GHS Classification Results by the Japanese Government
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 75-26-3 |
| Chemical Name | 2-Bromopropane |
| Substance ID | R03-B-031-METI, MOE |
| Classification year (FY) | FY2021 |
| Ministry who conducted the classification | Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2014 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 (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 |
| 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) |
- |
- | - | Liquid (GHS definition) |
| 3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
| 5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
| 6 | Flammable liquids | Category 2 |
 Danger |
H225 | P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
It was classified in Category 2 based on a flash point of -20 deg C (closed cup) and a boiling point of 59 deg C (GESTIS (Accessed Aug. 2021)). Besides, it is classified in Class 3, PG II in UNRTDG (UN2344). |
| 7 | Flammable solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
| 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 |
- |
- | - | No data available. Because it is classified in Class 3 in UNRTDG (UN2344), it does not correspond to pyrophoric substances, hazards of the highest precedence. Therefore, it was classified as "Not classified." |
| 10 | Pyrophoric solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid substances are not available. |
| 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) |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine. |
| 14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
| 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 low-temperature-boiling liquids are not available.No data available. |
| 17 | Desensitized explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1), it was classified as "Not classified." Also, based on the new findings, the classification result was changed. [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (OECD TG 401, GLP) (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), AICIS IMAP (2015)) |
| 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] Liquid (GHS definition). It was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Vapours) | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1), it was classified as "Not classified." Also, since the exposure concentration was lower than 90% (255,738 ppm) of the saturated vapor pressure concentration, it was judged to be in a vapor state and classified based on the reference value in units of ppmV. In addition, the category could not be identified for the data (2) and (3) of rats, it was classified based on the data of mice. [Evidence Data] (1) LC50 (4 hours) for mice: 31,171 ppm (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), AICIS IMAP (2015), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2005), OEL Documentations (Japan Society For Occupational Health (JSOH), 1999)) [Reference Data, etc.] (2) LC50 (exposure time unknown) for rats: 7,159 ppm (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), OEL Documentations (Japan Society For Occupational Health (JSOH), 1999)) (3) LC50 (6 hours) for rats: > 9,923 ppm (converted 4-hour equivalent value: > 12,153 ppm) (AICIS IMAP (2015)) |
| 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" (Category 3 in UN GHS classification). [Evidence Data] (1) It was reported that, in a skin irritation test with rabbits (n=3) (semi-occlusive, 4-hour application, observation for 72 hours), the primary dermal irritation index (PII) was 1.44 (erythema/eschar score: 1.7/1/1.7, edema score: 0/0/0) (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), ECETOC TR66 (1995)). |
| 3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." Besides, the classification result was changed by adding new findings and reviewing data. [Evidence Data] (1) It was reported that, in an acute eye irritation/corrosion test (OECD TG 405, observation for 72 hours) with rabbits (n=3), 24 hours after application, slight conjunctival redness was observed in 2 animals, and slight chemosis was observed in 2 other animals, but all regressed within 72 hours after application (cornea opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 0.3/0.7/0, chemosis score: 0/0.3/0.3) (ECETOC TR 48 (1998)). (2) It was reported that, in an acute eye irritation/corrosion test (OECD TG 405, observation for 4 days) with rabbits (n=3), conjunctival redness and chemosis were observed in all animals 1 hour after application, and persisted until 48 hours after application, and slight iris congestion was also observed in 1 animal. Slight conjunctival redness was also observed 72 hours after application, but all regressed on day 4 (AICIS IMAP (2015), 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) and (2), it was classified as "Not classified." Also, based on the new findings, the classification result was changed. [Evidence Data] (1) It was reported that, in a Maximization test (OECD TG 406, GLP, intradermal administration: 25% solution) with guinea pigs (n=10), 24 and 48 hours after challenge, very slight erythema was observed in 7/10 animals at 24 hours and in 1/10 animals at 48 hours, and results were judged as negative (AICIS IMAP (2015), REACH registration dossier (Accessed Sep. 2021)). (2) Available data indicate that this substance is not a skin sensitizing substance (AICIS IMAP (2015)). |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) As for in vivo, negative results were reported in a micronucleus assay (28-day intraperitoneal injection) using the bone marrow cells of rats, and positive results were reported in a micronucleus test (single intraperitoneal injection) using the fetuses removed after administration of this substance in the early stage of implantation of mother mice (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2005), AICIS IMAP (2015)), and negative results were reported in a mouse bone marrow micronucleus test (AICS IMAP, REACH registration dossier). (2) As for in vitro, positive results were obtained in a bacterial reverse mutation test, and negative or positive results were obtained in two chromosomal aberration tests using the cultured mammalian cells (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), Mutagenicity Test Data of Existing Chemical Substances based on the toxicity investigation system of the Industrial Safety and Health Law (Accessed August 2021)). (3) It was reported that this substance has genotoxicity (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016)) |
