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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Ames test: negative (±S9 mix) HPRT test: negative (±S9 mix) MNT test: negative (± S9 mix)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Three genetic toxicity in vitro assays were conducted with the substance covering different modes of action of genetic toxicity. The substance did not produce significant genetic toxicity in a reliable bacterial reverse mutation assay with S. typhimurium and E. coli, in an in vitro Gene Mutation Assay in Chinese Hamster V79 Cells (V79/HPRT) and in an in vitro micronucleus assay with human lymphocytes. It is therefore concluded that the substance is not genotoxic. Further testing on the genetic toxicity of Menthyl Acetate is not required.

Justification for selection of genetic toxicity endpoint
GLP and guideline study performed in mammalian cells to detect the activity of clastogenic and aneugenic chemicals.

Justification for classification or non-classification

Based on the above stated assessments on genotoxicity the test substance Menthyl Acetate is not considered to be genotoxic and does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.