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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	90-43-7
Chemical Name	Biphenyl-2-ol (synonym: o-Phenylphenol)
Substance ID	R03-C-024-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	FY2008
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	-	- -	-	-	-
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	-	- -	-	-	-

HEALTH HAZARDS

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	-	- -	-	-	-
5	Germ cell mutagenicity	-	- -	-	-	-
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Since positive results were obtained in two species of animals in (1) and (2), it was classified in Category 1B. [Evidence Data] (1) It was reported that, in a combined chronic toxicity/carcinogenicity study (OECD TG 453, GLP) with rats dosed by feeding for two years, a slight increase of urinary bladder tumors (papillomas and transitional cell carcinomas) was observed in males at or above 4,000 ppm, and an increased incidence of urinary bladder papillomas and/or transitional cell carcinomas was observed in males at 8,000 ppm (EFSA (2008), AICIS IMAP (2015), REACH registration dossier (Accessed Oct. 2021)). (2) It was reported that, in a combined chronic toxicity/carcinogenicity study (OECD TG 453, GLP) with mice dosed by feeding for two years, an increased incidence of hepatocellular adenoma, carcinoma, and hepatoblastoma was observed in males at or above 500 mg/kg/day (EFSA (2008), AICIS IMAP (2015), REACH registration dossier (Accessed Oct. 2021)). (3) As for the classification results by international evaluation organizations, in 2006, the EPA classified it as L based on the presence of urinary bladder tumors in rats and the presence of liver tumors in mice at or above 200 mg/kg/day (EPA Pesticides (2006)). Besides, it was classified as NL based on the evidence that a non-linear mode of action for bladder tumors was established at or below 200 mg/kg/day (EPA Pesticide (2006)). [Reference Data, etc.] (4) As for other classification results by international evaluation organizations, the DFG classified it in Category 4 in 2015 (List of MAK and BAT values 2020 (Accessed Oct. 2021)) and the IARC classified it in Group 3 (IARC 73 (1999)). (5) The EFSA reported on the tumors observed in (3) that, since liver tumors in mice naturally occurred at a high frequency in the strain used and it is generally judged that bladder tumors in mice cannot be extrapolated to humans, treatment-related effects were unclear (EFSA (2008)). (6) The DFG reported that, based on the data in (4) and the different sensitivities to chemical substances in the lower urothelium between humans and rats, the occurrence of bladder tumors in rats was not applicable to humans. However, with regard to liver tumors in (3), it concluded that since there was evidence of this substance having a PPAR-alpha agonist effect, an enzyme induction effect, and a cell proliferation effect, the possibility that the effects were caused by a nongenotoxic mode of action could not be excluded, and therefore, it was classified in Category 4 (DFG MAK (2015)). (7) In Australia, considering that this substance and its sodium salt (SOPP, CAS RN 132-27-4) are in a pH dependent equilibrium and are interconvertible in the body, and that the metabolites of this substance (phenylhydroquinone (PHQ) and phenylbenzoquinone (PBQ)) have genotoxic effects of in vitro and in vivo and tumor-promoting potential, it was judged that both this substance and its sodium salt could be classified in the same category for carcinogenicity and the carcinogenicity classification (Category 2) according to the country's regulations was applied (AICIS IMAP (2015)). (8) In Canada, it was reported that the mode of action for carcinogenicity from the sodium salt of this substance, SOPP, was applicable to this substance and this substance could induce DNA damage and chemically-induced cytotoxicity in the urothelium of the bladder (Canada CMP Screening Assessment (2020)). (9) As for the classification results by international evaluation organizations, the IARC classified the sodium salt of this substance, SOPP, in Group 2B (IARC 73 (1999)).
7	Reproductive toxicity	-	- -	-	-	-
8	Specific target organ toxicity - Single exposure	-	- -	-	-	-
9	Specific target organ toxicity - Repeated exposure	-	- -	-	-	-
10	Aspiration hazard	-	- -	-	-	-

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