Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

It is concluded that Silicic acid(H2Si2O5), barium salt(1:1), lead-doped is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay tested up to limit concentrations. Silicic acid(H2Si2O5), barium salt(1:1), lead-doped 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 while tested up to precipitating concentrations. TK mutation test system: In the absence of S9-mix, Silicic acid(H2Si2O5), barium salt(1:1), lead-doped did not induce a significant increase in the mutation frequency in the first experiment. This result was confirmed in a repeat experiment with modifications in the duration of treatment time. In the presence of S9-mix, Silicic acid(H2Si2O5), barium salt(1:1), lead-doped did not induce a significant increase in the mutation frequency in the first experiment. This result was confirmed in an independent experiment with modifications in the composition of the S9 concentration for metabolic activation. In conclusion, Silicic acid(H2Si2O5), barium salt(1:1), lead-doped is not mutagenic in the TK mutation test system under the experimental conditions described in the report with either cytotoxicity or precipitation occuring.

Based on the Ames test, chromosome aberration test and TK mutation test, Silicic acid(H2Si2O5), barium salt(1:1), lead-doped is considered to be negative for genetic toxicity.


Short description of key information:
It is concluded that Silicic acid(H2Si2O5), barium salt(1:1), lead-doped is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay, did not induce chromosome aberrations in the absence and presence of S9-mix, is not mutagenic in the TK mutation test system with and without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, Silicic acid (H2Si2O5), barium salt (1:1), lead-doped, does not need to be classified for genotoxicity according to Directive 67/548/EC or the CLP Regulation.