GHS Classification Results by the Japanese Government
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 151-56-4 |
| Chemical Name | Ethyleneimine; Aziridine (with stabilizer) |
| Substance ID | R02-B-083-MHLW, MOE |
| Classification year (FY) | FY2020 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2006 FY2011 |
| 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 |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." |
| 2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition). It was classified as "Not classified." |
| 3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. It was classified as "Not classified." |
| 4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition). It was classified as "Not classified." |
| 5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition). It was classified as "Not classified." |
| 6 | Flammable liquids | Category 2 |
 Danger |
H225 | P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
It was classified in Category 2 based on a flash point of -11 deg C (closed cup) and a boiling point of 56 deg C (NFPA (2010)). Besides, a stabilized one is classified in Division 6.1, Subsidiary Risk 3, PG I in UNRTDG (UN1185). |
| 7 | Flammable solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition). It was classified as "Not classified." |
| 8 | Self-reactive substances and mixtures | Type G |
- |
- | - | There is a chemical group associated with self-reactive properties, a strained ring (aziridine), present in the molecule, but because stabilized commercial products are classified in Division 6.1, Subsidiary Risk 3, PG I in UNRTDG (UN1185), and there are considered to be not applicable to self-reactive substances and mixtures, which are hazards of the highest precedence, they were classified in Type G. Besides, a pure substance, whose transportation is prohibited, is estimated to be Type A. |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 320 deg C (NFPA (2010)). |
| 10 | Pyrophoric solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition). It was classified as "Not classified." |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to liquid substances are not available. |
| 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). It was classified as "Not classified." |
| 13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified." |
| 14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition). It was classified as "Not classified." |
| 15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified." |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. Besides, there is information that steel and stainless steel are durable as containers (Hommel (1991)). |
| 17 | Desensitized explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Category 2 |
 Danger |
H300 | P301+P310 P264 P270 P321 P330 P405 P501 |
[Rationale for the Classification] It was classified in Category 2 from (1), (2). [Evidence Data] (1) LD50 for rats: 15 mg/kg (ACGIH (7th, 2009), JECFA 20 (1986), Environmental Risk Assessment for Chemical Substances vol. 12 (Ministry of the Environment, 2014), OEL Documentations (Japan Society For Occupational Health (JSOH), 2018), GESTIS (Access on May 2020), HSDB (Access on May 2020), Patty (6th, 2012)) (2) LD50 for rats: 17 mg/kg (JECFA 20 (1986)) |
| 1 | Acute toxicity (Dermal) | Category 1 |
Danger |
H310 | P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501 |
[Rationale for the Classification] It was classified in Category 1 from (1) - (4). [Evidence Data] (1) LD50 for rabbits: 4.2 mg (GESTIS (Access on May 2020)) (2) LD50 for rabbits: 13 mg/kg (ACGIH (7th, 2009), OEL Documentations (Japan Society For Occupational Health (JSOH), 2018), AICIS (formerly, NICNAS) IMAP (2014), HSDB (Access on May 2020), Patty (6th, 2012)) (3) LD50 for rats: 12.5 mg/kg (HSDB (Access on May 2020)) (4) LD50 for rats: 13 mg/kg (AICIS (formerly, NICNAS) IMAP (2014)) |
| 1 | Acute toxicity (Inhalation: Gases) | Not classified |
- |
- | - | [Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Vapours) | Category 1 |
Danger |
H330 | P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501 |
[Rationale for the Classification] It was classified in Category 1 from (1), (2). Besides, because exposure concentrations were lower than 90% of the saturated vapor pressure concentration (280,285 ppm), a reference value in the unit of ppm was applied as a vapor with little mist. [Evidence Data] (1) LC50 for rats (4 hours): 58 ppm (OEL Documentations (Japan Society For Occupational Health (JSOH), 2018), US AEGL (2010)) (2) LC50 for rats (8 hours): 15 ppm (converted 4-hour equivalent value: 21 ppm) (ACGIH (7th, 2009), AICIS (formerly, NICNAS) IMAP (2014)) (3) Vapor pressure of this substance: 213 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 280,285 ppm) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
