GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 688-84-6
Chemical Name 2-Ethylhexyl methacrylate
Substance ID H27-B-17-METI/M-020B_P
Classification year (FY) FY2015
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2012   FY2007   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 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 Category 4
-
Warning
H227 P370+P378
P403+P235
P210
P280
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.
7 Flammable solids Not applicable
-
-
- - Liquid (GHS definition)
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.
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)).
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 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."
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.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
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.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
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.
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."
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
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.
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)).
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
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.
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.
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."
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 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.
11 Hazardous to the aquatic environment (Long-term) 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.
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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