1.0 TEST SYSTEM DETAILS:
Species : Rattus norvegicus (Rats)
Strain: Sprague Dawley
Age: 6-7 weeks
Sex: Male and Female
No. of animals: 10 (5M+5F) animals per group
Total animals: 64 (60 + 4 Extra)
2.0 ALLOCATION OF GROUPS:
|
Groups |
Treatment |
Dose;
ROA |
No. of animals |
Dose Volume |
|
Main Groups |
10 mL/kg |
|||
|
G1 |
Normal Control |
0.5% MC, p.o., q.d. |
5M+5F |
|
|
G2 |
Low Dose |
X1 mg/kg; p.o., q.d. |
5M+5F |
|
|
G3 |
Median Dose |
X2 mg/kg; p.o., q.d. |
5M+5F |
|
|
G4 |
High Dose |
X3 mg/kg; p.o., q.d. |
5M+5F |
|
|
Recovery Groups |
||||
|
G5 |
Normal Control |
0.5% MC, p.o., q.d. |
5M+5F |
|
|
G6 |
High Dose |
X3 mg/kg; p.o., q.d. |
5M+5F |
|
Abbreviations: MC-Methyl Cellulose, p.o.-per os. q.d.: quaque die
3.0 METHOD:· The experiment will be conducted as per OECD guideline number 407. The animals will be randomly allocated to 4 main groups i.e., normal control, low, median & high dose, and 2 recovery groups i.e., normal control and high dose group based on their body weight. Each group will be comprised of 5 male and 5 female animals. All animals will be observed for any abnormal clinical signs before compound administration. Post-randomization, animals will be acclimatized for 5 days in an experimental room earmarked for the experiment.
· Animals of groups G1 and G5 will receive 0.5% MC, p.o., q.d. for 28 days.
· Animals of groups G2, G3, G4, and G6 will receive test compounds at doses ranging from 100-1000mg/kg, p.o., q.d. for 28 days.
· All animals will be observed daily for mortality and clinical signs after initiation of compound administration. Body weight, feed consumption, and detailed clinical examination will be performed once a week. Main group animals will be observed for 28 days while recovery group animals will be observed for an additional period of 14 days. Functional observational battery assessments and ophthalmological examinations will be conducted during 4th week for the main group animals and during the 6th week for the recovery group animals.
· After 28 days for the main group animals and 42 days for the recovery group animals, urinalysis will be performed and animals will be sacrificed under an overdose of thiopentone. After suitable anesthesia but before the animal dies, the blood sample will be collected from the retro-orbital route for estimation of hematological parameters and the serum will be separated by centrifugation for estimation of biochemical parameters. Immediately after the animal dies, their organs will be harvested and collected for histopathological analysis.
2.0 PARAMETERS TO BE EVALUATED:
· Clinical Signs
· Mortality
· Body Weight and feed consumption
· Ophthalmological examination
· Functional observational battery
· Urine analysis
· Hematology
· Serum biochemistry
· Absolute and relative organ weights
· Gross pathology
· Histopathology
3.0 REFERENCE(S):
1. Organization for Economic Co‐Operation and Development (OECD), “Test no. 407: repeated dose 28‐day oral toxicity study in rodents,”. OECD Guidelines for Testing of Chemicals, OECD, Paris, France (1995).
2. Balkrishna, A. et al. 28-day repeated dose toxicological evaluation of Coronil in Sprague Dawley rats: Behavioral, hematological, biochemical and histopathological assessments under GLP compliance. Drug Chem. Toxicol. 0, 1–14 (2022).
3. Balkrishna, A. et al. Polyherbal Medicine Divya Sarva-Kalp-Kwath Ameliorates Persistent Carbon Tetrachloride Induced Biochemical and Pathological Liver Impairments in Wistar Rats and in HepG2 Cells. Front. Pharmacol. 11, 1–18 (2020).
END OF THE DOCUMENT
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