| 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 |
[Rationale for the Classification] It was classified in Category 1 from (1) - (4). [Evidence Data] (1) This substance was corrosive, and contact with the skin caused erythema, skin burns, and blisters, and entry in the eye caused erythema, pain, and severe burns (Environmental Risk Assessment for Chemical Substances vol. 12 (Ministry of the Environment, 2014)). (2) In a test with rabbits, this substance caused necrosis of the skin within 1.5 hours after application and corrosion of the cornea in the eye (AICIS (formerly, NICNAS) IMAP (2014), REACH registration dossier (Access on August 2020)). (3) Skin disorder, disorder of the anterior part of the eye, disorder of the respiratory tract/lung, or disorder of the kidney caused by this substance was designated as occupational diseases listed in Appended Table 1-2 of the Ordinance for Enforcement of the Labor Standards Act (notification No. 33 (1996)). (4) This substance was strongly irritative and corrosive to the skin and mucosa (GESTIS (Access on May 2020), HSDB (Access on May 2020)). [Reference Data, etc.] (5) It was classified in Skin Corr. 1B (H314) in EU-CLP classification (EU CLP classification (Access on August 2020)). |
| 3 | Serious eye damage/eye irritation | Category 1 |
Danger |
H318 | P305+P351+P338 P280 P310 |
[Rationale for the Classification] It was classified in Category 1 from (1) - (5). [Evidence Data] (1) This substance was corrosive, and contact with the skin caused erythema, skin burns, and blisters, and entry in the eye caused erythema, pain, and severe burns (Environmental Risk Assessment for Chemical Substances vol. 12 (Ministry of the Environment, 2014)). (2) In a test with rabbits, this substance caused necrosis of the skin within 1.5 hours after application and corrosion of the cornea in the eye (AICIS (formerly, NICNAS) IMAP (2014), REACH registration dossier (Access on August 2020)). (3) Skin disorder, disorder of the anterior part of the eye, disorder of the respiratory tract/lung, or disorder of the kidney caused by this substance was designated as occupational diseases listed in Appended Table 1-2 of the Ordinance for Enforcement of the Labor Standards Act (notification No. 33 (1996)). (4) This substance was strongly irritative and corrosive to the skin and mucosa (GESTIS (Access on May 2020), HSDB (Access on May 2020)). (5) This substance was classified in Category 1 in skin corrosivity. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] There were descriptions of (1), (2), but (1) was a finding by acute exposure, and it was difficult to judge as sensitizing, and (2) was not data sufficient for classification. Therefore, it was classified as "Classification not possible." [Reference Data, etc.] (1) Occupational exposure to this substance produced skin sensitization and slow-healing dermatitis (US AEGL (2010)). (2) In a skin sensitization test with guinea pigs (BASF test), this substance was not sensitizing, but it was pointed out that it can induce contact hypersensitivity in humans (GESTIS (Access on May 2020)). |
| 5 | Germ cell mutagenicity | Category 1B |
 Danger |
H340 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] It was classified in Category 1B from (1), (2). [Evidence Data] (1) As for in vivo, it was reported to be positive in a dominant lethal test by intraperitoneal administration to mice and micronucleus tests with bone marrow cells and peripheral blood from rats (IARC 71 (1999), Environmental Risk Assessment for Chemical Substances vol. 12 (Ministry of the Environment, 2014), OEL Documentations (Japan Society For Occupational Health (JSOH), 2018), AICIS (formerly, NICNAS) IMAP (2014)). (2) As for in vitro, there were reports on positive results in a bacterial reverse mutation test, chromosomal aberration tests with WI-36 cells and leukocytes from humans, and a gene mutation test with cultured mammalian cells (same as the above). [Reference Data, etc.] (3) It is reported that there was no significant increase in chromosome aberrations in leukocytes of workers exposed to < 0.5 ppm of this substance for a mean of 8 years (US AEGL (2010)). (4) It was classified in Muta. 1B in EU CLP classification. |
