Castor Oil, reaction product with Soybean Oil

Endpoint summary

Additional information

The mutagenic potential of the substance was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471 (Nern, 2011). Evidence of mutagenic activity was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed in any of the strains tested. Based on this test, the test substance was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.

In another test on point mutagenic effects the substance was investigated at the hypoxanthine-guanine phosphoribosyl transferase locus (HPRT test) in Chinese hamster V79 cells according to OECD TG 476 (Hall, 2011). The assay was performed in two independent experiments. The cells were exposed to the test item for 4 hours in the first and second experiment with and without metabolic activation. In both experiments no substantial and reproducible dose dependent increase of the mutation frequency was observed for the test item in the cultures with and without S9 mix when tested up to cytotoxic concentrations. Based on these results the test substance is considered to be non-mutagenic in the HPRT assay.

In an in vitro micronucleus test with Chinese hamster V79 cells (OECD TG 487) the substance was examined for chromosome breakage (clastogenic effects) and misdistribution of chromosomes (aneugenic effects) (Sutter and Jung, 2011). The negative/solvent control and appropriate positive controls with known mutagens demonstrated the suitability and sensitivity of the test system. The test item showed no biologically relevant increase in the frequency of micronucleus containing V79 cells in the absence (4 hours or 24 hours treatment) or in the presence of S9 mix (4 hours treatment) when tested up to cytotoxic or precipitating concentrations. Thus, the substance did not induce clastogenic or aneugenic effects in the in vitro micronucleus test.

Justification for selection of genetic toxicity endpoint
No study was selected, since all relevant key studies (Ames test, HPRT test and micronucleus test in vitro) were negative.

Short description of key information:
Salmonella/microsome test (Ames test; strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 ): negative (+/- S9 mix)
HPRT test (V79 cells): negative (+/- S9 mix)
Micronucleus test in vitro (Chinese hamster V79 cells): negative (+/- S9 mix)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the study results (negative in Ames test, HPRT test and micronucleus test in vitro) a classification according to Regulation (EC) No.1272/2008 (CLP) is not required.