• To assist in evaluating reproductive toxicity and the effect on the development of the embryo-fetus, the US Food and Drug Administration (FDA) has announced final guidance for industry on reproductive toxicity testing and labeling recommendations for oncologic drugs. (medscape.com)
  • Although not binding, the new guidance provides recommendations on evaluating toxicity to the growing embryo/fetus for various types of pharmaceuticals and on whether an assessment of reproductive toxicity is warranted for products used by specific patient populations (eg, drugs used only by men or only by postmenopausal women). (medscape.com)
  • The FDA's new guidance, however, does not address the risks of reproductive toxicity from radiopharmaceuticals, cellular and gene therapy products, cancer vaccines, biosimilar or interchangeable products, or generic drugs. (medscape.com)
  • The FDA notes that when the weight of evidence clearly shows reproductive toxicity for a given drug, there is no need to conduct a dedicated embryo-fetal development (EFD) study. (medscape.com)
  • This type of specific research that looks for malformations in fetal development is called Developmental and Reproductive Toxicology (DART) Testing for developmental toxicant is done in different stages: Fertilization to implantation - Fertilization followed by increase in cell number, cleavage and cavitation to form the blastocyst which gets implanted. (wikipedia.org)
  • Sparks' interest in toxicology took root during a developmental biology course in college. (nih.gov)
  • The results of these meetings have been compiled and presented in a form which is likely to be of most benefit to professionals working in the field of developmental toxicology. (bund.de)
  • During the last two years, a new version of the Terminology in Developmental Toxicology was developed by the Teratology Society, the European and the Japanese Teratology Societies and afterwards published in all three Societies' journals, which will be integrated into the current lexicon. (bund.de)
  • In April 2017, Developmental and Reproductive Toxicology Technical Committee of the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) hold a workshop to address the question of adopting an alternative approach to address the developmental toxicity other than that of experimenting on the pregnant laboratory animals. (alliedacademies.org)
  • Such models are the future of developmental testing and foundations of predictive toxicology. (alliedacademies.org)
  • Reproductive and developmental toxicity of metals : proceedings of a joint meeting organized by the Division of Toxicology, University of Rochester, and the Scientific Committee on the Toxicology of Metals of the Permanent Commission and the International Association on Occupational Health and cosponsored by the World Health Organization, held May 24-27, 1982, in Rochester, New York / edited by Thomas W. Clarkson, Gunnar F. Nordberg and Polly R. Sager. (who.int)
  • Developmental effects are among the most important and least well-understood concerns in toxicology. (nih.gov)
  • There is no knowledge of which congeners interact with receptors (other than AHR), induce CYPs or exert toxicity in premier nonmammalian models for developmental and environmental toxicology (zebrafish, Danio rerio and killifish, Fundulus heterociitus ). (nih.gov)
  • The Frog Embryo Teratogenesis Assay-Xenopus (FETAX) was considered for use as a developmental toxicity screen. (nih.gov)
  • The Virtual Embryo like approaches may help reliable prediction and fast chemical risk assessment for the developmental toxicity testing domain. (alliedacademies.org)
  • Developmental toxicity is all about knowing the adverse outcomes of a chemical on the developing embryo. (alliedacademies.org)
  • Objectives: The present study aimed to investigate the acute toxicity and the developmental alterations induced by triclosan (TCS) exposure in zebrafish early-life stages using fish embryo acute toxicity tests as a methodological approach. (unite.it)
  • Of the forms of mercury in this study, the organic form (MeHg) proved the most toxic followed by inorganic mercury (HgCl2), both producing embryo developmental toxicity. (virginia.edu)
  • 21 ] reported that there were no marked toxicities in examinations including macroscopic findings, cesarean section parameters, fetal morphological findings in prenatal developmental toxicity study for TiO 2 nanoparticles (primary size: 17.8±5.46 nm) [ 21 ]. (eaht.org)
