Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

There are no data available on the aquatic toxicity of the target substance. In order to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).For this read-across approach different stereoisomers from menthol were used for the assessment of the target substance.

The target substance is a racemic mixture of D-, and L-menthol. The source substances L-menthol (CAS 2216-51-5) and D/L-menthol (CAS 1490-04-6) are stereo-isomers of the target substance. This allows the use of experimental data from L-menthol and D/L-menthol for the assessment of the target substance.

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. Please refer to IUCLID section 13 for a detailed justification of the category approach.

Experimental studies cover the toxicity to three different trophic levels (fish, aquatic invertebrates and algae). All studies were performed according to internationally accepted guidelines and the principles of GLP. Freshwater fish turned out to be the most sensitive species with a LC50 (96 h) of 15.6 mg/L followed by freshwater algae with an ErC50 (72 h) of 16.2 mg/L and aquatic invertebrates with an EC50 (48 h) of 26.6 mg/L. Except for aquatic algae (NOEC (72 h): 4.6 mg/L, based on the growth rate) no chronic toxicity data are available.
The respiration inhibition of activated sludge was investigated in two experimental studies. Both resulted in comparable effect concentrations with an EC50 (3 h) of 237 mg/L and 306 mg/L, respectively. In the key study an additional EC10 (3 h) of 51 mg/L was calculated.