Magnesium potassium titanium oxide

Endpoint summary

Additional information

Amest test

Mutagenic activity of Terracess P was tested in the first mutation assay at a concentration range of 33 to 3330 µg/plate in the absence and presence of 5% (v/v) S9 -mix in tester strains TA1535, TA1537, TA98. In an independent repeat of the assay with additional parameters, Terracess P was tested at the same concentration range as the first assay in the absence and presence of 10% (v/v) S9-mix in tester strains TA1535, TA1537, TA98, TA100 and WP₂uvrA. Precipitation was observed at 3330 μg/ml. Terracess P did not induce a significant dose-related increase in the number of revertant (His⁺) colonies in each of the four 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 an independently repeated experiment. Based on the results of this study it is concluded that Terracess P is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.

Chromosome aberration test

Terracess P was for the ability to induce chromosome aberrations in cultured human lymphocytes up to 100 µg/ml for a 3h exposure time with a 24 h fixation time in the absence and presence of 1.8% (v/v) S9 -fraction. In the second cytogenetic assay, Terracess P was tested up to 100 µg/ml for a 24 h and 48 h continuous exposure time with a 24 h and 48 h fixation time in the absence of S9-mix. In the presence of S9-mix Terracess P was also tested up to 100 µg/mL for a 3 h exposure time with a 48 h fixation time. Terracess P 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 two independently repeated experiments. Therefore it can be concluded that Terracess P is not clastogenic in human lymphocytes under the experimental conditions described.

MLA assay

Terracess P was tested up to concentrations of 100 μg/ml (dose range finding test) and 33 μg/ml in the absence and presence of 8% (v/v) S9 -mix with a 3 h incubation time in the first experiment. In the second experiment,

Terracess P was again tested up to concentrations of 33 µg/mL but in the absence and presence of 12% (v/v) S9 -mix. Incubation times were 24 and 3 hours in the absence and presence of S9 -mix, respectively. No toxicity was observed, but at the highest dose levels precipitation occurred. In the presence and absence of S9-mix, Terracess P did not induce a significant increase in the mutation frequency in the presence and absence of S9 -mix, in the first experiment and confirmed in the independent repeat experiment. It is concluded that Terracess P is not mutagenic in the mouse lymphoma L5178Y test system under the experimental conditions described.

Short description of key information:
Negative in the Ames test (EC B13/14/OECD 471)
Negative in the in vitro mammalian chromosome aberration test (EC B.10/OECD 473)
Negative in the in vitro mammalian gene mutation test (EC B.7/OECD 476)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available studies, Terracess P does not have to be classified for mutagenicity according to Directive 67/548/EEC and CLP Regulation EC (No.) 1272/2008.