GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 79-46-9 |
| Chemical Name | 2-Nitropropane |
| Substance ID | H29-B-109 |
| 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 | 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 (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 classified |
- |
- | - | There is a chemical group associated with explosive properties (nitro group) in the molecule, but because it is classified in Class 3, PGIII in UNRTDG (UN 2608), it does not correspond to explosives, hazard class with the highest precedence. |
| 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 | Category 3 |
 Warning |
H226 |
P303+P361+P353
P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
A flash point is 24 deg C (closed cup) (ICSC (J) (2006)). Besides, nitropropanes are classified in Class 3, PGIII in UNRTDG (UN 2608). |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 8 | Self-reactive substances and mixtures | Type G |
- |
- | - | There is a chemical group associated with explosive properties (nitro group) in the molecule, but because it is classified in Class 3, PGIII in UNRTDG (UN 2608), it does not correspond to self-reactive substances and mixtures, hazard class with the highest precedence. |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 425 deg C (GESTIS (Access on September 2017)). |
| 10 | Pyrophoric solids | 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 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 | Classification not possible |
- |
- | - | It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (N). However, the classification is not possible due to no data. |
| 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 |
Based on a reported LD50 value of 720 mg/kg for rats (ACGIH (7th, 2001)), it was classified in Category 4. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | There is a report of an LD50 value of > 2,000 mg/kg for rabbits (HSDB (Access on August 2017)). In addition, there is a report that in another single dermal dose test with rabbits, no toxic effect was observed at 2,000 mg/kg (EHC 138 (1992)). Therefore, it was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Category 2 |
 Danger |
H330 |
P304+P340
P403+P233 P260 P271 P284 P310 P320 P405 P501 |
There are the following 4 reports of LC50 values for rats: 400 ppm (converted 4-hour equivalent value: 490 ppm) (male) in a 6-hour inhalation exposure test (ACGIH (7th, 2001), IARC 29 (1982), JECFA FAS 26 (1989)); 400 ppm (converted 4-hour equivalent value: 490 ppm) (male) and 720 ppm (converted 4-hour equivalent value: 882 ppm) (female) in another 6-hour inhalation exposure test (both in EHC 138 (1992)); and 1,513 ppm (converted 4-hour equivalent value: 1,605 ppm) in a 4.5-hour inhalation exposure test (JECFA FAS 26 (1989)). Two cases correspond to Category 2, and the other two correspond to Category 3. By adopting the category with higher hazard, it was classified in Category 2. Besides, a reference value in the unit of ppm was applied as vapour with little mist because the exposure concentrations were lower than 90% of the saturated vapour pressure concentration (22,700 ppm). |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | There are descriptions that in two tests in which this substance was applied to the skin of rabbits, local effects were not observed and no skin irritation was observed (both in EHC 138 (1992)). On the other hand, there is a conflicting report with the description that this substance is irritating to the skin (HSDB (Access on August 2017)). Therefore, it was classified as "Classification not possible." Based on the information obtained in this investigation, the category was changed. |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 |
P305+P351+P338
P337+P313 P264 |
Since there are descriptions that this substance is irritating to the eyes (HSDB (Access on August 2017)), and that in an eye irritation test (not compliant with the guideline) with rabbits, this substance was slightly irritating to the eyes (ECHA registration dossier (Access on November 2017)), it was classified in Category 2B. IUCLID (2000) used as the evidence for the classification in the previous classification was not used this time because it is not currently available. The category was changed based on the information obtained in this investigation. |
| 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. Besides, there is a report that this substance showed skin sensitization in a skin sensitization test with guinea pigs (equivalent to the guideline test (Landsteiner and Jacobs method)) (ECHA registration dossier (Access on November 2017)), however, since there were no reports on humans, it was classified as "Classification not possible." |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 |
P308+P313
P201 P202 P280 P405 P501 |
