GHS Classification Guidance for the Japanese Government
GHS Classification Guidance for the Japanese Government GHS Classification Guidance for the Japanese Government
http://www.cdc.gov/niosh/npg/npgdrtec.html ● WHO/IPCS “International Chemical Safety Cards” (ICSC): http://www.ilo.org/public/english/protection/safework/cis/products/icsc/dtasht/index.htm (ICSC Japanese version:http://www.nihs.go.jp/ICSC/) 3-3) EU classification ● When classification based on Annex І of EU Directive 67/548/EEC (hereinafter abbreviated as " EU classification")together with its evidence information is not available, the substance shall fall under "Classification not possible". ● If EU classification together with its evidence information is available and if classification criteria of EU classification are different from those of GHS classification, EU classification may be used for GHS classification only when the evidence information is scientifically valid. ● If EU classification together with its evidence information is available and classification criteria of EU classification accord with that of GHS classification, GHS classification may be performed according to EU classification Fundamentally, classification shall be performed based on quality, reliability, and consistency of evidence obtained from the information source, with the evidence weighted and experts judgment added where appropriate. 98
3-1-2 Order of precedence when multiple data exist (1)Order of Precedence when multiple data exist among information sources in List1 A) Data obtained from tests which were performed according to internationally recognized test guidelines (for example, those of OECD) and GLP, take precedence. B) If there are no data falling under A), data obtained from tests which were performed according to internationally recognized test guidelines (for example, those of OECD) but not clearly according to GLP, take precedence. C) When it is difficult to classify according to data based on reliability as shown in A) and B), data considered to have the highest scientific validity shall be adopted after examination of recency of data, dosage selection of the test, selected test animal species, validity of the administration route, etc. If a decision is difficult, it is necessary to seek for judgement by experts. (2)Order of Precedence when conflicting data exist among information sources other than List1 A) Among data collected from other information sources (for example, information sources shown in List 2), data considered to be reliable(data in accordance with GLP, or data for which supporting data are clearly indicated and evaluated, data considered to have the highest scientific validity after examination of dosage selection of the test, selected test animal species, validity of the administration route, etc.) are adopted. This decision procedure is the same as that in (1). B) In this case, the recency of assessment documents and databases or the reliability of cited documents are considered. C) For classification, it is required to evaluate and judge the reliability and validity of data comprehensively. When categorization of data based on reliability as shown in A) and B) is not possible, it is necessary to seek for judgement by expert’s. 99
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3-1-2 Order of precedence when multiple data exist<br />
(1)Order of Precedence when multiple data exist among in<strong>for</strong>mation sources in List1<br />
A) Data obtained from tests which were per<strong>for</strong>med according to internationally recognized<br />
test guidelines (<strong>for</strong> example, those of OECD) and GLP, take precedence.<br />
B) If <strong>the</strong>re are no data falling under A), data obtained from tests which were per<strong>for</strong>med<br />
according to internationally recognized test guidelines (<strong>for</strong> example, those of OECD) but<br />
not clearly according to GLP, take precedence.<br />
C) When it is difficult to classify according to data based on reliability as shown in A) and B),<br />
data considered to have <strong>the</strong> highest scientific validity shall be adopted after examination of<br />
recency of data, dosage selection of <strong>the</strong> test, selected test animal species, validity of <strong>the</strong><br />
administration route, etc. If a decision is difficult, it is necessary to seek <strong>for</strong> judgement by<br />
experts.<br />
(2)Order of Precedence when conflicting data exist among in<strong>for</strong>mation sources o<strong>the</strong>r than List1<br />
A) Among data collected from o<strong>the</strong>r in<strong>for</strong>mation sources (<strong>for</strong> example, in<strong>for</strong>mation sources<br />
shown in List 2), data considered to be reliable(data in accordance with GLP, or data <strong>for</strong><br />
which supporting data are clearly indicated and evaluated, data considered to have <strong>the</strong><br />
highest scientific validity after examination of dosage selection of <strong>the</strong> test, selected test<br />
animal species, validity of <strong>the</strong> administration route, etc.) are adopted. This decision<br />
procedure is <strong>the</strong> same as that in (1).<br />
B) In this case, <strong>the</strong> recency of assessment documents and databases or <strong>the</strong> reliability of cited<br />
documents are considered.<br />
C) For classification, it is required to evaluate and judge <strong>the</strong> reliability and validity of data<br />
comprehensively. When categorization of data based on reliability as shown in A) and B)<br />
is not possible, it is necessary to seek <strong>for</strong> judgement by expert’s.<br />
99
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