Birth Defects Research Part B: Developmental and Reproductive Toxicology
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Inter-laboratory control data for reproductive endpoints required in the OPPTS 870.3800/OECD 416 reproduction and fertility test
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CONCLUSIONS: These inter-laboratory control data provide a means for laboratories to review their performance on reproductive toxicity measures, and provide perspective for interpreting their own control data and data from treated animals. Birth Defects Res (Part B), 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - November 17, 2009 Category: Perinatology & Neonatology Authors: M. S. Marty, B. Allen, R. E. Chapin, R. Cooper, G. P. Daston, J. A. Flaws, P. M. D. Foster, S. L. Makris, E. Mylchreest, D. Sandler, R. W. Tyl Source Type: journals
Dietary selenium plus folic acid as an antioxidant therapy for ethanol-exposed pups
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CONCLUSIONS: These results suggest that folic acid+Se could be effective in neutralising the damage of ethanol consumption in pups since it prevents peroxidation protein products. Birth Defects Res (Part B), 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - November 16, 2009 Category: Perinatology & Neonatology Authors: M. L. Ojeda, F. Nogales, K. Jotty, M. J. Barrero, M. L. Murillo, O. Carreras Source Type: journals
Anticonvulsant profile and teratogenic evaluation of potent new analogues of a valproic acid urea derivative in NMRI mice
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CONCLUSIONS: The CNS-active VPA analogs containing a urea moiety, which have better anticonvulsant potency and lack teratogenicity, are good potential candidates as second-generation VPA antiepileptic drugs. Birth Defects Res (Part B) xx:1-8, 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - October 14, 2009 Category: Perinatology & Neonatology Authors: Akinobu Okada, Hiroko Noyori, Boris Yagen, Jakob Avi Shimshoni, Meir Bialer, Michio Fujiwara Source Type: journals
Gestational high saturated fat diet alters C57BL/6 mouse perinatal skeletal formation
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CONCLUSIONS: The theory of HFD-associated, OS-mediated placental damage and skeletal pathogenesis was supported by demonstrating a protective effect of the dietary antioxidant quercetin (Q) against HFD-associated fetal skeletal developmental delay. Improved understanding of the role of HFD and elevated OS in fetal skeletal development will help to more completely elucidate the importance of the prenatal environment to fetal formation, and will be applied to better understand the contribution of the fetal environment to long-term risk of adult-onset disease. Birth Defects Res (Part B), 2009. © 2009 Wiley-Liss, Inc. (Source...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - September 10, 2009 Category: Perinatology & Neonatology Authors: Chengya Liang, Megan E. Oest, Jeryl C. Jones, M. Renee Prater Source Type: journals
Intrauterine exposure to high saturated fat diet elevates risk of adult-onset chronic diseases in C57BL/6 mice
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CONCLUSIONS: Collectively, these data suggest that offspring of dams who consume a diet rich in saturated fats during pregnancy are at increased risk of adult-onset chronic disease. Additionally, these chronic diseases were determined to be in-part OS-mediated, and preventable by increasing a prenatal dietary antioxidant; this knowledge offers both a putative mechanism of disease pathogenesis and suggests a potential preventive strategy. Birth Defects Res (Part B), 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - September 10, 2009 Category: Perinatology & Neonatology Authors: Chengya Liang, Megan E. Oest, M. Renee Prater Source Type: journals
Reproductive toxicity of BioThrax® in rabbits
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CONCLUSIONS: AVA directly, or indirectly through the production of anti-PA IgG, did not appear to have an adverse effect on the pregnant females or their offspring, as measured by mating and fertility indices, natural delivery observations, clinical signs, gross lesions, in utero growth and survival, morphological development, or kit viability. Birth Defects Res (Part B), 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - August 28, 2009 Category: Perinatology & Neonatology Authors: Cynthia Franco, Elise Lewis, Sandra Morseth, Louise Simon, A. Thomas Waytes Source Type: journals
Experimental study on protection of vitamin B6 on TCDD-induced palatal cleft formation in the mice
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CONCLUSIONS: It was demonstrated in this study that B6 could not antagonize 2, 3, 7, 8-TCDD-indued cleft palate. Birth Defects Res (Part B), 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - August 27, 2009 Category: Perinatology & Neonatology Authors: Cheng-hao Li, Wei He, Tian Meng, Bing Shi Source Type: journals
An interspecies comparison of placental antibody transfer: New insights into developmental toxicity testing of monoclonal antibodies
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There are profound differences in maternofetal transfer of immunoglobulins between species with extensive gestational transfer of maternal immunoglobulins in primates (including humans) via the chorioallantoic placenta as well as in rabbits and guinea pigs via the inverted yolk sac splanchnopleure. In contrast, other neonatal rodents (rats and mice) receive passive immunity predominantly postnatally. This transfer is mediated principally via FcRn receptors. Therapeutic monoclonal antibodies (mAbs) are most commonly of the IgG1 subclass, which is transported most efficiently to the fetus. In all animal species used for test...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - July 22, 2009 Category: Perinatology & Neonatology Authors: Nele Pent[scaron]uk, Jan Willem van der Laan Source Type: journals
Reproductive toxicity and pharmacokinetics of di-n-butyl phthalate (DBP) following dietary exposure of pregnant rats
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This study characterized the developmental toxicity of dietary DBP. Pregnant CD rats were given nominal doses of 0, 100, or 500 mg DBP/kg/day in diet (actual intake 0, 112, and 582 mg/kg/day) from gestational day (GD) 12 through the morning of GD 19. Rats were killed 4 or 24 hr thereafter. DBP dietary exposure resulted in significant dose-dependent reductions in testicular mRNA concentration of scavenger receptor class B, member 1; steroidogenic acute regulatory protein; cytochrome P450, family 11, subfamily a, polypeptide 1; and cytochrome P450 family 17, subfamily a, polypeptide 1. These effects were most pronounced 4 hr...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - July 7, 2009 Category: Perinatology & Neonatology Authors: Melanie F. Struve, Kevin W. Gaido, Janan B. Hensley, Kim P. Lehmann, Susan M. Ross, Mark A. Sochaski, Gabrielle A. Willson, David C. Dorman Source Type: journals
Evaluation of hydroxyurea-induced fetal skeletal changes in Dutch belted rabbits by micro-computed tomography and alizarin red staining
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CONCLUSIONS: These results indicate that micro-CT imaging can effectively assess rabbit fetal skeletal structures, and for those laboratories with this resource, may be used to significantly reduce time prior to skeletal evaluation and hazardous wastes associated with staining. Birth Defects Res (Part B), 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - May 31, 2009 Category: Perinatology & Neonatology Authors: L. David Wise, Christopher T. Winkelmann Source Type: journals
Micro-computed tomography and alizarin red evaluations of boric acid-induced fetal skeletal changes in Sprague-Dawley rats
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CONCLUSIONS: These results indicate that micro-CT imaging can effectively assess rat fetal skeletal structures, and for those laboratories with this resource, it may be used to significantly reduce time prior to skeletal evaluation and hazardous wastes associated with staining. Birth Defects Res (Part B), 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - May 28, 2009 Category: Perinatology & Neonatology Authors: L. David Wise, Christopher T. Winkelmann Source Type: journals
Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals
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This report discusses the principles of developmental and reproductive toxicity (DART) testing for biopharmaceuticals. Biopharmaceuticals are large-molecular-weight proteins or peptides produced by modern biotechnology techniques incorporating genetic engineering and hybridoma technologies. The principles of DART testing for biopharmaceuticals are similar to those for small-molecule pharmaceuticals and in general follow the regulatory guidance outlined in International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) document S5(R2). However, because many biophar...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - May 24, 2009 Category: Perinatology & Neonatology Authors: Pauline L. Martin, William Breslin, Meredith Rocca, David Wright, Joy Cavagnaro Source Type: journals
Reduced water intake: Implications for rodent developmental and reproductive toxicity studies
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In developmental and reproductive toxicity studies, drinking water is a common means of delivering the test agent. Reduced consumption of toxicant-containing water raises questions about indirect effects of reduced maternal fluid consumption resulting from unpalatability, versus direct effects of the test compound. Issues to consider include: objective assessment of dehydration and thirst, the relative contributions of innate and learned behaviors to drinking behavior and flavor preference, and the objective assessment of physiologic stress. Not only do lab animals under ad lib conditions consume more water than the minimu...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - May 20, 2009 Category: Perinatology & Neonatology Authors: Marlissa A. Campbell, Mari S. Golub, Poorni Iyer, Farla L. Kaufman, Ling-Hong Li, Francisco Moran Messen, James E. Morgan, James M. Donald Source Type: journals
Developmental and reproductive toxicity studies on artemisone
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CONCLUSIONS: In summary, artemisone was shown to be embryo- and fetotoxic and induced cardiac ventricular septal defects and retarded ossification in dosages where total litter loss and abortions were observed. However, no effect on reproductive and developmental parameters below severe toxic dosages could be observed. Birth Defects Res (Part B) 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 22, 2009 Category: Perinatology & Neonatology Authors: G. Schmuck, A.-M. Klaus, F. Krötlinger, F.W. Langewische Source Type: journals
The guinea pig as an animal model for developmental and reproductive toxicology studies
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CONCLUSION: In cases where the traditional animal models are not relevant, the guinea pig can be used successfully for DART studies. Birth Defects Res (Part B) 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 20, 2009 Category: Perinatology & Neonatology Authors: Meredith S. Rocca, Nancy G. Wehner Source Type: journals
Evaluation of the safety and pharmacokinetics of the multi-targeted receptor tyrosine kinase inhibitor sunitinib during embryo-fetal development in rats and rabbits
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CONCLUSIONS: Similar effects have been reported with the prototype monoclonal antibody bevacizumab. As is typically observed for potent inhibitors of RTKs involved in angiogenesis, sunitinib was associated with embryo-fetal developmental toxicity in rats and rabbits at clinically relevant dose levels. Birth Defects Res (Part B) 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 18, 2009 Category: Perinatology & Neonatology Authors: S. Patyna, J. Haznedar, D. Morris, K. Freshwater, G. Peng, J. Sukbuntherng, G. Chmielewski, D. Matsumoto Source Type: journals
Sodium benzoate exposure downregulates the expression of tyrosine hydroxylase and dopamine transporter in dopaminergic neuronsin developing zebrafish
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CONCLUSIONS: The results suggest that SB exposure can cause significantly decreased survival rates of zebrafish embryos in a time- and dose-dependent manner and downregulated expression of TH and DAT in dopaminergic neurons in the zebrafish ventral diencephalon, which results in decreased locomotor activity of zebrafish larvae. This study may provide some important information for further elucidating the mechanism underlying SB-induced developmental neurotoxicity. Birth Defects Res (Part B) 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 17, 2009 Category: Perinatology & Neonatology Authors: Qian Chen, Nan-nan Huang, Jin-tao Huang, Shen Chen, Jinjin Fan, Chaohong Li, Fu-kang Xie Source Type: journals
Effects of natalizumab, an [alpha]4 integrin inhibitor, on the development of Hartley guinea pigs
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CONCLUSION: No fetotoxicity or teratogenic effects were attributable to natalizumab in these studies. Birth Defects Res (Part B) 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 17, 2009 Category: Perinatology & Neonatology Authors: Nancy G. Wehner, George Shopp, Meredith S. Rocca, Janet Clarke Source Type: journals
Effects of natalizumab, an [alpha]4 integrin inhibitor, on fertility in male and female guinea pigs
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CONCLUSIONS: Natalizumab had no effects on male fertility, but did result in a reduction in pregnancy rates in females treated with the high dose of 30 mg/kg. Birth Defects Res (Part B) 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 13, 2009 Category: Perinatology & Neonatology Authors: Nancy G. Wehner, Michael Skov, George Shopp, Meredith S. Rocca, Janet Clarke Source Type: journals
Postnatal development in cynomolgus monkeys following prenatal exposure to natalizumab, an [alpha]4 integrin inhibitor
