Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Using the typical composition of clary sage oil, ecotoxicity results are as follow:

-         Aquatic Invertebrates: 48-h EL50 was 14 mg test material/L (lowest acute E(L)C50 value)

-         Aquatic algae: 72-h ErL50 was 18 mg test material/L

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

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

Additional information

Clary sage oil is a Natural Complex Substance (UVCB) with a well-defined composition for which the relative percentage of each constituent is known.

Therefore, it has been decided that the ecotoxicity of the substance will be derived from knowledge of the constituents. The mixture ecotoxicity properties may be derived from the ecotoxicity of the individual constituents.

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 toxicities to aquatic organisms have been investigated using an in-house 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 composition of the registered substance has been investigated.

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, rapidly degradable substance with Log Kow > 4.