As for in vivo, it was negative in a dominant lethal test with rats, positive in a gene mutation test with mouse liver, negative with bone marrow cells and positive with hepatocytes in a micronucleus tests with rats, negative in micronucleus tests with mouse bone marrow cells and peripheral blood, positive in a comet assay with bone marrow cells of rats and stomach, intestine, and liver of mice, positive with liver and negative with lung, kidney, bone marrow, and brain in DNA damage tests with rats, and positive in an unscheduled DNA synthesis test with rat liver (IARC 71 (1999), EHC 138 (1992), OECD ROBUST STUDY SUMMARIES (Access on September 2017), ACGIH (7th, 2001), SIAP (2010)). As for in vitro, it was positive in a bacterial reverse mutation test, and positive in a gene mutation test, negative in a micronucleus test, and positive and negative in chromosomal aberration tests and sister chromatid exchange tests with mammalian cultured cells (IARC 71 (1999), EHC 138 (1992), ACGIH (7th, 2001), DFGOT Vol. 3 (1992), NTP DB (Access on September 2017), OECD ROBUST STUDY SUMMARIES (Access on September 2017)). Besides, in new assessment reports, this substance is described as genotoxic both in vitro and in vivo (Screening Assessment for the Challenge, Environment Canada and Health Canada (2010)), and it is also described that this substance is mutagenic both in vitro and in vivo, and it is obviously genotoxic (SIAP (2010)). From the above, it was classified in Category 2 according to the GHS classification guidance for the Japanese government. The new information source was added, and the result of the previous classification was revised. |
| 6 | Carcinogenicity | Category 1B |
Danger |
H350 |
P308+P313
P201 P202 P280 P405 P501 |
There is no information on carcinogenicity in humans. As for experimental animals, in one of two inhalation exposure tests with rats, hepatocellular carcinomas were found in all of the 10 animals in the exposed group, and in the other test, a significant increase in the incidence of neoplastic nodules of hepatocytes was observed (IARC 29 (1982), IARC 71 (1999), DFGOT Vol. 3 (1992), ACGIH (7th, 2001), NTP RoC (14th, 2016)). In addition, as a result of necropsy after weaned male rats were dosed by gavage for 16 weeks and held for 77 weeks, malignant tumors in the liver were found in all of the 22 animals in the administered group (control group: 0/29 animals) (IARC 71 (1999), DFGOT Vol. 3 (1992), NTP RoC (14th, 2016)). From the above, IARC classified it in Group 2B, describing that there was sufficient evidence of carcinogenicity in experimental animals. Other than this, ACGIH classified it in A3 (ACGIH (7th, 2001)), NTP as R (NTP RoC (14th, 2016)), EU in Carc. 1B (ECHA CL Inventory (Access on August 2016)), and Japan Society For Occupational Health (JSOH) in Group 2B (Recommendation of Occupational Exposure Limits (2016): proposal in 1991). From the above, Category 2 or Category 1B is supported from the classification results by other organizations. From the test reports, malignant tumors in the liver were observed with an incidence of 100% by multiple routes though they were found in only one species of rats. Thus, it was possible to judge that there was sufficient evidence of carcinogenicity in experimental animals. Therefore, the classification result by EU was supported, and it was classified in Category 1B for this hazard class. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, in a study in which this substance was intraperitoneally administered to pregnant rats at 170 mg/kg/day on gestational day 1-15, a decrease in pre- and post-implantation embryo/fetal survival rate, a fetal growth retardation, and a developmental delay in the cardiovascular system were observed (IARC 71 (1999), ACGIH (7th, 2001), HSDB (Access on August 2017)), however, they were not adopted in consideration of an intraperitoneal administration. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, liver, haemal system), Category 3 (narcotic effects) |
Danger Warning |
H370
H336 |
P308+P311
P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
As for humans, a number of accidents are reported in which workers who handled solvents containing this substance in an insufficiently ventilated environment were exposed by inhalation to this substance at high concentrations (IARC 29 (1982), EHC 138 (1992), DFGOT Vol. 3 (1992), ACGIH (7th, 2001)). Early symptoms were headaches, nausea, dizziness, drowsiness, weakness, anorexia, vomiting, diarrhea, pain in the neck, throat and abdomen. As the subsequent symptoms, persistent nausea, vomiting, anorexia, jaundice, oliguria, diarrhea, hematochezia, delirium, restlessness, loss of reflex, elevation of blood aminotransferase activity and other findings of liver damage, etc. were observed, and seven of the 11 cases died 4-26 days after exposure. In every case, the main cause of death was acute hepatic failure. As for experimental animals, it is described that in single inhalation exposure tests with rats, rabbits, and cats, exposure at high concentrations caused