Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX)

Importancia y uso:

5.1 FETAX is a rapid test for identifying potential developmental toxicity. Data may be extrapolated to other species including mammals. FETAX might be used to prioritize samples for further tests which use mammals. Validation studies using compounds with known mammalian or human developmental toxicity, or both, suggest that the predictive accuracy will exceed 85 % (2) . When evaluating a test material for mammalian developmental toxicity, FETAX must be used with and without a metabolic activation system (MAS). Use of this exogenous MAS should increase the predictive accuracy of the assay to approximately 95 %. The accuracy rate compares favorably with other currently available “ in vitro teratogenesis screening assays” (3). Any assay employing cells, parts of embryos, or whole embryos other than in vivo mammalian embryos is considered to be an in vitro assay.

5.2 It is important to measure developmental toxicity because embryo mortality, malformation, and growth inhibition can often occur at concentrations far less than those required to affect adult organisms.

5.3 Because of the sensitivity of embryonic and early life stages, FETAX provides information that might be useful in estimating the chronic toxicity of a test material to aquatic organisms.

5.4 Results from FETAX might be useful when deriving water quality criteria for aquatic organisms (4).

5.5 FETAX results might be useful for studying structure-activity relationships between test materials and for studying bioavailability.

Subcomité:

E50.47

Referida por:

E2591-22

Volúmen:

11.09

Número ICS:

07.080 (Biology. Botany. Zoology)

Palabras clave:

amphibia; developmental toxicity; FETAX; screening test; short-term chronic test; teratogenicity; Xenopus;