A 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


Autoria(s): ALVES, Eloisa Nunes; PRESGRAVE, Rosaura de Farias; PRESGRAVE, Octavio Augusto Franca; SABAGH, Fernanda Peres; FREITAS, Joao Carlos Borges Rolim de; CORRADO, Alexandre Pinto
Contribuinte(s)

UNIVERSIDADE DE SÃO PAULO

Data(s)

19/10/2012

19/10/2012

2008

Resumo

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 (131); 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.

Identificador

ATLA-ALTERNATIVES TO LABORATORY ANIMALS, v.36, n.3, p.275-284, 2008

0261-1929

http://producao.usp.br/handle/BDPI/24236

http://apps.isiknowledge.com/InboundService.do?Func=Frame&product=WOS&action=retrieve&SrcApp=EndNote&UT=000258132100015&Init=Yes&SrcAuth=ResearchSoft&mode=FullRecord

Idioma(s)

eng

Publicador

FRAME

Relação

Atla-alternatives to Laboratory Animals

Direitos

closedAccess

Copyright FRAME

Palavras-Chave #Draize test #eye irritation #haemolysis #protein denaturation #RBC assay #HET-CAM TEST #ALTERNATIVES PROGRAM #INTERLABORATORY VALIDATION #REGULATORY TOXICOLOGY #CTFA EVALUATION #PHASE-II #EYE #DENATURATION #CYTOTOXICITY #HEMOGLOBIN #Veterinary Sciences
Tipo

article

original article

publishedVersion