Registration Dossier
Registration Dossier
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EC number: 205-288-3 | CAS number: 137-30-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
A compliance check (CCH-D-2114586980-34-01/F) on genetic toxicity is ongoing. To meet the request of the recent compliance check, a new in vivo genetic toxicity study is planned according to the autoritiy´s request. The dossier will be updated accordingly and submitted in regard to the defined deadline (21 Nov 2023).
Genotoxicity was evaluated in bacterial and mammalian cell assays. The Ames test yielded a clear positive result whereas the Mouse Lymphoma Assay showed no genotoxic effects. The chromosomal aberration assay performed in mammalian cells assay did not show a clastogenic effect.
The appraisal that Ziram should not be classified as genotoxic is confirmed by three in-vivo assays, two micronucleus assays in murine blood and bone marrow and a cytogenetic assay in murine spermatogonia. All assays were clearly negative.
Short description of key information:
Thiram was mutagenic in bacteria, but negative in mammalian test systems, including in-vivo assays.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The appraisal that Ziram should not be classified as genotoxic is confirmed by three in-vivo assays, two micronucleus assays in murine blood and bone marrow and a cytogenetic assay in murine spermatogonia. All assays were clearly negative.
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