Reassessment of the In Vitro RBC Haemolysis Assay with Defibrinated Sheep Blood for the Determination of the Ocular Irritation Potential of Cosmetic Products: Comparison with the In Vivo Draize Rabbit Test

We examined the correlation between results obtained from the in vivo Draize test for ocular irritation and in vitro results obtained from the sheep red blood cell (RBC) haemolytic assay, which assesses haemolysis and protein denaturation in erythrocytes, induced by cosmetic products. We sought to v...

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Bibliographic Details
Published in:Alternatives to laboratory animals 2008-07, Vol.36 (3), p.275-284
Main Authors: Alves, Eloísa Nunes, Presgrave, Rosaura de Farias, Presgrave, Octávio Augusto França, Sabagh, Fernanda Peres, Freitas, João Carlos Borges Rolim de, Corrado, Alexandre Pinto
Format: Article
Language:English
Subjects:
animal models
Animal Testing Alternatives - methods
Animals
Biological and medical sciences
Cosmetics - toxicity
cosmetics testing
denaturation
Domestic and cosmetic products toxicology
Eye - drug effects
eye irritation tests
Female
hemolysis
Hemolysis - drug effects
in vitro studies
in vivo studies
Irritants - classification
Irritants - toxicity
Male
Medical sciences
Predictive Value of Tests
proteins
Rabbits
RBC assay
Sheep
Toxicology
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Summary:We examined the correlation between results obtained from the in vivo Draize test for ocular irritation and in vitro results obtained from the sheep red blood cell (RBC) haemolytic assay, which assesses haemolysis and protein denaturation in erythrocytes, induced by cosmetic products. We sought to validate the haemolytic assay as a preliminary test for identifying highly-irritative products, and also to evaluate the in vitro test as alternative assay for replacement of the in vivo test. In vitro and in vivo analyses were carried out on 19 cosmetic products, in order to correlate the lesions in the ocular structures with three in vitro parameters: (i) the extent of haemolysis (H50); (ii) the protein denaturation index (DI); and (iii) the H50/DI ratio, which reflects the irritation potential (IP). There was significant correlation between maximum average scores (MAS) and the parameters determined in vitro (r = 0.752-0.764). These results indicate that the RBC assay is a useful and rapid test for use as a screening method to assess the IP of cosmetic products,and for predicting the IP value with a high level of concordance (94.7%). The assay showed high sensitivity and specificity rates of 91.6% and 100%, respectively.
ISSN:0261-1929
2632-3559
DOI:10.1177/026119290803600305