Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The mutagenic activity of the substance was evaluated in accordance with OECD 471 (1997) and according to GLP principles. The test was performed in two independent experiments, both in the absence and presence of S9-mix. The substance was tested up to or beyond a precipitating dose level. No cytotoxicity was observed up to the limit concentration. Adequate solvent and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA, both in the absence and presence of S9-metabolic activation. These results were confirmed in independently repeated experiments. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay with and without metabolic activation.

In accordance with OECD 473 (1998) and according to GLP principles, a chromosome aberration study with the substance was performed in cultured peripheral human lymphocytes in two independent experiments with and without metabolic activation. Adequate solvent and positive controls were included. The substance was tested up to and above precipitating concentrations (100 µg/mL). The substance did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of S9-mix, in either of the two independently repeated experiments. No effects of the substance on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Based on the results of this study, it is concluded that the substance does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations.

A mouse lymphoma assay with SrHPO4 was conducted according to OECD 476 guideline and GLP principles.

No toxicity was observed up to and including the highest tested precipitated dose levels in both experiments in the absence and presence of S9-mix. In the absence of S9-mix, SrHPO4 did not induce a significant increase in the mutation frequency in the first experiment. This result was confirmed in an independent repeat experiment with modifications in the duration of treatment time. In the presence of S9-mix, SrHPO4 did not induce a significant increase in the mutation frequency in one experiment. Positive control chemicals, methyl methane sulfonate and cyclophosphamide induced appropriate responses.It is concluded that SrHPO4 is not mutagenic in the TK mutation test system under the experimental conditions described in the absence and presence of S9 -mix.


Justification for selection of genetic toxicity endpoint
No single study was selected as key study, as the endpoint conclusion is derived by weight-of-evidence using three in vitro studies.

Short description of key information:
Three in vitro studies are available with Strontium hydrogenphosphate. All studies were performed according to OECD/EC guidelines and GLP principles (Klimisch 1). In all studies, the test substance was negative with and without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, Strontium hydrogenphosphate is not classified for genotoxicity according to the criteria specified by the CLP Regulation.