2Existing Evaluations and Regulatory Information

2Existing Evaluations and Regulatory Information

26/03/2010mecoprop prioritisn dossier

Mecoprop

1Chemical identity

Common name / Mecoprop [1]
Chemical name (IUPAC) / (R,S)-2-(4-chloro-o-tolyloxy)- propionic acid
Synonym(s) / MCPP
Chemical class (when available/relevant) / Phenoxypropionic acid herbicide
CAS number / 7085-19-0 (mecoprop: racemate of R and S enantiomers)
16484-77-8 (mecoprop-p)
EU number / 607-049-00-2 (mecoprop: racemate of R and S enantiomers)
240-539-0 (mecoprop –p)
Molecular formula / C10H11ClO3
Molecular structure /
Molecular weight (g.mol-1) / 214.6

2Existing evaluations and Regulatory information

Annex III EQS Dir. (2008/105/EC) / Included
Existing Substances Reg. (793/93/EC) / Not applicable
Pesticides(91/414/EEC) / Both mecoprop and mecoprop-p are Included in Annex I
Biocides (98/8/EC) / Not included in Annex I
PBT substances / Not investigated
Substances of Very High Concern (1907/2006/EC) / No
POPs (Stockholm convention) / No
Other relevant chemical regulation (veterinary products, medicament, ...) / No
Endocrine disrupter / Not investigated

3Proposed Quality Standards (QS)

3.1Environmental Quality Standard (EQS)

QS for -- is the “critical QS” for derivation of an Environmental Quality Standard

Add any comment on possible residual uncertainty.

Value / Comments
Proposed AA-EQS for [matrix] [unit]
Corresponding AA-EQS in [water] [µg.L-1] / Critical QS is QS--.
See section7
Proposed MAC-EQS for [freshwater] [µg.L-1]
Proposed MAC-EQS for [marine waters] [µg.L-1] / See section 7.1

3.2Specific Quality Standard (QS)

Protection objective[2] / Unit / Value / Comments
Pelagic community (freshwater) / [µg.l-1] / See section 7.1
Pelagic community (marine waters) / [µg.l-1]
Benthic community (freshwater) / [µg.kg-1dw] / e.g. EqP,
see section 7.1
[µg.l-1]
Benthic community (marine) / [µg.kg-1dw]
[µg.l-1] / -
Predators (secondary poisoning) / [µg.kg-1biota ww] / See section 7.2
[µg.l-1] / (freshwaters)
(marine waters)
Human health via consumption of fishery products / [µg.kg-1biota ww] / See section 7.3
[µg.l-1] / (freshwaters)
(marine waters)
Human health via consumption of water / [µg.l-1]

4Major uses and Environmental Emissions

4.1Uses and Quantities

Mecoprop is a potent auxin, selectively killing dicotyledenous plant species but monocotyledonous species (e.g. cereals and grasses) are tolerant. It is therefore applied post-emergence as a selective herbicide to control broad-leaved weeds (i.e. dicotyledonous species) especially in cereal crops such as wheat, oats and barley, and in grassland.

Normal application rates are in the range 1.0 – 2.4 kg active ingredient/ha, usually in Spring. Application rates for product based on the MCPP-p enantiomer are lower, up to 1.5 kg/ha. In 2009, approximately 400 tonnes of mecoprop were applied throughout Europefor agricultural uses (Nufarm GmbH & co., pers. Comm..). The trend of usage is declining from annual EU tonnage of approximately 1000 tonnes in 2005.

4.2Estimated Environmental Emissions

Mecoprop is not widely discharged from industrial or commercial premises and therefore measured concentrations in effluents are sparse. The main potential route for contamination of water bodies is by accidental overspray, spillage and runoff from treated areas into watercourses. Reported environmental concentrations are given in Section 6.

5Environmental Behaviour

5.1Environmental distribution

Master reference
Water solubility (mg.l-1) / 6600 at pH4
>250000 at pH 7 and 10 / DG SANCO, 2003
Volatilisation
Vapour pressure (Pa) / 1.6 x 10-3at 25°C / DG SANCO, 2003
Henry's Law constant (Pa.m3.mol-1) / 2.18 x 10-4 / DG SANCO, 2003
Adsorption
Organic carbon – water partition coefficient (KOC) / KOC = 20–43 L/kg in soils ranging from pH 5.6-7.6 / DG SANCO, 2003
Suspended matter – water partition coefficient(Ksusp-water) / No data
Bioaccumulation
Octanol-water partition coefficient (Log Kow) / MCPP-p:
pH5: 1.43
pH7: 0.02
pH9: -0.18
Mecoprop:
pH 4: 156
pH 7: 0.64
pH 10: 0.23 / Nufarm Ltd, pers. comm.
DG SANCO, 2003
BCF (measured) / 1.2 – 5.5 depending on tissue (whole fish = 3.0) / DG SANCO, 2003

