A qualitative retrospective analysis of positive control data in developmental neurotoxicity studies

Neurotoxicology and Teratology

Volumn 26, Issue 3, 2004, Pages 345-352

  Crofton, K M ^a   Makris, S L ^b   Sette, W F ^b   Mendez, E ^b   Raffaele, K C ^b  

^a U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

^b U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

Author keywords

Developmental neurotoxicity; Positive control data; Startle response

Indexed keywords

ANIMAL EXPERIMENT; BRAIN REGION; CLINICAL OBSERVATION; CONTROL GROUP; DATA ANALYSIS; FEMALE; GENDER; INDUSTRIAL AREA; INFORMATION; LABORATORY; LEARNING; MALE; MEMORY; MORPHOMETRICS; MOTOR ACTIVITY; NERVE CELL DIFFERENTIATION; NEUROPATHOLOGY; NEUROTOXICITY; NONHUMAN; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; QUALITY CONTROL; RAT; REVIEW; STARTLE REFLEX; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE;

ANIMALS; ENDPOINT DETERMINATION; EVALUATION STUDIES; FEMALE; HUMANS; MALE; NERVOUS SYSTEM DISEASES; PREGNANCY; PRENATAL EXPOSURE DELAYED EFFECTS; QUALITY CONTROL; REFERENCE STANDARDS; RESEARCH; RETROSPECTIVE STUDIES; RISK ASSESSMENT; SENSITIVITY AND SPECIFICITY; TOXICITY TESTS; TOXICOLOGY;

ANIMALIA;

EID: 2042441794     PISSN: 08920362     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ntt.2004.02.007     Document Type: Review

References (46)

