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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	105-16-8
Chemical Name	2-(Diethylamino)ethyl methacrylate
Substance ID	R01-B-014
Classification year (FY)	FY2019
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
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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
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 (Dean (15th, 1999)).
7	Flammable solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
8	Self-reactive substances and mixtures	*	- -	-	-	There is a chemical group associated with self-reactive properties (unsaturated bond) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	*	- -	-	-	No data available.
10	Pyrophoric solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
11	Self-heating substances and mixtures	*	- -	-	-	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	*	- -	-	-	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 (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	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 (Not applicable)."
14	Oxidizing solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	No data available.
17	Desensitized explosives	*	- -	-	-	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] The GLP/TG test in (1) was judged to be reliable, and it was classified in Category 4. Besides, the category was changed from the previous classification by using new information sources. [Evidence Data] (1) LD50 for rats: > 300 - < 2,000 mg/kg (REACH registration dossier (Access on July 2019)) (2) LD50 for rats: 4,696 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006), HSDB (Access on June 2019))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] Based on (1), it was classified in Category 4. The category was changed from the previous classification by the use of the new information sources. [Evidence Data] (1) LC50 value for rats (aerosol, 4 hours): 1.8 mg/L (REACH registration dossier (Access on July 2019))
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] Based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) In a skin irritation test (4-hour semiocclusive application) with rabbits compliant with OECD TG 404, the score for erythema at 24/48/72 hours was 4, and it was evaluated as an irreversible reaction (REACH registration dossier (Access on July 2019)). (2) This substance was strongly irritating to the skin of guinea pigs and the conjunctiva of rabbits (HSDB (Access on June 2019)). [Reference Data, etc.] (3) It was classified as "Skin Irrit. 2 (H315)" in the EU CLP classification (EU CLP classification (Access on July 2019)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Since it was judged to be a skin corrosive substance (Category 1) based on data in (1) and (2), it was classified in Category 1 in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) In a skin irritation test (4-hour semi-occlusive application) with rabbits compliant with OECD TG 404, the mean score at 24/48/72 hours was 4, and it was judged as Category 1 (REACH registration dossier (Access on July 2019)). (2) This substance was strongly irritating to the skin of guinea pigs and the conjunctiva of rabbits (HSDB (Access on June 2019)). [Reference Data, etc.] (3) It was classified as "Eye Irrit. 2 (H319)" in the EU-CLP classification (EU CLP classification (Access on July 2019)).
4	Respiratory sensitization	*	- -	-	-	[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] Based on (1) and (2), it was classified in Category 1. Besides, the category was changed since new information was obtained. [Evidence Data] (1) It was proved that the allergic reactions that a 36-year-old Japanese man experienced while handling this substance at his working place are caused by this substance (REACH registration dossier (Access on July 2019)). (2) Cases of allergic or cross-allergic reactions were assumed due to experiences available from many alkyl methacrylates, and this substance was also assessed as a skin-sensitizing agent (GESTIS (Access on July 2019)). [Reference Data, etc.] (3) It was classified in Skin Sens. 1 in the EU CLP classification (EU CLP classification (Access on July 2019)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), a positive finding was observed in an in vitro chromosomal aberration test. However, since it was negative in an in vivo micronucleus test, it was classified as "Not classified" in accordance with expert judgment. [Evidence Data] (1) As for in vivo, there is a report on a negative result in a micronucleus test with mice (JECDB (Access on June 2019)). (2) As for in vitro, there is a report on a negative result in a bacterial reverse mutation test and a positive result in a mammalian cell chromosomal aberration test (JECDB (Access on June 2019)). However, as for the result of the chromosomal aberration test, there is also a report that the level of concern for this substance is negligible based on the weight of evidence which also takes into account in silico data, and mutagenicity data for substances with similar structures (Morita et al, Mutat. Res., 741, 32-56, 2012).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), no general toxicity was observed in maternal animals. However, since a decreased trend in the number of live births and a decreased delivery index were observed, it was classified in Category 1B. [Evidence Data] (1) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, no abnormalities on general condition, body weight, food consumption and pathological examination were observed in maternal animals. In paternal animals, decreased values of hemoglobin level, mean corpuscular volume, mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration, higher values of urea nitrogen, and higher values of absolute and relative kidney weight were observed. As for reproductive effects, a decreased trend in the number of live births due to prenatal deaths of embryos/fetuses (control group: 172 animals, 500 mg/kg/day group: 104 animals) and a decreased delivery index (control group: 95.0%, 500 mg/kg/day group: 68.8%) were observed (Environmental Risk Assessment for Chemical Substances Vol.5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006), JECDB (Access on June 2019)).
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2 (respiratory organs). By using new information sources, the classification result was changed from the previous classification. [Evidence Data] (1) In a test in which male rats were exposed by inhalation to the aerosol of this substance for 4 hours, nasal discharge was observed at or above 0.4 mg/L, and labored breathing and abnormal breath sounds were observed at or above 1.1 mg/L (equivalent to Category 2). The lethal concentration was 1.8 mg/L, the highest dose (REACH registration dossier (Access on July 2019)). [Reference Data, etc.] (2) Administrating this substance (doses not described) by gastric gavage to rabbits initially suppressed brain electrical activity and then induced clonic-tonic spasms (HSDB (Access on June 2019)).
9	Specific target organ toxicity - Repeated exposure	*	- -	-	-	[Rationale for the Classification] Based on (1), effects on the kidney were observed within the range of Category 2 in oral administration to rats but these were not accompanied by tissue changes. Therefore, the kidney was not adopted as a target organ. As for oral administration, it was considered as "Not classified." Besides, there was no information on other routes. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) In a study in which this substance was administered at 50-500 mg/kg/day by gavage to male rats from 14 days before mating for 49 days and to female rats from lactation day 3 for 41-54 Days, increased relative kidney weight and increased blood urea nitrogen concentration were observed at or above 150 mg/kg/day (converted guidance value: 68 mg/kg/day, within the range of Category 2), and changes in hematological parameters, increased liver and kidney weights, and increased AST were observed at 500 mg/kg/day (converted guidance value: 228 mg/kg/day, exceeding Category 2) (JECDB (Access on June 2019), Environmental Risk Assessment for Chemical Substances Vol.5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)).
10	Aspiration hazard	*	- -	-	-	[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 Short term (Acute)	Not classified	- -	-	-	It was classified as "Not classified" from 48-hour EC50 = 362 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified as "Not classified" due to being rapidly degradable (a degradation rate by BOD: 89, 35, 86% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1994)), and 72-hour NOEC = 3.1 mg/L for algae (Raphidocelis subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to 48-hour EC50 = 362 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)), being rapidly degradable (a degradation rate by BOD: 89, 35, 86% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1994)), and a low bioaccumulation estimate (log Kow = 1.95 (KOWWIN)). By drawing a comparison between the above results, it was classified as "Not classified."
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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