5.2Abiotic and Biotic degradations

Master reference
Hydrolysis / No abiotic hydrolysis at pH5-9 within 8 days at 70oC / DG SANCO, 2003
Photolysis / DT50= 21 daylight hours (but MCPP-p)
In water, DT50 values are longer, 32 – 44 days, depending on pH / DG SANCO, 2003
DG SANCO, 2003
Biodegradation / DT50(type of water)=24-49 d in river and stream simulation studies
MCPP-p is readily biodegradable (85% of ThODNH4) after 28 days / DG SANCO, 2003
Feil, 2010

6Aquatic environmental concentrations

6.1Estimated concentrations

Compartment / Predicted environmental concentration (PEC) / Master reference
Freshwater
Marine waters (coastal and/or transitional)
Sediment
Biota (freshwater)
Biota (marine)
Biota (marine predators)

6.2Measured concentrations

Compartment / Measured environmental concentration (MEC) / Master reference
Freshwater[3] / PEC1 (values <DL ignored): 0.35 ug/l
PEC2 (values <DL assumed to be =DL): 0.065 ug/l / OIEAU factsheet, 2009
Marine waters (coastal and/or transitional) / No data
WWTP effluent / No data
Sediment[4] / PEC1 (values <DL ignored): 87 ug/kg
PEC2 (values <DL assumed to be =DL): 50 ug/kg / OIEAU factsheet, 2009
Biota / No data
Biota (marine predators) / No data

7Effects and Quality Standards

7.1Acute and chronic aquatic ecotoxicity[5]

ACUTE EFFECTS / Master reference
Algae & aquatic plants
(mg.l-1) / Freshwater / Navicula pelliculosa 5d
EC50:0.24 (acid equivalents) / Hoberg, 1992 cited in Environment Agency, 2007
Lemna minor 7day
EC50: 6mg/l / Ineris, 2010
Marine / Skeletonema costatum 5d
EC50: 0.017 (acid equivalents) / Hoberg, 1992 cited in Environment Agency, 2007
Invertebrates
(mg.l-1) / Freshwater / Daphnia magna 48hEC50:>100 / Nitschke et al, 1999 cited in Environment Agency, 2007
Marine / [6]Nitocra spinipes 96hLC50: 87 / Linden et al, 1979 cited in Environment Agency, 2007
Sediment / No data
Fish
(mg.l-1) / Freshwater / Oncorhynchus mykiss96h LC50:76
[7]Rasbora heteromorpha 96h LC50: 11 / Memmert and Knoch, 1993 cited in Environment Agency, 2007
Alabaster, 1969 cited in Environment Agency, 2007
Marine / 3Alburnus alburnus 96h LC50: 115 (acid equivalents) / Linden et al, 1979cited in Environment Agency, 2007
Sediment / No data
Other taxonomic groups / No data

Acute toxicity data are available for four taxa (algae, macrophytes, invertebrates and fish). Those highlighted above are the lowest credible effects concentrations from a total of 29 (25 freshwater and 4 saltwater) acute studies (Environment Agency, 2007).

CHRONIC EFFECTS / Master reference
Algae & aquatic plants
(mg.l-1) / Freshwater / Selenastrum capricornutum 5d
NOEC: <0.055 (acid equivalents)
Navicula pelliculosa 5d NOEC: 0.055 (acid equivalents) / Hoberg, 1992 cited in Environment Agency, 2007
Lemna minor/14d
NOEC: 0.44mg/l / Ineris, 2010
Marine / Skeletonema costatum 5d NOEC:
0.003 (acid equivalents) / Hoberg, 1992 cited in Environment Agency, 2007
Invertebrates
(mg.l-1) / Freshwater / Daphnia magna 28d NOEC: 22.2 (acid equivalents) / Mullerschon, 1990 cited in Environment Agency, 2007
Marine / [8]Crassostrea gigas 9d EC10: 0.13 (acid equivalents) / His and Seaman, 1993 cited in Environment Agency, 2007
Sediment / No data
Fish
(mg.l-1) / Freshwater / Oncorhynchus mykiss 28d NOEC: 50 (acid equivalents) / Munk, 1993 cited in Environment Agency, 2007
Marine / No data
Sediment / No data
Other taxonomic groups / No data

Chronic toxicity data are available for five taxa (algae, molluscs, macrophytes, crustaceans and fish). Those highlighted above are the lowest credible no-effects concentrations from a total of 18 (15 freshwater and 3 saltwater) chronic studies (Environment Agency, 2007).

