GHS Classification Result

“ϊ–{Œκ‚Ε•\Ž¦



GENERAL INFORMATION
Item Information
CAS RN 25167-67-3
Chemical Name Butene (all isomers)
Substance ID H27-A-001, C-001A_P
Classification year (FY) FY2015
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
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 (UN1012) (a lower explosion limit 1.6 to 1.8, an upper limit 9 to 10 % (ACGIH (7th, 2008))).
3 Aerosols Not applicable
-
-
- -  Not an aerosol product.
4 Oxidizing gases Not classified
-
-
- -  It is classified in class 2.1 in UNRTDG (UN1012) and flammable gases.
5 Gases under pressure Liquefied gas


Warning
H280 P410+P403  From critical temperatures (146.5 degrees C (1-butene), 155.5 degrees C (trans-2-butene), 162.4 degrees C (cis-2-butene), 144.7 degrees C (isobutene)) (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.
1 Acute toxicity (Dermal) Not applicable
-
-
- -  "Gases" according to GHS definition.
1 Acute toxicity (Inhalation: Gases) Classification not possible
-
-
- -  The classification is not possible due to lack of data.
 The category cannot be determined from a reported LC50 value (4 hours) > 10,000 ppm for rats for a mixture consisting of trans-2-butene (55.3 vol%), cis-2-butene (42.4 vol%), and others (n-butane, 1-butene, and so on) (2.3 vol%) (SIDS (2012)).
 Besides, an LC50 value (4 hours) 270,000 ppm for rats of isobutene is reported (SIDS (2012)).
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 reported in SIDS (2012) that a liquefied product of 2-butene could cause frostbite in direct contact with skin.
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
-
-
- -  The classification is not possible due to lack of data. There is no in vivo information on a mixture of butene isomers.
 As for in vivo data on isomers, it is reported a micronucleus test using mice on 1-butene was negative (SIDS (2012), ACGIH (7th, 2001)). As for isobutene, it is reported a DNA adduct formation test using rats and mice was negative and a micronucleus test using mouse bone marrow cells was negative (SIDS (2012), ACGIH (7th, 2001)).
 As for in vitro, it is reported a bacterial reverse mutation test was negative (NTP DB (Access on June 2015)).
 As in vitro data on isomers, it is reported that a bacterial reverse mutation test on 1-butene was negative (SIDS (2012), ACGIH (7th, 2001)), a bacterial reverse mutation test and in vitro mammalian cell chromosomal aberration test on 2-butene were negative (SIDS (2012), ACGIH (7th, 2001)), and a bacterial reverse mutation test , a mouse lymphoma test, a transformation test using mouse embryo fibroblast cells, and a micronucleus test using human lymphocytes on isobutene were negative (SIDS (2012), ACGIH (7th, 2001)).
6 Carcinogenicity Classification not possible
-
-
- -  There is no human carcinogenicity information on a mixture of butene isomers.
 As for experimental animals, a carcinogenicity test using rats and mice with 2-year inhalation exposure was conducted only on isobutene which is one of the isomers, and in male rats, follicular cell carcinomas in the thyroid were observed in 5/50 animals of the highest concentration 8,000 ppm group (SIDS (2012), ACGIH (7th, 2008)). However, because the evidence of carcinogenicity, including the thyroid, was not shown in female rats nor male or female mice, and the relevance of thyroid tumor formation in for humans is unclear (SIDS (2012), ACGIH (7th, 2008)), ACGIH classified the carcinogenicity of isobutene in A4 (ACGIH (7th, 2008)). Because isobutene is classified in A4 by ACGIH and no information on the other isomers is not available, a mixture of butene isomers was classified as "Classification not possible."
7 Reproductive toxicity Classification not possible
-
-
- -  No reproductive toxicity data on a mixture of butene isomers.
 As for data on isomers, rats were in inhalation exposure to 1-butene (purity not less than 99%) or 2-butene (a mixture of cis- and trans-isomers, purity not less than 95%) two weeks before mating, through mating and gestation periods in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422). No effects on sexual organs and fertility of parent animals and no effects on survival rate and growth until four days after the birth of the offspring are observed (SIDS (2012), ACGIH (7th, 2008)).
 Besides, in a teratogenicity test in which pregnant rats were in inhalation exposure to isobutene on day 5 to 21 of gestation, maternal toxicity, fetal toxicity, or teratogenicity were not observed (SIDS (2012), ACGIH (7th, 2008)).
