Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In the Bacterial Reverse Mutation test (Ames), mandarin oil did not show biologically significant increases in the frequency of revertant colonies for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method. The test item, Mandarin oil, (Citrus Reticulata Blanco) ext, was therefore considered to be non-mutagenic under the conditions of this test.

Based upon an equal result in the Ames tests of all oils from the Citrus category, the results of the available cytogenicity tests and gene mutation tests in mammalian cells with a citrus oil can be read across to the other oils. For both orange oil and lemon oil, the gene mutation study in mammalian cells were negative. Furthermore, available in vitro cytogenicity studies in orange, lemon, lime, and grapefruit oil were negative. The results of these tests can be read across to mandarin oil. This read across is considered valid because of:1) the similar origin of the oils in this group, 2) the dominant presence of D-limonene in all oils of this group, and 3) the same and similar other constituents.


Short description of key information:
Ames test with mandarin oil: not genotoxic.
Read across within citrus oils and major constituent limonene: not genotoxic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available information, the substance mandarin oil does not need to be classified for mutagenicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).and Annex VI of 67/548/EEC.