Abstract

TOBON MARULANDA, Flor Ángela; LOPEZ GIRALDO, Luis Alirio  and  RAMIREZ VILLEGAS, John Fernando. Predictive bioanalysis of skin tolerance of cosmetics for babies in vivo. Rev Cubana Farm [online]. 2013, vol.47, n.2, pp.193-204. ISSN 0034-7515.

Objective: to prevent the potential risk of dermal irritability from a cream and a lotion for babies, in order to obtain health registration and to reduce possible health risks. Methods: in vivo predictive bioanalysis of dermal tolerance carried out in rabbits through a qualitative and histopathological clinical exploratory-type study, based on the Lex Artis approach to explain the comparable risk/effectiveness in humans. There was applied the single acute exposure technique (occlusive patch test) in six rabbits to test each product. Dermal effects were then measured in a value scale defining the cosmetic exposure-attributed unsafeness probabilities, according to the dermal toxicity test of the Organization for Economic Cooperation and Development, with some modifications by the authors. Results: the bioanalysis found some dermal irritability in the rabbits' skin after using the single dose of cosmetic for 92 days. The clinical study was supplemented with the histopathological analysis of a sample of irritated skin, without significant changes other than those observed. Conclusions: the clinical and hisopathological analysis showed mild to negligible dermal irritability, which indicates the need for improvements to the formulation of the studied cosmetics in order to obtain the health registration and thus to early advise the manufacturer and the community about the safety and efficacy of products.

Keywords : dermal irritability; qualitative and histopathological study; cosmetics; rabbits; babies.

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