Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
8.8 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
4.652 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.465 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.925 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
53.33 mg/kg food
Assessment factor:
300

Additional information

Environmental fate and pathways:

The substance is considered to be readily biodegradable (OECD Guideline 301F) and contains organic functional groups that are relatively or completely inert with respect of hydrolysis. The average bioconcentration factor (BCF) of the registered substance determined at 373 L/kg indicates that the substance did not bioaccumulate in the rainbow trout (in vivo OECD Guideline 305 and in vitro biotransformation assays). Finally, the adsorption coefficient (log Koc) of the substance was determined to be 3.72 (OECD Guideline 121). This result indicates that the substance is immobile in soil(according to McCall et al., 1980).

Aquatic toxicity:

No toxic effects were observed up to the attainable limit of solubility of the substance in experimental acute studies for the three trophic levels (fish, aquatic invertebrates and algae).

Regarding long-term exposure, no toxic effect was observed in the algae experimental study at the maximum attainable mean test concentration but EC10 values were determined by High Accuracy QSAR predictions (iSafeRat QSAR model) at 0.088 mg/L for aquatic invertebrates and 0.10 mg/L for fish.

Based on therespiration inhibition test, the substance had no inhibitory effect on the respiration rate of activated sludge, after the incubation period of 3 hours at the maximum test item concentration tested of 100 mg/L.

A testing proposal is included in the dossier to conduct an experimental Daphnia magna reproduction test, according to OECD Guideline 211, on the registered substance. The test on aquatic invertebrates is proposed, since according to the outcome of iSafeRat QSAR model, Daphnia magna is the most sensitive species in chronic exposure. An experimentally- determined EC10 value would allow to conclude appropriately on the environmental classification of the registered substance. After acceptance of the submitted testing proposal for a Daphnia magna reproduction test, by ECHA, and when the new experimental study report is made available, the dossier and the final environmental classification will be updated.

Terrestrial toxicity:

According to section R.7.11.5.3., Chapter R.7c of the ECHA Guidance on information requirements and chemical safety assessment (version 3.0, June 2017), the registered substance should be classed as a soil hazard category 3 (high adsorption of the substance in soil with log Kow > 5 and Koc > 5000; and not very toxic to aquatic organisms).

In the context of an integrated testing strategy for soil toxicity, the Guidance advocates performing an initial screening assessment based upon the Equilibrium Partitioning Method (EPM), together with a confirmatory long-term soil toxicity test (e.g. one limit test with the most sensitive organism group as indicated from aquatic toxicity data). Indeed, for substances that show a high potential to partition to soil, like the registered substance, long-term exposure of terrestrial organisms is possible and should be assessed. The choice of test (invertebrate / plant / micro-organism) should be based on all the information available. For the registered substance, the most sensitive organism group in aquatic toxicity data is the aquatic invertebrates. Therefore, an invertebrate assay is chosen to assess the long-term soil toxicity.

Hence, a testing proposal is included in the dossier to conduct an earthworm reproduction test, according to OECD Guideline 222. A simplified study with a limit test is proposed in a first step, as suggested in the ECHA Guidance, to confirm the absence of risk for soil organisms observed in the screening assessment.

Conclusion on classification

No harmonised classification is available.

Data available:

- readily biodegradable;

- average BCF value of 373 L/kg (in vivo OECD Guideline 305 and in vitro biotransformation assay using liver S9 fractions and hepatocytes from rainbow trout)

- acute data: no acute toxic effects were observed on all trophic levels at or even close to the water solubility of the substance;

- chronic data: chronic effects were predicted by iSafeRat QSAR models on fish and daphnid, with a lowest EC10 value at 0.088 mg/L for daphnid. In that case, this would trigger a change in environmental classification. An eventual change in classification should be supported by experimental data, therefore a testing proposal is included in the dossier to conduct an experimental Daphnia magna reproduction test, according to OECD Guideline 211, on the registered substance.

The test on aquatic invertebrates is proposed, since according to the outcome of iSafeRat QSAR model, Daphnia magna is the most sensitive species in chronic exposure. An experimentally- determined EC10 value would allow to conclude appropriately on the environmental classification of the registered substance. After acceptance of the submitted testing proposal for a Daphnia magna reproduction test, by ECHA, and when the new experimental study report is made available, the dossier and the final environmental classification will be updated.

Classification according to the Annex I of the Regulation (EC) No 1272/2008 (CLP): The registered substance is not classified for the environment based on acute toxicity data and the ready biodegradability.