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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	110-19-0
Chemical Name	Isobutyle acetate
Substance ID	H26-B-117, R-055
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 18 deg C (closed cup) and a boiling point of 118 deg C (ICSC (2003)). Besides, it is classified in Class 3, PG II (UN1213) 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 421 deg C (ICSC (2003)).
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	Not classified	- -	-	-	Because it is described that steel, stainless steel, and aluminum are resistant as a container (Hommel (1991)), it was judged not to be corrosive to metals.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	There are reports of LD50 values of >3,200 mg/kg (SIDS (2009)), 13,400 mg/kg (SIDS (2009), DFGOT vol.19 (2003)) and 15,000 mg/kg (SIDS (2009)) for rats. It was classified as "Not classified" to which the larger number of data corresponded.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on reports of LD50 values of >5,000 mg/kg (SIDS (2009)) and >17,400 mg/kg (SIDS (2009), DFGOT vol.19 (2003)) for rabbits, 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 reports that 4/6 animals died in a 4-hour exposure test with rats at 8,000 ppm (SIDS (2009), DFGOT vol.19 (2003)), and of an LCLo value (1 hour) of 8,000 ppm for rats (converted 4-hour equivalent value: 4,000 ppm) (SIDS (2009)), LC50 values were estimated to be within the range of 4,000-8,000 ppm, therefore, it was classified in Category 4.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on a report of an LC0 value (6 hours) of 3,000 ppm (14,250 mg/m3) (converted 4-hour equivalent value: 21.3 mg/L) for rats (SIDS (2009)), it was classified as "Not classified." Based on a description that the test was conducted with an aerosol, the reference value as a mist was applied. The new information source (SIDS (2009)) was added, and the category was revised.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	There is a report that no irritation was observed after a 24-hour non-occlusive application of 0.01 mL of this substance to the skin of rabbits (SIDS (2009), DFGOT vol.19 (2003), CICAD (2005)). In addition, there is a report that no irritation was observed after a 48-hour occlusive application of 2% of this substance dissolved in petrolatum to the skin of humans (SIDS (2009)). The above results were judged to be inadequate to use for evaluation due to the small application amounts. Besides, although there is a report that moderate irritation was observed after a 24-hour occlusive application of the undiluted liquid of this substance to the skin of rabbits (SIDS (2009)), due to the result of 24-hour application, it was not used for classification. Information in RTECS adopted in the previous classification was the information in List 3, therefore, it was not adopted. From the above, it was classified as "Classification not possible."
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Based on a description that slight irritation was observed after application of 0.5 mL of this substance to the conjunctival sac of rabbits (SIDS (2009), DFGOT vol. 19 (2003), CICAD (2005)), it was classified in Category 2B.
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, there is a report that no sensitization was observed in a skin sensitization test with guinea pigs (SIDS (2009), DFGOT vol.19 (2003), CICAD (2005)). In addition, there is a report that a maximization test in which 2% of this substance was applied to 28 volunteers gave a negative result (SIDS (2009) DFGOT vol.19 (2003)). Since details were unknown about the test methods and results of both reports, it was judged to be inadequate to use for classification.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There were no in vivo data. As for in vitro, it was negative in a bacterial reverse mutation test and a chromosomal aberration test with cultured mammalian cells (SIDS (2009), CICAD 64 (2005), DFGOT vol. 19 (2003), HSDB (Access on September 2014)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, although there were no data of this substance, in SIDS (2009) and CICAD 64 (2005), it was evaluated based on isobutanol, a major metabolite. As for isobutanol, there is a report that neither parental toxicity nor reproductive toxicity was observed in a two-generation reproduction toxicity study with rats by the inhalation route (SIDS (2009), CICAD (2005)). In the teratogenicity test with rats or rabbits by the inhalation route, no developmental toxicity was observed even at doses where slightly decreased body weight gain was observed in maternal animals. In addition, there is a report that maternal toxicity and developmental toxicity were not observed in rats (SIDS (2009), CICAD (2005)).
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 (PATTY (6th, 2012), SIDS (2009), ACGIH (7th, 2001), CICAD 64 (2005)). There is a report on dizziness, vomiting, drowsiness and loss of consciousness by the inhalation exposure in humans (PATTY (6th, 2012)). As for experimental animals, there was a report of narcotic effects, labored respiration and loss of coordination by an inhalation exposure of rats at 21,301 ppm (101 mg/L) (SIDS (2009)). From the above, it was classified in Category 3 (respiratory tract irritation, narcotic effects).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There was no study report using this substance itself as a test substance. However, it is described that this substance was rapidly metabolized to isobutanol (CAS RN: 78-83-1) by esterase in the gastrointestinal tract, skin or lung through any route, oral, dermal or inhalation, which was the major active metabolite in the circulating blood after administration of this substance, and the findings of isobutanol exposure were available for assessment of a hazard by exposure to this substance (SIDS (2009), CICAD 64 (2005)). In studies in which isobutanol was administered by inhalation exposure or by gavage for 90 days with rats, no toxic findings were observed at doses within or lower the guidance value range of Category 2 in both tests, and NOAELs were 3.03 mg/L/6 hours and 316 mg/kg/day by the inhalation and oral route, respectively (SIDS (2009), CICAD 64 (2005)). From the above, although this substance was also estimated to correspond to "Not Classified" through the inhalation and oral routes in experimental animals, there were no adverse findings through the dermal route or in humans, therefore, it was classified as "Classification not possible" due to lack of data.
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 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour LC50 = 17 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1999)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a 20-day degradation rate by BOD: 79-81% (SIDS, 2009)), 21-day NOEC = 23 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1999)). 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 rapid degradability (a 20-day degradation rate by BOD: 79-81% (SIDS, 2009)), and a low bioaccumulation estimate (log Kow = 1.78 (PHYSPROP Database, 2009)) despite 96-hour LC50 = 17 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1999)). From the above results, it was classified as "Not classified."
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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