GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 100-61-8 |
| Chemical Name | N-Methylaniline |
| Substance ID | H29-B-112 |
| 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 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 | Category 4 |
Warning |
H227 |
P370+P378
P403+P235 P210 P280 P501 |
A flash point is 79.5 deg C (closed cup) (ICSC (J) (2006)). |
| 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 estimated that it does not ignite at normal temperatures from an autoignition temperature of 500 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 | 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 |
Based on a report of LD50 values of 716 mg/kg (female), 782 mg/kg (male) for rats (JECDB (Access on August 2017)), it was classified in Category 4. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, there is a report that in a dermal exposure test with rabbits, death was observed at doses of not less than 3000 mg/kg which corresponds to "Not Classified" (Category 5 in UN GHS classification) (DFGOT vol. 6 (1993), ACGIH (7th, 2001)). |
| 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 | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, there is a description this substance is readily absorbed through the skin, and does not cause local irritation even at high doses (DFGOT vol. 6 (1993)). However, it was not adopted because the details of local irritation were unknown. Chemical Substance Hazard Data (CERI, 2002) which was used for the previous classification was not adopted because it is the information source listed as List 3. Based on the information source obtained by this investigation, the category was changed. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, there is a description that mild eye irritation was observed in an eye irritation test in which isolated chicken eyeballs were used (in accordance with OECD TG 438) (ECHA registered information (Access on November 2017)), but the data was not adopted because the test was to confirm whether the substance could cause serious eye damage. Chemical Substance Hazard Data (CERI, 2002) and ICSC which were used for the previous classification were not adopted because they are the information sources in List 3. Therefore, the classification result was changed. |
| 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. There is a description that this substance did not cause skin sensitization in a sensitization test of LLNA method with mice (in accordance with OECD TG 429) (ECHA registered information (Access on November 2017)), but no information on other animal experiments or humans could be obtained. Therefore, it was classified as "Classification not possible." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. There is no in vivo data, and as for in vitro, a bacterial reverse mutation test was negative, and a mammalian cell chromosome aberration test was positive (JECDB (Access on August 2017), Environmental Risk Assessment for Chemical Substances Vol. 12 (Ministry of the Environment, 2014), DFGOT vol. 6 (1993), NTP DB (Access on August 2017)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - |
There is no information on carcinogenicity in humans. As for experimental animals, no tumor was observed in the liver or the other organs macroscopically in the test with rats dosed by feeding (0.06%) the hydrochloride salt of this substance (administration period unknown) (Environmental Risk Assessment for Chemical Substances, Vol. 12 (Ministry of the Environment, 2014), DFGOT vol. 6 (1993)). In addition, even in the test where mice were dosed by feeding (0.195%) for 28 weeks and then an autopsy was conducted after 12 weeks, no increase in the incidence of lung tumors was observed (treated group 17% vs control group 14%), but in the group dosed by drinking water to which 0.1% of sodium nitrite was added concurrently with this substance, the incidence of lung adenomas was significantly increased to 61% (Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014), DFGOT vol. 6 (1993)). The authors concluded that nitrosation to generate carcinogenic nitrosamines had taken place in the group with sodium nitrite added (DFGOT vol. 6 (1993)). From the above, no carcinogenicity was observed in the tests with rats and mice dosed of this substance alone. However, the tests were performed at only one dose, the administration period was inadequate or unknown, and histopathological inspection was not carried out enough. Therefore, every test is not suitable for a carcinogenic evaluation. Other than these, there is no available data for classification, therefore, classification was not possible due to lack of data. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (haemal system, kidney), Category 2 (nervous system) |
 Danger Warning |
H370
