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

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Model and exposure Husbandry a Immature Wistar, gavage x 4 days Adult ovariectomized Wistar, gavage x 4 days Immature Sprague– Dawley, s.c. x 3 days Other rat organs Ovariectomized Sprague–Dawley, daily gavage for 5 weeks Adult ovariectomized Sprague–Dawley, treated in feed Adult ovariectomized Sprague–Dawley and F344, by s.c. implant x 3 days Adult ovariectomized Wistar, s.c. x 7 days Mouse uterus Immature CFLP, s.c. x 3 days Adult ovariectomized CD-1, s.c. x 1 Juvenile-adult ovariectomized B6C3F1, s.c. x 4 days Papaconstantinou et al. (2000) Juvenile-adult ovariectomized B6C3F 1, s.c. x 4 days Papaconstantinou et al. (2001) Juvenile-adult ovariectomized B6C3F1, s.c. x 4 days Papaconstantinou et al. (2002) Juvenile-adult ovariectomized B6C3F 1, s.c. x 1 Papaconstantinou et al. (2003) Adult ovariectomized transgenic ER-reporter, s.c. x 1 AO4C diet, wire cage AO4C diet, wire cage PMI Certified Rodent Diet TD89222 diet, metal cage Phytoestrogenfree diet Not indicated Not indicated Not indicated Not indicated Purina 5001, polypropylene cage, chip bedding Purina 5001, polypropylene cage, cellulose fiber bedding Purina 5001, polypropylene cage, cellulose fiber bedding Purina 5001, polypropylene cage, cellulose fiber bedding Purina 5001, polystyrene cage Birth Defects Research (Part B) 83:157–395, 2008 BISPHENOL A Table 53 Continued Endpoint Molar potency/comparator b Vaginal cornification Vaginal cornification Vaginal weight Prevention of bone mineral density decline Prevention of bone mineral density decline Serum prolactin Pituitary weight Serum prolactin Relative uterine weight IGF1 expression Uterine wet weight Endothelial proliferation Induction of grp94 Induction of hsp72 Induction of hsp90 Uterine weight Induction of hsp90a Induction of grp24 Blotted uterine weight, 6 hr after dose Blotted uterine weight, 12 hr after dose Uterine wet weight ER activation [3.8 x 10 -4 ]/17b-estradiol No effect at bisphenol A dose of 100 mg/kg bw/day; 17b-estradiol was positive at 0.1 mg/kg bw/day [5.3 x 10 -7 ]/ethinyl estradiol No effect at bisphenol A dose up to 10 mg/kg bw/day; no standard estrogen comparator No effect at bisphenol A dose r 370 mg/kg bw/day; estradiol benzoate was effective at 1.18 mg/ kg bw/day F344: [1.7 x 10 -2 ]/17b-estradiol Sprague Dawley: no effect of bisphenol A at 40–45 mg/day or 17bestradiol at 1.2–1.5 mg/day Increased compared to vehicle control at 128 but not 78 mg/kg bw/day Increased compared to vehicle control at 128 mg/kg bw/day No response at up to 0.5 mg [B50 mg/ kg bw/day] [8.4 x 10 -4 ]/17b-estradiol [2.3 x 10 -5 ]/17b-estradiol [6.9 x 10 -6 ]/17b-estradiol [2.4 x 10 -5 ]/17b-estradiol [3.5 x 10 -6 ]/17b-estradiol [5.3 x 10 -6 ]/17b-estradiol [5.3 x 10 -6 ]/17b-estradiol [1.2 x 10 -5 ]/17b-estradiol [8.4 x 10 -6 ]/17b-estradiol [8.4 x 10 -6 ]/17b-estradiol [4.2 x 10 -6 ]/17b-estradiol [2.9 x 10 -5 ]/diethylstilbestrol [1.0 x 10 -4 ]/diethylstilbestrol Reference 217 Stroheker et al. (2003) Kim et al. (2005) Dodge et al. (1996) Seidlová-Wuttke et al. (2004) Steinmetz et al. (1997) Goloubkova et al. (2000) Coldham et al. (1997) Klotz et al. (2000) Nagel et al. (2001) Nagel et al. (2001)
218 Model and exposure Husbandry a CHAPIN ET AL. Table 53 Continued Endpoint Molar potency/comparator b Reference Immature AP, s.c. x 3 RM1 diet, plastic Blotted uterine weight [2.3 x 10 -5 ]/diethylstilbestrol in 4 of 8 Tinwell and days cage, sawdust trials; other trials showed no effect Joiner (2000) and shredded at bisphenol doses up to 300 mg/kg paper bedding bw/day Immature AP, RM1 diet, plastic Blotted uterine weight No effect at bisphenol A doses up to Tinwell and gavage x 3 days cage, sawdust 300 mg/kg bw/day; Joiner (2000) and shredded diethylstilbestrol produced paper bedding response at 10 mg/kg bw/day Immature CD-1, RM1 diet Lactoferrin expression No effect at bisphenol A doses up to Mehmood et al. s.c. x 3 days 1000 mg/kg bw/day; (2000) diethylstilbestrol showed effect at 0.1 mg/kg bw/day Uterine weight, BrdU No effect at bisphenol A doses up to incorporation, 100 mg/kg bw/day; peroxidase production diethylstilbestrol showed effect at 1–5 mg/kg bw/day Immature CD-1, s.c. RMH 3000 diet, Uterine wet weight [1.6 x 10 -5 ]/17b-estradiol Markey et al. minipump x 3 days cage, and (2001b) bedding estrogennegative by E- Screen Epithelial cell height [3.8 x 10 -5 ]/17b-estradiol Lactoferrin expression [3.9 x 10 -5 ]/17b-estradiol Ovariectomized adult Not indicated Relative uterine to body [3.6–74 x 10 -5 ]/17b-estradiol Kitamura et al. B6C3F1, i.p. x 3 days weight (2005) Ovariectomized adult Economy Increased uterine B1 x10 -4 /17b-estradiol Milligan et al. Swiss, s.c. x 1 Rodent vascular permeability (1998) Maintenance diet Other mouse organs Juvenile-adult NMF diet Uterine and ovarian Dietary bisphenol A (0.1%) exerted Toda et al. (2002) aromatase knock-out, histology, bone mineral estrogenic effects. Mean7SD serum diet x 4 months density bisphenol A 84.378.7 mg/L. No comparator estrogen was used for these endpoints Fish Immature rainbow Plasma vitellogenin [3 x 10 -4 ]/17b-estradiol Christiansen trout, injected et al. (1997) Juvenile rainbow trout, Plasma vitellogenin [5.6 x 10 -3 ]/17b-estradiol Andersen et al. injected (1999a) Juvenile rainbow trout, Plasma vitellogenin [B8.4 x 10 -5 ]/17b-estradiol Lindholst et al. exposed in water (2000) Male medaka, exposed Plasma vitellogenin [1.4 x 10 -4 ]/ethinyl estradiol Chikae et al. in feed (2003) Male medaka, exposed Hepatic vitellogenin and [8.4 x 10 -6 ]/17b-estradiol Yamaguchi et al. in water ERa mRNA (2005) Male killfish, injected Plasma vitellogenin [2.7 x 10 -4 ]/17b-estradiol Pait and Nelson (2003) Male zebrafish, Plasma vitellogenin [B0.2]/ethinyl estradiol Van den Belt juvenile rainbow trout, et al.(2003) exposed in water Invertebrates Mud snail, exposed in New embryo production [1.5 x 10 -4 ]/ethinyl estradiol Jobling et al. water (2004) Ramshorn snail, Egg production Increased (EC 10 13.9 ng/L); blocked by Oehlmann et al. exposed in water Faslodex and tamoxifen. No (2006) comparison to reference estrogen a Husbandry information for rodent studies includes caging and bedding materials and diet when indicated by the authors. b Estimates include comparison of administered dose, magnitude of effect, and molecular weight. represents fluid inbibition and not true tissue growth. A 42/43 with bisphenol A by gavage at 400 or 600 mg/kg dose-related decrease in blotted uterine weight and body bw/day (George et al., 2003). weight, with no effect on weight-adjusted uterine For studies showing an increase in uterine weight after weight, was shown in pubertal rats treated on PND 22– bisphenol A treatment, dose route affects response; Birth Defects Research (Part B) 83:157–395, 2008
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National Toxicology Program U.S. De
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[This page inTenTionally lefT blank
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NTP.will.transmit.the.NTP-CERHR.<st
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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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of.normal.sex-based.differences.bet
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death.(168),.synaptic.plasticity.(1
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gland.carcinogen.or.that.bisphenol.
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understand.the.possible.long-term.c
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strategies.to.improve.the.sensitivi
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and.cystic.endometrial.hyperplasia.
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cutaneous. injection. 20 . vom. Saa
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are CurrenT exposures To bisphenol
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w/day;.95th.percentiles.0.289.-.0.2
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nTp ConClusions The.NTP.reached.the
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appendix a: inTerpreTaTion of blood
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µg/kg.bw/day.based.on.the.assumpti
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concentrations.from.maternal,.fetal
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65.. Alonso-Magdalena. P,. Laribi.
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91.. Calabrese.EJ,.Baldwin.LA.(2003
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Thyroid.Function.in.Juvenile.Female
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droxylase.immunoreactivity..76:423.
