NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	106-97-8
Chemical Name	n-Butane
Substance ID	R01-B-017
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	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)
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	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
2	Flammable gases	Category 1	Danger	H220	P210 P377 P381 P403	It was classified in Category 1 from explosion limits (1.8-8.4% (ICSC (2003))). Besides, it is classified in Division 2.1 in UNRTDG (UN1011).
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	It was classified as "Not classified" because it was classified as flammable gases.
5	Gases under pressure	Low pressure liquefied gas	Warning	-	-	It was classified as low-pressure liquefied gases from the information that it is partially liquid at temperatures above -50 deg C, and a critical temperature is about 152 deg C (Hommel (1991)).
6	Flammable liquids	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
8	Self-reactive substances and mixtures	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
11	Self-heating substances and mixtures	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Gas (GHS definition). It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to gas substances are not available.
17	Desensitized explosives	*	- -	-	-	Gas (GHS definition). 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] Gas (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Gas (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LC50 for rats (4 hours): 276,798.8 ppm (DFGOT vol.20 (2003), ACGIH (7th, 2001), OEL Documentations (Japan Society For Occupational Health (JSOH), 1988), BUA 144 (1994), HSDB (Access on June 2019))
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Gas (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Gas (GHS definition). It was classified as "Not classified (Not applicable)."
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Based on (1), since it is a gas at normal temperature, it was classified as "Not classified." [Evidence Data] (1) Gas (GHS definition). [Reference Data, etc.] (2) Liquefied n-butane may cause chemical freezing on the skin and eyes (DFGOT vol.20 (2003), PATTY (6th, 2012)).
3	Serious eye damage/eye irritation	*	- -	-	-	[Rationale for the Classification] Based on (1), since it is a gas at normal temperature, it was classified as "Not classified." [Evidence Data] (1) Gas (GHS definition). [Reference Data, etc.] (2) This substance is not irritating to the eyes of rabbits (DFGOT vol.20 (2003)). (3) Liquefied n-butane may cause chemical freezing on the skin and eyes (DFGOT vol.20 (2003), PATTY (6th, 2012)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] There are no in vivo data of this substance itself. Therefore, it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Reference Data, etc.] (1) As for in vivo, there is a report of a positive result in a mouse erythrocyte micronucleus test by inhalation exposure to domestic cooking gas containing this substance (PATTY (6th, 2012)). However, it was not reproducible in a confirmatory test, which gave a negative result (McKee et al, Int J Toxicol., 33 (1) suppl, 28S-51S, 2014). (2) As for in vitro, there is a report of a negative result in a bacterial reverse mutation test (DFGOT vol.20 (2003), PATTY (6th, 2012), ACGIH (7th, 2017)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Based on (1), no effects were observed on reproduction and development, however, this test was a screening test and there were no data on developmental toxicity tests. Therefore, it was classified as "Classification not possible" due to lack of data. [Evidence Data] (1) A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats by inhalation exposure was conducted. No toxicologically important changes were observed in parental animals, and no reproductive or developmental effects were observed (McKee et al, Int J Toxicol., 33 (1) suppl, 28S-51S, 2014). [Reference Data, etc.] (2) A woman who suffered severe intoxication with butane gas in Week 27 of gestation (no other details), gave birth to a child with hydranencephaly. The authors suspect that the malformation was caused by intrauterine anoxia during development of the fetal brain (DFGOT vol.20 (2003)). (3) A woman who attempted suicide with butane gas in week 30 of gestation, gave birth to a child that died 11 hours after the birth. Severe multi-cystic encephalomalacia was diagnosed. It was considered not to be a substance-specific effect of butane gas, but damage caused by maternal anoxia (DFGOT vol.20 (2003)). (4) It is described in PATTY (6th, 2012) that both of the above case reports suggest that butane exposure to pregnant women can cause significant neurodevelopmental damage to the fetus.
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on reports of narcotic effects on humans and animals in (1)-(4), it was classified in Category 3 (narcotic effects). [Evidence Data] (1) As for humans, there is a report that dizziness was observed after inhalation at 10,000 ppm of this substance for 10 minutes (DFGOT vol.20 (2003)). (2) There is a description that the concentration where narcotic effects to humans by this substance is produced is 17,000 ppm (DFGOT vol.20 (2003)). (3) There is a report that euphoria and hallucinations were observed in most of 12 persons who repeatedly inhaled butane gas (DFGOT vol.20 (2003)). It is considered that these effects were probably observed also on first inhalation exposure. (4) As for mice, there is a report that anesthetic action was observed after inhalation at 130,000 ppm of this substance for 25 minutes (ACGIH (7th, 2001), DFGOT vol.20 (2003), PATTY (6th, 2012)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1)-(3), it was classified in Category 1 (central nervous system). The classification result was changed from the previous classification by the addition of the new information sources. [Evidence Data] (1) Severe brain damage developed in a 15-year-old girl who abused butane gas from lighter refill cans for 4 weeks, and neurological complications developed after hospitalization. As a result of MRI scans, disintegrating gray matter and cerebral atrophy, etc. were observed (PATTY (6th, 2012)). (2) There are some reports that neurological symptoms such as visual or auditory hallucinations developed in young men and women who abused butane gas (PATTY (6th, 2012)). (3) There is a report that euphoria and hallucinations were observed in most of 12 persons who repeatedly inhaled butane gas (DFGOT vol.20 (2003)). [Reference Data, etc.] (4) Significant neurological effects and deaths due to butane gas abuse were reported. Most of the victims were young men, and deaths were attributed to hypoxia and cardiac failure (ACGIH (7th, 2017)). (5) In 22 workers exposed to 8,000 mg/m3 in a liquid gas filling station of propane and butane, a dry throat, a dry cough, severe agitation and dizziness are reported. As a result of electrocardiography, tachycardia, extrasystoles and incomplete right bundle-branch block were observed (DFGOT vol.20 (2003), ACGIH (7th, 2017)). (6) A 28-year-old man who filled butane and propane gases was admitted to the hospital complaining of nausea, etc. He was diagnosed with acute hepatitis, likely due to chronic exposure to butane and propane (PATTY (6th, 2012)). (7) Butane and isobutane increase the sensitivity of the heart muscle to adrenaline (mechanism is unknown) (DFGOT vol.20 (2003)).
10	Aspiration hazard	*	- -	-	-	[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 Short term (Acute)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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.

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