GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 606-20-2 |
| Chemical Name | 2,6-Dinitrotoluene |
| Substance ID | H28-B-15-METI, M-007B |
| Classification year (FY) | FY2016 |
| 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 | 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 nitro group as a chemical group associated with explosive properties present in the molecule, and the calculated value of oxygen balance is -114. However, because it is classified in Division 6.1 (Poisonous Material), PG II (UN 3454, 1600 if molten) in UNRTDG, it is estimated that it does not correspond to explosives which is hazard class with the highest precedence. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Solid (GHS definition). |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Solid (GHS definition). |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Solid (GHS definition). |
| 6 | Flammable liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 7 | Flammable solids | Classification not possible |
- |
- | - | No data available. Besides, there is the information of combustible (ICSC (2005)). |
| 8 | Self-reactive substances and mixtures | Type G |
- |
- | - | There is a nitro group as a chemical group associated with explosive properties present in the molecule, but because it is classified in Division 6.1 (Poisonous Material), PG II (UN 3454, 1600 if molten) in UNRTDG, it is estimated that it does not correspond to self-reactive substances, and mixtures which is hazard class with the highest precedence. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of about 400 deg C (Hommel (1991)). |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) 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 | Not applicable |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | The substance is an organic compound containing oxygen which is chemically bonded to the element other than carbon or hydrogen (N), but the classification is not possible due to no data. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not 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 4 reported LD50 values for rats of 180 mg/kg (Male) (ATSDR (2016), Initial Risk Assessment (NITE, CERI, NEDO, 2005), IARC 65 (1996)), 535 mg/kg (Male) (ATSDR (2016)), 795 mg/kg (Female) (ATSDR (2016), Initial Risk Assessment (NITE, CERI, NEDO, 2005)), and 535 to 800 mg/kg (DFGOT vol. 21 (2005)). One report corresponds to Category 3, and three reports correspond to Category 4. It was classified in Category 4 with the largest number of reports. Since the LD50 value of 535 mg/kg used in the previous classification is in SIDS (2005)), which is the assessment report of dinitrotoluene (CAS RN 25321-14-6), is the data on a mixture of isomers with the content of this substance of 20%, it was not adopted for the classification. In addition, since the LD50 value of 177 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2005)) is a data from RTECS and not available, it was not adopted. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Category 3 |
 Danger |
H331 |
P304+P340
P403+P233 P261 P271 P311 P321 P405 P501 |
There are four reported LC50 values (6 hours) for rats of > 0.026 mg/L (both sexes) (converted 4-hour equivalent value: >0.032 mg/L) (ATSDR (2016)), 0.24 mg/L (male) (converted 4-hour equivalent value: 0.36 mg/L) (ATSDR (2016), Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), 0.66 mg/L (female) (converted 4-hour equivalent value: 0.99 mg/L), and 0.43 mg/L (both sexes) (converted 4-hour equivalent value: 0.65 mg/L) (ATSDR (2016), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). One report corresponds to Category 1 - "Not classified," one report to Category 2, and 2 reports correspond to Category 3. It was classified in Category 3 with the largest number of reports. Based on new information, category was revised. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, it was reported that in a Draize test using rabbits, no irritation was seen by application of this substance (DFGOT vol. 6 (1992)), however, because the details of the test conditions, etc. are unknown, it was judged to be insufficient data for classification. In addition, it was reported that in a skin irritation test using rabbits, mild irritation was observed after applying this substance and 2,4-dinitrotoluene (dose unknown) (Initial Risk Assessment (NITE, CERI, NEDO, 2005)). |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, it is reported that in an eye irritation test using rabbits, there was no irritation in the test applying this substance (Initial Risk Assessment (NITE, CERI, NEDO, 2005), DFGOT vol. 6 (1992)). Because the details of test conditions, etc. are unknown, it was judged as insufficient data for classification. |
