Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

Data on short-term ecotoxicity are available on the substance itself and on a similar substance 01.

A Justification for Read Across is detailed in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13. No chronic data are available and the substance is not readily biodegradable.

According to CLP Regulation 1272/2008/EC, 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/L and 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:

EC50 Daphnia (substance itself): 63.7 mg/L at 48 hours;

EC50 Daphnia (Similar substance 01): 17 mg/L at 48 hours;

ECb50 Algae (Similar substance 01): 13 mg/L; NOEbC 0.44 mg/L at 72 hours.

The NOEC from this test may be used as an additional NOEC when other long-term data are available. In general, an algal NOEC should not be used unsupported by long term NOECs of species of other trophic levels, then here not considered.

Acute data on fish is also available on the substance itself (EC50 158 mg/L).

 

The values on similar substances 01 are lower than the substance itself (Daphnia and algae), but in the same criteria CLP range (> 10 to ≤ 100 mg/L). As conclusion, according to the classification criteria of the CLP regulation n. 1272/2008, the substance can be classified in Category Chronic 3, H412.