| 6 | Carcinogenicity | Category 2 |
Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] There was no available report on exposure to this substance in humans. It was classified in Category 2 from (1) - (3). [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Group 2B by IARC (IARC 71 (1999)), Group 2B by the Japan Society for Occupational Health (JSOH) (OEL Documentations (Japan Society For Occupational Health (JSOH), 2018)), A3 by ACGIH (ACGIH (7th, 2009)), 2 in MAK (DFG) (DFG List of MAK and BAT Values (2019)), and Carc.1B in EU CLP classification (EU CLP classification (Access on May 2020)). (2) In a carcinogenicity test by 78-week oral administration (gavage + feeding) of this substance to male and female mice, significant increases in the incidences of hepatocellular carcinoma and lung tumors were observed in males and females (OEL Documentations (Japan Society For Occupational Health (JSOH), 2018), Environmental Risk Assessment for Chemical Substances vol. 12 (Ministry of the Environment, 2014)). (3) In tests by subcutaneous injection of this substance to male and female rats, sarcoma at injection sites in males and females and transitional cell carcinoma in males were seen (OEL Documentations (Japan Society For Occupational Health (JSOH), 2018), Environmental Risk Assessment for Chemical Substances vol. 12 (Ministry of the Environment, 2014)). |
| 7 | Reproductive toxicity | Category 2 |
Warning |
H361 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1) and (2), the degree of maternal and fetal toxicity and other factors were unknown, and according to the GHS Classification Guidance for the Japanese Government, it should be classified in Category 2. Also, taking (3) into account, it was classified in Category 2. [Evidence Data] (1) In a 20-day inhalation exposure test with pregnant rats dosed at the concentration of 10 mg/m3 (exposure time unknown), reduced body weight gain and a decrease in fertility rate were observed in dams and an increase in hematomas were observed in fetuses (Environmental Risk Assessment for Chemical Substances Vol. 12 (Ministry of the Environment, 2014), OEL Documentations (Reproductive toxicant classification) (Japan Society for Occupational Health (JSOH), 2014)). (2) In a developmental toxicity study with female rats dosed by gavage on days 5 to 15 of gestation (dosage: 1.04 or 2.6 mg/kg/day), an apparent decrease in body weight and bleeding from the vagina were observed in dams in 2.6 mg/kg/day group. In addition, a decrease in the number of survived fetuses, an increase in malformations in the skeletal system, and lower body weight were observed at the same dose (Environmental Risk Assessment for Chemical Substances Vol. 12 (Ministry of the Environment, 2014)). (3) The Japan Society for Occupational Health (JSOH) classified it in Group 3 of reproductive toxicant (substance which is suspected of reproductive toxicity to humans) (OEL Documentations (Japan Society for Occupational Health (JSOH), 2014)). [Reference Data, etc.] (4) In a dominant lethal test using intraperitoneal injection in mice, positive results were reported (IARC 71 (1999), Environmental Risk Assessment for Chemical Substances Vol. 12 (Ministry of the Environment, 2014), OEL Documentations (Japan Society for Occupational Health (JSOH), 2014)). |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, respiratory organs, kidney) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
[Rationale for the Classification] Based on (1) to (7), it was classified in Category 1 (central nervous system, respiratory organs, kidney). The findings on the visual organs and skin were judged to be due to intense irritation and were excluded. As for the findings on the liver, there was only one case in humans, and no effect was observed in the test using experimental animals. Therefore, the effects on the liver were excluded. As a result of a review of the evaluation using a new information source, the classification was changed from the previous classification. [Evidence Data] (1) Toxicity due to exposure to this substance in humans was generally delayed and included irritation to the contact organs (skin, eyes, oral cavity, and upper and lower respiratory tracts), systemic toxicity, and death depending upon the concentration (US AEGL (2010)) (2) Acute inhalation or dermal exposure of this substance to workers caused effects on the central nervous system, retention of fluid in the lungs, and damages to the liver and kidney, and in some