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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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).