Tentative QSwater / Relevant study for derivation of QS / Assessment factor / Tentative QS[9] / Reference
MACfreshwater, eco / Navicula pelliculosa 5d
EC50: 0.24 mg.l-1
Skeletonema costatum 5d EC50: 0.017 mg.l-1 / 10 / 24 µg.l-1 / Environment Agency, 2007
MACmarine water, eco / 10 / 1.7 µg.l-1 / Environment Agency, 2007
MACfreshwater,eco / Lemna minor 7d EC50 6mg/l / 10 / 600ug/l / Ineris, 2010
MACmarine water eco / Not proposed by Ineris
AA-QSfreshwater, eco / Navicula pelliculosa 5d
NOEC: 0.055 mg.l-1
Skeletonema costatum 5d NOEC: 0.003 mg.l-1 / 10 / 5.5 µg.l-1 / Environment Agency, 2007
AA-QSmarine water, eco / 10 / 0.3 µg.l-1
AA-QSfreshwater,eco / Lemna minor, 14day LOEC, 0.44mg/l / 20 / 22ug/l / Ineris, 2010
AA-QSfreshwater, sed. / n/a / Field studies show mecoprop remains in water column. Therefore no sediment PNEC is warranted[10]
AA-QSmarine water, sed. / n/a

7.2Secondary poisoning

Secondary poisoning of top predators / Master reference
Mammalian oral toxicity / Rat/ Oral (diet)/ 2 years/ kidney effects: increase in weight and chronic nephropathy + liver effects: increase in weight and enzyme induction
NOAEL: 1.1 mg.kg-1bw.d-1 (males) / BASF, 1988 cited in Environment Agency, 2007
Avian oral toxicity / Mallard/Oral (diet)/ 5 d/ reduced food consumption and growth
NOEC : 1,780 mg.kg-1biota ww / ACP, 1994 cited in Environment Agency, 2007
Tentative QSbiota / Relevant study for derivation of QS / Assessment
factor / Tentative QS
Biota / BCF values for mecoprop are low, and below the trigger of 100. This indicates little potential to bioaccumulate and to pose a risk to predators through secondary poisoning[11]

7.3human health

Human health via consumption of fishery products / Master reference
Mammalian oral toxicity / Rat/ Oral (diet)/ 2 years/ kidney effects: increase in weight and chronic nephropathy + liver effects: increase in weight and enzyme induction
NOAEL: 1.1 mg.kg-1bw.d-1 (males) / BASF, 1988 cited in Environment Agency, 2007
CMR / No evidence of mutagenic or carcinogenic properties. Some evidence of reproductive effects in rats (reduced weight gain in pups, NOAEL: 10 mg.kg-1bw.d-1 and skeletal variations at maternal toxic dose, NOAEL: 50 mg.kg-1bw.d-1) / DG SANCO, 2003
Tentative QSbiota, hh / Relevant study for derivation
of QSbiota, hh / Assessment
Factor / Tentative QSbiota, hh
Human health / No PNEC[12]
Human health via consumption of drinking water / Master reference
Existing drinking water standard(s) / Threshold of 0.1ug/l set for all pesticides / Directive 98/83/EC
Any guideline / WHO drinking water guideline = 0.01 mg/l / WHO Drinking Water Guidelines, 3rd Edition, 2004

8Bibliography, Sources and supportiveinformation

WHO (2004) Drinking Water Guidelines, 3rd Edition

Environment Agency (2007) Proposed EQS for Water Framework Directive Annex VIII Substances: mecoprop. Science Report HOEP670085/SR19

DG SANCO (2003) Review report for the active substance mecoprop. SANCO/3063/99-Final

Feil, N. (2010) Ready biodegradability of mecoprop-p in a manometric respirometry test. Final Report, Project 55481163, Institut fur Biologische Analytik und Consulting IBACON GMBH, Germany

INERIS (2010). Review of mecoprop

EU, 2010. Monitoring data summary sheet. Ineris

9Substances factsheet of chemical pollutants

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10Mecoprop(CAS n° 93-65-2)

