Registration Dossier
Registration Dossier
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EC number: 231-151-2 | CAS number: 7440-42-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterial reverse mutation assays/Ames tests (OECD 471; GLP compliant): negative
in vitro micronucleus study (OECD 487; GLP compliant): negative
in vitro gene mutation study in mammalian cells (OECD 476; GLP compliant): negative
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The overall database of test data on genetic toxicity shows conclusively that elemental boron is void of genotoxic effect whatsoever.
- an Ames tests (May, 2001 and Flügge 2013) performed according to OECD 471 (1997; GLP compliant) shows that boron under the experimental conditions described, is not mutagenic to S. typhimurium strains TA1535, TA1537, TA98, TA100, and E. coli strain WP2 uvrA (pkm 101) in the presence and absence of a metabolising system.
- an in vitro gene mutation test in the cell line V79 (Flügge 2013) did not show any gene mutation in the presence and absence of a metabolic activation system, up to the maximum concentration limited by precipitation.
- an in vitro micronucleus test in human peripheral blood lymphocytes (Flügge 2013) did not show any chromosome (clastogenicity) or genome (aneuploidy and polyploidy) mutation in the presence and absence of a metabolic activation system, up to the maximum concentration limited by precipitation.
Justification for classification or non-classification
The available reliable study showed no genetic toxicity for boron amorphous in three different in vitro test systems, addressing all mutagenic effects. Thus, no classification is required according to regulation (EC) 1272/2008 and directive 67/548/EEC and subsequent regulations.
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