Monograph on the Potential Human Reproductive and ... - OEHHA

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developmental endpoints that may be susceptible to bisphenol A disruption, as follows: * For neural and behavioral effects, the Expert Panel has some concern; * For prostate effects, the Expert Panel has minimal concern; * For the potential effect of accelerated puberty, the Expert Panel has minimal concern; and * For birth defects and malformations, the Expert Panel has negligible concern. 2. For infants and children, the Expert Panel has the following levels of concern for biological processes that might be altered by Bisphenol A, as follows: * Some concern for neural and behavioral effects; and * Minimal concern for the effect of accelerated puberty. 3. For adults, the Expert Panel has negligible concern for adverse reproductive effects following exposures in the general population to Bisphenol A. For highly exposed subgroups, such as occupationally exposed populations, the level of concern is elevated to minimal. 5.5 Critical Data Needs 1. Neural and behavioral endpoints. A concerted effort is needed to better understand the effects of gestational and lactational exposure to bisphenol A on maternal behavior and offspring brain structure and behavior. This effort should include molecular and cellular studies to ascertain the sensitivity of the developing brain to bisphenol Ainduced structural and biochemical alterations. The association between bisphenol A and neural and behavioral endpoints should also be examined in longitudinal studies of pregnancy and child development in humans. 2. Human exposure assessment. Additional data are needed to clarify bisphenol A exposures and internal dosimetry in the general population, newborns, and occupationally-exposed individuals. Available data demonstrate that a large fraction of children and adults have detectable levels of bisphenol A metabolites in their urine. What are needed are duplicate diet studies to identify in detail the sources and routes of exposure of bisphenol A. For example, while research suggests diet is the major source of BPA for U.S. infants and young children, the detailed analysis of BPA levels has primarily focused on polycarbonate baby bottle leachates and canned food. The contributions of non-canned food and drinking water routes of exposure for U.S. youth and adults not occupationally-exposed to BPA remain unknown and in need of further study. Levels of BPA in residential drinking water wells and community water sources have not been systematically studied. Also unknown is the impact of landfill leachates on levels of bisphenol A in U.S. drinking well waters and whether chlorinated congeners of bisphenol A are found in Birth Defects Research (Part B) 83:157–395, 2008 BISPHENOL A 383 U.S. municipal water supplies. Finally, more measurement are needed of free and total bisphenol A, its glucuronide conjugate, and other metabolite concentrations from maternal, fetal, and neonatal tissues or fluids (i.e., placenta, amniotic fluid, breast milk, urine, serum). These data would provide insight into the roles of metabolism and exposure route on internal dose. 3. Human studies relating adult exposure to reproduction and development, including effects on hormone levels. 4. Physiologically-based pharmacokinetic (PBPK) models. PBPK models are needed to facilitate the interpretation and applicability of animal studies, including rodents and nonhuman primates, for human risk assessment. 5. Effects on prostate and mammary gland development. Additional data are needed to understand the susceptibility to disruption of prostate and mammary gland development in humans and animals by bisphenol A exposure. Laboratory animal studies should initially focus on the oral route of exposure and should be informed by any new knowledge about human exposure and human internal dosimetry. A particular data need is an improved understanding of the biology of PIN (prostatic intraepithelial neoplasia) in animal models and its relationship to prostate cancer. Similarly, bisphenol A-induced alterations in mammary gland development and their potential relationship to mammary cancer should be investigated across a broad range of internal concentrations and external doses. 6. Altered puberty. The robustness and biologic basis for altered puberty following bisphenol A exposure should be evaluated in mouse, rat, and gerbil. In laboratory animals, this evaluation should be performed following combined gestational and lactational exposure, and following pubertal exposure alone, and should include an assessment of any changes in hormonal responsivity at later ages, and all related to internal and tissue concentrations of bisphenol A. In addition, longitudinal cohort studies examining the potential modulation by bisphenol A of the onset, progression, and control of puberty in humans should be performed. 7. Biological mechanism for low-dose-only effects. Most useful would be data that provided a biologicallyplausible explanation for effects that appear at low doses but not higher doses. This might involve the membrane-bound estrogen receptor and its possible activation by bisphenol A. 8. More work directed toward urinary tract morphological and histologic changes after developmental exposure would be helpful to determine the robustness and relevance of the limited report of these effects in one study. 9. Inter-laboratory replication of studies. Inter-laboratory replication of critical findings is a sine qua non for enhancing confidence in experimental results. Such studies should be supported by funding agencies, and should be facilitated by the open sharing of experimental details and approaches. The future reproducibility should also be considered by investigators as they design their studies.