| 6 | Carcinogenicity | Category 1B |
 Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1) to (3), an increase in the incidence was confirmed in many males and females, and therefore, it was classified in Category 1B. Besides, it was classified based on new information. [Evidence Data] (1) In a carcinogenicity study by 2-year (104-week) inhalation exposure (vapor: 67 to 600 ppm: 6 hours/day, 5 days/week) with rats, an increase in the incidence of tumors including malign tumors was observed in many sites all over the body both in males and females. In males, tumors increased in the ceruminous gland (malign external auditory canal adenocarcinoma) at or above 67 ppm; in the large intestine (adenocarcinoma), thyroid (follicular adenoma), and subcutis (fibroma) at or above 200 ppm; and in the skin/appendage (basal cell carcinoma, sebaceous gland adenoma), small intestine (adenocarcinoma), and lymph node (lymphoma) at 600 ppm, and an increasing tendency of tumors was also observed in the preputial gland, lung, stomach, pancreas, brain, and spleen. In females, tumors increased in the mammary gland (fibroadenoma: only at 200 ppm, adenocarcinoma), vagina (squamous cell papilloma: only at 200 ppm), and spleen (mononuclear cell leukemia: only at 200 ppm) at or above 200 ppm, and an increasing tendency of tumors was also observed in the ceruminous gland, clitoral gland, skin, large intestine, pancreas, uterus, and subcutis. At 600 ppm, all animals died, and most deaths were caused by carcinoma (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2019)). (2) The Chemical Risk Assessment Study Meeting (Hazard Assessment Subcommittee) concluded that this substance might cause cancer to workers and it was necessary to publicize the ministerial guidelines (Material of the Hazard Assessment Subcommittee of the 2nd Meeting of the Chemical Risk Assessment Study Meeting, Ministry of Health, Labour and Welfare in FY2020). (3) As for the classification results by domestic and international organizations, the Japan Society For Occupational Health (JSOH) proposed this substance in Group 2B (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), proposed in 2021)). |
| 7 | Reproductive toxicity | Category 1A |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1) to (5), it was classified in Category 1A. [Evidence Data] (1) An unusually high number of cessation of menstruation was found among workers in the process of handling this substance at a Korean electronics manufacturing factory, and as a result of survey, cessation of menstruation was observed in 16 out of 25 women, aspermia was observed in 2 out of 8 men, and oligospermia was observed in 4 men. Follicle stimulating hormone (FSH) was elevated in all 16 women, and luteinizing hormone (LH) was also elevated in most of the women with cessation of menstruation, many of whom complained of hot flashes. Testosterone of the men with aspermia or oligospermia was within a range of normal values (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), OEL Documentations (Reproductive toxicant classification) (Japan Society For Occupational Health (JSOH)), 2013), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2005), AICIS IMAP (2015)). (2) In a laparoscopic examination of the ovary of 6 women conducted after a 2-year follow-up of the 16 women with cessation of menstruation in (1), findings were varied from atrophied ovaries to near normal ovaries. Among them, the biopsy results of 4 women were similar with focal or diffuse fibrosis observed in the ovarian cortex, no follicles observed in each development phase, primordial follicles irregularly atrophied, and markedly decreased number of primordial follicles except in 1 case. In addition, primordial follicles lacked oocytes or granulosa cells, the number of corpora albicans decreased throughout the tissues, and hyalinization of blood vessels was observed in the medulla (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2005), NTP CERHR (2003)). (3) In two repeated toxicity tests by inhalation exposure with male rats, testicular toxicity (seminiferous tubule atrophy, germ cell loss) and adverse effects on sperms (a decrease in sperm count, a decrease in sperm motility, an increase in morphologically abnormal spermatozoa) were observed. In addition, in two repeated toxicity tests by inhalation exposure with female rats, decreases in primordial follicles and developing follicles, a decreased number of normal follicles, marked increases in atretic follicles and cystic follicles, a decreased number of corpora lutea, irregular sexual cycle, etc. were observed (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2005)). (4) This substance was classified in Group 1 of reproductive toxicants by the Japan Society For Occupational Health (JSOH) (OEL Documentations (Reproductive toxicant classification) (Japan Society For Occupational Health (JSOH)), 2013)). In EU, it was classified in Repr. 1A (EU CLP Classification Results (Accessed August 2021)). (5) In a repeated toxicity study by inhalation exposure with female rats (from 2 weeks before mating to day 19 of gestation), no maternal toxicity was observed up to the highest concentration (1,000 ppm), but a decreased number of liveborn pups was observed (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2005)). |
