NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	100-61-8
Chemical Name	N-Methylaniline
Substance ID	m-nite-100-61-8_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	A flash point is 79.5 deg C (closed cup) (ICSC (J) (2006)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (blood 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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood 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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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