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Conclusion: Natalizumab had no adverse effects on the general health, survival, development, or immunological structure and function of infants born to dams treated with natalizumab during pregnancy. Birth Defects Res (Part B) 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 12, 2009 Category: Perinatology & Neonatology Authors: Nancy G. Wehner, George Shopp, Ingrid Osterburg, Antje Fuchs, Eberhard Buse, Janet Clarke Source Type: journals
The effects of Scutellaria baicalensis extract on embryonic development in mice
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This study aims to evaluate the effects of S. baicalensis aqueous extract on embryonic development in ICR mice. METHODS: Aqueous extract of S. baicalensis roots was prepared in accordance with clinical application. Pregnant mice were randomly divided into four groups, i.e., mice treated by gavage with water as negative control, with aqueous extract of 2 (1.8 times of human daily dose), 8 or 32 g/kg/day from gestation day (Gd) 6 to 15 as low-, middle-, and high-dose groups, respectively. The parameters of live and dead fetuses, resorptions, external and skeletal malformed fetuses, maternal body weight, maternal liver, kidne...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 12, 2009 Category: Perinatology & Neonatology Authors: Xiao Ying Tian, Lok Man Cheung, Kevin Leung, Chen Qi, Bin Deng, Ping Xiang Deng, Min Xu Source Type: journals
Embryo/fetal development in cynomolgus monkeys exposed to natalizumab, an [alpha]4 integrin inhibitor
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CONCLUSION: Natalizumab had no abortifacient or teratogenic effects, but was associated with changes in fetal hematopoiesis and leukocyte trafficking. Birth Defects Res (Part B) 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 10, 2009 Category: Perinatology & Neonatology Authors: Nancy G. Wehner, George Shopp, Satoru Oneda, Janet Clarke Source Type: journals
Reproductive and developmental effects and physical and chemical properties of pentaerythritol tetranitrate (PETN) in the rat
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Pentaerythritol tetranitrate (PETN) is an explosive chemical that has been detected in environmental media. Although previous toxicology studies have shown PETN to be relatively benign, a lack of available information concerning developmental and reproductive effects from oral PETN exposure was needed. Sprague-Dawley rats were exposed to oral daily adjusted volumetric doses of 0, 100, 500, or 1,000 mg PETN/kg body mass in a corn oil vehicle for up to 56 days. Mating, duration of gestation, body weight, feed consumption, overall condition of adults, and the number, sex, and condition of pups were recorded. Histological exam...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - February 8, 2009 Category: Perinatology & Neonatology Authors: Michael J. Quinn Jr, Lee C.B. Crouse, Craig A. McFarland, Emily M. LaFiandra, Mark S. Johnson Source Type: journals
Caspase-8: a key role in the pathogenesis of diabetic embryopathy
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Maternal diabetes causes neural tube defects in embryos, which are associated with increased apoptosis in the neuroepithelium. Many factors, including effector caspases, have been shown to be involved in the events. However, the key regulators have not been identified and the underlying mechanisms remain to be addressed. Caspase-8, an initiator caspase, has been shown to be altered in diabetic embryopathy, suggesting a role as an upstream apoptotic regulator. Using mouse embryos as a model system, this study demonstrates that caspase-8 is required for the production of hyperglycemia-associated embryonic malformations. Casp...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - February 5, 2009 Category: Perinatology & Neonatology Authors: Zhiyong Zhao, Peixin Yang, Richard L. Eckert, E. Albert Reece Source Type: journals
Polyamines protect rat embryo in vitro from high glucose-induced developmental delay and dysmorphogenesis
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Conclusions: Polyamines directly protect the embryo from the toxic effect of high glucose concentration on growth and development, although the mechanism remains to be elucidated. Birth Defects Res (Part B) © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - January 25, 2009 Category: Perinatology & Neonatology Authors: Gladys Chirino-Galindo, Luis A. Baiza-Gutman, Eduardo Barrera-Escorcia, Martín Palomar-Morales Source Type: journals
The effects of marginal maternal vitamin A status on penta-brominated diphenyl ether mixture-induced alterations in maternal and conceptal vitamin A and fetal development in the Sprague Dawley rat
