GHS Classification Guidance for the Japanese Government

d) All organs described as affected in List 1 shall be indicated. However, when organs
listed in multiple assessment documents based on the same type of tests are not the
same, indicate the commonly listed organs. When a toxic symptom alone is described
and the affected organ cannot be identified, put “systemic toxicity” instead. When the
target organ is identified, fundamentally, a description of toxic symptom is not required.
e) When the affected organ can be identified, indicate the applicable category along with
the affected organ in parentheses in “GHS classification”. When the affected organ
cannot be identified, put “systemic toxicity” in parentheses.
[Decision criteria 1b]: Animal tests meeting all of conditions below
a) Any animal species is applicable.
b) Exposure amount is identified and toxic symptom is induced within the guidance value
range of Category 1
c) The test is described in List 1 or an OECD TG test in List 2, is according to GLP, and
has received some degree of approval (by multiple reviewers)
(Notes)
a) As for toxic effects, read the UN GHS second revised edition and the following
documents carefully.
b) Effects on organs that are obviously known to be secondary effects shall be excluded
from description. Judgement by experts shall be sought for where necessary as to
whether the effects are secondary or not.
c) Effects on respiratory system by site of contact are included here and are placed in
Category 1 (pneumoconiosis, etc.). However, such effects by site of contact other than
respiratory tract, for example, irritation/inflammation reaction in digestive system in a
case of oral administration of a corrosive/irritant, are considered to be subsumed under
other toxicity items such as skin corrosion and are not classified in specific target organ
toxicity.
d) When only minimal symptoms (slight fever, etc.) are reported, the substance is placed
in “Not classified”.
e) All organs described as affected in List 1 shall be indicated. However, when organs
listed in multiple assessment documents based on the same type of tests are not the
same, indicate the commonly listed organs. When a toxic symptom alone is described
and the affected organ cannot be identified, put “systemic toxicity” instead. When the
target organ is identified, fundamentally, a description of toxic symptom is not required.
f) As for conversion of exposure amount, the technical guideline for acute toxicity shall be
used (except for the criteria for dealing with animal species difference).
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