GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 75-25-2 |
| Chemical Name | Tribromomethane |
| Substance ID | H29-B-065 |
| Classification year (FY) | FY2017 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2006 |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 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) | MHLW Website (in Japanese Only) |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 6 | Flammable liquids | Not classified |
- |
- | - | It is not combustible (ICSC (J) (2009)). |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It is not combustible (ICSC (J) (2009)). |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is not combustible (ICSC (J) (2009)). |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | 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 applicable |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 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. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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. |
| 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. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (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. |
| 11 | Hazardous to the aquatic environment (Long-term) | 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. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |