NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	141-78-6
Chemical Name	Ethyl acetate
Substance ID	R01-B-086
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	FY2009 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 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 2 based on a flash point of -4 deg C (closed cup) and a boiling point of 77 deg C (NFPA (2010)). Besides, it is classified in Class 3, PG II in UNRTDG (UN1173).
7	Flammable solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 426 deg C (NFPA (2010)).
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)	*	- -	-	-	[Rationale for the Classification] Based on (1)-(4), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 5,600 mg/kg (ACGIH (7th, 2001)) (2) LD50 for rats: 10,100 mg/kg (DFGOT vol.12 (1999)) (3) LD50 for rats: 11.3 g/kg (11,300 mg/kg) (IRIS (1987)) (4) LD50 for rats: 5,620 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: > 18,000 mg/kg (SIDS (2008), DFGOT vol. 12 (1999)) (2) LD50 for rabbits: > 20 mL/kg (18,000 mg/kg) (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012))
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)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 4. Besides, since the exposure concentrations were lower than 90% of the saturated vapor pressure concentration (123,000 ppm), the reference value in units of ppm was applied as a vapour with little mist. [Evidence Data] (1) LC50 for rats (4 hours): 14,640 mL/m3 (14,640 ppm) (DFGOT vol.12 (1999)) (2) LC50 for rats (6 hours): 16,000 ppm (converted 4-hour equivalent value: 19,600 ppm) (HSDB (Access on September 2019)) [Reference Data, etc.] (3) LC50 for rats (4 hours): 4,000 ppm (HSDB (Access on September 2019)) (4) LC50 for rats (6 hours): > 6,000 ppm (converted 4-hour equivalent value: 7,300 ppm) (SIDS (2008))
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) No skin reaction was observed in a skin irritation test with a 4-hour semi-occlusive application to the skin of rabbits according to the US Federal Register protocol (REACH registration dossier (Access on October 2019)). (2) Based on available information, it was not irritating to the skin and eyes (SIDS (2008)). [Reference Data, etc.] (3) Repeated application of this substance for 1 hour over 6 days will lead to defatting of the skin and damage to the stratum corneum, but a 48-hour occlusive application of a 10% petrolatum preparation of this substance did not produce skin irritation (DFGOT vol.12 (1999)). (4) Repeated occlusive application of this substance causes irritation to the skin (DFGOT vol.12 (1999)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] Based on (1)-(3), it was classified in Category 2B. [Evidence Data] (1) In an eye irritation test with rabbits, transient irritation was observed and the total scores (maximum 110) at 24/48/72 hours were 11, 2, and 2, with all effects having disappeared by day 7. The modified maximum average score was 15 (maximum value = 110) (ECETOC TR48 (1998), SIDS (2008), REACH registration dossier (Access on October 2019)). (2) This substance is irritating to the eyes, nose and throat of humans at 400 ppm (ACGIH (7th,2001), HSDB (Access on September 2019)). (3) This substance is irritating to the eyes and respiratory organs (PATTY (6th, 2012), GESTIS (Access on September 2019)). [Reference Data, etc.] (4) It was classified as "Eye Irrit. 2 (H319)" in the EU-CLP classification (EU CLP classification (Access on September 2019)). (5) This substance is irritating to the eyes, nose and throat in humans at or above 1,500 mL/m3 (DFGOT vol.12 (1999)). (6) Based on available information, this substance was not irritating to the skin and eyes (SIDS (2008)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) It was negative in a guinea pig maximization test compliant with OECD TG 406 (SIDS (2008)). (2) According to the available information, this substance was not a skin sensitizer or a skin or eye irritant (SIDS (2008)). [Reference Data, etc.] (3) The sensitizing potential of this substance was reported but it was rare (HSDB (Access on September 2019)). (4) There is no information suggesting skin sensitization based on studies in humans with this substance and on its structure (DFGOT vol.12 (1999)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), since all the standard combination tests, including in vivo and in vitro tests, showed negative results, it was classified as "Not classified." [Evidence Data] (1) As for in vivo, negative results were reported in micronucleus tests with the bone marrow cells of mice and hamsters by oral administration or intraperitoneal administration (DFGOT vol.12 (1999), SIDS (2008)). (2) As for in vitro, negative results were reported in bacterial reverse mutation tests and a chromosomal aberration test with cultured mammalian cells (DFGOT vol.12 (1999), NTP DB (Access on September 2019), SIDS (2008), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	Category 3 (narcotic effects, respiratory tract irritation)	Warning	H336 H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on the information in (1)-(4) in humans and experimental animals, it was classified in Category 3 (narcotic effects, respiratory tract irritation). [Evidence Data] (1) There is a report that in a study in which 10 volunteers were exposed by inhalation to 400 ppm of this substance for 3-5 minutes, subjects complained of irritation in the eyes, nose and throat (DFGOT vol.12 (1999), ACGIH (7th, 2001)). (2) There is a report that in a study in which 16 male volunteers were exposed by inhalation to 402 ppm of this substance for 4 hours, subjects complained of irritation in the eyes, mouth, and throat during the exposure period (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). (3) There is a report that in a single inhalation exposure test with cats, exposure to this substance at 20,000 ppm for 45 min resulted in deep narcosis, but the cats recovered (ACGIH (7th, 2001)). (4) There is a report that in a 6-hour single inhalation exposure test with rats, typical central nervous system depression symptoms such as loss of voluntary movement were observed, but there were no dead animals at up to 6,000 ppm (22.5 mg/L) (SIDS (2008)).
9	Specific target organ toxicity - Repeated exposure	*	- -	-	-	[Rationale for the Classification] Based on (1), as for the oral route, it was not applicable to any hazard class. As for the inhalation route, there was a result showing effects on the respiratory organs within the range of Category 1 by inhalation exposure with rats in (2), but in (3), it was reported that no symptoms were observed in humans at higher concentrations than in (2). Therefore, it was considered to be "Not classified." [Evidence Data] (1) Only reduced body weight gain and decreased food consumption were observed at 3,600 mg/kg/day after oral administration to rats for 90 days (SIDS (2008), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). (2) When rats were exposed by inhalation for 13 weeks (6 hours/day, 5 days/week), very slight to moderate degeneration of the nose (olfactory epithelium) was observed in males and females at or above 350 ppm (converted guidance value: 0.9 mg/L, within the range of Category 1) (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). (3) No symptoms were observed in workers exposed for several months at 375-1,500 ppm (ACGIH (7th, 2001)).
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 = 262 mg/L for crustacea (Daphnia pulex) and 96-hour LC50 = 230 mg/L for fish (Pimephales promelas) (both, Environmental Risk Assessment for Chemical Substances Vol. 10 (Ministry of the Environment, 2012)).
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" because it was rapidly degradable (a 28-day degradation rate by BOD = 66, 112, 105% (Official Bulletin of Ministry of International Trade and Industry, 1993)), and due to 21-day NOEC = 2.4 mg/L for crustacea (Daphnia magna) (ECETOC TR91, 2003). 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" because it was rapidly degradable (a 28-day degradation rate by BOD = 66, 112, 105% (Official Bulletin of Ministry of International Trade and Industry, 1993)), and due to log Kow = 0.73 (KOWWIN), and acute toxicity data for fish corresponding to "Not classified." From 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.

To GHS Information