Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

The key ecotoxicity values of the registered substance are as follow:

-         Aquatic Invertebrates: 48-h EL50 is 10 mg test material/L (lowest acute E(L)C50 value)

-         Aquatic algae: 72-h ErL50 is 12 mg test material/L

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

Therefore, the registered 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) with a well-defined composition, for which typical percentages of the constituents and their ranges within the substance are known. Therefore, it has been decided that the ecotoxicity of the substance will be derived from knowledge of the constituents.

Key acute toxicities to daphnids and to freshwater algae have been determined using a calculation method that replaces OECD 202 and 201 studies respectively and guideline OECD No. 23 (i.e. WAF conditions). For these studies, the typical composition have been investigated. This calculation method was based on HA-QSARs fully validated following the OECD (2004) recommendations. These studies were considered acceptable to be used alone to fulfill annex VII ecotoxicological endpoints.

Moreover, short-term toxicity to fish was not provided in the data set because the tonnage band does not require this 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: category 2. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L)C50 value is between 1 and 10 mg/L, not rapidly degradable substance with some constituents having Log Kow > 4.