NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	108-94-1
Chemical Name	Cyclohexanone
Substance ID	m-nite-108-94-1_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 associated with explosive properties present in the molecules.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Classified into Category 3 since flash point is 44 degC (closed-cup) (HSDB (2002)). The substance is classified into Class 3, PG III in UNRTDG (UN1915).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified	- -	-	-	Auto-ignition point is 420 degC (Hommel (1996)) exceeding 70 degC.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	LD50 values are 1620, 1840, 1800, 1400, 1296, 1540, 1550, 800 - 1600, 1840, 2000, 2650, 3460 and 1534 mg/kg for rats (SIDS (access on April. 2009), DFGOT vol. 10 (1998). Since one value is a duplicate, nine values range between 3002000 mg/kg, the substance was classified into Category 4.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	Based on a LD50 value of 947 mg/kg for rabbits (DFGOT (1998), PATTY (2001)), the substance was classified into Category 3.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	Based on a LC50 value of 2450 ppm (9.8 mg/L) for rats (ACGIH (2003)), the substance was classified into Category 3. Since saturated vapour pressure concentration was 5700 ppm (25 degC) (Howard, 1997), the classification criteria for vapour was adopted.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on a LC50 value of 8000 ppm (32.1 mg/L) for rats (ACGIH (2003)), the substance was classified as "Not classified". Since the saturated vapour pressure concentration is 5700 ppm (25 degC) (Howard, 1997), the test was considered to be conducted for mist.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Although there is a report that in a rabbit test with 2 samples of cyclohexanone, rabbits exhibited necrosis after occlusive application of one sample, then the sample was classified as corrosive (SIDS (access on Apr. 2009)), in an evaluation for corrosiveness in rabbits, no corrosion occurred in any rabbit (SIDS (access on Apr. 2009)). Application of the undiluted substance with open contact was non-irritating to rabbit skin (SIDS (access on Apr. 2009)). Additionally, although application of a 99% solution for 24-hour under occlusive conditions caused strong skin irritation, the effects slowly resolved and disappeared during a seven day period after application (PATTY (5th, 2001)). Based on these evidences of non-corrosive, the substance was classified into Category 2.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	The undiluted substance placed in the eyes of rabbits produced marked irritation and corneal injury (ACGIH (2003)). When the undiluted substance was applied to rabbit eyes, corneal injury with mild iritis and conjunctivitis was reversible, but the eyes still showed mild corneal damage at 14 days (SIDS (access on Apr. 2009)). Based on these data, the substance was classified into Category 2A. There is a result of corrosive when a solution of the substance was applied to rabbit eyes (SIDS (access on Apr. 2009)). The information for human eye irritation (PATTY (5th, 2001)) was not used as the basis of classification since the reported effect was for an inhalation exposure test.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Since the substance is on the Frosch contact allergen list (FROSCH, TEXTBOOK OF CONTACT DERMATITIS), the substance was classified into Category 1.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	Based on a positive result in a rat bone marrow chromosomal aberration test by subcutaneous injection (in vivo somatic cell mutagenicity test) (SIDS (access on Apr. 2009)), the substance was classified into Category 2. As relevant information, from other in vivo mutagenicity tests, there are reports of a negative mouse dominant lethal test by inhalation exposure (in vivo heritable mutagenicity test) (SIDS (access on Apr. 2009)) and a negative rat bone marrow chromosomal aberration test by inhalation exposure (in vivo somatic cell mutagenicity test) (SIDS (access on Apr. 2009)). From in vitro mutagenicity tests, there are reports of negative and positive Ames tests (IARC 47 (1989), SIDS (access on Apr. 2009)), a negative CHO cell chromosomal aberration test, a positive human lymphocyte chromosomal aberration test (IARC 47 (1989), SIDS (access on Apr. 2009)) and a negative mouse lymphoma L51784 cell forward mutation test (SIDS (access on Apr. 2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Not classified	- -	-	-	The substance is classified into "Group 3" in IARC (IARC 47 (1989), IARC 71 (1999)) and into "A3" in ACGIH (ACGIH (2003)). Since the evaluation result of ACGIH (2003) is not based on the latest information, the substance was classified as "Not classified" in accordance with the classification in IARC. Carcinogenicity tests were conducted in rats and mice, in which the substance was administered in the drinking water for 2-year. For rats, a significant increase in the incidence of adrenal cortical adenomas in low-dose males and (non-significant) increase in the incidence of thyroid follicular-cell adenomas and carcinomas in high-dose males were observed (IARC 47 (1989)). For mice, a significant increase in the incidence of liver-cell adenomas or carcinomas in low-dose males and an increase in the incidence of malignant lymphomas and leukaemia in low-dose females were observed (IARC 47 (1989)). These slight increases in the incidence of tumours were observed only in animals given the low dose. Additionally, these tumours occur commonly in this strain of mice.