Registration Dossier
Registration Dossier
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EC number: 236-631-5 | CAS number: 13453-69-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
An OECD TG 473 in vitro test has been conducted to determine the possible clastogenicity of dilithium tetraborate using cultured human lymphocytes. Both in the absence and presence of S9-mix, dilithium tetraborate did not induce any statistically significant and biologically relevant increase in the number of cells with chromosome aberrations in two independent experiments.
In an OECD TG 471 in vitro study, dilithium tetraborate induced dose related increases in tester strain TA100 (Salmonella typhimurium) in the absence and presence of S9-mix in two independent experiments (2.0 and 2.3-fold), respectively. The results in TA100 are therefore considered equivocal.
Since at physiological pH, all lithium borate substances will dissociate and release boric acid and lithium ions as a result of relevant transformation pathways then read-across to the results above are proposed. Variations in structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes to the results.
As the results were equivocal, a testing proposal is submitted for dilithium tetraborate for further investigations of the mutagenic effect of these lithium borates.
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
On the basis of the equivocal results obtained in the bacterial reverse mutation assay (OECD TG 471) further testing is proposed.
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