GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 615-28-1
Chemical Name o-Phenylenediamine dihydrochloride
Substance ID R03-C-006-MHLW
Classification year (FY) FY2021
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
New/Revised Revised
Classification result in other fiscal year FY2019  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
1 Explosives -
-
-
- - -
2 Flammable gases -
-
-
- - -
3 Aerosols -
-
-
- - -
4 Oxidizing gases -
-
-
- - -
5 Gases under pressure -
-
-
- - -
6 Flammable liquids -
-
-
- - -
7 Flammable solids -
-
-
- - -
8 Self-reactive substances and mixtures -
-
-
- - -
9 Pyrophoric liquids -
-
-
- - -
10 Pyrophoric solids -
-
-
- - -
11 Self-heating substances and mixtures -
-
-
- - -
12 Substances and mixtures which, in contact with water, emit flammable gases -
-
-
- - -
13 Oxidizing liquids -
-
-
- - -
14 Oxidizing solids -
-
-
- - -
15 Organic peroxides -
-
-
- - -
16 Corrosive to metals -
-
-
- - -
17 Desensitized explosives -
-
-
- - -

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
1 Acute toxicity (Oral) -
-
-
- - -
1 Acute toxicity (Dermal) -
-
-
- - -
1 Acute toxicity (Inhalation: Gases) -
-
-
- - -
1 Acute toxicity (Inhalation: Vapours) -
-
-
- - -
1 Acute toxicity (Inhalation: Dusts and mists) -
-
-
- - -
2 Skin corrosion/irritation -
-
-
- - -
3 Serious eye damage/eye irritation -
-
-
- - -
4 Respiratory sensitization -
-
-
- - -
4 Skin sensitization -
-
-
- - -
5 Germ cell mutagenicity -
-
-
- - -
6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501 		[Rationale for the Classification]
Based on (1) to (3), clear evidence of carcinogenicity including malignant tumors was observed in two animal species, and based on (4), this substance is a target substance in the public announcement on guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare based on paragraph (3) of Article 28 of the Industrial Safety and Health Act, and emphasizing these, it was classified in Category 1B.

[Evidence Data]
(1) In a carcinogenicity study (OECD TG 451, GLP) with rats dosed by drinking water for two years using this substance as the test substance, marked increases in the incidences of hepatocellular adenoma and hepatocellular carcinoma were observed in the liver in males and females, and in addition, an increase in the incidence of transitional cell papilloma and transitional cell papilloma or carcinoma (combined) was observed in the urinary bladder of males. It was concluded that these results were clear evidence of carcinogenicity of this substance in male and female rats (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2004), IARC 123 (2020)).
(2) In a carcinogenicity study (OECD TG 451, GLP) with mice dosed by drinking water for two years using this substance as the test substance, an increase in the incidence of hepatocellular adenoma in the liver was observed in males, a marked increase in the incidence of hepatocellular adenoma and hepatocellular carcinoma was observed in females, and an increase in the incidence of papillary adenoma was also observed in the gall bladder of males and females. It was concluded that these results were evidence of carcinogenicity of this substance in male mice and clear evidence of carcinogenicity in female mice (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2004), IARC 123 (2020)).
(3) Since this substance and free base o-phenylenediamine (CAS RN 95-54-5) are expected to undergo a pH-dependent acid-base equilibrium in the body, the results of carcinogenicity study for one compound can be used as information on the carcinogenicity assessment for the other (IARC 123 (2020)).
(4) This substance is a target substance in the public announcement on guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare based on paragraph (3) of Article 28 of the Industrial Safety and Health Act (guidelines in order to prevent the impairment of worker's health, announcement No. 27 on February 7, 2020).
(5) As for the classification results by domestic and international organizations, the IARC classified this substance in Group 2B (IARC 123 (2020)), the Japan Society For Occupational Health (JSOH) classified it in Group 2B (Recommendation of Occupational Exposure Limits (2020): Proposed in 2019) and the EU classified it in Carc. 2 (EU-CLP Classification Results (Accessed Sep. 2021)).

[Reference Data, etc.]
(6) Also in a carcinogenicity study with male rats and male and female mice dosed by feeding this substance for 18 months (rats were necropsied 6 months later), an increase in the incidence of hepatocellular carcinoma was observed (IARC 123 (2020), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2014), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2014), AICIS (previous NICNAS) IMAP (2013), ACGIH (7th, 2001), Patty (6th, 2012)).
(7) As for the assessment of carcinogenicity of this substance, no human data were available (IARC 123 (2020)).
7 Reproductive toxicity -
-
-
- - -
8 Specific target organ toxicity - Single exposure -
-
-
- - -
9 Specific target organ toxicity - Repeated exposure -
-
-
- - -
10 Aspiration hazard -
-
-
- - -

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
11 Hazardous to the aquatic environment Short term (Acute) -
-
-
- - -
11 Hazardous to the aquatic environment Long term (Chronic) -
-
-
- - -
12 Hazardous to the ozone layer -
-
-
- - -


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
  • An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

To GHS Information