GHS Classification Guidance for the Japanese Government

*As for substances of which only mixture data are available (provided mixed or diluted
with solvents without toxicity), their GHS classification as pure substances are
performed by estimating from concentrations appropriately, and the estimation
processes are to be described as a ground for classification.
B) Regarding classification procedure
1) Substances meeting [Decision criteria 1a] or [Decision criteria 1b] below are placed in
Category 1.
[Decision criteria 1a]: Substances for which evidence of inducing toxic effects in humans are
(Notes)
available in List 1.
a) Effects on organs that are obviously known to be secondary effects shall be excluded
from the description. Judgement by expert’s shall be sought for where necessary about
whether the effects are secondary effects or not. When such a judgment is difficult, all
organs affected shall be cited.
b) 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 into specific target
organ.
c) When only minimal symptoms (slight fever, languor, etc.)are described, the substance is
placed in “Not classified”.
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, description of toxic symptom is not required.
e) When the affected organ can be identified, indicate the applicable category along with
the affected organs given in parentheses are indicated 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 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
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