  • The soil extract fractions were tested for genotoxicity using the DT40 chicken lymphocyte bioassay and developmental toxicity using the embryonic zebrafish (Danio rerio) bioassay. (oregonstate.edu)
  • New insights into triazole fungicide-caused hematopoietic abnormality in zebrafish based on GRα screening developmental toxicity. (bvsalud.org)
  • Material and Methods: Zebrafish embryos were exposed to five concentrations of TCS and the four lethal alterations were daily recorded to determine the toxicological endpoints of acute toxicity. (unite.it)
  • Conclusion: The data confirmed the developmental toxicity of TCS on aquatic organisms and the sublethal alterations developed by zebrafish larvae, indicated its cardiotoxicity and neurotoxicity. (unite.it)
  • Moreover, the developmental toxicity was strongly influenced by the concentration tested and the number of survived zebrafish developing this alteration varying according to the time of exposure. (unite.it)
  • To control the pandemic of developmental neurotoxicity, we propose a global prevention strategy. (drkyle.com)
  • Untested chemicals should not be presumed to be safe to brain development, and chemicals in existing use and all new chemicals must therefore be tested for developmental neurotoxicity. (drkyle.com)
  • These studies usually involve exposing laboratory animals (rats and mice) for 3 months to evaluate the toxicity, but exposure can be any duration less than one year. (nih.gov)
  • This study was performed to obtain safety data for new TiO 2 powder, GST (Green Sludge Titanium) produced through sludge recycling of the sewage treatment plant for Reproduction/developmental toxicity screening test in Sprague-Dawley (SD) rats in according to the OECD test guideline (TG 421). (eaht.org)
  • Based on the results of the dose-range finding study (14-day repeated toxicity), GST was orally administered to rats at doses of 0, 500, 1000, and 2000 mg/kg B.W/day. (eaht.org)
  • In a GLP study conducted according to OECD guideline 422, three groups, each comprising of ten male and ten female rats for the Main (reproductive) phase and five female rats for the Toxicity phase received the test item at doses of 100, 300 or 1000 mg/kg/day at a dose volume of 5 mL/kg/day. (europa.eu)
  • 2,3-Dichloro-1,3-butadiene (DCBD): Inhalation Developmental Toxicity Study in Rats. (epa.gov)
  • 24-Month Combined Chronic Toxicity and Oncogenicity Whole Body Vapor Inhalation Study of Octamethylcyclo-Tetrasiloxane (D4) in Fischer 344 Rats. (epa.gov)
  • 7 Final Reports from the Subchronic (39 Week) Inhalation Toxicity Study of Silicon Carbide Fibers in Rats and a Summary by an Arco Chem. (epa.gov)
  • 90-day Repeated Inhalation Toxicity Study of Cumene Hydroperoxide in Rats with Cover Letter dated 041086. (epa.gov)
  • Acute (4-Hour) Inhalation Toxicity Study with an Aerosol of SILRES(reg) BS 29 A (5% Actives) in Rats. (epa.gov)
  • Acute (4-Hour) Inhalation Toxicity Study with an Aerosol of Wacker Finish WR 1300 in Rats. (epa.gov)
  • Acute (4-Hour) Inhalation Toxicity Study with Dynasylan VPS 8815 in Rats. (epa.gov)
  • No effects on fertility became obvious in a one-generation reproduction toxicity study on rats following parameters of OECD 416. (europa.eu)
  • dose selection was based on results of a subacute toxicity study in Wistar rats with 100 -1000 ppm in the diet. (europa.eu)
  • This one-generation reproduction toxicity study was not only performed according to OECD 415 (1983), but also parameters of OECD 416 of 2001 were included taking into account the updated guideline requirements. (europa.eu)
  • Assessment of developmental toxicity: neuropsychological batteries. (nih.gov)
  • The DevTox project comprises the development of a lexicon and a data base as an electronic resource to support the assessment of developmental toxicity studies and classification and labelling of developmental anomalies with regard to the human health risk assessment procedure of plant protection products, biocides, other chemicals and chemical products. (bund.de)
  • Being not only a resource but also a preliminary prediction for multiple chemicals, this is a next generation tool to move towards the laboratory animal free era of testing drug toxicity [ 3 ]. (alliedacademies.org)
  • These findings provide new insights into the developmental toxicity and ecotoxicological risk of TFs. (bvsalud.org)
  • Our findings suggest that toxicity of binary mixtures of IM and TM is primarily driven by IM, and that mixtures of IM with TM do not appear to cause significant additive toxicity when compared with our previous studies evaluating each neonicotinoid alone. (frontiersin.org)