384 CHAPIN ET AL. 10. Critical design components for all future research on BPA: a. Appropriate experimental design and statistical analysis, especially accounting for litter effects; b. Appropriate route (oral) of exposure. Studies with non-oral route of administration should include internal dose measurements of free BPA; c. Multiple dose groups ranging from low to high; d. Linkage of effects to adverse effects; and e. Relevant endpoints, with biologically plausible outcomes especially for estrogen-mediated effects on reproduction and behavior. REFERENCES Ackermann GE, Brombacher E, Fent K. 2002. Development of a fish reporter gene system for the assessment of estrogenic compounds and sewage treatment plant effluents. Environ Toxicol Chem 21:1864–1875. Adachi T, Yasuda K, Mori C, Yoshinaga M, Aoki N, Tsujimoto G, Tsuda K. 2005. Promoting insulin secretion in pancreatic islets by means of bisphenol A and nonylphenol via intracellular estrogen receptors. Food Chem Toxicol 43:713–719. Adriani W, Seta DD, Dessi-Fulgheri F, Farabollini F, Laviola G. 2003. Altered profiles of spontaneous novelty seeking, impulsive behavior, and response to D-amphetamine in rats perinatally exposed to bisphenol A. Environ Health Perspect 111:395–401. Adriani W, Seta DD, Dessi-Fulgheri F, Farabollini F, Laviola G. 2005. Erratum for Adriani et al. [Environ Health Perspect 111:395–401]. Environ Health Perspect 113:A368. Aikawa H, Koyama S, Matsuda M, Nakahashi K, Akazome Y, Mori T. 2004. Relief effect of vitamin A on the decreased motility of sperm and the increased incidence of malformed sperm in mice exposed neonatally to bisphenol A. Cell Tissue Res 315: 119–124. Akingbemi BT, Sottas CM, Koulova AI, Klinefelter GR, Hardy MP. 2004. Inhibition of testicular steroidogenesis by the xenoestrogen bisphenol A is associated with reduced pituitary luteinizing hormone secretion and decreased steroidogenic enzyme gene expression in rat Leydig cells. Endocrinology 145:592–603. Al-Hiyasat AS, Darmani H, Elbetieha AM. 2002. Effects of bisphenol A on adult male mouse fertility. Eur J Oral Sci 110:163–167. [Erratum: Eur J Oral Sci 2003;2111:2547]. Al-Hiyasat AS, Darmani H, Elbetieha AM. 2004. Leached components from dental composites and their effects on fertility of female mice. Eur J Oral Sci 112:267–272. Aloisi AM, Della Seta D, Rendo C, Ceccarelli I, Scaramuzzino A, Farabollini F. 2002. Exposure to the estrogenic pollutant bisphenol A affects pain behavior induced by subcutaneous formalin injection in male and female rats. Brain Res 937:1–7. Alonso-Magdalena P, Laribi O, Ropero AB, Fuentes E, Ripoll C, Soria B, Nadal A. 2005. Low doses of bisphenol A and diethylstilbestrol impair Ca21 signals in pancreatic alpha-cells through a nonclassical membrane estrogen receptor within intact islets of Langerhans. Environ Health Perspect 113:969–977. Alonso-Magdalena P, Morimoto S, Ripoll C, Fuentes E, Nadal A. 2006. The estrogenic effect of bisphenol A disrupts pancreatic beta-cell function in vivo and induces insulin resistance. Environ Health Perspect 114:106–112. American Dental Association. 1998. ADA positions and statements: estrogenic effects of bisphenol A lacking in dental sealants. Available at http://www.ada.org/prof/resources/positions/statements/ seal_est.aspx3. American Industrial Hygiene Association. 