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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	1331-22-2
Chemical Name	Methylcyclohexanone (isomer mixture)
Substance ID	R01-B-113
Classification year (FY)	FY2019
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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 3 based on a flash point of 48 deg C (closed cup) (Hommel (1991)). Besides, it is classified in Class 3, PG III in UNRTDG (UN2297).
7	Flammable solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Because it is classified in Class 3, PG III in UNRTDG (UN2297), it does not correspond to pyrophoric substances, hazards of the highest precedence, and was classified as "Not classified."
10	Pyrophoric solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
11	Self-heating substances and mixtures	*	- -	-	-	Classification is not possible because test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	No data available.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) LD50 (2-methylcyclohexanone (CAS RN 583-60-8)) for rats: 2,140 mg/kg (PATTY (6th, 2012))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LDLo for rabbits: 4,900-7,200 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 1987), PATTY (6th, 2012))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified (Not applicable).
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] 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	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) 2-Methylcyclohexanone (CAS RN 583-60-8), a constituent of this substance, was mildly irritating to rabbit skin, and it caused severe corneal burns when instilled into the eyes (PATTY (6th, 2012)). (2) The biological effects of this substance are narcotic and irritation of the skin and mucous membranes at high exposure levels (OEL Documentations (Japan Society For Occupational Health (JSOH), 1987)). [Reference Data, etc.] (3) Repeated administration of this substance to the intact skin of rabbits (6 days, unknown dose) caused irritation to the skin (ACGIH (7th, 2001)). (4) In human clinical cases, this substance caused no effect following skin application, but it was a relatively strong irritant for the mucous membranes. (PATTY (6th, 2012)).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Based on (1)-(4), it was classified in Category 2. [Evidence Data] (1) Exposure of mice to this substance (450 ppm, unknown exposure time) caused irritation to the mucous membranes (ACGIH (7th, 2001), PATTY (6th, 2012)). (2) This substance may be irritating to the mucous membranes (PATTY (6th, 2012)). (3) The biological effects of this substance are narcotic and irritation of the skin and mucous membranes at high exposure levels (OEL Documentations (Japan Society For Occupational Health (JSOH), 1987)). (4) 2-Methylcyclohexanone (CAS RN 583-60-8), a constituent of the substance, caused mild skin irritation to the skin of rabbits and it caused severe corneal burns when instilled into the eyes (PATTY (6th, 2012)). [Reference Data, etc.] (5) In human clinical cases, this substance caused no effect following skin application, but it was a relatively strong irritant for the mucous membranes. (PATTY (6th, 2012)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	Category 3 (narcotic effects, respiratory tract irritation)	Warning	H336 H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] There is no report on a single exposure to this substance in humans. Based on the information in (1)-(3) in experimental animals, this substance was classified in Category 3 (narcotic effects, respiratory tract irritation). [Evidence Data] (1) In 30-minute single inhalation exposure tests with mice, guinea pigs and rats, by exposure at 3,500 ppm of this substance, irritation of the mucous membranes and signs of central nervous system depression were observed (ACGIH (7th, 2001)). (2) Although there was no description of exposure time, irritation of the mucous membranes was observed when mice were exposed by inhalation to 450 ppm of this substance (ACGIH (7th, 2001), PATTY (6th, 2012)). (3) Labored breathing, unsteady gait, and somnolence were observed in rabbits and cats following inhalation exposure to 2,500 ppm of this substance for 1 hour (ACGIH (7th, 2001), PATTY (6th, 2012)).
9	Specific target organ toxicity - Repeated exposure	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) There are reports that in a 3-week inhalation toxicity study with rabbits (6 hours/day, 5 days/week), conjunctival irritation, lacrimation, salivation, and lethargy were observed at or above 1139 ppm (converted guidance value: 0.87 mg/L, within the range of Category 2) (PATTY (6th, 2012), ACGIH (7th, 2001)) and that in a study in which exposure was extended to 10 weeks, slight lesions of the liver and kidneys (details unspecified) were reported (PATTY (6th, 2012)).
10	Aspiration hazard	*	- -	-	-	[Rationale for the Classification] Based on (1), this substance may correspond to Category 2 according to the UN GHS classification criteria. However, since Category 2 was not adopted for Aspiration hazard by JIS, it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. The classification based on the previous GHS Classification Guidance for the Japanese Government was changed. [Reference Data, etc.] (1) It is a ketone composed of carbon atoms of 13 or less. (2) The kinematic viscosity at 40 deg C was unknown. (3) Category 2 for Aspiration hazard was not adopted by JIS.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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