Registration Dossier
Registration Dossier
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EC number: 248-374-6 | CAS number: 27253-32-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No genetic toxicity study with manganese neodecanoate is available, thus the genetic toxicity will be addressed with existing data on the individual moieties manganese and neodecanoate.
Manganese neodecanoate is not expected to be genotoxic, since the two moieties manganese and neodecanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vitro clastogenicity.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Manganese
No genotoxic effects were observed in a bacterial reverse mutation assay with manganese sulphate. The in vitro mammalian chromosome aberration test and in vitro mammalian cell gene mutation test were also negative.
Additionally, manganese chloride did not produce any in vivo genotoxicity in the mammalian erythrocyte micronucleus test.
These in vivo and in vitro data suggest that manganese is not genotoxic. No classification for genetic toxicity is indicated according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.
Neodecanoate
Neodecanoic acid is not mutagenic in vitro in bacterial mutation assays (with and without metabolic activation) and was not clastogenic in a cytogenetic assay. Although a test on in vitro gene mutation in mammalian cells is not provided, the bacterial reverse mutation test covering the same endpoint did not show any sign of mutagenic potential with an without metabolic activation. This data suggests that neodecanoic acid is not genotoxic in vitro and likely not genotoxic in vivo.
No classification for genetic toxicity is indicated according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.
Manganese neodecanoate
Manganese neodecanoate is not expected to be genotoxic, since the two moieties manganese and neodecanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vitro clastogenicity. In addition, manganese chloride did not produce any in vivo genotoxicity in the erythrocyte micronucleus test in female mice. Further testing is not required. Thus, manganese neodecanoate is not to be classified according to regulation (EC) 1272/2008 as genetic toxicant. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.
Justification for classification or non-classification
Manganese neodecanoate is not expected to be genotoxic, since the two moieties manganese and neodecanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vitro clastogenicity. Thus, manganese neodecanoate is not to be classified according to regulation (EC) 1272/2008 as genetic toxicant.
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