PEC groundwater
6.6 Overall conclusions fate and behaviour It can be concluded that:
1. the active substance metobromuron meets the standards for persistence in soil as laid down in the RGB.
2. the proposed application of the active substance metobromuron meets the standards for leaching to the shallow groundwater as laid down in the RGB.
3. the proposed application of metabolite desmethoxy-metobromuron meets the standards for leaching to shallow groundwater as laid down in the RGB.
4. the proposed application of the active substance metobromuron meets the standards for surface water destined for the production of drinking water as laid down in the RGB.
7 Ecotoxicology
The List of Endpoints is taken from the EFSA Conclusion (EFSA Journal 2014;12(2):3541).
List of Endpoints Ecotoxicology Effects on non-target organisms
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)
Species Test substance Time scale End point (mg/kg
Japanese quail a.s. Short-term >274.1 >10000 Bobwhite quail a.s. Long-term NOEL = 21.6* NOEC = 240*
Mammals ‡
Mouse a.s. Acute 2098** -
Rat Preparation Acute > 2000 -
rat a.s. Long-term 19*** 150
Additional higher tier studies ‡ -
* at this endpoint the number of 14 day survivors per female was 5.4% less than the control.
** acute oral LD50 in mice for both sexes calculated in the study report by probit analysis method (2098 mg/kg bw) and considered to be relevant for mammals risk assessment as it is more conservative than the acute oral LD50 in rat for both sexes (2603 mg/kg bw). (See vol. 3 B.9.3.1)
*** Overall mean test substance intake (See vol. 3 B.9.3.1)
Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2, Annex IIIA, point 10.2)
Test organism Test Test item Toxicity
endpoint Toxicity value Fish
Test organism Test Test item Toxicity
endpoint Toxicity value technical
(Anabaena flos-aquae) chronic
Metobromuron
(Lemna gibba) Chronic
chronic Metobromuron 500 SC
Test organism Test Test item Toxicity
endpoint Toxicity value length)
* The results of the 21-day fish short-term reproduction assay are in line with the results of the 28-day prolonged fish test on rainbow trout, where, likewise, no adverse effect other than growth inhibition was observed. The NOEC of 0.5 mg a.s./L from the 28d prolonged fish study is above the NOEC of 0.25 mg a.s./L and below the LOEC of 0.8 mg a.s./kg from the 21d short-term reproduction assay. Thus, disregarding the fact that different test guidelines were followed and other fish species were tested, the result is supportive of the original NOEC of 0.5 mg a.s./L. Therefore, the overall NOEC for fish was 0.5 mg/L (see full justification in section B.9.2-1-1; Fish short-term reproduction assay – Test for endocrine disruption).
Active Annex VI Trigger for the
bioconcentration factor - - Level and nature of residues
(%) in organisms after the 14 day depuration phase
Not available,
Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4)
Test substance Acute oral toxicity
(LD50 µg/bee) Field or semi-field tests
Indicate if not required
1 for preparations indicate whether end point is expressed in units of a.s. or preparation
Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5) Laboratory tests with standard sensitive species
Species Test
Substance End point Effect (LR50 g/ha1) Typhlodromus pyri ‡ Metobromuron
500 SC Mortality LR50 = 99.9 mL product /ha (i.e. 51.2 g a.s./ha)
Aphidius rhopalosiphi ‡ Metobromuron
500 SC Mortality LR50 > 8000 mL product/ha (i.e. > 4098 g a.s./ha)
1 for preparations, end point is expressed in units of preparation and a.s.
Extended laboratory studies ‡
Species
1 initial residues
2 for preparations dose is expressed in units of preparation and a.s.
3 positive percentages relate to adverse effects
* 2.77% of the maximum single application rate (1 m distance)
Aged residue test ‡ Species Test substance,
substrate and duration
Dose (g/ha)1,2
End point % effect Trigger value
Typhlodromus pyri
Metobromuron 500 SC
Up to 4 L product/ha (i.e. 2049 g a.s./ha)
Mortality (corr.) at 4L/ha
Effect on reprod.
