GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 106-99-0
Chemical Name 1,3-Butadiene
Substance ID H29-B-038
Classification year (FY) FY2017
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 FY2006  
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
-
-
- - Gas (GHS definition)
2 Flammable gases (including chemically unstable gases) Category 1


Danger
H220 P210
P377
P381
P403
From explosion limit (1.1-16.3% (ICSC (J) (2000))), it was classified in Category 1. Besides, the stabilized one is classified in Division 2.1 in UNRTDG (UN 1010). Besides, it is evaluated as "Not classified" as chemically unstable gas (UNRTDG Manuals of Tests and Criteria 5th Revised Edition, p.37).
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not classified
-
-
- - It is flammable gases (Dicision 2.1in UNRTDG).
5 Gases under pressure Liquefied gas


Warning
H280 P410+P403 A boiling point is -4 deg C (ICSC (J) (2000)), and liquid phase exists partially at temperatures below that at normal pressures. Low pressure liquefied gas (a critical temperature 161.8 deg C (HSDB (Access on June 2017))).
6 Flammable liquids Not applicable
-
-
- - Gas (GHS definition)
7 Flammable solids Not applicable
-
-
- - Gas (GHS definition)
8 Self-reactive substances and mixtures Not applicable
-
-
- - Gas (GHS definition)
9 Pyrophoric liquids Not applicable
-
-
- - Gas (GHS definition)
10 Pyrophoric solids Not applicable
-
-
- - Gas (GHS definition)
11 Self-heating substances and mixtures Not applicable
-
-
- - Gas (GHS definition)
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- - Gas (GHS definition)
13 Oxidizing liquids Not applicable
-
-
- - Gas (GHS definition)
14 Oxidizing solids Not applicable
-
-
- - Gas (GHS definition)
15 Organic peroxides Not applicable
-
-
- - Gas (GHS definition)
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to gas substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not applicable
-
-
- - Gas (GHS definition)
1 Acute toxicity (Dermal) Not applicable
-
-
- - Gas (GHS definition)
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - Based on a report of an LC50 value of 129,000 ppm in a 4-hour inhalation test with rats (ACGIH (7th, 2001), EU-RAR (2002), Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2012)), it was classified as "Not classified."
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - Gas (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Not applicable
-
-
- - Gas (GHS definition)
2 Skin corrosion/irritation Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, there is a case report that skin frostbite was caused by contact with liquefied 1,3-butadiene (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2012)).
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
There are reports that in eye irritation tests in which mice were exposed to this substance (gas) at 90,000-140,000 ppm and rabbits at 150,000-250,000 ppm, conjunctivitis or lacrimation occurred (EU-RAR (2002)), and there is a case of workers who were exposed to this substance (gas) at 2,000 ppm for 7 hours or at 4,000 ppm for 6 hours and showed eye irritation (ATSDR (2012), EU-RAR (2002)). Also, since it is considered to be irritating to the eyes of humans and animals, it was classified in Category 2. Besides, there is a description that since butadiene is in a gaseous state at room temperatures, it is impossible to conduct a conventional eye irritation test (EU-RAR (2002)).
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
5 Germ cell mutagenicity Category 1B


Danger
H340 P308+P313
P201
P202
P280
P405
P501
As for in vivo, a mouse dominant lethal test was positive, a mouse reciprocal translocation test was positive, micronucleus tests with mouse bone marrow cells and peripheral blood were positive, micronucleus tests with rat bone marrow cells and peripheral blood were negative, a chromosomal aberration test with mouse bone marrow cells was positive, a chromosomal aberration test with rat bone marrow cells was negative, a mouse spot test was positive, transgenic mouse gene mutation tests were positive in bone marrow cells and spleen cells, a gene mutation test with mouse splenic T-lymphocytes was positive, a micronucleus test and a sister chromatid exchange test with mouse germ cells were positive, a sister chromatid exchange test with mouse bone marrow cells was positive, DNA damage tests with the liver, lung and testes of mice and rats were positive, and unscheduled DNA synthesis tests with the liver of mice and rats were negative (Hazard Assessment Report (CERI, NITE, 2008), CICAD 30 (2001), ATSDR (2012), EU-RAR (2002), CaPSAR (1999)). As for in vitro, bacterial reverse mutation tests were positive and negative results, a mouse lymphoma test with mammalian cultured cells was negative, sister chromatid exchange tests were positive and negative results (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2012), EU-RAR (2002)). From the above, it was classified in Category 1B according to the GHS classification guidance for the Japanese government.
6 Carcinogenicity Category 1A


Danger
H350 P308+P313
P201
P202
P280
P405
P501
The epidemiological studies in the styrene-butadiene rubber manufacturing industry indicated an excess of leukemia due to occupational exposure, and revealed it has a dose-response relationship with cumulative exposure to butadiene. In addition, in the studies in the butadiene monomer industry, excesses of leukemia and malignant lymphomas due to occupational exposure were shown (IARC 100F (2012)). On the other hand, as for experimental animals, in carcinogenicity tests with rats and mice exposed by inhalation, increases in tumor incidence in multiple organs were observed in females and males of both species (IARC 100F (2012)). IARC classified this substance in Group 1 as there is sufficient evidence of carcinogenicity in both humans and experimental animals (IARC 100F (2012)). Other than this, NTP classified it as K (NTP RoC (14th, 2016)), EPA as CaH (IRIS (2002)), and EU in Carc. 1A (ECHA CL Inventory (Access on June 2017)), and Japan Society For Occupational Health (JSOH) in Group 1 (Recommendation of Occupational Exposure Limits (2016): proposal in 2001), respectively. From the above, it was classified in Category 1A.
7 Reproductive toxicity Category 1B


