Agrochemical Developmental and Reproductive Toxicology (DART) Evaluations

Agrochemical Developmental and Reproductive Toxicology (DART) Evaluations

Developmental and reproductive toxicology studies evaluate the reproductive safety of pesticides after repeated or chronic exposure. DART has been a growing field in recent years and is under constant regulation and public scrutiny. Several agrochemicals have been shown to affect the sexual function, fertility and development of animals. As a result, regulatory agencies in many countries require evidence of their impacts on animal development as part of registration. As scientific knowledge and technology advance, novel data derived from research are needed to minimize their use in animals. BOC Sciences is ready to provide a suit of services to simplify and optimize DART to ensure your agrochemical's regulatory success.

Figure 1. The stages of the reproductive life cycle needed to assess reproductive and developmental effects of toxicity in animals. (Chapman, K. L.; et al. 2013)

A Suite of DART Studies for Your Agrochemical

• OECD 414: Prenatal developmental toxicity study
• OECD 421: Reproduction/developmental toxicity screening test
• OECD 422: Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test
• OECD 416: Two-generation reproduction toxicity
• OECD 443: Extended one-generation reproductive toxicity study (EOGRTS)

DART Endpoints Assay

Our expertise in histopathology, animal behavior and analysis allows us to analyze all a diverse of DART endpoints:

Histopathological capabilities

• Fetal pathology including Wilson's sectioning and microdissection techniques, staining for bone and cartilage
• Computer-assisted sperm assessment (CASA)
• Specialist neuropathology and morphometric measurements of the brain
• Specialist pathology of male and female reproductive organs

Mating assessments and behavioral capabilities

• Extensive, proven behavioral testing
• Dedicated team of experts involved in monitoring of oestrous cycles, mating performance and fertility

Chemical analytic capabilities

• Thyroid hormone tests (T3, T4)
• TSH

Figure 2. Examples of in vitro and in vivo methods. (Chapman, K. L.; et al. 2013)

Features of Our Services

• Our team has over 40 years of experience in developmental and reproductive toxicology, which is developed based on the validated techniques and a comprehensive historical data.
• We have accumulated expertise and experience in histopathology, anatomy and chemical endpoints to address all behaviors required for DART studies for a diversity of agrochemicals.
• Our professional researchers and expert reproductive toxicology animal technicians will execute your study efficiently and to high animal welfare and GLP standards.
• With flexible space and capacity, combined with careful logistics management, we can easily manage a wide range of multi-generational DART studies.
• BOC Sciences has established a dedicated team of senior scientists, behavioral experts, and animal technicians specializing in reproductive toxicology to provide successful studies.
• State-of-the-art facilities with high animal welfare standards to ensure the integrity and reliability of your agrochemicals analysis.

BOC Sciences Advantages

• Highly specialized technical and analytical services for the worldwide registration and regulatory compliance of agrochemicals
• Robust analytical testing programs that span from research and product development through the production process to final product
• Relies on broad industrial experience, ensuring that all of our work meets the high standards expected by our clients
• Our regulatory experts, toxicology consultants, scientists and inspectors will ensure that you receive maximum levels of guidance, testing and inspection you need.

Reference

• Chapman, K. L.; et al. Pharmaceutical Toxicology: Designing studies to reduce animal use, while maximizing human translation. Regulatory Toxicology and Pharmacology. 2013. 66(1).