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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	36483-57-5
Chemical Name	3-Bromo-2,2-bis(bromomethyl)propan-1-ol
Substance ID	R03-A-003-MHLW, MOE
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
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)
Model SDS by MHLW (External link)
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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
7	Flammable solids	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (GESTIS (Accessed Sep. 2021)).
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.
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (GESTIS (Accessed Sep. 2021)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (GESTIS (Accessed Sep. 2021)).
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).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in an acute dermal irritation/corrosion test with rabbits (n=3) (OECD TG 404, semiocclusive, 4-hour application, observation for 72 hours), no skin irritation was observed (erythema score: 0/0/0, edema score: 0/0/0) (REACH registration dossier (Accessed Sep. 2021)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1), it was classified in Category 1. [Evidence Data] (1) It was reported that, in an acute eye irritation/corrosion test with rabbits (n=3) (OECD TG405, GLP, observation for 21 days), effects on the eyes resolved within 14 days in two animals, but in one animal, cornea opacity persisted until 21 days after instillation (REACH registration dossier (Accessed Sep. 2021)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in a Local Lymph Node Assay (LLNA) with mice (n=5/group) (OECD TG 429, GLP), the stimulation index (SI) values were 1.1 (1%), 1.1 (5%), 0.9 (10%) (REACH registration dossier (Accessed Sep. 2021)).
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Although this substance was negative in the in vivo tests of (1), the positive (+S9) results in the in vitro Ames test in (2), the positive (+S9) results in the MLA, and the positive results in the chromosome aberration test could not be ruled out. In (3), the CLP conducted a read-across assessment for this substance and classified it in Muta. 1B. Accordingly, based on the comprehensive judgment of these results, it was classified in Category 2. [Evidence Data] (1) As for in vivo, in an Unscheduled DNA Synthesis (UDS) test with rat liver cells and a micronucleus test using the bone marrow cells of mice, this substance was negative (CLH Report (2019), ECHA RAC (Background Doc.) (2020), ECHA RAC Opinion (2020), REACH registration dossier (Accessed Sep. 2021)). (2) As for in vitro, in a bacterial reverse mutation test and a gene mutation test with the cultured mammalian cells (mouse lymphoma cells), positive (+S9) results were obtained, and in a chromosome aberration study using the human peripheral blood lymphocytes, positive (+S9, -S9 (highest concentration)) results were obtained (CLH Report (2019), ECHA RAC (Background Doc.) (2020), ECHA RAC Opinion (2020), REACH registration dossier (Accessed Sep. 2021)). (3) As for this substance, the ECHA conducted a read-across assessment for the category of chemically structural analogs including 2,2-bis(bromomethyl)propane-1,3-diol (BMP, CAS RN 3296-90-0), which has one fewer bromine atom than this substance, and as a result, decided that this substance was classified in Muta. 1B/Carc. 1B in the EU CLP classification and designated it as an SVHC (EU REACH SVHC Support Doc. (2021)). [Reference Data, etc.] (4) BMP, which is a structural analog, is currently classified in Category 2 for this hazard class in Japan (GHS Classification Results in FY2007) and Muta. 1B in the EU (EU-CLP Classification Results (Accessed Sep. 2021)).
