GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 75-85-4
Chemical name 2-Methyl-2-butanol
Substance ID 23A5162
Fiscal year of classification conducted FY2011
Classifier(s) (Ministries) Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
New/Revised New
Download in Excel format Excel file

REFERENCE INFORMATION

Item Information
Guidance used for classification (External link) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010)
Environmental Hazards: UN GHS Document (4th revised edition)
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
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
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 - - - "Liquids" according to GHS definition.
3 Aerosols Not applicable - - - Not an aerosol product.
4 Oxidizing gases Not applicable - - - "Liquids" according to GHS definition.
5 Gases under pressure Not applicable - - - "Liquids" according to GHS definition.
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.
7 Flammable solids Not applicable - - - "Liquids" according to GHS definition.
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 classified - - - It is conceivable that it does not ignite at normal temperatures from an ignition point of 435 degrees C (Ullmanns (E) (6th, 2003)).
10 Pyrophoric solids Not applicable - - - "Liquids" according to GHS definition.
11 Self-heating substances and mixtures Classification not possible - - - No established test method suitable for liquid substances.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids 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.
14 Oxidizing solids Not applicable - - - "Liquids" according to GHS definition.
15 Organic peroxides Not applicable - - - An organic compound that does not contain -O-O- structure.
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))

HEALTH HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
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.
1 Acute toxicity (Dermal) Category 4

Warning
H312
P302+P352
P280
P312
P322
P363
P501
From an LD50 value of 1720 mg/kg for rabbits (PATTY (5th, 2001)), it was classified in Category 4.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - "Liquids" according to GHS definition.
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)).
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - No data.
2 Skin corrosion/irritation Category 2

Warning
H315
P302+P352
P332+P313
P264
P280
P321
P362
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.
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.
4 Respiratory sensitization Classification not possible - - - No data.
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."
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)).
6 Carcinogenicity Classification not possible - - - No data.
7 Reproductive toxicity Classification not possible - - - No data.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system), Category 3 (narcotic effects)

Danger

Warning
H370
H336
P307+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).
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).
10 Aspiration hazard Classification not possible - - - No data.

ENVIRONMENTAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
11 Hazardous to the aquatic environment (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).
11 Hazardous to the aquatic environment (Long-term) 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."
12 Hazardous to the ozone layer Classification not possible - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* 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.



Updated date:
2016/11/16 Addition of Rationale for the classification

List of GHS Classification Results