cases, it may lead to death (ACGIH (7th, 2009), AICIS (previous NICNAS) IMAP (2014)). (3) Among five students who were exposed to this substance by inhalation for about two hours, throat soreness, severe eye irritation, conjunctivitis, vomiting, coughing, upper and lower respiratory tract inflammation, transitory polycythemia, leukocytosis, eosinophilia, albuminuria, etc. were observed several hours later (ACGIH (7th, 2009), US AEGL (2010), HSDB (Access on May 2020), Environmental Risk Assessment for Chemical Substances Vol. 12 (Ministry of the Environment, 2014), OEL Documentations (Japan Society for Occupational Health (JSOH), 2018)) (4) A 57-year-old man who was exposed to this substance by inhalation (for less than five minutes) showed irritation of the eyes, nose, and larynx, salivation, vomiting, breathlessness, and pulmonary edema. Three weeks after discharge from hospital, he developed shortness of breath and a wheezy cough. When he was readmitted to the hospital, he showed bronchospasm. Endoscopy of the trachea showed extensive ulcerations with stenosis, and he died two weeks after the readmission (Environmental Risk Assessment for Chemical Substances Vol. 12 (Ministry of the Environment, 2014), OEL Documentations (Japan Society for Occupational Health (JSOH), 2018), US AEGL (2010)). (5) Skin disorder, disorder in the anterior part of the eye, respiratory tract/lung disorder, and kidney disorder caused by this substance were specified as occupational diseases stated in Appended Table 1-2, Ordinance for Enforcement of the Labor Standards Act (Ministry of Labour Notification No. 33, 1996)). (6) In an inhalation exposure test using experimental animals, delayed lung injury with congestion, edema, and hemorrhage was observed, and in addition, kidney damage was observed (ACGIH (7th, 2009)). (7) In a dermal application test with experimental animals, all animals exhibited characteristic kidney damage (proteins, erythrocytes, leucocytes, renal epithelia in the urine, increased blood urea, necrosis of the renal medulla or papillae) in addition to skin necroses (GESTIS (Access on May 2020)). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs, liver, kidney) |
Danger |
H372 | P260 P264 P270 P314 P501 |
[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1 (respiratory organs, liver, kidney). [Evidence Data] (1) In a 1.5-month inhalation exposure test of this substance with rats (4 hours/day, every day), at 8.8 mg/m3 (converted guidance value: 0.003 mg/L, within the range for Category 1), catarrhal inflammation in the bronchus, decreased lymphatic elements in the lymph glands, and degenerative changes in the liver and kidney were observed (OEL Documentations (Reproductive toxicant classification) (Japan Society for Occupational Health (JSOH), 2018), AICIS (previous NICNAS) IMAP (2014), Environmental Risk Assessment for Chemical Substances Vol. 12 (Ministry of the Environment, 2014), ACGIH (7th, 2009), IARC 9 (1975)). (2) Skin disorder, disorder in the anterior part of the eye, respiratory tract/lung disorder, and kidney disorder caused by this substance have been designated as simple chemical substances or compounds (including alloys) designated by the Minister of Health, Labour and Welfare, or disease designated by the Minister of Health, Labour and Welfare based on Appended Table 1-2, (iv) 1 of the Ordinance for Enforcement of the Labor Standards Act (Ministry of Labour Notification No. 33, 1996)). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
| 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) | Category 2 |
- |
H401 | P273 P501 |
It was classified in Category 2 from 72-hour EC50 = 8.85 mg/L for algae (Raphidocelis subcapitata) (REACH registration dossier, 2020). The classification result was changed from the previous classification by using new information. |
| 11 | Hazardous to the aquatic environment Long term (Chronic) | Category 2 |
 - |
H411 | P273 P391 P501 |
Reliable chronic toxicity data were not obtained. It was classified in Category 2 because it was not rapidly degradable (not readily degradable, a degradation rate by BOD: < 20% (Environmental Risk Assessment for Chemical Substances Vol. 12 (Ministry of the Environment, 2014))), and it was classified in Category 2 in acute toxicity. The classification result was revised from the previous classification by a change in the classification result for acute toxicity. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
NOTE:
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