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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	15625-89-5
Chemical Name	2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate
Substance ID	R02-B-026-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	FY2008
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	Not classified	- -	-	-	From a flash point of 149 deg C (open cup) (NFPA (14th, 2010)), it is estimated to be > 93 deg C also in the prescribed method (closed cup). Therefore, it was classified as "Not classified."
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 is a chemical group associated with self-reactive properties, an unsaturated bond, 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 385 deg C (EU REACH CoRAP (2019)).
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)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (5). [Evidence Data] (1) LD50 for rats: 3.84-7.01 mL/kg (4,262-7,781 mg/kg) (NTP DMM3 (2005)) (2) LD50 for rats: 5,000 mg/kg (NTP DMM3 (2005)) (3) LD50 for rats: 5,170 mg/kg (GESTIS (Access on May 2020)) (4) LD50 for rats: 5,190 mg/kg (HSDB (Access on May 2020)) (5) LD50 for rats: > 5,000 mg/kg (AICIS IMAP (2017))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) LD50 for rabbits: 3.89-10.04 mL/kg (4,318-11,144 mg/kg) (NTP DMM3 (2005)) (2) LD50 for rabbits: 5,170 mg/kg (NTP DMM3 (2005), GESTIS (Access on May 2020), HSDB (Access on April 2020)) (3) LD50 for rabbits: > 4.7 mL/kg (> 5,170 mg/kg) (AICIS IMAP (2017))
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] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. There are data in (1), but because the category cannot be determined with the data alone, it was classified as "Classification not possible." Besides, because the exposure concentration was higher than the saturated vapor pressure concentration (0.776 ppm), it was judged as a test on mist. [Reference Data, etc.] (1) LC50 for rats (6 hours): > 0.55 mg/L (45.4 ppm) (converted 4-hour equivalent value: > 0.825 mg/L) (AICIS IMAP (2017), REACH registration dossier (Access on June 2020)) (2) Vapor pressure of this substance: 5.9E-004 mmHg (25 deg C) (HSDB (Access on April 2020)) (converted value for the saturated vapor pressure concentration: 0.776 ppm)
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" (corresponding to Category 3 in UN GHS classification) from (1), (2). The classification result was changed due to new data obtained in (1), (2). [Evidence Data] (1) In a skin irritation test with rabbits according to OECD TG 404, slight to defined erythema and edema were observed at 24 hours after application, and the mean score at 24 and 72 hours after application for erythema and edema was 2.25 and 1.5, respectively (AICIS IMAP (2017), NTP TR576 (2012), HSDB (Access on April 2020)). (2) In a skin irritation test with rabbits (3 animals) according to OECD TG 404, slight to well-defined erythema and edema were observed, with mean individual scores of less than 2.3 after 24-72 hours (REACH registration dossier (Access on June 2020)). [Reference Data, etc.] (3) In a skin irritation test with rabbits by 24-hour occlusive application, slight to well-defined erythema and edema were observed, and the mean score at 24 and 72 hours after application for erythema and edema was 1 and 0.33, respectively (REACH registration dossier (Access on June 2020)). (4) It was classified in Skin Irrit. 2 (H315) in EU-CLP classification (EU CLP classification (Access on June 2020)).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] It was classified in Category 2A from (1), (2). [Evidence Data] (1) In an eye irritation test with rabbits (3 animals) according to OECD TG 405, it was judged as an irritant, with slight corneal damage and iritis and moderate to severe lesions of the conjunctiva found at 24 hours after application, and the degree of corneal damage increased during the post-treatment period (AICIS IMAP (2017), EU REACH CoRAP (2019)). (2) In an eye irritation test with rabbits (2 animals) (equivalent to a Draize test), the mean score after 24-72 hours for conjunctival redness exceeded 2 for both animals (REACH registration dossier (Access on June 2020)). [Reference Data, etc.] (3) In an in-vitro eye damage test with the bovine cornea (BCOP) according to OECD TG 437, a mean in vitro irritancy score (IVIS) was 0.9, corresponding to"Not classified" (EU REACH CoRAP (2019)). (4) It was classified in Eye Irrit. 2 (H319) 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 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1 from (1), (2). [Evidence Data] (1) In a skin sensitization test with guinea pigs according to OECD TG 406 (maximization test, intradermal administration 1%), the positive rate was 25% for a 0.1% solution and 66% for a 0.5% solution (AICIS IMAP (2017)). (2) In a skin sensitization test with guinea pigs (maximization test), the positive rate was 20% for a 0.5% solution and 50% for a 10% solution (EU REACH CoRAP (2019), MAK (DFG) vol.16 (2001), AICIS IMAP (2017)). [Reference Data, etc.] (3) It was negative in a mouse local lymph node assay (LLNA, application concentration 0.05%, 0.1%, 0.25%) and a mouse ear swelling test (MEST) (AICIS IMAP (2017), NTP DMM3 (2005), EU REACH CoRAP (2019)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] From (1), (2), it was classified as "Not classified" based on expert judgment. [Evidence Data] (1) As for in vivo, it was reported to be negative in a chromosomal aberration test in the bone marrow after single oral administration to rats and negative in a micronucleus test by 6-month dermal administration to transgenic mice (TG.AC) (IARC 122 (2019)). It is reported that it was