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 |
Item | Information |
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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 |
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." |
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. |
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. |
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