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Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

No genetic toxicity study with strontium oxide is available. Since strontium oxide completely dissolves upon contact and during the reaction with water and based on the assumption that strontium is the moiety of concern, the genetic toxicity will be addressed only with existing data on the moiety strontium. 

Strontium oxide is not expected to be genotoxic, since the moiety strontium has not shown gene mutation potential in bacteria and mammalian cells.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

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 Regulation (EC) No 1272/2008, strontium neodecanoate is not considered to be genotoxic, and hence no classification or labelling is required.

 

Strontium oxide

Although no data on genetic toxicity for strontium oxide are available, studies conducted with the highly soluble strontium neodecanoate have not shown any mutation potential. Thus, strontium oxide is not expected to be genotoxic, since the moiety of concern strontium has not shown gene mutation potential in bacteria and mammalian cells. Further testing is not required. For further information on the toxicity of strontium, please refer to the relevant sections in the IUCLID and CSR.

Justification for classification or non-classification

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