GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 106-91-2 |
| Chemical Name | 2,3-Epoxypropyl methacrylate |
| Substance ID | H29-B-036 |
| Classification year (FY) | FY2017 |
| 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 |
| 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 |
| 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 associated with explosive properties present in the molecule. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 6 | Flammable liquids | Category 4 |
Warning |
H227 |
P370+P378
P403+P235 P210 P280 P501 |
From a flash point data of 84 deg C (open-cup) (HSDB (Access on June 2017)), it is estimated that the result corresponding to Category 4 will be obtained in the prescribed test method. |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | There are chemical groups associated with self-reactive properties (ethylene group and epoxides) in the molecule, but the classification is not possible due to no data. |
| 9 | Pyrophoric liquids | Classification not possible |
- |
- | - | No data available. |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid substances are not available. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | 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). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Category 4 |
 Warning |
H302 |
P301+P312
P264 P270 P330 P501 |
Based on a report of an LD50 value of 597 mg/kg (SIDS (2002)) for rats, this substance was classified in Category 4. |
| 1 | Acute toxicity (Dermal) | Category 3 |
 Danger |
H311 |
P302+P352
P361+P364 P280 P312 P321 P405 P501 |
Based on a report of an LD50 value of 480 mg/kg (SIDS (2002)) for rabbits, this substance was classified in Category 3. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | There is a report of an LC50 value of 45 ppm (Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004): Tentative Hazard Assessment Sheet) in a 4-hour inhalation exposure test with rats. However, it was not adopted as evidence for classification because the information source is RTECS which is listed as List 3, the original source is not available, and no details are confirmed. In addition, there is a report that in another inhalation exposure test according to OECD TG 403 (4 hours), no death was observed even at 2,394 mg/m3 (corresponding to 412 ppm) (SIDS (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), but it is not possible to specify the category only from this data. It was classified as "Classification not possible" because no other information is available. Besides, the exposure concentration was lower than 90% of the saturated vapor pressure concentration (4,158 ppm), therefore, a reference value in the unit of ppm was applied as vapor with little mist. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | 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 |
It is reported that in skin irritation tests on rabbits, in multiple studies where this substance was applied for 4 hours, moderate to severe or corrosive skin irritation was produced, and that in a 5-day application, redness, edema and blistering after one or two days, subdermal bleeding and ulcers after three days, and induration, thickening, cracking, pigmentation of the skin after five days were produced. It is reported that pathological changes including degeneration and necrosis of surface skin cells and disappearance of cellular boundaries were observed (SIDS (2002)). Based on these reports, this substance was classified in Category 1. Besides, this substance was classified as "Skin Irrit. 2" in the EU CLP classification (ECHA CL Inventory (Access on June 2017)). |
| 3 | Serious eye damage/eye irritation | Category 1 |
Danger |
H318 |
P305+P351+P338
P280 P310 |
This substance was classified in Category 1 for skin corrosion/irritation. There is a report that in an eye irritation test with rabbits, moderate to severe corneal damage was induced, and corneal damage did not resolve within 7 days post-dosing (SIDS (2002)). From this information, this substance was classified in Category 1. Besides, this substance was classified as "Eye Irrit. 2" in the EU CLP classification (ECHA CL Inventory (Access on June 2017)). |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
Based on a report that a positive reaction was seen in two epidemiological cases in humans (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), a report that in a skin sensitization test with guinea pigs, a positive reaction was observed in seven out of ten (SIDS (2002)), and a report that this substance showed strong allergenicity (SIDS (2002)), it was classified in Category 1. Besides, this substance was classified as "Skin Sens. 1" in the EU CLP classification (ECHA CL Inventory (Access on June 2017)). |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 |
P308+P313
P201 P202 P280 P405 P501 |
As for in vivo, there were positive and negative results in micronucleus tests with mouse bone marrow cells by oral administration and intraperitoneal administration, negative in gene mutation tests with olfactory epithelium cells and respiratory epithelium cells of transgenic rats dosed by inhalation, and positive in an unscheduled DNA synthesis test with germ cells of mice dosed by intraperitoneal, but no dose dependency was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), JECDB (Access on June 2017), SIDS (2002)). As for in vitro, bacterial reverse mutation tests, gene mutation tests, a chromosomal aberration test, and a sister chromatid exchange test with cultured mammalian cells were positive (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), JECDB (Access on June 2017), SIDS (2002), NTP DB (Access on June 2017)). From the above, this substance was classified in Category 2 according to the GHS Classification Guidance for the Japanese Government. |
| 6 | Carcinogenicity | Category 1B |
Danger |
H350 |
P308+P313
P201 P202 P280 P405 P501 |
There is no information on carcinogenicity in humans. As for experimental animals, in 2-year carcinogenicity studies with rats and mice exposed by inhalation, in rats, tumors in the nasal cavity (squamous epithelium carcinoma, adenosquamous carcinoma, esthesioneuroepithelioma, etc.) were observed in both sexes, in addition, neoplastic lesions in the peritoneum (mesothelioma), skin (basal cell tumor/basal cell carcinoma) and subcutis (fibroma) in males, mammary glands (fibroadenoma, etc.) and uterus (endometrium stromal sarcoma) in females were observed. Also in mice, tumors in the nasal cavity (hemangioma, hemangiosarcoma, etc.) were observed in both sexes, in addition, neoplastic lesions in the forestomach (squamous papilloma) in males, lungs (bronchioloalveolar carcinoma) and uterus (histiocyto sarcomas) in females were observed (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, Access on June 2017)). As the above, this substance was classified in Category 1B since clear evidence of carcinogenicity was observed in both males and females of two species. |
