User Guide to Thresholds and Classification - Environmental ...

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406User Guide for Thresholds and ClassificationsQuantitative predictionThe calculation of the MATC from a NOEC value can be problematic as none of the test guidelinesrequires doses to be in a specified concentration series. As a result, an up-front conversion factor cannotbe used based on the maximum differences between the NOEC and LOEC.Maximum acceptable toxicant concentration values expressed in units of parts per million diet ormilligrams per kilogram body weight, while chronic threshold is limited to parts per million dietThe expression of the MATC in milligrams per kilogram (mg/kg) body weight is inconsistent with the chronicthreshold (see 21.2.2 2(1)(c)(iii)). Equations to determine the average food intake per body weight forstandard test species are provided by Guidance Document on Risk Assessment for Birds and Mammalsunder Council Directive 91/414/EEC (EC, 2002). To accurately determine the food intake for a species, thebody weight and diet must be provided within the test report. Given these data, the units of dose can beconverted from mg/kg body weight to ppm diet (mg/kg) following the equations, data tables, and examplesfound in Appendix 21C.21.1.3. MetabolitesThe substances may be transformed in the environment by abiotic or biotic processes. The potential hazardsthat these metabolites pose to terrestrial organisms must be evaluated when classifying the parentsubstance. An in-depth discussion of the classification of metabolites is in chapter 18 above.21.1.4. Weight of evidenceThe best quality data should be used as the fundamental basis for classification. Preferably, classificationshould be based on primary data sources. It is essential that test conditions be clearly and completelyarticulated.Data from internationally harmonised test methods are preferred for classification under this subclass.Preferably, data should be derived using Organisation for Economic Co-operation and Development (OECD)test guidelines or equivalent, according to the principles of Good Laboratory Practice (GLP). Where suchdata are not available, classification should be based on the best available data using a weight-of-evidenceapproach.See section 1.3 in chapter 1 above for information about assessing data quality.See Appendix 21B below for a detailed list of acceptable test methods for acute toxicity.When experimental data for acute toxicity are available in several vertebrate species, scientific judgementshould be used in selecting the most appropriate LD 50 or LC 50 value from among valid, well-performed tests.21.2. Hazard thresholds and classification criteria for terrestrial vertebrateecotoxicity21.2.1. ThresholdsJanuary 2012 EPA0109
407User Guide for Thresholds and ClassificationsSchedule 6 to the Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001 states:2 Minimum degrees of hazard(1) A substance with ecotoxic properties is not hazardous for the purposes of the Act unless—…(c) the substance is ecotoxic to terrestrial vertebrates because—(i) data for the substance indicates an acute avian or mammalian oral or dermal LD 50 of2000 milligrams or less of the substance per kilogram of body weight, as a result ofexposure to the substance; or(ii) data for the substance indicates an acute avian or mammalian LC 50 of 5000 parts orless of the substance per million in the diet, as a result of exposure to the substance;or(iii) data for the substance indicates a chronic avian or mammalian MATC of 100 partsor less of the substance per million in the diet, as a result of exposure to thesubstance.21.2.2. ClassificationSchedule 6 to the Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001 identifies threeclassification categories for substances that are ecotoxic to terrestrial vertebrates (subclass 9.3).A subclass 9.3 classification and the subsequent category apply to any substance that meets the followingcriteria.Category 9.3A – substances that are very ecotoxic to terrestrial vertebratesa. A substance for which data indicate an acute avian or mammalian (oral or dermal) LD 50 ≤ 50milligrams of the substance per kilogram of bodyweight; orb. A substance for which data indicate an acute avian or mammalian LC 50 ≤ 500 parts per million of thesubstance in the diet.Category 9.3B – substances that are ecotoxic to terrestrial vertebratesa. A substance for which data indicate an acute avian or mammalian (oral or dermal) LD 50 > 50milligrams, but ≤ 500 milligrams, of the substance per kilogram of bodyweight; orb. A substance for which data indicate an acute avian or mammalian LC 50 > 500 parts per million, but ≤1,000 parts per million, of the substance in the diet.Category 9.3C – substances that are harmful to terrestrial vertebratesa. A substance for which data indicate an acute avian or mammalian (oral or dermal) LD 50 > 500milligrams, but ≤ 2,000 milligrams, of the substance per kilogram of bodyweight; orb. A substance for which data indicate an acute avian or mammalian LC 50 > 1,000 parts per million, but≤ 5,000 parts per million, in the diet; orc. A substance for which data indicate a chronic avian or mammalian MATC ≤ 100 parts per million ofthe substance in the diet, but that does not meet the criteria for hazard classification 9.3A or 9.3B.January 2012 EPA0109
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