NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	52-51-7
Chemical Name	2-Bromo-2-nitropropane-1,3-diol (Bronopol)
Substance ID	m-nite-52-51-7_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)	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	- -	-	-	Since the substance is rated UNRTDG 4.1 III, it is not classified into Explosives.	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	Category 2	Warning	H228	P370+P378 P210 P240 P241 P280	The substance rated UNRTDG 4.1 III, ERG 133 is classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group associated with explosive properties (nitro compounds) present in the molecule. However, because it is classified in Division 4.1 PG III (UN3241) in UNRTDG and does not correspond to hazards of the highest precedence, self-reactive substances and mixtures, it was classified as Type G.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	- -	-	-	Since the substance is rated UNRTDG 4.1 III, it is not classified into Pyrophoric solids.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Its melting point is 130 - 133degC (Chapman Ver. 16: 2 (2008)). Test methods applicable to solid (melting point <= 140degC) substances are not 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 (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	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	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds 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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Since three among four of its rat LD50 values (180 mg/kg, 307 mg/kg (male), 342 mg/kg (female), and 400 mg/kg (the above, DFGOT vol. 2 (1991)) were equivalent to the guidance value of Category 4, the substance was classified into Category 4.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on its rat LD50 = 3500 mg/kg (DFGOT vol. 2 (1991)), the substance was classified into "Not classified" in JIS classification (Category 5 in UN 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)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Based on its rat LC50 = 180 mg/m3/4h (= 0.18 mg/L/4h) (DFGOT vol. 2 (1991)), the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	In a skin irritation test (application for 24 hours) with a 20% aqueous solution using rabbits, moderate to severe irritation was noted (DFGOT vol. 2 (1991)), but with 1% in acetone and 5% in polyethylene glycol for six hours, no irritation was found (DFGOT vol. 2 (1991)), and no irritation was observed after application of 0.5 g of the powder for 24 hours (DFGOT vol. 2 (1991)). On the other hand, in human patch tests, 0.25% and 1% in Vaseline, or a 0.25% aqueous solution, showed mild irritation (DFGOT vol. 2 (1991)). The substance is rated Xi; R37/38 in the EU classification. Therefore, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It is documented that in a test using rabbits, application of 5% in polyethylene glycol caused reversible severe damage (DFGOT vol. 2 (1991)), in cases of application of 10, 20% aqueous solution, caused severe damage, reversible after 35 days (DFGOT vol. 2 (1991)), and it was considered that in cases of high concentration solutions, damage is not fully reversible within 21 days, and the substance was classified into Category 1.	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	Classification not possible	- -	-	-	In a maximization test using guinea pigs, weak sensitization (2/10) was reported. However, in another test using guinea pigs, no sensitization was indicated, and in human patch tests, no sensitization or false-positive results were reported. Therefore, the substance was classified into "Classification not possible".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	Since the substance was negative in a mouse in vivo dominant lethal test (DFGOT vol. 2 (1991)), and also showed negative results in a micronucleus test using mouse bone marrow cells (HSDB (2004)), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Classification not possible	- -	-	-	In both an oral administration test for two years using rats and a percutaneous administration test for 80 weeks using mice, no carcinogenicity was observed (DFGOT vol. 2 (1991)). However, since each test provided data of only one animal, due to the lack of data, the substance was classified into "Classification not possible".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Classification not possible	- -	-	-	No effects on fetal development were detected in rats that received oral or percutaneous exposure during the organogenetic period or rabbits that received oral exposure during the organogenetic period (DFGOT vol. 2 (1991)). However, since these tests do not provide sufficient data on effects on parental sexual functions or fertility, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	It is documented that in rats, after exposure by the dermal route, labored breathing and lung congestion were noted, and after inhalation exposure (mist), respiratory organ signs were noted, such as dyspnea and pneumonitis (HSDB (2004)). However, since the test does not provide the onset dose or exposure duration, it is not possible to classify the substance into Category 1 or 2. But, based on the description that inhalation (mist) caused dyspnea (HSDB), the substance was classified into Category 3 (respiratory tract irritation).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 2 (respiratory system)	Warning	H373	P260 P314 P501	In a 13-week oral administration test using rats, at doses of 80 mg/kg/day or more, high mortality was noted, and most animals showed respiratory distress (gasping, wheezing), and gaseous and fluid distention of the gastrointestinal tract was seen at autopsy. At the dose of 160 mg/kg/day, signs became severer, and hemorrhagic foci in and raised white areas on the mucosa of the glandular stomach occurred (HSDB (2004)). Many rats exhibited GI lesions (superficial ulceration with underlying inflammation, epithelial hyperplasia and hyperkeratosis), and mortality became higher (HSDB (2004)). In addition, in the kidneys, distended or dilated tubules with eosinophilic material were seen in males in treatment groups (HSDB (2004)). However, stomach lesions were considered to be topical effects by irritation of the substance, and changes in the kidneys might be hyaline droplet degeneration by alpha2u globulin accumulation, unique to male rats, and they were not evaluated. As for effects on the respiratory system causing respiratory distress, since it was noted at the dose of 80 mg/kg/day or more, the substance was classified into Category 2 (respiratory system). As relevant information, other tests with oral or percutaneous administration using rats and other animal species were conducted (DFGOT vol.2 (1991), HSDB (2004)). However, none of the data obtained were considered to be sufficient for classification evidence.	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 2	- -	H401	P273 P501	Based on its 48h-EC50 = 1.6 mg/L for crustaceans (Daphinia magna) (AQUIRE, 2008), the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Since its preexisting classification for acute toxicity is Category 2, and it is not rapidly biodegradable (BOD degradability, 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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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