 From the above, in the tests on an individual isomer neither reproductive nor developmental toxicity were found. However, the reproductive toxicity tests other than the teratogenicity test on isobutene were screening tests and it is considered that there is no data set which completely deny the effects on reproductive/developmental toxicity of each isomer. Therefore, the substance 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), it is reported that the inhalation exposure to isobutene, 1-butene, cis-2-butene, or trans-2-butene (17.2 to 22.7%) caused narcotic action within 10 minutes and that asphyxia was caused after the inhalation exposure to 1-butene, cis-2-butene, or trans-2-butene of 21-27% (210,000-270,000 ppm), isobutene of 32% (320,000 ppm) (ACGIH (7th, 2008), SIDS (2012), PATTY (6th, 2012)).
 As for humans, it is reported that the inhalation of isobutene could cause narcotic action or asphyxia by reducing the available concentration of oxygen (SIDS (2012)).
 Because the asphyxia and narcosis mentioned above were due to lack of oxygen in a limited space, the substance was classified as "Classification not possible." Besides, there is no information on a mixture of butenes.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- -  No repeated dose toxicity information on a mixture of butene isomers.
 As for experimental animals, toxicity information in an inhalation route was obtained on 1-butene, 2-butene, and isobutene that are the isomers, and toxicity information in an oral route was obtained on isobutene.
 Regarding an inhalation route, toxicity effects were not observed on 1-butene and 2-butene up to doses of 5,000 ppm or 8,000 ppm in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test using rats by an inhalation route (SIDS (2012)). The doses correspond to a dose above Category 2. However, because these tests are screening tests and there is not sufficient information, the classification is not possible.
 Regarding isobutene, in a 14-week inhalation toxicity test using rats, minimal hypertrophy of goblet cells in the nasopharyngeal duct in the nasal cavity was observed from the lowest concentration of 500 ppm. In a 105-week inhalation toxicity test using rats, increased hyaline degeneration of the olfactory epithelium in the nasal cavity was observed from the lowest concentration of 500 ppm. With mice, no effect was observed in a 14-week inhalation toxicity test and in a 105-week inhalation toxicity test, increased hyaline degeneration of the respiratory epithelium in the nasal cavity were observed from the lowest concentration of 500 ppm and increased hyaline degeneration of the olfactory epithelium from 2,000 ppm (NTP TR487 (1998)).
 However, SIDS remarked that these effects on mucous membrane in the nasal cavity were non-specific and adaptive changes to an irritant and not significant toxic effects and that the NOAEL was 8,000 ppm (a converted value based on an exposure condition: 6,222 ppm) in a 14-week inhalation toxicity test using rats, 2,000 ppm in a 105-week inhalation toxicity test using rats, 8,000 ppm (a converted value based on an exposure condition: 6,222 ppm) in a 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."
 Besides, isobutene was dissolved in olive oil in a freezer to make a solution which was used in a 28-day gavage administration toxicity test using rats. Although no effects were observed up to the highest dose of 150 mg/kg/day (a converted value from dosing days: 46.7 mg/kg/day), the classification is not possible due to being within a range of Category 2 (SIDS (2012)).
 Because a mixture of butene isomers is gas and an inhalation route is considered to be the principal exposure route, it is estimated to be "Not classified."
 But it was classified as "Classification not possible" due to lack of data.
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, 96-hour EC50 = 12 to 15 mg/L for algae, 48-hour EC50 = 19 to 23 mg/L for crustacea, and 96-hour LC50 = 18 to 21 mg/L for fish as QSAR estimation (all SIDS, 2012) are reported in SIDS, but 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, a 96-hour chronic value = 1.6 to 1.8 mg/L for algae, a 16-day chronic value = 1.2 to 1.4 mg/L for crustacea, and a 30-day chronic value = 2.4 to 2.9 mg/L for fish as QSAR estimation (all SIDS, 2012) are reported in SIDS, but 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 iGHSj in United Nations.

To GHS Information