NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	106-91-2
Chemical Name	2,3-Epoxypropyl methacrylate
Substance ID	R02-B-023-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 FY2017
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	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 4	- Warning	H227	P370+P378 P210 P280 P403 P501	It was classified in Category 4 based on a flash point of 76 deg C (closed cup) (GESTIS (Access on April 2020)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There are chemical groups associated with self-reactive properties, an unsaturated bond and an epoxide, present in the molecule, but the classification is not possible due to no data.
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 389 deg C (RAC (Background Document) (2015)).
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)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. 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.
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."

HEALTH HAZARDS

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	[Rationale for the Classification] It was classified in Category 4 from (1) - (7). [Evidence Data] (1) LD50 for rats: 597 mg/kg (CLH Report (2015), SIAR (2002), OEL Documentations (Japan Society For Occupational Health (JSOH), 2018), HSDB (Access on April 2020)) (2) LD50 for rats: 290-827 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) (3) LD50 for rats: 451 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2018)) (4) LD50 for rats: 500 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 17 (Ministry of the Environment, 2019), GESTIS (Access on April 2020)) (5) LD50 for rats: 700 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2018)) (6) LD50 for rats: 1,050 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2018)) (7) LD50 for rats: 0.29 g/kg (290 mg/kg) (HSDB (Access on April 2020))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	[Rationale for the Classification] It was classified in Category 3 from (1) - (5). [Evidence Data] (1) LD50 for rabbits: 480 mg/kg (CLH Report (2015), SIAR (2002), OEL Documentations (Japan Society For Occupational Health (JSOH), 2018)) (2) LD50 for rabbits: 483-996 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) (3) LD50 for rabbits: 484 mg/kg (GESTIS (Access on April 2020)) (4) LD50 for rabbits: 450 microL/kg (converted value: 486 mg/kg) (Environmental Risk Assessment for Chemical Substances vol. 17 (Ministry of the Environment, 2019)) (5) LD50 for rabbits: 469 mg/kg (HSDB (Access on April 2020))
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)	Classification not possible	- -	-	-	[Rationale for the Classification] The classification is not possible because the category could not be determined from (1). Because an exposure concentration was lower than 90% of the saturated vapor pressure concentration (4,145 ppm), a reference value in the unit of ppm was applied as a vapor with little mist. Besides, the information source for an LC50 value of 45 ppm listed in Reference Data, etc. was RTECS, whose origin could not be obtained, and it was not adopted as Evidence Data due to unknown details. [Evidence Data] (1) An inhalation exposure test in rats (4 hours): no dead animals at > 412 ppm (CLH Report (2015)), no death at 2,394 mg/m3 (412 ppm) (SIAR (2002), OEL Documentations (Japan Society For Occupational Health (JSOH), 2018)), 105-412 ppm (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) (2) Vapor pressure of this substance: 4.2 hPa (25 deg C) (GESTIS (Access on April 2020)) (converted value for the saturated vapor pressure concentration: 4,145 ppm) [Reference Data, etc.] (3) LC50 for rats (4 hours): 45 ppm (Environmental Risk Assessment for Chemical Substances vol. 17 (Ministry of the Environment, 2019), OEL Documentations (Japan Society For Occupational Health (JSOH), 2018)) (4) LC50 for rats (4 hours): 45 to > 412 ppm (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) (5) LC50 for rats (4 hours): 0.262 mg/L (45.1 ppm) (GESTIS (Access on April 2020))
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) - (5). [Evidence Data] (1) In a skin irritation test with rabbits equivalent to OECD TG 404, moderate necrosis of the skin was seen in 2/6 animals (CLH Report (2015)). (2) This substance was corrosive to the skin of rabbits, and the area applied 0.1 mL showed red, swelled and blistered after one or two days, subdermal bleeding and ulcers after three days (CLH Report (2015), SIAR (2002)). (3) In a skin irritation test with rabbits (4-hour application), it induced moderate to severe skin irritation, including necrosis with slight to moderate edema (SIAR (2002)). (4) It was corrosive in a skin irritation test with rabbits according to OECD TG404 (REACH registration dossier (Access on June 2020)). [Reference Data, etc.] (5) This substance is expected to induce piercing pain and corrosion on the skin after contact, and skin contact might also entail blistering, but it only caused moderate irritations on the rabbit skin (GESTIS (Access on April 2020)). (6) Severe irritation was seen in a skin irritation test in which 500 microL of this substance was applied to the rabbit skin for 24 hours (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (7) This substance is severely irritating to the eye, skin, and respiratory tract (Environmental Risk Assessment for Chemical Substances vol. 17 (Ministry of the Environment, 2019)). (8) It was classified in Skin Corr. 1C (H314) in EU CLP classification (EU CLP classification (Access on June 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), (2). [Evidence Data] (1) This substance (0.02-0.1 mL) triggers moderate to