![]() Link to relevant study records Reference open all close allĮndpoint: in vitro gene mutation study in bacteria Type of information: read-across based on grouping of substances (category approach) Adequacy of study: key study Study period: 15 July 2021 - 11 March 2022 Reliability: 1 (reliable without restriction) Rationale for reliability incl. Lack of genotoxicity for sulfites (details see below). Genotoxicity assays for sulfites, thiosulfates, sodium dithionite, inĬombination with reliable in vivo studies for sodium sulfite confirm a Overall, the comprehensive set of in vitro Performed according to the current guidelines and in compliance with GLPĪnd are considered to be reliable without restrictions. to OECD TG 476), and in a mammalian cellĬytogenicity test (acc. to OECD TG 471), in a mammalian cell gene Genetic toxicity of sodium dithionite has been evaluated in a bacterial Time of conduct and in compliance with GLP. Were performed according to the current OECD guidelines in force at the to OECD 476, 1997), and in aĬhromosomal aberration test (acc. Moreover, ammonium thiosulfate has been evaluated Guidelines and in compliance with GLP and are considered to be reliable These studies were performed according to the current to OECD TG 471) and in a mammalian cell cytogenicity study (acc. Sodium thiosulfate has been evaluated in a bacterial gene mutation assay Genotoxicity of the thiosulfates has been evaluated using sodium Of limited reliability, since these exhibit reporting and/or otherĮxperimental deficiencies and lack biological plausibility. A number of in vivo clastogenicity studies were assessed as being Test in rats after single and repeated oral administration (feed) in This finding is supported by a negative dominant lethal Not show an increase of micronuclei formation up to the maximum In vivo study with sodium sulfite via subcutaneous injection in mice did The existing in vivoĭata base was evaluated in a weight-of-evidence approach. These studies were performedĪccording to the current guidelines and in compliance with GLP and areĬonsidered to be reliable without restrictions. to OECD TG 476), and in mammalian cellĬytogenicity tests (acc. Toxicity of sodium sulfite and disodium disulfite has been evaluated inīacterial gene mutation assays (acc. Supported by read-across information from thiosulfates and sodium The available data on genetic toxicity allowĪ conclusive statement on the genetic toxicity for sulfites, which is
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