GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 563-80-4
Chemical Name Isopropyl methyl ketone
Substance ID H27-B-067/C-103B_P
Classification year (FY) FY2015
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 (Ver. 1.1))
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
Based on a flash point of -1 deg C (closed cup), and a boiling point of 93-95 deg C (ICSC (2013)), it was classified in Category 2. Besides, it is classified in Class 3, PG II (UN 2397) 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 475 deg C (ICSC (2013)).
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 for rats of 2,572 m/kg, 3,078-3,200 mg/kg, 4,100 mg/kg (PATTY (6th, 2012)), 3,200 mg/kg (ACGIH (7th, 2011)), and 4,509 mg/kg (PATTY (6th, 2012), ACGIH (7th, 2011)), the substance was classified as "Not Classified" (Category 5 in UN GHS classification).
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on the reports of LD50 values for rabbits of 5,112 mg/kg (PATTY (6th, 2012), ACGIH (7th, 2011)) and > 5,000 mg/kg (PATTY (6th, 2012)), this substance 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 (6 hours) for rats of 6,377 ppm (converted 4-hour equivalent value: 7,810 ppm) (PATTY (6th, 2012)), it was classified in Category 4. Besides, since the LC50 value was lower than 90% of the saturated vapor pressure concentration (68,684 ppm), the reference values in the unit of ppm was applied as vapor without mist. The classification 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
This substance was classified in Category 2 based on a description that it is irritating to human skin (HSDB (Access on August 2015)). Besides, there is a report that as a result of application of this substance (undiluted) to rabbits for 24 hours, moderate irritation was observed (PATTY (6th, 2012)), and there is another report that the application of this substance (undiluted) to guinea pigs for 24 hours resulted in moderate irritation, and after 24 hours, edema and necrosis were observed (PATTY (6th, 2012)). However, these were not adopted for the classification because they are 24-hour application tests.
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
It is reported that in an eye irritation test with rabbits, mild irritation was observed but resolved within 7 days (PATTY (6th, 2012)) and there is a description that this substance caused irritation to human eyes (HSDB (Access on August 2015)). Based on the description in the report on rabbits that it was reversible within 7 days, this substance was classified as Category 2B.
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. Besides, it is reported that sensitization was not observed in a sensitization test with guinea pigs (PATTY (6th, 2012)) and there is a report that as a result of human patch tests on 25 persons, sensitization was not observed (PATTY (6th, 2012)). However, these were judged to be inadequate data for use in classification because the details such as information on the test method and the control group are unknown.
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
6 Carcinogenicity Classification not possible
-
-
- - Since there are no classification results by other organizations, classification was not possible due to lack of data.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
In a reproduction/developmental toxicity screening test by the inhalation route with rats, there is a description that in the parent animals, dose-dependent reduction in activity during exposure at or above 1,000 mg/m3, and reduced body weight gain or decreased food consumption before mating or during the gestation period at 2,500-5,000 mg/m3 were observed, but no adverse effects on the genetic organs were observed. On the other hand, there is a description that in pups, an increased number of dead pups per litter on postnatal day 0 or day 4 at or above 2,500 mg/m3 and a decreased litter size at 5,000 mg/m3 were observed (ACGIH (7th, 2011)). It is a screening test, but at the dose at which general toxic effects were observed in the parent animals, a developmental toxicity effect indicated by the increased number of dead pups before or after birth was shown in the pups. Therefore, it was classified in Category 2 for this hazard class.
Besides, ACGIH (7th, 2001) was available in the previous classification, but this data was not quoted in it, and in this reclassification, for this hazard class, data available for classification were obtained for the first time.
8 Specific target organ toxicity - Single exposure Category 3 (respiratory tract irritation, narcotic effects)


Warning
H335
H336
P304+P340
P403+P233
P261
P271
P312
P405
P501
This substance shows respiratory tract irritation in humans (ACGIH (7th, 2011), PATTY (6th, 2012)). In experimental animals, there is a report on central nervous system depression and narcotic effects by inhalation exposure in rats (ACGIH (7th, 2011), PATTY (6th, 2012)). From the above, it was classified in Category 3 (respiratory tract irritation, narcotic effects).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - Classification not possible due to lack of data.
10 Aspiration hazard Classification not possible
-
-
- - Findings directly showing respiratory hazards due to aspiration in humans were not obtained from information sources in List 1 and List 2. However, there is a description in ICSC listed as List 3 that if this substance is swallowed, vomiting may occur and there is a danger of aspiration pneumonitis (ICSC (2013), ICSC (J) (2013)), but it was thought that this was not directly based on hazard cases in humans but expressed a presumed concern from the acute exposure effects in humans and the physicochemical properties.
Besides, this substance belongs to ketones composed of carbon atoms not less than 3 and not more than 13, and based on numerical data (viscosity: 0.5 mPa*s (16 deg C), density (specific gravity): 0.81 g/cm3 (20 deg C)) in GESTIS (Access on August 2015) of List 3, the calculated kinematic viscosity is 0.617 mm2/sec (16/20 deg C). Based on the above, although it corresponds to Category 2 in the UN GHS classification, this substance was classified as "Classification not possible" according to the current guidance revised after the previous classification.

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
-
-
- - From 96-hour LC50 = 864 mg/L for fish (Pimephales promelas) (ECETOC TR91, 2003), it was classified as "Not classified."
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - Reliable chronic toxicity data were not obtained. Due to being not water-insoluble (water solubility = 60800mg/L, PHYSPROP Database, 2009), and "Not classified" in acute toxicity, it was classified as "Not classified."
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* 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.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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