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EC number: 413-920-6
CAS number: 88949-33-1
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.
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