H371 |
P308+P311
P260 P264 P270 P321 P405 P501 |
There are no single-exposure data on this substance in humans. As for experimental animals, there is a report that in a single oral dose test with rats, a decrease in locomotor activity, cyanosis, and brown urine were observed at 512 mg/kg corresponding to Category 2: lateral position, prone position, contraction of the whole body, lacrimation, and hypothermia were observed at or above lethal dose of 1000 mg/kg (JECDB (Access on August 2017)). In addition, there are reports that in an single oral dose test with rabbits, at 180 mg/kg corresponding to Category 1, the blood hemoglobin level rose up to 23-45%, and decreased erythrocyte count, increased hematopoiesis in the bone marrow, albuminuria, glycosuria and dark brown discoloration of the urine were observed (DFGOT vol. 6 (1993)), and that minimal lethal dose was 240 mg/kg corresponding to Category 1, acute toxicity symptoms were cyanosis, prostration, weight loss, dyspnea, occasional terminal convulsion (DFGOT vol. 6 (1993), ACGIH (7th, 2001)). In dermal exposure, there is a report that in a test where this substance was applied to the skin of rabbits for one hour, cyanosis and death were observed at or above 3,000 mg/kg (DFGOT vol. 6 (1993), ACGIH (7th, 2001)). From the above information, this substance is considered to affect the haemal system and kidney at the doses corresponding to Category 1, and the nervous system at the dose corresponding to Category 2. Therefore, it was classified in Category 1 (haemal system, kidney) and Category 2 (nervous system). In the previous classification, it was classified in Category 3 (respiratory tract irritation) based on the description in Chemical Substance Hazard Data (CERI, 2002), but it was not adopted because Chemical Substance Hazard Data (CERI) is an information source in List 3 today, and there is no other information to be evidence. Therefore, the classification result was changed. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (haemal system, respiratory organs, liver, kidney) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
There is no information in humans. In a 28-day repeated oral dose toxicity test with rats, the following items were observed: hyperemia and pigment deposit of the spleen, hyaline droplet degeneration in the kidney at or above 5 mg/kg/day (converted guidance value: 0.6 mg/kg/day) within a guidance value range for Category 1, decreased hematocrit level and erythrocytes count, increased reticulocytes ratio, increased hematopoiesis in the bone marrow, extramedullary hematopoiesis in the liver and spleen at or above 25 mg/kg/day (converted guidance value: 7.8 mg/kg/day), prothrombin time extension, an increase in total bilirubin, yellowish-brown urine, deposit of pigment at the proximal tubules in the kidney at 125 mg/kg/day (converted guidance value: 38.9 mg/kg/day) (JECDB (Access on August 2017), Environmental Risk Assessment for Chemical Substances, Vol. 12 (Ministry of the Environment, 2014)). In addition, it is reported that in an inhalation exposure test with rats for 130 times (7 hours/day), the formation of Heinz bodies at 2.4 ppm = 10.5 mg/m3 (converted guidance value: 0.0123 mg/L) and death, methemoglobinemia, centrilobular hepatocellular necrosis in the liver, moderate kidney damage, pulmonary edema, and interstitial pneumonia at 7.6 ppm = 33.3 mg/m3 (converted guidance value: 0.038 mg/L) were observed (ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances, Vol.12 (Ministry of the Environment, 2014)). From the above, in addition to mainly observed effects on the blood and others related to them, effects on the respiratory organs, liver, and kidney were also observed, therefore, it was classified in Category 1. Besides, this classification result was different from the previous one since a new information source was used. |
| 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 48-hour EC50 = 5.58 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 12 (Ministry of the Environment, 2014)), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 2 |
 - |
H411 |
P273
P391 P501 |
If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 1.4% (J-CHECK, 1977)), and 21-day NOEC (reproduction inhibition) = 0.29 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, 2017), Environmental Risk Assessment for Chemical Substances vol. 12 (Ministry of the Environment, 2014)). 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, a degradation rate by BOD: 1.4% (J-CHECK, 1977)), and 96-hour LC50 = 57.5 mg/L for fish (Oryzias latipes) (Environmental Risk Assessment for Chemical Substances vol. 12 (Ministry of the Environment, 2014)). From the above results, it was classified in Category 2. |
| 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. |