Alternatives to Animal Testing

by Hester, R. E.; Harrison, R. M.

• ISBN13: 9780854042111
• ISBN10: 0854042113
• Format: Hardcover
• Copyright: 2006-07-25
• Publisher: Royal Society of Chemistry

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 cosmetics industries.

Table of Contents

General Overview of the Safety Evaluation of Chemicals	1	(27)
Paul Illing
1 Introduction	1	(1)
2 Legislation and Regulatory Requirements	2	(2)
3 The Regulatory Paradigm	4	(7)
4 The Interface between Toxicology and Risk Assessment	11	(4)
5 Interpreting Toxicology	15	(9)
6 Conclusions	24	(1)
References	25	(3)
International Validation and Barriers to the Validation of Alternative Tests	28	(25)
Michael Balls
1 Introduction	28	(1)
2 Background to the Validation Process	29	(1)
3 The Validation Process	30	(4)
4 Problems being Encountered in Implementing the Validation Process	34	(12)
5 The Need for an Invalidation Process	46	(4)
6 Concluding Remarks	50	(1)
References	50	(3)
In Vitro Testing for Endocrine Disruptors	53	(21)
Robert D. Combes
1 Introduction	53	(4)
2 In Silky Approaches	57	(2)
3 In Vitro Tests for EDs	59	(3)
4 Discussion	62	(6)
5 Conclusions	68	(1)
Acknowledgement	69	(1)
References	69	(5)
Intelligent Approaches to Safety Evaluation	74	(21)
Derek J. Knight
1 Introduction	74	(1)
2 Hazardous Properties Assessment	75	(1)
3 Risk Assessment	75	(4)
4 Existing Studies and Literature Data	79	(1)
5 Surrogate Data: Calculation, Read Across and SAR/QSAR	80	(1)
6 Alternatives to Animal Toxicology Studies	81	(1)
7 Data Waivers	82	(2)
8 Expert Reports and Weight of Evidence	84	(1)
9 Preliminary Risk Assessments	85	(1)
10 EU Registration, Evaluation and Registration Scheme (REACH)	85	(2)
11 Data for REACH	87	(3)
12 Regulatory Planning & Liaison with the Regulators	90	(2)
13 Common Themes	92	(1)
Acknowledgements	93	(1)
References	93	(2)
Alternative Tests and the 7th Amendment to the Cosmetics Directive	95	(24)
Carl Westmoreland
1 Introduction	95	(1)
2 Overview of Current Approaches to Risk Assessment for Cosmetics	95	(4)
3 7th Amendment to the EU Cosmetics Directive (76/768/EEC)	99	(1)
4 Status of Alternative Tests	100	(3)
5 Endpoints where Risk Assessment for Cosmetics can be Achieved without using Animal Data	103	(3)
6 Endpoints where Risk Assessment for Cosmetics cannot currently be Achieved without using Animal Data	106	(8)
7 New Approaches to Risk Assessment without Animals	114	(1)
Acknowledgements	115	(1)
Abbreviations	115	(1)
References	115	(4)
Subject Index	119