replacement alternatives

/Tag:replacement alternatives

ECVAM’s Response to the Changing Political Environment for Alternatives: Consequences of the European Union Chemicals and Cosmetics Policies

Thomas Hartung, Susanne Bremer, Silvia Casati, Sandra Coecke, Raffaella Corvi, Salvador Fortaner, Laura Gribaldo, Marlies Halder, Annett Janusch Roi, Pilar Prieto, Enrico Sabbioni, Andrew Worth and Valerie Zuang

The European Centre for the Validation of Alternative Methods (ECVAM) has restructured its services by directly targeting the animal tests that need to be replaced. In view of the short time-lines for making available and implementing validated methods, ECVAM is offering to steer the process by bringing together the inputs of stakeholders and encouraging the early involvement of regulators. In essence, steering groups formed by ECVAM senior staff, and complemented with external experts, will carry out the project management and will coordinate the various inputs.
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A Survey of Stakeholder Organisations on the Proposed New European Chemicals Policy

Jennifer Dandrea and Robert D. Combes

In February 2001, the European Commission published a White Paper proposing that a single new system of chemical regulation should be applied throughout the Member States of the European Union. The proposed Registration, Evaluation and Authorisation of Chemicals (REACH) system was to include both new and existing chemicals, with the aim of ensuring that sufficient pertinent data were made available to enable human health and the environment to be protected. The policy was founded on the principle of sustainable industrial development, and ambitiously attempted to incorporate the needs and views of key stakeholder organisations, such as industry, trade associations, consumer groups, environmentalists, animal welfarists and Member State governments. During the period between the publication of the White Paper and the on-line publication of consultation documents, as part of a public consultation exercise, in May 2003, many of these key stakeholder organisations produced material in support of or critical of the White Paper, either in part or as a whole. In this paper, we have attempted to review this extensive material and to present it in the context of the current chemical regulatory system that the REACH system will replace. Emphasis is placed on the impact of the new policy on the number of animals used in the testing regimes within the REACH system and the inclusion of alternative methods into the legislation. Although supportive of the overriding aims of the new policy, FRAME believes that the fundamental concept
of a risk-free environment is flawed, and that the new REACH system will involve the unjustifiable use of millions of laboratory animals. The new policy does include alternative methods, particularly for baseset substances. Nevertheless, alternative testing methods that are already available have been excluded and replaced with outdated in vivo versions. There is also insufficient detail with regard to the further development and validation of alternative methods, particularly for substances of high concern, such as endocrine disrupters or reproductive toxins, for which no alternative testing methods currently exist.
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Botulinum Toxin Testing in Animals: The Questions Remain Unanswered

Michael Balls

Questions are raised concerning the testing of botulinum toxin in animals, and the British Government’s answers to Parliamentary Questions on this issue are reviewed, with an emphasis on the potential for reducing, refining and replacing the animal tests, which can involve substantial severity, and on the responsibility of the Home Office so see that the Three Rs approach is fully applied in this specific case.
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Report of a Meeting to Discuss a National Centre for the Replacement of Animals in Experiments

Christine Brock, Gill Langley and Carol Newman

Following the publication of their joint proposal for a National Centre for the Replacement of Animals in Experiments in 2002, the Dr Hadwen Trust and the Lord Dowding Fund organised a meeting, held on 18 November 2003 at Portcullis House, Westminster, in London, in order to discuss the concept further. A one-page summary of their proposal is attached as an appendix, and full copies are available from the Lord Dowding Fund and the Dr Hadwen Trust. The meeting aimed to discuss the need to stimulate and promote research to replace animal experiments by means of a National Centre (a coordinating body), and how this should be established and funded. Participants, numbering about 80 in total, included politicians (national and European), government officials, scientists, funding bodies and animal welfare representatives. This report is a summary of the issues raised by speakers and other participants at the meeting.
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Assessment of the Eye Irritating Properties of Chemicals by Applying Alternatives to the Draize Rabbit Eye Test: The Use of QSARs and In Vitro Tests for the Classification of Eye Irritation

Ingrid Gerner, Manfred Liebsch and Horst Spielmann

Huggins has reported on the current situation relating to the development of alternatives to the Draize eye irritation test with rabbits, and an ECVAM Working Group have reviewed the efforts needed in order to replace this animal test within the next 10 years by using the results of non-animal assessment methods. Our report reviews regulatory experience gained over the last 20 years with the EU chemicals notification procedure with respect to the assessment of eye lesions observed in Draize tests. The nature of eye lesions and their importance for classification and labelling of possible hazards to human eyes are evaluated and discussed, with a view to promoting the development of specific in vitro assays which are able to discriminate between eye damage, moderate eye irritation, and minor irritation effects which are completely reversible within a few days. Structural alerts for the prediction of eye irritation/corrosion hazards to be classified and labelled according to international classification criteria, are presented, which should be validated in accordance with internationally agreed (OECD) principles for (Q)SAR system validation. Physicochemical limit values for prediction of the absence of any eye irritation potential relevant for human health can make available a definition of the applicability domains of alternative methods developed for the replacement of the Draize eye irritation test.
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A Survey of Stakeholder Organisations on the Proposed New European Chemicals Policy

Jennifer Dandrea and Robert D. Combes

In February 2001, the European Commission published a White Paper proposing that a single new system of chemical regulation should be applied throughout the Member States of the European Union. The proposed Registration, Evaluation and Authorisation of Chemicals (REACH) system was to include both new and existing chemicals, with the aim of ensuring that sufficient pertinent data were made available to enable human health and the environment to be protected. The policy was founded on the principle of sustainable industrial development, and ambitiously attempted to incorporate the needs and views of key stakeholder organisations, such as industry, trade associations, consumer groups, environmentalists, animal welfarists and Member State governments. During the period between the publication of the White Paper and the on-line publication of consultation documents, as part of a public consultation exercise, in May 2003, many of these key stakeholder organisations produced material in support of or critical of the White Paper, either in part or as a whole. In this paper, we have attempted to review this extensive material and to present it in the context of the current chemical regulatory system that the REACH system will replace. Emphasis is placed on the impact of the new policy on the number of animals used in the testing regimes within the REACH system and the inclusion of alternative methods into the legislation. Although supportive of the overriding aims of the new policy, FRAME believes that the fundamental concept of a risk-free environment is flawed, and that the new REACH system will involve the unjustifiable use of millions of laboratory animals. The new policy does include alternative methods, particularly for baseset substances. Nevertheless, alternative testing methods that are already available have been excluded and replaced with outdated in vivo versions. There is also insufficient detail with regard to the further development and validation of alternative methods, particularly for substances of high concern, such as endocrine disrupters or reproductive toxins, for which no alternative testing methods currently exist.
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The FRAME Research Programme Under the Direction of Dr Richard Clothier

Robert D. Combes

The work of Dr Richard Clothier (Reader in Cellular Toxicology and Director of the FRAME Alternatives Laboratory in the University of Nottingham Medical School) in relation to the FRAME Research Programme, is reviewed. He made a very substantial contribution to FRAME’s laboratory research work over the last 20 years, by publishing many research papers, mainly with respect to method development and the application of new replacement toxicity test methods, particularly those involving the use of human cells in tissue culture. In addition, he participated in a number of international validation studies that have facilitated the regulatory acceptance of certain new methods. Lastly, he has been closely involved in the logistical aspects of obtaining and maintaining external research funding for FRAME from industrial sponsors.
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