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stanceschimiques.gc.ca/challenge-de
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Watanabe.H,.Ohta.Y,.Iguchi.T.(2006)
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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
Page 89 and 90: 166 CHAPIN ET AL. Table 6 Continued
Page 91 and 92: 168 CHAPIN ET AL. comparison of the
Page 93 and 94: 170 CHAPIN ET AL. Table 8 Urinary C
Page 95 and 96: 172 CHAPIN ET AL. the blood of male
Page 97 and 98: 174 CHAPIN ET AL. Table 11 Bispheno
Page 99 and 100: 176 CHAPIN ET AL. Table 13 Summarie
Page 101 and 102: 178 CHAPIN ET AL. Table 15 Estimate
Page 103 and 104: 180 CHAPIN ET AL. Table 17 Maximum
Page 105 and 106: 182 CHAPIN ET AL. 2.0 GENERAL TOXIC
Page 107 and 108: 184 CHAPIN ET AL. fetuses (3.572.7
Page 109 and 110: 186 CHAPIN ET AL. Secondary sources
Page 111 and 112: 188 CHAPIN ET AL. Table 25 Maternal
Page 113 and 114: 190 CHAPIN ET AL. Table 27 Bispheno
Page 115 and 116: 192 CHAPIN ET AL. Table 31 Qualitat
Page 117 and 118: 194 CHAPIN ET AL. Table 33 Toxicoki
Page 121 and 122: 198 CHAPIN ET AL. appeared to occur
Page 123 and 124: 200 CHAPIN ET AL. Table 43 Biliary
Page 125 and 126: 202 CHAPIN ET AL. suggesting that 4
Page 127 and 128: 204 CHAPIN ET AL. low following ora
Page 129 and 130: 206 CHAPIN ET AL. scaling and speci
Page 131 and 132: 208 CHAPIN ET AL. 60-100% in each d
Page 133 and 134: 210 CHAPIN ET AL. related. No histo
Page 135 and 136: 212 CHAPIN ET AL. Table 52 Continue
Page 137 and 138: 214 CHAPIN ET AL. Model and exposur
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Page 143 and 144: 220 CHAPIN ET AL. Table 54 Differen
Page 145 and 146: 222 CHAPIN ET AL. Table 56 Anti-And
Page 147 and 148: 224 Table 57 In Vitro Genetic Toxic
Page 149 and 150: 226 CHAPIN ET AL. Table 58 In Vivo
Page 151 and 152: 228 CHAPIN ET AL. Table 59 Developm
Page 155 and 156: 232 CHAPIN ET AL. Table 64 Tissue R
Page 159 and 160: 236 CHAPIN ET AL. treatment conditi
Page 161 and 162: 238 CHAPIN ET AL. clinical signs, b
Page 163 and 164: 240 CHAPIN ET AL. Table 71 Benchmar
Page 165 and 166: 242 CHAPIN ET AL. group, 5 from 1 l
Page 167 and 168: 244 CHAPIN ET AL. least significant
Page 169 and 170: 246 CHAPIN ET AL. group was a reduc
Page 171 and 172: 248 CHAPIN ET AL. 100-151 g for fem
Page 173 and 174: 250 CHAPIN ET AL. 3.2.3.2 Developme
Page 175 and 176: 252 CHAPIN ET AL. weights, bispheno
Page 177 and 178: 254 CHAPIN ET AL. 120 mg/kg bw/day
Page 179 and 180: 256 CHAPIN ET AL. comparisons condu
Page 181 and 182: 258 CHAPIN ET AL. the findings of t
Page 183 and 184: 260 CHAPIN ET AL. analyzed.] Anogen
Page 185 and 186: 262 CHAPIN ET AL. purposeful confou
Page 187 and 188: 264 CHAPIN ET AL. increased lordosi
Page 189 and 190: 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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332 CHAPIN ET AL. antinuclear antib
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334 CHAPIN ET AL. least 6 animals.
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336 CHAPIN ET AL. Utility (Adequacy
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338 CHAPIN ET AL. stomach weight wa
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340 CHAPIN ET AL. Schirling et al.
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342 CHAPIN ET AL. Endpoint Table 88
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344 CHAPIN ET AL. different diets b
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346 CHAPIN ET AL. with 40 mg vitami
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348 CHAPIN ET AL. the bisphenol A v
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350 CHAPIN ET AL. and determining t
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352 CHAPIN ET AL. expression [to B6
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354 CHAPIN ET AL. indicated] at 0 (
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356 CHAPIN ET AL. concentrations us
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358 CHAPIN ET AL. animals were non-
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360 CHAPIN ET AL. following adjustm
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362 CHAPIN ET AL. Table 94 Treatmen
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364 CHAPIN ET AL. Table 97 Effects
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366 CHAPIN ET AL. Table 99 Treatmen
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368 CHAPIN ET AL. Therefore the NTP
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370 CHAPIN ET AL. weeks before mati
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374 Table 101 Summary of High Utili
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376 Table 102 Summary of Limited Ut
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380 CHAPIN ET AL. from other suppli
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382 CHAPIN ET AL. U.S. populations.
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384 CHAPIN ET AL. 10. Critical desi
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386 CHAPIN ET AL. Engel SM, Levy B,
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388 CHAPIN ET AL. alpha and beta ex
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390 CHAPIN ET AL. Murray TJ, Maffin
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392 CHAPIN ET AL. Ryan BC, Vandenbe
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394 CHAPIN ET AL. Thomas P, Dong J.
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appendix iii. publiC CommenTs and p
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