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

Guidance on the Application of the CLP Criteria Version 3.0 - November 2012203.7.5 Re-classification of substances and mixtures classified for reproductive toxicityaccording to DSD and DPD..................................................................................................3573.7.5.1 Is direct “translation” of classification and labelling possible?.............................3573.8 SPECIFIC TARGET ORGAN TOXICITY – SINGLE EXPOSURE (STOT-SE)...........................3583.8.1 Definitions and general considerations for STOT-SE ..........................................................3583.8.2 Classification of substances for STOT-SE ...........................................................................3593.8.2.1 Identification of hazard information .....................................................................3593.8.2.1.1 Identification of human data ...............................................................3593.8.2.1.2 Identification of non human data.........................................................3593.8.2.2 Classification criteria for Categories 1 and 2 ........................................................3613.8.2.2.1 Guidance values ..................................................................................3623.8.2.3 Classification criteria for Category 3: Transient target organ effects ...................3623.8.2.4 Evaluation of hazard information on STOT-SE for substances ............................3643.8.2.4.1 Evaluation of human data....................................................................3643.8.2.4.2 Evaluation of non human data.............................................................3663.8.2.4.3 Evaluation of non-testing and in vitro data .........................................3683.8.2.4.4 Conversions.........................................................................................3683.8.2.4.5 Weight of evidence..............................................................................3683.8.2.5 Decision on classification of substances ...............................................................3693.8.2.6 Setting of specific concentration limits for STOT-SE ..........................................3693.8.2.7 Decision logic........................................................................................................3723.8.3 Classification of mixtures for STOT-SE ..............................................................................3743.8.3.1 Identification of hazard information .....................................................................3743.8.3.2 Classification criteria for mixtures........................................................................3743.8.3.2.1 When data are available for the complete mixture..............................3743.8.3.2.2 When data are not available for the complete mixture: bridgingprinciples .............................................................................................3743.8.3.2.3 When data are available for all components or only for somecomponents of the mixture..................................................................3743.8.3.2.4 Components of a mixture that should be taken into account forthe purpose of classification................................................................3753.8.3.3 Generic concentration limits for substances triggering classification ofmixtures for STOT-SE ..........................................................................................375Categories 1 and 2 ................................................................................................................3753.8.3.4 Decision logic for mixtures...................................................................................3763.8.4 Hazard communication in form of labelling for STOT-SE ..................................................3803.8.4.1 Pictograms, signal words, hazard statements and precautionary statements.........3803.8.4.2 Additional labelling provisions .............................................................................3813.8.5 Re-classification of substances and mixtures classified for STOT-SE according toDSD and DPD ......................................................................................................................3813.8.5.1 Is direct “translation” of Classification and Labelling possible for STOT-SEsubstances?............................................................................................................3813.8.5.2 Re-evaluation of the STOT-SE data......................................................................3823.8.6 Examples of classification for STOT-SE .............................................................................3833.8.6.1 Examples of substances fulfilling the criteria for classification............................3833.8.6.1.1 Example 1: Methanol ..........................................................................3833.8.6.1.2 Example 2: Tricresyl phosphate..........................................................3843.8.6.1.3 Example 3: Sulfur dioxide...................................................................3843.8.6.1.4 Example 4: Toluene ............................................................................3843.8.6.2 Examples of substances not fulfilling the criteria for classification......................3853.8.6.2.1 Example 5: ABC .................................................................................3853.8.6.2.2 Example 6: N,N-Dimethylaniline........................................................3853.9 SPECIFIC TARGET ORGAN TOXICITY – REPEATED EXPOSURE (STOT-RE) ....................3863.9.1 Definitions and general considerations for STOT-RE..........................................................386