Test No. 443: Extended One-Generation Reproductive Toxicity Study PDF Download
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Author: OECD
Publisher: OECD Publishing
ISBN: 9264122559
Category :
Languages : en
Pages : 25
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Book Description
This Test Guideline is designed to provide an evaluation of reproductive and developmental effects that may occur as a result of pre- and postnatal chemical exposure as well as an evaluation of systemic toxicity in pregnant and lactating females and ...
Author: OECD
Publisher: OECD Publishing
ISBN: 9264122559
Category :
Languages : en
Pages : 25
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Book Description
This Test Guideline is designed to provide an evaluation of reproductive and developmental effects that may occur as a result of pre- and postnatal chemical exposure as well as an evaluation of systemic toxicity in pregnant and lactating females and ...
Author:
Publisher:
ISBN: 9789294952271
Category :
Languages : en
Pages : 10
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Book Description
The extended one-generation reproductive toxicity study (EOGRTS) is a modular test method where breeding and assessment of a second filial (F2) generation and testing for developmental neurotoxicity (DNT) and developmental immunotoxicity (DIT) are distinct and independent modules. The appropriate study design needs to be defined, justified and documented. Specification is required for the: - length of the premating exposure duration and dose level selection, - need to extend Cohort 1B to include the mating of F1 animals to produce a F2 generation, - need to include the DNT cohorts, and - need to include the DIT cohort. The information sources the Agency considers crucial for defining the EOGRTS design are discussed in this document in addition to aspects of triggering the study itself and its various designs.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264070842
Category :
Languages : en
Pages : 9
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Book Description
This Test Guideline for reproduction testing is designed to provide general information concerning the effects of a test substance (Solid, liquid, gas or vapour) on male and female reproductive performance. The test substance is administered orally ...
Author: OECD
Publisher: OECD Publishing
ISBN: 9264185372
Category :
Languages : en
Pages : 25
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Book Description
This Test Guideline is designed to provide an evaluation of reproductive and developmental effects that may occur as a result of pre- and postnatal chemical exposure as well as an evaluation of systemic toxicity in pregnant and lactating females and ...
Author: OECD
Publisher: OECD Publishing
ISBN: 9264070869
Category :
Languages : en
Pages : 13
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Book Description
This Test Guideline for two-generation reproduction testing is designed to provide general information concerning the effects of a test substance on the integrity and performance of the male and female reproductive systems, and on the growth and ...
Author:
Publisher:
ISBN: 9789294682628
Category :
Languages : en
Pages : 0
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Book Description
The focus of this project was to evaluate the performance of the extended one-generation reproductive toxicity study (EOGRTS) in terms of design, conduct, analysis, and reporting, and how the results support hazard assessment in the EU regulatory context. To achieve this, the study summaries of REACH registration dossiers and the corresponding full study reports of 55 EOGRTS were evaluated. The main findings highlighted issues related to identifying effect levels and reproductive toxicants/endocrine disruptors, using the F2 generation, selecting adequate dose levels, methodological aspects, reporting issues, and proficiency for conducting investigations. While the EOGRTS was found to be generally effective in identifying substances of concern and the F2 generation was deemed useful, some methodological issues were identified. The selection of inadequate dose levels was regularly observed, and the developmental immunotoxicity (DIT) and developmental neurotoxicity (DNT) cohorts were particularly challenging in terms of test laboratory proficiency. This report also includes two sections on recommendations to support test laboratories and sponsors to improve the design, conduct, analysis, and reporting of future EOGRTS.
Author: Ramesh C Gupta
Publisher: Academic Press
ISBN: 0123820332
Category : Medical
Languages : en
Pages : 1243
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Book Description
Reproductive toxicology is a complex subject dealing with three components—parent, placenta, and fetus—and the continuous changes that occur in each. Reproductive and Developmental Toxicology is a comprehensive and authoritative resource providing the latest literature enriched with relevant references describing every aspect of this area of science. It addresses a broad range of topics including nanoparticles and radiation, gases and solvents, smoking, alcohol and drugs of abuse, food additives, nutraceuticals and pharmaceuticals, and metals, among others. With a special focus on placental toxicity, this book is the only available reference to connect the three key risk stages, and is the only resource to include reproductive and developmental toxicity in domestic animals, fish, and wildlife. Provides a complete, integrated source of information on the key risk stages during reproduction and development Includes coverage of emerging science such as stem cell application, toxicoproteomics, metabolomics, phthalates, infertility, teratogenicity, endocrine disruption, surveillance and regulatory considerations, and risk assessment Offers diverse and unique in vitro and in vivo toxicity models for reproductive and developmental toxicity testing in a user-friendly format that assists in comparative analysis
Author: OECD
Publisher: OECD Publishing
ISBN: 9264070826
Category :
Languages : en
Pages : 14
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Book Description
This Test Guideline for developmental toxicity testing is designed to provide general information concerning the effects of prenatal exposure on the pregnant test animal and on the developing organism. The test substance is normally administered to ...
Author: Andrew G. Mtewa
Publisher: John Wiley & Sons
ISBN: 1119650232
Category : Science
Languages : en
Pages : 444
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Book Description
Focusing on phytochemicals and their potential for drug discovery, this book offers a comprehensive resource on poisonous plants and their applications in chemistry and in pharmacology. Provides a comprehensive resource on phytotoxins, covering historical perspectives, modern applications, and their potential in drug discovery Covers the mechanisms, benefits, risks and management protocols of phytotoxins in a scientific laboratory and the usefulness in drug discovery Presents chapters in a carefully designed, clear order, making it an ideal resource for the academic researcher or the industry professional at any stage in their career
Author:
Publisher:
ISBN:
Category : Lead
Languages : en
Pages : 584
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Book Description