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

Guidance on the Application of the CLP Criteria Version 3.0 - November 2012183.5.3.1.2 When data are not available for the complete mixture: bridgingprinciples .............................................................................................2943.5.3.2 Generic concentration limits for substances triggering classification ofmixtures.................................................................................................................2943.5.3.3 Decision logic for mixtures...................................................................................2953.5.4 Hazard communication in form of labelling for germ cell mutagenicity .............................2973.5.4.1 Pictograms, signal words, hazard statements and precautionary statements.........2973.5.4.2 Additional labelling provisions .............................................................................2973.5.5 Re-classification of substances classified for germ cell mutagenicity according to DSDand DPD ...............................................................................................................................2983.6 CARCINOGENICITY ......................................................................................................................2983.6.1 Definitions and general considerations for classification for carcinogenicity......................2983.6.2 Classification of substances for carcinogenicity...................................................................2993.6.2.1 Identification of hazard information .....................................................................2993.6.2.2 Classification criteria for substances.....................................................................2993.6.2.3 Evaluation of hazard information..........................................................................3003.6.2.3.1 Specific considerations for classification............................................3013.6.2.3.2 Additional considerations for classification ........................................302(f) Whether responses are in a single species or several species.......................................................3063.6.2.3.3 Consideration of mutagenicity ............................................................3103.6.2.3.4 Non testing data...................................................................................3103.6.2.4 Decision on classification......................................................................................3113.6.2.5 Setting of specific concentration limits.................................................................3113.6.2.6 Decision logic for classification of substances......................................................3133.6.3 Classification of mixtures for carcinogenicity......................................................................3143.6.3.1 Classification criteria for mixtures........................................................................3143.6.3.1.1 When data are available for all ingredients or only for someingredients ...........................................................................................3143.6.3.1.2 When data are available for the complete mixture..............................3143.6.3.1.3 When data are not available for the complete mixture: bridgingprinciples .............................................................................................3153.6.3.2 Decision logic for classification of mixtures.........................................................3163.6.4 Hazard communication in form of labelling for carcinogenicity..........................................3173.6.4.1 Pictograms, signal words, hazard statements and precautionary statements.........3173.6.4.2 Additional labelling provisions .............................................................................3173.6.5 Re-classification of substances and mixtures classified for carcinogenicity accordingto DSD and DPD ..................................................................................................................3183.6.5.1 Is direct “translation” of classification and labelling possible?.............................3183.6.5.2 Some additional considerations for re-classification.............................................3183.6.6 Examples of classification for carcinogenicity.....................................................................3183.6.7 References ............................................................................................................................3183.7 REPRODUCTIVE TOXICITY.........................................................................................................3213.7.1 Definitions and general considerations for reproductive toxicity.........................................3213.7.1.1 Special considerations on effects on or via lactation ............................................3223.7.2 Classification of substances for reproductive toxicity..........................................................3233.7.2.1 Identification of hazard information .....................................................................3233.7.2.1.1 Identification of human data ...............................................................3233.7.2.1.2 Identification of non human data.........................................................3233.7.2.2 Classification criteria.............................................................................................3233.7.2.2.1 Classification in the presence of parental toxicity...............................3243.7.2.2.1.1 Effects to be considered in the presence of markedsystemic effects ......................................................................3243.7.2.2.1.2 Relevance of specific effects in the parent .......................3253.7.2.2.2 Substances causing effects on or via lactation ....................................326