GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 78-93-3
Chemical Name Methyl ethyl ketone
Substance ID H26-B-100, R-045
Classification year (FY) FY2014
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 FY2006  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2013 revised edition)
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
-
-
- - Liquid (GHS definition)
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not applicable
-
-
- - Liquid (GHS definition)
6 Flammable liquids Category 2


Danger
H225 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
It was classified in Category 2 based on a flash point of -9 deg C (closed cup) and a boiling point of 80 deg C (ICSC (1998)).
Besides, it is classified in Class 3, PG II (UN1193) in UNRTDG.
7 Flammable solids Not applicable
-
-
- - Liquid (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 estimated that it does not ignite at normal temperatures from an autoignition temperature of 505 deg C (ICSC (1998)).
10 Pyrophoric solids Not applicable
-
-
- - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to liquid 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
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable
-
-
- - Liquid (GHS definition)
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible
-
-
- - No data available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - Based on the reports of LD50 values of 2,737 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008), IRIS TR (2003), ATSDR (1992)), 5,522 mg/kg (PATTY (6th, 2012), IRIS TR (2003), ACGIH (7th, 2001), ATSDR (1992), EHC 143 (1992)), 2,000-6,000 mg/kg (DFGOT vol. 12 (1999), EHC 143 (1993)) and 2,600-5,400 mg/kg (SIDS (2011)) for rats, it was classified as "Not classified." New information sources (PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008), DFGOT vol. 12 (1999)) were added, and the category was revised.
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on reports of LD50 values of > 5,000 mg/kg (PATTY (6th, 2012)), 6,480 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008)), > 8,000 mg/kg (PATTY (6th, 2012), DFGOT vol. 12 (1999), EHC 143 (1993), ATSDR (1992)), 6,400-8,000 mg/kg (SIDS (2011)) and 13,000 mg/kg (PATTY (6th, 2012)) for rabbits, it was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 4


Warning
H332 P304+P340
P261
P271
P312
Based on a report of an LC50 value of 11,700 ppm for rats (PATTY (6th, 2012), IRIS TR (2003), EHC 143 (1993), ATSDR (1992)), it was classified in Category 4. Besides, since the LC50 value was lower than 90% of the saturated vapor concentration (103,653 ppm), the reference value in units of ppm was applied as a vapour without a mist. The information source (PATTY (6th, 2012)) was updated, and the category was revised.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
As a result of application of this substance to the skin of rabbits, there are reports of slight to moderate irritation (SIDS (2011), EHC 143 (1993), DFGOT vol. 12 (1999)) and of slight irritation (EHC 143 (1993), DFGOT vol. 12 (1999), PATTY (6th, 2012), ATSDR (1992)). In addition, in humans, there is a report that no irritation by exposure was seen (PATTY (6th, 2012)). From the above, based on the "moderate irritation" in rabbits, it was classified in Category 2.
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280
As a result of application of this substance to the eyes of rabbits, there are reports that severe irritation was observed (SIDS (2011), EHC 143 (1993), DFGOT vol. 12 (1999)), and that cornea damage, scleral hemorrhage, edema in the eyelids and chemical burns were observed (EHC 143 (1993)). Other than these, in an application test with rabbits, there are reports that the average scores after 24 hours were 2.5 for corneal opacity and 2 for the conjunctival redness, but these had almost disappeared within 7 days (ECETOC TR48 (1992)), and that there was slight irritation (EHC 143 (1992), DFGOT vol.12 (1999), PATTY (6th, 2012), ATSDR (1992)). In humans, on exposure to this substance, there are both a report that irritation was observed (PATTY (6th, 2012)) and one where irritation was not (PATTY (6th, 2012)). As in the above, based on the "severe irritation," it was classified in Category 2A. Besides, this substance was classified as "Xi; R36" in the EU DSD classification, and as "Eye Irrt. 2 H319" in the EU CLP classification.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
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 bone marrow cells of mice and Chinese hamsters (Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008), SIDS (2011), EHC 143 (1993), IRIS TR (2003), PATTY (6th, 2012), DFGOT vol. 12 (1999)). As for in vitro, it was negative in bacterial reverse mutation tests, and a gene mutation test and a chromosomal aberration test with cultured mammalian cells (NTP DB (Access on October 2014), IRIS TR (2003), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008), ACGIH (7th, 2001), SIDS (2011), EHC 143 (1993), PATTY (6th, 2012)).
6 Carcinogenicity Classification not possible
-
-
- - Since it was classified as I (inadequate) by EPA (IRIS (2003)), it was classified as "Classification not possible."
7 Reproductive toxicity Classification not possible
-
-
- - There is a report that in a teratogenicity test with rats in the inhalation route, even at the dose (3,000 ppm) where effects (decreased body weight gain) were observed in maternal animals, only slight effects (delayed ossifications, extra ribs) were observed in fetuses, and no malformation was observed (PATTY (6th, 2012), SIDS (2011), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008), IRIS (2003) ACGIH (7th, 2001), DFGOT vol.12 (1999)). In addition, there is a report that in a teratogenicity study with mice through the inhalation route, although a slight effect on the fetuses (decreased fetal weight) was observed at a dose (3,000 ppm) where maternal toxicity (increases in the relative weights of the liver and kidneys) was observed, no significant increase in the incidence of malformations was observed (PATTY (6th, 2012), SIDS (2011), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008), IRIS (2003) ACGIH (7th, 2001), DFGOT vol.12 (1999)).
As above, no teratogenicity was seen. Although it was classified as "Not classified" only from the result of teratogenicity tests in the previous classification, there is no report on fertility tests, therefore, it was classified as "Classification not possible."
8 Specific target organ toxicity - Single exposure Category 2 (kidney), Category 3 (respiratory tract irritation, narcotic effects)



