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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	3296-90-0
Chemical Name	2,2-bis(bromomethyl)propane-1,3-diol (synonym: Dibromoneopentyl glycol)
Substance ID	R03-C-037-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	FY2007
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 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)).
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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