| 7 | Reproductive toxicity | Category 2 |
Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
There is a description that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, a decrease in the fertility index was observed at the dose (100 mg/kg/day) where general toxicity (tissue changes of the forestomach) was observed (JECDB (Access on June 2017), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2002)). In addition, there is a report that in a test in which female rats were dosed by gavage during the organogenesis period (Gestational Day 5-15), a decrease in body weight gain and an increase in resorption were observed at 108 mg/kg/day in maternal animals (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2002)). From the above, it was classified in Category 2 for this hazard class. Besides, there is a report that in two developmental toxicity tests with pregnant rabbits exposed by inhalation during the organogenesis period (Gestational Day 7-19), signs of significant irritation in the nasal cavity, eyes, etc. and tissue changes were observed at up to 10 ppm in maternal animals, but no effects were observed in fetuses (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2002)). |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (respiratory organs) |
Danger |
H370 |
P308+P311
P260 P264 P270 P321 P405 P501 |
As for experimental animals, there is a report that in a 4-hour single inhalation exposure test with rats, labored breathing and a decrease in body weight were observed at 1.56 mg/L (269 ppm) (SIDS (2002)). There is a report that in a 6-hour single inhalation exposure test with rats, rabbits, guinea pigs, and dogs, changes in the lungs, thorax, and respiration were observed at 1.4 mg/L (converted 4-hour equivalent value: 1.71 mg/L (294.9 ppm)) (SIDS (2002)). These doses correspond to Category 1. In addition, as toxic symptoms of this substance, a decrease in locomotor activity, labored respiration, grasping respiration, tachypnea, muscle weakness, convulsions, piloerection, hypothermia, etc. were reported (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), but this was not adopted as evidence for the classification because there is no detailed description on the route or dose. Together with the above information, this substance was classified in Category 1 (respiratory organs). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
No information on humans is available. As for experimental animals, there are reports that in 13-week inhalation toxicity tests with rats and mice (vapour, 6 hours/day, 60-61 times exposure), in rats, a decrease in body weight gain, regeneration, hyperplasia, squamous metaplasia, and erosion in the respiratory epithelium of the respiratory area of the nasal cavity, and necrosis, atrophy and regeneration in the olfactory epithelium of the olfactory area were observed at 20 ppm (converted guidance value: 0.078 mg/L), which is within the guidance value range for Category 1, and that in mice, changes in the respiratory epithelium, olfactory epithelium and olfactory gland of the nasal cavity were observed at or above 1 ppm (converted guidance value: 0.0039 mg/L), which is within the guidance value range for Category 1 (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, Access on June 2017)). Also in another 13-week inhalation toxicity test with rats, effects on the respiratory organs were observed within the range of Category 1 (Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004): Tentative Hazard Assessment Sheet, SIDS (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, also in 104-week inhalation toxicity tests with rats and mice, effects on the respiratory organs were observed within a guidance value range for Category 1 (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, Access on June 2017)). In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage, squamous epithelial proliferation of the forestomach and edema of the forestomach submucosa at or above 30 mg/kg/day (converted guidance value: 15 mg/kg/day) which is within the guidance value range for Category 2 are reported (JECDB (Access on June 2017), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004): Tentative Hazard Assessment Sheet, SIDS (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Of the above, the findings observed in the oral route were considered to be due to irritation, so were not adopted as evidence of the classification. Therefore, it was classified in Category 1 (respiratory organs). Besides, as a result of confirmation on the description of damage to the central nervous system, cardiovascular system, liver and kidneys for experimental animals in SIDS (2002) in the previous classification, a wide range of chronic toxic effects such as liver and spleen weight, aminotransferase in blood and tissues, and lesions in the central nervous system, cardiovascular system, liver and kidney were observed in 26-week inhalation toxicity tests with rats and rabbits, however, the original author suggested that from the high vapor pressure and low purity, the test substance used in these tests contained components other than this substance, which may have contributed to the toxicity observed (Ouyang Guoshun, et al., Gongye Weisheng Yu Zhiyebing, 16 (1), 1-6 (1990)), so these systemic toxicities observed in the studies are regarded as questionable in SIDS (2002). Therefore, the classification result was changed from the previous classification since these findings were not adopted as evidence of classification. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | 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 (Acute) | Category 2 |
- |
H401 |
P273
P501 |
From 96-hour LC50 = 2.8 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017), OECD SIDS: 2000), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 |
P273
P501 |
Due to being rapidly degradable (readily biodegradable, average degradation rate by BOD: 93.5% (J-CHECK, 1991)), no bioaccumulation (LogKow: 0.81 (SRC PhysProp Database: 2017)), and 21-day NOEC (reproduction inhibition) = 1.0 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)), it was classified in Category 3. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |