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EC number: 807-840-4
CAS number: 64896-70-4
BACTERIAL MUTAGENICITY TEST ON SALMONELLA TYPHIMURIUM HIS- (5 STRAINS)
USING B.N. AMES'S TECHNIQUE
THIS STUDY WAS CARRIED OUT IN COMPLIANCE WITH GOOD LABORATORY PRACTICE
Strains used : TA 1535, TA1537, TA98, TA100, TA102
Preliminary test of toxic activity : carried out on 5 strains –
Incubation period: 48 hours
Sterility test : absence of contamination
Mutagenicity test : carried out both with and without metabolic
activation using hepatic microsomes from rat livers induced by Aroclor
1254 – Incubation period: 48h
Number of assays : 2 (the second assay with metabolic activation was
performed according to pre-incubation method)
Solvent : DMSO
Limiting factor for maximum dose : maximum dose according to OECD
Doses used in main test : expressed as μg/plate pure LAB3822
T = Toxicity (- non toxic; + slightly toxic; ++ moderately toxic; +++
strongly toxic; N no bacterial growth)
P = Precipitate (- absence; + slight precipitate; ++ moderate
precipitate; +++ important precipitate hindering scoring)
The test item LAB3822 induced no toxicity either with or without
metabolic activation, whatever the dose tested. However, the highest
concentration of 5000 μg/plate induced a decrease in the number of
reverstants in strain TA 102, in presence and in absence of metabolic
activation, and in strain TA 1535 in absence of metabolic activation.
The maximum dose retained for the first mutagenicity assay was 5000
μg/plate with and without metabolic activation in all strains tested,
except in strain TA1535, without metabolic activation, and strain TA102,
with and without metabolic activation, where the top dose retained was
of 3000 μg/plate.
(a) Induction Ratio = number of revertants in the treated/number of
revertants in the control
Under these experimental conditions, the test item LAB3822 (Batch FAL
07/25) provided by ROQUETTE induced no mutagenic activity in any of the
five Salmonella typhimurium tested in presence as well as in absence of
The determination of LAB3822 in treatment solutions was performed using
a validated analytical method. The dosing results are thus considered as
reliable. The results obtained for the concentration assay of LAB3822 in
treatment solutions used in the Ames test FSP-IPL 070707, were within
the range 80-120% of the theoretical values, except for 4 samples, with
67.6 to 123.5% of recovery between theoretical and nominal values.
Nevertheless, this was considered only as a slight deviation and did not
affect either the integrity or the validity of the current study. It is
noteworthy that the blanks were below the limit of quantification, as
expected. Finally, LAB3822 is considered as stable in DMSO solutions for
8 months, when stored at –80°C.
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