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

Guidance on the Application of the CLP Criteria Version 3.0 - November 20123.9.6.3.3 Example 7............................................................................................4173.9.6.3.4 Example 8............................................................................................4173.9.6.4 Example of mixtures not fulfilling the criteria for classification ..........................4183.9.6.4.1 Example 9............................................................................................4183.9.7 References ............................................................................................................................4184 PART 4: ENVIRONMENTAL HAZARDS .....................................................................................4194.1 HAZARDOUS TO THE AQUATIC ENVIRONMENT ..................................................................4194.1.1 Introduction ..........................................................................................................................4194.1.2 Scope ....................................................................................................................................4194.1.3 Classification of substances hazardous to the aquatic environment .....................................4204.1.3.1 Information applicable for classification of substances hazardous to theaquatic environment ..............................................................................................4204.1.3.1.1 Substance properties used for classification........................................4204.1.3.1.2 Information and data availability ........................................................4204.1.3.2 Evaluation of available information......................................................................4214.1.3.2.1 General considerations ........................................................................4214.1.3.2.2 Substances difficult to test...................................................................4214.1.3.2.3 Interpretation of data for aquatic toxicity, degradation andbioaccumulation ..................................................................................4234.1.3.2.3.1 Aquatic toxicity ................................................................4234.1.3.2.3.2 Degradation ......................................................................4244.1.3.2.3.3 Bioaccumulation...............................................................4274.1.3.2.4 Using weight of evidence in evaluations in the context of C&L ........4294.1.3.2.4.1 General aspects of weight of evidence .............................4294.1.3.2.4.2 Guidance on WoE for data deficient substances ..............4294.1.3.2.4.3 Guidance on WoE for substances for which morethan one valid piece of data is available for a given dataelement ...................................................................................4304.1.3.2.4.4 Outliers .............................................................................4304.1.3.2.4.5 Weight of evidence in degradation...................................4314.1.3.2.4.6 Weight of evidence in bioaccumulation ...........................4314.1.3.3 Classification categories and criteria.....................................................................4314.1.3.3.1 Outline of the core classification system.............................................4314.1.3.3.2 The “safety net”...................................................................................4364.1.3.3.3 Setting an M-factor for highly toxic substances..................................4374.1.3.4 Decision on classification: examples for substances.............................................4384.1.3.4.1 Example A: Hydrophilic substance, straightforward classificationbased on acute and chronic toxicity data.............................................4404.1.3.4.2 Example B: Hydrophilic substance, straightforward classificationbased on acute data, no chronic data available....................................4434.1.3.4.3 Example C: Moderately water soluble substance, straightforwardclassification based on acute data, chronic data available for twotrophic levels only; combined set of QSAR data and experimentaldata ......................................................................................................4464.1.3.4.4 Example D: Substance with several toxicity data for a trophiclevel .....................................................................................................4494.1.3.4.5 Example E: “Safety net” classification category Chronic 4................4524.1.3.4.6 Example F: Substance difficult to test, toxicity above level ofwater solubility....................................................................................4544.1.4 Classification of mixtures hazardous to the aquatic environment ........................................4574.1.4.1 General considerations for classification of mixtures hazardous to the aquaticenvironment...........................................................................................................4574.1.4.2 Information requirements......................................................................................45922