ECHA - Guidance of the application of CLP criteria [November 2012]

Guidance on the Application of the CLP Criteria Version 3.0 - November 2012163.3.3 Classification of mixtures for serious eye damage/eye irritation..........................................2553.3.3.1 Identification of hazard information .....................................................................2553.3.3.1.1 Identification of existing human data..................................................2563.3.3.2 Classification criteria.............................................................................................2563.3.3.2.1 When data are available for the complete mixture..............................2563.3.3.2.1.1 Mixtures with extreme pH................................................2573.3.3.2.2 When data are not available for the complete mixture: bridgingprinciples .............................................................................................2583.3.3.2.3 When data are available for all components or only for somecomponents of the mixture..................................................................2583.3.3.2.3.1 Components that should be taken into account for thepurpose of classification.........................................................2583.3.3.2.3.2 The additivity approach is applicable...............................2583.3.3.2.3.3 The additivity approach is not applicable.........................2593.3.3.3 Generic concentration limits for substances triggering classification ofmixtures.................................................................................................................2593.3.3.3.1 When the additivity approach is applicable ........................................2603.3.3.3.2 When the additivity approach is not applicable ..................................2603.3.3.4 Decision logic........................................................................................................2603.3.4 Hazard communication in form of labelling for serious eye damage/eye irritation .............2633.3.4.1 Pictograms, signal words, hazard statements and precautionary statements.........2633.3.5 Re-classification of substances and mixtures classified for serious eye damage/eyeirritation according to DSD and DPD...................................................................................2633.3.5.1 Is direct “translation” of classification and labelling possible?.............................2633.3.5.2 Re-evaluation of data ............................................................................................2643.3.6 Examples of classification for serious eye damage/eye irritation.........................................2643.3.6.1 Examples of substances fulfilling the criteria for classification............................2643.3.6.1.1 Example 1: Standard test according to OECD TG 405 with threeanimals ................................................................................................2643.3.6.1.2 Example 2: Test carried out with more than 3 rabbits.........................266Cornea: 2663.3.6.2 Examples of mixtures fulfilling the criteria for classification...............................2673.3.6.2.1 Example 3: Application of the additivity approach for mixturescontaining ingredients without SCLs ..................................................2673.3.6.2.2 Example 4: Application of the additivity approach for mixturescontaining ingredients which may have SCLs ....................................2683.3.6.2.3 Example 5: Application of the additivity approach for mixturescontaining ingredients which may have SCLs ....................................2683.3.7 References ............................................................................................................................2693.4 RESPIRATORY OR SKIN SENSITISATION ................................................................................2693.4.1 Definitions and general considerations for respiratory or skin sensitisation ........................2693.4.2 Classification of substances for respiratory or skin sensitisation .........................................2703.4.2.1 Identification of hazard information .....................................................................2703.4.2.1.1 Identification of human data ...............................................................2703.4.2.1.2 Identification of non human data.........................................................2703.4.2.2 Classification criteria for substances.....................................................................2713.4.2.3 Evaluation of hazard information..........................................................................2713.4.2.3.1 Human data on respiratory sensitisation .............................................2713.4.2.3.2 Human data on skin sensitisation ........................................................2713.4.2.3.3 Non human data on respiratory sensitisation ......................................2713.4.2.3.4 Non human data on skin sensitisation .................................................2723.4.2.3.4.1 Mouse Local Lymph Node Assay (LLNA, OECD TG429).........................................................................................2723.4.2.3.4.2 Guinea Pig Maximisation Test (GPMT, OECD TG406).........................................................................................273