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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	108-21-4
Chemical Name	Isopropyl acetate
Substance ID	H26-B-149, R-143
Classification year (FY)	FY2014
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)
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 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 2 deg C (closed cup) and a boiling point of 89 deg C (ICSC (1998)). Besides, it is classified in Class 3 PG II (UN1220) in UNRTDG.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 460 deg C (ICSC (1998)).
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 reports of LD50 values of 3,000 mg/kg (ACGIH (2003)) and 12,500 mg/kg (female) for rats (SIDS (2008)), it was classified as "Not classified" (Category 5 in UN GHS classification or "Not classified"). A new information source (SIDS (2008)) was added, and the category was revised.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of >17,436 mg/kg (male) for rabbits (SIDS (2008)), it was classified as "Not classified."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Based on a report of an LC50 value (8 hours) of 12,114 ppm (female) (converted 4-hour equivalent value: 17,132 ppm) for rats (SIDS (2008)), it was classified in Category 4. A new information source (SIDS (2008)) was added, and the category was revised. Besides, since the LC50 value was lower than 90% of the saturated vapor concentration (794,669 ppm), the reference value in units of ppm was applied as a vapour without a mist. Since the set guidance range of Category 4 in the previous classification, 2,500-5,000 ppm was changed to 2,500-20,000 ppm, the category was changed.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	There is a report that in a test in which 0.01 mL of this substance (undiluted) was applied to rabbits for 24 hours, irritation index was 1 (maximum value 10) and it was not irritating or slightly irritating (SIDS (2008)). In addition, there is a report that slight irritation was observed in a Draize test in which 500 mg of this substance was applied to rabbits for 24 hours (ACGIH (7th, 2003)). From the above results, it was judged to be "Not classified" (Category 3 in UN GHS classification). Since the evidence in the previous classification was the effects after repeated application and the information in List 3, they were deleted, and the category was changed based on information in SIDS (2008).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In an eye irritation test with rabbits, the irritation index was 2 (maximum value 10; 1 of the irritation index corresponding to the case where necrosis in a small area was observed after application of 0.5 ml of undiluted solution), and it was judged to be moderately irritating (SIDS (2008)). In addition, there is a description that although it might be corrosive to the cornea, symptoms disappeared within 3-10 days (PATTY (6th, 2012)), and there is a report that it was irritating to the eyes of humans (PATTY (6th, 2012), ACGIH (7th, 2003)). On the other hand, there is a report that irritation was slight in a standard Draize test (ACGIH (7th, 2003)). From the above, based on the descriptions of moderate irritation and possibility of corrosivity, it was judged to be Category 2A. Information in SIDS (2008) was added, and the category was changed. Besides, this substance was classified as "Xi; R 36" in the EU DSD classification, and as "Eye Irrit. 2 H319" in the EU CLP classification.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, although there is a report that no sensitization was observed in a skin sensitization test with guinea pigs (IUCLID (2000)), details of the test method, etc. were unknown, therefore, the data was judged inadequate for use in classification.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. As for in vivo, there were no data on this substance. As for in vitro, it was negative in a bacterial reverse mutation test (SIDS (2008)). Besides, this substance is rapidly and completely degraded to isopropyl alcohol in vivo (SIDS (2008)). As for isopropyl alcohol, there was a report of it being negative in an in-vivo micronucleus test with mouse bone marrow cells (SIDS (2008), JECFA FAS42 (1999)).
6	Carcinogenicity	Classification not possible	- -	-	-	There was no classification for carcinogenicity by international organizations, etc. There were no data in humans. Although data in experimental animals were limited, there is a report that in 2-year inhalation carcinogenicity studies with male and female rats and mice, no carcinogenicity was observed in mice of either sex, and in rats, although no carcinogenicity was observed in females, a tendency to increase the incidence of the peritoneal mesothelioma was observed in males (incidences of mesothelioma: the control group (2/50 animals), 1,000 ppm group (2/50 animals), 2,000 ppm group (1/50 animals), 4,000 ppm group (7/50 animals); a statistically significant difference at 4,000 ppm), and the incidence of mesothelioma in the 4000 ppm group exceeded the range of historical control data (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (2009): Japan Bioassay Research Center (2009)). From the above, although carcinogenicity in male rats was suggested, it was positive data only in one sex, and no other positive reports were observed, therefore, it was classified as "Classification not possible."
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	Category 3 (respiratory tract irritation, narcotic effects)	Warning	H335 H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	This substance was irritating to the respiratory tract in humans (ACGIH (7th, 2001), PATTY (6th, 2012)). As for experimental animals, there is a report of central nervous system depression (reduction in mobility) by an inhalation exposure of mice at 1,605 ppm (6.7 mg/L) (time unknown) (ACGIH (7th, 2001)). This finding was considered narcotic effects. From the above, it was classified in Category 3 (respiratory tract irritation, narcotic effects). The previous classification was changed.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In humans, there were no reports on the effects of repeated exposure except for a description that skin contact might cause local skin damage by repeated irritation (ACGIH (7th, 2001)). As for experimental animals, in studies in which rats or mice were exposed by inhalation to the vapour of this substance for 13 weeks or 2 years, tissue changes in the nasal cavity (atrophy of the olfactory epithelium, eosinophilic changes of the respiratory epithelium) were observed at higher concentrations (above 1,000 ppm: converted guidance value: > 4.2 mg/L/6 hours), which correspond to "Not classified" exceeding the guidance value range of Category 2 (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on December 2014)). Besides, in SIDS, the hazard with this substance was estimated based on the results of repeated inhalation exposure studies with isopropyl alcohol, a metabolite of this substance, and it is reported that as a result of inhalation exposure of rats and mice for 13 weeks, central nervous system depression symptoms, decreased red blood cell parameters and increased relative liver weight were observed above 1.23 mg/L exceeding the guidance value range of Category 2 (SIDS (2008)). From the above, as for experimental animals, it was considered equivalent to "Not classified" through the inhalation route, but there were no toxicological information through the other routes and the hazardous findings in humans, therefore, classification was not possible due to lack of data. Besides, in the previous classification, although it was classified in Category 1 (respiratory organs, liver) based on a description in information sources in List 3 that there was a risk of affecting a damage to the respiratory systems and liver in humans, there were no descriptions of reports of effects on the respiratory organs and liver by chronic exposure in humans in any of the information sources in List 1 (ACGIH (7th, 2001), SIDS (2008), JECFA (1999), PATTY (6th, 2012)), List 2 (HSDB (Access on December 2014)), and List 3 (GESTIS (Access on December 2014), ICSC (1999)), and the effect on "respiratory organs" was only described as an acute exposure effect due to respiratory tract irritation. Therefore, in this classification, both the respiratory organs and liver were excluded from the target organs.
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)	Not classified	- -	-	-	It was classified as "Not classified" from 48-hour EC50 = 110 mg/L for crustacea (Artemia salina) and 96-hour LC50 = 390.25 mg/L for fish (Pimephales promelas) (both SIDS, 2008).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. It was classified as "Not classified" because it is not water-insoluble (water solubility = 30,900 mg/L, PHYSPROP Database 2009), and it was classified as "Not classified" in acute toxicity.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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