SEXUAL MATURATION DATA FOR CRL SPRAGUE-DAWLEY RATS: CRITERIA AND CONFOUNDING FACTORS

REFERENCES

• Christian M.S., Hoberman A.M. Perspectives on the US, EEC, and Japanese Developmental Toxicity Testing Guidelines. Handbook of Developmental Toxicology, R.D. Hood. CRL Press Inc., New York 1997; 551–595
   Google Scholar
• Steinberger E., Lloyd J.A. Chemicals Affecting the Development of Reproductive Capacity. Reproductive Toxicology: Target Organ Toxicology Series, R.L. Dixon. Raven Press, New York 1985; 1–20
   Google Scholar
• Goldman J.M., Laws S.C., Balchak S.K., Cooper R.L., Kavlock R.J. Endocrine-Disrupting Chemicals: Prepubertal Exposures and Effects on Sexual Maturation and Thyroid Function in the Female Rat. A Focus on the EDSTAC Recommendations. Crit. Rev. Toxicol. 2000; 30: 135–196
   PubMed Web of Science ®Google Scholar
• Stocker T.E., Parks L.G., Gray E., Cooper R.L. Endocrine-Disrupting Chemicals: Prepubertal Exposures and Effects on Sexual Maturation and Thyroid Function in the Male Rat. A Focus on the EDSTAC Recommendations. Crit. Rev. Toxicol. 2000; 30: 197–252
   PubMed Web of Science ®Google Scholar
• U.S. Environmental Protection Agency (US EPA). 1998a. Health Effects Test Guidelines; Developmental Neurotoxicity Study. Office of Prevention, Pesticides and Toxic Substances (OPPTS) 870.6300, August 1998
   Google Scholar
• U.S. Environmental Protection Agency (US EPA). 1998b. Health Effects Test Guideline; Reproduction and Fertility Effects. Office of Prevention, Pesticides and Toxic Substances (OPPTS) 870.3800, August 1998
   Google Scholar
• U.S. Food and Drug Administration (US FDA). International Conference on Harmonisation; Guideline on Detection of Toxicity to Reproduction for Medicinal Products. Federal Register, September 22, 1994, Vol. 59, No. 183
   Google Scholar
• Research Triangle Institute. Draft Protocol: “One-generation Extension Study of Vinclozolin and di-n-butyl Phthalate Administered by Gavage on Gestational Day 6 to Postnatal Day 21 in CD® (Sprague-Dawley) rats.” Study No. RTA-ED01. Research Triangle Institute, Research Triangle Park, NC, for the US EPA, 2001
   Google Scholar
• Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC). 1998a. Male 20-Day Thyroid/Pubertal Assay in Rodents. In: EDSTAC Final Report 1, 5–30
   Google Scholar
• Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC). 1998b. Female 20-Day Thyroid/Pubertal Assay in Rodents. In: EDSTAC Final Report 1, 5–26
   Google Scholar
• Staples R.E., Haseman J.K. Selection of Appropriate Experimental Units in Teratology. Teratology 1974; 9: 259–260
   PubMedGoogle Scholar
• Haseman J.K., Hogan M.D. Selection of the Experimental Unit in Teratology Studies. Teratology 1975; 12: 165–171
   PubMedGoogle Scholar
• Piegorsch W.W., Haseman J.K. Statistical Methods for Analyzing Developmental Toxicity Data. Teratog. Carcinog. Mutagen. 1991; 11: 115–133
   PubMedGoogle Scholar
• Christian M.S., Hoberman A.M., Bachman S., Hellwig J. Variability in the Uterotrophic Response Assay (an in vivo estrogenic response assay) in Untreated Control and Positive Control (DES-DP, 2.5 µg/kg, BID) Wistar and Sprague-Dawley Rats. Drug Chem. Toxicol. 1998; 21: 51–100
   Web of Science ®Google Scholar
• Janszen D.B., Elswick B.A., Welsch F. The Effect of Sampling Design on the Outcome of Endocrine, Reproductive and Developmental Toxicity Studies. The Toxicologist 2000; 54: 256A
   Google Scholar
• Ulbrich B. Litter Variability in Behavioral Testing: Is Testing of One Animal Per Litter Enough? Reprod. Toxicol. 2001; 15: 450–451A
   Google Scholar
• U.S. Food and Drug Administration (US FDA). Good Laboratory Practice Regulations; Final Rule. 21 CFR Part 58
   Google Scholar
• Japanese Ministry of Health and Welfare (JMHW). Good Laboratory Practice Standard for Safety Studies on Drugs, MHW, Ordinance Number 21, 1997
   Google Scholar
• Organization for Economic Co-operation and Development. The Revised OECD Principles of Good Laboratory Practices [C(97)186/Final], 1998
   Google Scholar