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (4), it was classified in Category 1B. [Evidence Data] (1) As for this substance, the ECHA conducted a read-across assessment for the category of chemically structural analogs including 2,2-bis(bromomethyl)propane-1,3-diol (BMP, CAS RN 3296-90-0), which has one fewer bromine atom than this substance, and as a result, decided that this substance was classified in Carc. 1B in the EU CLP classification and designated as an SVHC (EU REACH SVHC Support Doc. (2021)). (2) BMP, which is a structural analog, is currently classified in Category 1B in Japan (GHS Classification Results in FY2021) and Carc. 1B in the EU (EU-CLP Classification Results (Accessed Sep. 2021)). (3) In a 2-year combined chronic toxicity/carcinogenicity study for BMP with rats dosed by feeding (OECD TG 453), an increase in the incidence of neoplasms in the skin, subcutaneous tissue, mammary gland, Zymbal gland, oral cavity, esophagus, forestomach, small intestine, large intestine, mesothelium, kidney, urinary bladder, lung, thyroid gland, seminal vesicle, and hematopoietic system (mononuclear cell leukemia) was observed in males, and an increase in the incidence of neoplasms in the mammary gland, oral cavity, esophagus, and thyroid gland was observed in females (CLH Report (2017), IARC Monograph 77, AICS IMAP (2018), NTP TR452 (1996)). (4) In a 2-year combined chronic toxicity/carcinogenicity studies for BMP with mice dosed by feeding (OECD TG 453), an increase in the incidence of neoplasms in the lung, kidney, and Harder's gland was observed in males, and an increase in the incidence of neoplasms in the subcutaneous tissue, lung, and Harder's gland was observed in females (CLH Report (2017), IARC Monograph 77, AICS IMAP (2018), NTP TR452 (1996)). [Reference Data, etc.] (5) In a dermal administration study of 2,3-DBPA (2,3-dibromopropyl alcohol, CAS RN: 96-13-9) in mice (male: 36-39 weeks, female: 39-42 weeks), a significant increase in the incidence of epithelial tumors in the skin (squamous papillomas and sebaceous adenomas) was observed and a significant increase in focal hyperplasia of the epithelial lining of bronchi, bronchioles or alveoli was observed. In males, an increase in the incidence of hepatocellular adenomas in the liver was observed (IARC Monograph 77, AICS IMAP (2015)). (6) In a dermal administration study of 2,3-DBPA (2,3-dibromopropyl alcohol, CAS RN: 96-13-9), an increase in the incidence of epithelial tumors (squamous carcinomas, basal cell tumors, sebaceous adenomas, keratoacanthomas) of the skin at or around the site of application was observed, and squamous-cell papilloma and carcinomas of the oral mucosa, esophagus, or forestomach were observed. An increase in the incidence of adenocarcinomas of the small intestine was observed in males, and an increase in the incidence of adenomatous polyps of the large intestine, adenomas of the nasal mucosa, Zymbal gland adenomas or adenocarcinomas was observed in both males and females (IARC Monograph 77, AICS IMAP (2015)).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, based on (1), it is considered that there are few concerns about developmental toxicity and no data is available on effects on reproductive potential (fertility) and sexual function. [Reference Data, etc.] (1) It was reported that, in a prenatal developmental toxicity study with rats dosed by gavage (OECD TG 414, GLP, days 6 to 19 of gestation), an increased incidence of the minor abnormalities delayed/incomplete ossification/unossified pelvic bones (within the HCD range) was observed in pups at or above 300 mg/kg/day, and since sacrifice in extremis (2 of 20 animals) and lower body weight were observed in parental animals at 1,000 mg/kg/day, the dose was reduced to 500 mg/kg/day, and as a result, only a slight decrease in body weight was observed (CLH Report (2019), ECHA RAC (Background Doc.) (2020), ECHA RAC Opinion (2020)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" in the oral route. However, the classification was not possible due to lack of data since there was no information on toxicity in the other routes. Besides, the effects on the liver in (1) were adaptative changes, therefore, the liver was not adopted as a target organ. [Evidence Data] (1) It was reported that, in a repeated dose 28-day oral toxicity study in rodents dosed by gavage with rats (OECD TG 407, GLP), increased liver weight and slight centrilobular hepatocyte hypertrophy were observed at or above 150 mg/kg/day (converted guidance value: 46.7 mg/kg/day, within the range for Category 2), and excessive salivation and chin rubbing were observed at 500 mg/kg/day (converted guidance value: 156 mg/kg/day, in the range corresponding to "Not classified") (CLH Report (2019)). (2) It was reported that, in a repeated dose 90-day oral toxicity study in rodents dosed by gavage with rats (OECD TG 408, GLP), at 150 mg/kg/day (in the range corresponding to "Not classified"), perineum wet with urine was observed, and effects on the kidney (an increase in serum creatinine, an increase in urea nitrogen level, increased eosinophilic hyalin droplets in the cortical tubular epithelium) and diffuse epithelial hyperplasia in the urinary bladder were observed in males; and at 450 mg/kg/day (in the range corresponding to "Not classified"), renal papillary necrosis was observed (ECHA RAC Opinion (2020)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour LC50 = 32 mg/L for fish (Cyprinus carpio) (REACH registration dossier, 2021).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	If chronic toxicity data are used, then it is classified as "Not classified" due to being not rapidly degradable (BIOWIN) and 72-hour NOErC = 2.2 mg/L for algae (Raphidocelis subcapitata) (REACH registration dossier, 2021). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (crustacea, fish), then it is classified in Category 3 due to being not rapidly degradable and 96-hour LC50 = 32 mg/L for fish (Cyprinus carpio) (REACH registration dossier, 2021). By drawing a comparison between the above results, it was classified in Category 3.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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