Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Based on experimental studies on the registered substance performed in compliance with GLP statements, the key ecotoxicity values of the substance are as follow:

-         Aquatic Invertebrates: 48-h EC50 was 63.2 mg test material/L, based on nominal concentrations (lowest acute E(L)C50)

-         Aquatic algae: 72-h ErC50 was 99.5 mg test material/L based on growth rate

Based on these results, the lowest acute E(L)C50 is higher than 1 mg/L.

Therefore, the substance would not be classified as acute 1 to aquatic organisms in accordance with the classification of the CLP.

Additional information

Short-term toxicity to fish was not provided in the dataset since the tonnage band (1 -10 tonnes/year) does not require that endpoint.

Acute toxicity to aquatic invertebrates (Daphnia magna) and to algae have been determined in experimental studies performed under GLP compliance in accordance with OECD 202 and OECD 201 guidelines respectively. The studies were considered as valid. They were acceptable for these ecotoxicological endpoints required for annex VII.

CLP Classification proposal

It is proposed to compare submission substance dataset to CLP environmental criteria laid down in CLP Regulation (including 2nd Adaptation to Technical Progress, Com Reg No 286/2011).

Acute aquatic hazard: not classified. Reasoning: lowest E(L)C50 higher than 1 mg/L.

Chronic aquatic hazard: category 3. Reasoning: sufficient chronic toxicity data are not available, lowest acute E(L)C50 value is between 10 and 100 mg/L (aquatic invertebrate: 63.2 mg/L), the substance is not rapidly degradable and has at least one constituent with a log kow > 4.