)
Some crop protection chemicals have been shown to impact the sexual function, fertility and development of animals. Regulators therefore demand evidence of an agrochemical’s impact on animal development as part of registration. With advances in scientific knowledge and technology, new types of data derived from studies minimizing the use of animals are demanded. As a result, developmental and reproductive toxicology (DART) is an evolving field, under constant regulatory and public scrutiny.
How to get the most out of the DART studies for your agrochemical
DART studies are long, complex and expensive with many variables that can lead to scientific and logistical headaches. There are many questions to consider, such as the following:
- How many multiple groups of adults and off-spring will you need to effectively power your study?
- Have you got the capacity to house all the adults, off-spring and extended generations, if triggered?
- How will you manage mating to smooth study start date and reduce peaks in testing?
- Have you got the expertise to address all the behavioral, histopathological, anatomical and chemical endpoints required for DART studies?
- What about historical control data?
- Do your assays detect the low concentrations of chemicals, like thyroid hormones, that occur in young animals?
- Are you sure you are making the right investment?
Simplifying and optimizing DART to ensure your agrochemical’s regulatory success
DART studies are critical to the commercial success of your agrochemical. We will work with you to deliver your regulatory DART requirements cost effectively. Our study directors and regulatory experts will use their scientific creativity and strategic insight 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. With flexible space and capacity, plus careful logistical management, we can easily manage extensive multigenerational DART studies.
Whatever your DART needs, Labcorp will tailor a solution to you.
High-quality DART studies delivering reliable study outcomes for your agrochemical
Our dedicated teams can conduct a suite of DART studies for your agrochemical 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)
Delivering reliable, verifiable data through specialist expertise in histopathology, behavioral testing and chemical analytics
Our expertise in histopathology, animal behavior and analytics, equips us to assay all DART endpoints. As leaders in many DART assessments, you will benefit from our scientific insight, innovative approaches and heritage. For example, our thyroid hormone analytics can detect very low thyroid hormone concentrations at all life stages (adult, pup, fetus) in the rat. The interpretation of endpoint data is further enhanced by our comprehensive historical control data, which are available for standard tests and newer tests like endocrine disruptor endpoints.