ABSTRACT
Objective To establish bovine corneal opacity and permeability （BCOP） test， and determine its predictive ability for the eye irritation evaluation of cosmetics. Methods A total of ten reference chemicals were selected to establish the BCOP test. Then eye irritation of 16 routinely collected cosmetics in our laboratory was predicted. In vitro scores were calculated by the change in the opacity and sodium fluorescein permeability after exposure to the testing cosmetics， and subsequently compared with the historical data by Draize test. Results Reference chemicals with known irritation classification were correctly classified by the BCOP test， which was consistent with the classification of UN globally harmonized system of classification and labeling of chemicals. Moreover， the specificity of the BCOP test for the classification of non-irritating cosmetics samples was 80.0% （8/10）， and the sensitivity for weak to mild irritating cosmetics samples was 83.3% （5/6）. The BCOP test demonstrated an overall classification consistency of 81.3% （13/16） with in vivo test. Conclusion BCOP test may be independently used to identify chemicals with potential eye irritation and serious eye damage， suggesting it is significant for in vitro integrated test strategy for predicting eye irritation due to cosmetics.
ABSTRACT
Tests in animals are used as models in toxicological and investigative studies. However, such tests have been considered inhumane because they can cause pain and suffering to experimental animals, while these methods can often be subjective. Protests calling for animal protection have questioned the effectiveness of in vivo tests and suggest the introduction of alternative, in vitro methods. International organizations, such as the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Institute of Health (NIH), the Organization for Economic Co-operation and Development (OECD), that regulate and develop new alternative animal models, have indicated the running of preliminary assays and execution of sequential tests, which consider physical-chemical properties and data of in vitro assays, before performing in vivo studies. Towards this background, the objective of the present article was to select promising alternative methods such as Corrositex®, BCOP and HET-CAM, intended to refine or replace the use of animals and reduce their suffering.
Testes em animais são utilizados como modelos em estudos toxicológicos e de pesquisa. Entretanto, tais testes têm sido considerados desumanos, porque causam dor e sofrimento aos animais experimentais, porquanto estes métodos podem, freqüentemente, ser subjetivos. Protestos clamando pela proteção animal têm questionado a eficácia dos testes in vivo e sugerem a introdução de métodos alternativos in vitro. Organizações internacionais, tais como Comitê de Coordenação Interagências de Métodos de Validação Alternativos (ICCVAM), Instituto Nacional de Saúde (NIH), Organização para Cooperação Econômica e Desenvolvimento (OECD), que regulam e desenvolvem novos métodos alternativos aos modelos animais, indicaram a realização de ensaios preliminares e a execução de testes seqüenciais, que consideram as propriedades físico-químicas e os dados dos ensaios in vitro, antes de efetuarem estudos in vivo. Nessa direção, o objetivo do presente artigo foi selecionar métodos alternativos promissores, tais como Corrositex®, BCOP e HET-CAM, com o intuito de aperfeiçoar ou substituir o uso de animais e reduzir seus sofrimento.