  • Whole water for organic substances
  • Sediment fraction <2mm

10.1► Mecoprop - Fraction Whole water for organic substances

10.1.1♦ Summary statistics on the fraction

Analyses / 42846
Stations / 2877
Member States (MSs) / 13
River Basin Districts (RBDs) / 76
PNEC / 2.20e+1 ug/l
PEC 1 / 3.48e-1 ug/l
PEC 2 / 6.45e-2 ug/l
Analyses <= DLs (used in PEC2 calculation) / 37900
% analysis <=DLs for which DLs>2PNEC / 0 %
Minimum of the average by station / 5.84e-4 ug/l
Maximum of the average by station / 7.93e+1 ug/l
Minimum of analyses / 5.84e-4 ug/l
Maximum of analyses / 2.13e+3 ug/l

10.1.2♦ Numerical distribution of quantified data

10.1.2.1Quantified values compared to the PNEC
Concentration class / Stations with quantified results (>DL) / Analyses >DL (used in PEC1 and PEC2 calculation) / Nb MS / Nb RBDs / Analyses <=DLs (used in PEC2 calculation)
100 PNEC < concentration / 0 / 0 / 0 / 0 / 0
10 PNEC < concentration < 100 PNEC / 2 / 2 / 1 / 2 / 0
PNEC < concentration < 10 PNEC / 5 / 5 / 2 / 4 / 0
concentration < PNEC / 1118 / 4939 / 11 / 48 / 37900
10.1.2.2Quantified values compared to the LoQ
Concentration class / Nb stations with quantified results (>DL) / Nb analysis >DL (used in PEC1 and PEC2 calc.) / Nb MS / Nb RBDs
100 LoQ < concentration / 5 / 6 / 2 / 4
10 LoQ < concentration < 100 LoQ / 38 / 48 / 5 / 10
LoQ < concentration < 10 LoQ / 237 / 784 / 8 / 28
no LoQ / 877 / 4108 / 3 / 20

10.1.3♦ Distribution of quantified and non quantified values

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10.2► Mecoprop - Fraction Sediment fraction <2mm

10.2.1♦ Summary statistics on the fraction

Analyses / 1717
Stations / 682
Member States (MSs) / 1
River Basin Districts (RBDs) / 6
PNEC / 1.86e+2 ug/kg dw
PEC 1 / 8.70e+1 ug/kg dw
PEC 2 / 5.00e+1 ug/kg dw
Analyses <= DLs (used in PEC2 calculation) / 1715
% analysis <=DLs for which DLs>2PNEC / 0 %
Minimum of the average by station / 2.50e+0 ug/kg dw
Maximum of the average by station / 6.23e+1 ug/kg dw
Minimum of analyses / 5.00e-3 ug/kg dw
Maximum of analyses / 8.70e+1 ug/kg dw

10.2.2♦ Numerical distribution of quantified data

10.2.2.1Quantified values compared to the PNEC
Concentration class / Stations with quantified results (>DL) / Analyses >DL (used in PEC1 and PEC2 calculation) / Nb MS / Nb RBDs / Analyses <=DLs (used in PEC2 calculation)
100 PNEC < concentration / 0 / 0 / 0 / 0 / 0
10 PNEC < concentration < 100 PNEC / 0 / 0 / 0 / 0 / 0
PNEC < concentration < 10 PNEC / 0 / 0 / 0 / 0 / 0
concentration < PNEC / 2 / 2 / 1 / 1 / 1715
10.2.2.2Quantified values compared to the LoQ
Concentration class / Nb stations with quantified results (>DL) / Nb analysis >DL (used in PEC1 and PEC2 calc.) / Nb MS / Nb RBDs
100 LoQ < concentration / 0 / 0 / 0 / 0
10 LoQ < concentration < 100 LoQ / 0 / 0 / 0 / 0
LoQ < concentration < 10 LoQ / 0 / 0 / 0 / 0
no LoQ / 2 / 2 / 1 / 1

10.2.3♦ Distribution of quantified and non quantified values

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11Substances factsheet of chemical pollutants

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12Mecoprop-P(CAS n° 16484-77-8)

  • Whole water for organic substances
  • Sediment fraction <2mm

12.1► Mecoprop-P - Fraction Whole water for organic substances

12.1.1♦ Summary statistics on the fraction

Analyses / 1571
Stations / 195
Member States (MSs) / 1
River Basin Districts (RBDs) / 5
PNEC / -
PEC 1 / -
PEC 2 / 5.00e-2 ug/l
Analyses <= DLs (used in PEC2 calculation) / 1571
% analysis <=DLs for which DLs>2PNEC / 0 %
Minimum of the average by station / 5.00e-3 ug/l
Maximum of the average by station / 2.50e-2 ug/l
Minimum of analyses / 5.00e-3 ug/l
Maximum of analyses / 2.50e-2 ug/l

