Project Description

OECD 492: EpiOcularTM Eye Irritation Test

SERVICE INFORMATION

Reconstructed human cornea-like epithelium (RhCE), EpiOcularTM eye irritation test method, is an in vitro animal-replacement method for the identification of chemicals not requiring classification and labelling for eye irritation or serious eye damage. Test chemicals are exposed to the RhCE EpiOcularTM model, with those causing irritation and serious damage identified by a reduced viability detected by MTT. Follow-up testing may then be required using additional models such as the ex vivo bovine corneal opacity and permeability test (BCOP) under OECD 437.

EpiOcularTM OECD 492 eye irritation test has been validated and laboratory proficiency under OECD 492 established at Gentronix, with services available in both GLP and non-GLP formats.

OECD guidelineOECD 492
What is being assessedPotential for eye irritation and serious eye damage
Why is this importantIdentifying chemicals which are not requiring classification or labelling for eye irritaton and damage is an important aspect of chemical risk assessment and registration. Identifying chemistry that does present this risk enables further investigative work to be prioritised.
Test SystemMatTek EpiOcular ™ RhCE model
Cytotoxicity determined using MTT
Test Item Requirements 5 g / 5 ml
Preliminary TestingAssessment for MTT reducers; Test Chemical Interference

EpiOcularTM OECD 492 Proficiency Summary

Test Chemicalin vivo classification (OECD 405)*Physical StateExpected Result, Based on In Vivo Classification*Gentronix Classification Correct?
MethylthioglycolateCategory 1LiquidNo Prediction Can Be Made
Hydroxyethyl acrylateCategory 1LiquidNo Prediction Can Be Made
2,5-Dimethyl-2,5-hexanediolCategory 1SolidNo Prediction Can Be Made
Sodium oxalateCategory 1SolidNo Prediction Can Be Made
2,4,11,13- Tetraazatetradecanediimidamide, N,N''- bis(4-chlorophenyl)- 3,12- diimino-, di-D- gluconate (20%, aqueous)Category 2ALiquidNo Prediction Can Be Made
Sodium benzoateCategory 2ASolidNo Prediction Can Be Made
Diethyl toluamideCategory 2BSolidNo Prediction Can Be Made
2,2-Dimethyl-3- methylenebicyclo [2.2.1] heptaneCategory 2BSolidNo Prediction Can Be Made
1-Ethyl-3- methylimidazolium ethylsulphate No CategoryLiquidNo Category
Dicaprylyl ether No CategoryLiquidNo Category
Piperonyl butoxide No CategoryLiquidNo Category
Polyethylene glycol (PEG-40) hydrogenated castor oil No CategoryViscousNo Category
1-(4-Chlorophenyl)-3- (3,4- dichlorophenyl) urea No CategorySolidNo Category
2,2'-Methylene-bis-(6- (2Hbenzotriazol-2- yl)- 4- (1,1,3,3- tetramethylbutyl)- phenol) No CategorySolidNo Category
Potassium tetrafluoroborate No CategorySolidNo Category
*reported from OECD guideline 492
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