Developmental &Reproductive Toxicology (DART) Services

Key Differentiators

• Direct Access to Experts: Hands-on guidance from PhD, DABT study directors
• Regulatory Alignment: Full compliance with ICH, OECD, FDA, EMA, and REACH guidelines
• Specialty Expertise: Inhalation and dermal routes, complex dosing regimens
• Integrated Support: Bioanalytical, clinical pathology, and immunology services in-house
• GLP-compliant facilities with large study capabilities
  
• Proven Track Record: Decades of experience and historical database
• Accreditations: AAALAC, USDA, NIH (OLAW), USDEA, CDC

Comprehensive Expertise for Regulatory Success

Developmental and reproductive toxicology (DART) studies are essential for IND- and NDA-enabling programs and global regulatory submissions. IITRI designs and executes GLP-compliant DART programs aligned with FDA, EMA, and REACH expectations.

Our PhD, DABT study directors lead fertility, embryo-fetal, and pre-/post-natal studies in rats and rabbits, including inhalation and other specialty routes. We support small molecules, biologics, vaccines, chemicals, and agrochemicals.

From protocol development through final report, we provide direct scientific oversight and regulatory-ready interpretation to help move your program forward.

STUDY Capabilities

ICH-Aligned Reproductive Toxicology Studies 

• Fertility and Early Embonic Development (Segment I) – ICH S5(R3)
• Embryo-Fetal Development (Segment II) – ICH S5(R3)
• Pre- and Post-Natal Development (Segment III) – ICH S5(R3)
• Juvenile Toxicity Studies

OECD Test Guidelines

• Reproduction/Developmental Toxicity Screening Study – OECD 421
• Extended One-Generation Reproductive Toxicity Study (EOGRTS) – OECD 443

Juvenile Safety and Toxicity Studies

•  Studies to assess the safety of compounds (pharmaceuticals/chemicals) on developing systems, typically starting at PND7 in rodents

Customized programs for pharmaceuticals, biologics, vaccines, chemicals, and agrochemicals

Species and models

• Rats, mice, rabbits, dogs
• Expanded capabilities: minipigs, ferrets, guinea pigs, and nonhuman primates (NHPs) upon request

routes of administration

• Oral, IV, IM, SC, dermal, ocular, inhalation
• Specialty expertise in inhalation and dermal studies

supporting labs and analyses

• Bioanalytical method development and optimization
• Clinical pathology
• Immunology endpoints (ADA, cytokines, flow cytometry)
• Histopathology
• Sperm analysis (IVOS)

IITRI Publications for dart programs

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.