Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In-vitro Gene mutation in bacteria (AMES acc. to OECD TG 471, GLP): negative (BASF2010; 40M0358/10M055).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Avaliable toxicity data for isopulegol have been derived with or have been filed under the identity of a respective enantiomer, i.e. (1R,2S,5R)-5-methyl-2-(1-methylethenyl)-cyclohexanol (CAS 89 -79 -2). This enantiomer represents one main component of the registered substance DL-isopulegol and the respective data allow to cover the given toxicological endpoint.

In-vitro:

Gene mutation in bacteria

In the key study according to OECD TG 471 and GLP, isopulegol was not mutagenic with and without metabolic activation when tested up to 5000 μg/plate using Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA (BASF2010; 40M0358/10M055).


Justification for classification or non-classification

The present data on genetic toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008 and therefore, a non-classification is warranted.