Registration Dossier
Registration Dossier
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EC number: 235-310-7 | CAS number: 12163-26-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
A genetic toxicity study with magnesium diniobate is not available, thus the genetic toxicity will be addressed with existing data on the individual constituents magnesium and niobium.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
A genetic toxicity study with magnesium diniobate is not available, thus the genetic toxicity will be addressed with existing data on the individual constituents magnesium and niobium.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Magnesium diniobate
Magnesium diniobate is not expected to be genotoxic, since the two constituents magnesium and niobium do not have a gene mutation potential in bacteria and mammalian cells as well as in vitro clastogenicity. Further testing is not required. For further information on the toxicity of the individual constituents, please refer to the relevant sections in the IUCLID and CSR.
Magnesium
Taking into consideration the biochemical role of magnesium in the human body, an in vivo genotoxic effect is considered highly unlikely at test concentrations usually applied in genotoxicity testing, and in consideration of normal dietary requirements. The use of magnesium substances as essential supplements in mammalian cell culture media demonstrates that there is an intrinsic absence of a mutagenic potential of magnesium substances. Thus, magnesium should be considered void of genotoxicity based on its essentiality and an in vitro mammalian cell gene mutation assay (equivalent or similar to OECD 476).
Niobium
Diniobium pentaoxide should be considered void of genotoxicity based on a bacterial reverse mutation assay (OECD 471), an in vitro mammalian chromosome aberration test (OECD 473) and an in vitro mammalian cell gene mutation assay (OECD 476).
Justification for classification or non-classification
Magnesium diniobate should be considered void of genotoxicity and is not to be classified as genetic toxicant according to Regulation (EC) 1272/2008 since all in vitro studies with the respective constituents did not reveal any gene mutation potential.
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