negative in a micronucleus test in the peripheral blood after 3-month dermal administration to mice, but it was reported that it did not follow any guideline and no positive control was included (IARC 122 (2019), EU REACH CoRAP (2019)), and it is reported that in a comet assay by intravenous administration to mice (OECD TG 489), it was negative for the liver and positive for the bone marrow, but there were problems in part of the test methods (EU REACH CoRAP (2019)). (2) As for in vitro, it is reported that it was negative in a bacterial reverse mutation test, and as for tests in cultured mammalian cells, the result was positive in a chromosomal aberration test, positive in a micronucleus test, negative in an unscheduled DNA synthesis test, negative in an HPRT gene mutation test, and positive and negative in mouse lymphoma tests (IARC 122 (2019), EU REACH CoRAP (2019)). [Reference Data, etc.] (3)The IARC stated there is weak evidence that this substance is genotoxic (IARC 122 (2019)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1) - (3). [Evidence Data] (1) As for classification results by domestic and international organizations, the technical-grade of this substance was classified in Group 2B by IARC (IARC 122 (2019)) and Group 2B by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), proposed in 2019)). (2) In carcinogenicity tests by 2-year dermal application of this substance to male and female rats and mice, significant increases in the incidences of malignant mesothelioma in male rats, uncommon malignant liver neoplasms (hepatoblastoma and hepatocholangiocarcinoma) and stromal polyp or stromal sarcoma (combined) of the uterus in female mice were observed. From this, it was concluded that there was equivocal evidence of carcinogenicity of this substance in male rats, some evidence of carcinogenicity of this substance in female mice (NTP TR576 (2012)). (3) In a test by 28-week dermal application of this substance to male and female transgenic mice (Tg.AC Hemizygous), significant increases in the incidences of squamous cell papilloma of the skin at the site of application in males and females and squamous cell papilloma of the forestomach in females were found (NTP DMM3 (2005), IARC 122 (2019)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1B [Evidence Data] (1) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 28 of gestation, increases in incidences of fetal toxicity (malformations of the organs (small eye, cataract, liver edema, ascite) and skeletal variations (sternum with the supernumerary ossification site)) was observed at a dose at which no maternal toxicity was observed (EU REACH CoRAP (2019)). (2) In a developmental toxicity study in which one dose was given to female rabbits by gavage on days 6 to 28 of gestation to confirm the fetal toxicity observed in (1) above, similar malformations of the organs and skeletal variations were not observed, but a decrease in litter size and low fetal weight were observed at a dose at which no maternal toxicity was observed (EU REACH CoRAP (2019)). The EU REACH CoRAP (2019) determined that even if the fetal toxicity observed in (1) was not consistently observed in (2), its relevance could not be totally excluded since only one dose was tested in (2), and thus, the fetal toxicity observed in (1) was regarded as an adverse effect. [Reference Data, etc.] (3) In combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats in the oral route, no reproductive effects were observed even at a dose at which parental toxicity (local effects in the forestomach) was observed (EU REACH CoRAP (2019)). (4) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, even at a dose at which maternal toxicity effects (death (4/22 cases), stomach lesions) were observed, no effect was observed in fetuses (EU REACH CoRAP (2019)).
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] There was no report on single exposure to this substance in humans. Based on (1), it was classified in Category 3 (narcotic effects). [Evidence Data] (1) It was reported that, in a dermal exposure test with mice, lethargy, inactivity, and salivation were observed shortly after the exposure to 50 mg of this substance (converted guidance value: 2,500 mg/kg, within the range exceeding Category 2) (NTP TR576 (2012)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. [Reference Data, etc.] (1) In a test by oral administration of this substance to rats, effects on the stomach were observed (EU REACH CoRAP (2019), AICIS IMAP (2017)), and these findings were considered to be due to its irritation.
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, kinematic viscosity was calculated as 109 mm2/sec at 20 deg C in (1), but no other information could be obtained. [Reference Data, etc.] (1) Kinematic viscosity was 109 mm2/sec at 20 deg C (calculated from viscosity at 20 deg C: 122 mPa*s (EU REACH CoRAP (2019)) and density of 1.11 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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 96-hour LC50 = 0.87 mg/L for fish (Danio rerio) (EU REACH CoRAP, 2019). The classification result was changed from the previous classification by using new information.
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it was not rapidly degradable (not readily degradable, a 4-week degradation rate by BOD: 19% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1996)), and it was classified in Category 1 in acute toxicity. The classification result was revised from the previous classification by changing the classification result in acute toxicity.
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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