Reaction mass of 1,3-diacetoxypropan-2-yl 12-acetoxyoctadecanoate and 2,3-diacetoxypropyl 12-acetoxyoctadecanoate

Endpoint summary

Additional information

A battery of in vivo and in vitro genotoxicity tests has explored the possible genotoxic potential of TS-ED 532. Altogether, TS-ED 532 has been tested in three in vitro mutagenicity tests. Furthermore, TS-ED 532 was tested for in vivo mutagenicity in the micronucleus test, in which potential for chromosome damage and aneuploidy was investigated. The results showed that TS-ED 532 does not have the potential for inducing neither mutations nor genotoxicity in vivo and in vitro.

Furthermore, no evidence of pre-neoplastic changes was observed in the 90-day oral toxicity study, indicating no basis for induction of carcinogenicity. The data from the in vivo mammalian erythrocyte micronucleus test and the data from the 90-study indicates that TS-ED 532 does not have the potential to induce carcinogenicity in vivo.

Short description of key information:
TS-ED 532 was found to be non-mutagenic in the in vitro Ames test using S. typhimurium strains TA1535, TA1537, TA98, TA100 and TA102, non-clastogenic in the in vitro chromosome aberration test using human lymphocytes and non-clastogenic to L5178Y mouse lymphoma cells treated in vitro. All tests was performed both with and without metabolic activation.

TS-ED 532 was found to be non-genotoxic in vivo in the micronucleus test. TS-ED 532 did not induce chromosome damage or aneuploidy.

In summary, a battery of negative in vivo and in vitro genotoxicity tests has proved that TS-ED 532 does not have any genotoxic properties

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In summary, a full battery of negative in vivo and in vitro genotoxicity tests has proved that TS-ED 532 does not have genotoxic properties. Based on these results, TS-ED 532 is not hazardous and shal not be classified according to GHS and DSD-DPD.