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Act on the Registration and Evaluation of Chemicals (K-REACH) and replacement, reduction or refinement best practices
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Act on the Registration and Evaluation of Chemicals (K-REACH) and replacement, reduction or refinement best practices

논문 기본 정보

자료유형
학술저널
저자정보
Soojin Ha (Ewha Womans University College of Pharmacy) Troy Seidle (Humane Society International) Kyung-Min Lim (Ewha Womans University College of Pharmacy)
저널정보
환경독성보건학회 Environmental Analysis Health and Toxicology Environmental Health and Toxicology Vol.31 KCI Accredited Journals SCOPUS
발행연도
2016.12
수록면
153 - 161 (9page)

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Act on the Registration and Evaluation of Chemicals (K-REACH) and replacement, reduction or refinement best practices
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Objectives Korea’s Act on the Registration and Evaluation of Chemicals (K-REACH) was enacted for the protection of human health and the environment in 2015. Considering that about 2000 new substances are introduced annually across the globe, the extent of animal testing requirement could be overwhelming unless regulators and companies work proactively to institute and enforce global best practices to replace, reduce or refine animal use. In this review, the way to reduce the animal use for K-REACH is discussed.
Methods Background of the enforcement of the K-REACH and its details was reviewed along with the papers and regulatory documents regarding the limitation of animal experiments and its alternatives in order to discuss the regulatory adoption of alternative tests.
Results Depending on the tonnage of the chemical used, the data required ranges from acute and other short-term studies for a single exposure route to testing via multiple exposure routes and costly, longer-term studies such as a full two-generation reproducibility toxicity. The European Registration, Evaluation, Authorization and Restriction of Chemicals regulation provides for mandatory sharing of vertebrate test data to avoid unnecessary duplication of animal use and test costs, and obligation to revise data requirements and test guidelines “as soon as possible” after relevant, validated replacement, reduction or refinement (3R) methods become available. Furthermore, the Organization for Economic Cooperation and Development actively accepts alternative animal tests and 3R to chemical toxicity tests.
Conclusions Alternative tests which are more ethical and efficient than animal experiments should be widely used to assess the toxicity of chemicals for K-REACH registration. The relevant regulatory agencies will have to make efforts to actively adopt and uptake new alternative tests and 3R to K-REACH.

목차

Introduction
Act on the Registration and Evaluation of Chemicals: Data Requirements, Test Guidelines and Skyrocketing Animal Use
Limitation and Problems of Conventional Animal Experiments
New Methods as Replacements for Conventional Animal Tests
Development of Non-animal Based Alternatives and Their Adoption byRegulatory Science
Pros and Cons of In Vitro Alternatives to Animal Tests
Barriers to Acceptance of Non-animal Based Alternatives in Act on the Registration and Evaluation of Chemicals and Recommendations
Conclusion
References

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UCI(KEPA) : I410-ECN-0101-2017-539-002198253