Zebrafish Toxicology Testing
Microtest has confirmed and implemented the application of zebrafish embryos (Danio rerio) in screening a variety of materials for toxicity. With the company's new in-vitro toxicology tests, medical device manufacturers and pharmaceutical companies can screen thousands of materials in less than a week — yielding significant economic value in terms of time and expense.
Zebrafish Embryo Toxicity Test for Medical Devices
Fast-track zebrafish embryo toxicity (ZET) testing is a much more robust and sensitive model for evaluating vertebrate development pathways and toxicity than small-animal models. Genotoxicity and developmental toxicity are readily viewable through the transparent embryo during development. Microtest's zebrafish embryo assay has better sensitivity and generates more scientific data than the small-animal tests currently recommended by the U.S. Food and Drug Administration (FDA). It also saves time and money because the embryos develop in 72 hours.
Currently, the FDA requires biocompatibility testing for medical devices according to ISO 10993. Extracts of medical devices (or components) are tested according to standard procedures. These procedures utilize small animal models or cell cultures. The testing encompasses systemic toxicity, irritation, sensitization, and implantation requirements. These tests do not give one a complete toxicological profile. Most tests are subjectively scored. In contrast, ZET is ideal for biocompatibility testing of medical devices and polymers as a preliminary screening method.
OECD Fish Embryo Toxicity Test Offered for Pharmaceutical and Pesticide Manufacturers
Microtest will offer OECD fish embryo toxicity (FET) testing to its portfolio of pharmaceutical testing services. The new service will complement the company’s ZET test.
FET is an approved Organization for Economic Co-Operative Development (OECD) guideline published in 2013. Similar to Microtest’s ZET test, it utilizes the embryo of the zebrafish and exposes it to various compounds to observe potential toxic effects.
The OECD method has been developed for environmental and hazard classification applications. Pesticides and whole effluent would be prime examples of the types of compounds tested. The FET testing samples are diluted to various concentrations to determine the LC50, NOEC, and LOEC. The standard incubation time is 96 hours with sample renewal every 24 hours. Assessment of toxicity is determined by apical end points that include coagulation, heart beat presence/absence, formation of a somite, and detachment of the tail from the yolk sac. Thorough controls and requirements for high fertilization and viability rates of the embryos ensure that observed toxic effects are in fact linked to the test compound, and also ensure quality and consistency of results.