Registration Dossier
Registration Dossier
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EC number: 278-758-9 | CAS number: 77745-66-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro mammalian cell gene mutation (CHO, hprt; OECD 476) - negative
In vitro gene mutation in bacteria (Ames, OECD 471) - negative
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
In vivo mouse micronucleus (OECD 474) - negative
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
All available genetic toxicity study results for TiTDP are negative.
Test results are available for TiTDP in in vitro bacterial and mammalian cell gene mutation assays, and in an in vivo chromosome aberration study.
Bacterial Gene Mutation (Ames Test)
In a reliable OECD Guideline 471 GLP study, TiTDP was not mutagenic to any of 5 strains of S. typhimurium when tested in the absence and presence of an exogenous metabolic activation system (rat liver S9) at concentrations up to those producing cytoxicity.
Mammalian Gene Mutation (CHO, hprt)
In a reliable OECD 476 GLP study, TiTDP did not induce gene mutations at the hprt locus of CHO-K1 cells, in the absence and presence of metabolic activation.
Chromosomal Aberration (Mouse Micronucleus)
In a reliable OECD 474 Guideline GLP study (Gaikwad, 2014), TiTDP did not cause micronucleus induction in male and female mice when administered at a limit dose of 2000 mg/kg bw by gavage for two consecutive days.
Negative read across results are available in similar assays for the structural analog TDP. See read across justification document in Section 13.
Justification for selection of genetic toxicity endpoint
All available genetic toxicity study results are negative.
Short description of key information:
Negative bacterial gene mutation (OECD 471) and negative in vivo
chromosome aberration (OECD 474) studies. Negative read across studies
(OECD 471, OECD 474) are also available for the structural analogue TDP.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
All available genetic toxicity study results for TiTDP are negative. Therefore, it is concluded that TiTDP is not genotoxic and does not warrant classification for mutagenicity.
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