Evaluation of a three-dimensional human dermal model as a predictor of shampoo ocular irritation.

A three-dimensional human tissue model (Skin(2) ZK1100) was used to evaluate 43 adult and baby shampoos. The ZK1100 model consists of metabolically active proliferating human fibroblasts isolated from the dermis of neonatal foreskins and seeded onto a nylon mesh. The fibroblasts multiply and produce matrix proteins to form a living tissue. MTT reduction (mitochondrial function) was used as the cytotoxicity endpoint. The primary components of the adult shampoos are alkyl sulfate surfactants, while the baby shampoos contain ethoxylated alkyl sulfates and amphoteric surfactants. All shampoos were diluted to five concentrations (100, 300, 700, 1000 and 3000 mug/ml) in aqueous cell culture media and the tissue exposed for 24 hr. An EC(50) value for each test was generated from a dose-response curve. All samples were tested in two or more separate experiments, and the EC(50) values were averaged and plotted versus their respective 24-hr unwashed Draize eye irritation values (r(2) = 0.81). The adult shampoos had Draize values in the moderate irritation category and EC(50) values ranging from 220 to 1051 mug/ml, while the baby shampoos had Draize values in the minimal irritation category and EC(50) values ranging from 820 to 2285 mug/ml. These results indicate that the three-dimensional human tissue model can be useful in predicting the Draize ocular irritation category for shampoos.