  • The NOAEL for reproductive/developmental screening toxicity was concluded to be 2000 mg/kg/day under the present study conditions. (eaht.org)
  • However, there is little toxicological information during reproduction and developmental period. (eaht.org)
  • NICEATM supports efforts to develop, validate, and implement alternatives to animal testing to identify potential developmental toxicants. (nih.gov)
  • The effect of the developmental toxicants depends on the type of substance, dose, duration, and time of the exposure. (wikipedia.org)
  • Acute Oral and Vapor Toxicity of Dinonylphenol with Cover Letter Dated 05/20/1996. (epa.gov)
  • PFHxS toxicity was further investigated in combination with exposure to a human-relevant mixture of 12 endocrine disrupting chemicals. (dtu.dk)
  • Total RNA was extracted from survivors three days after exposure to MeHg (0.1 µM), HgCl2 (1 µM), α-HgS (10 µM), or β-HgS (10 µM) to examine toxicity-related gene expression. (virginia.edu)
  • 13-Week Inhalation Toxicity Study (with a 4-Week Recovery) of Caprolactam (494-95A) in the Rat via Whole-Body Exposure with Cover Letter Dated 04/30/1997. (epa.gov)
  • The contact toxicities of extracts of anise (Pimpinella anisum L.), coriander (Coriandrum sativum L.), cumin (Cuminum cyminum L.), dill (Anethum graveolens) and fennel (Foeniculum vulgare Mill. (sdu.edu.tr)
  • Transgenic Mouse Models Transferred into the Test Tube: New Perspectives for Developmental Toxicity Testing In Vitro? (norecopa.no)
  • Innovative in vitro toxicity screening assays aimed at reducing or replacing the use of animal models are required for the REACH initiative (Europe) and Tox21 initiative (US) to evaluate thousands of chemicals for safety. (stemina.com)
  • We have created a predictive, human in vitro pluripotent stem cell-based developmental toxicity assay that can reduce costs, animal and compound use, and has potential to increase pharmaceutical and chemical safety. (stemina.com)
  • Toxicity data were found for five of these compounds (thallium sulfate, thallium oxide, thallium nitrate, thallium acetate, and thallium carbonate). (cdc.gov)
  • The toxicity of chromium compounds depends on the oxidation state of the metal. (cdc.gov)
  • Induced pluripotent stem (iPS) cells were exposed to 8 concentrations of 66 pharmaceutical, environmental and industrial compounds that have been associated with developmental toxicity or considered to be free of developmental toxicity. (stemina.com)
  • This study examined developmental toxicity of different mercury compounds, including some used in traditional medicines. (virginia.edu)
  • Chemical forms of mercury compounds proved to be a major determinant in their developmental toxicity. (virginia.edu)
  • The term developmental toxicity has widely replaced the early term for the study of primarily structural congenital abnormalities, teratology, to enable inclusion of a more diverse spectrum of congenital disorders. (wikipedia.org)
  • The increased toxicity measured postbioremediation is not likely due to the 88 PAHs measured in this study (including quinones), because most were not present in the toxic polar fractions and/or because their concentrations did not increase postbioremediation. (oregonstate.edu)
  • There was no maternal mortality during the study and there was no dose-related increase in the incidence of clinical signs of toxicity. (nih.gov)
  • 14-Day Range-Finding Vapor Inhalation Toxicity Study with Dow Corning 244 Fluid (Octamethylcyclotetrasiloxane) in the Rat with Cover Letter Dated 04/20/1994. (epa.gov)
  • 90-day Subacute Aerosol Inhalation Toxicity Study with Octamethylcyclotetrasiloxane in Cynomolgus Monkeys. (epa.gov)
  • Acue Oral Toxicity Study with Attached Cover Letter. (epa.gov)
  • Our study for the first time has shown the feasibility of using ES cells in the developmental toxicity testing of remedies. (positivehealth.com)
  • Advancing alternatives to animal testing for developmental toxicity is a top concern of NICEATM. (nih.gov)
  • Recognition of the developmental toxic effects of various molecules is recent development. (wikipedia.org)
  • There are a number of chemicals, biological agents (such as bacteria and viruses), and physical agents (such as radiation) used in a variety of workplaces that are known to cause developmental disorders. (wikipedia.org)
  • The more than 80,000 chemicals in commerce present a challenge for hazard assessments that toxicity testing in the 21st century strives to address through high-throughput screening (HTS) assays. (nih.gov)