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a two-generation reproduction test in rats by inhalation exposure (DFGOT vol. 10 (1998), SIDS (access on Apr. 2009)), toxic symptoms such as lacrimation, irregular breathing and ataxia was observed in the high dose group (5700 mg/m3). In this group, there was a reduction in the number of offspring, which was interpreted by the authors as a decrease in male fertility, and reduced survival of the offspring. Based on the data, the substance was classified into Category 2. In developmental toxicity tests by inhalation or oral exposure to rats, mice and rabbits during gestation or organogenesis period (SIDS (access on Apr. 2009), DFGOT vol. 10 (1998)), no adverse effects were reported on fetal development including teratogenicity.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory system), Category 2 (central nervous system), Category 3 (narcotic effects)	Danger Warning	H370 H371 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	Following oral administration of the substance to rats and mice, hypnotic signs appeared (SIDS (access on Apr. 2009)). As a symptom following inhalation exposure to guinea pigs and oral administration to rabbits, anesthesia is reported (SIDS (access on Apr. 2009)). Based on the data, the substance was classified into Category 3 (narcotic effects). Since there are reports that a high concentration exposure resulted in deaths and that symptoms noted at acute toxic doses (LD50: 1300 - 3500 mg/kg) were CNS depression, the substance was classified into Category 2 (central nervous system). Based on the findings of hemorrhage of lungs in rat by oral administration of 475 - 3800 mg/kg (SIDS (access on Apr. 2009)) and lesions such as congestion and edema of the lungs, focal to diffuse hemorrhage of the lung parenchyma (SIDS (access on Apr. 2009)), the substance was classified into Category 1 (respiratory system). Pronounced irritation of the nose and throat observed in a volunteer test (ACGIH (2003)) is judged to be an effect on the respiratory system rather than respiratory tract irritation. In accidental or suicidal exposure cases (DFGOT vol. 10 (1998), PATTY (5th, 2001)), findings of hepatic dysfunction such as hepatitis, elevation of hepatic enzymes, swelling of hepatocytes and inflammatory infiltration were observed. However, these case reports were not used as the basis of classification since these effects were induced by exposure to mixtures and other components may be responsible. Although there is a report for the effects on spleen (PATTY (5th, 2001)), the data were not used as the basis of classification since the animal species, dose levels and exposure periods were not specified and no related information is found in other documents.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system, bone)	Danger	H372	P260 P264 P270 P314 P501	Neurotoxic effects were examined in a group of 75 workers from a furniture factory who were exposed while coating wood with cyclohexanone. The exposures were observed to cause an increase in the percentage of reported neurotoxic symptoms (mood disorders, memory difficulties, sleep disturbances, etc.) (PATTY (5th, 2001)). There is a report that the substance depresses the central nervous system (ACGIH (2003)). Based on these data, the substance was classified into Category 1 (central nervous system). In the above mentioned examination, an increase in the percentage of reported rheumatic symptoms (bone pain, joint pain, and muscular pain) was observed. Out of these symptoms, bone pain was reported on another document (ACGIH (7th, 2003)). Therefore, the substance was classified into Category 1 (bone). Although there is a report of "Liver and kidney effects" (PATTY (5th, 2001)), the data were not used as the basis of classification since the detailed data are unknown and similar information is not reported in other documents.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	Since the kinematic viscosity is estimated to be <14 mm2/s at 40 degC, extrapolated from 2.13 mm2/s (24 degC) (Renzo (3rd, 1986)) and the substance is a ketone with a composition of not more than 13 carbon atoms, the substance corresponds to Category 2 in GHS classification. However, classification was not possible due to lack of data corresponding to Category 1 and according to guidance of JIS Classification in which category 2 is not set.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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)	Not classified	- -	-	-	Classified into Not classified from its 96h-LC50 = 527 mg/L for fish (Fathead minnow) (SIDS, 1996, etc) and 24h-LC50 = 800 mg/L for Crustacea (Daphnia magna) (SIDS, 1996).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Classified into Not classified since its acute toxicity is Not classified and it is not non-water soluble (Water solubility = 25000 mg/L (PHYSPROP Database, 2009).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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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