A retrospective analysis of developmental toxicity studies in rat and rabbit: What is the added value of the rabbit as an additional test species?

Regulatory Toxicology and Pharmacology

Volumn 50, Issue 2, 2008, Pages 206-217

  Janer, Gemma ^a   Slob, Wout ^a   Hakkert, Betty C ^a   Vermeire, Theo ^a   Piersma, Aldert H ^a  

^a NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

Author keywords

Classification and labeling; Developmental toxicity; NOAEL; Rabbit; Rat; Risk assessment

Indexed keywords

AEROSIL; AMELTOLIDE; AMETANTRONE; BECLOMETASONE; CHLOROFORM; CIDOFOVIR; COLCHICINE; DEFEROXAMINE; DEZAGUANINE; DIFLUCORTOLONE VALERATE; DIFLUNISAL; DORZOLAMIDE; FLECAINIDE; GLIMEPIRIDE; GLIQUIDONE; HYDROXYLAMINE; IMIPRAMINE; LEVODOPA; LITHIUM; LYNESTRENOL; MEDROXYPROGESTERONE ACETATE; MOMETASONE FUROATE; PHENYLEPHRINE; PIPERAZINE; RALOXIFENE; RITODRINE; SALMETEROL; TACROLIMUS; THALIDOMIDE; ZOLMITRIPTAN;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; CONTROLLED STUDY; DECISION MAKING; DEVELOPMENTAL DISORDER; DIAGNOSTIC ACCURACY; NONHUMAN; PRIORITY JOURNAL; RABBIT; RAT; RETROSPECTIVE STUDY; SENSITIVITY ANALYSIS; SPECIES DIFFERENCE; SPECIES IDENTIFICATION; TERATOGENICITY; TOXICITY TESTING;

ANIMALS; ENVIRONMENTAL POLLUTANTS; FEMALE; GOVERNMENT AGENCIES; GROWTH AND DEVELOPMENT; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PREGNANCY; RABBITS; RATS; RETROSPECTIVE STUDIES; RISK ASSESSMENT; SPECIES SPECIFICITY; TERATOGENS; TOXICITY TESTS; UNITED STATES;

ORYCTOLAGUS CUNICULUS; RATTUS; RODENTIA;

EID: 38949183272     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2007.11.007     Document Type: Article

References (30)

1. Bokkers B.G., and Slob W. Deriving a data-based interspecies assessment factor using the benchmark dose approach. Crit. Rev. Toxicol. 37 (2007) 353-377
2. Brent R.L. Drug testing in animals for teratogenic effects. Thalidomide in the pregnant rat. J. Pediatr. 64 (1964) 762-770
3. Christian M.S., and Hoberman A.M. Perspectives on the U.S., EEC and Japanese developmental toxicity guidelines. In: Hood R.D. (Ed). Handbook of Developmental Toxicology (1996), Taylor and Francis 551-596 (Chapter 18)
4. Christianson R.E., van den Berg B.J., Milkovich L., and Oechsli F.W. Incidence of congenital anomalies among white and black live births with long-term follow-up. Am. J. Public Health 71 (1981) 1333-1341
5. ECETOC, 1995. The toxicity of glycol ethers and its relevance to man. Technical report 64.
6. EMEA, 1999. Apramycin. Summary report. EMEA/MRL/526/98.
7. European Comission, 2003. Technical Guidance Document on Risk Assessment.
8. Fabro S., and Smith R.L. The teratogenic activity of thalidomide in the rabbit. J. Pathol. Bacteriol. 91 (1966) 511-519
9. Frankos V.H. FDA perspectives on the use of teratology data for human risk assessment. Fundam. Appl. Toxicol. 5 (1985) 615-625
10. Fratta I.D., Sigg E.B., and Maiorana K. Teratogenic effects of thalidomide in rabbits, rats, hamsters, and mice. Toxicol. Appl. Pharmacol. 7 (1965) 268-286
11. Haas J.F., and Schottenfeld D. Risks to the offspring from parental occupational exposures. J. Occup. Med. 21 (1979) 607-613
12. Hurtt M.E., Cappon G.D., and Browning A. Proposal for a tiered approach to developmental toxicity testing for veterinary pharmaceutical products for food-producing animals. Food Chem. Toxicol. 41 (2003) 611-619
13. Jelovsek F.R., Mattison D.R., and Chen J.J. Prediction of risk for human developmental toxicity: how important are animal studies for hazard identification?. Obstet. Gynecol. 74 (1989) 624-636
14. JMPR, 1995. Carbendazim (Pesticide residues in food: 1995 evaluations Part II: toxicological and environmental).
15. Jonsson B.G. Teratological studies on thalidomide in rabbits. Acta Pharmacol. Toxicol. (Copenh) 31 (1972) 17-23
16. Low J.A., and Galbraith R.S. Pregnancy characteristics of intrauterine growth retardation. Obstet. Gynecol. 44 (1974) 122-126
17. McBride W.G. Thalidomide and congenital abnormalities. Lancet 2 (1961) 1358
18. Nelson T., Oakley G.P., and Shepard T.H. Collection of human embryos and fetuses. II. Clarification and tabulation of conceptual wastage with observations on type of malformation, sex ratio and chromosome studies. In: Hook R.B., Janerich D.T., and Porter I.H. (Eds). Monitoring Birth Defects and Environment (1971), Academic Press, New York p. 45
19. Newman L.M., Johnson E.M., and Staples R.E. Assessment of the effectiveness of animal developmental toxicity testing for human safety. Reprod. Toxicol. 7 (1993) 359-390
20. Pearn J.H., and Vickers T.H. The rabbit thalidomide embryopathy. Br. J. Exp. Pathol. 47 (1966) 186-192
21. Piersma A.H., Janer G., Wolterink G., Bessems J.G., Hakkert B.C., and Slob W. Quantitative extrapolation of in vitro whole embryo culture embryotoxicity data to developmental toxicity in vivo using the Benchmark Dose approach. Toxicol. Sci. 101 (2008) 91-100
22. Poland B.J., Miller J.R., Harris M., and Livingston J. Spontaneous abortions. A study of 1962 women and their conceptuses. Acta Obstet. Gynecol. Scand. Suppl. 102 (1981) 1-32
23. Schardein J.L., and Keller K.A. Potential human developmental toxicants and the role of animal testing in their identification and characterization. Crit. Rev. Toxicol. 19 (1989) 251-339
24. Schardein J. Chemically Induced Birth Defects. third ed. (2000), Marcel Dekker Inc, New York
25. Schumacher H., Blake D.A., Gurian J.M., and Gillette J.R. A comparison of the teratogenic activity of thalidomide in rabbits and rats. J. Pharmacol. Exp. Ther. 160 (1968) 189-200
26. Shepard T.H., and Fantel A.G. Embryonic and early fetal loss. Clin. Perinatol. 6 (1979) 219-243
27. Shepard T.H. Catalog of teratogenic agents. ninth ed. (1998), Johns Hopkins University Press, Baltimore (MD)
28. Silverman W.A. The schizophrenic career of a "monster drug". Pediatrics 110 (2002) 404-406
29. Staples R.E., and Holtkamp D.E. Effects of parental thalidomide treatment on gestation and fetal development. Exp. Mol. Pathol. 2 (1963) 81-106
30. Sterz H., Nothdurft H., Lexa P., and Ockenfels H. Teratologic studies on the Himalayan rabbit: new aspects of thalidomide-induced teratogenesis. Arch. Toxicol. 60 (1987) 376-381