Registration Dossier
Registration Dossier
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EC number: 309-358-5 | CAS number: 100209-50-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Mutagenic effects were evaluated according to a bacterial reverse mutation assay (OECD471) under GLP conditions. Based on the results of this study it is concluded that Wheat Solubles, Hydrolyzed is mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coil reverse mutation assay mainly at precipitating dose levels.
Mutagenic effects were then evaluated according to a Mammalian Chromosome Aberration Test (OECD473) under GLP conditions. Based on the results of this study it is concluded that Wheat Solubles, Hydrolyzed is not clastogenic in human lymphocytes under experimental conditions.
The substance has a long history of safe use as an added source of nutrition in animal feed. Evidences of this use are available to the registrant. Thus it can be concluded that the substance is not of concern for its mutagenicity profile.
Short description of key information:
Bacterial reverse mutation assay (in vitro, OECD471): positive
Mammalian Chromosome Aberration Test (in-vitro, OECD 473): negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Germ cell mutagenicity: conclusive but not sufficient for classification
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