GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 115-11-7
Chemical Name Isobutene [2-methylpropene or isobutylene]
Substance ID H27-B-005/C-026B_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 FY2008  
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 applicable
-
-
- - "Gases" according to GHS definition.
2 Flammable gases (including chemically unstable gases) Category 1


Danger
H220 P210
P377
P381
P403
It is classified in class 2.1 in UNRTDG (UN1055) (lower explosion limit 1.8%, upper limit 9.6% (ICSC (2000))).
3 Aerosols Not applicable
-
-
- - Not an aerosol product.
4 Oxidizing gases Not classified
-
-
- - It was classified in Flammable gases of class 2.1 in UNRTDG.
5 Gases under pressure Liquefied gas


Warning
H280 P410+P403 From a critical temperature of 144.7 degrees C (GESTIS (Access on June 2015)) above 65 degrees C, it was classified in liquefied gas (low pressure liquefied gas).
6 Flammable liquids Not applicable
-
-
- - "Gases" according to GHS definition.
7 Flammable solids Not applicable
-
-
- - "Gases" according to GHS definition.
8 Self-reactive substances and mixtures Not applicable
-
-
- - "Gases" according to GHS definition.
9 Pyrophoric liquids Not applicable
-
-
- - "Gases" according to GHS definition.
10 Pyrophoric solids Not applicable
-
-
- - "Gases" according to GHS definition.
11 Self-heating substances and mixtures Not applicable
-
-
- - "Gases" according to GHS definition.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- - "Gases" according to GHS definition.
13 Oxidizing liquids Not applicable
-
-
- - "Gases" according to GHS definition.
14 Oxidizing solids Not applicable
-
-
- - "Gases" according to GHS definition.
15 Organic peroxides Not applicable
-
-
- - "Gases" according to GHS definition.
16 Corrosive to metals Classification not possible
-
-
- - No established test method suitable for gaseous substances.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not applicable
-
-
- - "Gases" according to GHS definition. Besides, it is reported that after 29.7 mg this substance was dissolved in 1 mL corn oil and administered by gavage to rats at a dose of 150 mg/kg, toxicity effects were not observed (SIDS (2012)), but the category cannot be determined only from this data.
1 Acute toxicity (Dermal) Not applicable
-
-
- - "Gases" according to GHS definition.
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - From a reported LC50 value (4 hours) of 270,000 ppm for rats (PATTY (6th, 2012), SIDS (2012), NTP TR487 (1998)), it was classified as "Not classified."
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - "Gases" according to GHS definition.
1 Acute toxicity (Inhalation: Dusts and mists) Not applicable
-
-
- - "Gases" according to GHS definition.
2 Skin corrosion/irritation Classification not possible
-
-
- - The classification is not possible due to lack of data.
Besides, it is written that contact with liquid butene could cause frostbite (SIDS (2012)).
3 Serious eye damage/eye irritation Classification not possible
-
-
- - The classification is not possible due to lack of data. Besides, it is written that 1-butene is mildly irritating to eyes (HSDB (Access on June 2015)).
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 Classification not possible
-
-
- - Because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government, it was classified as "Classification not possible." As for in vivo, a micronucleus test in mouse bone marrow cells and peripheral blood erythrocytes was negative (SIDS (2012), NTP TR487 (1998), ACGIH (7th, 2008)), and a DNA damage test (DNA adduct formation) in rats and mice was negative (ACGIH (7th, 2008)). As for in vitro, a bacterial reverse mutation test and a mouse lymphoma test in cultured mammalian cells were negative (NTP TR487 (1998), NTP DB (Access on July 2015), ACGIH (7th, 2008), SIDS (2012), PATTY (6th, 2012)).
6 Carcinogenicity Classification not possible
-
-
- - There is no carcinogenicity information in humans. As for experimental animals, a 2-year inhalation exposure carcinogenicity test using rats and mice was conducted, and thyroid follicular cell carcinomas were observed in 5/50 animals of male rats in an 8,000 ppm group of the highest concentration (SIDS (2012), ACGIH (7th, 2008)). However, evidence of carcinogenicity was not shown including thyroid gland in female rats and male and female mice, and there is the comment in both ACGIH and SIDS that it is unclear if thyroid tumors are applicable to humans (SIDS (2012), ACGIH (7th, 2008)), and ACGIH classified it in A4 (ACGIH (7th, 2008)). From the above, the substance was classified as "Classification not possible" for this hazard class.
