GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 110-83-8
Chemical Name Cyclohexene
Substance ID R03-B-002-MHLW, MOE
Classification year (FY) FY2021
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 FY2009   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 (FY2019 revised edition (Ver. 2.0))
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 classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products.
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not classified (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 -17 deg C (closed cup) and a boiling point of 83 deg C (GESTIS (Accessed Sep. 2021)). Besides, it is classified in Class 3, PG II in UNRTDG (UN 2256).
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
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.
9 Pyrophoric liquids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 265 deg C (GESTIS (Accessed Oct. 2021)).
10 Pyrophoric solids Not classified (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 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).
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine.
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - No data available.
17 Desensitized explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
[Rationale for the Classification]
Based on (1) to (4), it was classified in Category 4 by adopting the category with the higher hazard.

[Evidence Data]
(1) LD50 for rats: 1,300 mg/kg (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012))
(2) LD50 for rats: 1,946 mg/kg (SIAR (2002), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), DFG MAK (2000), ACGIH (2020), HSDB in PubChem (Accessed Oct. 2021))
(3) LD50 for rats: between 1,000 to 2,000 mg/kg (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (2001))
(4) LD50 for rats: Between 1,000 to 2,000 mg/kg (OECD TG 401, GLP) (SIAR (2002), ACGIH (2020), REACH registration dossier (Accessed Oct. 2021))

[Reference Data, etc.]
(5) LD50 for rats: 2,824 mg/kg (ACGIH (2020))
(6) LD50 for rats: 2,880 mg/kg (DFG MAK (2000))
(7) LD50 for mice: > 2,595 mg/kg (SIAR (2002), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), ACGIH (2020))
1 Acute toxicity (Dermal) Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was not classified in Categories 1 to 3, but no category could be identified, and the classification was not possible due to lack of data. Also, based on the new findings, the classification result was changed.

[Evidence Data]
(1) LD50 for rabbits: > 1,600 mg/kg (DFG MAK (2000))
(2) LD50 for rabbits: > 1,620 mg/kg (ACGIH (2020))
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Liquid (GHS definition). It was classified as "Not classified."
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1), it was not classified in Categories 1 to 3, but no category could be identified, and the classification was not possible due to lack of data. Also, since the exposure concentration was lower than 90% (79,052 ppm) of the saturated vapor pressure concentration, it was judged to be a vapor state and classified based on the reference value in units of ppmV.

[Evidence Data]
(1) LC50 (4 hours) for rats: > 6,370 ppm (SIAR (2002), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), DFG MAK (2000), ACGIH (2020))
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified" (Category 3 in UN GHS classification).

[Evidence Data]
(1) It was reported that, in a skin irritation test with rabbits (n=6) (24-hour application), slight or very slight erythema was observed in the majority of the animals, but it resolved within 7 days (ACGIH (8th, 2020)).

[Reference Data, etc.]
(2) It was reported that 5 to 20 mL/kg of undiluted solutions of this substance were applied to the skin of guinea pigs, and severe skin responses that included necrosis and eschars were observed (ACGIH (8th, 2020)).
(3) It was reported that, in an in vitro skin corrosion test (OECD TG431, GLP) using EpiSkin, the cell viability was 101.6%, 106.1%, and 22.3% after 3-minute, 60-minute, and 4-hour exposures, respectively (ACGIH (8th, 2020), REACH registration dossier (Accessed Oct. 2021)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified." Also, based on the new findings, the classification result was changed.

[Evidence Data]
(1) In an eye irritation test with rabbits (n=6) (observation for 48 hours), no effects were observed in 2 animals. Chemosis and discharge were observed in 4 animals, but they resolved within 48 hours. It was reported that the mean Draize score from this study was 0.3 supporting a slight irritation conclusion (ACGIH 8th, 2020).
(2) It was reported that, in an in vitro isolated chicken eye test method for identifying ocular corrosives and severe irritants (OECD TG 438, GLP), the rate of corneal swelling was 9% (ICE class: II), the level of corneal opacity was 0.17 (ICE class: I), and the fluorescein retention score was 0.17 (ICE class: I), and the combinations of the three indexes were 2xI and 1xII ("Not classified") (REACH registration dossier (Accessed Oct. 2020)).

[Reference Data, etc.]
(3) This substance is irritating to the eyes, skin, and respiratory tract (ACGIH (8th, 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), HSDB (Accessed Oct. 2021)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified." Also, based on the new findings, the classification result was changed.

