GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 542-56-3
Chemical Name Isobutyl nitrite
Substance ID H27-B-029/C-050B_P
Classification year (FY) FY2015
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 FY2012   FY2007  
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 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).
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - "Liquids" according to GHS definition.
3 Aerosols Not applicable
-
-
- - Not an aerosol product.
4 Oxidizing gases Not applicable
-
-
- - "Liquids" according to GHS definition.
5 Gases under pressure Not applicable
-
-
- - "Liquids" according to GHS definition.
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).
7 Flammable solids Not applicable
-
-
- - "Liquids" according to GHS definition.
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).
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).
10 Pyrophoric solids Not applicable
-
-
- - "Liquids" according to GHS definition.
11 Self-heating substances and mixtures Classification not possible
-
-
- - No established test method suitable for liquid substances.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- - Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
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.
14 Oxidizing solids Not applicable
-
-
- - "Liquids" according to GHS definition.
15 Organic peroxides Not applicable
-
-
- - It is an organic compound that does not contain bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - Due to no data, the classification is not possible.

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
From an LD50 value of 410 mg/kg for rats (ACGIH (7th, 2003)), it was classified in Category 4.
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - "Liquids" according to GHS definition.
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).
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
2 Skin corrosion/irritation Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
3 Serious eye damage/eye irritation Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
4 Respiratory sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
4 Skin sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
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.
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.
7 Reproductive toxicity Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, respiratory organs, cardiovascular system, haemal 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.
9 Specific target organ toxicity - Repeated exposure Category 1 (immune system), Category 2 (respiratory organs, haemal 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).
10 Aspiration hazard Classification not possible
-
-
- - Due to lack of data, the classification is not possible.

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


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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