NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	59536-65-1,67774-32-7
Chemical Name	Polybrominated biphenyl (FireMaster BP-6 (Polybrominated biphenyl mixture (Br 5-7))
Substance ID	m-nite-59536-65-1_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)
Sample SDS by MHLW (External link)
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Not classified	- -	-	-	Classified into Not classified since the substance is an inert solid and has been used as the flame retardant (Sax (11th, 2004)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Not classified	- -	-	-	Classified into Not classified since the substance is a flame retardant (Sax (11th, 2004).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Classified into Not classified since the substance is an inert solid and has been used as the flame retardant (Sax (11th, 2004)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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 a LD50 value of 21,500 mg/kg for rats (FireMaster BP-6) (IARC 41 (1986)), the substance was classified into "Not classified".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a LD50 value of 21500 mg/kg for rats (FireMaster BP-6) (IARC 41 (1986)), the substance was classified as "Not classified".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on no mortality in rats exposed to for the substance (71 mg/L) (FireMaster BP-6) for 1-hour (18 mg/L/4h) (EHC 152 (1994)), the substance was classified as "Not classified". Since the substance was a solid at ambient temperature, the test was considered to be conducted for dusts.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Not classified	- -	-	-	Based on negative results in rat spermatogonium and bone marrow chromosomal aberration tests of FireMaster BP-6 (in vivo germ cell or somatic cell mutagenicity test) and mouse bone marrow chromosomal aberration test of FireMaster FF-1 (in vivo somatic cell mutagenicity test) (IARC 41 (1986)), the substance was classified as "Not classified". As relevant information, there is a report of a negative mouse hepatocyte unscheduled DNA synthesis test (EHC 152 (1994)). From in vitro mutagenicity tests, there are reports of a negative Chinese hamster V79 cell gene mutation test (IARC 41 (1986)) and an Ames test (EHC 152 (1994)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Information on carcinogenicity in humans is limited to (6). Based on the IARC's classification result (1) and test results of (2)-(5), it was classified in Category 1B. The category was revised as the result of reviewing the previous classification due to the revision of the classification in 2016 by IARC. [Evidence Data] (1) It is described in IARC that there is inadequate evidence in experimental animals for Firemaster BP-6 which is a component of this substance (polybrominated biphenyl (Br 5-7)). However, IARC classified the whole polybrominated biphenyls in Group 2A by stating that there is sufficient evidence for the carcinogenicity of Firemaster FF-1 (CAS: 67774-32-7) in animal tests on the substance, a commercial mixture of FireMaster BP-6 and 2% calcium polysilicate added for anti-caking, and by considering mechanism and so on and similarities to PCB (IARC 107 (2016)). As for classification results by other domestic and international organizations, Japan Society for Occupational Health (JSOH) classified it in Group 2B (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH) 2018)). (2) In a test in which mice were dosed with Firemaster FF-1 by gavage for six months, an increase in hepatocellular carcinoma was observed in males and females after 30 months (NTP TR244 (1983), IARC 107 (2016)). (3) In a test in which mice were dosed with Firemaster FF-1 by diet for two years, an increase in hepatocellular adenoma and carcinoma was observed in males and females. Moreover, after exposure only in the perinatal period in the same protocol, an increase in hepatocellular adenoma and carcinoma was also observed in males and females. After exposure during the perinatal and adult period, increases in hepatocellular adenoma and carcinoma in males and females and thyroid follicular cell adenoma in males were observed (NTP TR398 (1993), IARC 107 (2016)). (4) In a test in which rats were dosed with Firemaster FF-1 by gavage for six months, increases in neoplastic nodules, hepatocellular carcinoma, and cholangiocarcinoma were observed in males and females after 30 months, and mononuclear cell leukemia was also observed in males (NTP TR244 (1983), IARC 107 (2016)). (5) In a test in which rats were dosed with Firemaster FF-1 by diet for two years, an increase in hepatocellular adenoma and carcinoma was observed in males and females. Moreover, after exposure during the perinatal and adult period in the same protocol, increases in mononuclear cell leukemia in males and females and hepatocellular adenoma and carcinoma in females were observed (NTP TR398 (1993), IARC 107 (2016)). [Reference Data, etc.] (6) In a nested case-control study on a cohort of people who were exposed via food contaminated with polybrominated biphenyls (PBB) after the accident in the chemical plant in Michigan, USA, a trend toward increases in lymphoma and cancers of the digestive system are suggested (IARC 107 (2016)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a test in pregnant rats administered a single oral dose of 40 - 800 mg/kg of FireMaster BP-6 on one of days 6 - 14 of gestation, all treated females lost weight and malformed fetuses (mainly, diaphragmatic hernia and cleft palate) were seen at a dose level of 800 mg/kg, regardless of the day of exposure (IARC 41 (1986)). In mice treated with FireMaster BP-6 during organogenesis at up to 130 mg/kg/day, an increase in exencephaly, cleft palate and hydronephrosis was reported (PATTY (5th, 2001)). Based on all information, the substance was classified into Category 2. As relevant information, effects considered as neurodevelopmental disorder were reported in offspring of rats that received the substance from day 6 of gestation through day 24 postpartum (ATSDR (2004)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 2 (liver)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	It was reported that rats developed enlarged livers with fatty and necrotic changes leading to fibrosis and nodulation following administration of FireMaster FF-1 as a single dose of 1000 mg/kg and observed for 2 – 23 months post-treatment (ATSDR (2004), EHC 152 (1994)). Since the results were observed at a dose level within the guidance value range for Category 2, the substance was classified into Category 1 (liver).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, nervous system)	Danger	H372	P260 P264 P270 P314 P501	In oral tests with FireMaster FF-1, incidences of hepatocellular hypertrophy, cytoplasmic vacuolation, atypical foci and oval cell hyperplasia were increased in rats fed >=0.5 mg/kg/day for up to 104 weeks, and hepatocyte necrosis and/or vacuolation were induced in mice receiving >=3 mg/kg/day for 4 - 6 weeks. In rat and mouse 6-month oral tests (3 days/week), decreased motor activity, grip strength and startle responsiveness were observed at dose levels of 3 - 10 mg/kg/day (ATSDR (2004)). Since the reported results were observed at dose level within the guidance value range for Category 1, the substance was classified into Category 1 (liver, nervous system).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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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