NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	92-52-4
Chemical Name	Biphenyl
Substance ID	m-nite-92-52-4_v1
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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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	- -	-	-	Information on its flammable range is available (Hommel (1991) Card No. 241, etc.); however, that using standardized testing methods is not 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	- -	-	-	Its autoignition point is 540degC (ICSC (J) (1994)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data 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.	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 molecule contains no oxygen, fluorine, or chlorine.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Containing no bivalent -O-O- structure in the molecule	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 rat LD50 values of 2400 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 1, 2002) and 3280 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 1, 2002; ACGIH 7th, 2001; PATTY 4th, 1994), the substance was classified into the "Not classified" category (Category 5 in the United Nations classification).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Its rabbit LD50 values are 2500 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 1, 2002) and >5010 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 1, 2002). Using the smaller value of the two, the substance was classified into the "Not classified" category (Category 5 in the United Nations classification).	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	- -	-	-	According to CICAD 6 (1999), its 4-hour mouse LC50 is >43 ppm (unit conversion: 0.27 mg/L). Since classification is not feasible based on this value, the substance was classified into the "Classification not possible" category as sufficient test results are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Both rabbit tests and dermal application tests with humans found the substance not irritating to skin (CICAD 6 (1999)). These results suggested that this substance falls under "Not classified" category. However, it is reported to irritate skin according to the Initial Risk Assessment Report (NITE, CERI, NEDO (vol. 1, 2002)), and its EU Risk Phrase is R36/37/38, which indicates that the substance is a mild skin irritant. Thus, the substance was classified into the "Classification not possible" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Since the substance was slightly irritating when applied to rabbits' eyes in an eye irritation test (CICAD 6 (1999)), it was classified into Category 2B.	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	- -	-	-	In a guinea pig maximization test, there was reportedly no evidence of a skin sensitizing potential for this substance (CICAD 6 (1999)). Thus, the substance was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	Since an in vivo mutagenicity test using somatic cells (chromosomal aberration test using rat bone marrow cells) gave negative results (CICAD 6, 1999), the substance was classified into the "Not classified" category.	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] 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	Not classified	- -	-	-	In a rat reproduction test, no effects of the substance on fertility were detected (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 1, 2002; CICAD 6 (1999); PATTY (4th, 1994); IRIS (2005)). In addition, in an oral administration test using pregnant rats, no serious reproductive toxicity was detected at doses that cause general toxic effects on the parental animals (Hazard Data Book for Chemical Substance (CERI, 1999), CICAD 6 (1999), PATTY (4th, 1994), IRIS (2005)). Based on these reports, the substance was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	In inhalation exposure tests using mice, mild respiratory discomfort were noted (CICAD 6 (1999)). Nevertheless, due to lack of sufficient test results, the substance was classified into the "Classification not possible" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, nervous system, respiratory organs), Category 2 (kidney)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	In occupational exposure cases related to this substance, liver damage, effects on the central and peripheral nervous systems, and bronchitis were reported (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol.1, 2002; CICAD 6 (1999); ACGIH (7th, 2001), PATTY (4th, 1994)). Thus, the substance was classified into Category 1 for the liver, nervous system, and respiratory system. In addition, in a 21-day mixed diet administration test using rats, effects on the kidney was noted (CICAD 6 (1999)) at the doses that fall under the range of Category 2 guidance values. Thus, the substance was classified into Category 2 for the kidney.	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	It was classified into Category 1 from 48-hour LC50=360microg/L of Crustacea (Daphnia magna) (MOE Risk Assessment No.1, 2002).	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Since rapidly degrading (BOD: 66% (existing chemical safety inspections data)), and less bio-accumulative (log Kow=3.98 (PHYSPROP Database, 2005)).	FY2006	GHS Classification Manual （10 Feb, 2006）
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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