Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.1 mg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.036 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:
0.13 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Chronic toxicity data (ECx or NOEC) would normally override acute data for long-term hazard classification. However, when assessing the adequacy there may be some cases (such as data poor substances) where the chronic data do not represent the species that is considered the most sensitive in available short-term tests. In such cases the classification should be based on the data (acute or chronic) that gives the most strict classification and M-factor.

Data on short-term ecotoxicity are available on the Similar substance 01. One long-term study on Daphnia is available on Similar substance 01. The substance is not readily biodegradable.

Based on the Read Across principle, the results can be considered for the ecotoxicology assessment of the substance. Justification for Read Across is detailed in the report attached to the IUCLID section 13.

Chronic toxicity data (ECx or NOEC) would normally override acute data for long-term hazard classification. However, when assessing the adequacy there may be some cases where the chronic data do not represent the species that is considered the most sensitive in available short-term tests. In such cases the classification should be based on the data (acute or chronic) that gives the most strict classification and M-factor.

As considered for the calculation of the PNEC, the available data do not show the most sensitive trophic level, therefore the classification based on the short-data.

According to CLP Regulation 1272/2008, when only acute (short-term) data are available and the substance is not biodegradable, different categories define the classification:

Category Acute 1:

96 hr LC50 (for fish) ≤ 1 mg/L and/or

48 hr EC50 (for crustacea) ≤ 1 mg/L and/or

72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/L

Category Chronic 1:

96 hr LC50 (for fish) ≤ 1 mg/L and/or

48 hr EC50 (for crustacea) ≤ 1 mg/L and/or

72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/L and the substance is not rapidly degradable and/or the experimentally determined BCF≥ 500 (or, if absent, the log Kow≥ 4)

Category Chronic 2:

96 hr LC50 (for fish) > 1 to ≤10 mg/L and/or

48 hr EC50 (for crustacea) > 1 to ≤10 mg/L and/or

72 or 96 hr ErC50 (for algae or other aquatic plants) > 1 to ≤10 mg/L and the substance is not rapidly degradable and/or the experimentally determined BCF≥ 500 (or, if absent, the log Kow≥ 4)

Category Chronic 3:

96 hr LC50 (for fish) > 10 to ≤ 100 mg/L and/or

48 hr EC50 (for crustacea)> 10 to ≤ 100 mg/L and/or

72 or 96 hr ErC50 (for algae or other aquatic plants)> 10 to ≤ 100 mg/Land the substance is not rapidly degradable and/or the experimentally determined BCF≥ 500 (or, if absent, the log Kow≥ 4)

The short-term ecotoxicity values are:

Fish:

96h-LC50 (carp) > 100 mg/L

Invertebrates (Daphnia):

48h-EC50 > 100 mg/L

Algae:

72h-ErC50 > 100 mg/L

The values on the Similar substances 01 are out of the triggering CLP criteria for the classification.

As conclusion, according to the classification criteria of the CLP regulation n. 1272/2008, the registered substance is not classified for the environment.