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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Additional information

- Genetic toxicity in-vitro, Ames Test: negative result

- Genetic toxicity in-vitro, chromosome aberration test (chinese hamster ovary cells):

Without metabolic activation: negative

With metabolic activation: positive

Conclusion from the in-vitro chromosome aberration test: Classification of the test substance as to its mutagenic properties does not seem to be necessary, as the clastogenic effects only appear in the higher concentration range, where also cytotoxic effects begin to show.

- Genetic toxicity in-vivo (mouse): negative


Short description of key information:
In total there are three Klimisch-1-rated genetic toxicity studies available. Two in-vitro studies, Ames Test and in-vitro chromosome aberration test, were conducted in 1995. An in-vivo micronucleus test was conducted in 1997. As an overall assessment, no classification of CA 2343 as to its genotoxic properties is being proposed.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All studies on genetic toxicity revealed negative results, except the in-vitro chromosome aberration study, which was positive with metabolic activation and negative without metabolic activation. Taking into account all these study results, and with special emphasis on the absence of genetic toxicity effects in the in-vivo micronucleus study, as an overall assessment no classification of CA 2343 as to its genotoxic properties is being proposed.