NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	542-56-3
Chemical Name	Isobutyl nitrite
Substance ID	24B6510
Classification year (FY)	FY2012
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	FY2007
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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 classified	- -	-	-	There is a chemical group associated with explosive properties (N-O) present in the molecule. However, because it is classified in Class 3 in UNRTDG (UN2351), not corresponding to hazards of the highest precedence, explosives, Class 1, it was classified as "Not classified."
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It corresponds to Category 2 from a flash point of -21 deg C [closed-cup] (MSDS (Sigma-Aldrich, 2010)) < 23 deg C and a boiling point of 67 deg C (Merck (14th, 2006)) > 35 deg C. Besides, it is classified in Class 3, PG II, III in UNRTDG (UN2351).
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group associated with explosive properties (N-O) present in the molecule. However, because it is classified in Class 3 in UNRTDG (UN2351), not corresponding to hazards of the highest precedence, self-reactive substances and mixtures (Division 4.1, PG I), it was judged to correspond to Type G.
9	Pyrophoric liquids	Not classified	- -	-	-	It was classified as "Not classified" because it is classified in Class 3 in UNRTDG (UN2351), not corresponding to hazards of the highest precedence, pyrophoric liquids.
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not applicable	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13	Oxidizing liquids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to the element other than carbon or hydrogen (nitrogen). However, the classification is not possible due to no data.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	It was classified in Category 4 based on an LD50 value of 410 mg/kg for rats (ACGIH (2003)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	It was classified in Category 3 based on an LC50 value (4-hour exposure) of 777 ppm for rats (NTP TR 448 (1996)). Besides, because the test concentration was lower than 90% of the saturated vapour pressure concentration (12833 ppm), the reference value of gas was applied as a vapour with little mist. Besides, it was classified in Xn; R20 in EU classification (EC-JRC (ESIS) (2012)).
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 2 based on a positive result in a micronucleus test with peripheral blood after 90-day inhalation exposure of mice (in vivo somatic cell mutagenicity test), although reactions were weak and not dose-dependent (NTP DB (Access on Apr. 2012)). Besides, as for in vitro tests, it is reported that it was positive in an Ames test (NTP DB (1982, 1987, 1988)), a chromosomal aberration test with CHO cells (NTP DB (Access on Apr. 2012)), and a mouse lymphoma test (ACGIH (2003)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 2 because ACGIH classified it in A3 for carcinogenicity (ACGIH (2003)). Besides, it is reported that in carcinogenicity tests by 2-year inhalation exposure of rats and mice, there was clear evidence of carcinogenicity in male and female rats based on increased incidences of alveolar/bronchiolar adenoma and alveolar/bronchiolar adenoma or carcinoma (combined), and there was some evidence of carcinogenicity in male and female mice based on increased incidences of alveolar/bronchiolar adenoma and alveolar/bronchiolar adenoma or carcinoma (combined) (NTP TR 448 (1996)).
7	Reproductive toxicity	Classification not possible	- -	-	-	No data available.
8	Specific target organ toxicity - Single exposure	Category 1 (haemal system, respiratory system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	Methemoglobinemia is a characteristic effect of exposure to nitrites and has been reported in animals and humans after oral administration or inhalation of this substance (NTP TR 448 (1996)). This substance is widely used as a room deodorizer, and there are reports on a person who developed methemoglobinemia and died after ingesting such a deodorizer (NTP TR 448 (1996)) and a 36-year-old man who ingested 15 mL of this substance and developed methemoglobinemia but recovered after injection of methylene blue (NTP TR 448 (1996)). Therefore, it was classified in Category 1 (blood system). On the other hand, it was classified in Category 1 (respiratory system) because acute inhalation exposure to this substance was reported to produce pulmonary edema and tracheobronchitis, and severe and prolonged tracheobronchitis was reported in a 23-year-old man who ingested two bottles of a room deodorizer containing this substance (NTP TR 448 (1996)). Besides, also in animal tests, oral administration to mice resulted in severe methemoglobinemia, and inhalation exposure of rats caused cyanosis, prostration, and (rarely) convulsions (NTP TR 448 (1996)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (haemal system, respiratory system)	Warning	H373	P260 P314 P501	In 13-week inhalation exposure tests with rats and mice, in rats, at or above 75 ppm (0.315 mg/L), very mild methemoglobinemia and anemia occurred, and there was hematopoietic hyperplasia in the bone marrow, which was considered to be a secondary response to the above, and hemosiderin pigment accumulation occurred in the spleen (NTP TR 448 (1996)). In mice, very mild methemoglobinemia at or above 150 ppm (0.630 mg/L) and very mild anemia at 300 ppm (1.260 mg/L) occurred, increased hematopoiesis of the spleen was observed in males at or above 75 ppm and females at or above 150 ppm, and increased hemosiderosis of the spleen was found in males at 300 ppm and females at or above 75 ppm (NTP TR 448 (1996)). From the above, because findings related to methemoglobinemia and anemia were seen in both rats and mice within the guidance value range for Category 2, it was classified in Category 2 (blood system). On the other hand, epithelial cell hyperplasia of the nasal mucosa in rats at 300 ppm and hyperplasia of the bronchiolar epithelium in mice at 300 ppm were observed, but these findings were also slightly seen at 75 ppm (0.315 mg/L) or 150 ppm (0.630 mg/L), which corresponds to the guidance values for Category 2 (NTP TR 448 (1996)). Therefore, it was classified in Category 2 (respiratory system).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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