Table 3.

Prenatal developmental toxicity study requirements for inclusion.

Study Parameters	Criteria
Species	Rats, mice, or rabbits
Route of administration to dams/does	Oral gavage, feed, water, inhalation, or subcutaneous injection
Doses tested	At least one dose and concurrent control group
Number of dams/does tested	Minimum of six viable pregnant females per dose and control group at the end of the study
Dosing window	Dosing occurs between gestational day 0 to parturition (single “day” treatment is acceptable)
Maternal end points	Toxicological end points (e.g., weight gain) and clinical observations performed and noted (e.g., clinical signs of toxicity, food and/or water consumption)
Fetal end points	Litter measurements performed and noted (e.g., live/dead, malformations, sex ratio)