467号测试：严重眼部损伤和眼部刺激的确定方法

OECD/OCDEYou are free to use this material subject to the terms and conditions available athttp://www.oecd.org/termsandconditions/1OECD GUIDELINE FORTHETESTING OF CHEMICALSDefined Approaches (DAs) for Serious Eye Damage and Eye Irritation forincluding a new DA for solidsThis document, as well as any data and map included herein, are without prejudice to the status of or sovereignty over any territory, to thedelimitation of international frontiers and boundaries and to the name of any territory, city or area. ©OECD, (2024) OECD/OCDE2Table of ContentsDAs and Use Scenarios included in the GuidelinePerformance and Applicability1.3.2. Applicability domain of the DAs and of the individual components of the DAs2. PART I-Defined Approaches 1 (DAL-1), based on physicochemical propertiesandin vitrodata, for neat non-surfactant liquids2.1.2. Data interpretation procedure2.1.3. Description and limitations of the individual information sources2.1.4. Procedure for dealing with borderline result in test guidelines relevant to DAL-12.1.5. Predictive capacity of the DAL-1 PCP/EpiOcular/LLBO vs. the Draize Eye test2.1.6. Predictive capacity of the DAL-1 PCP/SkinEthic/LLBO vs. the Draize Eye test2.1.7. Demonstration of Proficiency3. PART II–Defined Approaches 2 (DAL-2), based onin vitrodata, for non-surfactant neat liquids, liquids and solids dissolved in water3.1.2. Data interpretation procedure3.1.3. Description and limitations of the individual information sources3.1.4. Procedures for dealing with borderline results in the test guidelines relevant to DAL-23.1.5. Predictive capacity of the DAL-2 STE/LLBO vs. the Draize Eye test4. PART III–Defined Approaches (DAS), based onin vitrodata, for neat solids ©OECD, (2024)1. IntroductionGeneral Introduction1.3.1. Performance of the DAs1.3.3. Uncertainty of DAsReferencesDAL-12.1.1. Summary2.1.8. Reporting of the DAReferencesDAL-23.1.1. SummarySTE/LLBO predictions3.1.6. Proficiency chemicals3.1.7. Reporting of the DAReferencesDAS SkinEthic/LLBO4.1.1. Summary 44677889111111111515161617171819191919222222232324252525 OECD/OCDE34.1.2. Data interpretation procedure4.1.3. Description and limitations of the individual information sources4.1.4. Procedures for dealing with borderline results in the test guidelines relevant to DAS4.1.5. Predictive capacity of the DAS SkinEthic/LLBO vs. the Draize Eye testTable1.1Summary of the DAs included in this Guideline–Eye hazard identificationTable2.1. Performance of DAL-1 PCP/EpiOcular/LLBO in comparison to Draize Eyereference dataTable2.2. Performance of DAL-1 PCP/SkinEthic/LLBO in comparison to Draize Eyereference dataTable3.1. Performance of DAL-2 STE/LLBO in comparison to Draize Eye referencedataTable4.1. Performance of DAS SkinEthic/LLBO in comparison to Draize Eyereference dataFigure 3.1. Scheme of the DAL-2 STE/LLBO option 1: start with the STE test method followed by the BCOPFigure 3.2. Scheme of the DAL-2 STE/LLBO option 2: start with the BCOP LLBO test method followed by theFigure 4.1. Scheme of the DAS SkinEthic/LLBO: start with the SkinEthic™HCE EITS test methodfollowed by 467252727272828298816172328202126 ©OECD, (2024)SkinEthic/LLBO predictions4.1.6. Proficiency chemicals4.1.7. Reporting of the DAReferencesTablesFiguresLLBO test methodSTE test method.the BCOP LLBO test OECD/OCDE4The assessment of eye irritation/serious eye damageoriginally involved the use ofalbino rabbits according to the Draize eye test method (OECD Test Guideline 405) (1). Thehazard potential of a test chemical was determined based on its effect on corneal opacity(CO), iritis (IR), conjunctival redness (CR), and conjunctival chemosis (CC). Based on theseverityof effects and/or the timing of their reversibility,classifications are derivedaccording to the serious eye damage/eye irritation classification criteria defined by theUnited Nations (UN) Globally Harmonized System of Classification and Labelling ofChemicals (GHS) (2). According to the UN GHS classification system, Category 1/seriousdamage (Cat. 1) is defined as causing irreversible effects (not fully reversible within 21days) on the eye/serious damage to the eye. Category 2/irritation (Cat. 2) is defined ascausing reversible effects (fully reversible within 21 days) on the eye/eye irritation. Thiscategory may be divided into the optional Categories 2A (effects fully reversible within 21days) and 2B (effects fully reversible within 7 days). When none of the Cat. 1 or Cat. 2classification criteria are met, the test chemical doesnot require classification whichcorresponds to No Category (No Cat.).In 2022, a stand-alonein vitromethod (OECD TG 492B was adopted for theidentification of test chemicals not requiring classification (UN GHS No Cat), requiringclassification for eye irritation (UN GHS Cat 2) and requiring classification for serious eyedamage (UN GHS Cat 1) (3). Furthermore, several Test Guidelines (TGs) onin vitromethods have been adopted for the identification of test chemicals inducing serious eyedam