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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	75-28-5
Chemical Name	2-Methylpropane
Substance ID	H30-B-033-MHLW, MOE
Classification year (FY)	FY2018
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
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	- -	-	-	Gas (GHS definition)
2	Flammable gases (including chemically unstable gases)	Category 1	Danger	H220	P210 P377 P381 P403	It was classified in Category 1 from an explosion limit (1.8-8.4 vol% (ICSC (J) 1998)). Besides, it is classified in Division 2.1 (UN1969) in UNRTDG.
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified	- -	-	-	It is a flammable gas which is classified in Division 2.1 (UN1969) in UNRTDG.
5	Gases under pressure	Low pressure liquefied gas	Warning	H280	P410+P403	From a boiling point of -11.7 deg C (Ullmanns (E) (6th, 2003)), it is a gas (GHS definition). Because a critical temperature (134.69 deg C (HSDB (Accessed Nov. 2018))) is above +65 deg C, it was classified as liquefied gas (low pressure liquefied gas).
6	Flammable liquids	Not applicable	- -	-	-	Gas (GHS definition)
7	Flammable solids	Not applicable	- -	-	-	Gas (GHS definition)
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	Gas (GHS definition)
9	Pyrophoric liquids	Not applicable	- -	-	-	Gas (GHS definition)
10	Pyrophoric solids	Not applicable	- -	-	-	Gas (GHS definition)
11	Self-heating substances and mixtures	Not applicable	- -	-	-	Gas (GHS definition)
12	Substances and mixtures which, in contact with water, emit flammable gases	Not applicable	- -	-	-	Gas (GHS definition)
13	Oxidizing liquids	Not applicable	- -	-	-	Gas (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	Gas (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Gas (GHS definition)
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to gas substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not applicable	- -	-	-	[Rationale for the Classification] Gas (GHS definition)
1	Acute toxicity (Dermal)	Not applicable	- -	-	-	[Rationale for the Classification] Gas (GHS definition)
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(4), 1 case corresponds to Category 4, 1 case to Category 4-"Not classified," and 2 cases to "Not classified." Therefore, it was classified as "Not classified" with the largest number of cases. Besides, since the category could not be specified with data of rats in (1), data of mice in (2)-(4) were also used for classification. The category was changed using new information sources. [Evidence Data] (1) LC50 for rats (4 hours): >32.21 mg/L (>13,550 ppm) (Patty (6th, 2012)) (2) LC50 for mice (1 hour): 52 mg/L (converted 4-hour equivalent value: 10,938 ppm) (Patty (6th, 2012)) (3) LC50 for mice (2 hours): 520,000 ppm (converted 4-hour equivalent value: 376,696 ppm) (DFGOT vol. 20 (2003)). (4) Minimum lethal dose by inhalation with mice (72 minutes): 410,000 ppm (converted 4-hour equivalent value: 224,556 ppm) (ACGIH (7th, 2017)).
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	[Rationale for the Classification] Gas (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Not applicable	- -	-	-	[Rationale for the Classification] Gas (GHS definition)
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) There is a report that this substance is gaseous in general status and is not irritating to the skin (DFGOT vol. 20 (2003), GESTIS (Accessed Dec. 2018), Patty (6th, 2012)). [Reference Data, etc.] (2) There is a report that evaporation of this substance which is cooled and liquefied or contact with this substance in the liquid state may cause frostbite to the skin (DFGOT vol. 20 (2003), ACGIH (7th, 2017), GESTIS (Accessed Dec. 2018)). (3) There is a report that as a result of application of preparations containing 74-90% of this substance in a skin irritation test (n=5) with rabbits, no irritation or moderate erythema and edema were observed (irritation score was 0.29-2.025 out of 8 points) (DFGOT vol. 20 (2003)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) There is a report that this substance is gaseous in its general status and does not show eye irritation (DFGOT vol. 20 (2003), GESTIS (Accessed Dec. 2018), Patty (6th, 2012)). [Reference Data, etc.] (2) There is a report that evaporation of this substance which is cooled and liquefied or contact with this substance in the liquid state may cause frostbite in the eyes (DFGOT vol. 20 (2003), ACGIH (7th, 2017), GESTIS (Accessed Dec. 2018)). (3) There is a report that as a result of spraying 0.1 mL of a hairspray containing 22% of this substance into rabbit eyes followed by washing after 4 seconds, no abnormalities were observed in the cornea after 1 hour, but transient iritis and weak conjunctivitis were observed (DFGOT vol. 20 (2003), Patty (6th, 2012)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Although there is a report (1) suggesting that there is no sensitization, but it was not adopted because no specific case report nor test data were shown. [Reference Data, etc.] (1) It is reported that despite long-term occupational and non-occupational experience (also used as a propellant in spray cans), there are no indications of a sensitizing effect. (GESTIS (Accessed Dec. 2018)).
