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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

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

Magnesium 2 -ethylhexanoate is not expected to be genotoxic, since the two assessment entites magnesium and 2-ethylhexanoic acid have not shown gene mutation potential in bacteria and mammalian cells.

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

Genetic toxicity in vivo

Description of key information

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

Magnesium 2 -ethylhexanoate is not expected to be genotoxic, since the assessment entiy 2 -ethylhexanoic acid has not shown a clastogenic potential in an in vivo cytogenicity. The assessment entity is not considered genotoxic in vivo based on the information provided below.

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

Additional information

Magnesium

Results of several in vitro genetic toxicity studies and the crucial role of magnesium in cellular processes such as DNA-polymerase functioning and DNA repair processes show that magnesium has no genotoxic effects to human cells. All cells in every organism are highly dependent on magnesium maintaining their functionality. Therefore it appears highly unlikely that magnesium exerts any genotoxic or mutagenic effects to human cells. Based on the above existing information on the genotoxicity, magnesium substances are considered as non-genotoxic.

 

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).

 

Magnesium 2-ethylhexanoate

Magnesium 2-ethylhexanoate is not expected to be genotoxic, since the two assessment entites magnesium and 2-ethylhexanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vivo cytogenicity. Further experimental testing is therefore 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 assessment entites of magnesium 2 -ethylhexanoate do not have a genotoxic activity, one may therefore safely assume that magnesium 2‑ethylhexanoate has also no potential to induce genotoxic effects.

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