GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 288-32-4
Chemical Name Imidazole
Substance ID R03-C-056-MHLW
Classification year (FY) FY2021
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
New/Revised Revised
Classification result in other fiscal year FY2012  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
1 Explosives -
-
-
- - -
2 Flammable gases -
-
-
- - -
3 Aerosols -
-
-
- - -
4 Oxidizing gases -
-
-
- - -
5 Gases under pressure -
-
-
- - -
6 Flammable liquids -
-
-
- - -
7 Flammable solids -
-
-
- - -
8 Self-reactive substances and mixtures -
-
-
- - -
9 Pyrophoric liquids -
-
-
- - -
10 Pyrophoric solids -
-
-
- - -
11 Self-heating substances and mixtures -
-
-
- - -
12 Substances and mixtures which, in contact with water, emit flammable gases -
-
-
- - -
13 Oxidizing liquids -
-
-
- - -
14 Oxidizing solids -
-
-
- - -
15 Organic peroxides -
-
-
- - -
16 Corrosive to metals -
-
-
- - -
17 Desensitized explosives -
-
-
- - -

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
1 Acute toxicity (Oral) -
-
-
- - -
1 Acute toxicity (Dermal) -
-
-
- - -
1 Acute toxicity (Inhalation: Gases) -
-
-
- - -
1 Acute toxicity (Inhalation: Vapours) -
-
-
- - -
1 Acute toxicity (Inhalation: Dusts and mists) -
-
-
- - -
2 Skin corrosion/irritation -
-
-
- - -
3 Serious eye damage/eye irritation -
-
-
- - -
4 Respiratory sensitization -
-
-
- - -
4 Skin sensitization -
-
-
- - -
5 Germ cell mutagenicity -
-
-
- - -
6 Carcinogenicity -
-
-
- - -
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)).
8 Specific target organ toxicity - Single exposure -
-
-
- - -
9 Specific target organ toxicity - Repeated exposure -
-
-
- - -
10 Aspiration hazard -
-
-
- - -

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
11 Hazardous to the aquatic environment Short term (Acute) -
-
-
- - -
11 Hazardous to the aquatic environment Long term (Chronic) -
-
-
- - -
12 Hazardous to the ozone layer -
-
-
- - -


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.

To GHS Information