NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	3296-90-0
Chemical Name	2,2-Bis(bromomethyl)propane-1,3-diol; Dibromoneopentylglycol
Substance ID	m-nite-3296-90-0_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.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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).	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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)	-	- Warning	-	-	Since its rat LD50 is 3458 mg/kg in an oral administration test (IARC vol. 77 (2000)), the substance was classified into Category 5.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Since the substance is a solid (GHS definition), it was classified into the "Not applicable" category.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	In vivo micronucleus test using mouse bone marrow cells and that using peripheral blood both gave positive results (IARC vol. 77 (2000)), and no test results in in-vivo mutagenicity tests using germ cells have been conducted. Based on this information, the substance was classified into Category 2.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification Based on the positive results in two species of experimental animals in (1) and (2), it was judged that there was sufficient evidence of carcinogenicity in animal studies, and this substance was classified in Category 1B. [Evidence Data] (1) In a carcinogenicity study for commercial products of this substance (FR-1138, content rate of this substance: 78.6%) with rats (Fischer 344/N) dosed by feeding for two years (2-year administration of 2,500 to 10,000 ppm: 100 to 460 mg/kg/day, and in addition, 3-month administration of 20,000 ppm: 800 mg/kg/day to males), increased incidences of tumors of the skin (combined incidences of squamous cell papilloma, or squamous cell carcinoma, etc.), subcutaneous tissue of the skin (incidences of fibroma, and fibrosarcoma or sarcoma (combined)), mammary gland (combined incidences of fibroadenoma or adenoma), Zymbal gland (combined incidences of adenoma or carcinoma), oral cavity (combined incidences of squamous cell papilloma, or carcinoma, etc.), esophagus (squamous cell papilloma), forestomach (squamous cell papilloma), large intestine (combined incidences of adenoma or carcinoma), small intestine (combined incidences of adenoma or carcinoma), peritoneum (malignant mesothelioma), urinary bladder (combined incidences of transitional cell papilloma or carcinoma), lung (combined incidences of bronchiolar/alveolar adenoma or carcinoma, squamous cell carcinoma), thyroid (combined incidences of follicular cell adenoma or carcinoma), seminal vesicle (combined incidences of adenoma or carcinoma), and hematopoietic system (mononuclear cell leukemia) were observed in males,; and increased incidences of tumors of oral cavity (combined incidences of squamous cell papilloma or carcinoma), esophagus (squamous cell papilloma), mammary gland (fibroadenoma), and thyroid (combined incidences of follicular cell adenoma or carcinoma) were observed in females (NTP TR452 (1996), IARC 77 (2000), CLH Report (2017)). (2) In a carcinogenicity study for commercial products of this substance (FR-1138, content rate of this substance: 78.6%) with mice dosed by feeding for two years (312 to 1,250 ppm: 35 to 170 mg/kg/day), increased incidences of tumors of the Harderian gland (combined incidences of adenoma or carcinoma), and lung (combined incidences of bronchiolar/alveolar adenoma or carcinoma) were observed in males and females, and in addition, increased incidences of tumors of the kidney (adenoma) in males, and subcutaneous tissue of the skin (sarcoma) in females were observed (NTP TR452 (1996), IARC 77 (2000), CLH Report (2017)). (3) As for the classification results by domestic and international organizations, the EU classified this substance in Carc. 1B (EU-CLP Classification Results (Accessed Oct. 2021): proposed in 2018). In addition, the IARC classified it in Group 2B (IARC 77 (2000)), the Japan Society For Occupational Health (JSOH) classified it in Group 2B (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2020): proposed in 2001)), and the NTP classified it in R (NTP RoC (14th, 2016)). [Reference Data, etc.] (4) In a carcinogenicity study for commercial products of this substance (FR-1138, content rate of this substance: 80%) with rats (SD strain) dosed by feeding for two years (equivalent to 5, 100 mg/kg/day), there was no increase in the incidence of tumors related to the administration (IARC 77 (2000), CLH Report (2017)). (5) This substance was tested for carcinogenicity as a commercial mixture (FR1138R) containing this substance (approx. 80%) in one experiment in mice and in two experiments in rats by oral administration in the diet. In a carcinogenicity study with mice, increased incidences of tumors of the Harderian gland, forestomach, and lung in both males and females, and increased incidences of subcutaneous sarcomas in females were observed. In a carcinogenicity study with rats, increased incidences of tumors in the esophagus, mammary gland, and thyroid were observed in males and females, and in addition, increased incidences of tumors in the skin, lung, subcutaneous tissue, Zymbal gland, oral cavity, forestomach, small/large intestine, and peritoneum (malignant mesothelioma) were observed in males. In contrast, in a study with rats of a different strain, there was no increase in the incidence of tumors at a dose equivalent to 100 mg/kg/day (IARC 77 (1999), CLH Report (2017)). (6) There is sufficient evidence of carcinogenicity in experimental animals, but it only suggests the possibility of mutagenicity as the mode of action, and there are no human data, and therefore, the IARC classified this substance in Group 2B (IARC 77 (2000)). (7) This substance induced dose-dependent multi-site tumors in two species, rats and mice, in a well-conducted OECD TG 453-study carried out by the NTP under GLP conditions and with limited general toxicity. Both benign and malignant tumors were observed in the respective tissues, showing the ability of the tumors to progress to malignancy. The stop-exposure group in males showed that only 3 months of exposure induced tumors at most sites where tumors were observed in the 2-year continuous-exposure groups. The incidences of neoplasms were greater at some sites (lungs, small/large intestine, thyroid). Since most cancer-sites are relevant for humans, and this substance is a strong multi-site carcinogen, the RAC of the ECHA agrees with the proposal for classification in Category 1B (CLH Report (2017), ECHA RAC Opinion (2018)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a two-generation reproduction test using mice, decreased body weight in pups, decreased number of live pups born per litter, increased number of fetal deaths, and lowered fertility rates were noted (IARC vol. 77 (2000)). Based on this report, the substance was classified into Category 2.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 90-day repeated oral administration test using rats or mice, papillary degeneration and necrosis of the renal papilla, and hyperplasia of the urinary bladder were noted (NTP TR 452 (1996)). Since these symptoms occurred at doses above Category 2 guidance values, and no other test results are available, classification is not possible due to insufficient test results available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）

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.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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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