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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

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.