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

Guidance on the Application of the CLP Criteria Version 3.0 - November 20123.1.3.5 Decision on classification......................................................................................2093.1.3.6 Decision logic........................................................................................................2103.1.4 Hazard communication in form of labelling for acute toxicity.............................................2113.1.4.1 Pictograms, signal words, hazard statements and precautionary statements.........2113.1.4.2 Additional labelling provisions .............................................................................2133.1.5 Re-classification of substances and mixtures classified for acute toxicity according toDSD and DPD ......................................................................................................................2133.1.5.1 Is direct “translation” of classification and labelling possible?.............................2133.1.5.2 Re-evaluation of data ............................................................................................2143.1.6 Examples of classification for acute toxicity........................................................................2143.1.6.1 Examples of substances fulfilling the criteria for classification............................2143.1.6.1.1 Example 1: Methanol ..........................................................................2143.1.6.1.2 Example 2: N,N-Dimethylaniline........................................................2143.1.6.1.3 Example 3............................................................................................2153.1.6.1.4 Example 4............................................................................................2163.1.6.1.5 Example 5............................................................................................2163.1.6.1.6 Example 6............................................................................................2163.1.6.1.7 Example 7: 2,3-Dichloropropene ........................................................2173.1.6.1.8 Example 8............................................................................................2173.1.6.1.9 Example 9............................................................................................2183.1.6.2 Examples of substances not fulfilling the criteria for classification......................2183.1.6.2.1 Example 10..........................................................................................2183.1.6.3 Examples of mixtures fulfilling the criteria for classification...............................2193.1.6.3.1 Example 11..........................................................................................2193.1.6.3.2 Example 12 a.......................................................................................2203.1.6.4 Examples of mixtures not fulfilling the criteria for classification.........................2213.1.6.4.1 Example 12 b.......................................................................................2213.1.7 References ............................................................................................................................2223.2 SKIN CORROSION/IRRITATION..................................................................................................2223.2.1 Definitions for classification for skin corrosion/irritation ....................................................2223.2.2 Classification of substances for skin corrosion/irritation .....................................................2223.2.2.1 Identification of hazard information .....................................................................2223.2.2.1.1 Identification of human data ...............................................................2223.2.2.1.2 Identification of non human data.........................................................2223.2.2.1.2.1 Consideration of physico-chemical properties .................2233.2.2.1.2.2 Non-testing methods: (Q)SARs and expert systems ........2233.2.2.1.2.3 Testing-methods: pH and acid/alkaline reserve................2233.2.2.1.2.4 Testing methods: in vitro methods ...................................2233.2.2.1.2.5 Testing methods: In vivo data...........................................2253.2.2.2 Classification criteria.............................................................................................2253.2.2.3 Evaluation of hazard information..........................................................................2263.2.2.3.1 Evaluation of human data....................................................................2273.2.2.3.2 Evaluation of non human data.............................................................2273.2.2.3.2.1 In vitro data.......................................................................2273.2.2.3.2.2 In vivo data.......................................................................2273.2.2.3.3 Weight of evidence..............................................................................2283.2.2.4 Decision on classification......................................................................................2293.2.2.5 Setting of specific concentration limits.................................................................2293.2.2.6 Decision logic for classification of substances......................................................2303.2.3 Classification of mixtures for skin corrosion/irritation.........................................................2333.2.3.1 Identification of hazard information .....................................................................2333.2.3.2 Classification criteria.............................................................................................2333.2.3.2.1 When data are available for the complete mixture..............................2333.2.3.2.1.1 Mixtures with extreme pH................................................23314