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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

No genetic toxicity study with strontium bis(2-ethylhexanoate) is available, thus the genetic toxicity will be addressed with existing data on the individual moieties strontium and 2-ethylhexanoic acid.

Strontium bis(2-ethylhexanoate) is not expected to be genotoxic, since the two moieties strontium and 2-ethylhexanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vivo cytogenicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Strontium

The GLP conform bacterial reverse mutation assay performed according to OECD 471, the GLP conform in vitro mammalian cell micronucleus test performed according to OECD 487 and the GLP conform in vitro mammalian cell gene mutation assay performed according to OECD 476 showed that the test item did not induce gene mutations and is not clastogenic and not aneugenic.

Thus, according to Directive 67/548 /EEC as amended and according to Regulation (EC) No 1272/2008 as amended, the test substance is not considered to be genotoxic, and hence no classification or labelling is required.

2-ethylhexanoic acid

in vitro

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 vivo

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).

 

Strontium bis(2-ethylhexanoate)

Strontium bis(2-ethylhexanoate) is not expected to be genotoxic, since the two moieties strontium and 2-ethylhexanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vivo cytogenicity. Further testing is not required. 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

As the two moieties of strontium bis(2-ethylhexanoate) do not have a genotoxic activity, strontium bis(2-ethylhexanoate)in all probability has also no potential to induce genotoxic effects.

According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptions, strontium bis(2-ethylhexanoate) does not have to be classified and has no obligatory labelling requirement for germ cell mutagenicity.