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

Author:

York M.1,Basketter DA1,Cuthbert JA2,Neilson L.2

Affiliation:

1. Unilever, Enviromental Safety Laboratory, Colworth House, Shambrook, Bedford MK44 1LQ

2. Inveresk Research International Limited, Tranent, Scotland, EH33 2NE

Abstract

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.

Publisher

SAGE Publications

Subject

Health, Toxicology and Mutagenesis,Toxicology,General Medicine

Reference14 articles.

1. Guideline 404, Acute Dermal Irritation;Oecd.,1993

2. Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests

3. A comparison of rabbit and human skin response to certain irritants

4. 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.

5. The identification and classification of skin irritation hazard by a human patch test

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