Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Tests on the mutagenic potential of strontium compounds in bacteria are considered dispensable or irrelevant for principal considerations, since inorganic metal compounds are frequently negative in this assay due to limited capacity for uptake of metal ions (Guidance on information requirements and chemical safety assessment, Chapter R.7a, p. 565; HERAG facts sheet 05, mutagenicity, August 2007 Chapter 2.1).

Consequently, in the case of Barium peroxide, the ames test is not scientiffically relevant.

Nevertheless, in vitro studies are available on similar compound : Barium chloride (BaCl2). The results of these studies can be used in a read-across approach, as supporting information for not considering barium peroxide as mutagenic. These Two studies on barium chloride are presented as supporting studies. These studies are chromosome aberration study in mammalian cells (CHO) and in vitro study in mammalian cells (mouse lymphoma L5178Y cells). The two studies do not provide positive results.

The global conclusion in the NTP report is that barium chloride is not to be considered as inducing genetic toxicity. Consequently, based on a read-across, we can consider that barium peroxyde is not mutagenic.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Tests on the mutagenic potential of strontium compounds in bacteria are considered dispensable or irrelevant for principal considerations, since inorganic metal compounds are frequently negative in this assay due to limited capacity for uptake of metal ions (Guidance on information requirements and chemical safety assessment, Chapter R.7a, p. 565; HERAG facts sheet 05, mutagenicity, August 2007 Chapter 2.1).
Consequently, in the case of Barium peroxide, the ames test is not scientifically relevant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

Considering that performing an ames test on barium peroxide is not relevant, and considering the existing results on similar compounds, it can be conclude that the classification criteria according to regulation (EC) 1272/2008 as germ cell mutagen are not met for barium peroxide.