Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The test item NovaPK was examined for the ability to induce gene mutations in tester strains TA1535, TA1537, TA98, TA100 and WP2 uvrA (Cinelli, 2009). Experiments were performed both in the absence and presence of metabolic activation.

Aqueous solutions of the test item NovaPK were assayed at dose levels of 5000, 2500, 1250, 625 and 313 μg/plate. As no relevant increases in revertant numbers were observed at any concentration tested, a pre-incubation step was included for all treatments of Main Assay II. The test item was assayed at the same concentrations employed in Main Assay I. No toxicity was observed at any dose level with any tester strain, in the absence or presence of S9 metabolic activation. No precipitation of the test item was noted at the end of the incubation period at any concentration tested. The test item did not induce significant increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose level, in any tester strain, in the absence or presence of S9 metabolism.


Short description of key information:
Ames Test: negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

A highly reliable Ames Test performed with tripotassium trihydrogen phosphate dihydrate was found to be negative. Further studies on genotoxicity were not available. However, as cell culture media used in in vitro cytogenicity tests are based on potassium phosphate buffers an adverse effect of the substance on genotoxicity is unlikely. Thus, no classification is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC) classification criteria for genetic toxicity.