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

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 994-05-8
Chemical Name tert-Amyl methyl ether [TAME or 2-methoxy-2-methylbentane]
Substance ID m-nite-994-05-8_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 present in the molecule associated with explosive properties. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Flammable gases Not classified (Not applicable)
-
-
- - "Liquids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Aerosols Not classified (Not applicable)
-
-
- - Not an aerosol product. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Oxidizing gases Not classified (Not applicable)
-
-
- - "Liquids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Gases under pressure Not classified (Not applicable)
-
-
- - "Liquids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Flammable liquids Category 2


Danger
H225 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501 		Based on a flash point of -11 degrees C and a boiling point of 86.3 degrees C (ICSC (2014)), it was classified in Category 2. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Flammable solids Not classified (Not applicable)
-
-
- - "Liquids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Pyrophoric liquids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an ignition point of 430 degrees C (ICSC (2014)). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - "Liquids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Self-heating substances and mixtures Classification not possible
-
-
- - No established test method suitable for liquid substances. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified (Not applicable)
-
-
- - Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is not chemically bonded to the elements other than carbon or hydrogen. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14 Oxidizing solids Not classified (Not applicable)
-
-
- - "Liquids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15 Organic peroxides Not classified (Not applicable)
-
-
- - It is an organic compound that does not contain bivalent -O-O- structure in the molecule. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16 Corrosive to metals Classification not possible
-
-
- - Due to no data, the classification is not possible. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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
-
-
- - From reported LD50 values of about 2,100 mg/kg (ACGIH (7th, 2002)) and 2,152 mg/kg (EU-RAR (2006)) for rats, it was classified as "Not classified" (Category 5 in UN GHS classification). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Due to lack of data, the classification is not possible. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - "Liquids" according to GHS definition. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
The category cannot be determined only from a reported LC50 value (4 hours) of > 5,400 mg/m3 (1,292 ppm) for rats (HSDB (Access on June 2015)). Besides, a reference value in the unit of ppm was applied as vapour without mist because the LC50 value is lower than 90 % of the saturated vapour pressure concentration (98,947 ppm). 		FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Due to lack of data, the classification is not possible. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Skin corrosion/irritation Not classified
-
-
- - In a skin irritation test using rabbits (OECD TG 404, GLP compliance), 4-hour application with 500 micro L this substance (98.4%) resulted in the irritation score of 0, and it was judged to be not irritating (EU-RAR (2006)). From the above result, it was judged to be "Not classified." FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264 		In an eye irritation test using rabbits (OECD TG 405, GLP compliance), redness (an average score 1.7) and swelling were observed but resolved after seven days (EU-RAR (2006)). From the above result, it was judged to be Category 2B.
Besides, it is written that this substance is not irritating to eyes (HSDB (Access on June 2015)) although it is not specific information. 		FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Respiratory sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Skin sensitization Not classified
-
-
- - In a Buehler test using guinea pigs (GLP compliance), skin reaction was not observed after application with undiluted this substance, and the sensitization score was 0 (20 animals/group) while a positive control group showed a 100% reaction rate. It is judged in EU-RAR (2006) that this substance is not sensitizing (EU-RAR (2006)). From the above result, the substance was judged to be "Not classified." FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Germ cell mutagenicity 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, it was classified as "Classification not possible." Namely, as for in vivo, a micronucleus test using mouse bone marrow cells was negative (ACGIH (7th, 2002), EU-RAR (2006)). As for in vitro, a bacterial reverse mutation test and a gene mutation test in cultured mammalian cells were negative, and a chromosomal aberration test in cultured mammalian cells was positive (ACGIH (7th, 2002), EU-RAR (2006), NTP DB (Access on July 2015)). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Carcinogenicity Classification not possible
-
-
- - In a carcinogenicity test, in which rats were administered by gavage at 250 or 750 mg/kg/day of this substance for 78 weeks (4 days/week) and continued to be observed until week 143 when all animals died naturally, it is reported that hemo-lymphoreticular tumors (lymphomas and leukemia) increased significantly only in females in a higher dose group in a chi-squared test, and increased in the groups including a lower dose group in a dose relationship test (EU-RAR (2006)). However, due to no graph showing mortality, it is impossible to calculate tumor incidences against an animal number usable for assessment. On top of that, because the report lacks description such as that of general conditions and because hemo-lymphoreticular tumors were not observed in a 2-year inhalation toxicity test for methyl tert-butyl ether, a structurally analog substance of this substance, it was judged in EU-RAR that these test results are unreliable (EU-RAR (2006)).
Besides this, there is no carcinogenicity information in either humans or experimental animals, and the classification is not possible due to lack of data.
 FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501 		There is no information on reproductive effects in humans. As for experimental animals, F0 and F1 male and female parent rats were exposed to the vapour of this substance within a dose range up to maximum 3,000 ppm before mating and through a mating period until gestation and lactation for ten weeks in a two-generation reproductive toxicity test in inhalation exposure, the following was observed (EU-RAR (2006), ACGIH (7th, 2002)): lower body weights in F1 and F2 pups until weaning, decreased survival, and a delayed acquisition of preputial separation (males of F2 generation only) at doses of 1,500 ppm or higher where F0 and F1 parent animals showed general toxicity effects (ataxia, lower body weights, and increased relative weights of the liver and kidney);
and a delayed acquisition of vaginal patency in F1 and F2 pups and reduced anogenital distance (AGD) (males and females) only in F2 pups at 3,000 ppm.
Besides, in a teratogenicity test in inhalation exposure, pregnant rats and mice were exposed both at 250 to 3,500 ppm of this substance on day 6 to 19 and day 6 to 11 of gestation respectively and had a Caesarean section on day 20 of gestation. In rats, fetuses showed lower body weights only and no malformation even at the highest dose (3,500 ppm) where maternal toxicity (decreased body weights, ataxia, lethargy, slow respirations, gasping and so on) was noted. But in a mouse test, maternal toxicity (increased liver weights (1,500 ppm), severe toxic effects were added such as deaths (4/25), decreased food consumption, and lethargy at the highest dose of 3,500 ppm) occurred at doses (1,500 ppm or above). At the doses, an increased incidence of malformations (mainly cleft palate) was observed (EU-RAR (2006), ACGIH (7th, 2002)).
As above, in a rat two-generation test, growth retardation and secondary effects which are considered to result from it including delayed sexual maturation and reduced AGD were found in F1 and F2 pups at the doses where general toxic effects were observed in parent animals. As toxic effects on development, fetal toxicity occurred both in rats and mice and an increased incidence of malformations was observed further in mice at the doses where maternal toxicity was found.
From the above, the substance was classified in Category 2. 		FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8 Specific target organ toxicity - Single exposure Category 1 (respiratory organs), Category 3 (narcotic effects)