• U.S. Environmental Protection Agency (US EPA). Federal Insecticide, Fungicide and Rodenticide Act (FIFRA); Good Laboratory Practice Standards; Final Rule. 40 CFR Part 160, 1998c
   Google Scholar
• U.S. Environmental Protection Agency (US EPA). Toxic Substances Control Act (TSCA); Good Laboratory Practice Standards; Final Rule. 40 CFR Part 792, 1998d
   Google Scholar
• National Research Council (NRC). Guide for the Care and Use of Laboratory Animals; National Academy Press: Washington, D.C, 1996; 125
   Google Scholar
• Snedecor G.W., Cochran W.G. Analysis of Variance. Statistical Methods. Iowa State University Press, Ames 1967; 258–275
   Google Scholar
• Dunnett C.W. A Multiple Comparison Procedure for Comparing Several Treatments with a Control. Journal of the American Statistical Association 1955; 50: 1096–1129
   Web of Science ®Google Scholar
• Sheskin D.J. Handbook of Parametric and Nonparametric Statistical Procedures. CRC Press Inc., Boca Raton 1997
   Google Scholar
• Christian M.S. Problems in Developmental Toxicology Caused by Incorrect Use of Terminology. Journal of the American College of Toxicology 1993; 12: 323–328
   Google Scholar
• Barnett J.F., Jr., Lewis D., Tappen A., Hoberman A.M., Christian M.S. Reproductive Indices, Fetal Gross, Visceral and Skeletal Alterations, Sexual Maturation, Passive Avoidance and Water Maze Data, a Comparison of Results in CD(SD)IGS Rats and CD(SD) Rats. Biological Reference Data on CD(SD)IGS-2000, T. Matsuzawa, H. Inoue. CD(SD)IGS Study Group, Yokohama 2000; 159–173
   Google Scholar
• Kai S., Kohmura H. Comparison of Developmental Indices Between Crj:CD(SD)IGS Rats and Crj:CD(SD) Rats. Biological reference data on CD(SD)IGS-1999, T Matsuzawa, H Inoue. CD(SD)IGS Study Group, Yokohama 1999; 157–167
   Google Scholar
• Ohkubo Y., Furuya K., Yamada M., Akamatsu H., Moritomo A., Ishida S., Watanabe K., Hayashi Y. Reproductive and Developmental Data in Crj:CD(SD)IGS Rats. Biological Reference Data on CD(SD)IGS-1999, T. Matsuzawa, H. Inoue. CD(SD)IGS Study Group, Yokohama 1999; 153–156
   Google Scholar
• Pau M.Y., Milner J.A. Dietary Arginine and Sexual Maturation of the Female Rat. J. Nutr. 1982; 112: 1834–1842
   PubMed Web of Science ®Google Scholar
• Urbanski H.F., Ojeda S.R. Gonadal-Independent Activation of Enhanced Afternoon Luteinizing Hormone Release During Pubertal Development in the Female Rat. Endocrinology 1987; 121: 907–913
   PubMed Web of Science ®Google Scholar
• Dees W.L., Skelley C.W. Effects of Ethanol During the Onset of Female Puberty. Neuroendocrinology 1990; 51: 64–69
   PubMed Web of Science ®Google Scholar
• Junier M.P., Wolff A., Hoffman G.E., Ma Y.J., Ojeda S.R. Effect of Hypothalamic Lesions that Induce Precocious Puberty on the Morphological and Functional Maturation of the Luteinizing Hormone-Releasing Hormone Neuronal System. Endocrinology 1992; 131: 787–798
   PubMed Web of Science ®Google Scholar
• Nyberg C.L., Hiney J.K., Minks J.B., Dees W.L. Ethanol Alters N-methyl-dl-aspartic Acid-Induced Secretion of Luteinizing Hormone Releasing Hormone and the Onset of Puberty in the Female Rat. Neuroendocrinology 1993; 57: 863–868
   PubMed Web of Science ®Google Scholar
• Smyth C., Wilkinson M. A Critical Period for Glutamate Receptor-Mediated Induction of Precocious Puberty in Female Rats. J. Neuroendocrinol. 1994; 6: 275–284
   PubMed Web of Science ®Google Scholar
• Gruaz N.M., Arsenijevic Y., Wehrenberg W.B., Sizonenko P.C., Aubert M.L. Growth Hormone (GH) Deprivation Induced by Passive Immunization Against Rat GH-Releasing Factor does not Disturb the Course of Sexual Maturation and Fertility in the Female Rat. Endocrinology 1994; 135: 509–519
   PubMed Web of Science ®Google Scholar
• Pierroz D.D., Gruaz N.M., d'Alieves V., Aubert M.L. Chronic Administration of Neuropeptide Y into the Lateral Ventricle Starting at 30 Days of Life Delays Sexual Maturation in the Female Rat. Neuroendocrinology 1995; 61: 293–300
   PubMed Web of Science ®Google Scholar
• Johnston F.E., Malina R.M., Galbraith M.A., Frisch R.E., Revelle R., Cook S. Height, Weight, and Age at Menarche and the “Critical Weight” Hypothesis. Science 1971; 174: 1148–1149
