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 11 mg test material/L (lowest acute E(L)C50 value)

-         Aquatic algae: 72-h ErL50 is 13 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 Carrot seeds oil is a Natural Complex Substance (UVCB) composed by two qualities: one rich in carotol and another one rich in geraniol. Both qualities have well-defined compositions for which typical percentages of the constituents are known. The mixture ecotoxicity properties may be derived from the ecotoxicity of the individual constituents. 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 freshwater algae have been determined using a calculation method that replaces OECD 201 and 202 studies and guideline for Testing of Chemicals No. 23 (i.e. WAF conditions). For these studies, the typical compositions of both qualities have been investigated. For each endpoint, one toxicity value was predicted for each quality of the substance. The key value selected for each endpoint was the most conservative value between both qualities. This calculation method was based on HA-QSARs fully validated following the OECD (2004) recommendations. It was 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 3. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L)C50 value is between 10 and 100 mg/L, not rapidly degradable substance with at least one constituent having a Log Kow > 4.