Fatty acids, C9-13-neo-, barium salts

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

No genetic toxicity study with fatty acids, C9-13-neo-, barium salts is available, thus the genetic toxicity will be addressed with existing data on the individual assessment entities barium and neodecanoate. As detailed in the RAAF report, neodecanoic is considered as representative of fatty acids, C9-13 -neo-. Fatty acids, C9-13-neo-, barium salts is not expected to be genotoxic, since both assessment entities barium and neodecanoate have not shown gene mutation potential in bacteria and mammalian cells as well as in 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

Barium

None of the in vitro genotoxicity studies rated as reliable showed any effect in bacterial reverse mutation assays, in mammalian cell gene mutation tests (TK assay) or in mammalian cell chromosome aberration tests, thus the classification criteria according to regulation (EC) 1272/2008 as germ cell mutagen are not met.

 

in vitro clastogenicity

Based on the outcome of guideline-compliant studies barium dichloride does not induce chromosome aberrations in mammalian cells, when tested up to toxic and/or precipitating concentrations in two independent experiments in the absence and presence of a rat liver metabolic activation system (S9 mix).

Overall it can be concluded that barium dichloride does not induce chromosome aberrations in vitro in somatic mammalian cells. Therefore, the conduct of in vivo clastogenicity experiments is not required.

 

in vitro gene mutation

Anonymous (1994)

The authors state that barium dichloride induces gene mutations in cultured mouse lymphoma cells (L5178Y) in the presence of S9 in a statistical significant manner. However, the mutation frequency increased from 32 per 106

cells in the control culture to a maximum of 59 per 106 cells at 1000µg/mL (with a RTG of 10%). Being a statistical significant increase in mutation frequency, the biological significance however is considered questionable, since the highest MF is still well below the value recommended by the IWGT (Moore et al., 2003; Moore et al., 2006; Moore et al., 2007) of 154 per 106 cells. Furthermore, a comparison with historical data for the performing laboratory is not possible, since the data was not given in the study report.

Due to the questionable biological relevance, the statistical significant increase in mutation frequency in both barium dichloride cultures with metabolic activation is not considered as clear positive response. Therefore, it was decided to repeat the whole experiment under clearly defined conditions, which a highly pure test item under guideline and GLP compliant conditions.

 

Lloyd (2010)

It is concluded that barium dichloride did not induce gene mutations in the TK locus of L5178Y mouse lymphoma cells when tested up to toxic and/or precipitating concentrations in two independent experiments in the absence and presence of a rat liver metabolic activation system (S9 mix).

Overall it can be concluded that barium dichloride does not induce gene mutations in vitro in bacteria and somatic mammalian cells. Therefore, the conduct of in vivo gene mutation experiments is not required.

 

 

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.

 

Fatty acids, C9-13-neo-, barium salts Fatty acids, C9-13-neo-, barium salts is not expected to be genotoxic, since the two assessment entities barium and neodecanoate have not shown gene mutation potential in bacteria and mammalian cells as well as in in vitro clastogenicity. Further testing is not required. For further information on the toxicity of the individual assessment entities, please refer to the relevant sections in the IUCLID and CSR.

Justification for classification or non-classification

Fatty acids, C9-13-neo-, barium salts is not to be classified according to regulation (EC) 1272/2008 for germ cell mutagenicity, since all in vitro studies with both assessment entities did not show any gene mutation potential.