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Conclusions: The results of this study support the concept that marginal vitamin A status enhances the disruptive effects of DE-71 during prenatal development. Birth Defects Research (Part B) 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - January 15, 2009 Category: Perinatology & Neonatology Authors: Robert G. Ellis-Hutchings, Gary N. Cherr, Lynn A. Hanna, Carl L. Keen Source Type: journals
The roles of p53 and p21 in normal development and hyperthermia-induced malformations
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CONCLUSIONS: Our study confirms that p53 plays a role in normal development and has shown, for the first time that p53 and p21 function to suppress HS-induced malformations. Birth Defects Res (Part B) 2009. © 2009 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - January 13, 2009 Category: Perinatology & Neonatology Authors: Hiromi Hosako, Liezl E. Francisco, Gail S. Martin, Philip E. Mirkes Source Type: journals
A lifestage-specific approach to hazard and dose-response characterization for children's health risk assessment
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This article summarizes the lifestage-specific issues discussed in the Framework related to the qualitative and the quantitative hazard and dose-response characterization. Lifestage-specific hazard characterization includes an evaluation of relevant human and experimental animal studies, focusing on the identification of critical windows of development (i.e., exposure intervals of maximum susceptibility) for observed outcomes, evaluation of differential exposure at individual lifestages, the relevance and impact of lifestage-specific toxicokinetic and toxicodynamic data, mode of action information, variability and latency ...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - December 10, 2008 Category: Perinatology & Neonatology Authors: Susan L. Makris, Chad M. Thompson, Susan Y. Euling, Sherry G. Selevan, Babasaheb Sonawane Source Type: journals
Early-Life environment, developmental immunotoxicology, and the risk of pediatric allergic disease including asthma
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Incidence of childhood allergic disease including asthma (AD-A) has risen since the mid-20th century with much of the increase linked to changes in environment affecting the immune system. Childhood allergy is an early life disease where predisposing environmental exposures, sensitization, and onset of symptoms all occur before adulthood. Predisposition toward allergic disease (AD) is among the constellation of adverse outcomes following developmental immunotoxicity (DIT; problematic exposure of the developing immune system to xenobiotics and physical environmental factors). Because novel immune maturation events occur in ...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - December 9, 2008 Category: Perinatology & Neonatology Authors: Rodney R. Dietert, Judith T. Zelikoff Source Type: journals
Micro-CT evaluation of murine fetal skeletal development yields greater morphometric precision over traditional clear-staining methods
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Traditional techniques for quantification of murine fetal skeletal development (gross measurements, clear-staining) are severely limited by specimen processing, soft tissue presence, diffuse staining, and unclear landmarks between which to make measurements. Nondestructive microcomputed tomography (micro-CT) imaging is a versatile, well-documented tool traditionally used to generate high-resolution 3-D images and quantify microarchitectural parameters of trabecular bone. Although previously described as a tool for phenotyping fetal murine specimens, micro-CT has not previously been used to directly measure individual fetal...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - December 1, 2008 Category: Perinatology & Neonatology Authors: Megan E. Oest, Jeryl C. Jones, Cindy Hatfield, M. Renee Prater Source Type: journals
Species-specificity of ethylene glycol-induced developmental toxicity: toxicokinetic and whole embryo culture studies in the rabbit
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High-dose gavage exposure to ethylene glycol (EG) is teratogenic in rats, but not rabbits. To investigate the reason for this species difference, toxicokinetic and whole embryo culture (WEC) studies were conducted in gestation day 9 New Zealand White rabbits, and the data compared to very similar data previously generated in pregnant rats. In the toxicokinetic study, maximal levels of unchanged EG in rabbits were comparable to those reported for rats. However, maximal levels of EG's teratogenic metabolite, glycolic acid (GA), in rabbit maternal blood and embryo were only 46% and 10% of the respective levels in rats. The to...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - November 22, 2008 Category: Perinatology & Neonatology Authors: Edward W. Carney, Belen Tornesi, Daniel A. Markham, Reza J. Rasoulpour, Nigel Moore Source Type: journals
