data exceed the drinking water threshold of 0.1 µg/L, which is close to the MPC-INS. On three locations an exceeding of the drinking water threshold was observed. An occasional exceeding of the MPC-INS/AA-EQS can therefore not be entirely excluded. It should be noted that for the drinking water criterion a more severe way of aggregation and examination is used (based on maximum measured values) while for the AA-EQS the average value of the monthly averages is used to examine exceedings (see for details the explanation in the Pesticide Atlas).


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

Total no of locations

(2010)

n > authorisation threshold

 

n > indicative/ad hoc MPC threshold

 

n > MPC-INS threshold (= AA-EQS) *

63**

1

0

> 

* > : exceeding expected to be higher than with indicative/ad hoc MPC value

** the number of observations at each location varies between 1 and 30, total number of measurements is 348 in 2010.

 

As can been seen in table M.4, there is a difference between the exceeding in authorisation threshold and indicative MPC threshold, even though both are set at 1.0 µg/L. This difference is due to the aggregation method used in the Pesticide Atlas: 90th percentile value of all the measurements used for the authorisation threshold and the 50th percentile value of all the measurements used for the indicative MPC threshold.

 

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

 

In version 1.0 of the Pesticide Atlas there are too few measurements of exceeding of the authorisation threshold to draw conclusions.

The exceeding of the AA-EQS is limited to a small number of locations and cannot be related to specific applications.

 

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

 

phenmedipham

The active substance phenmedipham was observed in the surface water (most recent data from 2010). 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 2.5 µg/L (05/03/2007, consisting of first or higher tier acute or chronic ecotoxicological threshold value used for risk assessment (in this case 0.1*NOEC Daphnia) and to the indicative Maximum Permissible Concentration (MPC) of 0.5 µg/L as presented in the Pesticide Atlas.

 

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

 

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

Total no of locations

(2010)

n > authorisation threshold

n > indicative/ad hoc MPC threshold

n > MPC-INS threshold *

77 **

0

0

n.a.

* n.a.: no MPC-INS available.

** the number of observations at each location varies between 1 and 30, total number of measurements is 403 in 2010.

 

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

 

Drinking water criterion (Dutch specific aspect)

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

 

It follows from the decision of the Court of Appeal on Trade and Industry of 19 August 2005 (Awb 04/37 (General Administrative Law Act)) that when considering an application, the Ctgb should, on the basis of the scientific and technical knowledge and taking into account the data submitted with the application, also judge the application according to the drinking water criterion ‘surface water intended for drinking water production’.

The assessment methodology followed is developed by the WG implementation drinking water criterion and outlined in Alterra report 1635[1].

 

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

-          For new substances, a preregistration calculation is performed.

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

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

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

 

Active substance 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 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 RGB: the proposed application 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 risk assessment we refer to the member state of the original authorization (UK).

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.

 

The following restriction sentences were proposed by the applicant:

None.

 

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

None.

 

6.6       Overall conclusions fate and behaviour

It can be concluded that:

1.      the proposed application of the active substance desmedipham meets the standards for leaching to the shallow groundwater as laid down in the RGB.

2.      the proposed application of the active substance phenmedipham meets the standards for leaching to the shallow groundwater as laid down in the RGB.

3.      the proposed application of metabolite EHPC meets the standards for leaching to shallow groundwater as laid down in the RGB.

4.      the proposed application of metabolite MHPC meets the standards for leaching to shallow groundwater as laid down in the RGB.

5.      Member State UK did not assess the product with regard to the standards for surface water destined for the production of drinking water, however, the proposed application of the product complies 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 and phenmedipham and on the UK authorisation for Betanal Maxxim (MAPP 14186).

 

List of Endpoints Ecotoxicology

 

Desmedipham

 

Desmedipham is an existing substance, placed on Annex I per 1 March 2005. The applicant has a LoA for the Annex II and Annex III dossier. For the risk assessment the List of Endpoints (LoEP d.d. 24/11/2003) as presented in the Review Report (d.d. 13/02/2004) is used. 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

Toxicity (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 %

 

30 %

 

 

Chrysosperla

carnea

 

life cycle

 

Betanal Progress

 

6 l/ha ->

DMP: 0.096

 

 

reproduction

 

15 %

 

30 %

 

 

Coccinella septem-punctata

 

larvae

 

Betanal Progress

 

 

6 l/ha ->

DMP:

0.096

 

development

 

- %

 

30 %

 

 

Typhlodromus pyri

 

proto-nymphs

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

 

1.25 and 3 l/ha -> DMP:

0.200

and 0.480

 

mortality

escaping

repro-duction

 

 

5 - 7 %

8 - 12 %

11 - 28 %

 

 

30 %

 

 

Aphidius rhopalosiphi

 

adult

 

Betanal Progress

 

1.7 l/ha->

DMP:

0.044

 

mortality

fecundity

 

54 %

69 %

 

30 %

 

 

Aphidius rhopalosiphi

 

adult

 

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

 

3 l/ha -> DMP:

0.480

 

mortality

 

73 %

 

30%

 

 

1 Formulation Betanal progress (EC) : 25 g/L desmedipham, 150 g/L ethofumesate, 75 g/L phenmedipham (previous formulation of Betanal Expert)

 

2 Adverse effect means:

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

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

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

 

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

 

 

 

Field or semi-field tests

 

- Aphidius rhopalosiphi adults were exposed on treated barley plants (DMP 0.063 kg/ha). No mortality or decrease in fecundity was observed.

