NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	90-43-7
Chemical Name	biphenyl-2-ol; 2-hydroxybiphenyl; 2-phenylphenol (ISO)
Substance ID	m-nite-90-43-7_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified	- -	-	-	Since its autoignition point is approx. over 70degC, the substance does not ignite spontaneously at room temperature.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140degC) substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	Based on the rat oral LD50 values of 2800mg/kg (DFGOT (1991)), 2600-2800mg/kg (PATTY 5th, (2001)), and 3000mg/kg (IARC (1989)), the substance was classified into "Not classified" using JIS classification criteria (Category 5 in UN classification).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the rabbit dermal LD50 > 5000mg/kg (PATTY 5th, (2001)), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Its 4-hour or 4-hour-corrected LC50 values have been documented to be > 0.24mg/L (IUCLID (2000)). However, since these values did not provide a basis for classification, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Results of rabbit tests (complying with OECD guidelines 404) (IUCLID (2000)) showed that the substance was slightly to highly irritating. Based on the information, the substance was classified into Category 2. As relevant notes, no irritation was observed in humans and rabbits when a 0.1% aqueous solution of this substance was applied to skin for 24 hours (DFGOT (1991)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	Results of rabbit tests (IUCLID (2000)) showed that the substance was moderately to highly irritating. Based on the information, the substance was classified into Category 2A.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Not classified	- -	-	-	No signs of skin sensitization were observed in either maximization tests or Buehler tests using guinea pigs (IUCLID (2000)), (PATTY 5th, (2001)). No sensitization was also observed in human tests involving 200 people (PATTY 5th, (2001)). Based on these results, the substance was classified into "Not classified". As relevant notes, a positive reaction was observed in 7 out of 588 persons to whom a 1% solution of this substance in petrolatum was applied. However, the severity of the reaction was not described in the literature. In addition, two cases of severe contact dermatitis through occupational exposure were described in the literature, which the author put down to the effects of this substance in hand cream and in metal-working fluids (DFGOT (1991)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	The substance was classified into "Not classified" based on negative results obtained in both dominant lethal tests using mice (in vivo heritable mutagenicity tests) and chromosomal aberration tests using rat bone marrow cells (IARC (1999) vol. 73, IARC (1983) vol. 30). In addition, negative results have been obtained from oral administration in chromosomal aberration tests using rat bone marrow cells (IARC (1999) vol. 73).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Reproductive toxicity	Not classified	- -	-	-	In the 2-generation reproduction tests using rats, there were no effects on reproduction or development at the doses that cause general toxicity such as decreased body weight gain in parental animals and histological changes in the kidney and urinary bladder (PATTY 5th, (2001)). In other studies involving rats, rabbits and mice that were exposed during the organogenetic period, the substance had no adverse effects such as teratogenic effects in the offspring, although in parental animals, decreased body weight gain, mortality, and pathological changes in the kidney and liver were observed at high dosages in all species tested (IARC (1999) vol. 73, PATTY 5th, (2001), CERI hazard data 5th (2007)). From these results, the substance was classified into "Not classified". As additional notes, increased incidences of embryo resorption by exposure to this substance during the organogenetic period were documented. However, since this symptom was observed only in one of two rat studies conducted, the result may be accidental.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In 3-month oral exposure studies using rats, pathological changes were observed in the kidney at 1000-1500mg/kg/day. However, in other rat oral exposure studies of 3-month and 6-month durations, no pathological changes were observed at 500-1000mg/kg/day (DFGOT (1991)). In two other rat studies performing 12 or 13-week oral route exposure, NOAEL were reported to be >= 420mg/kg/day and >= 780mg/kg/day (PATTY 5th (2001)). On the other hand, in 2-year oral route exposure studies with mice, decreased body weight gain and histological changes in livers were observed at >= 250mg/kg/day, and NOEL was indicated to be 100mg/kg/day (PATTY 5th (2001)). There are no studies on humans, and toxicity to organs observed in animal tests was associated only with administration doses higher than the guidance values. Although these results suggested that the substance falls into "Not classified" (oral), there were no data on other routes available. Thus, the substance was classified into "Classification not possible".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	Based on its 48-hour LC50 of 0.71mg/L for crustaceans (Daphnia magna) (AQUIRE, 2008), the substance was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Its classification for acute toxicity is Category 1, it is rapidly degradable (BOD degradability: 47-86% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1980)), and its potential for bioaccumulation is estimated to be low (log Kow = 3.09 (SRC, 2005)). Based on the information, the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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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