GHS Classification Result (Revision of the past classification result)

Chemical Name:Cyclohexanone
CAS:108-94-1

Result:
ID: 21B3037
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
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 3 Warning H226: Flammable liquid and vapour P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against static discharge.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
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).
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 - - - - Auto-ignition point is 420 degC (Hommel (1996)) exceeding 70 degC.
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 contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
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.
1 Acute toxicity (Dermal) Category 3 Danger H311: Toxic in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment (see ... on this label).
P361: Remove/Take off immediately all contaminated clothing.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on a LD50 value of 947 mg/kg for rabbits (DFGOT (1998), PATTY (2001)), the substance was classified into Category 3.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 3 Danger H331: Toxic if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P311: Call a POISON CENTER or doctor/physician.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
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.
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P362: Take off contaminated clothing and wash before reuse.
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.
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
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.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
Since the substance is on the Frosch contact allergen list (FROSCH, TEXTBOOK OF CONTACT DERMATITIS), the substance was classified into Category 1.
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
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)).
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.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
8 Specific target organ toxicity - Single exposure Category 1 (respiratory system), Category 2 (central nervous system), Category 3 (narcotic effects) Danger
Warning
H370: Causes damage to organs (respiratory system)
H371: May cause damage to organs (central nervous system)
H336: May cause drowsiness or dizziness (narcotic effects)
P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
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.
9 Specific target organ toxicity - Repeated exposure Category 1 (central nervous system, bone) Danger H372: Cause damage to organs through prolonged or repeated exposure (central nervous system, bone) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
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.
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.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (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).
11 Hazardous to the aquatic environment (Long-term) 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).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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