NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	288-32-4
Chemical Name	Imidazole
Substance ID	m-nite-288-32-4_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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	There is information that it is combustible (ICSC (J) (2012)), but there are no data in the prescribed test.	FY2012	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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 480 deg C (ICSC (2008)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2012	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).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2012	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.	FY2012	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	It was classified in Category 4 based on an LD50 value of 960-970 mg/kg for rats (SIDS (2004)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	In a test in which 0.5 mL of paste-like test substance containing 80% of this substance and water was applied to the rabbit skin for 4 hours, severe erythema developed overnight and persisted by day 8 after the observation period, slight necrosis appeared overnight, and necrosis in all layers was pathologically observed after the observation period. As a result, this substance was assessed to be corrosive (SIDS (2004)). Therefore, it was classified in Category 1.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In a test in which 100 mg of the undiluted test substance was applied to the rabbit eye (OECD TG405; GLP), the irritation index, MMAS (equivalent to AOI), was 59.3, and it was assessed to be irritating (SIDS (2004)). Therefore, it was classified in Category 2A. And it is reported that in another test with rabbits using almost the same conditions as in the above (Federal Register 38 No. 178), the irritation index was 57.4, and it was irritating (SIDS (2004)), and it would also be classified in Category 2A with the results.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a micronucleus test with bone marrow after single oral administration to mice (OECD TG 474 GLP) (SIDS (2004)). Besides, as for in vitro tests, it was reported to be negative in an Ames test (SIDS (2004)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2012	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), an increase in the incidence mainly of external and skeletal malformations in fetuses was clearly observed at a dose at which minor general toxicity effects were observed in dams, and therefore, it was classified in Category 1B. [Evidence Data] (1) In a developmental toxicity study with female rats dosed by gavage (days 6-19 of gestation), dams with total resorption (3/25 animals), an increase in post-implantation loss (43% on average vs 8% in controls), and a decrease in live fetuses/litter (6.3% vs 9% in controls) were observed at a high dose (180 mg/kg/day) at which general toxicity effects (reduced body weight gain, reduced food consumption, salivation (6/25 animals), vaginal hemorrhage (1/25 animals)) were observed in dams. In addition, an increase in the incidence of malformations (total incidence: 12% (per fetus), 11% (per litter)) such as external malformations (cleft palate, anasarca), skeletal malformations (shortened scapula, bent radius/ulna, malpositioned and bipartite sternebrae, etc.) was observed in fetuses. It was reported that malformed fetuses were occasionally observed also at or below the mid-dose (60 and 20 mg/kg/day), but there was no difference in the incidence of malformations compared to controls (EU REACH CoRAP (2018), ECHA RAC Opinion (Background Doc.) (2013), AICIS (Former NICNAS) IMAP (2017)). [Reference Data, etc.] (2) It was reported that, in an in vitro whole embryo culture test employing rat and mouse embryos, at added concentrations of 30 and 60 micro g/mL of this substance, increases in dose-dependent fetal death (up to 37.5% in rats and up to 83% in mice vs 0% in controls at 60 micro g/mL) and abnormalities (decreased brain size, clear blisters: up to 80% in rats and 100% in mice vs 0% in controls at 60 micro g/mL) were observed (EU REACH CoRAP (2018), ECHA RAC Opinion (Background Doc.) (2013)). (3) It was reported that, in a 90-day oral toxicity study with rats dosed by gavage, no findings that might adversely affect fertility were detected up to the highest dose of 180 mg/kg/day in the histopathological examination of male and female reproductive organs, sperm test, and estrus cycle analysis results (EU REACH CoRAP (2018), ECHA RAC Opinion (Background Doc.) (2013), AICIS IMAP (2017)). (4) In the EU, it was classified in Repr. 1B (EU-CLP Classification Results (Accessed Nov. 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	In an acute toxicity test with rats orally dosed 500-5,000 mg/kg (LD50 = 960-970 mg/kg), convulsions, disequilibria, lateral posture, and death were observed within 1 hour after administration, and survivors showed apathy, minor disequilibria, and accelerated respiration. Oral administration of 1,000 mg/kg to mice caused irregular respiration, piloerection, and closed eyelids (in some animals) after 15-30 minutes, and at 2,000 mg/kg, squatting posture was found in some animals including dead one (SIDS (2004)). Besides, the sign of trembling was also reported at 150 mg/kg, although it was after intraperitoneal administration to rats (SIDS (2004)). From the above, it was classified in Category 2 (nervous system) based on the general signs found within the dose range corresponding to the guidance values for Category 2.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 90-day repeated oral administration test with rats (OECD TG 408; GLP), centrilobular liver cell hypertrophy in males and females at the high dose of 180 mg/kg/day and accumulation of alpha 2-microglobulin in the proximal tubules the renal cortex in males at 180 mg/kg/day were reported as significant changes, but the dose was above the guidance value range (SIDS (2004)). On the other hand, in a 28-day repeated oral administration test with rats, decreases in hemoglobin and hematocrit values at or above 125 mg/kg/day (converted guidance value: 38.9 mg/kg/day), a decrease in red blood cell count at or above 250 mg/kg/day (converted guidance value: 77.8 mg/kg/day), hepatomegaly at or above 125 mg/kg/day, and an increase in kidney weights in males at or above 250 mg/kg/day were reported (SIDS (2004)). These findings were not adopted as evidence of the classification because effects in the kidney were most likely alpha 2-microglobulin nephropathy specific to male rats, and the changes in blood parameters in the 28-day repeated dose test were not seen in the 90-day repeated dose test, which was conducted later according to the international test guideline. And as for the liver, centrilobular liver cell hypertrophy at 180 mg/kg/day above the guidance value range after 90-day administration, hepatomegaly at or above 125 mg/kg/day (converted guidance value: 38.9 mg/kg/day) and increases in creatinine and ALT in males at 500 mg/kg/day (155.6 mg/kg/day) after 28-day administration were reported (SIDS (2004)), however, it was impossible to judge if there are adverse effects around the upper limit of the guidance values (100 mg/kg/day) due to lack of data. Therefore, it was classified as "Classification not possible."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2012	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	- -	-	-	It was classified as "Not classified" because acute toxicity is not reported at 100 mg/L for algae, crustacea, and fish (SIDS, 2005).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD: 90% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2003)), and 72-hour NOEC = 25 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2005). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it is not water-insoluble (water solubility = 159100 mg/L, PHYSPROP Database (2009)), and it corresponds to "Not classified" in acute toxicity for crustacea and fish (SIDS, 2005). From the above results, it was classified as "Not classified."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2012	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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