2004. AIHA WEEL meeting minutes. An BS, Choi KC, Kang SK, Hwang WS, Jeung EB. 2003. Novel calbindin D(9k) protein as a useful biomarker for environmental estrogenic compounds in the uterus of immature rats. Reprod Toxicol 17: 311–319. An BS, Kang SK, Shin JH, Jeung EB. 2002. Stimulation of calbindin-D(9k) mRNA expression in the rat uterus by octyl-phenol, nonylphenol and bisphenol. Mol Cell Endocrinol 191:177–186. Anahara R, Yoshida M, Toyama Y, Maekawa M, Kai M, Ishino F, Toshimori K, Mori C. 2006. Estrogen agonists, 17beta-estradiol, bisphenol A, and diethylstilbestrol, decrease cortactin expression in the mouse testis. Arch Histol Cytol 69:101–107. Andersen HR, Andersson AM, Arnold SF, Autrup H, Barfoed M, Beresford NA, Bjerregaard P, Christiansen LB, Gissel B, Hummel R, Jorgensen EB, Korsgaard B, Le Guevel R, Leffers H, McLachlan J, Moller A, Nielsen JB, Olea N, Oles-Karasko A, Pakdel F, Pedersen KL, Perez P, Skakkeboek NE, Sonnenschein C, Soto AM, et al. 1999a. Comparison of short-term estrogenicity tests for identification of hormone-disrupting chemicals. Environ Health Perspect 107(Suppl):89–108. Andersen HR, Halling-Sorensen B, Kusk KO. 1999b. A parameter for detecting estrogenic exposure in the copepod Acartia tonsa. Ecotoxicol Environ Saf 44:56–61. Arakawa C, Fujimaki K, Yoshinaga J, Imai H, Serizawa S, Shiraishi H. 2004. Daily urinary excretion of bisphenol A. Environ Health Prevent Med 9:22–26. Arenholt-Bindslev D, Breinholt V, Preiss A, Schmalz G. 1999. Time-related bisphenol A content and estrogenic activity in saliva samples collected in relation to placement of fissure sealants. Clin Oral Invest 3:120–125. Ashby J. 2002. Scientific issues associated with the validation of in vitro and in vivo methods for assessing endocrine disrupting chemicals. Toxicology 181–182:389–397. Ashby J, Tinwell H, Lefevre PA, Joiner R, Haseman J. 2003. The effect on sperm production in adult Sprague-Dawley rats exposed by gavage to bisphenol A between postnatal days 91–97. Toxicol Sci 74:129–138. Ashby J, Odum J. 2004. Gene expression changes in the immature rat uterus: effects of uterotrophic and sub-uterotrophic doses of bisphenol A. Toxicol Sci 82:458–467. Ashby J, Odum J, Paton D, Lefevre PA, Beresford N, Sumpter JP. 2000. Reevaluation of the first synthetic estrogen, 1-keto-1,2,3,4-tetrahydrophenanthrene, and bisphenol A, using both the ovariectomised rat model used in 1933 and additional assays. Toxicol Lett 115:231–238. Ashby J, Tinwell H. 1998. Uterotrophic activity of bisphenol A in the immature rat. Environ Health Perspect 106:719–720. Ashby J, Tinwell H, Haseman J. 1999. Lack of effects for low dose levels of bisphenol A and diethylstilbestrol on the prostate gland of CF1 mice exposed in utero. Regul Toxicol Pharmacol 30:156–166. Ashby J, Tinwell H, Odum J, Lefevre P. 2004. Natural variability and the influence of concurrent control values on the detection and interpretation of low-dose or weak endocrine toxicities. Environ Health Perspect 112:847–853. Atanassova N, McKinnell C, Turner KJ, Walker M, Fisher JS, Morley M, Millar MR, Groome NP, Sharpe RM. 2000. Comparative effects of neonatal exposure of male rats to potent and weak (environmental) estrogens on spermatogenesis at puberty and the relationship to adult testis size and fertility: evidence for stimulatory effects of low estrogen levels. Endocrinology 141:3898–3907. Atkinson A, Roy D. 1995a. In vitro conversion of