Danger
Warning
H370
H336 		P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312 		This substance is irritating to the respiratory tract (EU-RAR (2006)). No human data.
As for experimental animals, in inhalation exposure in rats, rales at 5.4 mg/L, prostration, labored breathing, lethargy, and central nervous system depression at 1.04, 6.27, 14.62 mg/L, sedation, coma, ataxia, eyelid ptosis, irritability, hypoactivity, and anomaly of attitude at 2.09, 8.36, 16.72 mg/L were observed.
Also in inhalation exposure in mice at 1.04, 6.27, 14.62 mg/L, the similar signs as in rats were found.
Moreover, in oral administration in rats at 2,000, 2,500 or 3,000 mg/kg, sedation, ataxia, emaciation, hypothermia, dyspnea, rales, piloerection and so on were observed (EU-RAR (2006)).
From the above findings, narcotic effects were found for this substance. Besides, from rales in inhalation exposure, effects on respiratory organs were conceivable at doses corresponding to Category 1.
Therefore, the substance was classified in Category 1 (respiratory organs), Category 3 (narcotic effects). 		FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - No human information.
Central nervous system depression was observed in a 90-day inhalation toxicity test using rats at 1,500 ppm (converted to a Guidance value equivalent: 4.6 mg/L) (ACGIH (7th, 2002), EU-RAR (2006)) and in a 4-week inhalation exposure test using rats at 2,000 ppm (converted to a Guidance value equivalent: 1.9 mg/L) (ACGIH (7th, 2002), EU-RAR (2006), PATTY (6th, 2012)). In a 90-day inhalation toxicity test using mice, central nervous system depression and centrilobular hepatocellular hypertrophy were found at 1,500 ppm (converted to a Guidance value equivalent: 4.6 mg/L) (ACGIH (7th, 2002), EU-RAR (2006)).
These were doses above the range of Category 2.
In a 28-day gavage administration toxicity test using rats, an absolute and relative increase of adrenal weights was observed at 125 mg/kg/day (converted to a 90-day equivalent: 38.9 mg/kg/day) (EU-RAR (2006)). However, it was not used for the classification due to change only in weights.
Besides, information was not obtained in a dermal route.
As above, although only weak effects were observed in inhalation and oral routes, because there is no information in a dermal route, the substance was classified as "Classification not possible" due to lack of data. 		FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Aspiration hazard Classification not possible
-
-
- - This substance is not a hydrocarbon and has a kinematic viscosity of 0.5 mm2/sec, but because there are no surface tension data and no case report on aspiration hazard in humans, it is written in EU-RAR that it does not correspond to R65 (EU-RAR (2006)). Namely, the classification is not possible due to lack of data. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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) Category 3
-
-
H402 P273
P501 		From a 96-hour LC50 = 14 mg/L for crustacea (Mysidopsis bahia) (SIAP, Conclusions Agreed in SIAM21, 2005; EU-RAR, 2006), it was classified in Category 3. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Hazardous to the aquatic environment Long term (Chronic) Not classified
-
-
- - If chronic toxicity data are used, then it is classified as "Not classified" due to 72-hour NOEC = 77 mg/L for algae (Pseudokirchneriella subcapitata) (SIAP, Conclusions Agreed in SIAM21, 2005; EU-RAR, 2006) and 28-day NOEC = 3.39 mg/L for crustacea (Mysidopsis bahia) (EU-RAR, 2006) although no appropriate data obtained on rapid degradability.
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" due to 96-hour LC50 = 580 mg/L for fish (Oncorhynchus mykiss) (SIAP, Conclusions Agreed in SIAM21, 2005; EU-RAR, 2006) although no appropriate data obtained on rapid degradability.
From the above results, it was classified as "Not classified."
 FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))


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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