Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (3) Evaluation of the haemolysis test

Toxicology in Vitro : an International Journal Published in Association with BIBRA
Y OkamotoY Ohno

Abstract

The haemolysis test using sheep red blood cells (RBC) was evaluated as an alternative method to the Draize rabbit eye irritation test (Draize test) by six to nine laboratories. The participating laboratories performed the test according to the standard operating procedure (SOP). Thirty-eight cosmetic ingredients and isotonic sodium chloride solution were used as test substances in this validation study. The concentrations of the test substances that induced 50% haemolysis (HC(50) value) was obtained to serve as a toxicological index and compared with in vivo Draize scores. HC(50) values were not obtained for coloured or water-insoluble (turbid) substances. Three acids caused denaturation of haemoglobin leaked from RBC and consequently interfered with the determination of the HC(50) value. Interlaboratory reproducibility was relatively good except in the case of water-insoluble substances. The average values of coefficient of variation (CV) was 37%. The correlation coefficient and Spearman's rank correlation between the HC(50) value and maximum average Draize total score (MAS) were -0.631 and 0.641, respectively. The equivalence ratio between the haemolysis test and MAS was 70.0% when MAS 15 was set as the in vivo cut-off point....Continue Reading

References

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Citations

Oct 22, 2002·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·M G SoniG A Burdock
Nov 16, 2010·Drug Development and Industrial Pharmacy·Dharmendra JainRinti Banerjee
Aug 19, 2007·Journal of Pharmaceutical Sciences·M P Vinardell, M Mitjans
Jul 21, 2004·Colloids and Surfaces. B, Biointerfaces·L PérezA Pinazo
Nov 15, 2012·Chemical Research in Toxicology·Renee SolimeoHao Zhu
Jan 11, 2013·International Journal of Toxicology·Lillian C BeckerF Alan Andersen
Oct 1, 2005·Alternatives to Laboratory Animals : ATLA·Chantra EskesValérie Zuang

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