environmental estrogenic chemical bisphenol A to DNA binding metabolite(s). Biochem Biophys Res Commun 210:424–433. Atkinson A, Roy D. 1995b. In vivo DNA adduct formation by bisphenol A. Environ Mol Mutagen 26:60–66. Belfroid A, van Velzen M, van der Horst B, Vethaak D. 2002. Occurrence of bisphenol A in surface water and uptake in fish: evaluation of field measurements. Chemosphere 49:97–103. Beresford N, Routledge EJ, Sumpter JP. 2000. Issues arising when interpreting results from an in vitro assay for estrogenic activity. Toxicol Appl Pharmacol 162:22–33. Berg C, Halldin K, Brunstrom B. 2001. Effects of bisphenol A and tetrabromobisphenol A on sex organ development in quail and chicken embryos. Environ Toxicol Chem 20:2836–2840. Berger RG, Hancock T, Decatanzaro D. 2007. Influence of oral and subcutaneous bisphenol-A on intrauterine implantation of fertilized ova in inseminated female mice. Reprod Toxicol 23: 138–144. Bergeron RM, Thompson TB, Leonard LS, Pluta L, Gaido KW. 1999. Estrogenicity of bisphenol A in a human endometrial carcinoma cell line. Mol Cell Endocrinol 150:179–187. Berkowitz G. 2006. Limitations of a case-control study on bisphenol A (BPA) serum levels and recurrent miscarriage. Hum Reprod 21:565– 566. Biles JE, McNeal TP, Begley TH. 1997a. Determination of bisphenol A migrating from epoxy can coatings to infant formula liquid concentrates. J Agric Food Chem 45:4697–4700. Biles JE, McNeal TP, Begley TH, Hollifield HC. 1997b. Determination of bisphenol A in reusable polycarbonate food-contact plastics and migration to food-stimulating liquids. J Agric Food Chem 45: 3541–3544. Blair RM, Fang H, Branham WS, Hass BS, Dial SL, Moland CL, Tong W, Shi L, Perkins R, Sheehan DM. 2000. The estrogen receptor relative binding affinities of 188 natural and xenochemicals: structural diversity of ligands. Toxicol Sci 54:138–153. Bolger R, Wiese TE, Ervin K, Nestich S, Checovich W. 1998. Rapid screening of environmental chemicals for estrogen receptor binding capacity. Environ Health Perspect 106:551–557. Bolognesi C, Perrone E, Roggieri P, Pampanin DM, Sciutto A. 2006. Assessment of micronuclei induction in peripheral erythrocytes of Birth Defects Research (Part B) 83:157–395, 2008
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National Toxicology Program U.S. De
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National Toxicology Program U.S. De
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nTp brief tainers.with.internal.epo
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Population Adult General. Populatio
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Table 3. Blood and Breast Milk Biom
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Figure 2b. The weight of evidence t
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in.considering.the.biological.plaus
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isphenol.A.as.efficiently.as.adult.
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isphenol.A..For.example,.this.raise
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laboRaToRy aNImal STudIeS In.contra
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death.(168),.synaptic.plasticity.(1
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concentrations.from.maternal,.fetal
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droxylase.immunoreactivity..76:423.
