NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	688-84-6
Chemical Name	2-Ethylhexyl methacrylate
Substance ID	m-nite-688-84-6_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	From a flash point of 92 deg C (unknown test method) (ICSC (1998)), it is estimated that a flash point is > 60 deg C and <= 93 deg C in the prescribed test method. Therefore, it was classified in Category 4.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (olefins) present in the molecule, but the classification is not possible due to no data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 380 deg C (GESTIS (Access on November 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	Based on the reports of LD50 values for rats of > 2,000 mg/kg (OECD TG401) (JECDB (Access on November 2015), SIDS (2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol. 5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)) and 16,465 mg/kg (SIDS (2009)), this substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification was not possible due to lack of data. Besides, there is a report of an LD50 of > 17,620 mg/kg (SIDS (2009)) for guinea pigs. However, in the reclassification, it was not adopted as evidence of classification because no details were available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification was not possible due to lack of data. Besides, there is a report of an LC0 value (6 hours) of > 14 ppm (converted 4-hour equivalent value: > 17 ppm) for rats (SIDS (2009)), but it was not possible to identify the category from this value alone. Also, it was not adopted as evidence for the classification according to the description that this data was secondary data and it was unreliable (Reliability 4). Since the LC0 value was lower than 90% of the saturated vapor pressure concentration (17 ppm), the reference values in units of ppm was applied as a vapour without mist.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	There are two reports of skin irritation tests with rabbits where as a result of application of this substance (undiluted) for 24 hours, moderate irritation (PII=3.12, 4.04) was observed (SIDS (2009)). It is described in SIDS (2009) that these tests were not compliant with the current standard test (4-hour application), but they were available for judgement on primary skin irritation. Therefore, this substance was classified in Category 2.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	There are two reports of eye irritation tests with rabbits where it was reported that no effects were observed on applying this substance, the primary irritation index was 0 (maximum value 100) and it was not irritating (SIDS (2009)). In addition, there is a report that slight conjunctival irritation was observed in 4 of 6 animals, but this disappeared within 72 hours from the end of the observation period, therefore it was not irritating (SIDS (2009)). From the above, this substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	There is a report that in a maximization test (OECD TG 406, GLP-compliant) with guinea pigs, no sensitization (rate of positive animal: 0%) was observed (SIDS (2009)). In addition, there are multiple reports of negative results in maximization tests (SIDS (2009)). On the other hand, there are also several positive reports including reports that sensitization was observed in 4 out of 10 animals (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2009)). There are multiple reports that in human patch tests, no sensitization was observed for this substance (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2009)). It was concluded in SIDS (2009) that the sensitization of this substance is equivocal and short-chain methacrylates have a weak sensitizing potential. From the above, there was a report of negative in the test in compliance with the test guidelines, but there were reports of positive though the details were unknown, so sufficient information was not available for negative or positive judgment. Therefore, this substance was classified as "Classification not possible." Because there are the information from the test compliant with the test guidelines and positive results having unknown details, the category was changed.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification was not possible due to lack of data. There was no in vivo data, and as for in vitro, bacterial reverse mutation tests and mammalian cell chromosome aberration tests were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), JECDB (Access on November 2015), SIDS (2009)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a combined repeated dose toxicity study with reproduction/developmental toxicity screening test (OECD TG 422) with rats by the oral route, at 1,000 mg/kg/day where general toxicity (death (females: 1/12 (8.3%)), decreased body weight gain, decreased food consumption) appeared in parental animals as adverse effects on sexual function and fertility in maternal animals, a decrease in the number of estrus, prolongation of gestation period, decrease in number of corpus luteum and implantation sites, and a decrease in delivery index (77.8%) were observed in maternal animals, and all pups died in 3 out of 7 mothers during the lactation period. In the pups, low values in the numbers of neonates at or above 300 mg/kg/day and low values of those weights at 1,000 mg/kg/day were observed on day 0 of lactation (SIDS (2009), JECDB (Access on November 2015), Environmental Risk Assessment for Chemical Substances Vol. 5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)). As in the above, it was considered that by administration of this substance, at doses where the general toxicity was manifested, adverse effects on female pregnancy and parturition function occurred mainly and as a result, it also had an effect on the development in pups. In addition, there are no other data available for classification. Therefore, this substance was classified in Category 2 since all the pups died at 1,000 mg/kg/day where maternal toxicity (mortality rate of less than 10%) was observed.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	There is no data on humans. As for experimental animals, as a result of a single oral administration of 500-2,000 mg/kg to rats, there was no death, and no change was observed in general symptoms and necropsy findings except for low values of body weight in both sexes (JECDB (Access on November 2015)). From the above, it is thought to correspond to Category 2 or above in the oral route, but there was no report on effects by other exposure routes (dermal, inhalation). Therefore, classification was not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There is no data on humans. As for experimental animals, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422, GLP-compliant) with rats by the oral route, an increase in relative liver weights and an increase in absolute and relative kidney weights in males, and an increase in relative kidney weights in females were only observed at a dose of 300 mg/kg/day (converted guidance value: approximately 150 mg/kg/day) exceeding the upper limit of the guidance value range, while other effects including pathological changes were not reported (SIDS (2009), JECDB (Access on November 2015), Environmental Risk Assessment for Chemical Substances Vol. 5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)). From the result, it corresponds to "Not classified" for the oral route, but there was no or insufficient data on other routes, so its effects were unknown. Therefore, it was classified as "Classification not possible."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 2	- -	H401	P273 P501	From 96-hour LC50 = 2.78 mg/L for fish (Oryzias latipes) (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004), Initial Risk Assessment (NITE, CERI, NEDO, 2008)), it was classified in Category 2.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 in Category 3 due to being rapidly degradable (a degradation rate by 28-day BOD = 88%, a degradation rate by GC = 100% (Official Bulletin of Ministry of International Trade and Industry, 1997)), and 21-day NOEC (reproduction) = 0.105 mg/L for crustacea (Daphnia magna) (SIDS, 2009). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 from 96-hour LC50 = 2.78 mg/L for fish (Oryzias latipes) (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004), Initial Risk Assessment (NITE, CERI, NEDO, 2008)), and a high bioaccumulation estimate (log Kow = 4.54 (>4.0, PHYSPROP Database, 2009)) in spite of rapid degradability. By drawing a comparison between the above results, it was classified in Category 2.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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