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EC number: 285-998-8
CAS number: 85186-15-8
Preparation of experimental animals
About twenty hours before oral
administration the animals were not fed, drinking water was given ad
libitum. Immediately before application the animals were weighed and
distributed to groups with 3 animals. The feed was given to animals 3
hours after application of the test substance.
Course of study
The dose level of 2000 mg/kg was used as
the starting dose, because no toxicity of the test substance was
estimated on the basis of information about testing of similar
substances. Because this dose caused no death of females, the same dose
of 2000 mg/kg level was sequentially applied for confirmation
(application with time distance 24 hours) to group of 3 females. No
death of animals was observed in this group of 3 females.
Testing schedule (according to OECD Test
Guideline No. 423: Acute Oral Toxicity – Acute Toxic Class Method,
Adopted 17th December 2001)
START: 2000 mg/kg – 3 females (Step No. 1)
– no deaths ►2000 mg/kg – 3 females (Step No. 2): no deaths ► END of
Body weight recording
Animals were weighed before application,
at the 8th day of study and at the 15th day, before euthanasia of
animals. Average body weight in a group was calculated from individual
body weights. Body weight increments were calculated from body weight at
the start of the study, the first week and at the end of the study.
The test was performed according EU
Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method.
The test substance was administered
in a single dose as a suspension in vehicle (water), given orally via
gavage to female Wistar rats. The volume of administered suspension was
1 ml/100 g body weight of animals.
The dose level of 2000 mg/kg bw was
used as the starting dose, because no toxicity of the test substance was
estimated on the basis of the information about testing of similar
The dosing was performed
sequentially in two groups of three females: group No. 1 - using the
starting dose of 2000 mg/kg of body weight. No death of females caused
this dose, dose of 2000 mg/kg of body weight was sequentially applied
for confirmation to group No. 2.
The test substance administered at
the dose of 2000 mg/kg bw caused no death of animals. Only changes of
colour of faeces associated with the colour of the test substance were
observed first and second day during the clinical observation after the
application. Soft faeces were observed only on the day of the
application. No other clinical signs of intoxication were detected
during the whole study in all sixanimals administered by the dose 2000
mg/kg/body weight. No pathologic macroscopic changes were diagnosed
during pathological examination.
LD50 > 2000 mg/kg bw
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