12.1.2♦ Numerical distribution of quantified data

12.1.2.1Quantified values compared to the LoQ
Concentration class / Nb stations with quantified results (>DL) / Nb analysis >DL (used in PEC1 and PEC2 calc.) / Nb MS / Nb RBDs
100 LoQ < concentration / 0 / 0 / 0 / 0
10 LoQ < concentration < 100 LoQ / 0 / 0 / 0 / 0
LoQ < concentration < 10 LoQ / 0 / 0 / 0 / 0
no LoQ / 0 / 0 / 0 / 0

12.1.3♦ Distribution of quantified and non quantified values

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12.2► Mecoprop-P - Fraction Sediment fraction <2mm

12.2.1♦ Summary statistics on the fraction

Analyses / 13
Stations / 13
Member States (MSs) / 1
River Basin Districts (RBDs) / 2
PNEC / -
PEC 1 / -
PEC 2 / 2.50e+0 ug/kg dw
Analyses <= DLs (used in PEC2 calculation) / 13
% analysis <=DLs for which DLs>2PNEC / 0 %
Minimum of the average by station / 2.50e+0 ug/kg dw
Maximum of the average by station / 2.50e+0 ug/kg dw
Minimum of analyses / 2.50e+0 ug/kg dw
Maximum of analyses / 2.50e+0 ug/kg dw

12.2.2♦ Numerical distribution of quantified data

12.2.2.1Quantified values compared to the LoQ
Concentration class / Nb stations with quantified results (>DL) / Nb analysis >DL (used in PEC1 and PEC2 calc.) / Nb MS / Nb RBDs
100 LoQ < concentration / 0 / 0 / 0 / 0
10 LoQ < concentration < 100 LoQ / 0 / 0 / 0 / 0
LoQ < concentration < 10 LoQ / 0 / 0 / 0 / 0
no LoQ / 0 / 0 / 0 / 0

12.2.3♦ Distribution of quantified and non quantified values

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1

[1]Mecoprop comprises two enantiomers, the R-enantiomer mecoprop-p (MCPP-p) which is the herbicidally active enantiomer, and the S-enantiomer, which is inactive. The racemate is referred to as mecoprop or MCPP.

In this dossier, we provide data for the racemate but highlight any differences e.g. in toxicity between the two enantiomers in the relevant sections.

[2]Please note that as recommended in the Technical Guidance for deriving EQS (draft version), “EQSs […] are not reported for ‘transitional and marine waters’, but either for freshwater or marine waters”. If justified by substance properties or data available, QS for the different protection objectives are given independently for transitional waters or coastal and territorial waters.

[3]A total of 42, 846 analyses were made at 2877 stations from 76 river basins in 13 Member States. Of these, 37,900 were at or below DL (88%) (see attached factsheet)

[4]A total of 1,717 analyses were made at 682 stations from 6 river basins but in only one MemberState. Of these, only 2 samples contained mecoprop above the DL

[5]The data shown refer to studies with the herbicidally active R-enantiomer (MCPP-p). Theoretically, the racemate (MCPP) with a 50:50 combination of R- and S- enantiomers would be expected to be half as toxic to sensitive taxa such as algae and macrophytes. However, variability between studies caused by different endpoints and chemical forms (e.g. different salts of the free acid) obscures differences in toxicity between the racemate and R-enantiomer (Environment Agency, 2007)

[6] No analytical confirmation, but this is the only reported datum for marine invertebrates

[7] Lowest reported effect concentration but full experimental details not available

[8] Low reliability, but the only marine chronic study available

[9]Corresponding PNECs estimated by INERIS are appreciably higher because of the choice of critical study (Lemna rather than algae). The tentative PNECs are 22 ug/l for the AA-QSfreshwater, eco and 600 ug/l for the MACfreshwater, eco. Saltwater PNECs were not estimated by INERIS.

[10] INERIS estimate a QSsedimentby EqP of 123 ug/kg dry weight

[11] INERIS estimate a predator secondary poisoning QSbiota, sec pois of 666 ug/kg biota. This was based on a NOEC of 60mg/lg from a 90day study on rats and using an assessment factor of 90.

[12] INERIS estimate a human health secondary poisoning QSbiota, hh of 60.9 ug/kg biota