5	Germ cell mutagenicity	Classification not possible (when the content of butadiene as an impurity is 0.1% or more, it is classified in Category 1B)	- -	-	-	[Rationale for the Classification] There are no in vivo data. Therefore, classification was not possible due to lack of data. However, based on (1), when butadiene is contained as an impurity at not less than 0.1%, it was classified in Category 1B. Since this substance was classified in consideration of its impurities by referring to the CLP harmonized classification, the classification was changed. [Evidence Data] (1) Butadiene (1,3-Butadiene, CAS RN 106-99-0) was classified in Category 1B in the classification by the Japanese government (GHS Classification Result in FY 2017). [Reference Data, etc.] (2) As for in vitro data of this substance itself, there is a report that it was negative in a bacterial reverse mutation test (DFGOT vol. 20 (2003)). (3) This substance which contains not less than 0.1% of butadiene, a substance known as a carcinogen, as an impurity was classified as "Muta.1B" in the EU CLP.
6	Carcinogenicity	Classification not possible (when the content of butadiene as an impurity is 0.1% or more, it is classified in Category 1A)	- -	-	-	[Rationale for the Classification] Based on (1), classification was not possible due to lack of data. However, from (2), when butadiene is contained as an impurity at not less than 0.1%, it was classified in Category 1A. Since this substance was classified in consideration of impurities by referring to the CLP harmonized classification, the classification was changed. [Evidence Data] (1) There is no information related to carcinogenicity of this substance itself. (2) Butadiene (1,3-Butadiene, CAS RN 106-99-0) was classified in Category 1A in the Japanese classification (GHS Classification Result in FY 2017). It was classified in Group 1 by IARC (IARC 100F (2012)) and also in Group 1 by Japan Society For Occupational Health (JSOH) (OEL Documentations (Carcinogenicity classification), 2001). [Reference Data, etc.] (3) This substance which contains not less than 0.1% of butadiene, a known carcinogen, as an impurity was classified as "Carc. 1A" in the EU CLP.
7	Reproductive toxicity	Classification not possible (when the content of butadiene as an impurity is 0.3% or more, it is classified in Category 1B)	- -	-	-	[Rationale for the Classification] Based on (1), classification was not possible due to lack of data. However, from (2), when butadiene is contained as an impurity at not less than 0.3%, it was classified in Category 1B. As for this substance, the category was changed since impurities were considered in the classification by referring to the classification of germ cell mutagenicity and carcinogenicity in the CLP Harmonized Classification. [Evidence Data] (1) There is no information on the reproductive toxicity of this substance itself. (2) Butadiene (1,3-Butadiene, CAS RN 106-99-0) was classified in Category 1B in the classification by the Japanese government (GHS Classification Result in FY 2017). [Reference Data] (3) In the EU CLP, among CMR endpoints, as for germ cell mutagenicity and carcinogenicity, it was classified by considering the impurity, butadiene. However, no category was assigned to reproductive toxicity, and classification was not possible also for a mixture.
