Registration Dossier
Registration Dossier
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EC number: 248-145-0 | CAS number: 26966-75-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The several in vitro tests on o-TDA, usually the 3,4-TDA component, were generally positive in the presence of a metabolic activation system. However the positive responses were always described as marginal, minimal or weak. One reliable, rodent in vivo micronucleus test was negative in bone marrow and also in ascites tumour cells, while another was positive in erythrocytes. Although there was some indication for effects on the testes from a non-standard assay measuring a reduction of murine testicular DNA synthesis after 3,4-TDA, this is not direct and validated evidence of genotoxicity.
On the basis of the positive findings on bacterial and somatic cells in vitro, ortho-TDA is regarded as weakly mutagenic. There is evidence that this is translated to genotoxicity in vivo.
Short description of key information:
Weakly positive in in vitro systems with metabolic activation.
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
Ortho-TDA can be classified as Mutagen Category 2. according to the criteria described in Regulation (EC) No. 1272/2008.
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