Registration Dossier
Registration Dossier
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EC number: 248-375-1 | CAS number: 27253-33-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No genetic toxicity study with calcium neodecanoate is available, thus the genetic toxicity will be addressed with existing data on the individual moieties calcium and neodecanoate.
Calcium neodecanoate is not expected to be genotoxic, since the two moieties calcium 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
Description of key information
No genetic toxicity study with calcium neodecanoate is available, thus the genetic toxicity will be addressed with existing data on the individual moieties calcium and neodecanoate.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No genetic toxicity study with calcium neodecanoate is available, thus the genetic toxicity will be addressed with existing data on the individual constituents calcium and neodecanoate.
Calcium
Considering the overall weight of evidence, such as in vitro data and the crucial role of calcium in cellular processes such as DNA-polymerase and cell cycle functioning as well as its role in approved in vitro genotoxicity experiments show that calcium does not exert any genotoxic or mutagenic effects to mammalian cells. Based on the above existing information on the genotoxicity of calcium substances and the weight of evidence information, calcium is considered as not genotoxic.
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.
Calcium neodecanoate
Calcium neodecanoate is not expected to be genotoxic, since the two moieties calcium and neodecanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vitro clastogenicity. Further testing is not required. Thus, calcium neodecanoate is not to be classified according to regulation (EC) 1272/2008 as genetic toxicant. For further information on the toxicity of the individual constituents, please refer to the relevant sections in the IUCLID and CSR.
Justification for classification or non-classification
Calcium neodecanoate is not expected to be genotoxic, since the two moieties calcium and neodecanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vitro clastogenicity. Thus, calcium neodecanoate is not to be classified according to regulation (EC) 1272/2008 as genetic toxicant.
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