GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 868-77-9
Chemical Name 2-Hydroxyethyl methacrylate
Substance ID H29-B-100
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 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 (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

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 is 101 deg C (closed cup) (GESTIS (Access on August 2017)).
7 Flammable solids Not applicable
-
-
- - Liquid (GHS definition)
8 Self-reactive substances and mixtures Classification not possible
-
-
- - There is a chemical group associated with self-reactive properties (unsaturated bond: ethylene group) 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.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - Based on reports of five LD50 values for rats of 5,564 mg/kg (SIDS (2005), SIDS Dossier (2005)), 5,050 mg/kg, 8,700 mg/kg, 11,200 mg/kg, > 4,000 mg/kg (SIDS Dossier (2005)), this substance was classified as "Not classified."
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on a report of an LD50 value of > 3,000 mg/kg (SIDS (2005), DFGOT Vol. 13 (1999)) for rabbits, this substance was classified as "Not classified."
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) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- - Based on reports of no irritation or slight irritation (primary irritation score: 0.08, 1.0, 1.2) in three skin irritation tests with rabbits (SIDS (2005)), this substance was classified as "Not classified" (Category 3 in UN GHS classification). Besides, this substance was classified as "Skin Irrit. 2, H315" in the EU CLP classification (ECHA CL Inventory (Access on August 2017)).
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
It is described that in an eye irritation test with rabbits, the eye irritation score was 4.6 (maximum value 13) and it was moderately irritating. In addition, there is a description that in another test with rabbits, ulceration and thickening of the cornea were produced, but after 15 days, these resolved except for minor corneal defects in one animal, and this substance showed highly irritating potential (both SIDS (2005)). Moreover, it is described that the corneal injury remained for 7 days or more due to the application of this substance to rabbit eyes, and moderate to severe irritation was demonstrated (DFGOT Vol. 13 (1999)). Therefore, this substance was classified in Category 2. Besides, this substance was classified as "Eye Irrit. 2, H319" in the EU CLP classification (ECHA CL Inventory (Access on August 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
There is a report that dental technicians who developed contact dermatitis by handling this substance and a laboratory technician handling 80% solution of this substance were positive for this substance in patch tests. In addition to cases where persons who manufactured electron microscopic embedding media and soft contact lenses were sensitized to this substance, there are descriptions of multiple cases (SIDS (2005), DFGOT Vol. 13 (1999)). In skin sensitization tests with guinea pigs, multiple results of positive and negative were reported (SIDS (2005)). Based on these results, this substance was considered to have sensitizing potential, and was classified in Category 1. Besides, this substance was classified as "Skin Sens. 1, H317" in the EU CLP classification (ECHA CL Inventory (Access on August 2017)).
5 Germ cell mutagenicity Classification not possible
-
-
- - It was classified as "Classification not possible" since it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, a micronucleus test with rat bone marrow cells was negative (SIDS (2005)). As for in vitro, bacterial reverse mutation tests and a mammalian cell chromosome aberration test were negative (JECDB (Access on August 2017), SIDS (2005), DFGOT vol. 13 (1999)).
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
7 Reproductive toxicity Classification not possible
-
-
- - In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, no reproductive and developmental effects were observed at up to 1,000 mg/kg/day in both parental animals and pups (JECDB (Access on August 2017), SIDS (2005)). However, since it is impossible to classify it as "Not classified" with only this result, and this test is a screening test, this substance was classified as "Classification not possible."
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - There is no single exposure information of this substance in humans. As for experimental animals, there is a report that in a single oral dose test with rats, dose-related reduction of activity, tremor, disturbances of coordination and gait, reduced muscle tonus in limbs, elevated body temperature, and piloerection were observed at 10 minutes to 24 hours after administration, but these completely resolved in the surviving animals thereafter. It is described that the doses of this test were 3,403, 4,259, 5,350, 6,741 mg/kg which are all greater than Category 2, the mortality rates were 1/10, 1/10, 4/10 and 8/10 respectively, and no histopathological changes related to the test substance were observed. There is no description of the minimum dose where symptoms were observed, but the doses in this test are all more than Category 2 (SIDS Dossier (2005)). From the above, it was considered to have some effects on the central nervous system from the symptoms, but these were seen at doses exceeding Category 2, therefore, it was classified as "Classification not possible."
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - There is no information in humans.
As for experimental animals, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, an increasing tendency or increase in urea nitrogen at or above 30 mg/kg/day (converted guidance value: 16.3 mg/kg/day) and an increase in relative weight of the kidneys at or above 100 mg/kg/day (converted guidance value: 54.4 mg/kg/day (males), 45.6 mg/kg/day (females)) within a guidance value range for Category 2 were observed (JECDB (Access on August 2017), SIDS (2005)). Besides, regarding the histopathological findings in the kidney, dilatation of renal tubules and collection tubules were observed in only males at 1,000 mg/kg/day (converted guidance value: 544 mg/kg/day (males), 456 mg/kg/day (females)), which is above the guidance value range for Category 2 (JECDB (Access on August 2017), SIDS (2005)).
From the above, this substance was classified as "Classification not possible" because the observed effects were inadequate as evidence for classification.
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) Not classified
-
-
- - From 72-hour EC50 (rate method) = 710 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)), 96-hour LC50 >100 mg/L for fish (Oryzias latipes), and 48-hour EC50 = 380 mg/L for crustacea (Daphnia magna) (both Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017), OECD SIDS: 2001), it was classified as "Not classified."
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - Due to being rapidly degradable (readily biodegradable, average degradation rate by BOD: 95% (J-CHECK, 1989)), no bioaccumulation (LogKow: 0.47 (SRC PhysProp Database: 2017)), and 21-day NOEC (reproduction inhibition) = 24 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 as "Not classified."
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


NOTE:
* 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.

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