Registration Dossier
Registration Dossier
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EC number: 232-263-4 | CAS number: 7803-62-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
There is a single experimental result (Araki et al., 1993, reliability score 4) of a modified bacterial reverse mutation assay (Ames test) which gave a positive result for silane (CAS 7803-52-5; EC No. 232 -263 -4) in two strains of Salmonella typhimurium (TA98 and TA1537) with and without activation. Due to the limited details presented in the results and lack of concurrent or historical positive and negative controls, it is not possible to verify the validity of this study.
There are no key in vitro studies for cytogenicity or mammalian mutagenicity and no suitable read across data are available.
In accordance with Section 2 of REACH Annex XI, genetic toxicity studies do not need to be conducted because the substance is a pyrophoric gas and therefore testing is not feasible.
Genetic toxicity in vivo
Description of key information
There is no key in vivo study for genetic toxicity and no suitable read across data are available.
In accordance with Section 2 of REACH Annex XI, genetic toxicity studies do not need to be conducted because the substance is a pyrophoric gas and therefore testing is not feasible.
Additional information
There is a single experimental result (Araki et al., 1993, reliability score 4) of a modified bacterial reverse mutation assay (Ames test) which gave a positive result for silane (CAS 7803-62-5; EC No. 232-263-4) in two strains of Salmonella typhimurium (TA98 and TA1537) with and without activation. Due to the limited details presented in the results and lack of concurrent or historical positive and negative controls, it is not possible to verify the validity of this study. As it is not feasible to test in vivo, the possibility of mutagenic properties cannot be further explored and there is insufficient information to conclude that silane is a mutagen.
In accordance with Section 2 of REACH Annex XI, genetic toxicity studies do not need to be conducted because the substance is a pyrophoric gas and therefore, testing is not feasible.
Justification for classification or non-classification
Based on available information silane does not require classification for mutagenicity according to Regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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