Developmental and Reproductive Toxicology (DART)

Chemical Testing

There is well established evidence that some chemicals can impact the sexual function, fertility and development of animals. As scientific knowledge and technology advance, regulators demand new types of data derived from studies that minimize animal use in line with the 3Rs— Replacement, Reduction, Refinement. Developmental and reproductive toxicology (DART) is therefore still an evolving field which is under constant public scrutiny. 

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Bringing clarity and logistical excellence to DART

  • Over 40 years’ experience in developmental and reproductive toxicology, building vital scientific insights, validated technologies and comprehensive historic datasets.
  • Leverage the expertise of a large and experienced team of study directors, senior scientists, behavioral specialists, specialized reprotoxicology animal technicians, repro necropsy specialists and fetal pathologists to deliver study success.
  • State-of-the-art, AAALAC-accredited facilities with high animal welfare standards ensuring the integrity and reliability of your studies.

 

Your Needs

DART studies are long, complex and expensive, so you need to plan them carefully 

DART studies often need multiple groups of adults and off-spring and a large range of varied endpoints. More complex studies, like OECD 443, have additional breeding phases that can be triggered by effects observed during the conduct of the study which adds to the already complicated nature of the study. You will be investing a lot in DART studies, so you need to be confident of reliable outcomes that will satisfy regulatory requirements.

Some endpoints are difficult to measure reliably, and lack of historic datasets makes interpretation difficult

Behavioral, histopathological, anatomical and chemical endpoints can be required for DART studies. You need a validated team with the necessary expertise, facilities and equipment to conduct these assessments. Analytics in offspring and fetuses can be difficult as chemical assays must detect the low concentrations that occur in young animals. This is especially problematic for thyroid hormone testing for endocrine disruptor endpoints. In addition, it is important to ensure Historical Control is available for newer tests like endocrine disruptor endpoints.

DART studies can give you logistical headaches

DART studies are complex because they involve the mating of animals and management of multiple groups of adults and offspring. As the day of mating during the pairing period varies, DART study logistics can be unpredictable. The study start may span several days and involve peaks in test requirements related to peaks in mating and littering. This can cause you serious resource challenges over the course of a study.

 


 

Our Capabilities

Simplifying your DART journey to optimize the regulatory success of your chemical

We understand the importance of DART studies to the commercial success of your chemical. We’ll work in partnership with you to help you meet all your regulatory DART requirements in a cost-effective way. That means using the scientific creativity and strategic insight of our study directors and regulatory experts to design and plan joined-up study programs. Our expert study planners and specialized reprotoxicology animal technicians will execute your study efficiently and to high animal welfare and GLP standards. Regardless of your DART needs, Covance can help tailor a solution suited to you.

 

Specialist expertise in histopathology, behavioral testing and chemical analytics delivers reliable, verifiable data

Our expertise in histopathology, animal behavior and analytics, means our team is equipped and capable of assaying all DART endpoints. As leaders in many DART assessments, for example, thyroid hormone analytics, you’ll benefit from our scientific insight and innovative approaches.

High quality DART studies delivering reliable study outcomes

Our dedicated teams can conduct a suite of DART studies including:

  • 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)

 

Histopathological capabilities Mating assessments and behavioral capabilities Chemical analytic 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
  • Extensive, proven behavioral testing
  • Dedicated team of experts involved in monitoring of oestrous cycles, mating performance and fertility
  • Thyroid hormone tests (T3, T4)
  • TSH