1. A.C.P.A., Technical Comments on OP Data Call-In for Developmental Neurotoxicity Test, Letter to US EPA, American Crop Protection Association, 2001.
2. A.I.H.C., Positive Control Requirement for Neurotoxicity Testing. Letter from American Industrial Health Council to Richard Hill, Office of Prevention, Pesticides and Toxic Substances, US EPA, dated May 25, 1995.
3. Anastasi A. Pyschological Testing. 5th ed. 1982;Macmillian, New York
4. Cory-Slechta D.A., Crofton K.M., Sheets L.P., Ross J.F., Weiss B., Foran J.A. Methods to identify and characterize developmental neurotoxicity for human health risk assessment: I. Behavioral effects. Environ. Health Perspect. 109(Suppl. 1):2001;79-92
5. Crofton K.M., Howard J.L., Moser V.C., Gill M.W., Reiter L.W., Tilson H.A., MacPhail R.C. Interlaboratory comparison of motor activity experiments: implications for neurotoxicological assessments. Neurotoxicol. Teratol. 13:1991;599-609
6. Crofton K.M., Padilla S., Tilson H.A., Anthony D.C., Raymer J.H., MacPhail R.C. The impact of dose rate on the neurotoxicity of acrylamide: the interaction of administered dose, target tissue concentrations, tissue damage, and functional effects. Toxicol. Appl. Pharmacol. 139:1996;163-176
7. Davis M. Neurochemical modulation of sensory-motor reactivity: acoustic and tactile startle reflexes. Neurosci. Biobehav. Rev. 4:1980;241-263
8. De-Mello N., Carobrez A.P. Elevated T-maze as an animal model of memory: effects of scopolamine. Behav. Pharmacol. 13(2):2002 (Mar.);139-148
9. Erinoff L. General considerations in assessing neurotoxicity using neuroanatomical methods. Neurochem. Int. 26:1995;111-114
10. Geyer M.A., Petersen L.R., Rose G.J., Horwitt D.D., Light R.K., Adams L.M., Zook J.A., Hawkins R.L., Mandell A.J. The effects of lysergic acid diethylamide and mescaline-derived hallucinogens on sensory-integrative function: tactile startle. J. Pharmacol. Exp. Ther. 207:1978;837-847
11. Hamm C.W., Ali J.S., Herr D.W. A system for simultaneous multiple subject, multiple stimulus modality, and multiple channel collection and analysis of sensory evoked potentials. J. Neurosci. Methods. 102(2):2000 (Oct. 30);95-108
12. Henck J.W., Frahm D.T., Anderson J.A. Validation of automated behavioral test systems. Neurotoxicol. Teratol. 18:1996;189-197
13. Hiramatsu M., Hoshino T., Kameyama T., Nabeshima T. Involvement of kappa-opioid and sigma receptors in short-term memory in mice. Eur. J. Pharmacol. 453(1):2002 (Oct. 18);91-98
14. Hood R.D. Developmental Toxicology: Risk Assessment and the Future. 1989;16-18 Van Nostrand, New York
15. Ison J.R., Bowen G.P. Scopolamine reduces sensitivity to auditory gaps in the rat, suggesting a cholinergic contribution to temporal acuity. Hear. Res. 145:2000;169-176
16. Jones C.K., Shannon H.E. Muscarinic cholinergic modulation of prepulse inhibition of the acoustic startle reflex. J. Pharmacol. Exp. Ther. 294:2000;1017-1023
17. Kimmel C.A. Current status of behavioral teratology: science and regulation. CRC Crit. Rev. Toxicol. 19:1988;1-10
18. Kimmel C.A., Buelke-Sam J. Collaborative behavioral teratology study: background and overview. Neurobehav. Toxicol Teratol. 7:1985;541-545
19. Kimmel C.A., Makris S.L. Recent developments in regulatory requirements for developmental toxicology. Toxicol. Lett. 120:2001;73-82
20. Kimmel C.A., Rees D.C., Francis E.Z. Qualitative and quantitative comparability of human and animal developmental neurotoxicity. Neurotoxicol. Teratol. 12:1993;175-192
21. Lewis E.M., Barnett J.F. Jr., Freshwater L., Hoberman A.M., Christian M.S. Sexual maturation data for Crl Sprague-Dawley rats: criteria and confounding factors. Drug Chem. Toxicol. (4):2002 (Nov. 25);437-458
22. MacPhail R.C., Tilson H.A. Behavioral screening tests: past, present and future. Chang L., Slikker W. Neurotoxicology: Approaches and Methods. 1995;231-238 Academic Press, New York
23. MacPhail R.C., Peele D.B., Crofton K.M. Motor activity and screening for neurotoxicity. J. Amer. Coll. Toxicol. 8:1989;117-125
24. Manson J.M., Zenick H., Costlow R.D. Teratology test methods for laboratory animals. Hayes W.A. Principles and Methods of Toxicology. 1982;141-184 Raven Press, New York