Danger
H360 P308+P313
P201
P202
P280
P405
P501
In a test in which male mice were exposed by inhalation at 200-5,000 ppm for 5 days and were mated with untreated females, an increase in the number of females that showed intrauterine deaths was observed at or above 200 ppm (ATSDR (2012)). In addition, in the two tests in which male mice were exposed by inhalation at 65 ppm for 4 weeks or at 12.5 ppm for 10 weeks, and subsequently were mated with untreated females, an increase in early fatal death in the former, and an increase in late fetal death, exencephaly, and skeletal abnormalities in the latter were observed (ATSDR (2012)). On the other hand, in the developmental toxicity test in which pregnant rats or pregnant mice were exposed by inhalation at up to 1,000 ppm during organogenesis period (gestational day 6-15), no abnormality was observed in rats even in the 1,000 ppm exposure group, and only slight effects (low values of fetuses body weight, extra rib, delayed ossification) were observed in mice (ATSDR (2012), Hazard Assessment Report (CERI, NITE, 2008), EU-RAR (2002)). However, in a developmental toxicity test in which pregnant rats were exposed by inhalation at up to 8,000 ppm during the organogenesis period (gestational day 6-15), decreased body weight gain in maternal animals at or above 200 ppm, increased frequency of skeletal abnormality (wavy ribs) in fetuses at or above 1,000 ppm were observed, and at 8,000 ppm, increased frequency of major skeletal defects including the skull, vertebra, sternum, long bones, and ribs in the fetuses were observed additionally (ATSDR (2012), Hazard Assessment Report (CERI, NITE, 2008), EU-RAR (2002)).
From the above, in the three tests in which male mice were mated with untreated females after inhalation exposure, increased fetus deaths were observed at a dose where no general toxicity effect was manifested in parental animals, and in one test among them, external malformations and skeletal abnormalities were observed. Skeletal abnormalities were also detected in the developmental toxicity tests where pregnant rats were exposed at high concentrations during an organogenesis period. Therefore, it was classified in Category 1B for this hazard class. Besides, since it was classified based on the new information source, the classification result was changed from the previous one.
8 Specific target organ toxicity - Single exposure Category 3 (respiratory tract irritation, narcotic effects)


Warning
H335
H336
P304+P340
P403+P233
P261
P271
P312
P405
P501
As for humans, there is a report that the workers who were exposed to this substance during handling in the rubber manufacturing plant complained of irritation of the nose and throat, and cough and drowsiness were also observed in some of them, but these symptoms disappeared when the exposure finished (EU-RAR (2002), ATSDR (2012)). Additionally, there is a report that in a test with volunteers, slight irritation and dryness of the nose and throat were observed by exposure at 10,000 ppm for 5 minutes (EU-RAR (2002)). As for experimental animals, there is a report that in a single inhalation exposure test with mice, no effect was observed at 100,000 ppm, but mild narcotic effects were observed at 150,000 ppm, and exposure at 200,000 ppm for 6-12 minutes lead to an anesthetized state after excitement (ACGIH (7th, 2001)). Also, there is a report that in a single inhalation exposure test with rats, exposure at 129,000 ppm for an hour lead to a deep anesthetized state (EU-RAR (2002)). Additionally, there is a report that in a single inhalation exposure test with rabbits, exposure at 250,000 ppm for 25-30 minutes lead to an anesthetized state followed by death, but the animals recovered rapidly in the case of exposure for an extremely short time (ACGIH (7th, 2001)). Moreover, there is a description that this substance has been known as a relatively weak central nervous system depressant for over 50 years (ACGIH (7th, 2001)). From the above information, it was classified in Category 3 (respiratory tract irritation, narcotic effects).
9 Specific target organ toxicity - Repeated exposure Category 1 (genetic organs (women)), Category 2 (heart, haemal system, liver)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
No information on humans is available.
As for experimental animals, there is a report that in 2-year inhalation toxicity tests with mice, ovarian atrophy at or above 6.25 ppm within the guidance value range for Category 1, a decrease in the survival rate at or above 20 ppm, thymus atrophy, myocardial mineralization, macrocytic anemia, centrilobular necrosis of the liver at or above 62.5 ppm within the guidance value range for Category 2, and bone marrow atrophy and testicular atrophy, etc. at 625 ppm exceeding the guidance value range for Category 2 were observed (Hazard Assessment Report (CERI, NITE, 2008), NTP TR434 (1993)).
Therefore, it was classified in Category 1 (genetic organs (women)), Category 2 (heart, haemal system, liver).
Besides, in the previous classification, the bone marrow and testes were adopted as the target organ for Category 2. However, reconfirmation revealed that this was a finding at a dose exceeding the guidance value of Category 2, therefore, the classification result was changed.
10 Aspiration hazard Not applicable
-
-
- - Gas (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
-
-
- - Reliable acute toxicity data were not obtained
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- - No data available.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


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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