strong irritations in the rabbit eyes (GESTIS (Access on April 2020)). (2) This substance was classified in Category 1 in skin corrosion/irritation (GHS classification result in FY 2020). [Reference Data, etc.] (3) Moderate irritation was seen in an eye irritation test in which 100 microL of this substance was applied to the rabbit eye (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (4) This substance is severely irritating to the eye, skin, and respiratory tract (Environmental Risk Assessment for Chemical Substances vol. 17 (Ministry of the Environment, 2019)). (5) This substance induced slight to moderate conjunctivitis and slight corneal injury (that cleared in one week after application) in a test similar to OECD TG405 (CLH Report (2015)). (6) In an eye irritation test with 3 rabbits according to OECD TG405, the mean score at 24 to 72 hours after application for corneal opacity and iris exceeded 1 in 1/3 animals, the mean score for conjunctival redness or edema exceeded 2 in 1/3 animals, and all the findings disappeared within 7 days (ECETOC TR 48 (1998)). (7) It was classified in Eye Dam. 1 (H318) in EU CLP classification (EU CLP classification (Access on June 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Data supporting Category 1, Category 1A, or Category 1B were mixed in (2) - (4), but because the Japan Society for Occupational Health (JSOH) classified it in occupational skin sensitizers Group 2 in (1), it was classified in Category 1A in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) This substance was classified in occupational skin sensitizers Group 2 by the Japan Society for Occupational Health (JSOH) (OEL Documentations (Japan Society For Occupational Health (JSOH), 2018)). (2) It was reported to be positive (positive rate: 70-80%) in a skin sensitization test with guinea pigs (Buehler test, dermal administration 10-25%) (EU CLP CLH (2015), REACH registration dossier (Access on June 2020)). (3) There are reports that it was positive in patch tests in workers engaged in manufacturing adhesive sealant containing this substance and other persons (EU CLP CLH (2015)). (4) This substance is a moderate sensitizer in humans and guinea pigs (CLH Report (2015)). [Reference Data, etc.] (5) It was classified in Skin Sens. 1 (H317) in EU CLP classification (EU CLP classification (Access on June 2020)). (6) It was reported to be negative or positive in skin sensitization tests by dermal or intradermal administration to guinea pigs (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)).
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1), (2) in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for in vivo, it was positive and negative in micronucleus tests in bone marrow cells after oral administration and intraperitoneal administration to mice, respectively, negative in a gene mutation test in the olfactory or respiratory epithelium after inhalation exposure of transgenic rats, and positive without dose-dependency seen in an unscheduled DNA synthesis test in germ cells after intraperitoneal administration to mice (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIAR (2002), Environmental Risk Assessment for Chemical Substances vol. 17 (Ministry of the Environment, 2019)). (2) As for in vitro, it was positive in a bacterial reverse mutation test, a gene mutation test, a chromosomal aberration test, a sister chromatid exchange test, and an unscheduled DNA synthesis test in cultured mammalian cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIAR (2002), Environmental Risk Assessment for Chemical Substances vol. 17 (Ministry of the Environment, 2019)).
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There is no information on carcinogenicity in humans. This substance is a target substance in the guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare. It was classified in Category 1B based on (1) - (4). [Evidence Data] (1) As for classification results by domestic and international organizations, It was classified in Group 2A by IARC (IARC 125 (In prep.)), Group 2A by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH)) (proposed in 2018)), and 1B in EU CLP (EU CLP classification (Access on May 2020)). (2) In a carcinogenicity test by 104-week inhalation exposure of male and female rats to this substance, increased incidences were observed in tumors in the nasal cavity (squamous cell carcinoma, adenoma, esthesioneuroepithelioma, etc.) in both males and females, fibroma in the subcutis and mesothelioma in the peritoneum in males, and fibroadenoma in the mammary gland in females (Results from Carcinogenicity Studies (2015)). (3) In a carcinogenicity test by 104-week inhalation exposure of male and female mice to this substance, increased incidences were observed in tumors in the nasal cavity (hemangioma, hemangiosarcoma, etc. ) in both males and females, squamous cell papilloma in the forestomach in males, and bronchiolar-alveolar carcinoma in the lung and histiocytic sarcoma in the uterus in females (Results from Carcinogenicity Studies (2015)). (4) This substance is a target substance in the revised guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare based on paragraph (3) of Article 28 of the Industrial Safety and Health Act (Public announcement on guidelines, Feb. 7, 2020, No. 27).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), a decrease in fertility, which was considered to be related to effects on sperm, was observed; and based on (3), an increase in resorption was also observed, and therefore, it was classified in Category 1B. After a review of the evidence data, the classification result was changed from the previous classification. [Evidence Data] (1) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 422), at doses at which toxicity in parent animals (alterations in tissues of the forestomach) was observed, a decrease in fertility (0, 10, 30, 100 mg/kg/day: 81.8, 100.0, 91.7, 16.7%), which was considered to be due to decreased sperm motility, was observed (JECDB (Access on June 2017), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIAR (2002), CLH Report (2015)). (2) In two tests in which sperm was examined for abnormalities by intraperitoneal injection to male mice for 5 days, a decrease in spermatid count and an increase in abnormal sperm were observed (CLH Report (2015)). (3) In a developmental toxicity study with female rats dosed by gavage on days 5-15 of gestation, an increase in resorption was observed at a dose at which maternal toxicity (reduced body weight gain) was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIAR (2002), CLH Report (2015)). (4) The Japan Society for Occupational Health (JSOH) classified it in Group 3 of reproductive toxicants (substance which is suspected of reproductive toxicity to humans) based on the report of decreased fertility which was considered to be due to decreased sperm motility of male rats in (1), as evidence (OEL Documentations (Japan Society for Occupational Health (JSOH), 2018)). [Reference Data, etc.] (5) In two developmental toxicity studies by inhalation exposure of female rabbits on days 7-19 of gestation, no effect was observed in fetuses at doses at which maternal toxicity (degeneration, erosion, and necrosis of the nasal cavity epithelium) was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIAR (2002), OEL Documentations (Japan Society for Occupational Health (JSOH), 2018)). (6) In the EU CLP classification, it was classified as Repr.1B (Classification in EU CLP (Access on May 2020)).
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] There was no report on single exposure to this substance in humans. Based on (1) and (2), it was classified in Category 1 (respiratory organs). [Evidence Data] (1) It was reported that in a 4-hour acute inhalation exposure test with rats, at 1.563 mg/L (269 ppm, within the range for Category 1), labored breathing and a decrease in body weight were observed (SIAR (2002)). (2) It was reported that in a 6-hour acute inhalation exposure test with rats, rabbits, guinea pigs, and dogs, at 1.4 mg/L (converted 4-hour equivalent value: 1.71 mg/L (294.9 ppm, within the range for Category 1)), changes in the lung, thorax, and respiration were observed (SIAR (2002)). [Reference Data, etc.] (3) Although details of the administration route and the dose level were unknown, a decrease in locomotor activity, labored breathing, gasping, an increase in respiration rate, muscle weakness, convulsions, piloerection, subnormal temperature, etc. in rats and mice were reported (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] There was no report on repeated exposure to this substance in humans. Based on (1), there was information that effects on the nasal cavity were observed in experimental animals at doses within the range for Category 1. Therefore, it was classified in Category 1 (respiratory organs). [Evidence Data] (1) It was reported that in 13-week inhalation toxicity tests with rats and mice (exposed to vapors, 6 hours/day, 5 days/week), regeneration, hyperplasia, squamous metaplasia, and erosion of the respiratory epithelium; and necrosis, atrophy, and regeneration of the olfactory epithelium of the nasal cavity were observed in rats at 20 ppm (converted guidance value: 0.084 mg/L, within the range for Category 1); and alterations of the respiratory epithelium, olfactory epithelium, and olfactory gland of the nasal cavity were observed in mice at or above 1 ppm (converted guidance value: 0.0042 mg/L, within the range for Category 1) (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2015)). It was also reported that hyperplasia of the respiratory epithelium of the nasal cavity was observed in rats at 15 ppm (converted guidance value: 0.063 mg/L, within the range for Category 1) (OEL Documentations (Japan Society for Occupational Health (JSOH), 2018), CLH Report (2015), SIAR (2002), Environmental Risk Assessment for Chemical Substances Vol. 17 (Ministry of the Environment, 2019)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, kinematic viscosity was calculated as 5.1 mm2/sec at 21 deg C from (1), and kinematic viscosity at 40 deg C was not more than 14 mm2/s, but no other information could be obtained. [Reference Data, etc.] (1) Kinematic viscosity was 5.1 mm2/s at 21 deg C (calculated from viscosity at 21 deg C: 5.481 mPa*s (HSDB (Access on April 2020)) and density of 1.07 g/cm3 (HSDB (Access on April 2020))).

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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 96-hour LC50 = 2.8 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996), Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004), Environmental Risk Assessment for Chemical Substances Vol. 17 (Ministry of the Environment, 2019), Initial Risk Assessment (NITE, CERI, NEDO, 2008), SIAR, 2002).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	It was classified in Category 3 because it was rapidly degradable (a 4-week degradation rate by BOD: 94% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1991)) and due to 21-day NOEC = 1.0 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996), Environmental Risk Assessment for Chemical Substances Vol. 17 (Ministry of the Environment, 2019)).
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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