The need for developmental neurotoxicity studies in risk assessment for developmental toxicity

Reproductive Toxicology

Volumn 22, Issue 2, 2006, Pages 148-156

  Hass, Ulla ^a  

^a TECHNICAL UNIVERSITY OF DENMARK   (Denmark)

Author keywords

Cross species comparability; Developmental neurotoxicity; OECD guideline; Regulation; Risk assessment

Indexed keywords

ACETYLSALICYLIC ACID; ALCOHOL; ANESTHETIC AGENT; ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; ANXIOLYTIC AGENT; COCAINE; HEAVY METAL; INSECTICIDE; LEAD; MERCURY; METHADONE; MORPHINE; NARCOTIC AGENT; NEUROLEPTIC AGENT; NEUROTOXIN; NICOTINE; POLYCHLORINATED BIPHENYL; RETINOL; SOLVENT; STEROID; THALIDOMIDE; THYROID HORMONE;

ATTENTION DEFICIT DISORDER; AUTISM; BEHAVIOR DISORDER; BRAIN DEVELOPMENT; COGNITIVE DEFECT; DEVELOPMENTAL DISORDER; DYSLEXIA; ENVIRONMENTAL EXPOSURE; FETAL ALCOHOL SYNDROME; GROWTH RETARDATION; HUMAN; HYPERACTIVITY; MEMORY DISORDER; MENTAL DEFICIENCY; MERCURIALISM; MOTOR ACTIVITY; MOTOR PERFORMANCE; NERVE CELL DIFFERENTIATION; NERVOUS SYSTEM DEVELOPMENT; NEUROTOXICITY; NONHUMAN; OCCUPATIONAL EXPOSURE; PREMATURITY; PRENATAL DEVELOPMENT; REPRODUCTIVE TOXICITY; REVIEW; RISK ASSESSMENT; SENSORY DYSFUNCTION;

ANIMALS; EMBRYONIC DEVELOPMENT; FEMALE; FETAL DEVELOPMENT; GUIDELINES; HAZARDOUS SUBSTANCES; HUMANS; NERVOUS SYSTEM DISEASES; PREGNANCY; PRENATAL EXPOSURE DELAYED EFFECTS; RISK ASSESSMENT; TOXICITY TESTS;

ANIMALIA;

EID: 33745624828     PISSN: 08906238     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.reprotox.2006.04.009     Document Type: Review

References (52)

