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Key value for chemical safety assessment

Additional information

Ethyllinalool, linalool (CAS 78-70-6) and dehydrolinalool (CAS 29717-20-8) are structurally related substances having similar chemical structures. Their physical-chemical properties are comparable and available experimental data on the same toxicological endpoints, showed identical toxicological properties. This is applicable also to the genetic toxicity and therefore a read-across it justified.

Overall, mutagenicity and genotoxicity testing was unremarkable. All three substances were negative in the Ames test. Linalool and dehydrolinalool were negative in an in vivo micronucleus test. Linalool was also negative in an in vitro chromosome aberration test and in an in vitro forward mutation testing. Although dehydrolinalool was positive in the in vitro chromosomal aberration test in the absence of metabolic activation, the next higher Tier test i.e. the in vivo MNT in the bone marrow was clearly negative.

Short description of key information:
In vitro
- Gene mutation in bacteria (Bacterial Reverse Mutation Assay/Ames): not mutagenical substances
- Cytogenicity test (Mammalian Chromosome Aberration): not clastogenic (for linalool); clastogenic without metabolic activation (dehydrolinalool).
- Mammalian cell gene mutation assay (Mouse Lymphoma Forward Mutation) not mutagenic (linalool)
In vivo
- Cytogenicity test (Mammalian Erythrocyte Micronucleus Test): not mutagenic (linalool and dehydrolinalool).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Overall, mutagenicity and genotoxicity testing was unremarkable. Therefore, it can be concluded that the substance is not mutagenic and therefore does not need to be classified for mutagenicity according to the criteria outlined in 1272/2008/EC (CLP/EU-GHS).