Acute dermal irritation was induced and characterized in white Sinclair and Hanford minipigs (N = 2 per breed per study, 3-4 months old, all females) using a variety of known human irritants at increasing concentrations, as two pilot studies (single dose and 7-day repeat dose) to inform a larger validation study. During acclimation the areas of the dorsum of the minipig to be tested were shaved, and the topical dermal challenge sites were marked. Animals were administered 0.5 mL of test compound on gauze to a 4 cm2 area for 4 hours. Following dose administration, the gauze was removed (time 0) and animals were scored using a Modified Draize Scoring System for erythema (0-4) and edema (0-4), with a maximum score of 8. Scoring was conducted at 1, 24, 48, and 72 hours after test article removal following the single dose and at 1 hour post-dose daily in the repeat dose study. Materials tested were as follows: sodium hydroxide, formaldehyde, benzalkonium chloride, and sodium dodecyl sulfate.
Klein, J.A., Boley, S.E., Wakefield, G.A., Stricker-Krongrad, A., Bouchard, G.F.