Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Using the typical composition of Artemisia herba-alba oil (camphor type), ecotoxicity results are as follow:

-         Aquatic Invertebrates: 48-h EL50 was 24 mg test material/L (lowest acute E(L)C50 value)

-         Aquatic algae: 72-h ErL50 was 50 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 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.

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). The typical composition provided by the supplier of the substance has been investigated.

Short-term toxicity to fish was not provided in the dataset 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: 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.