GHS Classification Guidance for the Japanese Government

(c) Any consistent and significant adverse change in clinical biochemistry, haematology,
or urinalysis parameters;
(d) Significant organ damage that may be noted at necropsy and/or
subsequently seen or confirmed at microscopic examination;
(e) Multifocal or diffuse necrosis, fibrosis or granuloma formation in vital organs with
regenerative capacity;
(f) Morphological changes that are potentially reversible but provide clear evidence of
marked organ dysfunction (e.g. severe fatty change in the liver);
(g) Evidence of appreciable cell death (including cell degeneration and reduced cell
number) in vital organs incapable of regeneration.
Hazards listed below are treated separately in the UN GHS second revised edition and hence
are not included in specific target organ toxicity.
- Acute Toxicity (3-2-1)
- Skin Corrosion/Irritation (3-2-2)
- Serious Eye Damage/Eye Irritation (3-2-3)
- Respiratory or Skin Sensitization (3-2-4)
- Germ Cell Mutagenicity (3-2-5)
- Carcinogenicity (3-2-6)
- Reproductive Toxicity (3-2-7)
- Aspiration Hazard (3-2-10)
(4)Guidance for classification and judgment
A) Background of this item and points to be noted
As for background of this item, refer to Part 1, Introduction.
In classification, take the following points into account.
* Unless a description that definitely denies hazards or recognizes extremely low hazards
is available in List 1, the determination of “Not classified” should be performed
carefully. If there is any question, a given substance should rather be classified in
“Classification not possible” due to insufficient information for judgment.
*When an affected organ can be identified, indicate the applicable category along with the
affected organ in parentheses. When the organ cannot be identified, put “systemic
toxicity” in parentheses. (Example entry: Category 1 (liver, kidney, blood), or Category
1 (systemic toxicity))
* When the same substance is classified into different categories depending on the affected
organs, indicate the category for each of the affected organs. (Example entry: Category
1 (liver, kidney), Category 2 (blood)).
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