GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 92-52-4
Chemical Name Biphenyl
Substance ID H30-C-007-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 FY2008   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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-
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4 Oxidizing gases -
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5 Gases under pressure -
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-
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6 Flammable liquids -
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7 Flammable solids -
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-
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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 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
As for carcinogenicity, there is no available report in humans.
As for classification results by other organizations, EPA classified it in S as written in (3). However, it was classified in Category 1B by putting importance on the fact that clear evidence of carcinogenicity was observed in two animal species including malignant tumors in tests conducted according to appropriate test guidelines and GLP standards, (1) and (2), and that guidelines were issued by the ministry from concerns on carcinogenicity after discussions in the small committee of hazard evaluation.

[Evidence Data]
(1) In a carcinogenicity test in rats (2-year diet administration), an increased incidence of urinary bladder tumors (transitional cell papilloma, transitional cell carcinoma, and squamous cell carcinoma and papilloma in a few animals) was observed in a male dosed group. In dosed groups, calculus in the pelvis and urinary bladder and hyperplasia in the urinary bladder were observed in both males and females, but an increased incidence of tumors was not observed in the urinary bladder of females (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 1996)).
(2) In a carcinogenicity test in mice (2-year diet administration), an increased incidence of hepatocellular carcinoma was observed in female dosed groups (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 1996)).
(3) As for classification results by domestic and international organizations, EPA classified it in S.

[Reference Data, etc.]
(4) US EPA evaluated literature (1) and (2) (Umeda et al., 2002, 2005) and concluded that it is appropriate to classify it in S (Suggestive evidence of carcinogenic potential); although clear evidence of carcinogenicity was observed in two sites in two animal species, 1) urinary bladder tumors (in rats) and liver tumors (in mice) were not observed in other animal species, 2) mechanism of developing urinary bladder tumors in rats is a high-dose phenomenon closely related to the formation of urinary bladder calculi (IRIS (2013)).
(5) Based on paragraph (3) of Article 28 of the Industrial Safety and Health Act, this substance is subject to guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare (Public announcement on guidelines in order to prevent the impairment of worker's health, No. 23, Oct 10, 2012).
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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