Comparative assessment of 24-hr primary skin irritation test and human patch test data with in vitro skin irritation tests according to OECD Test Guideline 439 (for quasi-drugs in Japan)

Author:

Sugiyama Mariko12,Akita Masaharu13,Alépée Nathalie4,Fujishiro Miyuki5,Hagino Shigenobu12,Handa Yuki6,Ikeda Hidefumi17,Imai Noriyasu18,Jitsukawa Setsuko9,Katoh Masakazu10,Kurihara Koji11,Kyotani Daiki11,Nomura Shigeyuki8,Okamoto Yuko1,Okumura Hidenobu112,Omori Takashi113,Sugibayashi Kenji114,Todo Hiroaki114,Toyoda Akemi115,Ohno Yasuo116

Affiliation:

1. Working Group on Alternatives to Primary Skin Irritation Test, Japanese Society of Alternatives to Animal Experiments (JSAAE)

2. Shiseido Global Innovation Center

3. Faculty of Family and Consumer Sciences, Kamakura Women’s University

4. L’Oréal Research & Innovation, France

5. Cosmos Technical Center Co., Ltd.

6. Kurabo Industries Ltd.

7. Mandom Corp.

8. KOSÉ Corp., Ltd.

9. L’Oréal Research & Innovation

10. Japan Tissue Engineering Co., Ltd.

11. Nikoderm Research Inc.

12. Institute of Beauty and Health Science

13. Division of Biostatistics, Department of Social/Comunity Medicine and Health Science, Kobe University School of Medicine

14. Faculty of Pharmacy and Pharmaceutical Sciences, Josai University

15. Pola Chemical Industries, Inc.

16. Kihara Memorial Yokohama Foundation

Publisher

Japanese Society of Toxicology

Subject

Toxicology

Reference28 articles.

1. Balls, M., Blaauboer, B., Brusick, D., Frazier, J., Lamb, D., Pemberton, M., Reinhardt, C., Roberfroid, M., Rosenkranz, H., Schmid, B., Spielmann, H., Stammati, A. and Walum, E. (1990): Report and recommendations of the CAAT/ERGATT workshop on the validation of toxicity test procedures. Altern. Lab. Anim., 18, 313-337.

2. Basketter, D.A., York, M., McFadden, J.P. and Robinson, M.K. (2004): Determination of skin irritation potential in the human 4-h patch test. Contact Dermat., 51, 1-4.

3. Cosmetic and quasi-drugs manufacturing and selling guidebook study group (2017): Guide to Marketing and Manufacturing of Quasi-drug and cosmetic Regulations in Japan 2017, pp.154-157, Yakuji Nippo, Ltd., Tokyo. (in Japanese)

4. Cruzan, G., Dalbey, W.E., D’Aleo, C.J. and Singer, E.J. (1986): A composite model for multiple assays of skin irritation. Toxicol. Ind. Health, 2, 309-320.

5. Draize, J.H., Woodard, G. and Calvery, H.O. (1944): Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther., 82, 377-390.

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