25. Mendola P., Selevan S.G., Gutter S., Rice D. Environmental factors associated with a spectrum of neurodevelopmental deficits. Ment. Retard. Dev. Disabil. Res. Rev. 8(3):2002;188-197
26. Moore M.M., Collard D.D., Harrington-Brock K. Failure to adequately use positive control data leads to poor quality mouse lymphoma data assessments. Mutagenesis. 14:1999;261-263
27. Moser V.C. The functional observational battery in adult and developing rats. Neurotoxicology. 21:2000;989-996
28. Moser V.C., Becking G.C., Cuomo V., Frantik E., Kulig B.M., MacPhail R.C., Tilson H.A., Winneke G., Brightwell W.S., Cagiano R., Gill M.W., Haggerty G.C., Hornychova M., Lammers J., Larsen J.J., McDaniel K.L., Nelson B.K., Ostegaard G. The IPCS collaborative study on neurobehavioral screening methods: III. Results of proficiency studies. Steering group. Neurotoxicology. 18:1997;939-946
29. Moser V.C., Becking G.C., Cuomo V., Frantik E., Kulig B.M., MacPhail R.C., Tilson H.A., Winneke G., Brightwell W.S., De Salvia M.A., Gill M.W., Haggerty G.C., Hornychova M., Lammers J., Larsen J.J., McDaniel K.L., Nelson B.K., Ostergaard G. The IPCS collaborative study on neurobehavioral screening methods: IV. Control data. Steering group. Neurotoxicology. 18(4):1997;947-967
30. Moser V.C., Becking G.C., Cuomo V., Frantik E., Kulig B.M., MacPhail R.C., Tilson H.A., Winneke G., Brightwell W.S., De Salvia M.A., Gill M.W., Haggerty G.C., Hornychova M., Lammers J., Larsen J.J., McDaniel K.L., Nelson B.K., Ostergaard G. The IPCS collaborative study on neurobehavioral screening methods: V. Results of chemical testing. Neurotoxicology. 18(4):1997;969-1055
31. NRC, Pesticides in the Diets of Infants and Children. National Research Council, National Academy Press, Washington, DC, 1993.
32. OECD, OECD Guideline for the Testing of Chemicals: Proposal for a New Guideline 426 Draft Document - Developmental Neurotoxicity Study. Organization of Economic Cooperation and Development, 2003.
33. Peele D.B., Baron S.P. Effects of selection delays on radial maze performance: acquisition and effects of scopolamine. Pharmacol. Biochem. Behav. 29(1):1988 (Jan.);143-150
34. Sette W.F. Complexities of neurotoxicological assessments. Neurotox. Teratol. 9:1987;411-416
35. Sipos M.L., Burchnell V., Galbicka G. Effects of selected anticholinergics on acoustic startle response in rats. J. Appl. Toxicol. 21(1):2001;S95-S101
36. Spencer P.S., Schaumburg H.H. A review of acrylamide neurotoxicity: Part II. Experimental animal neurotoxicity and pathologic mechanisms. Can. J. Neurol. Sci. 1:1974;152-169
37. Stanhope K.J., Mirza N.R., Bickerdike M.J., Bright J.L., Harrington N.R., Hesselink M.B., Kennett G.A., Lightowler S., Sheardown M.J., Syed R., Upton R.L., Wadsworth G., Weiss S.M., Wyatt A. The muscarinic receptor agonist xanomeline has an antipsychotic-like profile in the rat. J. Pharmacol. Exp. Ther. 299(2):2001;782-792
38. Stein J., Schettler T., Wallinga D., Valenti M. In harm's way: toxic threats to child development. Dev. Behav. Pediatr. 23:2002;S13-S22
39. Tilson H.A. The neurotoxicity of acrylamide: an overview. Neurobehav. Toxicol. Teratol. 3:1981;445-461
40. Tilson H.A. Developmental neurotoxicology of endocrine disruptors and pesticides: identification of information gaps and research needs. Environ. Health Perspect. 106:1998;807-811
41. U.S. EPA Triethylene glycol monomethyl, monoethyl and monobutyl ethers: proposed test rule. Fed. Reg. 51(94):1986;17883-17894
42. U.S. EPA Revised Neurotoxicity Test Guidelines for Pesticides. 1991;National Technical Information Service, Washington, DC
43. U.S. EPA, U.S. Environmental Protection Agency Health Effects Test Guidelines. OPPTS 870.6300. Developmental Neurotoxicity Study. EPA Document 712-C-98-239, U.S. Environmental Protection Agency, Washington, DC, 1998.
44. U.S. EPA, Generic Non-OP Protocol Review Format (10/21/02). Unpublished document used as template for DNT Study Reviews. Health Effects Division, Office of Pesticide Programs, 2002, 7 pp.
45. Wise L.D., Gordon L.R., Soper K.A., Duchai D.M., Morrissey R.E. Developmental neurotoxicity evaluation of acrylamide in Sprague-Dawley rats. Neurotoxicol. Teratol. 17:1995;189-198
46. Zbinden G., Elsner J., Boelsterli U.A. Toxicological screening. Regul. Toxicol. Pharmacol. 4:1984;275-286