  • Virtual Tissue Models: Predicting how chemicals impact development are the developmental models simulating critical development steps used to predict the way a chemical may affect a human development. (alliedacademies.org)
  • In 2006, we did a systematic review and identified five industrial chemicals as developmental neurotoxicants: lead, methylmercury, polychlorinated biphenyls, arsenic, and toluene. (drkyle.com)
  • Evaluation of 1066 Toxcast Chemicals in a Human Stem Cell Assay for Developmental. (stemina.com)
  • The long-term goal of the research team led by John Stegeman, Ph.D., is to identify and understand developmental effects of chemicals that are abundant at Superfund sites, and molecular participants in effects. (nih.gov)
  • Researchers have been able to ascertain toxicity associated with abnormal development with new breakthrough in developmental biology. (wikipedia.org)
  • Mercury in any form is poisonous, with mercury toxicity most commonly affecting the neurologic, gastrointestinal (GI) and renal organ systems. (medscape.com)
  • Acute selenium toxicity can also be life threatening when the following symptoms occur: pulmonary oedema, comatose state, digestive tract disturbances, heart irregularities, and renal and liver dysfunction. (canada.ca)
  • Triazole fungicides (TFs) are known to be common environmental contaminants that can be toxic to aquatic animals , but their developmental toxicity is not fully understood. (bvsalud.org)
  • This PhD project therefore aimed at investigating the developmental toxicity of PFHxS, with an emphasis on the reproductive, the thyroid hormone and the immune systems. (dtu.dk)
  • We were not able to correlate the decreased thyroid hormone levels to behavioral effects in the offspring, but the literature suggests that the employed tests are insensitive measures of altered brain development due to developmental thyroid hormone reductions. (dtu.dk)
  • Until a suitable test for adverse effects due to developmental thyroid hormone disruption has been identified, a compromise designed to protect human cognition could be to regard decreased serum T4 as an adverse outcome in itself. (dtu.dk)
  • Developmental disorders can include a wide range of physical abnormalities, such as bone or organ deformities, or behavioral and learning problems, such as an intellectual disability. (wikipedia.org)
  • The 19th century saw developmental in descriptive embryology where abnormalities were now considered as malformations or errors during a developmental process giving rise to the concept of teratogenesis. (wikipedia.org)
  • Non-ortho (dioxin-like) PCBs bind to the aryl hydrocarbon receptor (AHR), induce cytochrome P4501 (CYPI) genes, and cause developmental abnormalities. (nih.gov)
  • These results indicate the lowest observed adverse effect level for MOXY-induced maternal toxicity was 80 mg/kg/day. (nih.gov)
  • NICEATM is exploring approaches to standardizing and automating collection of developmental toxicity data. (nih.gov)
  • Acrylate Toxicity Data for Ethyl Acrylate. (epa.gov)
  • Developmental toxicity tests evaluate the extent to which substances can interfere with normal development and cause adverse effects in the offspring. (nih.gov)
  • provide a historical control database of developmental effects in laboratory animals. (bund.de)
  • The NTP Toxicity Report Series (TOX) includes reports about short-term studies. (nih.gov)
  • Dose selection rationale: High dose same as used for repeated dose toxicity studies. (europa.eu)
  • Teratogenicity is one form of developmental toxicity, where a chemical causes permanent malformations. (opasnet.org)
  • Based on the above results, the developmental no observed adverse effect level for MOXY was greater than or equal to 105 mg/kg/day. (nih.gov)
  • Vevo ultra-high frequency imaging platforms provide superior resolution ideally suited for developmental and pregnancy research in small animals. (visualsonics.com)
  • To address this gap, we first used a glucocorticoid receptor α (GRα)-mediated dual luciferase reporter gene system to explore the possible development toxicity of ten TFs and found that flusilazole (FLU) exhibited stronger agonistic activity against GRα. (bvsalud.org)
  • The Biological systems are complex enough to be successfully modelled in a laboratory but still there are possible toxicity testing approaches that when adopted may help to reduce the animal testing. (alliedacademies.org)
  • A Biomarker Based Developmental Toxicity Screen Using Human Induced Pluripotent. (stemina.com)
  • If any signs or symptoms of toxicity develop during that time, admit the patient to the hospital. (medscape.com)