Developmental and reproductive toxicology

Pharmaceuticals and chemicals have sometimes unanticipated and complex impacts on reproductive capacity and/or embryonic development: they can affect sexual function and fertility in adult males and females or lead to malformations, developmental retardations or mortality of the fetus when pregnant women are exposed. Over the past 30 years, fundamental understanding of embryogenesis and mechanisms of developmental toxicity have greatly advanced as well as the regulatory framework of the developmental and reproductive toxicology (DART) studies.

ERBC’ scientists have extensive experience in DART conducting a broad range of ICH and OECD-based studies in rodents and rabbits as well as advanced investigations in rats. They have implemented a historical control database to ensure accuracy and reproducibility of ERBC test results and develop next generation testing approaches that support the 3R principles.

ICH-based studies

All studies presented below can include toxicokinetic analysis

Fertility – Segment I: fertility and early embryonic development to implantation study

Species: rat (only females, only males, both sexes)
Administration routes: oral, subcutaneous, intravenous (by bolus or continuous infusion), intravaginal, intraperitoneal (at an appropriate dose regimen)

Teratology – Segment II: embryo-fetal development study (preliminary and main study)

Species: rat, rabbit, mouse
Administration routes: oral, subcutaneous, dermal, intravenous (by bolus or continuous infusion only in rat and rabbit), intravaginal, intraperitoneal (at an appropriate dose regimen)

Fertility and teratology – Segment I and II: combined study

Species: rat
Administration routes: oral, subcutaneous, intravenous (by bolus or continuous infusion), intravaginal, intraperitoneal (at an appropriate dose regimen)

Pre- and post-natal – Segment III

Species: rat
Administration routes: oral, subcutaneous, intravenous (by bolus), intraperitoneal (at an appropriate dose regimen)

OECD-based studies

Pre-natal developmental toxicity study (preliminary and main study)

Species: rat, rabbit
Limit test or full test
Administration route: oral

Reproduction/Developmental toxicity screening test: preliminary and main study

Species: rat
Administration route: oral

Reproduction/Developmental toxicity screening test: combined repeated dose toxicity study

Species: rat
Administration route: oral

One-generation reproduction toxicity study

Species: rat
Administration route: oral

Two-generation reproduction toxicity study

Species: rat
Administration route: oral

Extended one-generation reproductive toxicity study

Species: rat
Administration route: oral

Additional studies

Uterotrophic assay in immature female

Species: rat
Administration route: oral

Neurotoxicity study in pregnant female and developmental neurotoxicity study

Species: rat
Administration route: oral