Inconsistencies in data requirements of EU legislation involving tests on animals

Wagner, Kristina

doi:10.14573/altex.2012.3.302

Cited by 6 publications

(4 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…To date, about 400 animal tests have been performed, without going through the proper consultation process (44). The uptake of available alternative methods into the Test Methods Regulation is painfully slow (45), and animal tests that could already have been replaced are still required. As a result, the 2014 ECHA report shows that, since 2009, more animal Including comprehensive lists of requirements to be fulfilled and functions to be performed tests than in vitro tests were carried out in experimental studies (Figure 6).…”

Section: The Eu Reach Regulationmentioning

confidence: 99%

How Long Must They Suffer? Success and Failure of our Efforts to End the Animal Tragedy in Laboratories

Kolar¹

2015

Altern Lab Anim

View full text Add to dashboard Cite

Scientific findings have revealed how much we have dramatically underestimated the intellectual, social and emotional capabilities of non-human animals, including their levels of self-consciousness and ability to suffer from psychological stress. In the 21st century, the field of animal ethics has evolved as a serious scientific discipline, and nowadays largely advocates that the way we treat animals, both legally and in practice, is morally wrong. Politics and legislation have reacted to these facts, to some extent, but neither current legislation nor current practice reflect the scientific and moral state-of-the-art. Too often, the will to change things is watered down in the decision-making process, e.g. in the drafting of legislation. In the field of animal experimentation there have been many genuine efforts by various players, to advance and apply the principles behind the Three Rs. However, the fundamental problem, i.e. the overall number of animals sacrificed for scientific purposes, has increased. Clearly, if we are serious about our will to regard animal experimentation as an ethical and societal problem, we have to put much more emphasis on addressing the question of how to avoid the use of animals in science. To achieve this goal, certain issues need to be considered: a) the present system of ethical evaluation of animal experiments, including testing for regulatory purposes, needs to be reformed and applied effectively to meet the legal and moral requirements; b) animal testing must be avoided in future legislation, and existing legislation has to be revised in that regard; c) resources from animal-based research have to re-allocated toward alternatives; and d) the academic curricula must be reformed to foster and integrate ethical and animal welfare issues.

show abstract

Section: The Eu Reach Regulationmentioning

confidence: 99%

How Long Must They Suffer? Success and Failure of our Efforts to End the Animal Tragedy in Laboratories

Kolar¹

2015

Altern Lab Anim

View full text Add to dashboard Cite

show abstract

“…We remain extremely concerned about the Agency's conservative approach and apparent dismissal of the legal text in this regard. Others also looking at the operation of ReACH in practice also are concerned about apparent inconsistencies with the legal text and a failure to promote alternative methods (Rovida, 2010;Rovida et al, 2011, Wagner et al, 2012.…”

Section: Recommendations To Echa To Registrants and To Agencies Considering Consultations Of This Kind In The Future 6 Conclusionmentioning

confidence: 99%

Experiences of the REACH testing proposals system to reduce animal testing

Taylor¹

2014

ALTEX

View full text Add to dashboard Cite

In order to reduce animal testing, companies registering chemical substances under the EU REACH legislation must propose rather than conduct certain tests on animals. Third parties can submit 'scientifically valid information' relevant to these proposals to the Agency responsible, the European Chemicals Agency (ECHA), who are obliged to take the information into account. The European Coalition to End Animal Experiments (ECEAE) provided comments on nearly half of the 817 proposals for vertebrate tests on 480 substances published for comment for the first REACH deadline (between 1 August 2009 and 31 July 2012). The paper summarises the response by registrants and the Agency to third party comments and highlights issues with the use of read across, in vitro tests, QSAR and weight of evidence approaches. Use of existing data and evidence that testing is legally or scientifically unjustified remain the most successful comments for third parties to submit. There is a worrying conservatism within the Agency regarding the acceptance of alternative approaches and examples of where registrants have also failed to maximise opportunities to avoid testing.

show abstract

“…The US Environmental Protection Agency (EPA), other international regulatory agencies, and pharmaceutical and consumer product companies need new tools to efficiently and effectively assess toxicity across a large number of chemicals. Under the current system, determining the toxicological hazards posed by chemicals relies heavily on animal experimentation . In a regulatory risk assessment context, these experiments are typically based on test guidelines whose protocols have been standardized and agreed upon across international agencies (e.g., OECD).…”

Section: Introductionmentioning

confidence: 99%

“…Under the current system, determining the toxicological hazards posed by chemicals relies heavily on animal experimentation. 1 In a regulatory risk assessment context, these experiments are typically based on test guidelines whose protocols have been standardized and agreed upon across international agencies (e.g., OECD). Depending on the toxicological end point of interest and the specific test guideline, a single study can take a year or more to complete and costs thousands to more than a million dollars.…”

Section: Introductionmentioning

confidence: 99%

Predicting Organ Toxicity Using in Vitro Bioactivity Data and Chemical Structure

Liu

Patlewicz

Williams

et al. 2017

Chem. Res. Toxicol.

View full text Add to dashboard Cite

Animal testing alone cannot practically evaluate the health hazard posed by tens of thousands of environmental chemicals. Computational approaches making use of high-throughput experimental data may provide more efficient means to predict chemical toxicity. Here, we use a supervised machine learning strategy to systematically investigate the relative importance of study type, machine learning algorithm, and type of descriptor on predicting in vivo repeat-dose toxicity at the organ-level. A total of 985 compounds were represented using chemical structural descriptors, ToxPrint chemotype descriptors, and bioactivity descriptors from ToxCast in vitro high-throughput screening assays. Using ToxRefDB, a total of 35 target organ outcomes were identified that contained at least 100 chemicals (50 positive and 50 negative). Supervised machine learning was performed using Naïve Bayes, k-nearest neighbor, random forest, classification and regression trees, and support vector classification approaches. Model performance was assessed based on F1 scores using 5-fold cross-validation with balanced bootstrap replicates. Fixed effects modeling showed the variance in F1 scores was explained mostly by target organ outcome, followed by descriptor type, machine learning algorithm, and interactions between these three factors. A combination of bioactivity and chemical structure or chemotype descriptors were the most predictive. Model performance improved with more chemicals (up to a maximum of 24%), and these gains were correlated (ρ = 0.92) with the number of chemicals. Overall, the results demonstrate that a combination of bioactivity and chemical descriptors can accurately predict a range of target organ toxicity outcomes in repeat-dose studies, but specific experimental and methodologic improvements may increase predictivity.

show abstract

Inconsistencies in data requirements of EU legislation involving tests on animals

Abstract: SummaryEuropean Union (EU)

Cited by 6 publications

References 9 publications

How Long Must They Suffer? Success and Failure of our Efforts to End the Animal Tragedy in Laboratories

How Long Must They Suffer? Success and Failure of our Efforts to End the Animal Tragedy in Laboratories

Experiences of the REACH testing proposals system to reduce animal testing

Predicting Organ Toxicity Using in Vitro Bioactivity Data and Chemical Structure

Contact Info

Product

Resources

About