2-ethylhexanoic acid, cerium salt

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

No genetic toxicity study with 2-ethylhexanoic acid, cerium salt is available, thus the genetic toxicity will be addressed with existing data on the individual assessment entities cerium and 2-ethylhexanoate.

2-ethylhexanoic acid, cerium salt is not expected to be genotoxic, since the two moieties cerium and 2-ethylhexanoic acid have not shown gene mutation potential in a range of in vitro test systems.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Cerium

Thompson (2013) performed an Ames test with S. typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2 uvr A. Different concentrations of cerium chloride were analysed with and without metabolic activation in all strains. The test item, cerium chloride, was considered to be non-mutagenic with and without metabolic activation, under the conditions of this test.

Bowles (2013) performed an in vitro Chromosome Aberration test in human lymphocytes (OECD Guideline 473 and EU Method B10) with cerium trinitrate. Two experiments were performed using different test concentrations with and without S9 activation (4h or 24h exposure; 20h expression period). In both experiments cerium trinitrate exhibited a modest dose-related inhibition of mitotic index in the dose levels tested. However, the substance did not induce any statistically significant increases in the frequency of cells with aberrations in either exposure group, which included a dose level that was generally within the optimal 50% mitotic inhibition. The test item did not induce a statistically significant increase in the numbers of polyploid cells at any dose level in any of the exposure groups. Cerium trinitrate was considered to be non-clastogenic both in the presence and absence of metabolic activation.

 

Morris (2013) performed a CHO hprt forward mutation assay with cerium trinitrate, targeting the HPRT locus of Chinese hamster ovary (CHO) cells, according to OECD Guideline 476 and EU Method B.17. The technique used is a plate assay using tissue culture flasks and 6-thioguanine (6-TG) as the selective agent. The vehicle and positive control were considered to be valid and the test item did not demonstrate dose related increases in mutant frequency either with or without metabolic activation, either in the first or the second experiment. Therefore, the test item was considered to be non-mutagenic to CHO cells at the HPRT locus under the conditions of this test.

2-ethylhexanoic acid

2-ethylhexanoic acid was negative in the bacterial Ames test with S. typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and E. coli WP2 uvr A (Jung et al., 1982; Zeiger et al., 1988; Warren et al., 1982), as well as in a HPRT locus assay with mammalian CHO cells (Schulz et al., 2007). In cultured human lymphocytes, 2-ethylhexanoic acid induced a minimal increase in frequency of sister-chromatid exchanges (below 1.5 fold increase at concentrations of the test substance of 0.63 to 2.5 mM; Sipi et al., 1992), which is not considered significant.

In an in vivo micronucleus assay with mice, 2-ethylhexanoic acid was administered by gavage up to the maximum tolerated oral dose of 1600 mg/kg/day. No bone marrow toxicity was observed, nor did the test substance induce any bone marrow micronuclei (Holstrom et al., 1994).

2-ethylhexanoic acid, cerium salt

2-ethylhexanoic acid, cerium salt is not expected to be genotoxic, since the two moieties cerium and 2-ethylhexanoic acid have not shown gene mutation potential in a range of in vitro test systems. Thus, 2-ethylhexanoic acid, cerium salt is not classified according to regulation (EC) 1272/2008 as genetic toxicant. Further testing is not required. For further information on the toxicity of the individual moieties, please refer to the relevant section in the IUCLID.

Justification for classification or non-classification

2-ethylhexanoic acid, cerium salt is not expected to be genotoxic, since the two moieties cerium and 2-ethylhexanoic acid have not shown gene mutation potential in a range of in vitro test systems. Thus, 2-ethylhexanoic acid, cerium salt is not classified according to regulation (EC) 1272/2008 as genetic toxicant.