Registration Dossier
Registration Dossier
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EC number: 451-530-8 | CAS number: 736150-63-3
Endpoint summary
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.
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