Lack of effects on fertility and developmental toxicity of a quadrivalent HPV vaccine in Sprague-Dawley rats
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The objective of the present study was to evaluate the potential effects of the vaccine on female fertility and F1 development, growth, behavior, and reproductive performance. In addition, anti-HPV antibodies in the F0 females and F1 offspring were measured during the study. Two groups of 65 virgin Sprague-Dawley rats were administered two or four intramuscular injections of the vaccine (full human dose of 0.5 mL at 5 and 2 weeks prior to mating, on Gestation Day [GD] 6, and Lactation Day [LD] 7; or GD 6 and LD 7 only). Additional groups of rats were administered phosphate-buffered saline or Merck Aluminum Adjuvant (MAA) a...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - November 21, 2008 Category: Perinatology & Neonatology Authors: L. David Wise, Jayanthi J. Wolf, Catherine V. Kaplanski, Cindy J. Pauley, Brian J. Ledwith Source Type: journals
Children's health risk assessment: incorporating a lifestage approach into the risk assessment process
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This overview paper provides the historical context for the incorporation of lifestage-specific concerns in human health risk assessment, briefly explains the process employed in a lifestage framework for risk assessment, and discusses the scientific rationale for how utilizing lifestage data will strengthen the overall risk assessment process. This risk assessment approach will add value by: (1) providing a more complete evaluation of the potential for vulnerability at different lifestages, including a focus on the underlying biological events and incorporation of mode of action information related to different critical d...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - November 21, 2008 Category: Perinatology & Neonatology Authors: Rebecca C. Brown, Stanley Barone Jr., Carole A. Kimmel Source Type: journals
A lifestage approach to assessing children's exposure
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Understanding and characterizing risks to children has been the focus of considerable research efforts at the U.S. Environmental Protection Agency (EPA). Potential health risks resulting from environmental exposures before conception and during pre- and postnatal development are often difficult to recognize and assess because of a potential time lag between the relevant periods of exposure during development and associated outcomes that may be expressed at later lifestages. Recognizing this challenge, a lifestage approach for assessing exposure and risk is presented in the recent EPA report titled A Framework for Assessing...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - November 21, 2008 Category: Perinatology & Neonatology Authors: Elaine A. Cohen Hubal, Jacqueline Moya, Sherry G. Selevan Source Type: journals
Review of reproductive and developmental toxicity studies with isopropanol
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Published studies for reproductive and developmental toxicity conducted with isopropanol have been conducted by the inhalation and oral gavage routes of administration. Interpretation of the data from these studies has resulted in discussions regarding NOAELs and additional benchmark dose modeling publications. Unpublished reproductive and developmental toxicity studies administered in the drinking water were also conducted by BIBRA, and the results of those studies are presented here. In addition, all of the reproductive and developmental toxicity studies conducted with isopropanol are summarized and evaluated for concord...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - October 16, 2008 Category: Perinatology & Neonatology Authors: Willem D. Faber, Kenneth L. Pavkov, Ralph Gingell Source Type: journals
Developmental toxicity assessment of d,l-Methylphenidate and d-Methylphenidate in rats and rabbits
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CONCLUSIONS: There was no teratogenicity with d-MPH. There was a low teratogenic risk with d,l-MPH in only the rabbit. Higher Cmax may explain differences in results from previous studies. Birth Defects Res (Part B) 2008. © 2008 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - October 15, 2008 Category: Perinatology & Neonatology Authors: David A. Beckman, Marilynn Schneider, Maureen Youreneff, Francis L.S. Tse Source Type: journals