7 Reproductive toxicity Classification not possible
-
-
- - In a teratogenicity test in which pregnant rats were in inhalation exposure to this substance on day 5 to 21 of gestation and fetuses were observed on day 22 of gestation, toxic effects were not observed in maternal animals and fetuses at the test concentrations up to 8,000 ppm. (SIDS (2012), ACGIH (7th, 2008)) However, because there are no test results investigating fertility effects of this substance, it was classified as "Classification not possible" due to lack of data.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - As for experimental animals (rats, mice), there is the information that an inhalation exposure (17.2-22.7%) to isobutene caused narcotic action within 10 minutes and it is reported that an inhalation exposure to 32% (320,000 ppm) of isobutene caused asphyxia (ACGIH (7th, 2008), SIDS (2012), PATTY (6th, 2012)). As for humans, it is reported that inhalation of isobutene could cause narcotic effects or asphyxia by decreasing available oxygen concentration (SIDS (2012)).
Because the asphyxia and narcotic effects mentioned above were due to a lack of oxygen in a limited space, the substance was classified as "the classification is not possible."
9 Specific target organ toxicity - Repeated exposure Not classified
-
-
- - There is no human information.
As for experimental animals, in an inhalation route, in a 14-week inhalation toxicity test using rats, minimal hypertrophy of goblet cells in the nasopharyngeal duct in nasal cavity was observed from the minimum concentration of 500 ppm. In a 105-week inhalation toxicity test using rats, minimal hypertrophy of goblet cells in the nasopharyngeal duct in the nasal cavity and increased hyaline degeneration of the olfactory epithelium in the nasal cavity were observed from the lowest concentration of 500 ppm. In mice, effects were not found in a 14-week inhalation toxicity test, and in a 105-week inhalation toxicity test, increased hyaline degeneration of respiratory epithelium in the nasal cavity was observed from the lowest concentration of 500 ppm, and increased hyaline degeneration of the olfactory epithelium was found from 2,000 ppm (NTP TR487 (1998)). However, there is the comment in SIDS (2012) that these effects found in mucous membrane in the nasal cavity were the non-specific adaptive reaction to irritating substance and not significant toxicity effects. It is concluded that NOAEL was 8,000 ppm (converted to an exposure condition equivalent: 6,222 ppm) in a 14-week inhalation toxicity test using rats, 2,000 ppm in 105-week inhalation toxicity test using rats, 8,000 ppm (converted to a exposure condition equivalent: 6,222 ppm) in an 14-week inhalation toxicity test using mice, and 8,000 ppm in a 105-week inhalation toxicity test using mice (SIDS (2012)). Therefore, it corresponds to "Not classified" in an inhalation route.
As for an oral route, in a 28-day gavage administration toxicity test using rats, effects were not observed up to the highest dose of 150 mg/kg/day (converted to a 90-day equivalent: 46.7 mg/kg/day) (SIDS 2012). However, due to this value within a range of Category 2, the classification is not possible for an oral route.
In the previous classification, the substance was classified as "the classification is not possible" due to no information in a dermal route. However, because the substance is a gas, and an inhalation route is considered to be the main exposure route, it was classified as "Not classified."
10 Aspiration hazard Not applicable
-
-
- - "Gases" according to GHS definition.

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
-
-
- - The classification is not possible because appropriate data are not obtained.
Besides, in SIDS, 96-hour EC50 = 14 mg/L for algae, 48-hour EC50 = 22 mg/L for crustacea, and 96-hour LC50 = 20 mg/L for fish as QSAR estimation are reported (all SIDS, 2012), however, they were not used for the classification.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- - The classification is not possible because appropriate data are not obtained.
Besides, in SIDS, 96-hour chronic value = 1.7 mg/L for algae, 16-day chronic value = 1.3 mg/L for crustacea, and 30-day chronic value = 2.7 mg/L for fish as QSAR estimation are reported (all SIDS, 2012), however, they were not used for the classification.
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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