| 8 | Specific target organ toxicity - Single exposure | Category 2 (nervous system) |
Warning |
H371 | P308+P311 P260 P264 P270 P405 P501 |
[Rationale for the Classification] Based on (1), it was classified in Category 2 (nervous system). [Evidence Data] (1) It was reported that, in an acute oral toxicity test with rats (OECD TG 401, GLP), symptoms of neurotoxicity, including ataxia, hypoactivity, and piloerection, were reported at 2,000 mg/kg (upper limit of Category 2) (AICIS IMAP (2015)). [Reference Data, etc.] (2) In an acute inhalation exposure test (4 hours) with mice, at 26,604 ppm (converted 4-hour equivalent value: 134 mg/L, in the range corresponding to "Not classified"), motions became slow in most animals, and motions became very active after the exposure. It was reported that, in a necropsy, there were no abnormal findings in the respiratory organs, reproductive organs, and liver in either dead or surviving animals (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2017)). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (hematopoietic system, reproductive organs) |
Danger |
H372 | P260 P264 P270 P314 P501 |
[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1 (hematopoietic system, reproductive organs). Since the effects on the blood system were considered to be the secondary effects of toxicity to the hematopoietic system, they were not adopted. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) An unusually high number of cessation of menstruation was found among workers in the process of handling this substance at a Korean electronics manufacturing factory, and as a result of survey, it was found that 1/8 workers (men) and 8/25 workers (women) also developed pancytopenia. Lower red blood cell count, hemoglobin level, hematocrit level, white blood cell count, and platelet count were observed, and as a result of a bone marrow biopsy, 2 women were diagnosed with severe hypoplastic marrow. Besides, in two other work processes of the relevant factory, no workers were diagnosed with low-functioning bone marrow. In addition, decreased sperm count or aspermia was observed in 6/8 workers (men), and cessation of menstruation was observed in 16/25 workers (women). Besides, it was reported that, in a follow-up study of 16 cases of cessation of menstruation, cessation of menstruation continued in 14 cases even after two years, and when biopsies of the ovaries were conducted (4 cases), common findings were no follicles observed in each development phase, atrophy and a decreased number of primordial follicles, and fibrosis of the cortex (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), OEL Documentations (Japan Society For Occupational Health (JSOH), 1999), AICIS IMAP (2015), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2005)). (2) In a survey of a plant manufacturing this substance in China, a significant correlation between exposure concentrations (0 to 8.6 ppm) and hemoglobin and hematocrit levels, which were anemia parameters, was observed in women with regular menstruation, and this suggested that the hematopoietic function could be affected by a long-time exposure even at low concentrations of 10 ppm or lower. It was also reported that, in the case of one 31-year-old man, sperm count and active sperm rate were greatly lower than the normal values, but this man was a technical supervisor at the start-up phase of the plant, had worked on the adjustment of equipment since then, and could have often been exposed to this substance at high concentrations (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2016), AICIS IMAP (2015), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2005), OEL Documentations (Japan Society For Occupational Health (JSOH), 1999)). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] 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 Short term (Acute) | Category 3 |
- |
H402 | P273 P501 |
It was classified in Category 3 from 48-hour EC50 = 23.1 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2000), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2005)). |
| 11 | Hazardous to the aquatic environment Long term (Chronic) | Not classified |
- |
- | - | If chronic toxicity data are used, then it is classified as "Not classified" due to being rapidly degradable (a degradation rate by BOD: 83% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1990)), and 21-day NOEC = 4.94 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2000), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2005)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (algae, fish), then it is classified as "Not classified" due to being rapidly degradable and a low bioaccumulation estimate (log Kow=2.14 (SRC PhysProp Database), despite 96-hour LC50 > 66.6 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2000), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2005)). From the above results, it was classified as "Not classified." The classification result was revised from the previous classification by changing how to classify it in chronic toxicity and using new information. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
NOTE:
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