Lack of adaptive response of gamma radiation for protection against neutron-induced teratogenesis
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CONCLUSIONS: Overall, this study shows that exposure to 0.3 Gy of gamma rays failed to induce an adaptive response of fetogenesis to a neutron challenge dose. Birth Defects Res (Part B) 2008. © 2008 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - October 13, 2008 Category: Perinatology & Neonatology Authors: Hae-June Lee, Joong-Sun Kim, Myoung-Sub Song, Heung-Sik Seo, Changjong Moon, Jong-Choon Kim, Sung-Kee Jo, Sung-Ho Kim Source Type: journals
Fetal death persists through recurrent pregnancies in mice following Ljungan virus infection
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CONCLUSIONS: Perinatal death persists across recurrent pregnancies in this mouse model of LV infection, both in animals infected as adults and in females exposed to the virus in utero. This implies that LV persists in mice long after intial infection, and is maintained in a quiescent state but can remain pathogenic in later pregnancies. Birth Defects Res (Part B) 2008. © 2008 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - October 10, 2008 Category: Perinatology & Neonatology Authors: Annika Samsioe, Åke Sjöholm, Bo Niklasson, William Klitz Source Type: journals
Embryotoxicity of artesunate in animal species related to drug tissue distribution and toxicokinetic profiles
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CONCLUSIONS: TK data showed that unchanged AS and DHA in the blood of pregnant rats were 1.53- and 3.74-fold, respectively, higher than those of non-pregnant animals, which all likely relate to the severe embryotoxicity of AS, even with a low-dosage regimen in pregnant animals. Birth Defects Res (Part B), 2008. Published 2008 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - July 18, 2008 Category: Perinatology & Neonatology Authors: Qigui Li, Yuanzheng Si, Kirsten S. Smith, Qiang Zeng, Peter J. Weina Source Type: journals
Sensitive periods for developmental toxicity of orally administered artesunate in the rat
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CONCLUSIONS: The sensitive window for developmental toxicity of artesunate in the rat was identified as days 10 to 14 pc. Single oral doses produced embryolethality and similar cardiovascular and skeletal malformations as previously reported in longer term dosing experiments. These single dose treatment regimens could be useful to further investigate the mechanistic basis for artesunate-induced developmental toxicity. Birth Defects Research (Part B) 2008. © 2008 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - July 11, 2008 Category: Perinatology & Neonatology Authors: Tacey E.K. White, Robert L. Clark Source Type: journals
Corrigendum
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No Abstract (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - July 10, 2008 Category: Perinatology & Neonatology Authors: Makoto Usami Source Type: journals
Lack of effect of butylparaben and methylparaben on the reproductive system in male rats
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CONCLUSIONS: Exposure to methyl- or butylparaben in the diet for eight weeks did not affect any male reproductive organs or parameters at exposures as high as 10,000 ppm, corresponding to a mean daily dose of 1,141.1±58.9 or 1,087.6±67.8 mg/kg/day for methyl- and butylparaben, respectively. The rapid metabolism of parabens by esterases probably explains why these weakly estrogenic substances elicit no in vivo effects when administered by relevant exposure routes (i.e., topical and oral). Birth Defects Research (Part B) 2008. 2008 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - April 8, 2008 Category: Perinatology & Neonatology Authors: Alan M. Hoberman, David K. Schreur, Tyra Leazer, George P. Daston, Philip Carthew, Thomas Re, Linda Loretz, Peter Mann Source Type: journals
Developmental toxicity assessment of thermoresponsive poly(N-isopropylacrylamide-co-acrylamide) oligomers in CD-1 mice
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CONCLUSIONS: At the highest dosages employed, maternal exposure to P(NIPAAm-co-AAm) was associated with decreased fetal weight. However, as the estimated human exposure levels for persons using this system would be some 1,500-fold lower than the lowest dosage administered in this study, the authors feel that this oligomer was not shown to pose a biologically significant risk at relevant human dosages. Birth Defects Res (Part B), 2008. © 2008 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - April 7, 2008 Category: Perinatology & Neonatology Authors: Induvadana Ankareddi, Melissa M. Bailey, Christopher S. Brazel, Jane F. Rasco, Ronald D. Hood Source Type: journals
