Item | Information |
---|---|
CAS RN | 591-27-5 |
Chemical Name | m-Aminophenol |
Substance ID | R03-C-049-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 | FY2012 FY2006 |
Download of Excel format | Excel file |
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 |
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 | - |
- |
- | - | - |
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 | Category 1A |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1A. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) It was reported that, in a Local Lymph Node Assay (LLNA) (OECD TG 429, GLP) using mice (n=4/group), the first stimulation indices (SI values) were 7.62 (1%), 12.57 (2.5%), 10.38 (5%), 7.19 (10%), and 6.00 (25%); the second SI values were 1.04 (0.05%), 1.41 (0.1%), 5.88 (0.5%), and 9.00 (1%); and the EC3 value was calculated to be 0.24% (DFG MAK (2013), AICIS IMAP (2016), REACH registration dossier (Accessed Dec. 2021)). (2) It was reported that, in a maximization test (intradermal injection: 1% solution) with guinea pigs, sensitization reaction was observed in all animals (DFG MAK (2013), REACH registration dossier (Accessed Dec. 2021)). [Reference Data, etc.] (3) It was reported that four Local Lymph Node Assays (LLNA) (OECD TG 429) using mice (n=4/group) were conducted, and the stimulation indices (SI values) were 2.8, 3.1, 2.8, and 3.3 at the concentration of 2.5%; 3.5, 7.6, 6.1, and 7.1 at the concentration of 5%; and 5.7, 9.7, 8.1, and 6.7 at the concentration of 10% (DFG MAK (2013), AICIS IMAP (2016), REACH registration dossier (Accessed Dec. 2021)). (4) Two semi-occlusive repeat insult patch tests with 98 and 99 test subjects were conducted. In the first study with 98 subjects, no reactions to the challenge patches were observed. In the second study with 99 subjects, additional rechallenge patches on different parts of the body were applied and 2 subjects showed reactions following the challenge patches (AICIS IMAP (2016)). (5) 2,939 consecutive eczema patients attending 12 dermatology clinics were patch tested with this substance. As a result, 1% of the tested patients developed positive reactions and this substance was considered to be sensitizing to skin of human patients (REACH registration dossier (Accessed Dec. 2021)). (6) In the DFG, it was classified in Sh. |
5 | Germ cell mutagenicity | - |
- |
- | - | - |
6 | Carcinogenicity | - |
- |
- | - | - |
7 | Reproductive toxicity | - |
- |
- | - | - |
8 | Specific target organ toxicity - Single exposure | - |
- |
- | - | - |
9 | Specific target organ toxicity - Repeated exposure | - |
- |
- | - | - |
10 | Aspiration hazard | - |
- |
- | - | - |
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 | - |
- |
- | - | - |
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