8	Specific target organ toxicity - Single exposure	Category 1 (circulatory organ system), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] According to (1)-(4), it is suggested that when humans are exposed by inhalation to large amounts of this substance, cardiac dysfunction and cardiac arrest may occur, and the circulatory organ system is considered to be the target organ. Based on (5) and (6), this substance is considered to have narcotic effects. Therefore, it was classified in Category 1 (circulatory organ system), Category 3 (narcotic effects). Besides, the category was changed from the previous classification by adding new information sources. [Evidence Data] (1) In 3 out of 4 persons who inhaled butane gas (amounts unknown) and died, a mixture of n-butane, isobutane (this substance), or a mixture of n-butane, this substance and propane were detected in the blood, brain and lung, and the total hydrocarbon concentration was the highest in the brain in all the persons. The authors reported that disturbances in heart rhythm were suspected to be the cause of death in 5 persons including one other of n-butane intoxication (DFGOT vol. 20 (2003)). (2) A 16-year-old boy developed cardiac arrest after the inhalation of butane gas. An abnormality was observed on his electrocardiogram, but the mechanism of cardiac arrest induction was unknown. The authors reported that, in addition to central depression, anoxia, ventricular flutter leading to cardiac arrest, or direct induction of cardiac arrest by butane were associated (DFGOT vol. 20 (2003)). (3) A 2-year-old girl developed ventricular tachycardia, tonoclonic seizure and hypokalemia after exposure to a deodorant containing this substance, butane and propane. The tachycardia is thought to be caused by the deodorant exposure and endogenous epinephrine (Patty (6th, 2012)). (4) After a 6-minute inhalation exposure in dogs (without anesthesia) to 50,000 ppm (converted 4-hour equivalent value: 7,906 ppm) of this substance, epinephrine-induced arrhythmia was caused by cardiac sensitization. Other than this, there are several reports that cardiac sensitizing responses by short-term inhalation of this substance were observed in experiments with anesthetized mice and dogs pretreated with epinephrine (ACGIH (7th, 2017)). (5) There are reports that the EC50 of central nervous system depression in rats by inhalation exposure to this substance was 200,000 ppm and narcotic effects in dogs by similar exposure were observed at 450,000 ppm (ACGIH (7th, 2017), DFGOT vol. 20 (2003)). (6) Based on the solubility of n-butane and this substance in olive oil and the distribution coefficient between air and olive oil, the concentration of narcotic effects in humans is estimated to be 17,000 ppm for n-butane and 24,000 ppm for this substance (DFGOT vol. 20 (2003)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), it was reported that no significant health effects were detected in humans by exposure to this substance alone. In addition, no adverse effects were detected from limited animal test reports in (2) and (3). Therefore, it was classified as "Classification not possible." [Evidence Data] (1) A total of 8 volunteers, 4 men and 4 women, were exposed by inhalation to this substance at 500 ppm for up to 8 hours/day, 5 days/week for 2 weeks, but no significant exposure-related effects were observed. However, although a decrease in the amplitude of the visual evoked response was observed in the second week, the authors stated that it might be the effect of central nervous system depression, but the significance of the findings was uncertain (DFGOT vol. 20 (2003), ACGIH (7th, 2017)). (2) When rats were exposed by inhalation to C4/C5 mixtures containing this substance (a mixture containing n-butane/n-pentane or isobutane/isopentane at a ratio of 50:50) at up to 4,489 ppm for 13 weeks, only slight nephropathy was observed in males in the group of interim necropsy after 28 days, and no effects including the kidneys were observed at the end of treatment. It is considered that nephropathy is a male-specific effect and is of low toxicological significance (ACGIH (7th, 2017), DFGOT vol. 20 (2003), Patty (6th, 2012)). (3) No adverse effects were detected in either a test in which a spray product containing 22% of this substance was sprayed to the head of rabbits for 13 weeks or in a test in which monkeys were exposed by inhalation to a deodorant containing propane and 65% of this substance for 90 days (ACGIH (7th, 2017), Patty (6th, 2012)).
10	Aspiration hazard	Not applicable	- -	-	-	[Rationale for the Classification] Gas (GHS definition)

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)	Classification not possible	- -	-	-	No data available.
11	Hazardous to the aquatic environment (Long-term)	Classification not possible	- -	-	-	No data available.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

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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