1. Kimmel C.A. Current status of behavioral teratology: science and regulation. Crit Rev Toxicol 19 (1988) 1-10
2. Jones K.L., and Smith D.W. Recognition of the fetal alcohol syndrome in early infancy. Lancet 2 (1973) 999-1001
3. Burbacher T.M., Rodier P.M., and Weiss B. Methylmercury developmental neurotoxicity: a comparison of effects in humans and animals. Neurotoxicol Teratol 12 (1990) 191-202
4. Adams J., Voorhees C.V., and Middaugh L.D. Developmental neurotoxicity of anticonvulsants: humans and animal evidence on phenytoin. Neurotoxicol Teratol 12 (1990) 203-214
5. Tilson H.A., Jacobson J.L., and Rogan W.J. Polychlorinated biphenyls and the developing nervous system: cross-species comparisons. Neurotoxicol Teratol 12 (1990) 239-248
6. Davis J.M., Otto D.A., Weil D.E., and Grant L.D. The comparative developmental neurotoxicity of lead in humans and animals. Neurotoxicol Teratol 12 (1990) 215-230
7. Nelson B.K. Evidence for behavioral teratogenicity in humans. Appl Toxicol 11 (1991) 33-37
8. Roeleveld N., Zielhuis G.A., and Gabreëls F. Occupational exposure and defects of the central nervous system in offspring: a review. Br J Ind Med 47 (1990) 580-588
9. Kimmel C.A., and Gaylor W.G. Issues in qualitative and quantitative risk analysis for developmental toxicology. Risk Anal 8 (1988) 15-20
10. Francis E.Z., Kimmel C.A., and Rees D.C. Workshop on the qualitative and quantitative comparability of human and animal developmental neurotoxicity: summary and implications. Neurotoxicol Teratol 12 (1990) 285-292
11. National Academy of Sciences. Research on children and adolescents with mental, behavioral, and developmental disorders (1988), National Academy Press, Washington, DC
12. USEPA. Developmental Neurotoxicity Study. Series 83-6, Addendum 10 (Neurotoxicity), Subdivision F: Hazard Evaluation: Human and Domestic Animals. EPA Publication No. 540/09-91-123; NTIS Publication No. PB 91-154617. Washington: DC; 1991.
13. USEPA. Health Effects Test Guidelines. OPPTS 870.6300, Developmental Neurotoxicity Study, EPA 712-C-98-239, Washington: DC; 1998. Available at: http://www.epa.gov/opptsfrs/home/guidelin.htm.
14. OECD Guideline for the testing of chemicals. Proposal for a new guideline 426 Developmental Neurotoxicity Study. Draft document, October 1999.
15. Buxbaum L., Boyle C., Yeargin-Allsopp M., Murphy C.C., and Roberts H.E. Etiology of mental retardation among children ages 3-10: the metropolitan Atlanta developmental disabilities surveillance program (2000), Centers for Disease Control and Prevention, Atlanta, GA
16. Kiely M. The prevalence of mental retardation. Epidemiol Rev 9 (1987) 194-208
17. Siegel E. Hjerneskadede børn (1971), Hans Reitzel, København p. 18-20
18. Kruuse E. Skoleforløbet for børn med lav fødselvægt (1984), Dansk psykologisk forlag, København p. 7-24
19. Møller M. Indlæringsvanskeligheder hos børn (1976), Gjellerup, København p. 32-6
20. Lipkin P.H. Epidemiology of the developmental disabilities. In: Capute A.J., and Accardo P.J. (Eds). Developmental disabilities in infancy and childhood (1996), Paul H. Brookes Publishing Co.
21. Lederer R., Elsner J., and Zbinden G. Animal models in behavioural toxicology and teratology. Arch Toxicol 14 (1991) 15-24
22. Nelson B.K. Evidence for behavioral teratogenicity in humans. Appl Toxicol 11 (1991) 33-37
23. The National Academy of Sciences. Scientific frontiers in developmental toxicity and risk assessment (2000), National Academy Press, Washington, DC
24. Burbacher T.M., Rodier P.M., and Weiss B. Methylmercury developmental neurotoxicity: a comparison of effects in humans and animals. Neurotoxicol Teratol 12 (1990) 191-202
25. Projuan B.J. Research highlight. Tox-tips 135 (1987) 5-6
26. Andreasen PB, Brandt NJ, Cohr K-H, Hansen EV, Hass U, Hauge M, et al. Embryo-fetal damage and chemical substances. Working party report. Copenhagen:Levnedsmiddelsyrelsen; 1989. p. 1-127.
27. Zoeller R.T., and Crofton K.M. Mode of action: developmental thyroid hormone insufficiency-neurological abnormalities resulting from exposure to propylthiouracil. Crit Rev Toxicol 35 (2005) 771-781
28. Grimm V.E. Effects of teratogenic exposure on the developing brain: research strategies and possible mechanisms. Dev Pharmacol Ther 10 (1987) 328-345
