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EC number: 946-963-9 | CAS number: -
Table 7.6.1/1: Range-finder experiment - 3 h treatment in the absence and presence of S-9
3 h treatment –S-9
3 h treatment +S-9
250 P PP
UTC: Untreated control
% RS: Percent relative survival adjusted by post treatment cell counts
P: Precipitation observed at the time of treatment
PP: Precipitation noted at end of treatment incubation period
Table 7.6.1/2: Mutation experiment - 3 h treatment in the absence and presence of S-9
Linear trend tests on mutant frequency +/-S-9: Not significant (negative trends)
UTC: Untreated control
§: 6‑TG resistant mutants/106viable cells 7 days after treatment
$: Heterogeneity observed between repllicate cultures
P: Precipitation noted at time of treatment
NS: Not significant
In an in vitro mammalian cell gene mutation test performed according to OECD Guideline 476 and in compliance with GLP, L5178Y tk+/-(3.7.2C) mouse lymphoma cells were exposed to test substance for 3 h at the following concentrations:
Range-Finder Experiment: 15.63, 31.25, 62.5, 125, 250, 500, 1000 and 2000 µg/mL, with and without S9
Without S9: 25, 50, 100, 150, 175, 200, 210, 220, 230, 240, 250 and 300 µg/mL
With S9: 25, 50, 100, 150, 175, 200, 250, 260, 270, 280, 290 and 300 µg/mL
Negative (untreated culture media), vehicle and positive control groups were also included in each mutagenicity test. Metabolic activation system used in this test was 2 % S9 mix (final concentration). S9 fraction was prepared from liver homogenates of rats treated with Aroclor 1254.
In the cytotoxicity Range-Finder Experiment, eight concentrations were tested in the absence and presence of S-9 ranging from 15.63 to 2000µg/mL (an acceptable maximum concentration forin vitrogenetic toxicology studies according to current regulatory guidelines).Post-treatment precipitate was observed in the four highest concentrations (250 to 2000 µg/mL). The highest concentration to give>10% relative survival (RS) was 125 µg/mL in the absence of S-9 and 250 µg/mL in the presence of S-9, which gave 69% and 16% RS, respectively.
In the Mutation Experiment, twelve concentrations, ranging from 25 to 300 µg/mL, were tested in the absence and presence of S-9. Post-treatment precipitation was observed at 300 µg/mL in the absence of S-9 and in the highest seven concentrations (200 to 300 µg/mL) in the absence of S-9. Seven days after treatment, the highest concentrations analysed to determine viability and 6TG resistance were 210 µg/mL in the absence of S-9 (limited by cytotoxicity) and 200 µg/mL in the presence of S-9 (limited by the appearance of post-treatment precipitate) which gave 14% and 66% RS, respectively.
Vehicle and positive control treatments were included in the Mutation Experiment in the absence and presence of S-9. Mutant frequencies (MF) in vehicle control cultures fell within acceptable ranges and clear increases in mutation were induced by the positive control chemicals 4-nitroquinoline 1-oxide (NQO) (without S-9) and benzo(a)pyrene (B[a]P) (with S-9). Therefore the study was accepted as valid.
No statistically significant increases in MF were observed following treatment withLabdanum gumat any concentration analysed in the absence and presence of S-9 and there were no statistically significant linear trends, indicating a clear negative result.
Under the test conditions, test substance did not induce mutation at the hprt locus of L5178Y mouse lymphoma cells when tested up to the limit of solubility, for 3 hours in the presence of a rat liver metabolic activation system (S-9) and up to toxic concentrations for 3 hours in the absence of S-9.
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