Eye irritation of low-irritant cosmetic formulations: correlation of in vitro results with clinical data and product composition

Determination of eye irritation potential of low-irritant products: comparison of in vitro results with the in vivo draize rabbit test

“…Although the in vitro HET-CAM test has been described as a suitable alternative method for the assessment of eye irritation of water-soluble, especially surfactant-containing materials (Luepke and Kemper 1986;Steiling et al 1999), some authors have reported a poor correlation of HET-CAM results with those of in vivo Draize test (Doucet et al 1999;Debbasch et al 2005). Despite the fact that HET-CAM had been accepted by the European Union to identify the ocular corrosives and severe irritants in ICCVAM 2006).…”

“…However, those assays are solely employed to corrosive and severe ocular irritant ingredients, being not applicable to a great number of ingredients with low-irritant potential or products that produce human eye distress in the absence of macroscopic adverse clinical evidence. The present challenge is to develop a non-animal test method -or an assessment strategy -suitable to evaluate mild and moderate irritant materials (Debbasch et al 2005;McNamme et al 2009;Barile 2010). In attempt to build up such an assessment strategy to evaluate the human eye irritation, a reevaluation of some currently used in vitro tests is needed, particularly concerning the non-irritants, mild and moderate irritants.…”

Avaliação da irritabilidade ocular induzida por ingredientes de cosméticos através do teste de Draize e dos métodos HET-CAM e RBC.

“…modelos de pele reconstituída para avaliação da irritação dérmica induzida por cosméticos ou os testes in vitro para detecção da presença de contaminantes pirogênicos em imunobiológicos, (ALVES et al, 2008). Esses e outros exemplos demonstram que existem diversas alternativas possíveis para avaliação do potencial irritante, entre elas o RBC e o HET-CAM (DE TORRES et al, 1997;TANI et al, 1999;DEBBASCH et al, 2005;TAVASKI;BUDAI, 2007;TAKAHASCHI et al, 2008).…”

“…Nas últimas décadas, vários grupos de pesquisadores vêm estudando e desenvolvendo métodos alternativos para determinação da irritação ocular (NOR-TH- ROOT et al, 1982;SHOPSIS;ENG, 1985;YANG;ACOSTA, 1994;VIAN et al, 1995;DE TORRES et al, 1997;TANI et al, 1999;ALVES et al, 2005;DEBBASCH et al, 2005;GERNER et al, 2005;LAGARTO et al, 2006;MEHLING et al, 2007;TAVASZI;BUDAI, 2007;ALVES et al 2008;MITJANS et al, 2008;ADRIAENS et al, 2008;ABREU, 2008;TAKAHASHI et al, 2008 Este estudo foi aprovado pela Comissão de Ética em Uso de Animais da Fiocruz (protocolos CEUA/Fiocruz P.0137-02 e P.0148-02).…”

A Reassessment of the in vitro total protein content determination (TPC) with SIRC and 3T3 cells for the evaluation of the ocular irritation potential of shampoos: comparison with the in vivo Draize rabbit test

“…For this reason, a combination of in vitro tests will be required to predict the human eye irritancy effectively (Rougier et al, 1992;Earl et al, 1997;Scott et al, 2010). The ideal is to obtain the data related to different outcomes; for example, vascularization (e.g., HET-CAM), opacity/ permeabilization (e.g., BCOP) and cytotoxicity (e.g., RBC) (Debbasch et al, 2005;Barile, 2010). Studies of new in vitro ocular toxicity methods are, however, still being compared to the data obtained in the tests that have been performed in the rabbits because adequate human data are not available (Roggeband et al, 2000;Princen, 2006).…”