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Key value for chemical safety assessment

Additional information

The isolated form of the read-across test substance, aluminum, benzoate C16-18-fatty acids complexes was used for these studies.

 

A key bacterial reversion assay (Ames test) was conducted on aluminum, benzoate C16-18-fatty acids complexes together with a micronucleus assay in human lymphocytes. In the Ames test, no significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria at any dose level, up to the maximum recommended, either with or without metabolic activation or exposure method. In the micronucleus test, aluminum, benzoate C16-18-fatty acids complexes did not induce statistically significant increase in the frequency of cells with micronuclei in cultured human peripheral blood lymphocytes when tested up to a limit of solubility in both the absence and presence of a rat liver metabolic activation system (S-9).

In the case of both studies the results were negative, therefore aluminum, benzoate C16-18-fatty acids complexes was considered to be non-mutagenic, non-clastogenic and non-aneugenic under the conditions of these tests.

As a consequence of the negative results in both key assays, a second mutation test was performed in accordance with Annex VIII REACH regulations in a mammalian cell system namely, the mouse lymphoma assay. This test was also negative.

Justification for selection of genetic toxicity endpoint
As no data was available for any genetic toxicity endpoints for (benzoato-O,O')hydroxy(octadecanoato-O,O')aluminium, data were read across from aluminum, benzoate C16-18-fatty acids complexes. No single study is selected as data are read-across from aluminum, benzoate C16-18 fatty acid complexes which was subjected to three good quality guideline studies for genotoxicity covering different genotoxicity mechanisms; an Ames in vitro reverse mutation study in bacteria, an in vitro micronucleus test for the detection of clastogenic and aneugenic potential in human lymphocytes and a mouse lymphoma assay for the detection of mutations at the thymidine kinase locus of mammalian cells caused by base pair changes, frameshift and small deletions. All three of these tests were negative.

Short description of key information:
in vitro:
- gene mutation (bacterial reversion assay/Ames test;The method was designed to conform to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF, and to meet the requirements of the OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B13/14 of Commission Directive 2000/32/EC and the, EPA (TSCA) OPPTS harmonised guidelines. ): Negative
- Clastogenicity and aneugenicity (micronucleus assay in human lymphocytes; The test method was designed to be compatible with, OECD Guidelines for Testing of Chemicals (2010) No 487:In Vitro Mammalian Cell Micronucleus Test. ): Negative
- Mammalian cell mutagenicity test where mouse lymphoma-TK assay detects the mutations at the thymidine kinase locus caused by base pair changes, frameshift and small deletions: Negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification for mutagenicity generally requires positive results from appropriate in vivo studies. Negative results from the three in vitro studies indicate that testing in vivo is not necessary. Since negative results were observed in all studies conducted, (benzoato-O,O')hydroxy(octadecanoato-O,O')aluminium is not classified for genetic toxicity.