Registration Dossier
Registration Dossier
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EC number: 939-227-3 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Not gene, chromosome or genome mutagen in 2 Ames tests (OECD 471, GLP), a Chromosome aberration test (OECD 473, GLP) and a Mouse Lymphoma Assay (OECD 476, GLP).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test material did not induce gene mutation by base pair changes or frameshifts in the genome of the strains used in the Bacterial Reverse Mutation assay.
Patchouli oil MD has shown no evidence of clastogenic activity in the study in the in vitro Chromosome aberration study in CHO cells.
All of the cloned cultures treated with Patchouli Oil Light in both the definitive and confirmatory mutation assays had mutant frequencies that were similar to that of their corresponding solvent control cultures. Therefore, under the test conditions, Patchouli Oil Light, is negative in the L5178Y TK+/- louse lymphoma mutagenesis assay.
No further in vivo studies are considered appropriate and the substance is considered not to be mutagenic or clastogenic, in vitro.
Short description of key information:
Salmonella typhimurium reverse mutation assay with patchouli oil
ironfree (OECD 471, Bacterial Reverse Mutation Assay).
Analysis of Metaphase Chromosomes Obtained from CHO Cells Cultured in
vitro and Treated with Patchouli Oil MD (OECD 473, In vitro Mammalian
Chromosome Aberration Test).
Evaluation of a Test Article in the L5178Y TK+/- Mouse Lymphoma
Mutagenesis Assay with Colony Size Evaluation in the Presence and
Absence of Induced Rat Liver S-9 with a Confirmatory Study (OECD 476, In
vitro Mammalian Cell Gene Mutation Test)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the data available on Patchouli ext., no classification is necessary according to the (EC) No 1272/2008 Regulation (CLP).
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