NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	115-11-7
Chemical Name	Isobutene [2-methylpropene or isobutylene]
Substance ID	m-nite-115-11-7_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Category 1	Danger	H220	P210 P377 P381 P403	It is classified in class 2.1 in UNRTDG (UN1055) (lower explosion limit 1.8%, upper limit 9.6% (ICSC (2000))).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified	- -	-	-	It was classified in Flammable gases of class 2.1 in UNRTDG.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Liquefied gas	Warning	H280	P410+P403	From a critical temperature of 144.7 degrees C (GESTIS (Access on June 2015)) above 65 degrees C, it was classified in liquefied gas (low pressure liquefied gas).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	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)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for gaseous substances.	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 (Not applicable)	- -	-	-	"Gases" according to GHS definition. Besides, it is reported that after 29.7 mg this substance was dissolved in 1 mL corn oil and administered by gavage to rats at a dose of 150 mg/kg, toxicity effects were not observed (SIDS (2012)), but the category cannot be determined only from this data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	From a reported LC50 value (4 hours) of 270,000 ppm for rats (PATTY (6th, 2012), SIDS (2012), NTP TR487 (1998)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	The classification is not possible due to lack of data. Besides, it is written that contact with liquid butene could cause frostbite (SIDS (2012)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	The classification is not possible due to lack of data. Besides, it is written that 1-butene is mildly irritating to eyes (HSDB (Access on June 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government, it was classified as "Classification not possible." As for in vivo, a micronucleus test in mouse bone marrow cells and peripheral blood erythrocytes was negative (SIDS (2012), NTP TR487 (1998), ACGIH (7th, 2008)), and a DNA damage test (DNA adduct formation) in rats and mice was negative (ACGIH (7th, 2008)). As for in vitro, a bacterial reverse mutation test and a mouse lymphoma test in cultured mammalian cells were negative (NTP TR487 (1998), NTP DB (Access on July 2015), ACGIH (7th, 2008), SIDS (2012), PATTY (6th, 2012)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	There is no carcinogenicity information in humans. As for experimental animals, a 2-year inhalation exposure carcinogenicity test using rats and mice was conducted, and thyroid follicular cell carcinomas were observed in 5/50 animals of male rats in an 8,000 ppm group of the highest concentration (SIDS (2012), ACGIH (7th, 2008)). However, evidence of carcinogenicity was not shown including thyroid gland in female rats and male and female mice, and there is the comment in both ACGIH and SIDS that it is unclear if thyroid tumors are applicable to humans (SIDS (2012), ACGIH (7th, 2008)), and ACGIH classified it in A4 (ACGIH (7th, 2008)). From the above, the substance was classified as "Classification not possible" for this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a teratogenicity test in which pregnant rats were in inhalation exposure to this substance on day 5 to 21 of gestation and fetuses were observed on day 22 of gestation, toxic effects were not observed in maternal animals and fetuses at the test concentrations up to 8,000 ppm. (SIDS (2012), ACGIH (7th, 2008)) However, because there are no test results investigating fertility effects of this substance, it was classified as "Classification not possible" due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	As for experimental animals (rats, mice), there is the information that an inhalation exposure (17.2-22.7%) to isobutene caused narcotic action within 10 minutes and it is reported that an inhalation exposure to 32% (320,000 ppm) of isobutene caused asphyxia (ACGIH (7th, 2008), SIDS (2012), PATTY (6th, 2012)). As for humans, it is reported that inhalation of isobutene could cause narcotic effects or asphyxia by decreasing available oxygen concentration (SIDS (2012)). Because the asphyxia and narcotic effects mentioned above were due to a lack of oxygen in a limited space, the substance was classified as "the classification is not possible."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Not classified	- -	-	-	There is no human information. As for experimental animals, in an inhalation route, in a 14-week inhalation toxicity test using rats, minimal hypertrophy of goblet cells in the nasopharyngeal duct in nasal cavity was observed from the minimum concentration of 500 ppm. In a 105-week inhalation toxicity test using rats, minimal hypertrophy of goblet cells in the nasopharyngeal duct in the nasal cavity and increased hyaline degeneration of the olfactory epithelium in the nasal cavity were observed from the lowest concentration of 500 ppm. In mice, effects were not found in a 14-week inhalation toxicity test, and in a 105-week inhalation toxicity test, increased hyaline degeneration of respiratory epithelium in the nasal cavity was observed from the lowest concentration of 500 ppm, and increased hyaline degeneration of the olfactory epithelium was found from 2,000 ppm (NTP TR487 (1998)). However, there is the comment in SIDS (2012) that these effects found in mucous membrane in the nasal cavity were the non-specific adaptive reaction to irritating substance and not significant toxicity effects. It is concluded that NOAEL was 8,000 ppm (converted to an exposure condition equivalent: 6,222 ppm) in a 14-week inhalation toxicity test using rats, 2,000 ppm in 105-week inhalation toxicity test using rats, 8,000 ppm (converted to a exposure condition equivalent: 6,222 ppm) in an 14-week inhalation toxicity test using mice, and 8,000 ppm in a 105-week inhalation toxicity test using mice (SIDS (2012)). Therefore, it corresponds to "Not classified" in an inhalation route. As for an oral route, in a 28-day gavage administration toxicity test using rats, effects were not observed up to the highest dose of 150 mg/kg/day (converted to a 90-day equivalent: 46.7 mg/kg/day) (SIDS 2012). However, due to this value within a range of Category 2, the classification is not possible for an oral route. In the previous classification, the substance was classified as "the classification is not possible" due to no information in a dermal route. However, because the substance is a gas, and an inhalation route is considered to be the main exposure route, it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Not classified (Not applicable)	- -	-	-	"Gases" according to GHS definition.	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)	Classification not possible	- -	-	-	The classification is not possible because appropriate data are not obtained. Besides, in SIDS, 96-hour EC50 = 14 mg/L for algae, 48-hour EC50 = 22 mg/L for crustacea, and 96-hour LC50 = 20 mg/L for fish as QSAR estimation are reported (all SIDS, 2012), however, they were not used for the classification.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	The classification is not possible because appropriate data are not obtained. Besides, in SIDS, 96-hour chronic value = 1.7 mg/L for algae, 16-day chronic value = 1.3 mg/L for crustacea, and 30-day chronic value = 2.7 mg/L for fish as QSAR estimation are reported (all SIDS, 2012), however, they were not used for the classification.	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.	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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