NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	693-98-1
Chemical Name	2-Methylimidazole
Substance ID	m-nite-693-98-1_v2
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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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 the mouse LD50 values of 1400 mg/kg (NTP TOX67 (2004)), the substance was classified into Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	The classification was concluded as "Category 2" based on the positive results in the micronucleus test using peripheral blood obtained from mice by the dietary administration for 14 weeks (in vivo mutagenicity test in somatic cells) (NTP TR 516 (2004)). As relevant information, negative results in the micronucleus test using bone marrow obtained from rats and mice single intraperitoneally administered (in vivo mutagenicity test in somatic cells) (NTP DB (Access on Sep. 2010)). And as for in vitro study, negative in the Ames test (NTP DB (Access on Sep. 2010)) were reported.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	In the 2-year dietary administration study in rats, it was concluded to be a certain evidence of carcinogenicity in males and a clear evidence in females from the data on increased incidence of follicular cell neoplasms in the thyroid (NTP TR 516 (2004)). In the 2-year dietary administration study in mice, it was concluded to be a certain evidence of carcinogenicity in males and females from the data on increased incidence of follicular cell adenomas in the thyroid and hepatocellular neoplasms in male, and from the data on increased incidence of hepatocellular neoplasms in females (NTP TR 516 (2004)). From the conclusion of the above data in 2-year oral administration studies in rats and mice, limited evidence of carcinogenicity in the two species of animals was suggested, and carcinogenicity in humans was suspected. Therefore, the classification was concluded as Category 2.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 1B. It was classified based on the new information source. [Evidence Data] (1) In a reproduction/developmental toxicity screening test (OECD TG 421, GLP) with rats dosed by gavage, at the highest dose of 500 mg/kg/day, 2/10 dams died during or shortly after parturition, which was considered to be an adverse effect of the administration of this substance on parturition (complicated parturition). In addition, reduced body weight gain, a tendency to an increase in the duration of pregnancy (within the background data), an increase in the number of stillborn pups, and a decrease in the live birth index were observed in dams of the same group. It was reported that, in offspring, a dose-dependent increase in the incidence with aneurysm (aorta, the region of the ductus arteriosus and the pulmonary trunk) was observed from the low dose (50 mg/kg/day), and a decrease in the viability index on postnatal days 0 to 4 was observed in the highest dose group (CLH Report (2016), AICIS IMAP (2016), ECHA RAC Opinion (2017), REACH registration dossier (Accessed Oct. 2021)). (2) It was reported that, in a developmental toxicity study (GLP) with female rats dosed by gavage from day 6 of gestation to postnatal day 3, no effects were observed in dams up to the highest dose of 50 mg/kg/day, but in offspring, an increase in the incidence with dissecting aneurysm of the aorta and intramural hemorrhage was observed from the low dose (2 mg/kg/day) (CLH Report (2016), AICIS IMAP (2016), ECHA RAC Opinion (2017), REACH registration dossier (Accessed Oct. 2021)). (3) Based on (1) and (2), a dose-dependent increase in the incidence of aneurysm was observed from the low dose of 2 mg/kg/day in two tests. A decrease in the viability index was observed in offspring at 500 mg/kg/day. Since the maternal toxicity is limited to body weight changes at 500mg/kg/day, the developmental effects in offspring cannot be considered to be secondary to maternal toxicity. Therefore, it was reported that the classification in Repr. 1B was determined to be appropriate (CLH Report (2016), ECHA RAC Opinion (2017)). [Reference Data, etc.] (4) In the EU CLP, it was classified in Repr. 1B (EU CLP Classification Results (Accessed Oct. 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	It was reported that the animals exposed to the substance exhibited convulsant activity containing restlessness and paralysis, etc. (NTP TOX 067 (2004)) and that the substance induced acute neurologic effects in mice by oral administration, 50% occurrence dose of convulsion was 1300 mg/kg (NTP TOX 067 (2004)). Based on the information, the substance was classified as Category 2 (nervous system).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (thyroid, hematopoietic system)	Warning	H373	P260 P314 P501	In the 14-week feeding study in rats, the incidences of follicular cell hyperplasia of the thyroid gland were significantly increased in both sexes, especially in males the changes were significantly increased at the dose level of 1250 ppm (80 mg/kg/day: equivalent to Category 2 of the guidance values) or higher (NTP TOX 67 (2004)). The effect on the thyroid gland may be caused by rodent-specific UDP-GT induction or alterations of thyroid hormone values. However, there was no description with regard to the relevancy, the effects on humans could not deny. Therefore, the substance was classified as Category 2 (thyroid gland). Similarly, in the 14-week feeding study in mice, the significant increase in the incidences of follicular cell hypertrophy of the thyroid gland was also reported (NTP TOX 67 (2004)). In addition, in the 2-year feeding study in mice, the incidence of hematopoietic cell proliferation in the spleen was significantly increased in all exposed groups (75 mg/kg/day or higher) in males and at 325 mg/kg/day in females, and the incidence of pigmentation was significantly increased in all exposed groups (75 mg/kg/day or higher) in males and in groups at 150 mg/kg/day or higher in females (NTP TR 516 (2004)). These results revealed that the effects were seen in the dose levels equivalent to Category 2 of the guidance values in males, and that macrocytic, normochromic to hypochromic anemia indicated in the hematology, and significant increase in incidences of hyperplasia of bone marrow and pigmentation in renal proximal tubule were also noted (NTP TR 516 (2004)). Therefore, the substance was additionally classified as Category 2 (hematopoietic system).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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)	Not classified	- -	-	-	Classified as "Not classified" from its 48h-EC50 = 200 mg/L for crustacea (Daphnia magna) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2006).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Classified as "Not classified" since its acute toxicity is "Not Classified" and it is not non-water soluble (water solubility: 80850 mg/L (PHYSPROP Database, 2011)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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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