GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 75-65-0
Chemical Name tert-Butanol
Substance ID 25B0053
Classification year (FY) FY2013
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 FY2010   FY2006  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance by the Japanese Government (July, 2013)
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
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - Solid (GHS definition)
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Solid (GHS definition)
5 Gases under pressure Not applicable
-
-
- - Solid (GHS definition)
6 Flammable liquids Not applicable
-
-
- - It is a solid (GHS definition). However, due to a melting point of 25.6 deg C, it became a liquid at higher temperatures. When it is in a liquid state, it corresponds to Category 2 due to a flash point of 11 deg C (closed-cup) (ICSC (2008)) and a boiling point of 83 deg C (ICSC (2008)).
7 Flammable solid Category 1


Danger
H228 P370+P378
P210
P240
P241
P280
From data on a flash point of 11 deg C (closed-cup) (ICSC (2008)), the substance is estimated to ignite and burn readily in contact with the fire source. Therefore, it was judged as Category 1.
8 Self-reactive substances and mixtures Not applicable
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable
-
-
- - Solid (GHS definition)
10 Pyrophoric solids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 470 deg C (ICSC (2008)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to solid (melting point <= 140 deg C) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable
-
-
- - Solid (GHS definition)
14 Oxidizing solids Not applicable
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule.
16 Corrosive to metals Not classified
-
-
- - This substance is a solid with a melting point of 55 deg C or lower, and its testing is possible, but there are no data. However, there is information that copper and aluminum can be used as a container in transporting the substance in a liquid state (Hommel (1996)), therefore, it was judged as "Not classified."

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - It was classified as "Not classified" (Category 5 in UN GHS classification) based on reports on LD50 values for rats of 2,298 mg/kg (females), 3,046 mg/kg (males) (Hazard Assessment Report (CERI, NITE, 2007)), 3,500 mg/kg (ACGIH (7th, 2001), NTP TR436 (1995), NTP TR53 (1997), PATTY (6th, 2012)), and 2,200-3,500 mg/kg (DFGOT vol. 19 (2003)).
1 Acute toxicity (Dermal) Not classified
-
-
- - It was classified as "Not classified" based on reports on an LD50 value for rabbits of > 2,000 mg/kg (Hazard Assessment Report (CERI, NITE, 2007), PATTY (6th, 2012)) and the description that no death was observed in a test with rabbits by an application at 2,000 mg/kg (DFGOT vol. 19 (2003)).
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - There are reports on LC50 values (4 hours) for rats of > 10,000 ppm (males and females) (Hazard Assessment Report (CERI, NITE, 2007)) and > 14,100 ppm (PATTY (6th, 2012)). Because it was not possible to determine Category 4 or "Not classified" with the data, it was classified as "Classification not possible." Besides, it is solid in the GHS definition, but vapour inhalation is estimated because there are reports on the melting point of 25 deg C (ICSC (2008)) and vapour pressure of 40.7 mmHg (25.6 deg C) (HSDB (Access on September 2013)). Both of the test concentrations above (10,000 ppm, 14,100 ppm) were lower than the saturated vapour pressure concentration (53,553 ppm), therefore a reference value in the unit of ppm was applied as a vapour with little dust/mist.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- - It is reported in DFGOT vol. 19 (2003) that in a test in which 0.5 mL of the undiluted test substance was applied to rabbits, no irritation was observed after 2 to 4 hours or 24 hours, and the skin irritation index was 0.4. It is reported in the Hazard Assessment Report (CERI, NITE, 2007) that slight skin irritation was seen in a test in which 0.5 mL of the test substance was applied to rabbit skin. And it is reported in ACGIH (7th, 2001) that in a test in which it was applied to five human subjects, slight erythema and hyperemia were found at the application site. It was classified as "Not classified" (Category 3 in UN GHS classification or "Not classified") based on the above information.
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280
It is described in the Hazard Assessment Report (CERI, NITE, 2007) that in a primary eye irritation test with rabbits, great (eyes not rinsed) or moderate (eyes rinsed) eye irritation is reported at the judgment 96 hours after the application of 100 microL, and corneal injury persisted in 2/6 animals even 34 days after the application. And it is described in DFGOT vol. 19 (2003) that in a test with rabbits, moderate irritation was observed for up to 96 hours after the undiluted test substance was applied to the eye, the induced corneal damage improved slowly, and the irritation was severe when eyes were not rinsed. This substance was classified in "Xi; R36/R38" in EU DSD classification and "Eye Irrit. 2 H319" in EU CLP classification. It was classified in Category 2A based on the above information.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - It is reported in DFGOT vol. 19 (2003) that in maximization tests with guinea pigs (OECD TG 406), no sensitization was observed in one test while positive rates were 25-30% in another test, which could not be judged as positive (judged to be positive in the GHS document if 30% or more animals react (when using adjuvant)). On the other hand, as for humans, one man who developed widespread itching erythema and vesicular eruption on the face, neck, arms, and chest from a sunscreen containing this substance was patch tested with a 70% solution of this substance, and erythema and bulla were found. Positive reactions are reported from cross-reaction to ethanol (Hazard Assessment Report (CERI, NITE, 2007)), and it is described that it cannot be concluded that this substance has significant sensitizing potential (DFGOT vol. 19 (2003)). Because the above information did not enable judging whether it is sensitizing, it was classified as "Classification not possible."
5 Germ cell mutagenicity Classification not possible
-
-
- - It was classified as "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. As for in vivo, it was negative in micronucleus tests with rat bone marrow cells and bone marrow cells and peripheral blood erythrocytes of mice (Hazard Assessment Report (CERI, NITE, 2007), NTP TR436 (1995), NTP DB (Access on September 2013)), and as for in vitro, it was negative in a bacterial reverse mutation test, a mouse lymphoma test and a chromosomal aberration test with cultured mammalian cells (Hazard Assessment Report (CERI, NITE, 2007), NTP TR436 (1995), IUCLID (2000)).
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, this substance was classified in A4 in ACGIH (1994), but there are no carcinogenicity assessments by other international organizations. Besides, in 2-year oral administration (drinking water) carcinogenicity tests with mice and rats on this substance, a significant increase in the incidence of follicular cell adenoma of the thyroid in the 20 mg/mL group of female mice and a significant increase in the incidence of renal tubule adenoma and adenocarcinoma (combined) in the 2.5 mg/mL group of male rats were observed (Hazard Assessment Report (CERI, NITE, 2007), NTP TR436 (1995)).
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
In a reproduction/developmental toxicity screening test (OECD TG 421) with rats in the oral route (gavage), an extension of a gestation period was observed at the dose where parent animals showed general toxicity (males: increased kidney weights, females: transient drowsiness, ataxia for 2-4 weeks after administration). Furthermore, an increased number of stillborn, a decreased number of offspring, lower body weights of offspring, and a decrease in the average litter size were found at the dose where increased liver weights in parent animals (males) and reduced weight gain during a gestation period in females were seen (Hazard Assessment Report (CERI, NITE, 2007)), and a dose-related decrease in litter size and an increase in the number of stillborn pups were observed after diet administration to mice on gestation days 6-20 (NTP TR53 (1997), Hazard Assessment Report (CERI, NITE, 2007), DFGOT vol. 19 (2003)). Moreover, after diet administration to rats from gestation day 8 to birth, decreased birth weights, reduced weight gain after birth, reduced litter size, and increased perinatal and postnatal mortality were shown at the dose where parent animals showed reduced weight gain (DFGOT vol. 19 (2003)). It was classified in Category 2 based on the above. Besides, no adverse effects on sexual function and fertility of parent animals or teratogenicity in the development of offspring were observed (Hazard Assessment Report (CERI, NITE, 2007), DFGOT vol. 19 (2003)).
8 Specific target organ toxicity - Single exposure Category 3 (narcotic effects, respiratory tract irritation)


