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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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Related Experiment Video

Updated: Jul 15, 2026

Long-term Behavioral and Reproductive Consequences of Embryonic Exposure to Low-dose Toxicants

Long-term Behavioral and Reproductive Consequences of Embryonic Exposure to Low-dose Toxicants

Published on: March 6, 2018

[The subchronic toxicity study on the biological amnion].

Li-kui Sun¹, Ren-dong Xin, Xue-tao Zhu

¹Jinan Quality Supervision and Inspection Center for Medical Devices, State Food and Drug Administration, Jinan.

Zhongguo Yi Liao Qi Xie Za Zhi = Chinese Journal of Medical Instrumentation

|April 17, 2007

Summary

This study evaluated the subchronic toxicity of biological amnion, a new material for cornea ulcer repair. Results indicate that biological amnion is safe for long-term implantation, showing no adverse effects in rats.

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Published on: April 14, 2012

Area of Science:

Ophthalmology
Biomaterials Science
Toxicology

Context:

Corneal ulcers represent a significant cause of vision impairment globally.
The development of innovative biomaterials is crucial for effective corneal regeneration.
Biological amnion is a promising candidate for corneal ulcer renovation due to its biocompatibility.

Purpose:

To assess the subchronic toxicity of biological amnion as a long-term implantable material for corneal ulcer repair.
To evaluate local and systemic effects following the implantation of biological amnion in a rat model.
To determine the safety profile of biological amnion according to ISO 10993 standards.

Summary:

A 92-day subchronic toxicity study was conducted in rats following the implantation of biological amnion.
Animals were monitored for mortality, and comprehensive analyses included necropsy, organ weight, histopathology, hematology, and clinical chemistry.
No statistically significant adverse effects or notable differences were observed between the biological amnion and control groups.

Impact:

This study provides critical safety data supporting the use of biological amnion as a medical device for corneal ulcer treatment.
The findings suggest that biological amnion is a safe and effective material for long-term corneal regeneration.
Demonstrates the potential of biological amnion to reduce the risks associated with traditional corneal repair methods.