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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	97-90-5
Chemical Name	Ethylene dimethacrylate
Substance ID	H30-B-023-MHLW, MOE
Classification year (FY)	FY2018
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 101.5 deg C (closed cup) (GESTIS (Accessed Sept. 2018)).
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 (ethylene group) present 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	- -	-	-	[Rationale for the Classification] Based on the data in (1), an LD50 value for rats, it was classified as "Not classified." [Evidence Data] (1) LD50 value for rats: 8,700 mg/kg (REACH registration dossier (Accessed Sept. 2018))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on the data in (1), an LD50 value for rats, it was classified as "Not classified." [Evidence Data] (1) LD50 value for rats: >2,000 mg/kg (REACH registration dossier (Accessed Sept. 2018))
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Liquid (GHS definition)
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.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) There is a report that in an eye irritation test with rabbits (n=6), the Draize score was 0, and it was not irritating (REACH registration dossier (Accessed Sept. 2018)). [Reference Data, etc.] (2) There is also a report that it is irritating to the eyes (HSDB (2002)), but detail information is unknown.
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1B	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1)-(4), it was classified in Category 1. In addition, based on (5), it was classified in Category 1B. Besides, the category was changed from the previous classification by using new information sources. [Evidence Data] (1) Among dentists and dental assistants who handled dental materials containing this substance, sensitization reactions to this substance are reported in 8 of 9 of them with allergic contact dermatitis (MAK/BAT (1999)). (2) Sensitization reactions (Type IV) to this substance are reported in 15 of 35 dental technicians with occupational allergic contact eczema (MAK/BAT (1999)). (3) In case reports on patients with allergic contact dermatitis, the sensitizing potential of this substance was indicated in patch tests of this substance (MAK/BAT (1999)). (4) There is a report that moderate to severe sensitization was observed in a maximization test (n=10 animals/group) with guinea pigs (MAK/BAT (1999)). (5) There is a report that in a maximization test with guinea pigs, after induction of sensitization with 1%, 5% or 10% preparations (in olive oil) of this substance, sensitization reactions were observed in 4/7 animals (57%), 12/14 animals (86%) and 19/22 animals (86%) by re-application (MAK/BAT (1999)). [Reference Data, etc.] (6) Patch tests with various substances including this substance were conducted on 82 workers who are suspected to be sensitized by exposure to acrylic acid, and sensitization is reported in 11 subjects (13.4%), but the further details are unknown (MAK/BAT (1999)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1)-(4), it was classified as "Classification not possible" according to the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for in vivo, there is a report that it was negative in a micronucleus test with mice (REACH registration dossier (Accessed Sept. 2018)). (2) As for in vivo, there is a report that it was negative in an unscheduled DNA synthesis test with rat liver (REACH registration dossier (Accessed Sept. 2018)). (3) As for in vitro, there is a report that it was negative in a mouse lymphoma test (HSDB (2002)) (4) As for in vitro, there is a report that it was positive in a chromosomal aberration test with cultured human lymphocytes (REACH registration dossier (Accessed Sept. 2018)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) As for ethylene glycol (CAS RN 107-21-1), the ester hydrolysate of this substance, an oral carcinogenicity study with mice showed that there was no evidence of carcinogenicity (REACH registration dossier (Accessed Sept. 2018)).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] There are the data in (1) only and no reproductive test data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) There is a report that in a developmental toxicity test in which rats of gestational days 6-20 were dosed by gavage, no developmental effect on the fetuses was observed at up to 500 mg/kg/day where maternal toxicities (deterioration of general condition, transient body weight loss and decreased food consumption) were manifested (REACH registration dossier (Accessed Sept. 2018), GESTIS (Accessed Sept. 2018)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Toxicity findings by which specific organs were regarded as target organs were not obtained from the results of available studies. Therefore, it was classified as "Classification not possible" for this hazard class. [Evidence Data] (1) In a single administration test with rats given this substance by gavage, doses used were extremely high, and there are no findings available for classification at doses up to the range of Category 2 (REACH registration dossier (Accessed Sept. 2018)). (2) In a single dermal application test of this substance with rats, only irritation effects at the application site were observed (REACH registration dossier (Accessed Sept. 2018)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on the data in (1), it was classified in Category 1 (respiratory organs). Besides, it is described in the GHS Classification Guidance for the Japanese Government that in principle, tests for 14 days or longer should be adopted, but the result from the 13-day test was used for classification on the basis that effects on the lung were observed after the 13 days. [Evidence Data] (1) In a study in which rats were exposed by inhalation to this substance (estimated as a vapor) at 120 ppm (1,000 mg/m3, converted guidance value: 0.14 mg/L) within the range of Category 1 for 13 days, lethargy was observed during exposure, and changes in the lung (discoloration, thickening of the alveoli, and lymphatic reactions in the alveolar area) were observed at necropsy at the end of the exposure period (GESTIS (Accessed Sept. 2018)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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)	Classification not possible	- -	-	-	No data available.
11	Hazardous to the aquatic environment (Long-term)	Classification not possible	- -	-	-	No data available.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

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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