Results of the negative control chemical allyl alcohol in the 15-day intact adult male rat screening assay for endocrine activity
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Development, standardization, and validation of methods to assess the potential of chemicals to disrupt hormonal homeostasis have been the focus of considerable research efforts over the past 10 years. As part of our validation effort, we evaluated the specificity of the 15-day intact adult male rat assay, using a negative control chemical, allyl alcohol, a known hepatotoxicant that was not expected to induce endocrine effects. Male rats were dosed for 15 days via oral gavage with 0, 10, 30, 40, or 50 mg/kg/day allyl alcohol. The endpoints evaluated included final body and organ weights, serum hormone concentrations, and a...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 28, 2008 Category: Perinatology & Neonatology Authors: John C. O'Connor, M. Sue Marty, Richard A. Becker, Suzanne Snajdr, A. Michael Kaplan Source Type: journals
Casimer T. Grabowski: 1927-2007
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No Abstract (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 27, 2008 Category: Perinatology & Neonatology Authors: George P. Daston, John M. Rogers Source Type: journals
Assessment of the Embryonic Stem Cell Test and application and use in the pharmaceutical industry
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CONCLUSIONS: The assay as currently constructed has a significant false-positive rate ([sim]40%), but a very low false-negative rate ([sim]7%). Additional moderate- and high-risk compounds need to be assessed to increase confidence, accuracy, and understanding in the EST's predictivity. Birth Defects Res (Part B), 2008. © 2008 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 24, 2008 Category: Perinatology & Neonatology Authors: Jennifer A. Paquette, Steven W. Kumpf, Randal D. Streck, Jason J. Thomson, Robert E. Chapin, Donald B. Stedman Source Type: journals
Implications for tooth development on ENU-induced ectodermal dysplasia mice
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CONCLUSIONS: The affected gene in ENU-induced ED mice showed several defects in ectodermal organogenesis and these results indicate that this gene plays an important role in mouse embryogenesis. Birth Defects Res (Part B) 2008. © 2008 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 21, 2008 Category: Perinatology & Neonatology Authors: Yeun-Jung Kim, Jae-Young Kim, Jae-Woo Cho, Dal-Sun Cha, Min-Jung Lee, Tadokoro Osamu, Hyuk-Jae Kwon, Kyu-Hyuk Cho, Joon H. Lee, Chang-Woo Song, Han-Sung Jung Source Type: journals
Proteomic analysis of selenium embryotoxicity in cultured postimplantation rat embryos
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CONCLUSION: The identified proteins with quantitative changes by selenate or selenite were considered to be candidate proteins involved in Se embryotoxicity: the actin-binding proteins for selenate embryotoxicity, proteins with the similar changes for the common Se embryotoxicity and antioxidant proteins for modification of Se embryotoxicity by redox-related treatments. These proteins may also be used as biomarkers in developmental toxicity studies. Birth Defects Res (Part B), 2008. © 2008 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 20, 2008 Category: Perinatology & Neonatology Authors: Makoto Usami, Katsuyoshi Mitsunaga, Ken Nakazawa, Osamu Doi Source Type: journals
Maternal and infantile dietary salt exposure may cause hypertension later in life
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No Abstract (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 10, 2008 Category: Perinatology & Neonatology Authors: Yalcin Tekol Source Type: journals
Evaluation of embryo-fetal development in rats housed in concrete or hwangto cages during pregnancy
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CONCLUSIONS: Overall, the exposure of pregnant rats to a concrete building environment under cool temperatures has adverse effects on the clinical signs, body weight, organ weight, and embryo-fetal development. On the other hand, exposure to a hwangto building environment does not have any adverse effects on pregnant dams or on embryo-fetal development in rats. Birth Defects Res (Part B), 2008. © 2008 Wiley-Liss, Inc. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - January 17, 2008 Category: Perinatology & Neonatology Authors: J. C. Lee, T. H. Ahn, Y. S. Yang, C. J. Moon, S. H. Kim, Y. B. Kim, S. C. Park, J. C. Kim Source Type: journals
