Skin irritation testing in man for hazard assessment--evaluation of four patch systems.
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 determining acute skin irritations 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 levels of response, although responses with Finn and Van der Bend were observed. Hill Top patches are recommended 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.
York
M
M
Unilever, Environmental Safety Laboratory, Sharnbrook, Bedford, UK.
Basketter
D A
DA
Cuthbert
J A
JA
Neilson
L
L
D000085:Acetates / Q000009:adverse effects; D019342:Acetic Acid; D000293:Adolescent; D000328:Adult; D000368:Aged; D002593:Cetrimonium Compounds / Q000009:adverse effects; D053138:Cyclohexenes; D004487:Edema / Q000139:chemically induced*; D004890:Erythema / Q000139:chemically induced*; D004983:Ethanolamines / Q000009:adverse effects; D005260:Female; D006801:Humans; D007509:Irritants / Q000008:administration & dosage / Q000009:adverse effects*; D000077222:Limonene; D008297:Male; D008875:Middle Aged; D010328:Patch Tests; D018570:Risk Assessment; D012967:Sodium Dodecyl Sulfate / Q000009:adverse effects; D012972:Sodium Hydroxide / Q000009:adverse effects; D013729:Terpenes / Q000009:adverse effects; D013997:Time Factors
D000085:Acetates; D002593:Cetrimonium Compounds; D053138:Cyclohexenes; D004983:Ethanolamines; D007509:Irritants; D013729:Terpenes; D012967:Sodium Dodecyl Sulfate; D012972:Sodium Hydroxide; D000077222:Limonene; C020283:diethanolamine; D019342:Acetic Acid