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EC number: 807-840-4
CAS number: 64896-70-4
STUDY OF GENOTOXIC ACTIVITY USING THE MICRONUCLEUS TEST IN RAT
(2 treatments, 1 sampling time)
SPONSOR : ROQUETTE
TEST ITEM : LAB3822
BATCH NUMBER : FAL 07/25
STUDY LOCATION : INSTITUT PASTEUR DE LILLE
Genetic Toxicology Laboratory
1, rue du Professeur Calmette - B.P. 245
59019 LILLE CEDEX
THIS STUDY WAS CARRIED OUT IN COMPLIANCE WITH GOOD LABORATORY PRACTICE
In accordance with the Amendment No. 1, no preliminary toxicity assay
was performed. Indeed, previous acute toxicity study by oral route (CERB
study number 20070258 TR) demonstrated that the DMT was higher than 2000
mg/kg in male and female Sprague Dawley rats. The genotoxicity assay was
thus performed at 2000 – 1000 and 500 mg/kg/day (x2). No clinical signs
were observed during the mean genotoxicity assay.
Number of sampling times : 1: negative control and treated: 24 hours
after the second treatment
1: positive control: 24 hours after single treatment
Number of polychromatic erythrocytes observed for each animal: 200
No statistically significant increase in the number of micronuclei was
noted in male and in female rats dosed with 2000 - 1000 and 500
The test item LAB3822 (batch FAL 07/25) provided by ROQUETTE was
investigated by means of the in vivo micronucleus test in male and
female OFA Sprague Dawley rats treated orally with 2000 – 1000 and 500
mg/kg/day (x2), followed by one sampling time 24 hours after the last
treatment. As a conclusion, LAB3822 induced no genotoxic activity under
these experimental conditions.
Thirty minutes, 2 or 4 hours after oral administration of 500, 1000 or
2000 mg/kg of LAB3822, plasmatic concentrations of Isosorbide measured
in OFA Sprague-Dawley rats clearly demonstrated a systemic exposure to
Isosorbide, and thus to LAB3822. (The determination of Isosorbide
concentrations in plasma was performed in a GLP-compliant laboratory
using a validated analytical method (CERB/Reference No. 20080183B). The
dosing results were thus considered as reliable).
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