Registration Dossier
Registration Dossier
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EC number: 283-815-6 | CAS number: 84731-55-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
There are no data for lithium isooctadecanoate but a gene mutation in bacterial cells (Ames) test is currently ongoing. Data have been read across data from fatty acids C18-(unsaturated) lithium salts, for which all results are negative.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
There are no data available for lithium isooctadecanoate but a gene mutation in bacterial cells (Ames) test is currently ongoing. The dossier will be updated with these results when the data are available.
Data on fatty acids C18-(unsaturated) lithium salts have been read across on the basis that the two substances have common structures of a lithium salt of C18 fatty acids. Lithium isooctadecanoate has a single methyl branch while fatty acids C18 (unsaturated) lithium salts contains unsaturated carbon-carbon double bonds. See IUCLID section 13 for read across justification.
A key bacterial reversion assay (Ames test), a chromosomal aberration assay and a mouse lymphoma assay have been conducted on fatty acids C18 (unsaturated) lithium salts and the results were negative. From the results of the experimental study on fatty acids C18 (unsaturated) lithium salts, it can be concluded that there is no evidence of genotoxicity associated with the lithium cation or the fatty acid anion, and there is a significant volume of published data to indicate that lithium salts of other fatty acids are not genotoxic. Therefore, it is appropriate to read across the negative genotoxicity data on fatty acids C18 (unsaturated) lithium salts to lithium isooctadecanoate, and lithium isooctadecanoate is considered negative for genetic toxicity.
Justification for classification or non-classification
Not classified for genetic toxicity. Negative results.
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