Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In a reverse gene mutation assay in bacteria, performed according to the OECD guideline 471, in compliance with GLP, CHIMEXANE NV was found not to be mutagenic in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 with and without metabolic activation.

In an in vitro chromosome aberration test performed with human primary lymphocytes according to OECD guideline 473 and in compliance with GLP, CHIMEXANE NV did not induce chromosome aberrations in cultured human lymphocytes with and without metabolic activation.

In an in vitro micronucleus test conducted according to OECD guideline 487 and in compliance with GLP, CHIMEXANE NV was negative in L5178Y TK+/- mouse lymphoma cells with and without metabolic activation.

In an in vitro mammalian cell gene mutation test conducted with L5178Y mouse lymphoma cells according to OECD guideline 476 and in compliance with GLP, CHIMEXANE NV did not induce mutation at the tk locus of L5178Y mouse lymphoma cells in the absence and presence of a rat liver metabolic activation system.


Justification for selection of genetic toxicity endpoint
No robust study summary was chosen for this endpoint because more than one study was used to complete this endpoint.

Short description of key information:
CHIMEXANE NV was found not to be mutagenic in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102, it did not induce chromosome aberrations in cultured human lymphocytes and it did not induce mutation at the tk locus of L5178Y mouse lymphoma cells.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

As Chimexane NV was negative in an in vitro reverse gene mutation assay in bacteria, an in vitro chromosome aberration test and in an in vitro mammalian cell gene mutation test, it is not classified as mutagenic according to Annex VI to the Directive 67/548/EEC and in CLP Regulation (EC) N° (1272-2008).