GHS Classification Guidance for the Japanese Government
GHS Classification Guidance for the Japanese Government GHS Classification Guidance for the Japanese Government
UNRTDG Class 6.1 is not sub-categorized by exposure route. Category 1 2 3 4 (Oral) GHS 5 50 300 2000 mg/kg EU classification R28 25 R25 200 R22 2000 (Dermal) GHS 50 200 1000 2000 mg/kg EU classification R27 50 R24 400 R21 2000 (Vepours) GHS 0.5 2 10 20 mg/L EU classification R26 0.5 R23 2 R20 20 (Dust・mist) GHS 0.05 0.5 1 5 mg/L EU classification R26 0.25 R23 1 R20 5 (Note)”Oral” and “Dermal” are LD50 values, and “Vapours” and “Dusts and Mists” are LC50 values. As for “Gases”, the description is omitted because they are not defined in the present EU classification. D) Guidance concerning data Care should be taken since, even when test data within 4 hours are not available, findings of other test reports suggest that units for halation toxicity vary depending on the shape of the inhaled substance. Classification should be performed on the basis of the values for gases (ppmV) if the test atmosphere consists of a gaseous phase including vapour that is substantially a gaseous phase, values for vapours (mg/L)if the test atmosphere consists of a liquid with a relatively low boiling point, and values for mists (mg/L)for other cases. (Reference)Conversion of ppmV and mg/L units(at 25°C and atmospheric pressure) (ppmV ) = {( mg/L)× 24.45 × 10 3 } / molecular weight (mg/L) = {( ppmV )× molecular weight × 10 -3 } / 24.45 (4)Guidance for classification and judgment A) Background of this item and points to be noted As for background of this item, refer to Part 1, Introduction. As for substances of which only mixture data are available (only mixed or diluted with solvents without toxicity), their GHS classification as pure substances are performed by appropriately estimating corresponding values from concentrations, and the estimation processes should be described. B) Decision when there are multiple descriptions related to Acute Toxicity When multiple descriptions related to Acute Toxicity with highly reliable data are available, 108
and when they fall under multiple categories, in principle, the category is determined according to “3-1-2 Order of Precedence when Conflicting Data Exist”(p.97). However, when the substance falls under multiple categories under the above order of precedence, the category under which the greatest number of data fall is adopted. In addition, if the numbers of data for the categories thus singled out are the same, the category with higher hazard is adopted. (Methods to classify mixtures by using categorization results include a method using conversion values in Table 3-2 based on the determined category and a method using values considered to be appropriate (the smallest one is adopted) among data shown in the classification reason.) C) Considerations in the case of assessing the Acute Toxicity LC50 in inhalation route 1) Values for inhalation toxicity are based on a 4-hour animal test. Data are adopted based on the following criteria, converted to the 4-hour values, and calculated. a) If 1-hour and 4-hour data are available, only these data are used, and calculation is performed. (1-hour data is converted to a 4-hour equivalent and calculated.) b) If the data satisfying the condition in 1) are not available, data of 30 minutes to 24 hours are used, and calculation is performed. c) If the data satisfying the condition in 1) and 2) are not available, the substance is classified as “Classification not possible”. However, a substance which shows lethal effect by exposure of 4 hours or less (including less than 30 minutes) with the concentration of the criterion value or below for Category 1 (determined by ATE/ LC50) is classified as Category 1 (inhalation). Method for converting LC50 value B for A hours into LC50 estimate value D for C hours: ・Gas/vapour: D = B√A / √C ・Dust/Mist: D = BA/C * When performing GHS classification, enter 4 (hours) for C. (Regarding conversion) When an experimental value is adopted from the 1-hour exposure test, it shall be converted into a 4-hour equivalent by dividing the 1-hour value by a factor of 2 in the case of gas and vapour and by a factor of 4 in the case of dust and mist. The experimental values other than for 1 hour are not described in the GHS text, but LC50 in 4 hours necessary for applying the GHS classification shall be obtained by using the above arithmetic formula. 2) In some cases, it is not clear whether the adopted data is from the vapour inhalation test or mist inhalation test. In such cases, the substance shall be determined as “Classification not 109
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UNRTDG Class 6.1 is not sub-categorized by exposure route.<br />
Category 1 2 3 4<br />
(Oral) <strong>GHS</strong> 5 50 300 2000<br />
mg/kg EU classification R28 25 R25 200 R22 2000<br />
(Dermal)<br />
<strong>GHS</strong> 50 200 1000 2000<br />
mg/kg EU classification R27 50 R24 400 R21 2000<br />
(Vepours) <strong>GHS</strong> 0.5 2 10 20<br />
mg/L EU classification R26 0.5 R23 2 R20 20<br />
(Dust・mist) <strong>GHS</strong> 0.05 0.5 1 5<br />
mg/L EU classification R26 0.25 R23 1 R20 5<br />
(Note)”Oral” and “Dermal” are LD50 values, and “Vapours” and “Dusts and Mists” are LC50<br />
values. As <strong>for</strong> “Gases”, <strong>the</strong> description is omitted because <strong>the</strong>y are not defined in <strong>the</strong> present EU<br />
classification.<br />
D) <strong>Guidance</strong> concerning data<br />
Care should be taken since, even when test data within 4 hours are not available, findings of<br />
o<strong>the</strong>r test reports suggest that units <strong>for</strong> halation toxicity vary depending on <strong>the</strong> shape of <strong>the</strong><br />
inhaled substance. <strong>Classification</strong> should be per<strong>for</strong>med on <strong>the</strong> basis of <strong>the</strong> values <strong>for</strong> gases<br />
(ppmV) if <strong>the</strong> test atmosphere consists of a gaseous phase including vapour that is substantially<br />
a gaseous phase, values <strong>for</strong> vapours (mg/L)if <strong>the</strong> test atmosphere consists of a liquid with a<br />
relatively low boiling point, and values <strong>for</strong> mists (mg/L)<strong>for</strong> o<strong>the</strong>r cases.<br />
(Reference)Conversion of ppmV and mg/L units(at 25°C and atmospheric pressure)<br />
(ppmV ) = {( mg/L)× 24.45 × 10 3 } / molecular weight<br />
(mg/L) = {( ppmV )× molecular weight × 10 -3 } / 24.45<br />
(4)<strong>Guidance</strong> <strong>for</strong> classification and judgment<br />
A) Background of this item and points to be noted<br />
As <strong>for</strong> background of this item, refer to Part 1, Introduction.<br />
As <strong>for</strong> substances of which only mixture data are available (only mixed or diluted with<br />
solvents without toxicity), <strong>the</strong>ir <strong>GHS</strong> classification as pure substances are per<strong>for</strong>med by<br />
appropriately estimating corresponding values from concentrations, and <strong>the</strong> estimation<br />
processes should be described.<br />
B) Decision when <strong>the</strong>re are multiple descriptions related to Acute Toxicity<br />
When multiple descriptions related to Acute Toxicity with highly reliable data are available,<br />
108