FETAX interlaboratory validation study: Phase 2 testing
- Oklahoma State Univ., Stillwater, OK (United States). Dept. of Zoology
- WYE Research and Educational Center, Queenstown, MD (United States)
- Ashland Univ., OH (United States). Dept. of Biology and Toxicology; and others
The Frog Embryo Teratogenesis Assay-Xenopus (FETAX) is a 96-h whole embryo developmental toxicity screening assay that can be used in ecotoxicology and in detecting mammalian developmental toxicants when an in vitro metabolic activation system is employed. A standardized American Society for Testing and Materials (ASTM) guide for the conduct of FETAX has been published along with a companion atlas that helps in embryo staging and identifying malformations. As part of the ASTM process, an interlaboratory validation study was undertaken to evaluate the repeatability and reliability of FETAX. Six different laboratories participated in the study. Each laboratory utilized one technician with the exception of one laboratory, which utilized two independent technicians. In Phase 1, FETAX proved to be more repeatable and reliable than many other bioassays. However, some excessive variation was observed in a few laboratories. Some of this variation may have been due to an initial lack of experience with the assay by some technicians. Phase 2, which is reported here, showed far less intralaboratory and interlaboratory variability than did Phase 1. Nonteratogens such as saccharin and sodium cyclamate showed the most consistent results, whereas more variability was observed for the teratogens caffeine and 5-fluorouracil. Interlaboratory coefficient of variation values for all FETAX end points ranged from 7.3 to 54.7%. The minimum concentration to inhibit growth proved to be the most variable end point for three of the four test chemicals, whereas the LC50 and EC50 (malformation) proved to be less variable.
- OSTI ID:
- 6945571
- Journal Information:
- Environmental Toxicology and Chemistry; (United States), Vol. 13:10; ISSN 0730-7268
- Country of Publication:
- United States
- Language:
- English
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Related Subjects
EMBRYOS
CONGENITAL MALFORMATIONS
FROGS
SENSITIVITY
TERATOGENS
BIOASSAY
INTERLABORATORY COMPARISONS
AMPHIBIANS
ANIMALS
AQUATIC ORGANISMS
MALFORMATIONS
PATHOLOGICAL CHANGES
VERTEBRATES
560300* - Chemicals Metabolism & Toxicology