GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 822-36-6
Chemical Name 4-Methylimidazole
Substance ID H27-A-032/C-062A_P
Classification year (FY) FY2015
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
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) 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 Not applicable
-
-
- - There are no chemical groups present in the molecule associated with explosive properties.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - "Solids" according to GHS definition.
3 Aerosols Not applicable
-
-
- - Not an aerosol product.
4 Oxidizing gases Not applicable
-
-
- - "Solids" according to GHS definition.
5 Gases under pressure Not applicable
-
-
- - "Solids" according to GHS definition.
6 Flammable liquids Not applicable
-
-
- - "Solids" according to GHS definition.
7 Flammable solids Classification not possible
-
-
- - Due to no data, the classification is not possible.
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 applicable
-
-
- - "Solids" according to GHS definition.
10 Pyrophoric solids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an ignition point of 555 degrees C (HSDB (Access on July 2015)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - No established test method suitable for solid substances with a melting point of 140 degrees C or lower.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- - Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable
-
-
- - "Solids" according to GHS definition.
14 Oxidizing solids Not applicable
-
-
- - It is an organic compound that does not contain oxygen, fluorine, or chlorine.
15 Organic peroxides Not applicable
-
-
- - It is an organic compound that does not contain bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - No established test method suitable for solid substances.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Category 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
From an LD50 value of 173 mg/kg for rats (NTP TR535 (2007)), it was classified in Category 3.
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
It is reported that burns in the skin were observed in a Draize test using rabbits, but there is no description of recovery (HSDB (Access on July 2015)). Besides, it is written that this substance is irritating to the skin (HSDB (Access on July 2015)). The substance was classified in Category 2 from the above results.
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
It is reported that eye irritation was observed in a Draize test using rabbits, but there is no description of recovery (HSDB (Access on July 2015)). Besides, it is written that this substance is irritating to the eyes (HSDB (Access on July 2015)). The substance was classified in Category 2 from the above results.
4 Respiratory sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
4 Skin sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
5 Germ cell mutagenicity Classification not possible
-
-
- - Because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government, it was classified as "Classification not possible."As for in vivo, a micronucleus test using bone marrow cells of rats and mice in intraperitoneal administration, and a micronucleus test using mouse peripheral erythrocytes in diet administration were all negative (IARC 101 (2012), NTP TOX067 (2004)). As for in vitro, a bacterial reverse mutation test was negative (IARC 101 (2012), NTP TOX067 (2004)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
There is no carcinogenicity information in humans. As for experimental animals, in a 2-year carcinogenicity test using rats and mice in an oral route (in the diet), increased incidences of the following were observed (NTP TR535 (2007), IARC 101 (2012)): alveolar/bronchiolar adenoma at 312 ppm (about 40 mg/kg/day) or higher in female mice and alveolar/bronchiolar adenoma and carcinoma (combined) at 625 ppm (about 80 mg/kg/day) or higher in female mice; and alveolar/bronchiolar carcinoma and alveolar/bronchiolar adenoma and carcinoma (combined) at 1,250 ppm (about 170 mg/kg/day) in male mice and mononuclear cell leukemia at 5,000 ppm (about 260 mg/kg/day) in female rats. From the above results, IARC considered that there is sufficient evidence of carcinogenicity in experimental animals, and classified it in Group 2B (IARC 101 (2012)). There is no classification result by other organizations. Therefore, the substance was classified in "Category 2" for this hazard class in accordance with the GHS classification guidance for the Japanese government.



7 Reproductive toxicity Classification not possible
-
-
- - As a result of 14-week diet administration of this substance in rats, dose-dependent degeneration of seminiferous tubules, atrophy of prostate, and decreased epididymal sperm motility were observed in males. NTP concluded that this substance is a reproductive toxic substance ("Reprotoxicant" described in the original text) in male rats based on dose-dependent testicular degeneration (NTP TR535 (2007)). Moreover, after subcutaneous injection of 50 to 100 mg/kg this substance in male rats, LH secretion decreased, and 2 hours after administration, decreased testosterone concentrations in serum and testicular interstitial fluid and decreased testicular interstitial fluid formation were observed. Therefore, this substance reduces male fertility by suppressing testosterone production and testicular interstitial fluid formation. Furthermore, it is written that mechanism via disrupting pituitary LH secretion by this substance is suggested for the mechanism of above actions (NTP TR535 (2007)).
From the above, this substance shows testicular toxicity in male rats "at doses above Category 2 in specific target organ toxicity (repeated exposure)." However, due to no report of a test in mating with unexposed or exposed females and unknown effects on fertility, the classification is not possible due to lack of data.
Besides, NTP announced that a continuous breeding test using rats was conducted and completed to investigate fertility in male and female rats (NTP Testing status (Access on July 2015)), but data have not been published as of September 2015.
8 Specific target organ toxicity - Single exposure Category 3 (Respiratory tract irritation)


Warning
H335 P304+P340
P403+P233
P261
P271
P312
P405
P501
From the information that inhaling this substance gives severe damage to the tissue of respiratory tract and mucous membranes (HSDB (Access on July 2015)), it was classified in Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 2 (liver)


Warning
H373 P260
P314
P501
There is no human information.
As for experimental animals, in a 2-year diet administration toxicity test (in the diet) using rats, histiocytosis, chronic inflammations, and focal fatty change of hepatocytes in the liver were observed at 1,250 ppm (males: 55 mg/kg/day, females: 60 mg/kg/day) within a range of Category 2 (NTP TR535 (2007)).
Therefore, it was classified in Category 2 (liver).
Besides, in a 14-week diet administration toxicity test (in the diet) using rats, effects on blood system, nervous system, liver, testis, and prostate were observed (NTP TOX067 (2004)). Moreover, in a 2-year repeated oral administration toxicity test (in the diet) using mice, effects on lung (alveolar epithelial hyperplasia) were found (NTP TR535 (2007)). However, these were in a range that is above Category 2.
10 Aspiration hazard Classification not possible
-
-
- - Due to lack of data, the classification is not possible.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible
-
-
- - The classification is not possible because appropriate data were not obtained.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- - No data.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data.


NOTE:
* 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.

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