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Additional information

For the registered Substance PR 264 an Ames test was available, a study provided by ECHA in a NONS file. In a bacterial reverse mutation assay according to EU Test Method B.13/14 (under GLP conditions) using the same strains as the key study, PR 264was found to be non-mutagenic with and without metabolic activation.

In addition, the NONS file included a chromosomal aberration study in vitro. As part of a NONS file, it was assumed to be reliable and considered as key study. Thestudy was conducted according to EU Test Method B.10 (under GLP conditions) using V79 cells. The registered substance PR 264 did not induce structural chromosome aberrations.

Furthermore, the genetic toxicity of the registered substance PR 264 was investigated in a Mouse Lymphoma assay using L5178Y cells according to OECD Test Guideline 476 under GLP conditions with and without metabolic activation (±S9 Mix). Based on the results of the preliminary Solubility and Toxicity Tests and regarding the practical difficulties with the handling, PR 264 was suspended and diluted in RPMI 5 Medium and the RPMI 5 Medium was parallel investigated as vehicle control.

The following concentrations were investigated in the Assay 1: 3-hour treatment (±S9 Mix): 50; 100; 250; 500 and 1000 μg/mL; The following concentrations were investigated in the Assay 2: 24-hour treatment (-S9 Mix): 50; 100; 250; 500 and 1000 μg/mL; 3-hour treatment (+S9 Mix): 50; 100; 250; 500 and 1000 μg/mL.

The performed Assays fulfilled the validity criteria regarding the negative control and positive controls as well as in connection with the number of analysable concentration levels (at least four). In the examined concentration range noticeable cytotoxicity did not occur at the 3-hour and 24-hour treatments.

In the performed assays the obtained mutation frequencies (in absence and also in presence of exogenous metabolic activation) did not show dose-related tendencies, did not exceed the relevant GEF thresholds for positive call and remained within the validity criterion range of the negative vehicle control cultures. The obtained statistically significantly differences from that of the corresponding vehicle control (Dunnett’s Test, α = 0.05) were considered to reflect the biological variability of the applied test system and were regarded as not biologically relevant. Under the conditions of this study, the PR 264 did not induce gene mutations in presence and absence of metabolic activation in the cultured mammalian cells (L5178Y TK+/- 3.7.2 C mouse lymphoma cell line) used.

Short description of key information:

Bacterial reverse mutation assay (Ames): negative

Chromosomal aberration (in vitro): negative

ML: negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on in vitro data from three different genetic toxicity tests, the registered substance does not need to be classified for genetic toxicity and mutagenicity.