Registration Dossier
Registration Dossier
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EC number: 284-515-8 | CAS number: 84929-31-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus limonum, Rutaceae.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
For this endpoint 3 in vitro tests, all performed according/similar to OECD Test Guidelines, were selected as key studies:
- In a Bacterial Reverse Mutation Assay Lemon oil (OECD 471) did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the 4 test strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in test strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment. Based on the results of this study it is concluded that Lemon oil is not mutagenic in the S. typhimurium reverse mutation assay and in the E. coli reverse mutation assay.
- In a chromosomal aberration test in vitro without metabolic activation Lemon oil did not significantly induce chromosomal aberrations in CHL cells in vitro at 3 different concentrations (maximum dose: 0.125 mg/ml) in the absence of metabolic activation, and was therefore considered not clastogenic in this test.
- In the in vitro Mammalian Cell Gene Mutation Test (OECD 476) in the absence and in the presence of S9-mix the Lemon oil did not induce a significant increase in the mutation frequency in both experiments. It is concluded that Lemon oil did not induce gene mutations in the cultured mammalian cells used, i.e. mouse lymphoma L5178Y test system, under the experimental conditions described in the report, as per guidance document, section 35, OECD 476.
Short description of key information:
- Gene mutation in bacteria: (Bacterial Reverse Mutation Assay/Ames) (according to OECD 471): Not mutagenic
- In vitro mammalian chromosome aberration test (equivalent or similar to OECD 473): Not clastogenic (without metabolic activation)
- In vitro mammalian cell gene mutation test (according to OECD 476): Negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
In all 3 key genetic toxicity studies (3 in vitro tests) Lemon oil did not show any genotoxic potential. Therefore, it can be concluded that the substance is not mutagenic, and 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.
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