Acute Toxicity testing in rodents

2. Acute Oral Toxicity Study
Name of species: Albino Rats
Strain of the animals: Sprague Dawley
No. of animals used: Maximum 05 female rats as per the
limit test of OECD-425.
Weight range: 150-160 g
Age at start of treatment: 8 to 10 weeks
Route of administration: Oral
Vehicle used: 0.3% Aq. carboxymethyl cellulose
suspension

3. Overview of the procedure
Fasted overnight
2000mg/kg
2 additional rats (48 h after)
Sacrifice after 14 days
Necropsy
Histopathological examination

4. Overview of the procedure
• If no lethality is observed following treatment with selected formulations in 3
consecutive animals, dosing to further animals will be stopped.
• Observations will be made at least once during first 30 minutes with special attention
during first 4 hours on the day of dosing and once daily thereafter for the total of 14
days.
• Body weights will be recorded prior to dosing and weekly thereafter.
• Feed consumption will be recorded at weekly interval.
• Necropsy will be performed and organs will be collected and organ weigh data will be
recorded.