lethargy, weakness, dyspnea, cyanosis, prostration, and they died in the comatose state though there is no description of the doses (EHC 183 (1992)). In addition, there are reports that in a one-hour single inhalation exposure test with rats, methemoglobin concentration in the blood increased to 0.2-8.6% at 2.8 mg/L (converted 4-hour equivalent value: 1.4 mg/L), and to 84% at 53.5 mg/L (converted 4-hour equivalent value: 26.8 mg/L), and that in single inhalation exposure tests with rabbits, after exposure at 8.5 mg/L (converted 4-hour equivalent value: 6.38 mg/L) for 2.25 hours or at 15.4 mg/L (converted 4-hour equivalent value: 16.33 mg/L) for 4.5 hours, Heinz body formation was observed in 45-80% of erythrocytes (EHC 138 (1992)). From the above, it is considered that the target organs of this substance are the central nervous system, liver, and haemal system, and it also has narcotic effects. Effects on the haemal system in experimental animals were observed at the doses within the range for Category 1. Therefore, it was classified in Category 1 (central nervous system, liver, haemal system), Category 3 (narcotic effects). Due to the revision of information sources, the classification result was changed from the previous classification. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (liver), Category 2 (haemal system, respiratory organs) |
Danger Warning |
H372
H373 |
P260
P264 P270 P314 P501 |
As for humans, there is a description in DFGOT Vol. 3 (1992) that nausea, vomiting, diarrhea, anorexia and severe headaches were seen after exposure for a prolonged period, but there is a description in EHC 138 (1992) that nausea, vomiting, anorexia and headache etc. in the case of human occupational exposure were acute effects by daily cycle, and there were no cases or epidemiological evidence on carcinogenicity and chronic effects. As for experimental animals, there is a report that in a 4-week repeated toxicity test with rats dosed by gavage, anemia etc. at or above 50 mg/kg/day (converted guidance value: 11 mg/kg/day) within the guidance value range for Category 2, and death, increases in ALT, AST and gamma-GT, increased weight of the liver, spleen, and heart, an increase in hemosiderin deposition in the spleen, polymorphism of hepatocytes and nuclei, single cell necrosis, proliferation of oval cells and biliary ducts in the liver at 250 mg/kg/day (converted guidance value: 56 mg/kg/day) were reported (EHC 138 (1992)). In a 6-month inhalation toxicity test with rats (7 hours/day, 5 days/week), at 750 mg/m3 (converted guidance value: 0.88 mg/L) within the guidance value range (vapor) for Category 2, lesions such as lung edema, increased liver weight, enlargement, hyperplasia and necrosis of hepatocytes were seen (EHC 138 (1992)). In a 18-month inhalation toxicity test (7 hours/day, 5 days/week) with rats, at 360 mg/m3 (converted guidance value: 0.42 mg/L) within the range of the guidance value (vapor) for Category 2, increased renal calcification, increased ALT, liver lesions (necrosis, vacuolar degeneration, enlargement etc.) were seen (EHC 138 (1992)). In a 22-month inhalation toxicity test (7 hours/day, 5 days/week) with rats, at 78 mg/m3 (converted guidance value: 0.091 mg/L) within the range of the guidance value (vapor) for Category 1, increased liver weight, focal hepatocellular vacuolation of the liver, slight hepatic congestion and increasing tendency of localized nodules in the liver were seen (IRIS (1991)). From the above, as for humans, effects of repeated exposures could not be identified. In experimental animals, effects were observed in the liver from the guidance value range for Category 1, and in the haemal system, respiratory system, and kidney within the guidance value range for Category 2, but the effect on the kidney was considered as an incidental finding, and it was not adopted as rationale for the classification. Therefore, it was classified in Category 1 (liver), Category 2 (haemal system, respiratory organs). Besides, since the effects on humans were not treated as effects in repeated exposure, and the information sources were revised, the classification result was different from the previous classification. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, the kinematic viscosity is calculated to be 0.73 mm2/sec (25 deg C) based on the numerical data (viscosity: 0.721 mPa*s (25 deg C), density: 0.9821 g/cm3 (25 deg C)) listed in HSDB (Access on August 2017). |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Not classified |
- |
- | - | From 96-hour LC50 >210 mg/L for fish (Pimephales promelas) (WHO EHC: 1992), it was classified as "Not classified." |
| 11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Chronic toxicity data were not obtained. Due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 14, 8% (J-CHECK, 1987)), and "Not classified" in acute toxicity, it was classified as "Not classified." |
| 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. |