Alternatives to animal testing / editors, R.E. Hester and R.M. Harrison ; [contributors, Michael Balls... and others].

Format:

Book

Contributor:

Hester, R. E. (Ronald E.)

Harrison, Roy M., 1948-

Balls, Michael, 1938-

Royal Society of Chemistry (Great Britain)

Series:

Issues in environmental science and technology 1350-7583 ; 23.

Issues in environmental science and technology, 1350-7583 ; 23

Language:

English

Subjects (All):

Alternative toxicity testing.

Animal experimentation.

Physical Description:

x, 123 pages : illustrations ; 25 cm.

Place of Publication:

Cambridge : Royal Society of Chemistry, [2006]

Summary:

Animal experimentation has long been a controversial issue with impassioned arguments on both sides of the debate. Increasingly it has become more expedient and feasible to develop new methods that avoid the use of animals. There is agreement on both sides that reduction and refinement of experiments on animals should be an important goal for the industries involved.

Alternatives to Animal Testing, written by leading experts in the field, discusses the issues involved and approaches that can be taken. Topics include; the safety evaluation of chemicals, international validation and barriers to the validation of alternative tests, in vitro testing for endocrine disruptors, intelligent approaches to safety evaluation of chemicals, alternative tests and the regulatory framework. The book provides an up-to-date discussion of the current state of development of alternatives to animal testing and is ideal for professionals and academics in the field. It would also be of use for graduate students wishing to pursue a career in the pharmaceutical and cosmetic industry.

Contents:

General Overview of the Safety Evaluation of Chemicals / Paul Illing 1

2 Legislation and Regulatory Requirements 2

3 The Regulatory Paradigm 4

4 The Interface between Toxicology and Risk Assessment 11

5 Interpreting Toxicology 15

International Validation and Barriers to the Validation of Alternative Tests / Michael Balls 28

2 Background to the Validation Process 29

3 The Validation Process 30

4 Problems being Encountered in Implementing the Validation Process 34

5 The Need for an Invalidation Process 46

In Vitro Testing for Endocrine Disruptors / Robert D. Combes 53

2 In Silico Approaches 57

3 In Vitro Tests for EDs 59

Intelligent Approaches to Safety Evaluation / Derek J. Knight 74

2 Hazardous Properties Assessment 75

3 Risk Assessment 75

4 Existing Studies and Literature Data 79

5 Surrogate Data: Calculation, Read Across and SAR/QSAR 80

6 Alternatives to Animal Toxicology Studies 81

7 Data Waivers 82

8 Expert Reports and Weight of Evidence 84

9 Preliminary Risk Assessments 85

10 EU Registration, Evaluation and Registration Scheme (REACH) 85

11 Data for REACH 87

12 Regulatory Planning & Liaison with the Regulators 90

13 Common Themes 92

Alternative Tests and the 7th Amendment to the Cosmetics Directive / Carl Westmoreland 95

2 Overview of Current Approaches to Risk Assessment for Cosmetics 95

3 7th Amendment to the EU Cosmetics Directive (76/768/EEC) 99

4 Status of Alternative Tests 100

5 Endpoints where Risk Assessment for Cosmetics can be Achieved without using Animal Data 103

6 Endpoints where Risk Assessment for Cosmetics cannot currently be Achieved without using Animal Data 106

7 New Approaches to Risk Assessment without Animals 114.

Notes:

Includes bibliographical references and index.

ISBN:

0854042113

OCLC:

70885520

Publisher Number:

9780854042111