CON4EI: Short Time Exposure (STE) test method for hazard identification and labelling of eye irritating chemicals

Assessment of ocular irritancy is an international regulatory requirement in the safety evaluation of industrial and consumer products. Although many in vitro ocular irritation assays exist, alone they are incapable of fully categorizing chemicals. Therefore, the CEFIC-LRI-AIMT6-VITO CON4EI consorti...

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Bibliographic Details
Published in:Toxicology in vitro 2018-06, Vol.49, p.65-76
Main Authors: Adriaens, E., Willoughby, J.A., Meyer, B.R., Blakeman, L.C., Alépée, N., Fochtman, P., Guest, R., Kandarova, H., Verstraelen, S., Van Rompay, A.R.
Format: Article
Language:English
Subjects:
Animals
Assaying
Cell Survival - drug effects
Chemicals
CON4EI
Consortia
Consumer goods
Consumer products
Cornea
Cornea - cytology
Exposure
Eyes & eyesight
Hazard identification
In vitro methods and tests
Irritants - classification
Irritants - toxicity
Irritation
Labeling
Ocular irritation
OECD Test Guideline 491
Organic chemistry
Product safety
Rabbits
Reliability analysis
Sensitivity
Sensitivity analysis
Short Time Exposure (STE) assay
Solids
Toxicity Tests - methods
Toxicology
Viability
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Summary:Assessment of ocular irritancy is an international regulatory requirement in the safety evaluation of industrial and consumer products. Although many in vitro ocular irritation assays exist, alone they are incapable of fully categorizing chemicals. Therefore, the CEFIC-LRI-AIMT6-VITO CON4EI consortium was developed to assess the reliability of eight in vitro test methods and establish an optimal tiered-testing strategy. One assay selected was the Short Time Exposure (STE) assay. This assay measures the viability of SIRC rabbit corneal cells after 5min exposure to 5% and 0.05% solutions of test material, and is capable of categorizing of Category 1 and No Category chemicals. The accuracy of the STE test method to identify Cat 1 chemicals was 61.3% with 23.7% sensitivity and 95.2% specificity. If non-soluble chemicals and unqualified results were excluded, the performance to identify Cat 1 chemicals remained similar (accuracy 62.2% with 22.7% sensitivity and 100% specificity). The accuracy of the STE test method to identify No Cat chemicals was 72.5% with 66.2% sensitivity and 100% specificity. Excluding highly volatile chemicals, non-surfactant solids and non-qualified results resulted in an important improvement of the performance of the STE test method (accuracy 96.2% with 81.8% sensitivity and 100% specificity). Furthermore, it seems that solids are more difficult to test in the STE, 71.4% of the solids resulted in unqualified results (solubility issues and/or high variation between independent runs) whereas for liquids 13.2% of the results were not qualified, supporting the restriction of the test method regarding the testing of solids. •CON4EI: CONsortium for in vitro Eye Irritation testing strategy (TS).•80 reference chemicals tested with the Slug Mucosal Irritation (SMI) test.•Eye damaging/Eye irritation potency predcited by amount of mucus produced.•The SMI test method correctly identified 65.8% of the Cat 1 chemicals.•Low over-prediction rate for in vivo Cat 2 and No Cat chemicals.
ISSN:0887-2333
1879-3177
DOI:10.1016/j.tiv.2017.08.002