GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 122-39-4
Chemical Name Diphenylamine
Substance ID H30-C-010-MHLW
Classification year (FY) FY2018
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
New/Revised Revised
Classification result in other fiscal year FY2014   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 (FY2013 revised edition (Ver. 1.1))
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 (including chemically unstable gases) -
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-
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3 Aerosols -
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4 Oxidizing gases -
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5 Gases under pressure -
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6 Flammable liquids -
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7 Flammable solids -
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8 Self-reactive substances and mixtures -
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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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15 Organic peroxides -
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16 Corrosive to metals -
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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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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 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
As for carcinogenicity, there is no available report in humans.
After classification results by domestic and international organizations in (3), in tests conducted according to appropriate test guidelines and GLP standards, (1) and (2), increased incidences of tumors were reported in two animal species. However, incidences of malignant tumors were not clear. Moreover, the substance was judged to be not applicable to guidelines after discussions in the risk evaluation meeting for chemical substances in FY2011 (the 4th small committee of hazard evaluation). Therefore, it was classified in Category 2 by judging that the results are insufficient to constitute evidence of carcinogenicity.

[Evidence Data]
(1) In a 2-year carcinogenicity test in rats dosed by feeding, a trend toward an increase in vascular tumors in the spleen and increased incidences of vascular tumors in all organs including the spleen and subcutis were observed in males, and a trend toward an increase in uterus adenocarcinoma was found in females (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2011)).
(2) In a 2-year carcinogenicity test in mice dosed by feeding, increased incidences of vascular tumors in all organs including the spleen and liver were observed in males (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2011)).
(3) As for classification results by domestic and international organizations, EPA classified it in NL (EPA OPP Annual Cancer Report (2017): classification in 1997), ACGIH classified it in A4 (ACGIH (7th, 2001)), but the results of (1) and (2) were not used in the evaluation.

[Reference Data, etc.]
(4) In two tests in which mice were orally administered (by feeding, by gavage) for 18 months, dose-related tumors were not observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), EU-RAR (2008), Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006), JMPR (1998), EPA Pesticide RED (1998)).
(5) In two 2-year diet administration tests in rats, dose-related tumors were not observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), EU-RAR (2008), ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), JMPR (1998)).
(6) In a 2-year diet administration test in beagle dogs, dose-related tumors were not observed (EU-RAR (2008), ACGIH (7th, 2001)).
(7) It is reported that it exhibited a promoter activity in tumors induced by N-ethyl-N-hydroxyethylnitrosamine (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), JMPR (1998)).
(8) It is described in an EU Risk Assessment Report that a guideline-compliant long-term test is not available, but neoplastic alterations related to this substance are not reported in a number of older investigations in several strains of rats and mice, and dogs (EU-RAR (2008)).
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 (Acute) -
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11 Hazardous to the aquatic environment (Long-term) -
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12 Hazardous to the ozone layer -
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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.

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