29. OECD Series on Testing and Assessment No. 43. Guidance document on reproductive testing and assessment. Draft February 2004.
30. Buelke-Sam J., Kimmel C.A., Adams J., Nelson C.J., Vorhees C.V., Wright D.C., et al. Collaborative behavioral teratology study: results. Neurobehav Toxicol Teratol 7 (1985) 591-624
31. Vorhees C.V. Comparison of the collaborative behavioral teratology study and Cincinnati behavioral test batteries. Neurobehav Toxicol Teratol 7 (1985) 625-633
32. Annau Z., and Cuomo V. Mechanisms of neurotoxicity and their relationship to behavioral changes. Toxicology 49 (1988) 219-225
33. MacPhail R.C., Tilson H.A., Moser V.C., Becking G.C., Cuomo V., Frantik E., et al. The IPCS collaborative study on neurobehavioral screening methods: I. Background and genesis. Neurotoxicol 18 (1997) 925-928
34. Moser V.C., Tilson H.A., MacPhail R.C., Becking G.C., Cuomo V., Frantik E., et al. The IPCS collaborative study on neurobehavioral screening methods: II. Protocol design and testing procedures. Neurotoxicology 18 (1997) 929-938
35. Catalano P.J., McDaniel K.L., and Moser V.C. The IPCS collaborative study on neurobehavioral screening methods: VI. Agreement and reliability of the data. Neurotoxicology 18 (1997) 1057-1064
36. Kimmel C.A., Rees D.C., and Francis E.Z. Qualitative and quantitative comparability of human and animal developmental neurotoxicity. Neurotoxicol Teratol 12 (1990) 173-292
37. Hutchings D.E. Issues of risk assessment: lessons from the use and abuse of drugs in pregnancy. Neurotoxicol Teratol 12 (1990) 183-189
38. Driscoll C.D., Streissguth A.P., and Riley E.P. Prenatal alcohol exposure: comparability of effects in humans and animal models. Neurotoxicol Teratol 12 (1990) 231-238
39. Schull W.L., Norton S., and Jensh R.P. Ionizing radiation and the developing brain. Neurotoxicol Teratol 12 (1990) 249-260
40. Kellogg C.K., and Guillet R. Developmental effects of neuroactive drugs. In: Scarpelli D.G., and Migaki G. (Eds). Transplacental effects on fetal health (1988), AR Liss, New York 265-277
41. Nishimura H., and Tanimura T. Clinical aspects of the teratogenicity of drugs (1976), Excerpta Medica, Amsterdam
42. Moore K.L. Before we are born: basic embryology and birth defects. 2nd ed. (1983), W.B. Saunders Company, Philadelphia p. 1-282
43. Beaudoin A.R. Embryology and teratology. In: Baker H.J., Lindsey J.R., and Weisbroth S.H. (Eds). The laboratory rat. vol. II, Research applications (1980), Academic Press, Orlando 75-101 [Chapter 4]
44. Dobbing J. Vulnerable periods of brain development. Lipids, malnutrition and the developing brain. Excerpta Medica (1972), Elsevier, Amsterdam p. 9-29
45. Makris S, Raffaele K, Sette W, Seed J. A retrospective analysis of twelve developmental neurotoxicity studies submitted to the USEPA Office of Prevention, Pesticides, and Toxic Substances (OPPTS). Presentation to the FIFRA Scientific Advisory Panel, December 8-9, 1998, US EPA, OPPTS, Washington, DC. http://www.epa.gov/scipoly/sap/1998/december/neuro.pdf.
46. Middaugh L.D., Dow-Edwards D., Li A.A., Sandler D., Seed J., Sheets L.P., et al. Neurobehavioral assessment: a survey of use and value in safety assessment studies. Toxicol Sci 76 (2003) 250-261
47. Claudio L., Kwa W.C., Russell A.L., and Wallinga D. Testing methods for developmental neurotoxicity of environmental chemicals. Toxicol Appl Pharmacol 164 (2000) 1-14
48. EEA (European Environmental Agency). Children's health and environment: a review of evidence. A joint report from European Environmental Agency and WHO Regional Office for Europe. Environmental issue report no. 29, Copenhagen; 2002.
49. EU Scientific Committee on Food (SCF). Further advice on the opinion of the Scientific Committee for Food expressed on the 19 September 1997 on a maximum residue limit (MRL) of 0.01 mg/kg for pesticides in food intended for infants and young children [adopted by SCF on 4 June 1998].
50. EU Technical Guidance Document for Risk Assessment. Section 3.12 Reproductive toxicity. Draft document; 2001.
51. Nelson B.K. Behavioral teratology of industrial solvents. In: Riley E.P., and Vorhees C.V. (Eds). Handbook of behavioral teratology (1986), Plenum Press, New York 391-406
52. Council of the European Union. Presidency Proposal concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH); December 2005.