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268User Guide for Thresholds and Classificationsand neurotoxicants). One should carefully evaluate the data and, where possible, not include secondary effects (forexample, a hepatotoxicant can produce secondary effects in the nervous or gastro-intestinal system).Table 17C.2: Comparison of Globally Harmonized System of Classification and Labelling of Chemicals (GHS) andHSNO Act specific target organ toxicity (repeat exposure)GHS specific target organ toxicity repeat exposure classificationCategory 1: Substances that have produced significant toxicity in humans, or that, on the basis ofevidence from studies in experimental animals can be presumed to have the potential to producesignificant toxicity in humans following repeated exposureHSNO ActequivalentcategoryPlacing a substance in category 1 is done on the basis of:reliable and good quality evidence from human cases or epidemiological studies; or6.9Aobservations from appropriate studies in experimental animals in which significant and/orsevere toxic effects, of relevance to human health, were produced at generally low exposureconcentrations. Guidance dose–concentration values are used as part of the weight-ofevidenceevaluation.Category 2: Substances that, on the basis of evidence from studies in experimental animals canbe presumed to have the potential to be harmful to human health following repeated exposurePlacing a substance in category 2 is done on the basis of observations from appropriate studies inexperimental animals in which significant toxic effects, of relevance to human health, wereproduced at generally moderate exposure concentrations. Guidance dose–concentration valuesare provided to help in classification. In exceptional cases, human evidence can also be used toplace a substance in category 2.6.9BNote: For both categories, the specific target organ or system that has been primarily affected by the classifiedsubstance may be identified, or the substance may be identified as a general systemic toxicant. Attempts shouldbe made to determine the primary target organ of toxicity and classify for that purpose (for example, hepatoxicantsand neurotoxicants). One should carefully evaluate the data and, where possible, not include secondary effects (forexample, a hepatotoxicant can produce secondary effects in the nervous or gastrointestinal system).ReferencesUnited Nations 2007. The Globally Harmonized System of Classification and Labelling of Chemicals (GHS),2nd revised edition. United Nations, Geneva.January 2012 EPA0109
269User Guide for Thresholds and ClassificationsAppendix 17D: Comparison of European Union specific targetorgan toxicity risk phrases with HSNO Act specific target organtoxicityThe European Union (EC, 1967) risk phrases are converted into the equivalent Hazardous Substances andNew Organisms Act 1996 (HSNO Act) classification in Table 17D.1.Table 17D.1: Comparison of European Union specific target organ toxicity risk phrases with HSNO Act equivalentclassification specific target organ toxicityEuropean Union risk phrasesVery Toxic (T+)A substance is determined to be hazardous and classified as Very Toxic (T+) and assigned one ofthe following risk phrases in accordance with the criteria given below.R39 Danger of very serious irreversible effectsHSNO ActequivalentcategoryStrong evidence that irreversible damage, other than the carcinogenicity, mutagenicity andreproductive effects referred to below, is likely to be caused by a single exposure in the doseranges used for classification as being Very Toxic (T+) by different routes; that is:inhalation LC 50 rat, for aerosols or particulates: 0.25 mg/L over 4 hours;inhalation LC 50 rat, for gases and vapours: 0.5 mg/L over 4 hours;dermal LD 5050 mg/kg;oral LD 50 rat 25 mg/kg.6.9AToxic (T)A substance is determined to be hazardous and classified as Toxic (T) and assigned one or moreof the following risk phrases in accordance with the criteria given below.R39 Danger of very serious irreversible effectsStrong evidence that irreversible damage other than carcinogenicity, mutagenicity andreproductive effects, is likely to be caused by a single exposure by an appropriate route.Substances are classified at least as Toxic (T) when these effects are observed at acutely toxicdose levels, that is:inhalation LC50 rat, for aerosols or particulates: 0.25 < LC50 1 mg/L over 4 hours;inhalation LC50 rat, for gases and vapours: 0.5 < LC50 2 mg/L over 4 hours;dermal LD50 rat or rabbit: 50 < LD50 400 mg/kg;oral LD50 rat: 25 < LD50 200 mg/kg.R48 Danger of serious damage to health by prolonged exposure (not acute)Serious damage (clear functional disturbance or morphological change that has toxicologicalsignificance) is likely to be caused by repeated or prolonged exposure by an appropriate route.Substances are classified at least as Toxic (T) when these effects are observed at the followingdose ranges:inhalation, rat 0.025 mg/L, 6 hours/day;oral, rat 5 mg/kg bw/day;dermal, rat or rabbit 10 mg/kg bw/day.6.9A6.9ANote theinhalationcut-off alsoJanuary 2012 EPA0109
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