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Toxicity Testing in Animals

Toxicity Testing in Animals

Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...

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The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...

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Related Experiment Video

Updated: Feb 19, 2026

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Published on: October 10, 2025

In vitro teratology.

B A Schwetz¹, R E Morrissey, F Welsch

¹National Institute of Environmental Health Sciences, Research Triangle Park, NC 27709.

Environmental Health Perspectives

|August 1, 1991

Summary

This conference highlighted the need for validated in vitro teratology assays to assess developmental toxicity. Further development and validation of these screens are crucial for regulatory and mechanistic studies.

Area of Science:

Toxicology
Developmental Biology
Assay Development

Background:

Conference convened to reevaluate in vitro teratology assays.
Examined validation processes for in vitro tests.
Discussed progress in validating in vitro teratology screens.

Framework:

Supported developing short-term in vivo and in vitro systems as prescreens for developmental toxicity.
Endorsed creating an updated reference list of developmental toxicants and non-toxicants.
Recommended an expert group evaluate performance characteristics of validated prescreens.

Implementation:

Need to clearly define the limits of prescreens for product development, regulatory use, and mechanistic investigations.
Few in vitro teratology prescreens have undergone multi-laboratory evaluation with common test agents.

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Agreed on the need to advance several assays in the validation pathway using reference compounds.

Implications:

Further development of in vitro teratology assays is essential for accurate developmental toxicity assessment.
Validated prescreens can aid in understanding toxicant mechanisms and informing regulatory decisions.
Standardized validation processes and reference compounds are key to advancing the field.