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EC number: 807-840-4
CAS number: 64896-70-4
Toxicity of the test item LAB 3822 (batch FAL 07/25) was evaluated after
a single administration by the oral route in the rat.
Qualitative and/or quantitative evaluation of toxic effects seen
following a single oral administration of LAB 3822 took place in male
and female mice inspired by general requirements of the OECD guideline
No.423 (December 17,2001).
The study involved 5 groups of 10 SPF Sprague-Dawley rats (each of 5
males and 5 females), 8 to 9 weeks old and weighing between 275.4 g and
310.9 g for males and between 215.0 g and 251.8 g for females on the day
of randomisation. Animals were purchased from Charles River Laboratories
France (Domaine des Oncins - 69592 L0Arbresle Cedex, France).
Groups were as follows:
• Group 1: control group dosed with sterile water.
• Group 2: dosed with LAB 3822 at the dose of 0.25 g/kg of DEI (0.29
g/kg of LAB 3822).
• Group 3: dosed with LAB 3822 at the dose of 0.5 g/kg of DEI (0.575
g/kg of LAB 3822).
• Group 4: dosed with LAB 3822 at the dose of 1 g/kg of DEI (1.15 g/kg
of LAB 3822).
• Group 5: dosed with LAB 3822 at the dose of 2 g/kg of DEI (2.3 g/kg of
LAB 3822 or sterile water were administered by the oral route at the
• Group 1: 2.35 mL/kg.
• Group 2: 0.30 mL/kg.
• Group 3: 0.59 mL/kg.
• Group 4: 1.17 mL/kg.
• Group 5: 2.35 mL/kg.
Animals were weighed on the day of randomisation (D-1), on D7, D14 and
D15. Mortality was recorded twice a day for 14 days. General
observations were performed on D1, 60 minutes ± 30 minutes after dosing,
again between 3 and 4 hours post-dose and then once a day for 14 days.
Functional and neurobehavioural tests were also assessed on D1 60
minutes ±30 minutes after dosing and then on D7. All animals surviving
at the end of the 14-day period were submitted to gross necropsy.
No mortality was seen in animals dosed with sterile water.
No effect on body weight gain, no clinical sign and no abnormality in
organs examined at necropsy was seen in animals dosed with sterile water.
No mortality was seen in animals dosed with LAB 3822 by the oral route.
No effect on body weight gain was seen in animals dosed with LAB 3822,
whatever the dose, when compared with the control group.
No relevant clinical sign was observed in animals dosed with LAB 3822,
whatever the dose.
No gross lesion was seen in organs examined at necropsy .
Under the experimental conditions adopted, LAB 3822 (batch FAL 07/25)
administered once by the oral route in male and female Swiss mice did
not induce any mortality or sign of toxicity up to the dose of 2 g/kg of
DEI (2.3 g/kg of LAB 3822).
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