Warning
H371
H335
H336
P308+P311
P260
P264
P270
P405
P501
P304+P340
P403+P233
P261
P271
P312
This substance has respiratory tract irritation and narcotic effects (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008), ACGIH (7th, 2001), ATSDR (1992)). In humans, there are reports of headache, dizziness, nausea, vomiting, ataxia, blurred vision, light-headedness, hyperventilation, vertigo, drowsiness, central nervous system depression, metabolic acidosis and unconsciousness by inhalation exposure and unconsciousness by oral intake (PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008), HSDB (Access on September 2014), ACGIH (7th, 2001), ATSDR (1992), EHC 143 (1993), IRIS TR (2003)).
As for experimental animals, narcotic effects, and by oral dose with rats at 1,080 mg/kg, slight tubular necrosis of the kidney were observed (ACGIH (7th, 2001), ATSDR (1992), EHC 143 (1993), PATTY (6th, 2012), IRIS TR (2003), HSDB (Access on September 2014)). Effects on the kidney in rats were observed at doses within the range of Category 2. This substance was considered to have effects on the kidney as well as respiratory tract irritation and narcotic effects.
From the above, it was classified in Category 2 (kidney), Category 3 (respiratory tract irritation, narcotic effects).
9 Specific target organ toxicity - Repeated exposure Category 1 (nervous system)


Danger
H372 P260
P264
P270
P314
P501
In humans, as adverse findings by exposure to this substance without other solvents, there is a report that in Italy, by chronic occupational exposure, although a diagnosis of neuropathy was not reached, a reduction in nerve conduction velocities was observed, and a case of US factory workers who complained of numbness of the fingers and arms is reported (EHC 143 (1993), DFGOT vol. 12 (1999)). From the findings of these occupational exposure cases, there was a concern first about the occurrence of nervous system disorders in humans by repeated exposure to this substance. On the other hand, since related case reports and the results of epidemiological studies had problems such as unclear situations of exposure and mixed exposure with other substances, IRIS concluded that there was limited and equivocal evidence that repeated exposure to this substance in the workplace increased the hazard for persistent neurological impairment (IRIS TR (2003)). However, ACGIH set the TLV value of this substance to avoid not only irritation to the upper respiratory tract but also adverse effects on the central nervous system and peripheral nervous system by inhalation exposure to this substance or the solvent containing this substance (ACGIH (7th, 2001)). Therefore, it is considered that there was still no strong evidence possible to deny the occurrence of nervous system disorders as effects by repeated exposure to this substance alone or by mixed repeated exposures with other solvents.
On the other hand, in experimental animals, although rats were exposed to the vapour of this substance at 5,000 ppm (14.7 mg/L: 1 ppm=2.91 mg/m3 (ACGIH (7th, 2001))) for 90 days, there were no general toxicity effects or neurotoxicity effects except for a decreased body weight gain and an increase in liver weight (considered to be an adaptive response in vivo) (SIDS (2011), EHC 143 (1993), IRIS TR (2003), Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)). In addition, negative results were obtained in multiple inhalation exposure tests with rats in which the presence or absence of neurotoxicity was examined, and it is described that this substance does not cause neurotoxicity because it does not form diketone metabolites (direct neurotoxic substances) similarly to n-hexane (SIDS (2011)).
Based on the above, in humans, it is considered that there was still a concern about the occurrence of adverse effects on the central nervous system and peripheral nervous system by repeated exposure to this substance alone or by mixed repeated exposure with other solvents, therefore, it was classified in Category 1 (nervous system).
10 Aspiration hazard Classification not possible
-
-
- - This substance is a ketone composed of no more than 13 carbon atoms, and its kinematic viscosity was 0.50 mm2/sec (25 deg C, calculated value by CERI). Since it corresponds to Category 2, it was classified as "Classification not possible" according to the Classification Guidance for the Japanese Government.

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 > 1200 mg/L for algae (Pseudokirchneriella subcapitata), 48-hour LC50 > 1000 mg/L for crustacea (Daphnia magna), and 96-hour LC50 > 100 mg/L for fish (Oncorhynchus mykiss) (all Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996); Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)).
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - If chronic toxicity data are used, then it is classified as "Not classified" from rapid degradability (a 20-day degradation rate by BOD = 89% (SIDS, 2011)), and 72-hour NOEC = 93 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996); Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)).
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 is not water-insoluble (water solubility = 223000 mg/L (PHYSPROP Database, 2009)).
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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