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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	818-61-1
Chemical Name	2-Hydroxyethyl acrylate
Substance ID	25B0013
Classification year (FY)	FY2013
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 by the Japanese Government (July, 2013)
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 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	Not classified	- -	-	-	A flash point 101 deg C (closed cup) (HSDB (Access on July 2013)) above 93 deg C.
7	Flammable solid	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is an acrylic group, which is an unsaturated bond in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 370 deg C (GESTIS (Access on July 2013)).
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.

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	Five LD50 values for rats (540 mg/kg, 548 mg/kg, 650 mg/kg, 610 mg/kg, and 1,070 mg/kg) (SIDS (2006)) were obtained, and all of them are within the range of 300-2,000 mg/kg. Therefore, it was classified in Category 4.
1	Acute toxicity (Dermal)	Category 2	Danger	H310	P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501	There are reports on an LD50 value for rats: > 1,000 mg/kg (SIDS (2006)) and LD50 values for rabbits: 154 mg/kg, 154 mg/kg, 250 mg/kg, and 298 mg/kg (SIDS (2006)), and lower LD50 values for rabbits were adopted. Among four LD50 values for rabbits, two corresponded to Category 2, and two corresponded to Category 3. By adopting the more hazardous category, it was classified in Category 2.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	After 4-hour exposure in rats, one out of six animals died at 1.87 mg/L, five out of six animals died at 2.37 mg/L (SIDS (2006)), and an LC50 value (4 hours) was estimated to be 1.87-2.37 mg/L and corresponds to Category 4. Therefore, it was classified in Category 4. Besides, from the saturated vapour concentration of 69.3 ppm (0.329 mg/L), it was judged to be a test on mist, and a reference value in the unit of mg/L was applied as mist. And after 7-hour exposure in rats, there is a report of LC0 = 1.25 mg/L (converted 4-hour equivalent value: 2.19 mg/L), LC100 = 10.58 mg/L (converted 4-hour equivalent value: 18.52 mg/L) (SIDS (2006)).
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	After 24-hour application of an undiluted substance to normal or abraded skin of rabbits, necrosis (epidermis), subcutaneous hemorrhage, and pitting edema were observed over a wide range, and necrosis was found in multiple tests with rabbits by 24-hour application, and it was assessed to be highly irritating in each test (SIDS (2006)). However, in SIDS (2006), moderate redness, severe swelling, and superficial necrosis in two our of six animals were observed after a 4-hour application, and it was assessed to be moderately irritating, and it is concluded that this substance is not corrosive (SIDS (2006)). Besides, this substance is classified in "C; R34" in EU DSD classification and "Skin Corr. 1B H314" in EU CLP classification. From the above information, it was classified in Category 2 based on the test results. EU DSD classification and EU CLP classification were obtained in this investigation and added.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In a Draize test with rabbits, after the application of an undiluted substance, it was highly irritating, and blister, corrosion, and/or ulceration, severe corneal necrosis, and inflammation of the eyelids were observed (SIDS (2006)). Also in another eye irritation test with rabbits, after the application of an undiluted substance, severe irritation was observed, and it caused extensive inflammation of the conjunctival membranes with corneal opacity, suggesting that some permanent vision impairment was likely (SIDS (2006)). Furthermore, as being corrosive to the skin, this substance is classified in "C; R34" in EU DSD classification and "Skin Corr. 1B H314" in EU CLP classification. It was classified in Category 1 based on the above information.
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	In SIDS (2006), multiple results of a local lymph node test with mice (LLNA method), a maximization test with guinea pigs, and a Buehler test with guinea pigs are described, and all showed positive results and sensitization. And multiple positive results in an epidemiological survey or a case report are described in humans. Furthermore, this substance is classified in "Sh" in DFGOT vol. 16 (2001), " R43" in EU DSD classification, and "Skin Sens. 1 H317" in EU CLP classification. It was classified in Category 1 based on the above information.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. As for in vivo, negative results are reported in a chromosomal aberration test with rat bone marrow cells and a micronucleus test with mouse bone marrow cells (SIDS (2006), Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)). On the other hand, as for in vitro, it was negative in a reverse mutation test, but it is reported that it was positive in a mouse lymphoma test, a chromosomal aberration test, and a micronucleus test with cultured mammalian cells (SIDS (2006), Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)). The category was changed according to the revised GHS classification guidance for the Japanese government.
