GHS Classification Guidance for the Japanese Government

criteria given below:”
a) If there is evidence in humans that the substance can lead to sensitization by skin contact
in a substantial number(*) of persons, and/or
b) If there are positive results from an appropriate animal test.
(*) “a substantial number” depends on the person responsible for classification. The grounds for
judging a given number to be substantial shall be indicated in the reason for judgment.
B) Classification criteria in GHS(Reference information)
In classification criteria of JIS Classification and that of GHS, the same categories are
adopted.
(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
Classification is performed based on the weight of evidence for respiratory or skin
sensitization. When considering the human evidence, it is necessary for a decision on
classification to take into account the size of the population exposed and the extent of
exposure.
A single category each is adopted for classification of respiratory sensitization and skin
sensitization, i.e., whether the substance induces sensitization (Category 1) or not (Not
classified). The signal word used for skin sensitization Category 1 is “Warning”, while the
word for respiratory sensitization Category 1 is “Danger”, since the latter is considered to
produce more serious effects on human health.
Reference may be made to the following items in each of classification systems below.
EU classification: R42・R43・R42/43
Recommendation of Acceptable Concentration by the Japan Society For Occupational
Health: respiratory tract sensitization and skin sensitization
TLV table of ACGIH:SEN or Sensitization substances
MAK (Germany): Labeling of Sensitization substance (Sa、Sh、Sah)
OECD test guidelines include the following test methods relating to respiratory or skin
sensitization.
OECD406 Skin sensitization
OECD429 Skin sensitization: Local Lymph Node Assay
B) Order of Precedence when Conflicting Data Exist
Refer to “3-1-2 Order of Precedence when Conflicting Data Exist” (p.97).
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