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solid.phase.extraction-high.perform
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appendix i. nTp-Cerhr bisphenol a e
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158 CHAPIN ET AL. the CERHR Core Co
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160 CHAPIN ET AL. referred to as 4,
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162 CHAPIN ET AL. concentrations in
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164 CHAPIN ET AL. Food (no. sampled
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166 CHAPIN ET AL. Table 6 Continued
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168 CHAPIN ET AL. comparison of the
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170 CHAPIN ET AL. Table 8 Urinary C
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172 CHAPIN ET AL. the blood of male
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174 CHAPIN ET AL. Table 11 Bispheno
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176 CHAPIN ET AL. Table 13 Summarie
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178 CHAPIN ET AL. Table 15 Estimate
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180 CHAPIN ET AL. Table 17 Maximum
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182 CHAPIN ET AL. 2.0 GENERAL TOXIC
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184 CHAPIN ET AL. fetuses (3.572.7
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186 CHAPIN ET AL. Secondary sources
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188 CHAPIN ET AL. Table 25 Maternal
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190 CHAPIN ET AL. Table 27 Bispheno
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192 CHAPIN ET AL. Table 31 Qualitat
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194 CHAPIN ET AL. Table 33 Toxicoki
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198 CHAPIN ET AL. appeared to occur
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200 CHAPIN ET AL. Table 43 Biliary
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202 CHAPIN ET AL. suggesting that 4
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204 CHAPIN ET AL. low following ora
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206 CHAPIN ET AL. scaling and speci
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208 CHAPIN ET AL. 60-100% in each d
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210 CHAPIN ET AL. related. No histo
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212 CHAPIN ET AL. Table 52 Continue
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214 CHAPIN ET AL. Model and exposur
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216 CHAPIN ET AL. Model and exposur
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218 Model and exposure Husbandry a
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220 CHAPIN ET AL. Table 54 Differen
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222 CHAPIN ET AL. Table 56 Anti-And
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224 Table 57 In Vitro Genetic Toxic
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226 CHAPIN ET AL. Table 58 In Vivo
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228 CHAPIN ET AL. Table 59 Developm
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232 CHAPIN ET AL. Table 64 Tissue R
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236 CHAPIN ET AL. treatment conditi
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238 CHAPIN ET AL. clinical signs, b
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240 CHAPIN ET AL. Table 71 Benchmar
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242 CHAPIN ET AL. group, 5 from 1 l
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244 CHAPIN ET AL. least significant
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246 CHAPIN ET AL. group was a reduc
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248 CHAPIN ET AL. 100-151 g for fem
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250 CHAPIN ET AL. 3.2.3.2 Developme
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252 CHAPIN ET AL. weights, bispheno
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254 CHAPIN ET AL. 120 mg/kg bw/day
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256 CHAPIN ET AL. comparisons condu
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258 CHAPIN ET AL. the findings of t
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260 CHAPIN ET AL. analyzed.] Anogen
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262 CHAPIN ET AL. purposeful confou
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264 CHAPIN ET AL. increased lordosi
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266 CHAPIN ET AL. that there was a
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268 CHAPIN ET AL. duration of adver
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270 CHAPIN ET AL. doses of potent e
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272 CHAPIN ET AL. Table 74 Effects
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274 CHAPIN ET AL. reproductive orga
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276 CHAPIN ET AL. tyrosine-hydroxly
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278 CHAPIN ET AL. include small sam
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280 CHAPIN ET AL. males/group. [It
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282 CHAPIN ET AL. termination, whic
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284 CHAPIN ET AL. provided a reliab
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286 CHAPIN ET AL. grooming, and out
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288 CHAPIN ET AL. method of oral do
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290 CHAPIN ET AL. reared by their d
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292 CHAPIN ET AL. has been informed
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294 CHAPIN ET AL. buffered paraform
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296 CHAPIN ET AL. unit. Further, th
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298 CHAPIN ET AL. PND 21 and housed
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300 CHAPIN ET AL. Tando et al. (200
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302 CHAPIN ET AL. Purina Certified
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304 CHAPIN ET AL. high-doses of bis
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306 CHAPIN ET AL. born to those dam
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308 CHAPIN ET AL. average weight we
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310 CHAPIN ET AL. study authors con
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312 CHAPIN ET AL. used for extracti
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314 CHAPIN ET AL. jar, and there we
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316 CHAPIN ET AL. of testes and com
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318 CHAPIN ET AL. differentiation o
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320 CHAPIN ET AL. Table 81 Summary
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322 CHAPIN ET AL. Table 82 Continue
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328 CHAPIN ET AL. 600 mg/kg bw/day)
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330 CHAPIN ET AL. (Nagao et al., 19
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