NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	75-85-4
Chemical Name	2-Methyl-2-butanol
Substance ID	m-nite-75-85-4_v1
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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	A flash point of 19 degrees C [closed cup] (Merck (14th, 2006)) which is < 23 degrees C, and a boiling point of 102.5 degrees C (Merck (14th, 2006)) which is > 35 degrees C, correspond to Category 2.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified	- -	-	-	It is conceivable that it does not ignite at normal temperatures from an ignition point of 435 degrees C (Ullmanns (E) (6th, 2003)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for liquid substances.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	An organic compound does not contain fluorine or chlorine but contains oxygen which is not chemically bonded to elements other than carbon or hydrogen.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain -O-O- structure.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data. Besides, there is the information which says "Suitable materials: Stainless steel, Aluminium."(GESTIS (Access on Nov. 2011))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	From LD50 values of 1000 mg/kg and 1000 to 2000 mg/kg for rats (above PATTY (5th, 2001)), it was classified in Category 4.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	From an LD50 value of 1720 mg/kg for rabbits (PATTY (5th, 2001)), it was classified in Category 4.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	On the basis that an LC50 value between 3000 and 5700 ppm (converted to a 4-hour exposure equivalent value: 3225 to 6983 ppm) was indicated based on the deaths within 24 hours at 5700 ppm and survival at 3000 ppm as a result of a 6-hour exposure to rats (PATTY (5th, 2001)), it was classified in Category 4. Besides, a reference value of gasses as vapour with hardly included mist was applied because the test concentration is lower than 90 % of the saturated vapour pressure concentration (22105 ppm). Furthermore, it is classified in Xn; R20 in EU classification (EC-JRC (ESIS) (Access on Nov. 2011)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	From the information that semi-occlusive application to rabbit skin (covered with a cloth) caused redness and exfoliation as a result (PATTY (5th, 2001)), it was classified in Category 2. Besides, it is reported that open application did not cause irritation even when applied repeatedly and occlusive application with an impermeable material caused severe necrosis (PATTY (5th, 2001)). But the result of semi-occlusive application shown in an OECD test guideline was used as a basis for classification. Besides, "Xi; R37/38" classification in EU classification (EC-JRC (ESIS) (Access on Nov. 2011)) corresponds to Category 2.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	From the reported information that moderate conjunctival edema, moderate to severe corneal opacity, and moderate iritis observed in the application of undiluted test substance to rabbit eyes did not reverse in 7 days, but fully reversed after 14 days (HSDB (2008)), it was classified in Category 2A.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	Because obtained data on a skin sensitizing test in guinea pigs (modified Maguire test) resulting in "None was sensitized" (HSDB (2008)) was not in the test method approved by OECD and has unknown details, it was classified as "Classification not possible."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, an Ames test reported a negative as an in vitro test (PATTY (5th, 2001)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	There are reports of human cases as follows. A woman drank intentionally about 27 g of this substance showed coma, dyspnea, irregular pulse, and dilatation then contraction of the pupils. (PATTY (5th, 2001)) An adult ingested 18 g showed unconsciousness, sleep lasting for more than one day, and a slow recovery. (HSDB (2008)) Both are judged to be signs of central nervous system depression. On the other hand, animal tests reported that rats survived after inhalation exposure showed unconsciousness and motor incoordination, also, a narcotic dose was 700 mg/kg at which 50 % of animals showed stupor and loss of voluntary movements in rabbits. (PATTY (5th, 2001)) From the above, it was classified in Category 1 (central nervous system), Category 3 (narcotic effects).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There is a 90-day inhalation exposure test (vapour) at 0, 50, 225, 1000 ppm/6h (converted values: 0, 0.180, 0.811, 3.61 mg/L/6h) in rats, mice, and dogs. Impaired motor coordination and increased liver weights at 1000 ppm and NOEL of 225 ppm (0.811 mg/L) for rats, and no exposure-related effects in each dose and NOEL of 1000 ppm (3.61 mg/L) for mice were reported. Staggering gait, impaired motor coordination, increased liver weights, and an increase in the serum ALP activity at 1000 ppm and hepatocellular cytoplasmic inclusion in 1 animal each in each dose in dogs were observed. (HSDB (2008)) From the above, adverse effects at doses within a range of Guidance values (not more than 1 mg/L) in each animal were not observed, but the classification in an inhalation route was not possible because effects near the upper limit of Guidance values (1 mg/L) are unknown. On the other hand, in a 4-week dermal administration test applied 0, 344, 3440 mg/kg/day (converted to a 90-day equivalent: 0, 106, 1058 mg/kg/day) to rabbits (HSDB (2008)), it corresponds to "Not classified" in dermal route from no systemic effects at a low dose of 344 mg/kg/day except local effects on skin. And there is no data in oral administration. Therefore, it was classified as "Classification not possible" in specific target organ toxicity (repeated exposure).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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	- -	-	-	It was classified as "Not classified" because acute toxicity tests for fish and crustacea were above 100 mg/L (AQUIRE, 2012; HSDB, 2008).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. From "Not classified" in acute toxicity and not water-insoluble (water solubility = 110000 mg/L (PHYSPROP Database, 2009)), it was classified as "Not classified."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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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