| 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, it was reported that in a maximization test using guinea pigs, a positive reaction was seen in 2 out of 10 animals (Initial Risk Assessment (NITE, CERI, NEDO, 2005), DFGOT vol. 6 (1992)), however, the data was judged as insufficient for classification because of unknown details of test conditions, etc. |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 |
P308+P313
P201 P202 P280 P405 P501 |
As for in vivo, micronucleus tests using bone marrow cells and peripheral blood of rats were negative, comet assays using the liver and peripheral blood of rats were positive, unscheduled DNA synthesis tests using rat liver were positive, and an unscheduled DNA synthesis test using rat spermatocytes was negative (Initial Risk Assessment (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011), IARC 65 (1996), ATSDR (2016)). As for in vitro, bacterial reverse mutation tests were positive, and in cultured mammalian cell system, gene mutation tests and a mouse lymphoma test were negative, and a chromosome aberration test was positive (Initial Risk Assessment (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011), IARC 65 (1996), ATSDR (2016), NTP DB (Access on October 2016)). From the above, it was classified in Category 2 according to the GHS classification guidance for the Japanese government. |
| 6 | Carcinogenicity | Category 1B |
Danger |
H350 |
P308+P313
P201 P202 P280 P405 P501 |
In humans, it is reported that in a cohort study of workers in the United States, an increased risk for cancer of the liver and gall-bladder was found among workers exposed to a mixture of this substance and 2,4-dinitrotoluenes, and that no such increase in risk for cacinogenesis was detected. Since the results were inconsistent, IARC concluded that there was insufficient evidence of carcinogenicity for dinitrotoluenes including this substance (IARC 65 (1996)). In experimental animals, liver tumors were seen in the two studies in which the substance was administered to male rats by feeding for one year, in one study, hepatocellular carcinoma or neoplastic nodules in the liver in 100% of animals, and in the other one, in addition to dose-dependent formation of hepatocellular carcinoma or neoplastic nodules in the liver, pulmonary metastasis of liver tumors were observed (IARC 65 (1996), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)). In addition, in the initiation-promotion test, this substance showed both effects of initiator and promoter, and it is suggested that this substance is a complete hepatocarcinogen (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), Initial Risk Assessment (NITE, CERI, NEDO, 2005)). As classification results by other organizations, IARC classified it as Group 2B because there is sufficient evidence in experimental animals (IARC 65 (1996)), while the EU classified it as Carc. 1B (ECHA C&L Inventory (Access on November 2016)). As above, it would be classified in Category 2 according to the IARC's old classification result, but based on the knowledge that this substance is a complete hepatocarcinogen in experimental animals and the newer classification result by the EU, it was classified in Category 1B. |
| 7 | Reproductive toxicity | Category 2 |
Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
There are no data of standard reproduction and developmental toxicity tests. However, it is reported that the oral administration to rats or dogs for 13 weeks resulted in testicular atrophy and degeneration and decreased spermatogenesis (Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011), Initial Risk Assessment (NITE, CERI, NEDO, 2005)). The EU classified it as Repr. 2 (ECHA C&L Inventory (Access on November 2016). From the above, it was classified in Category 2. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system), Category 3 (narcotic effects) |
Danger Warning |
H370
H336 |
P308+P311
P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
There is no data on single exposure to this substance in humans. In experimental animals, it is reported that in a single inhalation test using rats exposed to this substance for 6 hours, respiratory disorders, ataxia, lethargy and deaths were observed at 0.196 mg/L (converted 4-hour equivalent value: 0.294 mg/L), which is equivalent to Category 1, or higher, and that lung congestion and increased relative lung weight were seen in dead animals (ATSDR (2016), SIDS (2005), Initial Risk Assessment (NITE, CERI, NEDO, 2005), BUA 114 (1993)). Among these, with regard to the findings of the lung, because they were from dead animals, they were not used as the evidence for classification. Therefore, the substance was classified in Category 1 (central nervous system) and Category 3 (narcotic effects). Besides, it was reported that in a single intraperitoneal injection test in cats, increases in the blood methemoglobin level and Heinz body production were seen at 60 mg/kg or higher of this substance (Initial Risk Assessment (NITE, CERI, NEDO, 2005), DFGOT vol. 6 (1992), BUA 12 (1987)). However, since it is the data by intraperitoneal administration, it was not used as the evidence for classification. In addition, the original literature could not be confirmed for the description of ICSC (J) which was used as the basis for classification of the blood system in the previous classification. Based on the above, it was judged that the basis information was not sufficient to adopt the blood system as the target organ. In the previous classification, it was classified as Category 1 (liver) based on the description that extensive centrilobular hemorrhagic necrosis was observed in the liver in a test in which the substance was administered intraperitoneally or orally to rats (Initial Risk Assessment (NITE, CERI, NEDO, 2005)). However, as a result of checking the original literature, since it was the data by intraperitoneal administration, the classification result was changed, and the liver was not adopted as the target organ. Furthermore, although in the previous classification, the cardiovascular system was adopted as target organ based on the description of ICSC (J) at the time of the previous classification, ICSC (J) is the information source of List 3 in the current GHS classification guidance for the Japanese government, and other information on the cardiovascular effects could not be obtained, so the classification result was changed. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (haemal system, liver), Category 2 (nervous system, kidney, genetic organs (men)) |
Danger Warning |
H372
H373 |
P260
P264 P270 P314 P501 |
There is no information on this substance alone in humans. Dinitrotoluenes affect mainly the heart, blood and central nervous system in humans. Workers exposed to dinitrotoluens at the factory showed electrocardiogram abnormality, tachycardia, and an increase in mortality due to ischemic heart disease was observed for the workers who served for more than 15 years (Initial Risk Assessment (NITE, CERI, NEDO, 2005)). As for the experimental animals, in a 13-week repeated dose toxicity study using dogs dosed by gavage, at 4 mg/kg/day equivalent to Category 1, adaptive changes to the effects on the blood system (increased extramedullary hematopoiesis in the spleen), and at 20 mg/kg/day equivalent to Category 2 or higher, ankyloses, convulsions, paralysis, anemia, methemoglobinemia, increased platelets, decreased lymphocytes, increased alkaline phosphatase, increased ALT activity and urea nitrogen, hyperplasia of bile duct epithelium, hepatic degeneration/inflammation, and renal degeneration/inflammation, testicular atrophy were observed (Initial Risk Assessment (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011), ATSDR (2016)). In a one-year repeated dose toxicity study using rats by feeding, degeneration and vacuolization of hepatocytes, hyperplasia of bile duct epithelium, and increased ALT activity were seen at 7 mg/kg/day equivalent to Category 1 or higher (Initial Risk Assessment (NITE, CERI, NEDO, 2005)). In a 13-week repeated dose toxicity study using rats (by feeding), increased ALT activity, metohemoglobinemia, increased platelets, increased extramedullary hemetopoiesis in the spleen, and atrophy of the testes were observed at 35-37 mg/kg/day equivalent to Category 2 or higher (Initial Risk Assessment (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011), ATSDR (2016)). In a 13-week repeated dose toxicity study using mice by feeding, increased extramedullary hematopoiesis in the spleen, testicular atrophy, decreased spermatogenicity, and hyperplasia of bile duct epithelium were seen at 51 to 55 mg/kg/day equivalent to Category 2 or higher (Initial Risk Assessment (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011), ATSDR (2016)). Therefore, the substance was classified as Category 1 (blood system, liver), Category 2 (nervous system, kidney, genetic organs (men)). Besides, in the previous classification, the cardiovascular system was adopted as the target organ based on the description of ICSC (J) at the time of the previous classification, but because ICSC (J) is the information source of List 3 in the current GHS classification guidance for the Japanese government, and the information indicating the effects on cardiovascular system could not be obtained, classification result was changed. |
| 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 = 5 mg/L for crustacea (Mysidopsis bahia) (Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011)), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
 Warning |
H410 |
P273
P391 P501 |
Due to being not rapidly degradable (BIOWIN), and 21-day NOEC = 0.06 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 5, 2006, vol. 9 (Ministry of the Environment, 2011); Initial Risk Assessment (NITE, CERI, NEDO, 2005); ECETOC TR91, 2003), it was classified in Category 1. |
| 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. |