GHS Classification Guidance for the Japanese Government

[Decision Criteria 1]: In the cases where the substance is concluded to be positive in any
assessment document in List 1 (“Is concluded” does not mean “is suggested” or “has the
possibility”, but “is definitely stated (to be obviously positive).”).
(Exclusion Rule)
Even if the substance meets Decision Criteria 1, if it is proved that the substance
induces asthma in only those who have bronchial hypersensitivity, the substance is
determined as “Not classified”.
[Decision Criteria 2]: If there is evidence in humans that the substance can lead to specific
respiratory hypersensitivity.
Regarding evidence in humans, refer to the UN GHS second revised edition 3.4.2.1.2.
Evidence refers to the following points.
【GHS 2 nd revised edition】(3.4.2.1.2.3)
(a) clinical history and data from appropriate lung function tests related to exposure to
the substance, confirmed by other supportive evidence which may include:
(i) in vivo immunological test (e.g. skin prick test);
(ii) in vitro immunological test (e.g. serological analysis);
(iii) studies that may indicate other specific hypersensitivity reactions where
immunological mechanisms of action have not been proven, e.g. repeated
lowlevel irritation, pharmacologically mediated effects;
(iv) a chemical structure related to substances known to cause respiratory
hypersensitivity;
(b) data from positive bronchial challenge tests with the substance conducted according
to accepted guidelines for the determination of a specific hypersensitivity reaction.
[Decision Criteria 3]: If there are positive results from an appropriate animal test.
(At present, since recognized animal models for the testing of respiratory
hypersensitivity are not available(the UN GHS second revised edition 3.4.2.1.3 footnote
2), [Decision Criteria 3] is not adopted in this guidance. When an appropriate animal
model is set, this Decision Criteria will be adopted.)
2) Skin Sensitization:
Substances applicable to any of [Decision Criteria 1] through [Decision Criteria 4]
below shall be determined as belonging to Category 1. In classification, take into account
the UN GHS second revised edition 3.4.2.2.2. “Specific considerations”.
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