Registration Dossier
Registration Dossier
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EC number: 254-259-1 | CAS number: 39049-04-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No genetic toxicity study with neodecanoic acid, zirconium salt is available, thus the genetic toxicity will be addressed with existing data on the assessment entities zirconium and neodecanoate.
Neodecanoic acid, zirconium salt is not expected to be genotoxic, since the two moieties zirconium 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 study available
Additional information
Zirconium
Genetic toxicity in vitro
Bacterial Reverse Mutation Test: Two reliable bacterial reverse mutation studies with ZrO2 and one Ames test with zirconium acetate
were available. The studies were performed according to OECD guideline 471 and EU method B13/14. According to the results, the test substances are not mutagenic with and without metabolic activation.
In vitro mammalian chromosome aberration tests performed according to OECD Guideline 473 are available for zirconium dioxide and zirconium acetate . Both test items were neither mutagenic nor clastogenic with and without metabolic activation.
In vitro mammalian cell gene mutation tests according to OECD Guideline 476 were performed with zirconium dioxide and zirconium acetate. The test items were tested for mutation using L5178Y mouse lymphoma cells. Both test items were not mutagenic under the experimental conditions, with and without metabolic activation.
In vitro comet assay: One reliable Comet assay was available for ZrO2 performed according to following guideline: Single Cell Gel/Comet Assay: Guidelines for in vitro and in vivo genetic toxicology testing. Zirconium dioxide tested negative in human lymphocytes without metabolic activation.
Neodecanoic acid
Neodecanoic acid is not mutagenic in vitro in bacterial mutation assays, in mouse lymphoma cells, or in a human lymphocytes cytogenetics test with and without metabolism. 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.
Neodecanoic acid, zirconium salt
Neodecanoic acid, zirconium salt is not expected to be genotoxic, since the two assessment entities zirconium 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, neodecanoic acid, zirconium salt is not to be classified according to regulation (EC) 1272/2008 as germ cell mutagen. 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
Neodecanoic acid, zirconium salt is not expected to be genotoxic, since the two assessment entities zirconium and neodecanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vitro clastogenicity. Thus, neodecanoic acid, zirconium salt is not to be classified according to regulation (EC) 1272/2008 as germ cell mutagen.
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