C18 (branched) fatty acids, esters with mono-, di-, and tri-glycerol

Endpoint summary

Additional information

The mutagenic effects of Diglyceryl diisostearate was determined in a reverse mutation assay according to the OECD 471. Two independent studies were performed using the Salmonella typhimurium strains TA98, TA 100, TA1535 and TA1537 with and without the metabolic activation system S9 -mix. Test concentrations from 0.004 to 5 mg/plate were tested in triplicate in two independent experiments. Based on the results of this study, the test substance did not cause bacterial toxicity (as addressed by examination of the bacterial background lawn) and did not increase the number of revertants. Hence, the test substance registered is considered to be not point mutagenic under the test conditions in this Ames-test. No fifth strain is needed due to data available for the analogue substance confirming the absence of carcinogenic potential in rat and mouse under in-vivo condition.

In a mammalian cell gene mutation assay (OECD 476, HPRT locus),V79 cells cultured in vitro were exposed to Diglyceryl diisostearate suspended in cell culture medium (MEM) at concentrations of 0.316 up to 5000 microgram /plate with and without metabolic activation. Diglyceryl diisostearate was tested up to the cytotoxic concentrations. In both experiments no biologically relevant increase of mutants was found after treatment with the test item (with and without metabolic activation), No dose-response relationship was observed.

In an OECD 473 guideline study the potential of the test substance registered to induce chromosome aberrations was tested with and without metabolic activation. In conclusion it can be stated that during this in vitro chromosome aberration test and under experimental conditions reported the test item did not induce structural chromosomal aberrations in the V79 Chinese Hamster cell line. Therefore, the test substance registered is considered to be non-clastogenic in this chromosome aberration test.

Justification for selection of genetic toxicity endpoint
One reverse mutation assay according to the OECD 471, performed under GLP is available.
One in vitro Mammalian Cell Gene Mutation Test (HPRT-Locus) in Chinese Hamster V79 Cells according to OECD 476, performed under GLP is available.
One chromosome aberration test in Chinese Hamster V79 cells according to OCED 473 guideline and performed under GLP is also available.

Short description of key information:
The mutagenic effects of the test substance registered was determined in a reverse mutation assay according to the OECD 471.
Further an in vitro Mammalian Cell Gene Mutation Test (HPRT-Locus) in Chinese Hamster V79 Cells with the test substance registered is available.
Additionally one in vitro chromosomal aberration test (CA) was performed for detection of choromosomal aberration in cultured mammalian cells.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available in vitro genotoxicity tests, the test substance does not be calssified for genotoxicity according to the Directive 67/548/EEC and according to the EU Classification and Packaging of SUbstances and mixtures (CLP) Regulation No. 1272/2008.