GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 540-80-7
Chemical name tert-Butyl nitrite
Substance ID 23A5110
Fiscal year of classification conducted FY2011
Classifier(s) (Ministries) Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
New/Revised New
Download in Excel format Excel file

REFERENCE INFORMATION

Item Information
Guidance used for classification (External link) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010)
Environmental Hazards: UN GHS Document (4th revised edition)
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
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
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)).
2 Flammable gases (including chemically unstable gases) Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
3 Aerosols Not applicable - - - Not an aerosol product.
4 Oxidizing gases Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
5 Gases under pressure Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
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).
7 Flammable solids Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
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)).
9 Pyrophoric liquids Classification not possible - - - No data.
10 Pyrophoric solids Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
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 semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
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.
14 Oxidizing solids Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
15 Organic peroxides Not applicable - - - An organic compound that does not contain -O-O- structure.
16 Corrosive to metals Classification not possible - - - No data.

HEALTH HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
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).
1 Acute toxicity (Dermal) Classification not possible - - - No data.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
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)).
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - No data.
2 Skin corrosion/irritation Classification not possible - - - No data.
3 Serious eye damage/eye irritation Classification not possible - - - No data.
4 Respiratory sensitization Classification not possible - - - No data.
4 Skin sensitization Classification not possible - - - No data.
5 Germ cell mutagenicity Classification not possible - - - No data.
6 Carcinogenicity Classification not possible - - - No data.
7 Reproductive toxicity Classification not possible - - - No data.
8 Specific target organ toxicity - Single exposure Category 1 (cardiovascular system, blood system, nervous system)

Danger
H370
P307+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)).
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).
10 Aspiration hazard Classification not possible - - - No data.

ENVIRONMENTAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
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 - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* 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.



Updated date:
2016/8/17 Addition of Rationale for the classification

List of GHS Classification Results