How ECHA Identifies the Design for the Extended One-generation Reproductive Toxicity Study (EOGRTS) Under Dossier Evaluation PDF Download

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: 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: 9264304746
Category :
Languages : en
Pages : 692

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Book Description
This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals.

Author: OECD
Publisher: OECD Publishing
ISBN: 9264070966
Category :
Languages : en
Pages : 10

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Book Description
The test substance is administered in graduated doses to several groups of males and females. Males should be dosed for a minimum of four weeks. Females should be dosed throughout the study, so approximately 54 days. This Test Guideline is designed ...

Author: Qasim Chaudhry
Publisher: Royal Society of Chemistry
ISBN: 1788011368
Category : Technology & Engineering
Languages : en
Pages : 314

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Book Description
Nanotechnologies in Food provides an overview of the products and applications of nanotechnologies in agri-food and related sectors. Following on from the success of the first edition, this new edition has been revised and updated to bring the reader fully up to date on the emerging technological, societal, and policy and regulatory aspects in relation to nanotechnologies in food. This book contains new chapters discussing some of the aspects that have attracted a lot of debate and research in recent years, such as how the regulatory definition of ‘nanomaterial’ is shaping up in Europe and whether it will result in a number of exciting food additives being regarded as nanomaterials, how the new analytical challenges posed by manufactured nanoparticles in food are being addressed and whether the emerging field of nano delivery systems for food ingredients and supplements, made of food materials or other soft/degradable polymers, can raise any consumer safety concerns. The edition concludes by discussing the future trends of the technological developments in the area of nanotechnologies and potential future ‘fusion’ with other fields, such as biotechnology and synthetic biology. This book provides a source of much needed and up-to-date information on the products and applications of nanotechnology for the food sector - for scientists, regulators, and consumers alike. It also gives an independent, balanced, and impartial view of the potential benefits as well as risks that nanotechnology applications may bring to the food sector. Whilst providing an overview of the state-of-the-art and foreseeable applications to highlight opportunities for innovation, the book also discusses areas of uncertainty in relation to public perception of the new technological developments, and potential implications for consumer safety and current regulatory controls. The book also discusses the likely public perceptions of nanotechnologies in the light of past technological developments in the food sector, and how the new technology will possibly be regulated under the existing regulatory frameworks.

Author: OECD
Publisher: OECD Publishing
ISBN: 9264304797
Category :
Languages : en
Pages : 206

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Book Description
In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...

Author: Lynn L. Bergeson
Publisher: American Bar Association
ISBN: 9781634258333
Category : Law
Languages : en
Pages : 329

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Book Description
"With the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016, the main body of chemical management law in the United States changed dramatically. This guide summarizes the new law, highlights the changes that will have the greatest impact, and offers pertinent analysis on the implementation of the new law."--

Author: M. L. Richardson
Publisher: Elsevier
ISBN: 1782424954
Category : Technology & Engineering
Languages : en
Pages : 415

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Book Description
This volume of proceedings reviews the status of risks entailed in the manufacture, handling, use and disposal of the chemicals on which we all depend and suggests further action for the protection of both the workplace and the natural environment.

Author: James Njuguna
Publisher: Elsevier
ISBN: 0857096672
Category : Technology & Engineering
Languages : en
Pages : 345

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Book Description
Health and Environmental Safety of Nanomaterials addresses concerns about the impact of nanomaterials on the environment and human health, and examines the safety of specific nanomaterials. Understanding the unique chemical and physical properties of nanostructures has led to many developments in the applications of nanocomposite materials. While these materials have applications in a huge range of areas, their potential for toxicity must be thoroughly understood. Part one introduces the properties of nanomaterials, nanofillers, and nanocomposites, and questions whether they are more toxic than their bulk counterparts. Part two looks at the release and exposure of nanomaterials. The text covers sampling techniques and data analysis methods used to assess nanoparticle exposure, as well as protocols for testing the safety of polymer nanocomposites. It explains characterization techniques of airborne nanoparticles and life cycle assessment of engineered nanomaterials. Part three focuses on the safety of certain nanomaterials, including nanolayered silicates, carbon nanotubes, and metal oxides. In particular, it explores the potential ecotoxicological hazards associated with the different structures of carbon nanotubes and the safe recycling of inorganic and carbon nanoparticles. The final two chapters address the risks of nanomaterials in fire conditions: their thermal degradation, flammability, and toxicity in different fire scenarios. This is a scientific guide with technical background for professionals using nanomaterials in industry, scientists, academicians, research scholars, and polymer engineers. It also offers a deep understanding of the subject for undergraduate and postgraduate students. Introduces the properties of nanomaterials, nanofillers, and nanocomposites, and questions whether they are more toxic than their bulk counterparts Covers sampling techniques and data analysis methods used to assess nanoparticle exposure, as well as protocols for testing the safety of polymer nanocomposites Explores the potential ecotoxicological hazards associated with the different structures of carbon nanotubes and the safe recycling of inorganic and carbon nanoparticles

Author: OECD
Publisher: OECD Publishing
ISBN: 9264071202
Category :
Languages : en
Pages : 18

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Book Description
The objective of these chronic toxicity studies is to characterize the profile of a substance in a mammalian species (primarily rodents) following prolonged and repeated exposure. The Test Guideline focuses on rodents and oral administration. Both ...