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

Guidance on the Application of the CLP Criteria Version 3.0 - November 2012I.4 Substances which are difficult to test ...................................................................................490I.4.1 Unstable substances...............................................................................................490I.4.2 Poorly soluble substances......................................................................................491I.4.3 Other factors contributing to concentration loss ...................................................492I.4.4 Perturbation of the test media................................................................................492I.4.5 Complex substances ..............................................................................................493I.5 References ............................................................................................................................493II ANNEX II: RAPID DEGRADATION .............................................................................................494II.1 Introduction ..........................................................................................................................494II.2 Interpretation of degradability data ......................................................................................494II.2.1 Ready biodegradability .........................................................................................495II.2.1.1 Concentration of test substance...........................................................495II.2.1.2 Time window.......................................................................................495II.2.2 BOD 5 /COD............................................................................................................496II.2.3 Other convincing scientific evidence ....................................................................496II.2.3.1 Aquatic simulation tests ......................................................................496II.2.3.2 Field investigations .............................................................................497II.2.3.3 Monitoring data...................................................................................497II.2.3.4 Inherent and Enhanced Ready Biodegradability tests.........................497II.2.3.5 Sewage treatment plant simulation tests .............................................497II.2.3.6 Soil and sediment degradation data.....................................................498II.2.3.7 Anaerobic degradation data.................................................................498II.2.3.8 Hydrolysis ...........................................................................................498II.2.3.9 Photochemical degradation .................................................................498II.2.3.10 Estimation of degradation ...................................................................499II.2.3.11 Volatilisation .......................................................................................499II.2.4 No degradation data available...............................................................................499II.3 General interpretation problems ...........................................................................................499II.3.1 Complex substances ..............................................................................................499II.3.2 Availability of the substance.................................................................................500II.3.3 Test duration less than 28 days .............................................................................500II.3.4 Primary biodegradation.........................................................................................500II.3.5 Conflicting results from screening tests ................................................................501II.3.6 Variation in simulation test data............................................................................501II.4 Decision scheme ...................................................................................................................502II.5 References ............................................................................................................................503III24ANNEX III: BIOACCUMULATION...............................................................................................504III.1 Introduction ..........................................................................................................................504III.2 Interpretation of bioconcentration data.................................................................................504III.2.1 Bioconcentration factor (BCF)..............................................................................505III.2.1.1 BCF in different test species ...............................................................506III.2.1.2 Use of radio-labelled substances .........................................................506III.2.2 Octanol-water-partitioning coefficient (K ow ) ........................................................507III.2.2.1 Experimental determination of K ow .....................................................507III.2.2.2 Use of QSARs for determination of log K ow .......................................507III.3 Chemical classes that need special attention with respect to BCF and K ow values ..............508III.3.1 Substances difficult to test.....................................................................................508III.3.2 Poorly soluble and complex substances ................................................................509III.3.3 High molecular weight substances........................................................................509III.3.4 Surface-active substances (surfactants).................................................................509III.3.4.1 Octanol-water-partition coefficient (K ow ) ...........................................510III.4 Conflicting data and lack of data..........................................................................................510III.4.1 Conflicting BCF data ............................................................................................510III.4.2 Conflicting log K ow data........................................................................................510