Registration Dossier
Registration Dossier
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EC number: 701-311-0 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
All the data in vitro indicate no mutagenic activity. In addition the single in vivo study on boric acid also indicated no mutagenic activity.
Short description of key information:
The registered substance as manufactured was tested in a reverse
mutation bacterial study and an in vitro chromosomal abnormality study.
Both results were negative.
Additionally, in vitro gene mutation studies in bacteria (Stewart, 1991)
in vitro gene mutation studies in mammalian cells (Rudd, 1991) and in
vitro cytogenicity studies (NTP, 1987) concluded that boric acid is not
genotoxic under the conditions of the studies. In addition the results
of an in vivo bone marrow cytogenetic assay (chromosome aberration
assay, O’Loughlin 1991) also showed boric acid to be non genotoxic.
Cytotoxicity observed at 5 mg/mL in the in vitro gene mutation studies
in mammalian cells (Rudd, 1991).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Regulation 1272/2008 and Directive /548/EEC, the substance does not require classification for genotoxicity based on read across to boric acid.
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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