NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	540-80-7
Chemical Name	tert-Butyl nitrite
Substance ID	m-nite-540-80-7_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	- -	-	-	Because a marketed product containing a stabilizer is classified in class 3 in UNRTDG (UN2351), the classification "Not classified" is conceivable, though it contains a chemical group (N-O) associated with explosive properties. Besides, sub-categorization is not possible because a pure form is an unstable substance (Many alkyl nitrites are thermally unstable and may readily decompose or explode on heating. Methyl nitrite explodes more violently than ethyl nitrite. Lower alkyl nitrites have been known to decompose and burst the container, even in refrigerated storage.) (Bretherick (7th, 2007)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	A flash point of -13 degrees C [closed cup] (Bretherick (7th, 2007)), which is < 23 degrees C, and an initial boiling point of 63 degrees C (Merck (14th, 2006)), which is > 35 degrees C, correspond to Category 2. Besides, it is classified in 3PGII in UNRTDG (UN2351).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Type G	- -	-	-	Because a marketed product containing a stabilizer is classified in class 3 in UNRTDG (UN2351), it was classified in Type G, though it contains a chemical group (N-O) associated with explosive properties. Besides, sub-categorization is not possible because a pure form is an unstable substance (Many alkyl nitrites are thermally unstable and may readily decompose or explode on heating. Methyl nitrite explodes more violently than ethyl nitrite. Lower alkyl nitrites have been known to decompose and burst the container, even in refrigerated storage.) (Bretherick (7th, 2007)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for liquid substances.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Classification not possible	- -	-	-	An organic compound contains oxygen which is chemically bonded to nitrogen, but the classification is not possible due to no data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain -O-O- structure.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	On the basis of an LD50 value of 308 mg/kg for mice (7-day observation) (Research Communication in Substances of Abuse vol.3, No.2 (1982)), it was classified in Category 4. Besides, there is an LD50 value of 336 mg/kg for mice (2-hour observation) (PATTY (5th, 2001)). It is classified in Xn; R22 in EU classification (EC-JRC (ESIS) (Access on July. 2011)). Refer to analog compounds such as n-butyl nitrite (CAS Number: 544-16-1) and isobutyl nitrite (CAS Number: 542-56-3).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	On the basis of an LC50 value of 10852 ppm/1h = 5426 ppm/4h for mice (PATTY (5th, 2001)), it was classified in Category 4. Besides, a reference value of gasses as vapour with hardly included mist is applied because the LC50 value (10852 ppm/1h) is lower than 90 % of the saturated vapour pressure concentration (230269 ppm). In addition, it is classified in Xn; R20 in EU classification (EC-JRC (ESIS) (Access on July. 2011)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (cardiovascular system, blood system, nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	There is the information on nitrites that inhalation of high concentration relaxes smooth muscle, and the consequent intense peripheral vasodilation produces flushing, a fall in blood pressure, and a reflex increase in heart rate to maintain perfusion of vital organs (NIDA Research Monograph 83 (1988)), and that nervous system symptoms such as a headache, dizziness, ataxia, syncope, sedative action, a sense of weakness are observed (meeting material of the Committee on Designated Substances, Pharmaceutical Affairs and Food Sanitation Council, MHLW (2006)), therefore, it was classified in Category 1 (cardiovascular system, nervous system). Furthermore, effects of this substance on blood are also indicated from the information that nitro compounds such as nitrate and nitrite cause methemoglobinemia to animals (PATTY (5th, 2001)), side effects of medical isopentyl nitrite includes methemoglobinemia, cyanosis, and hemolytic anemia (Ethical pharmaceuticals (2010)), and butyl nitrites have a feature of methemoglobin formation in mice (NIDA Research Monograph 83 (1988)), therefore, it was classified in Category 1 (blood system). Besides, there is information that this substance is less potent in methemoglobin formation than n-butyl nitrite and isobutyl nitrite (NIDA Research Monograph 83 (1988)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	Lack of data. A repeated inhalation study in which mice were exposed to 1000 ppm (4.21 mg/L) for 7 hours a day for 60 days (a converted value for 6 hours a day for 90 days: 3.0 mg/L) reported that less than 20 % mortality was caused and major affected parameters were body weights, organ weights, and methemoglobinemia (PATTY (5th, 2001)), but the test was conducted by only one dose above a range of guidance values and details are unknown, therefore, the classification is not possible. Besides, it was considered to be a test by a vapour because the test concentration (1000 ppm) is lower than the saturated vapour pressure concentration (230263 ppm).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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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