NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	75-25-2
Chemical Name	Tribromomethane
Substance ID	m-nite-75-25-2_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 (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	It is not combustible (ICSC (J) (2009)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It is not combustible (ICSC (J) (2009)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (J) (2009)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	There are five reports of LD50 values for rats, which were 933 mg/kg (male and female) (DFGOT vol. 7 (1996), ATSDR (2005), Hazard Assessment Report (CERI, NITE, 2008)), 1,147 mg/kg (female), 1,388 mg/kg (male) (DFGOT vol. 7 (1996), ATSDR (2005)), 2,040 mg/kg (male), and 2,440 mg/kg (female) (Hazard Assessment Report (CERI, NITE, 2008)). The 3 cases correspond to Category 4, and the 2 cases correspond to "Not classified" (Category 5 in UN GHS classification). The category with larger number of cases was adopted, so it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Based on the description that irritation of the skin was seen in humans (Initial Risk Assessment (NITE, CERI, NEDO, 2007)), and the description that in a skin irritation test with rabbits, it showed moderate irritation (PATTY (6th, 2012)), this substance was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Based on the description that in an eye irritation test with rabbits, moderate eye irritation was shown, but resolved in 1-2 days (PATTY (6th, 2012), Initial Risk Assessment (NITE, CERI, NEDO, 2007)), this substance was classified in Category 2B.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	As for in vivo, it was negative in a micronucleus test with mouse bone marrow cells, positive in a chromosomal aberration test with rat bone marrow cells, negative in chromosomal aberration tests with mouse bone marrow cells, positive and negative results in sister chromatid exchange tests with mouse bone marrow cells, negative in a DNA damage test with rat liver and kidney, and negative in an unscheduled DNA synthesis test with rat liver (Hazard Assessment Report (CERI, NITE, 2008), IARC 71 (1999), ACGIH (7th, 2015), ATSDR (2005), DFGOT vol. 7 (1996)). As for in vitro, it was positive and negative in bacterial reverse mutation tests, positive in mouse lymphoma tests with mammalian cultured cells, and positive in chromosomal aberration tests and sister chromatid exchange tests (Hazard Assessment Report (CERI, NITE, 2008), IARC 71 (1999), ACGIH (7th, 2015), ATSDR (2005), DFGOT vol. 7 (1996), PATTY (6th, 2012), OEL Documentations (Japan Society For Occupational Health (JSOH), 1997)). Based on the above, it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	In a carcinogenicity study with rats and mice dosed by gavage for 2 years, no increased incidence of tumors was observed in mice, but in rats, adenomatous polyps or adenocarcinomas were observed in the large intestine (colon/rectum), which were found in 3/50 cases (6%) in males and in 9/50 cases (18%) in females of the administration group (historical incidence of neoplasms of the large intestine is 0.2% or less). NTP concluded that there was some evidence of carcinogenicity in male rats, and clear evidence of carcinogenicity in female rats by the administration of this substance (NTP TR 350 (1989)). As for the classifications by other organizations, IARC classified it in Group 3 based on the limited evidence of carcinogenicity in experimental animals (IARC 71 (1999)), while EPA classified it in B2 (probable human carcinogen) on the basis that there was sufficient evidence of carcinogenicity in experimental animals (IRIS (1993)). In addition, ACGIH classified it in A3 based on the significantly increased incidence of adenomatous polyp and adenocarcinoma in the administration group of rats (ACGIH (7th, 2015)). From the above, it was judged appropriate to classify it in Category 2 for this hazard class based on the positive result in experimental animals of one species and the latest classification result by ACGIH.	FY2017	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 continuous breeding study with mice dosed by gavage, at 200 mg/kg/day where general toxic effects (depressed body weight gain (males), a decrease in kidney weight and an increase in liver weight (males and females)) were observed in the F1 generation, there was no effect on fertility, however, a decrease in survival index in the F1 pups was found (DFGOT vol. 7 (1993), PATTY (6th, 2012), IRIS (1993), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). In addition, in one of the two developmental toxicity studies with rats dosed by gavage during the organogenesis period (6-15 days of gestation), at doses up to 200 mg/kg/day, there was no maternal toxicity and only a mild effect (skeletal variations) was seen in fetuses (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.3, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2004), DFGOT vol. 7 (1996), ATSDR (2005)), but there is a report in another study that full-litter resorption was observed at 200 mg/kg/day administration to maternal animals (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). From the above, on the basis that a decrease in the survival index of pups was seen at the general toxicity dose to parental animals in the continuous breeding study with mice and that in the developmental toxicity test with pregnant rats, full-litter resorption was observed, it was classified in Category 2 for this hazard class.