Developmental and Reproductive Toxicology (DART) for Industrial Chemicals

From early insight to regulatory ready data—delivered through integrated in vitro and in vivo solutions

Pregnant woman sitting on a couch and she is looking at a book

Why DART matters for industrial chemicals

Industrial chemicals can affect fertility, sexual function, embryo‑fetal development, and offspring health, making DART a cornerstone of human‑health risk assessment. Regulatory agencies (EPA, ECHA, global authorities) require reliable, interpretable and science based data across these complex endpoints.

As expectations evolve, regulators increasingly seek sensitivity for endocrine‑related endpoints, and alignment with the 3Rs—driving demand for thoughtful DART program design, early NAM insight, and high‑quality GLP execution.

What you gain with Labcorp

Decades of insight — Clear, defensible decisions

With over 60 years of DART experience, validated methodologies, and comprehensive historical datasets, you get interpretations grounded in scientific depth—not guesswork.

Expert teams aligned to your goals

Your studies are supported by an integrated, multidisciplinary structure that improves consistency and strengthens endpoint reliability.

study directors
senior scientists
behavioral specialists
specialized reprotoxicology technicians
necropsy specialists
fetal pathologists

High‑welfare, AAALAC‑accredited facilities

Our AAALAC‑accredited sites support robust data reproducibility, reduce confounders, and help build trusted datasets for challenging submissions.

U.S. capacity for complex chemical programs

Our expanded GLP capacity in Greenfield, Indiana provides more scheduling flexibility for OECD studies, multigenerational designs, and DNT work.

Earlier, human-relevant insight with devTOX quickPredict™

devTOX quickPredict is a human-cell–based in vitro NAM assay that provides early, predictive indicators of developmental toxicity risk before committing to in vivo studies.

Recommended workflow positioning

Place devTOX quickPredict before OECD 414/421/422 to streamline decision cycles and reduce downstream risk.

See If devTOX  quickPredict™ Fits Your Program

Use devTOX quickPredict to:

Prioritize substances faster
Identify potential hazards early
Inform dose selection and endpoint focus for OECD studies
Advance 3Rs through smarter program sequencing

Full regulatory DART program for industrial chemicals

Our studies form the backbone of regulatory‑ready safety packages, especially as chemical programs move toward mechanistic, structured, and defensible DART evidence.

Labcorp executes the complete suite of OECD DART studies required for global industrial chemical registrations:

OECD 414

Prenatal developmental toxicity study

OECD 421

Reproduction/developmental toxicity screening test

OECD 422

Combined repeated dose toxicity with reproduction/developmental screening test

OECD 416

Two‑generation reproduction toxicity

OECD 426

Developmental neurotoxicity study (DNT)

OECD 443

Extended one‑generation reproductive toxicity (EOGRTS)

Specialized capabilities that strengthen endpoint reliability

Histopathology and fetal pathology

Comprehensive fetal pathology including Wilson’s sectioning, microdissection, bone/cartilage staining, and specialized pathology for reproductive organs.

Behavioral and mating assessments

Dedicated behavioral endpoints, estrous‑cycle monitoring, mating performance, fertility assessment, and CASA (computer‑assisted sperm analysis).

Endocrine-related endpoint sensitivity

Low level thyroid hormone analytics (T3, T4, TSH) across adults, fetuses, and offspring—critical for evaluating endocrine disruptor risks where historical datasets may be limited.

Historical controls that support confident interpretation

Our large historical datasets provide context for both established and emerging endocrine endpoints—reducing false positives and improving regulatory defensibility.

Program design, logistics and risk management

DART programs are inherently complex—with variable pairing windows, staggered study starts, and peaks in testing during mating and littering.

Labcorp helps you navigate:

Mapping endpoints to decisions
Smoothing critical windows
Managing resource peaks
Maintaining GLP and welfare standards

DART educational resources

Articles — 24 April Apr 2026

Posters — 21 September Sep 2025

Frequently asked questions

How do you handle complex DART logistics (mating windows, peaks in testing)?

We plan joined‑up programs, manage variable pairing periods, and buffer capacity to navigate peaks in mating and littering while maintaining GLP and animal‑welfare standards.

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Do you have U.S. capacity for EOGRTS or other mammalian toxicology studies?

Yes—our expanded Greenfield, Indiana site provides additional scheduling flexibility and high‑quality execution.

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Where does devTOX quickPredict add the most value?

Upstream—before you commit to OECD 414/421/422, to prioritize candidates, inform dose selection, and support 3Rs.

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Which OECD DART studies can Labcorp run for industrial chemicals?

OECD 414, 421, 422, 416, 426 (DNT), and 443 (EOGRTS)—with program design and logistics optimized for reliability and regulatory success.

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Developmental and Reproductive Toxicology (DART) for Industrial Chemicals

Why DART matters for industrial chemicals

What you gain with Labcorp

Decades of insight — Clear, defensible decisions

Expert teams aligned to your goals

High‑welfare, AAALAC‑accredited facilities

U.S. capacity for complex chemical programs

Earlier, human-relevant insight with devTOX quickPredict™

Recommended workflow positioning

Use devTOX quickPredict to:

Full regulatory DART program for industrial chemicals

Labcorp executes the complete suite of OECD DART studies required for global industrial chemical registrations:

OECD 414

OECD 421

OECD 422

OECD 416

OECD 426

OECD 443

Specialized capabilities that strengthen endpoint reliability

Histopathology and fetal pathology

Behavioral and mating assessments

Endocrine-related endpoint sensitivity

Historical controls that support confident interpretation

Program design, logistics and risk management

Labcorp helps you navigate:

DART educational resources

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

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

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 with fewer uncertainties and clearer decisions?