Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

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

Genetic toxicity in vivo

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

Additional information

Justification for classification or non-classification

Several in vitro and in vivo state of the art mutagenicity tests have been performed with Hydroxyethyl-2-nitro-p-toluidine and did not reveal any potential to cause gene or chromosomal mutations in vitro. This lack of a genotoxic hazard was confirmed by a state of the art micronucleus test in vivo. An older test with limited validity also confirms the negative results. None of the tests revealed any indication that Hydroxyethyl-2-nitro-p-toluidine might cause mutagenic/ genotoxic effects in vivo. Taken together, the test results obtained in in vitro and in vivo assays, which cover all endpoints of mutagenicity, do demonstrate the absence of any genotoxic hazard for Hydroxyethyl-2-nitro-p-toluidine. Therefore, Hydroxyethyl-2-nitro-p-toluidine is considered not to pose any risk to humans with regard to genotoxicity.