GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 97-56-3
Chemical Name 2-Methyl-4-(2-tolyldiazenyl)aniline; o-Aminoazotoluene
Substance ID R02-B-078-MHLW, MOE
Classification year (FY) FY2020
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2006  
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 Not classified (Not applicable)
-
-
- - There is a neighboring nitrogen atoms (azo group) present in the molecule, which is an aromatic azo group, not a chemical group associated with explosive properties. Therefore, it was classified as "Not classified."
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. It was classified as "Not classified."
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
7 Flammable solids Classification not possible
-
-
- - No data available. Besides, there is information that it is combustible (GESTIS (Access on May 2020)), and there is a risk of dust explosion in the form of powder or dust (GESTIS (Access on May 2020)).
8 Self-reactive substances and mixtures Not classified (Not applicable)
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified."
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
10 Pyrophoric solids Classification not possible
-
-
- - No data available.
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified (Not applicable)
-
-
- - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified."
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified."
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16 Corrosive to metals Classification not possible
-
-
- - Classification is not possible because test methods applicable to solid substances are not available.
17 Desensitized explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Classification not possible
-
-
- - [Rationale for the Classification]
The category could not be specified from (1), (2), and it was classified as "Classification not possible."

[Reference Data, etc.]
(1) LDLo for rats: 1,500 mg/kg (MAK (DFG) (2013), AICIS (formerly, NICNAS) IMAP (2014), GESTIS (Access on May 2020))
(2) LDLo for mice: 800 mg/kg mg/kg (MAK (DFG) (2013), AICIS (formerly, NICNAS) IMAP (2014))
1 Acute toxicity (Dermal) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Solid (GHS definition). It was classified as "Not classified."
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
2 Skin corrosion/irritation Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
3 Serious eye damage/eye irritation Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
[Rationale for the Classification]
It was classified in Category 1 from (1).

[Evidence Data]
(1) This substance was reported to cause allergic contact eczema of the hands and arms in humans, which was subsequently verified by patch testing in humans. Cross-reactions to structurally-related azo dyes and other related compounds were also reported (AICIS (formerly, NICNAS) IMAP (2014)).

[Reference Data, etc.]
(2) A skin sensitization test with guinea pigs on this substance (open epicutaneous test, 10 applications of 2%/petrolatum) was conducted, and erosive and exudative reactions were observed, but no conclusion was reached (MAK (DFG) (2013), AICIS (formerly, NICNAS) IMAP (2014)).
(3) It was classified in Skin Sens. 1 (H317) in EU-CLP classification (EU CLP classification (Access on August 2020)).
5 Germ cell mutagenicity Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
It was classified in Category 2 from (1), (2). By reviewing information sources, the classification result was changed. Besides, a positive result in a specific locus test with mice described in the previous classification was presumed to be a positive result in a mouse lymphoma TK test.

[Evidence Data]
(1) As for in vivo, it was reported to be positive in a micronucleus test by intraperitoneal administration to mice, negative in a micronucleus test after intraperitoneal administration to rats, positive in unscheduled DNA synthesis tests after gavage administration to mice or rats, positive in a sister chromatid exchange test after intraperitoneal administration to mice, positive in a gene mutation test in lacZ transgenic mice, and positive in comet assays in mice (intraperitoneal administration: stomach, colon, liver, urinary bladder, lung, brain), (gavage administration: colon, liver, lung) (MAK (DFG) (2013), AICIS (formerly, NICNAS) IMAP (2014)).
(2) As for in vitro, it was reported to be positive in a bacterial reverse mutation test, and it was reported in test systems using cultured mammalian cells that it was positive in a sister chromatid exchange test and negative in a chromosomal aberration test (MAK (DFG) (2013), AICIS (formerly, NICNAS) IMAP (2014)).
6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
From (1), (2), IARC classified it in Group 2B, but tumor formation was observed at several tissue sites in several species of experimental animals, and based on the latest classification results by other organizations, it was classified in Category 1B. An investigation was conducted using new information sources, and the classification result was changed.

[Evidence Data]
(1) As for classification results by domestic and international organizations, it was classified in Group 2B by IARC (IARC Sup7 (1987)), Group 2B by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH)) (proposed in 1991)), R by NTP (NTP RoC (14th, 2016)), 2 in MAK (DFG) (MAK (DFG) (2013)), and Carc.1B in EU CLP classification (EU CLP classification (Access on May 2020)).
(2) This substance caused tumors in several species of experimental animals at several different tissue sites. Dietary administration of this substance caused hepatocellular adenoma or carcinoma in male and female mice, adenoma, hepatocellular carcinoma, cholangioma, or other carcinoma in male rats, hepatocellular adenoma or carcinoma in male and female hamsters, hepatocellular adenoma or carcinoma, adenocarcinoma, or cholangioma in dogs, and lung tumors and benign blood-vessel tumors (hemangioendothelioma in the lung) in male and female mice. In addition, papillary or transitional cell carcinoma in the urinary bladder was observed in hamsters of both sexes, and urinary bladder cancer in dogs, gallbladder tumors (papilloma or carcinoma) in female hamsters, adenocarcinoma in dogs, and mammary gland cancer (adenocarcinoma) in female hamsters were found (NTP RoC (14th, 2016)).
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data.

[Reference Data, etc.]
(1) There was information that this substance might cause irritative effects to the respiratory organs (GESTIS (Access on May 2020)).
(2) Due to reductive cleavage products of this substance generated in vivo, impaired oxygen transport functions of the blood due to methemoglobin formation and damage of the erythrocytes and, moreover, direct irritations of the efferent urinary tract and dysfunctions/damage of the kidneys were expected (GESTIS (Access on May 2020)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data.
10 Aspiration hazard Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

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) Classification not possible
-
-
- - No data available.
11 Hazardous to the aquatic environment Long term (Chronic) Classification not possible
-
-
- - No data available.
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


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.

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