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Developmental and Reproductive Toxicology (DART) for Crop Protection

Make safer, faster registration decisions with dependable studies and earlier human relevant insight
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Why DART matters for agrochemical registration

Regulators (EPA, EFSA, PMRA) require robust evidence on how an active ingredient or formulation may affect fertility, sexual function, embryo fetal development, and offspring health. These endpoints carry high scrutiny for crop protection products. Sound DART data underpin labeling and global submissions, and expectations continue to evolve as science advances and 3Rs considerations grow.

Labcorp DART advantage: Predictable, verifiable, registration‑ready

Get reliable information to support confident decision making—not just completed studies

Our programs combine deep experience, specialist teams and high-welfare facilities to help you move from study design to defensible interpretation—without surprises.

  • 60+ years of DART expertise supported by extensive historical control datasets 

  • Integrated specialist teams, including study directors, behavioral experts, reproductive toxicologists, fetal pathologists, necropsy specialists 

  • AAALAC-accredited facilities that protect data quality via high-welfare standards 

  • Expanded U.S. DART capacity in Greenfield, Indiana, for scheduling flexibility and timely program starts

Operational excellence for multigenerational studies

Multigenerational study windows vary in mating dates, start periods, and littering peaks. We minimize timeline risks through:

  • Endpoint‑to‑decision mapping
  • Synchronized resource planning
  • Smoothing of mating/littering peaks

Result: Fewer pauses, less rework, steadier progress toward submission.

Early, human‑relevant insight with devTOX quickPredict™ (NAM)

devTOX quickPredict is a pluripotent human cell–based in vitro assay powered by metabolomics that predicts developmental toxicity potential before in vivo studies begin.

What devTOX quickPredict measures

  • Exposure-based signals using LCMS metabolomics + viability

  • Mechanistic biomarker readout: Ornithine/cystine ratio, detecting early toxicity thresholds at non cytotoxic levels

  • Strong predictive alignment (~85–90%) with known developmental toxicants

When to use devTOX quickPredict

  • Early screening to avoid unnecessary multigenerational or triggered phase studies

  • Prioritizing active ingredients, impurities, degradants, formulation variants

  • Informing dose selection ahead of OECD 414/421/422

  • Reducing unnecessary vertebrate studies (3Rs)

Assay advantages
 

  • Rapid turnaround (weeks)

  • Low material requirement (~15 mg)—ideal for limited availability substances

  • Human-relevant metabolic mechanism

  • Supports weight-of-evidence strategies regulators recognize


Integration tip

Place devTOX quickPredict™ before OECD 414/421/422 to streamline decision cycles and derisk downstream study sequencing.
 


 

OECD DART studies for crop protection submissions

We design and run the full suite of OECD reproductive and developmental toxicology studies required for global submission packages:

OECD 414

Prenatal developmental toxicity study

OECD 416

Two-generation reproduction toxicity

OECD 443

Extended one-generation reproductive toxicity study (EOGRTS)

Why this matters

414 enables earlier decisions; 416/443 address multigenerational questions that often determine registration viability. 

Specialized capabilities that strengthen endpoint confidence

With deep expertise in histopathology, animal behavior, and analytics, we support robust data collection across all DART endpoints. As recognized leaders in DART assessments, we provide the scientific insight, innovative approaches, and proven heritage you can rely on.

Histopathology and fetal pathology

Wilson’s sectioning, microdissection, bone/cartilage staining, and specialist evaluation of male and female reproductive organs—executed by dedicated fetal pathologists for consistent, defensible reads.

Behavioral and mating assessments

Dedicated behavioral testing, estrous/oestrous cycle monitoring, mating performance, fertility assessment, and CASA (computer-assisted sperm analysis) to capture subtle functional effects that impact study outcomes.

Analytical sensitivity for endocrine‑related endpoints

Thyroid hormone analytics sensitive to very low T3/T4 levels across adult, pup, and fetus in rat, plus TSH to support endocrine disruptor evaluations—critical when small concentration shifts drive decisions.

Historical controls for confident calls

Comprehensive historical control datasets—especially valuable for newer endocrine-related endpoints—provide context that reduces false signals and supports regulatory dialogue.

Study design, logistics and execution—made predictable

We collaborate early to map endpoints to decisions, plan joined‑up study programs, and manage mating windows to avoid resource peaks. Flexible space and capacity support multigenerational studies and complex timelines while maintaining GLP and welfare standards.

DART educational resources

Articles  —  24 April Apr 2026

The early DART blind spot: Why developmental toxicity needs a rethink in 2026

Read More about The early DART blind spot: Why developmental toxicity needs a rethink in 2026
Articles  —  24 April Apr 2026

Inside preclinical NAMs innovation: A Q&A with Labcorp experts Darren Kidd and Jessica Palmer on devTOX quickPredict™

Read More about Inside preclinical NAMs innovation: A Q&A with Labcorp experts Darren Kidd and Jessica Palmer on devTOX quickPredict™
Posters  —  21 September Sep 2025

The importance of specification of minimum age requirements of female age at mating to achieve regulatory toxicology study objectives: An evaluation of age at mating on varying study types and correlation to litter size in three strains of laboratory rat

Read More about The importance of specification of minimum age requirements of female age at mating to achieve regulatory toxicology study objectives: An evaluation of age at mating on varying study types and correlation to litter size in three strains of laboratory rat

Frequently asked questions

Ready to design a DART program that anticipates risk—and minimizes surprises?