Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Based on experimental studies on the registered substance, the key ecotoxicity values of the substance are as follow:

-         Aquatic Invertebrates: 48-h EL50 was > 100 mg test material/L

-         Aquatic algae: 72-h ErL50 was > 100 mg test material/L

Based on these results, acute E(L)C50s are 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

The registered substance is a Natural Complex Substance (UVCB).

Acute toxicity of the registered substance to aquatic invertebrates (Daphnia magna) and to freshwater algae have been determined in experimental studies using WAFs and performed under GLP compliance in accordance with OECD 202 and 201 guidelines respectively. Based on the results of range-finding studies, limit tests on the registered substance have been performed, at a loading rate of 100 mg test item/L.

The respective validity criteria were fulfilled and both studies complied with the requirements of the test guidelines. These studies were therefore considered acceptable for the two endpoints.

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

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: not classified. Reasoning: Adequate chronic toxicity data are not available and the lowest acute E(L)C50 > 100 mg/L