Reproductive Toxicology

Developmental and reproductive toxicology (DART) studies assess the reproductive safety of drugs, chemicals, or pesticides after repeated or chronic exposure. Our team of scientists has extensive experience conducting a broad range of reproductive toxicology studies in models including rats, rabbits, and dogs. Our expertise extends to studies requiring inhalation as the route of administration and OECD studies.

DART Study Types

Screening Studies

• Reproduction/developmental toxicity screening test (OECD 421)

Segment I Studies (FEED)

• Fertility and early embryonic development toxicity studies in rats and mice ( ICH R5(R2))
• Fertility studies in mature male dogs

Segment II Studies (EFD/Teratology)

• Embryo-fetal development in mice, rats and rabbits (ICH R5(R2))

Segment III Studies (PPND)

• Pre- and post-natal development toxicity studies in rats, mice, and rabbits (ICH R5(R2))
• Prenatal developmental toxicity study (OECD 414)

Juvenile Studies

• Juvenile safety and toxicology

Extended one-generation reproductive toxicity

• (OECD 443)

DART Study Options

• Routes of administration including oral, IM, IV, dermal, ocular, and inhalation
• Small molecule drugs, biologics, vaccines, chemicals, consumer products and agrochemicals
• Sperm analysis (IVOS)

We have published two studies on the developmental toxicity in rats for an occupational exposure (inhaled building material fibers), and the fertility and embryofetal developmental toxicity of cytisine, a plant-based alkaloid used for smoking cessation in rats. See our peer-reviewed journal article list and posters and white papers pages for more information.