Skin irritation testing in man for hazard assessment — evaluation of four patch systems

Human and Experimental Toxicology - Tập 14 Số 9 - Trang 729-734 - 1995
Michael York1, D. A. Basketter1, Jennifer A. Cuthbert2, Louise Neilson2
1Unilever, Enviromental Safety Laboratory, Colworth House, Shambrook, Bedford MK44 1LQ
2Inveresk Research International Limited, Tranent, Scotland, EH33 2NE

Tóm tắt

1 The limitations of the Draize rabbit skin irritation test for hazard evaluation for man are widely documented. Nevertheless it remains the prescribed method for deter mining acute skin irritation hazard. 2 While the use of human testing for risk assessment of irritants is well established, the use of predictive testing in man for hazard identification has not been explored widely, and this is the object of the research programme. 3 The experiment described in this report evaluates the sensitivity of four patch testing systems (Finn chamber, Hill Top patch, Van der Bend chamber, and Webril patch) using a total of six irritant substances. 4 Following preliminary range-finding experiments, test materials were applied to the upper outer arm for up to 4 h. Assessments were performed immediately after patch removal and at 1, 24, 48 and 72 h. 5 Webril and Hill Top patches generated the greatest lev els of response, although responses with Finn and Van der Bend were observed. Hill Top patches are recom mended for future development work. 6 The use of very small preliminary panels to predict the effects in larger panels using different volunteers was only of limited value as each volunteer was found to have different irritant thresholds.

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Tài liệu tham khảo

EEC, Annex to Commission Directive 92/69/EEC of 31 July 1992 adapting to technical progress for the seventeenth time. Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal of the European Communities 1992; L383A, 35, 29 December 1992.

Oecd., 1993, Organisation for Economic Co-operation and Development. Guidelines for testing chemicals, Test

10.1016/0041-008X(71)90112-8

10.1016/0041-008X(72)90157-3

McCreesh AH, Steinberg M. Skin irritation testing in animals. In: Marzulli FN, Maibach HI (eds). Dermatotoxicology and Pharmacology. 193-210 Washington : Hemisphere Publishing Corporation , 1977.

10.1016/S0278-6915(09)80010-0

10.1111/j.1467-2494.1989.tb00503.x

Patrick E., Maibach HI Predictive skin irritation tests in animals and humans. In: Marzulli FN, Maibach HI (eds). Dermato-toxicology , Fourth Edition, 201-222. Washington: Hemisphere Publishing Corporation, 1992.

10.1111/j.1600-0536.1994.tb00617.x

10.1177/096032719501400209

10.1016/0887-2333(94)90086-8

Cronin E. Contact Dermatitis. 1980; London. Churchill Livingstone, 532-534.

Fisher AA Contact Dermatitis 1986; 3rd Edition. Philadelphia: Lea and Febiger, 264.

10.1111/j.1600-0536.1991.tb01836.x

Treaty of Helsinki. Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964, amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975, the 35th World Medical Assembly, Venice, Italy, October 1983 and the 41st World Medical Assembly, Hong Kong, September 1989.

Lammintausta K., 1987, Contact Dermatitis, 17, 276, 10.1111/j.1600-0536.1987.tb01477.x