Registration Dossier
Registration Dossier
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EC number: 236-751-8 | CAS number: 13473-90-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Studies in vitro
Studies were performed with the read-across substance aluminium sulphate.
No evidence for the induction of reverse mutation was seen in an Ames test (Verspeek-Rip, 2010) performed in S. typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and E. coli strain WP2uvrA in the absence and presence of metabolic activation and at concentrations up to the limit of 5000 µg/plate.
No evidence for the induction of micronuclei was seen in a study (Buskens, 2010) performed in cultured primary human peripheral lymphocytes in the absence and presence of metabolic activation and at concentrations exceeding the limit of solubility of the test material.
No evidence for the induction of forward mutation was seen in a mouse lymphoma assay (Verspeek-Rip, 2010) performed in L5178Y cells in the absence and presence of metabolic activation and at concentrations exceeding the limit of solubility of the test material.
The available data from high quality studiesin vitrotherefore demonstrate the absence of genotoxicity for this soluble aluminium salt.
Study in vivo
In a published study (Roy et al, 1991), repeated oral administration was reported to result in a dose-dependent inhibition of dividing cells and an increase in the number of chromosomal aberration in the bone marrow of rats exposed for up to 21 days. This published study is not considered to be of sufficient reliability and the apparently positive result is questionable given the clear absence of effects in studiesin vitroand the lack of evidence for the carcinogenicity of aluminium or its salts.
Justification for selection of genetic toxicity endpoint
A weight of evidence approach is taken to address the genotoxicity endpoint, based on the availability of three negative in vitro studies. No single study is therefore designated 'key'.
Short description of key information:
Modern, GLP- and guideline-compliant in vitro studies of bacterial mutation (Ames test), chromosomal aberration (micronucleus assay) and mammalian cell mutation (mouse lymphoma assay) are available for the read-across substance aluminium sulphate.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No classification for genotoxicity is proposed, based on the clear negative results obtained in an appropriate battery of guideline- and GLP-compliant studies in vitro.
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