NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	75-65-0
Chemical Name	tert-Butanol
Substance ID	m-nite-75-65-0_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Flammable liquids	Not classified (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)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Flammable solids	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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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."	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
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)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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."	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
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)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Not classified	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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