Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

No genotoxic activity was noted in an array of in vitro and in vivo studies. Dodecanedioic acid was not genotoxic in microbial and mammalian in vitro mutagenicity assays, both in the presence and absence of metabolic activation. Also no genotoxic effect was observed in the murine bone marrow micronucleus test in vivo. An additional study on the clastogenic activity in vitro is considered not necessary.


Short description of key information:
No mutagenic activity was noted with or without metabolic activation in two studies using microbial test systems and in a study using mammalian cells. No clastogenic activity was noted in vivo in a murine bone marrow micronucleus test. No genotoxic effects in Chinese hamster V79 cells in the presence or absence of metabolic activation was observed for the read across test substance dodecanedioic acid under the conditions of the study.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dodecanedioic acid was not genotoxic in vitro and in vivo, therefore classification is not required.