CON4EI: Short Time Exposure (STE) test method for hazard identification and labelling of eye irritating chemicals. (June 2018)

• Record Type: Journal Article
• 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.
• Is Part Of: Toxicology in vitro. Volume 49(2018)
• Page Start: 65
• Page End: 76
• Publication Date: 2018-06
• Subjects: Cat 1 UN GHS classification for chemicals causing irreversible effects on the eye/serious damage to the eye -- Cat 2 UN GHS classification for chemicals causing reversible effects on the eye/eye irritation, sub-catagorised in 2A (irritant to eyes, eye effects are not fully reversible within 7 days of observation) and 2B (mild irritant to eyes, eye effects fully reversible within 7 days of observation) -- CO Corneal Opacity -- Conj conjunctival redness (CR) and/or conjunctival chemosis (CC) -- CO pers. D21 CO persistence on day 21 -- CON4EI CONsortium for in vitro Eye Irritation testing strategy -- DRD Draize eye test Reference Database -- DMSO dimethyl sulfoxide -- FNR false negative rate -- FPR false positive rate -- IR iritis, MTT, 3-(4, 5-dimethylthiazolyl-2)-2, 5-diphenyltetrazolium bromide -- OD optical density -- OECD Organization for Economic Co-operation and Development -- PC positive control -- pers persistence -- SC solvent control -- SIRC Statens Seruminstitut Rabbit Cornea -- DPBS Dulbecco's Phosphate Buffered Saline -- SLS sodium lauryl sulfate -- STE Short Time Exposure -- TG Test Guideline -- UN GHS United Nations Globally Harmonized System of Classification and Labelling of Chemicals; CON4EI -- Ocular irritation -- Short Time Exposure (STE) assay -- OECD Test Guideline 491; Toxicity testing -- In vitro -- Periodicals; Toxicology -- Periodicals; 615.9
• DOI: 10.1016/j.tiv.2017.08.002
• Languages: English
• ISSNs: 0887-2333

Abstract

Abstract: 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 5 min 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. Highlights: 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.