GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 62-53-3
Chemical Name Aniline
Substance ID R03-C-010-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 FY2016   FY2009   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 -
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-
- - -
2 Flammable gases -
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-
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3 Aerosols -
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-
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4 Oxidizing gases -
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-
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5 Gases under pressure -
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6 Flammable liquids -
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-
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7 Flammable solids -
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-
- - -
8 Self-reactive substances and mixtures -
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-
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9 Pyrophoric liquids -
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10 Pyrophoric solids -
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-
- - -
11 Self-heating substances and mixtures -
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12 Substances and mixtures which, in contact with water, emit flammable gases -
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-
- - -
13 Oxidizing liquids -
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14 Oxidizing solids -
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-
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15 Organic peroxides -
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-
- - -
16 Corrosive to metals -
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-
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17 Desensitized explosives -
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-
- - -

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


Danger
H350 P308+P313
P201
P202
P280
P405
P501 		[Rationale for the Classification]
Based on (1) to (6), it was classified in Category 1B.

[Evidence Data]
(1) As for the classification results by international organizations, the IARC changed the category from the previous Group 3 (IARC (1987)) to Group 2A based on the data in (2) to (6) (IARC 127 (2021)).
(2) It was reported that, in a carcinogenicity study for aniline hydrochloride (CAS RN 142-04-1) used as a test substance with rats dosed by feeding for two years, at 3,000 to 6,000 ppm, an increase in the incidence of fibrosarcoma or sarcoma (not otherwise specified) and hemangiosarcoma of the spleen or of multiple organs other than spleen within the body cavities was observed in males. It was also reported that a trend towards increased incidences of pheochromocytoma of the adrenal gland in males and fibrosarcoma or sarcoma (not otherwise specified) of the spleen or of multiple organs other than spleen within the body cavities in females was observed (IARC 127 (2021), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), AICIS IMAP (2013), EU RAR (2004), IRIS (1990), NTP TR130 (1978)).
(3) It was reported that, in a carcinogenicity study for aniline hydrochloride used as a test substance with rats dosed by feeding for two years, at 10 to 100 mg/kg/day, increased incidences of stromal sarcoma and hemangiosarcoma of the spleen and mesothelioma of the tunica vaginalis of the testis (only at 30 mg/kg/day) were observed in males. Besides, it was reported that no increase in the incidence of tumors was observed in females (IARC 127 (2021), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), AICIS IMAP (2013), EU RAR (2004), IRIS (1990)).
(4) It was reported that, in a carcinogenicity study for aniline hydrochloride used as a test substance with mice dosed by feeding for two years, at 6,000 to 12,000 ppm, no increase in the incidence of tumors was observed (IARC 127 (2021), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), AICIS IMAP (2013), EU RAR (2004), IRIS (1990), NTP TR130 (1978)).
(5) This substance and its hydrochloride salt achieve a pH-dependent acid-base equilibrium in the body. Therefore, the classification of carcinogenic hazard may apply to both this substance and aniline hydrochloride (IARC 127 (2021)).
(6) The IARC concluded that since there was inadequate evidence in humans but sufficient evidence in experimental animals regarding the carcinogenicity of this substance and its hydrochloride salt, and since this substance also belongs, based on mechanistic considerations, to a class of aromatic amines which have been classified as carcinogenic to humans, it was classified in Group 2A (IARC 127 (2021)).

[Reference Data, etc.]
(7) This substance belongs, based on mechanistic consideration, to a class of aromatic amines, for which several members (such as 4-aminobiphenyl (para-phenylaniline), 2-naphthylamine, ortho-toluidine (ortho-methylaniline)) had been classified in Group 1 (carcinogenic to humans) (IARC 127 (2021)).
(8) As for epidemiological studies of this substance for the carcinogenicity in humans, several cohort studies and case-control studies reported concerns about induction of bladder cancer, but the finding was obtained from studies conducted under co-exposure to other bladder cancer-causing substances, such as ortho-toluidine, rather than exposure to this substance alone (IARC 127 (2021), DFG MAK (2018), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), EU RAR (2004), IRIS (1990)).
7 Reproductive toxicity -
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8 Specific target organ toxicity - Single exposure -
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9 Specific target organ toxicity - Repeated exposure -
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10 Aspiration hazard -
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- - -

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) -
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-
- - -
11 Hazardous to the aquatic environment Long term (Chronic) -
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-
- - -
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.

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