NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	542-56-3
Chemical Name	Isobutyl nitrite
Substance ID	m-nite-542-56-3_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	- -	-	-	There is a chemical group present in the molecule associated with explosive properties (N-O), but it does not correspond to hazards of the highest precedence, explosives because it is classified in class 3 in UNRTDG (UN2351).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	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 (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Based on a flash point of -21 degrees C (closed cup) (Sigma-Aldrich (Access on June 2015)) and a boiling point of 67 degrees C (HSDB (Access on June 2015)), it was classified in Category 2. Besides, it is classified in class 3, PGII, III in UNRTDG (UN2351).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group present in the molecule associated with explosive properties (N-O), but it does not correspond to hazards of the highest precedence, self-reactive substances and mixtures because it is classified in class 3 in UNRTDG (UN2351).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It contains a chemical group associated with explosive properties (N-O), but it does not correspond to hazards of the highest precedence, pyrophoric liquids because it is classified in class 3 in UNRTDG (UN2351).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for liquid substances.	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)	- -	-	-	Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Classification not possible	- -	-	-	It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (N), but the classification is not possible due to no data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	"Liquids" 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)	- -	-	-	It is an organic compound that does not contain bivalent -O-O- structure in the molecule.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	From an LD50 value of 410 mg/kg for rats (ACGIH (7th, 2003)), it was classified in Category 4.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	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))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	From a reported LC50 value (4 hours) of 777 ppm for rats (ACGIH (7th, 2003), NTP TR448 (1996)), it was classified in Category 3. Besides, a reference value in the unit of ppm was applied as vapour without mist because the LC50 value is lower than the saturated vapour pressure concentration (12,833 ppm).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	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))
2	Skin corrosion/irritation	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))
3	Serious eye damage/eye irritation	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	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	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	As for in vivo, a micronucleus test using mouse peripheral blood erythrocytes resulted in positive in both males and females (NTP TR448 (1996), ACGIH (7th, 2003)). As for in vitro, a bacterial reverse mutation test, a mouse lymphoma test, a chromosomal aberration test, and a sister chromatid exchange test in cultured mammalian cells were all positive (ACGIH (7th, 2003), NTP TR448 (1996), NTP DB (Access on August 2015)). From the above, it was classified in Category 2.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	There is no carcinogenicity information in humans. As for experimental animals, in a carcinogenicity test using rats or mice in 2-year inhalation exposure, increased incidences of alveolar/bronchiolar adenoma or adenoma and carcinoma combined were observed in 2 higher dose groups (75, 150 ppm) in both males and females of rats and mice (NTP TR448 (1996), ACGIH (7th, 2003)). Moreover, it is written that in an experiment in which C57BL6 female mice were injected with PYB6 tumor cells (injection site not mentioned) and exposed by inhalation to this substance at 900 ppm for maximum 16 days and checked on tumor growth, tumor incidence increased 3-fold to 75% compared to 21% in a control group, and tumor growth rate increased 4-fold, and tumor growth acceleration by this substance was demonstrated (ACGIH (7th, 2003)). As the classification results in carcinogenicity by other organizations, it is classified in A3 by ACGIH (ACGIH (7th, 2003)) and Carc. 1B in EU CLP classification (ECHA CL Inventory (Access on June 2015)). As above, as evidence of carcinogenicity for this substance, there is solid evidence in experimental animals, but it is unknown at this time if interspecific extrapolation to humans is appropriate. Therefore, by prioritizing ACGIH, the substance was classified in Category 2.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	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))
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, respiratory organs, cardiovascular system, blood system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	This substance can be used as a drug to treat angina in humans (ACGIH (7th, 2003)). This substance is irritating to nasal cavity (ACGIH (7th, 2003)). Poisoning cases in humans include that of people who developed tracheobronchitis and methemoglobinemia and died after oral ingestion of this substance used as a room deodorizer. Moreover, pulmonary edema, tracheobronchitis, and methemoglobinemia were reported in inhalation exposure (above ACGIH (7th, 2003), NTP TR448 (1996), HSDB (Access on June 2015)). As for experimental animals, it is reported that in oral administration in mice at 184 mg/kg (the dose corresponding to Category 1), incoordination, "extensor rigidity," fasciculations, pallor of extremities, prostration, dyspnea, and death from anoxia by severe methemoglobinemia were observed, and mortality was decreased by administering methylene blue before dosing this substance. Moreover, the following was reported (ACGIH (7th, 2003), NTP TR448 (1996), HSDB (Access on June 2015)): incoordination, "extensor rigidity," fasciculations, convulsions, pallor of extremities, prostration, dyspnea, cyanosis, respiratory failure from severe methemoglobinemia, cardiovascular disturbance from hypotension and vasodilatation in inhalation exposure in rats at 777 ppm (3.28 mg/L) (the dose corresponding to Category 1); decreased "motor performance" in inhalation exposure in mice at 175-1,000 ppm (0.74-4.22 mg/L) (the doses corresponding to Category 1); and decreased red blood cells and hemoglobin, transient anemia shown by decreased hematocrit in mice at 900 ppm (3.80 mg/L) (the dose corresponding to Category 1). As other effects of this substance in experimental animals, effects on blood cell function, blood cell destruction, decreased "spleen cellularity," decreased T cell responsiveness, and "compromise of immunocompetence" were reported, and it is written that targets of acute toxicity by this substance are cardiovascular system and hematopoietic system (ACGIH (7th, 2003)). From the above, because this substance affects the central nervous system, respiratory organs, cardiovascular system, blood system, it was classified in Category 1 (central nervous system, respiratory system, cardiovascular system, blood system). By adding new information, the previous classification was revised.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (immune system), Category 2 (respiratory organs, blood system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	As for experimental animals, the following was observed (NTP TR448 (1996)): methemoglobinemia, anemia, and hemosiderosis in the spleen at 75 ppm (converted to a Guidance value equivalent: 0.23 mg/L) or higher, hyperplasia of the bronchiolar epithelium and hyperplasia of nasal mucosa at 150 ppm (converted to a Guidance value equivalent: 0.46 mg/L) or above in a 13-week inhalation toxicity test using rats; and hyperplasia of the bronchiolar epithelium, splenic extramedullary hematopoiesis, and hemosiderosis in the spleen at 75 ppm (converted to a Guidance value equivalent: 0.23 mg/L) or higher, methemoglobinemia at 150 ppm (converted to a Guidance value equivalent: 0.46 mg/L) or above, and anemia and hyperplasia of nasal mucosa at 300 ppm (converted to a Guidance value equivalent: 0.98 mg/L) in a 13-week inhalation toxicity test using mice. In a 14-day inhalation toxicity test using mice, decreased leukocytes, increased erythrocytes, and decreased granulocyte-monocyte colony forming cells (CFU-GM) were observed at 900 ppm (converted to a Guidance value equivalent: 0.078 mg/L), and reversibility was observed for decreased leukocytes and increased erythrocytes within one week after exposure. However, decreased granulocyte-monocyte colony forming cells was not reversible within one week after exposure (ACGIH (7th, 2003)). As above, in both rats and mice, findings related to methemoglobinemia and anemia and findings of irritation to respiratory system were observed within a range of Category 2, and effects on the immune system were found within a range of Category 1. Therefore, the substance was classified in Category 1 (immune system), Category 2 (respiratory system, blood system).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	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))

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.	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	- -	-	-	No data.	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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