User Guide to Thresholds and Classification - Environmental ...

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144User Guide for Thresholds and Classifications1,000Conversion of inhalation data for gases specified as mg/m3 to ppm:ppm = mg/m 3 × 24.45gram molecularweight of substance(Note: 24.45 = the molar volume of air in litres at normal temperature (25ºC) and pressure (760 torr).)Conversion of oral or dermal data specified as mL/kg to mg/kg:mass (g) = volume (mL) × density (g/mL)Other considerationsUnits for inhalation toxicity are a function of the form of the inhaled material. Values for dusts and mists areexpressed in mg/L. Values for gases are expressed in parts per million by volume (ppmV). Table 10.1acknowledges the difficulties in testing vapours, some of which consist of mixtures of liquid and vapourphases, and provides values in units of mg/L. However, for those vapours that are near the gaseous phase,classification should be based on ppmV. As inhalation test methods are updated, the OECD and other testguideline programmes will need to define vapours in relation to mists for greater clarity.Vapour inhalation values are intended for use in the classification of acute toxicity for all sectors. It is alsorecognised that the saturated vapour concentration of a chemical is used by the transport sector as anadditional element in classifying chemicals for packing groups.Of particular importance is the use of well-articulated values in the high toxicity categories for dusts andmists. Inhaled particles between 1 and 4 μm in mean mass aerodynamic diameter (MMAD) will deposit in allregions of the rat respiratory tract. This particle size range corresponds to a maximum dose of about 2 mg/L.To achieve applicability of animal experiments to human exposure, dusts and mists are ideally tested in thisrange in rats.The cut-off values in Table 10.1 for dusts and mists allow clear distinctions to be made for materials with awide range of toxicities measured under varying test conditions.10.2.8. Synergistic and antagonistic effectsIf the applicant is aware of any available information about possible synergistic effects that may enhance thetoxicity of the substance as a mixture, this must be considered.If the applicant is aware of any available information that antagonistic effects may occur such that thesubstance as a mixture classification is lower than indicated from the calculated value, this should be noted.For example, the encapsulation of a substance as a mixture can lower the toxicity of the substance.January 2012 EPA0109
145User Guide for Thresholds and Classifications10.3. Classification of mixturesThe criteria for substances classify acute toxicity by use of lethal dose data (tested or derived). For mixtures,it is necessary to obtain or derive information that allows the criteria to be applied to the mixture for thepurpose of classification. The approach to classification for acute toxicity is tiered, and depends on theamount of information available for the mixture itself and for its ingredients. The flow chart in Figure 10.1outlines the process to be followed.Figure 10.1: Tiered approach to classification of mixtures for acute toxicityTest data on the mixture as a wholeNoYesSufficient data available Yeson similar mixtures to Apply bridging principles CLASSIFYestimate classificationhazardsNoYesAvailable data for Apply additivity formula CLASSIFYall ingredientsNoOther data available to Yesestimate conversion Apply additivity formula CLASSIFYvalues for classificationNoConvey hazards of theknown ingredientsApply additivity formula(unknown ingredients ≤10%);orApply additivity formula(unknown ingredients >10%)CLASSIFYJanuary 2012 EPA0109
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