   PubMed Web of Science ®Google Scholar
• Frish R.E. Pubertal Adipose Tissue: Is it Necessary for Normal Sexual Maturation. Federation Proceedings 1980; 39: 2395–2400
   PubMedGoogle Scholar
• Frish R.E. Body Fat, Puberty and Fertility. Biol. Rev. Camb. Philos. Soc. 1984; 59: 161–188
   PubMed Web of Science ®Google Scholar
• Hadley M.E. Endocrinology of Sex Differentiation and Development. Endocrinology, 4th Ed. Prentice-Hall Inc., New Jersey 1996; 370–391
   Google Scholar
• Frisch R.E. Body Fat, Menarche, Fitness and Fertility. Hum. Reprod. 1987; 2: 521–533
   PubMed Web of Science ®Google Scholar
• Frisch R.E., Wyshak G., Vincent L. Delayed Menarche and Amenorrhea in Ballet Dancers. N. Engl. J. Med. 1980; 303: 17–19
   PubMed Web of Science ®Google Scholar
• Baker E.R. Body Weight and the Initiation of Puberty. Clin. Obstret. Gynecol. 1985; 28: 573–579
   PubMed Web of Science ®Google Scholar
• Glass A.R., Anderson J., Herbert D. Sexual Maturation in Underfed Weight-Matched Rats. A Test of the “Critical Body Weight” Theory of Pubertal Timing in Males. Journal of Andrology 1987; 8: 116–122
   PubMed Web of Science ®Google Scholar
• Glass A.R., Dahms W.T., Swerdloff R.S. Body Fat at Puberty in Rats: Alteration by Changes in Diet. Pedriatr. Res. 1979; 13: 7–9
   PubMed Web of Science ®Google Scholar
• Aguilar E., Pinilla L., Guisado R., Gonzalez D., Lopez F. Relation Between Body Weight, Growth Rate, Chronological Age and Puberty in Male and Female Rats. Revista Española de Fisiologia 1984; 40: 83–86
   PubMedGoogle Scholar
• Bronson F.H. Puberty in Female Mice is not Associated with Increases in Either Body Fat or Leptin. Endocrinology 2001; 142: 4758–4761
   PubMed Web of Science ®Google Scholar
• Friedman J.M., Halaas J.L. Leptin and the Regulation of Body Weight in Mammals. Nature 1998; 395: 763–770
   PubMed Web of Science ®Google Scholar
• Chehab F., Mounzih K., Lu R., Lim M.E. Early Onset of Reproductive Function in Normal Female Mice Treated with Leptin. Science 1997; 275: 88–90
   PubMed Web of Science ®Google Scholar
• Ahima R.A., Dushay J., Flier S.N., Prabakaran D., Flier J.S. Leptin Accelerates the Timing of Puberty in Normal Female Mice. J. Clin. Invest. 1997; 99: 391–395
   PubMed Web of Science ®Google Scholar
• Clark I.J., Henry B.A. Leptin and Reproduction. Rev. Reprod. 1999; 4: 48–55
   PubMedGoogle Scholar
• Cheung C.C., Thornton J.E., Kuijper J.L., Weigle D.S., Clifton D.K., Steiner R.A. Leptin is a Metabolic Gate for the Onset of Puberty in the Female Rat. Endocrinology 1997; 138: 855–858
   PubMed Web of Science ®Google Scholar
• Dearth R.K., Hiney J.K., Dees W.L. Leptin Acts Centrally to Induce the Prepubertal Secretion of Luteinizing Hormone in the Female Rat. Peptides 2000; 21: 387–392
   PubMed Web of Science ®Google Scholar
• Cheung C.C., Thornton J.E., Nurani S.D., Clifton D.K., Steiner R.A. A Reassessment of Leptin's Role in Triggering the Onset of Puberty in the Rat and Mouse. Neuroendocrinology 2001; 74: 12–21
   PubMed Web of Science ®Google Scholar
• DeSesso J.M. Maternal Factors in Developmental Toxicity. Teratog. Carcinog. Mutagen. 1987; 7: 225–240
   PubMedGoogle Scholar
• Vorhees C.V. Maternal Age as a Factor in Determining the Reproductive and Behavioral Outcome of Rats Prenatally Exposed to Ethanol. Neurotoxicol. Teratol. 1988; 10: 23–34
   PubMed Web of Science ®Google Scholar
• Agnish N.D., Keller K.A. The Rationale for Culling of Rodent Litters. Fundam. Appl. Toxicol. 1997; 38: 2–6
   PubMedGoogle Scholar
• Palmer A.K., Ulbrich B.C. The Cult of Culling. Fundam. Appl. Toxicol. 1997; 38: 7–22
   PubMedGoogle Scholar
• Azzam S.M., Nielson M.K., Dickerson G.E. Postnatal Litter Size Effects on Growth and Reproduction in Rats. Journal of Animal Science 1984; 58: 1337–1342
   PubMed Web of Science ®Google Scholar
• Kirkpatrick B.W., Arias J.A., Rutledge J.J. Effects of Prenatal and Postnatal Fraternity Size on Long-Term Reproduction in Mice. Journal of Animal Science 1988; 66: 62–69
   PubMed Web of Science ®Google Scholar