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

        Ha, Soojin,Seidle, Troy,Lim, Kyung-Min The Korean Society of Environmental Toxicology 2016 환경독성보건학회지 Vol.31 No.-

        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.

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

        Soojin Ha,Troy Seidle,Kyung-Min Lim 환경독성보건학회 2016 환경독성보건학회지 Vol.31 No.-

        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.

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        Mental Stress from Animal Experiments

        Minji Kang,AhRam Han,Da-eun Kim,Troy Seidle,Kyung-Min Lim,SeungJin Bae 한국독성학회 2018 Toxicological Research Vol.34 No.1

        Animal experiments have been widely conducted in the life sciences for more than a century, and have long been a subject of ethical and societal controversy due to the deliberate infliction of harm upon sentient animals. However, the harmful use of animals may also negatively impact the mental health of researchers themselves. We sought to evaluate the anxiety level of researchers engaged in animal use to analyse the mental stress from animal testing. The State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) was used to evaluate how researchers feel when they conduct animal, as opposed to non-animal, based experiments (95 non-animal and 98 animal testing researchers). The Trait Anxiety Scale of STAI was employed to measure proneness to anxiety, namely the base trait of the researchers. Additionally, the information on sex, age, education, income, and total working periods was collected. While the Trait Anxiety scores were comparable (41.5 ± 10.9 versus 42.9 ± 10.1, p = 0.3682, ttest), the State Anxiety scores were statistically significantly higher for animal users than non-animal users (45.1 ± 10.7 versus 41.3 ± 9.4, p = 0.011). This trend was consistent for both male and female. Notably, younger animal testers (≤ 30 years of age) with less work experience (≤ 2 years) and lower income level (≤ 27,000 USD) exhibited higher anxiety scores, whereas these factors did not affect the anxiety level of non-animal users. The present study demonstrated that participation in animal experiments can negatively impact the mental health of researchers.

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