Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

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.

Cytotoxicity observed at 5 mg/mL in the in vitro gene mutation studies in mammalian cells (Rudd, 1991).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

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.

Please also refer to the read-across statement attached to section 13.

Justification for classification or non-classification

No classification is required for disodium octaborate terahydrate regarding genotoxicity as all results for boric acid were negative in the tests.