Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The genetic toxicity of MK92K has been investigated in an appropriate battery of tests in vitro.

No evidence of reverse mutation was seen in an Ames test performed using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA102 in the presence and absence of an exogenous metabolic activation system (S9 fraction) at concentrations sufficient to cause cytotoxicity. No evidence of forward mutation was seen in a mouse lymphoma assay in the presence and absence of an exogenous metabolic activation system (S9 fraction) at concentrations causing marked cytotoxicity. No evidence of micronucleus formation was apparent in an assay using cultures of human lymphocytes in the presence and absence of an exogenous metabolic activation system (S9 fraction) at concentrations sufficient to cause cytotoxicity.

In the absence of any indication of genetic toxicity in the studies in vitro, additional testing of MK92K for genetic toxicity in vivo is not required according to REACH guidance.


Short description of key information:
The genetic toxicity of MK92K has been investigated in an appropriate battery of tests in vitro. The results of an Ames test, a mouse lymphoma assay and a human lymphocyte micronucleus assay are all negative. No additional testing for genetic toxicity is required.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification is proposed in the absence of any indication of genetic toxicity in the avaialable studies in vitro.