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system), Category 3 (respiratory tract irritation, narcotic effects)	Danger Warning	H370 H335 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	As for humans, there is a report that by inhalation exposure to this substance, irritation of the respiratory tract, pharynx and larynx, lacrimation and salivation were caused (ACGIH (7th, 2001)). In addition, it is reported that suppression of the central nervous system accompanied by coma and loss of the righting reflex were observed due to accidental ingestion, and fatigue, headache, and vertigo were observed at low doses (ACGIH (7th, 2001), Hazard Assessment Report (CERI, NITE, 2008)). In experimental animals, there is a report that in a single oral administration test in rats, piloerection, sedation, muscle relaxation, ataxia, and prostration were observed, and at necropsy, congestion and hypertrophy in the liver, and congestion, hypertrophy, focal interstitial nephritis and fibrosis in the kidney were observed (Hazard Assessment Report (CERI, NITE, 2008)). Furthermore, there is a report that in a single oral administration test with mice, suppression of the central nervous system (ataxia, sedation, paralysis) was observed immediately after administration of a lethal dose, and at necropsy, fatty infiltration of the liver, fading of the kidney, and bleeding of the brain, lung, and adrenal gland were observed (Hazard Assessment Report (CERI, NITE, 2008)). Together with the above information, it was classified in Category 1 (central nervous system), and Category 3 (respiratory tract irritation, narcotic effects). The respiratory organs were also adopted as the target organ in the previous classification, but the information on pulmonary edema in humans (Hazard Assessment Report (CERI, NITE, 2008)) used as the evidence was not adopted because the details were unknown. In addition, regarding the liver, information of liver disorder effects in humans (Hazard Assessment Report (CERI, NITE, 2008)) used as evidence for the classification in the previous classification was not adopted because the details were unknown, and findings at necropsy of experimental animals could be those of dead animals. Therefore, the classification result was revised from the previous classification.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver), Category 2 (central nervous system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	No information on humans is available. As for experimental animals, there is a report that in a 13-week repeated oral dose toxicity test with rats, vacuolation of hepatocytes was observed at or above 12 mg/kg/day (converted guidance value: 8.7 mg/kg/day), which is within the guidance value range for Category 1, and lethargy was observed at or above 100 mg/kg/day (converted guidance value: 72.2 mg/kg/day), which was within the guidance value range for Category 2 (Hazard Assessment Report (CERI, NITE, 2008), Environmental Risk Assessment for Chemical Substances Vol.3, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2004), PATTY (6th, 2012), NTP TR350 (1989)). Besides this, effects mainly in the liver were reported within the range of guidance values of Category 2 in multiple repeated oral dose tests for 13 weeks or more (a 13-week test with mice, a 103-week test with mice and rats) (Hazard Assessment Report (CERI, NITE, 2008), Environmental Risk Assessment for Chemical Substances Vol.3, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2004), PATTY (6th, 2012), NTP TR 350 (1989)). In addition, in a 14-day repeated oral dose toxicity test with mice, focal liver inflammation, an increase in mitotic figures, hyperplasia of the renal tubular epithelium, and glomerular degeneration were observed at or above 145 mg/kg/day (converted guidance value: 22.6 mg/kg/day), which was within the guidance value range for Category 2, and in another 14-day repeated oral dose toxicity test with mice, lethargy, ataxia, and death were observed at or above 600 mg/kg/day (converted guidance value: 93.3 mg/kg/day), which was within the guidance value range for Category 2, and in a 14-day repeated oral dose toxicity test with rats, depressed body weight gain, thyroid hypertrophy, lethargy, ataxia, and death were observed at or above 400 mg/kg/day (converted guidance value: 62.2 mg/kg/day), which is within the guidance value range for Category 2 (Hazard Assessment Report (CERI, NITE, 2008), NTP TR 350 (1989)). Based on the above, it was classified in Category 1 (liver) and Category 2 (central nervous system) because it mainly affects the liver, and effects on the central nervous system are suggested. Besides, since effects on the kidneys observed in the 14-day oral dose toxicity study with mice and the effects on the thyroid gland observed in the 14-day oral dose toxicity test with rats were not observed within guidance value range in the multiple repeated oral dose tests of 13 weeks or more, they were not adopted as evidence of the classification. Therefore, the classification result was different from the previous one.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	From 96-hour LC50 = 7.1 mg/L for fish (Cyprinodon variegatus) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003), ECETOC TR91: 2003), it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 (non-biodegradable, no result in BOD, average degradation rate by GC: 0% (J-CHECK, 1986)), and 28-day NOEC (survival rate) = 4.8 mg/L for fish (Cyprinodon variegatus) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003), ECETOC TR91: 2003). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to being not rapidly degradable (non-biodegradable, no result in BOD, average degradation rate by GC: 0% (J-CHECK, 1986)), and 96-hour LC50 = 24.4 mg/L for crustacea (Americamysis bahia) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)). From the above results, it was classified in Category 3.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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