Table 6. U.S. Food & Drug Administration (FDA)’s guideline for the toxicity studies¹⁾

Name	Species	Number	Sex	Exposure
Acute toxicity studies
Short-term toxicity studies with rodents	Rodents (usually rats and mice)	10 rodents per sex per group	Both	14 or 28 days
Short-term toxicity studies with non-rodents	Non-rodents (usually dogs)	2 or 4 non-rodents per sex per group	Both	14 or 28 days
Sub-chronic toxicity studies
Subchronic toxicity studies with rodents	Rodents (usually rats and mice)	20 rodents per sex per group	Both	90 days
Subchronic toxicity studies with non-rodents	Non-rodents (usually dogs)	4 non-rodents per sex per group	Both	90 days
Chronic toxicity studies
Chronic toxicity studies with rodents	Rodents (usually rats and mice)	10 or 20 rodents per sex per group	Both	12 months
One-year toxicity studies with non-rodents	Non-rodents (usually dogs)	4 non-rodents per sex per group	Both	12 months

Data from U.S. Food & Drug Administration [67,68,72,73,77,99].