6	Carcinogenicity	Classification not possible	- -	-	-	No evidence of carcinogenicity was obtained in an 18-month inhalation exposure test with rats (SIDS (2006)). Furthermore, in a 2-year oral administration test with mice, there was no increase in tumors, and no evidence of carcinogenicity was obtained (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2003)). However, in a 2-year oral administration test with rats, males showed hepatocellular adenoma and basophilic foci, which are pre-neoplastic lesions, and it was thought to be evidence of carcinogenicity (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2003)). Oral carcinogenicity in rats was not found in females and was not clear, and a positive result of carcinogenicity was observed only in one species, one route, and one sex. It was judged that there is insufficient information to classify it in Category 2 or as "Not classified" because there are no classification results by other organizations or clear positive data. Therefore, it was classified as "Classification not possible."
7	Reproductive toxicity	Classification not possible	- -	-	-	After inhalation exposure in pregnant rats during the organogenesis period, no developmental effects were observed in fetuses at the concentration where maternal toxicity was shown (SIDS (2006)). However, the classification is not possible because there are no data on the effects on sexual function and fertility of parent animals exposed before mating.
8	Specific target organ toxicity - Single exposure	Category 3 (narcotic effects, respiratory tract irritation)	Warning	H336 H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	Hypoactivity was observed as general symptoms at all doses in an acute toxicity test with rats by oral administration (SIDS (2006)). Furthermore, lethargy was observed at all doses in an acute toxicity test with rabbits by dermal administration (SIDS (2006)). On the other hand, irritation of the mouth, nose, and respiratory tract was found in 4 or 8-hour inhalation exposure tests with rats (SIDS (2006)). It was classified in Category 3 (narcotic effects, respiratory tract irritation) from these results.
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	Effects of 28-day inhalation exposure (vapour) in rats were only irritation of the corneas at 5 ppm, but nasal irritation (ulcerative rhinitis) and shortness of breath were observed at 10 ppm (converted guidance value: 0.015 mg/L), and further at 25 ppm (converted guidance value: 0.040 mg/L), the animals showed severe dyspnea and died of respiratory failure with rapidly decreased body weights (SIDS (2006)). As a result, the respiratory system and eye were suggested as the target organs from the exposure effects, and the doses where the signs occurred of 10-25 ppm (converted guidance value: 0.015-0.040 mg/L) corresponded to the guidance values for Category 1. Therefore, it was classified in Category 1 (respiratory system). Besides, no effects of test substance were observed in oral administration tests in dogs for 97 days or rats for 100 days (SIDS (2006)).
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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)	Category 1	Warning	H400	P273 P391 P501	From 48-hour LC50 = 0.78 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009); SIDS, 2006), it was classified in Category 1.
11	Hazardous to the aquatic environment (Long-term)	Category 3	- -	H412	P273 P501	If chronic toxicity data are used, then it is classified in Category 3 due to rapid degradability (a degradation rate by BOD: 78% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1991; SIDS, 2006)), and 21-day NOEC = 0.48 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998); Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, there are data: 96-hour LC50 = 4.8 mg/L for fish (Pimephales promelas) (Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009); SIDS, 2006). However, it is rapidly degradable (a degradation rate by BOD: 78% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1991; SIDS, 2006)), and low bioaccumulation is estimated (log Kow = -0.21 (HSDB 2013)). Therefore, it is classified as "Not classified." By drawing a comparison between the above results, it was classified in Category 3.
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.

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