at 4 L/ha
40.6% (day 0) 15.1% (day 7)
39.3% (day 0) 16.8% (day 7)
<50 %
1 initial (day 0) and aged residues (day 7)
2 for preparations indicate whether dose is expressed in units of a.s. or preparation
Field or semi-field tests Not required
Effects on earthworms, other soil macro-organisms and soil micro-organisms (Annex IIA points 8.4 and 8.5. Annex IIIA, points, 10.6 and 10.7)
Test organism Test substance Time scale End point1 Earthworms
a.s. ‡ Acute 14 days
LC50 = 467 mg a.s./kg dry soil
LC50 corr. = 233.5 mg a.s./kg dry soil
a.s. ‡ Chronic 8
weeks -
Preparation Acute -
Preparation Chronic
NOEC > 281.4 mg
product/kg dry soil (>119.74 mg a.s./kg dry soil)
Desmethoxy-metobromuron Acute LC50 > 1000 mg/kg dry soil Other soil macro-organisms
Soil mite a.s. ‡ - -
Hypoaspis aculeifer Preparation Chronic 14 days
NOECreprod = 55.6 mg product/kg dry soil (23.66 mg a.s./kg dry soil)
Collembola a.s. ‡ - -
Folsomia candida Preparation Chronic 28 days
NOECreprod = 55.6 mg product/kg dry soil (23.66 mg a.s./kg dry soil)
Test organism Test substance Time scale End point1 Soil micro-organisms
Nitrogen
mineralisation a.s. ‡ - -
Preparation 84 days
at 65.87 mg Metobromuron 500 SC:
< ±25% at all samplings
Desmethoxy-metobromuron 28 days
at 3.15 mg Desmethoxy-metobromuron:
< ±25% at all samplings Carbon
mineralisation a.s. ‡ - -
Preparation 28 days
at 65.87 mg Metobromuron 500 SC:
< ±25% at all samplings
Desmethoxy-metobromuron 28 days
at 3.15 mg Desmethoxy-metobromuron:
< ±25% at all samplings Field studies2
Not required
1 end point (e.g. LC50corr) has been corrected due to log Pow >2.0 when soil with high organic content (10% peat) has been used in the toxicity test
Effects on non target plants (Annex IIA, point 8.6, Annex IIIA, point 10.8) Preliminary screening data
Not required for herbicides as ER50 tests should be provided Laboratory dose response tests
EC50 values [L Metobromuron 500 SC/ha]
Vegetative vigour Seedling emergence and growth Species
Mortality Injury Fresh
weight Emergence Injury Fresh weight
Allium cepa 2.57 1.28 0.61 >7.5 0.41 0.11
Lolium perenne 4.90 0.48 0.36 >7.5 2.67 0.91
Triticum aestivum >7.5 1.57 1.27 >7.5 5.88 4.67
Zea mays >7.5 1.08 1.34 >7.5 >7.5 3.71
Beta vulgaris 1.14 0.33 0.22 >7.5 0.51 0.49
Brassica napus 1.04 0.38 0.27 >7.5 0.67 0.43
Cucumis sativa 2.41 0.14 0.46 >7.5 0.49 0.56
Lycopersicon
esculentum 0.77 0.37 0.25 >7.5 0.85 1.03
Sinapis alba 3.46 0.40 0.79 >7.5 0.22 0.26
Spinacia oleraceae 0.92 0.17 0.19 >7.5 0.31 0.25
Overall lowest EC50 0.14 0.11
Overall lowest median HC5 (lower limit-upper limit)
0.1169 (0.0439-0.2035) 0.0882 (0.0213-0.1970)
Additional studies (e.g. semi-field or field studies) none
Effects on biological methods for sewage treatment (Annex IIA 8.7)
Test type/organism end point
Activated sludge The 3-hour EC50 was clearly higher than the highest test concentration of 100 mg/L (calculated 154.8 mg/L)
Ecotoxicologically relevant compounds (consider parent and all relevant metabolites requiring further assessment from the fate section)
Compartment
soil metobromuron
Water metobromuron
sediment metobromuron
groundwater metobromuron
Classification and proposed labelling with regard to ecotoxicological data (Annex IIA, point 10 and Annex IIIA, point 12.3)*
RMS/peer review proposal
Active substance Classification acc. to Reg. 1272/2008:
Proposed Label:
Symbol: Warning, GHS09
Indication of danger: Aquatic Acute
Category 1, Chronic Category 1 (M-factor:
1)
Risk phrases: H400, H410
Safety phrases: P273, P391, P501
* It should be noted that classification is formally proposed and decided in accordance with Regulation (EC) No 1272/2008.
Proposals for classification made in the context of the evaluation procedure under Regulation (EC) No 1107/2009 are not formal proposals.
Additional studies
Resisdue studies summarized and evaluated by the Ctgb, d.d. 18-11-2014
reference : Scherer, F. (2014) species : field trapped arthropods type of study : Field study to determine
residues in ground-dwelling arthropods
Test area : Bare soil fields without crop near Pforzheim (Baden-Württemberg, Germany) year of
execution
: 2014 treatment rate : Single treatment; nominal 2.0 kg a.s./ha
GLP statement : Yes sampling : Pitfall traps, sampling up to 21DAT
guideline : not available acceptability : Acceptable test substance : Proman® (Metobromuron 500
g/L SC), batch no: 131121/03
DT50 : not possible to determine probably > 21 days
composition : 509.8 g metobromuron/L RUD : Initial: 3.0 mg/kg f.w. per kg a.s./ha
Conclusion
Following a single treatment of crop-less bare soil fields with Proman (Metobromuron 500g/L SC) at nominal 2.0 kg a.s./ha, the initial residue of metobromuron (including metabolites with the
4-bromoaniline moiety) in sampled arthropods was 5.91mg/kg fresh weight (DAT0). 21-d TWA residue concentration is 3.59 mg/kg ground-dwelling arthropods based on mean total residues of
metobromuron equivalents. DT50 could not be calculated and is estimated to be >21 days. RUD initial is 3.0 mg/kg f.w. per kg a.s./ha.
reference : Scherer, F. (2014) species : Seeds (mixture of winter barley and gras)
type of study : Field study to determine residues in seeds
location : North of Pforzheim, Baden-Württemberg, Germany year of
execution
: 2013 treatment rate : Single treatment; nominal 2.0 kg a.s./ha
GLP statement : Yes acceptability : Acceptable
guideline : not available DT50 : 10.1 days
test substance : Proman® (Metobromuron 500 g/L SC), batch no: 100413/04
RUD : Initial: 22.6 mg/kg seed per kg a.s./ha
composition : 507 g metobromuron/L
Conclusion
Following a single treatment of a harvested barley field with Proman® at nominal 2.0 kg a.s./ha, the initial residue of metabromuron equivalents in sampled seeds was 43.1 mg/kg seeds (DAT 0). 21-d TWA residue concentration is 16.55 mg/kg seeds based on measured residues of metobromuron equivalents. SFO DT50 is 10.1 days. RUD initial for metobromuron equivalents is 22.6 mg/kg seeds per kg a.s./ha.