GHS Classification Guidance for the Japanese Government
GHS Classification Guidance for the Japanese Government GHS Classification Guidance for the Japanese Government
specifically for these effects as discussed in H.4 (Note: classification criteria of mixtures). For these categories 1 through 3, the specific target organ/system that has been primarily affected by the classified substance may be identified, or the substance may be identified as a general toxicant. Attempts should be made to determine the primary target organ, organ/system of toxicity, and classify for that purpose, e.g. hepatotoxicants, neurotoxicants. One should carefully evaluate the data and, where possible, not include secondary effects, e.g. a hepatotoxicant can produce secondary effects in the nervous or gastro-intestinal systems. Table 3-14: Guidance value ranges for single-dose exposures 172 Guidance value ranges for: Route of exposure Units Category 1 Category 2 Category 3 Oral (rat) Dermal (rat or rabbit) mg/kg body weight mg/kg body weight C≤300 300
espiratory tract irritation (RTI ) (e.g. electrophysiological responses, biomarkers of inflammation in nasal or bronchoalveolar lavage fluids; (c) The symptoms observed in humans should also be typical of those that would be produced in the exposed population rather than being an isolated idiosyncratic reaction or response triggered only in individuals with hypersensitive airways. Ambiguous reports simply of “irritation”should be excluded as this term is commonly used to describe a wide range of sensations including those such as smell, unpleasant taste, a tickling sensation, and dryness, w hich are outside the scope of this classification endpoint; (d) There are currently no validated animal tests that deal specifically with RTI, however, useful information may be obtained from the single and repeated inhalation toxicity tests. For example, animal studies may provide useful information in terms of clinical signs of toxicity (dyspnoea, rhinitis etc) and histopathology (e.g. hyperemia, edema, minimal inflammation, thickened mucous layer) which are reversible and may be reflective of the characteristic clinical symptoms described above. Such animal studies can be used as part of w eight of evidence evaluation; (e) This special classification would occur only when more severe organ effects including in the respiratory system are not observed. The GHS criteria for specific target organ toxicity (single exposure) Category 3 “narcotic effects” are as follows. 【GHS 2 nd revised edition】(3.8.2.2.2) The criteria for narcotic effects as Category 3 are: (a) Central nervous system depression including narcotic effects in humans such as drowsiness, narcosis, reduced alertness, loss of reflexes, lack of coordination, and vertigo are included. These effects can also be manifested as severe headache or nausea, and can lead to reduced judgment, dizziness, irritability, fatigue, impaired memory function, deficits in perception and coordination, reaction time, or sleepiness; (b) Narcotic effects observed in animal studies may include lethargy, lack of coordination righting reflex, narcosis, and ataxia. If these effects are not transient in nature, then they should be considered for classification as Category 1 or 2. (3)Items on information sources and data * Classification procedure can be referred to "3-1-1 Sources of Information available for classification". A) Data availability Sufficient information for classification cannot be obtained from simple descriptions in 173
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specifically <strong>for</strong> <strong>the</strong>se effects as discussed in H.4 (Note: classification criteria of mixtures).<br />
For <strong>the</strong>se categories 1 through 3, <strong>the</strong> specific target organ/system that has been primarily<br />
affected by <strong>the</strong> classified substance may be identified, or <strong>the</strong> substance may be identified as a<br />
general toxicant. Attempts should be made to determine <strong>the</strong> primary target organ, organ/system<br />
of toxicity, and classify <strong>for</strong> that purpose, e.g. hepatotoxicants, neurotoxicants. One should<br />
carefully evaluate <strong>the</strong> data and, where possible, not include secondary effects, e.g. a<br />
hepatotoxicant can produce secondary effects in <strong>the</strong> nervous or gastro-intestinal systems.<br />
Table 3-14: <strong>Guidance</strong> value ranges <strong>for</strong> single-dose exposures<br />
172<br />
<strong>Guidance</strong> value ranges <strong>for</strong>:<br />
Route of exposure Units Category 1 Category 2 Category 3<br />
Oral (rat)<br />
Dermal (rat or rabbit)<br />
mg/kg body<br />
weight<br />
mg/kg body<br />
weight<br />
C≤300 300
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