Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.08 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
9 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.249 µg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.025 µg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.4 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Relevance of transformation products:

A variety of metabolites of the test substance have been identified in environmental fate labaratory studies dosed with pyranone or nicotinic acld labeled 14C-parent. During degradation of the parent in the environment, the lipophilicity of the compund is generally decreasing by cleavage or oxidation of functional groups. Consequently, the activity of the compound to terrestrial and aquatic organisms is generally decreasing with decreasing liophilicity.

Terrestrial compartment:

Low level of activity or toxicity was shown e.g. by acute eatworm studies with the soil metabolites M4401002, M4401003, M4401005, and M4401024 which occured at levels > 10 of TAR in the aerobic environmental fate studies. ln 10-day earthworm studies, ER50 values were greater than the highest dose tested, 1000 mg ai/kg soil, and in no study were any effects observed at any concentration (see IUCLID pint 6.3.1 for details).

Therefore, no risk from the metabolites would be expected for terrestrial organisms and a risk assessment based on parent alone would be protective of terrestrial organisms from metabolite exposure.

Metabolites observed under anaerobic conditions were not considered as relevant since it is very unlikely that these transformation products will occur in deeper soil layers with anaerobic soil conditions due to the high sorption potential of the parent to soil. Furthermore, a potential organism exposure in anaerobic condltions is negligible.

Aquatic compartment:

ln the aerobic water/sediment study with the parent, no metabolites were found in the water column at any time at Ievels above 2.5% TAR. Therefore, no risk to pelagic/water column organisms would be expected and thus no ecotoxicological studies were conducted. ln the aerobic water/sediment study, one metabolite (M4401024) was observed in the

sediment at 10.8% TAR. Therefore, for this metabolite a 10-day Chironomus dilutus study was conducted. No effects were observed at the highest test concentration of 13 mg ai/kg sediment. Therefore, due to the lack of toxicity of M4401024 in sediment and due to the lack of metabolites in the water column, the aquatic risk assessment should be conducted on the parent compound alone without the addition of metabolites.

Metabolites observed under anaerobic conditions were not considered as relevant due to lack of potential organism exposure in anaerobic condltions.

Conclusion on classification

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The test substance was found to be not readily biodegradable under the test conditions. The most sensitive test for the aquatic compartments were the short-term toxicity test to aquatic invertebrates (marine water) and the long-term toxicity tes to aquatic invertebrates (marine water) . The acute study revealed a 96h-EC50 of 2.17 mg/L and the 28d-NOEC of a long-term toxicity to aquatic invertebrates test with the test substance was determined to be 0.000004 mg/L. Based on these results, the substance is not classified as aquatic acute toxicity but based on these results the substance is classified as aquatic chronic category 1 (M = 10000) according to table 4.1.0 of Annex I of Regulation (EC) No 1272/2008 and as H410: Very toxic to aquatic life with long lasting effects according to Regulation (EC) No 1272/2008 (CLP) as amended for the eighth time in Commision Regulation (EU) 2016/1688..