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286User Guide for Thresholds and ClassificationsSee Appendix 19D for detailed guidance on the classification of metals and inorganic metal compounds, andAppendix 19G for the details of the metal transformation and dissolution protocol.Figure 19.1: Determining rapid degradability of an organic substance19.1.5. MetabolitesData on metabolites in aquatic systems come from the aquatic degradation studies, including information onthe time course of appearance and concentration. These metabolites are relevant for aquatic organisms.Toxicity data or other supporting information may be needed to evaluate the hazards of the majormetabolites.January 2012 EPA0109
287User Guide for Thresholds and ClassificationsWhere the parent substance degrades to a more hazardous metabolite, the rate at which it is formed shouldbe taken into consideration when assigning a classification to the parent substance.See section 18.2.2 in chapter 18 for further information on metabolites.19.1.6. Use of Quantitative Structure Activity RelationshipsWhile experimentally derived test data are preferred, where no experimental data are available, validatedQuantitative Structure Activity Relationships (QSARs) for aquatic toxicity and log KOW may be used in theclassification process. Such validated QSARs may be used without modification to the agreed criteria, ifrestricted to chemicals for which their mode of action and applicability are well characterised.QSARs for predicting ready biodegradation are not yet sufficiently accurate to predict rapid degradation.See Appendix 19D for further information on the use of QSARs.19.1.7. Weight of evidenceSee section 1.3 in chapter 1 for information about assessing data quality.The best quality data should be used as the fundamental basis for classification. It is preferable thatclassification is based on primary data sources, and it is essential that test conditions are clearly andcompletely articulated.Where multiple studies for a taxonomic group are available, a decision on which studies are the mostsensitive and of the highest quality must be made. A judgement has to be made on a case-by-case basiswhether to use a study that is not based on Good Laboratory Practice (GLP) that has a more sensitiveobservation, or a study based on GLP that has a less sensitive observation. It appears that results thatindicate high toxicity from tests performed according to non-standard or non-GLP guidelines should be ableto be used for classification, whereas studies that demonstrate negligible toxicity require more carefulconsideration.Substances that are difficult to test may yield apparent results that are more or less severe than the truetoxicity of the substance. Expert judgement is needed for classification in these cases.When more than one acceptable test is available for the same taxonomic group, the most sensitive (the onewith the lowest L(E)C50 (that is, LC50 or EC50 data) or NOEC) is generally used for classification. However,this must be dealt with on a case-by-case basis. When larger data sets (that is, with four or more values) areavailable for the same species, the geometric mean of toxicity values may be used as the representativetoxicity value for that species. In estimating a mean value, it is not advisable to combine tests of differentspecies within a taxonomic group or in different life stages or tested under different conditions or duration.19.2. Aquatic hazard threshold and classification criteria19.2.1. Aquatic hazard threshold criteriaSchedule 6 to the Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001 states:January 2012 EPA0109
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