GHS Classification Guidance for the Japanese Government

(4)Guidance for classification and judgment
A) Background of this item and points to be noted
Regarding the background of this item, refer to Part 1, Introduction.
As for serious eye damage/eye irritation, classification should be conducted according to the
workflow of decision logic 3.3.1, which is the definite decision criteria of UN GHS, the
second revised edition. In classification, refer to the technical advices such as judging method
based on pre-existing test data described below.
Sub-categorization of eye irritation can be performed only when data is available which
shows that the grade of eye irritation reaction which allows the application of the GHS eye
irritation judgment (the UN GHS second revised edition, table 3.2.2) (for example, Draize
method for rabbit or human findings) is mild and showing full reversibility within 7 days .
Accordingly, only for such cases, sub-categorization is performed, and for other cases,
sub-categorization should not be performed.
In addition, note the following in classification.
* Unless description that definitely denies hazards or recognizes extremely low hazards is
available in List 1, determination of “Not classified” should be performed carefully. If
there is any question, not “Not classified” but “Classification not possible” is preferable,
which is based on the absence of sufficient information for judging.
B) Judgement by reliable existing revelation course
If there is a case that ascribes to a substance irreversible effects on eye (Category 1) or
reversible effects on eye (Category 2) in human or animal results, the substance shall be
classified as such. Refer to the UN GHS second revised edition, table 3.3.1 (Example:
accidental cases)
C) Judgement by liable existing test data
1) Decision by in vivo test(Draize test)result:
a) Decision criteria for serious eye damage(irreversible effects)(Category 1):
At least in one animal, effects on the cornea, iris, or conjunctiva that are not expected
to reverse or have not fully reversed within an observation period of 21 days after
installation of the test material.
At least in 2 of 3 tested animals, the calculated mean scores following grading at 24,
48, and 72 hours after installation of the test material are Corneal opacity ≥3 and/or
iritis >1.5.
b) Decision criteria for irritation (reversible effects) (Categories 2A, 2B or Category 2):
In the Draize test conducted using 3 animals, the calculated mean values of the scores
following grading at 24, 48, and 72 hours after installation of the test material are
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