GHS Classification Guidance for the Japanese Government

Table 3-4 Categories of skin irritation a)
Category Criteria
Skin
irritation
(Category2)
Any one of the below shall serve as the criterion.
a) The averaged score values of 2.3 or more and 4.0 or less for erythema/eschar or
for edema in at least 2 of 3 tested animal from gradings at 24, 48, and 72 hours
after patch removal or, if reactions are delayed, from gradings on 3 consecutive
days after the onset of skin responses; or
b) Inflammation that persists to the end of the observation period, normally 14 days,
in at least 2 animals, particularly taking into account of alopecia (in limited area),
hyperkeratosis, hyperplasia, and scaling; or
c) In some cases where there is pronounced variability of response among animals
and where very definite positive effects that are related to chemical exposure but
are less than the criteria above are observed in a single animal.
Note a) The use of human data is discussed in “Evidence from humans” (the UN GHS the second
revised edition 1.3.2.4.7).
B) Classification criteria in GHS(Reference Information)
In GHS classification, in addition to JIS Classification, Category 3 is set. Classification
criteria of GHS are as follows.
【GHS 2 nd revised edition】(3.2.2)
Table 3.2.1: Skin corrosion category and sub-categories a
Category 1: Corrosive Corrosive
(applies to authorities not
using sub-categories)
corrosive
sub-categories
(only applies to some
authorities)
115
Corrosive in 1 of 3 animals
Exposure Observation
1A ≤3 min ≤1h
1B >3min≤1h ≤14days
1C >1h≤4h ≤14days
a The use of human data is discussed in 3.2.2.1 and in “Classification of hazardous substances
and mixtures”(para.1.3.2.4.7.1)