Warning
H336
H335
P304+P340
P403+P233
P261
P271
P312
P405
P501
Central nervous system depression after oral administration (4,000-6,000 mg/kg) to rats (ACGIH (7th, 2001)) and narcotic effects after oral administration to rabbits or inhalation exposure in rats (ACGIH (7th, 2001), DFGOT vol. 19 (2003), Hazard Assessment Report (CERI, NITE, 2007), PATTY (6th, 2012)) were observed respectively, and drowsiness from exposure to high concentrations of the vapour was found (NIOSH Publications 81-123 (1978)). On the other hand, it is described that exposure for about 2 seconds caused nasal irritation in anosmic persons (DFGOT vol. 19 (2003)), and it was classified in R36/37 in EU classification. It was classified in Category 3 (narcotic effects, respiratory tract irritation) based on the above knowledge. Other than these findings, it is described that there were increased liver triglyceride levels after oral administration of 1,850 mg/kg to rats (ACGIH (7th, 2001), NTP TR53 (1997)), but oral administration of higher doses (4,000-6,000 mg/kg) did not cause changes in triglyceride, cholesterol, or phospholipid levels (ACGIH (7th, 2001)). Therefore, the findings in the liver were not adopted as evidence of the classification because the consistency of data was lacking, and there was no histopathological support.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - In 13-week or 2-year oral administration (drinking water) tests with rats and mice, no toxicity effects were seen at the doses within the guidance value range for Category 2, effects on the urinary bladder (transitional epithelial hyperplasia, inflammation) were observed at the higher doses (200 mg/kg/day or above) corresponding to "Not classified" in both rats and mice, and effects on the kidney (mineralization, chronic nephropathy (observed in both males and females, accompanied by increased hyaline droplets specific to male rats in males)) in rats and effects on the thyroid (follicular cell hyperplasia) in mice were also found at the doses corresponding to "Not classified" (NTP TR436 (1995), Hazard Assessment Report (CERI, NITE, 2007)). And in the inhalation route, in 13-week inhalation tests with rats and mice exposed to the vapour, decreases in erythrocyte counts, hemoglobin, and hematocrit values and increased weights of the liver and kidney in rats, and death and reduced weight gain in mice were observed at the high concentration (1080 ppm = 3.2 mg/L) above the guidance values for Category 2 (NTP TR53 (1997), Hazard Assessment Report (CERI, NITE, 2007)). Besides, in rats, a dose-dependent increase in the severity of nephropathy was found only in males from the concentration (135 ppm = 0.41 mg/L) within the guidance value range for Category 2, but it was estimated to be phenomenon specific to male rats due to alpha 2u-globulin because an increased severity of nephropathy with increased hyaline droplets was seen in males also in 13-week oral administration to rats. From the above, it corresponds to "Not classified" in the oral and inhalation routes. However, because of no toxicity information on dermal exposure, it was classified as "Classification not possible" due to lack of data.
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data.

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) Not classified
-
-
- - It was classified as "Not classified" from 72-hour ErC50 > 110 mg/L for algae (Pseudokirchneriella subcapitata), 48-hour EC50 > 110 mg/L for crustacea (Daphnia magna), and 96-hour LC50 > 120 mg/L for fish (Oryzias latipes) (all Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2009)).
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - If chronic toxicity data are used, then it is classified as "Not classified" due to 72-hour NOEC = 110 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2009)) although it is not rapidly degradable (a degradation rate by BOD: 2.5% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1977)).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it corresponds to "Not classified" in acute toxicity for fish, and it is not water-insoluble (miscible, ICSC, 2008).
From the above results, it was classified as "Not classified."
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.

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