 

- Aphidius rhopalosiphi adults were exposed on treated barley plants (DMP 0.480 kg/ha). No significant increase in mortality or decrease in fecundity was observed.

 

- Typhlodromus pyri adults were exposed to treated sugar beet leaves (DMP 0.480 kg/ha). No significant increase in mortality was observed, but a 28 % reduction in offspring production was noted.

 

- Coccinella septempunctata larvae were exposed to treated sugar beet leaves. DMP concentration of 0.063 kg/ha caused 35 % pre-imaginal mortality. The application rate of 3 x 0.050 kg/ha did not cause any decrease in beneficial capacity.

 

Conclusion:  In some lab studies effects higher than the trigger were seen. However, in the extended lab studies the effects were at acceptable level with recommended use rates. Therefore no further studies are required.

 

Earthworms

 

Acute toxicity:

> 79 mg DMP/kg soil (technical DMP)

> 160 mg DMP/kg soil (Betanal AM 11)

Reproductive toxicity:

NOEC 800 g DMP/ha in test with Betanal AM 11

corresponds to 1.1 mg DMP/kg soil dw à

refined NOEC 2.47 mg DMP/kg soil dw (based on actual bulk density and actual application amount)

 

 

Soil micro-organisms

 

Nitrogen mineralization:

Deviation < ± 25 % of control within 100 days in two studies:

 

Betanal AM 11: No significant effect up to

1.2 kg DMP/ha

 

1) Betanal Progress OF 1 x and 5 x field rate, corresponding to ca. 0.16 and 0.8 mg DMP/kg soil, 2 soils, 60 days.

2) Kemifam Pro FL 1 x and 10 x field rate, corresponding to ca. 0.12 and 1.2 mg DMP/kg soil, 2 soils, 97 days.

Carbon mineralization:

Deviation < ± 25 % of control within 100 days in two studies:

Betanal AM 11: No significant effect up to

1.2 kg DMP/ha

1) Betanal Progress OF 1 x and 5 x field rate, corresponding to ca. 0.16 and 0.8 mg DMP/kg soil, 2 soils, 60 days.

2) Kemifam Pro FL 1 x and 10 x field rate, corresponding to ca. 0.12 and 1.2 mg DMP/kg soil, 2 soils, 97 days.

 

Effects on other non-target organisms (flora and fauna) believed to be at risk (Annex IIA, point 8.6)

 

 

DMP and EHPC was tested in a herbicide secondary screen test which contains 12 grasses and 12 broad-leaved species. DMP had minor pre-emergence but clear post-emergence activity. EHPC has negligible herbicidal activity.

 


Effects on biological sewage treatment (Annex IIA, point 8.7)

 

No data available.

 

Sewage treatment plants are not likely to be exposed as a result of field uses, as intended for DMP.

 

 

Classification and proposed labelling (Annex IIA, point 10)

with regard to ecotoxicological data

N, R50-53, S60-61

 

 

 

Phenmedipham

 

Phenmedipham is an existing substance, placed on Annex I since 2005. The applicant has a LoA for the Annex II and Annex III dossier. For risk assessment, the final LoEP can be used  (d.d. 24/11/2003, Review report d.d. 13/02/2004). Comments and additions are given in italic.

 

Terrestrial Vertebrates

Acute toxicity to mammals:

rat: LD50 >8000 mg a.i./kg body weight (formulation >2000 mg/kg)

Acute toxicity to birds:

mallard duck: LD50 and NOEL >2100 mg/kg body weight

mallard duck & japanese quail: LD50 >2500 mg/kg body weight, NOEL 2500 mg/kg

as in the first study with mallard no effects were found, the higher NOEL value from the last study could be used in the risk assessment

Dietary toxicity to birds:

mallard duck : NOEC 2000 mg/kg feed

bobwhite quail: NOEC 5000 mg/kg feed

Reproductive toxicity to birds:

bobwhite quail: NOEC 1200 mg/kg feed ( = 121 mg a.s./kg bw/d, taken from DAR)

Reproductive toxicity to mammals:

2-generation rat study: NOAEL 100 mg/kg corresponding to 6.8 mg PMP/kg b.w./day

 

 

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,

                                                                                                                              Annex IIIA, point 10.2)

Group

Test substance

Time-scale

Endpoint

recalculated based on initially measured concentrations

Toxicity

(mg/l)

 

Laboratory tests

PMP:

 

 

 

 

Rainbow trout

technical phenmedipham

96 hours

LC50

1.71

Rainbow trout

Betanal

(157 g PMP/l)

96 hours

LC50

6.9

1.1 (a.i.)

Rainbow trout

technical phenmedipham

21 days

NOEC

0.32

Daphnia magna

technical phenmedipham

48 hours

EC50

0.41

Daphnia magna

Rubenal

(160 g PMP/l)

48 hours

EC50

5.7

0.9 (a.i.)

Daphnia magna

technical phenmedipham

21 days

NOEC