[Evidence Data]
(1) It was reported that, in a Local Lymph Node Assay (LLNA) (OECD TG 429, GLP) with mice (n=4/group), the stimulation index (SI) values were 1.4 (25%), 1.2 (50%), 2.7 (100%) (ACGIH (8th, 2020), REACH registration dossier (Accessed Oct. 2021)).
5 Germ cell mutagenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

[Reference Data, etc.]
(1) As for in vitro, negative results were obtained both in a bacterial reverse mutation test (OECD TG 471, GLP) and a chromosomal aberration test (OECD TG 473, GLP) using the cultured mammalian cells (Chinese hamster lung fibroblasts (CHL/IU)) (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (2001), SIAR (2002), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), ACGIH (8th, 2021), REACH registration dossier (Accessed Oct. 2021)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
There are no classification results by domestic and international organizations, but based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) As a result of a 2-year carcinogenicity study (OECD TG 451, GLP, 600 to 2,400 ppm) by inhalation exposure with rats, a trend toward an increase in liver tumors (combined incidence of hepatocellular adenoma and hepatocellular carcinoma) was observed in males, but there was no significant increase in the incidence, and it was judged that there was no evidence of carcinogenicity with this substance. No evidence for carcinogenicity was observed in females (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2004), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012)).
(2) As a result of a 2-year carcinogenicity study (OECD TG 451, GLP, 75 to 300 ppm) by inhalation exposure with mice, no increase in the incidence of tumors was observed in either males or females, and no evidence of carcinogenicity was obtained (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2004), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012)).
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1), no reproductive and developmental effects were detected in screening test results, but based on this result alone, it could not be concluded that this substance did not cause reproductive and developmental toxicity, and therefore, the classification was not possible due to lack of data.

[Evidence Data]
(1) It was reported that, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, no effects were observed on reproductive ability of parent animals and development and postnatal development of offspring at doses up to the highest dose of 500 mg/kg/day at which minor effects (salivation, lacrimation, an increase in relative kidney weight, etc.) were observed in parent animals (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (2001), SIAR (2002), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), ACGIH (8th, 2020), REACH registration dossier (Accessed Oct. 2021)).
8 Specific target organ toxicity - Single exposure Category 2 (nervous system), Category 3 (narcotic effects, respiratory tract irritation)



Warning
H371
H336
H335
P308+P311
P260
P264
P270
P405
P501
P304+P340
P403+P233
P261
P271
P312
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 2 (nervous system) and Category 3 (narcotic effects, respiratory tract irritation). Also, based on the new findings, the classification result was changed.

[Evidence Data]
(1) In an acute oral toxicity test (OECD TG 401, GLP) with rats, hypoactivity was observed at 500 mg/kg (within the range for Category 2), lacrimation was observed at 1,000 mg/kg (within the range for Category 2), and abnormal gait, adoption of a prone position, salivation, piloerection, and tremors were observed at 2,000 mg/kg (within the range for Category 2), and deaths were observed 3 days after the findings were observed. It was reported that necropsy revealed pulmonary congestion (SIAR (2002), Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (2001), ACGIH (2020)).
(2) It was reported that this substance caused irritation to the respiratory tract and effects on the central nervous system, coughing and lethargy by inhalation, and lethargy, suffocation, and nausea by oral ingestion (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) to (4), it was classified as "Not classified" in the oral route and inhalation route. However, the classification was not possible due to lack of data in the dermal route.

[Evidence Data]
(1) It was reported that, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG422, for up to 48 days from 14 days before mating (males), for up to 42 days from 14 days before mating to day 4 of lactation (females)), higher total bile (females) was observed at 50 mg/kg/day (within the range for Category 2), and salivation, higher total bile (males), and lacrimation (females) were observed at 150 mg/kg/day (in the range corresponding to "Not classified") (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (2001), SIAR (2002), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), ACGIH (2020)).
(2) It was reported that, in a 6-month repeated inhalation exposure study (vapor, 6 hours/day, 5 days/week) with rats, guinea pigs, and rabbits, only an increase in ALP was observed in rats at 0.25 mg/L (converted guidance value: 0.179 mg/L, within the range for Category 1), and no other effects were observed (SIAR (2002), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), DFG MAK (2000), ACGIH (2020)).
(3) It was reported that, in a 2-year carcinogenicity study (OECD TG451, GLP) with rats, no effects were observed at 2.02 mg/L (converted guidance value: 1.44 mg/L, in the range corresponding to "Not classified")
(Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2004), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012)).
(4) It was reported that, in a 2-year carcinogenicity study (OECD TG451, GLP) with mice, no effects were observed at doses up to 1.01 mg/L (converted guidance value: 0.721 mg/L, within the range for Category 2) (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2004), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012)).
10 Aspiration hazard Category 1


Danger
H304 P301+P310
P331
P405
P501
[Rationale for the Classification]
Based on (1) - (3), it was classified in Category 1.

[Evidence Data]
(1) When ingested, it represents a low to moderate pulmonary aspiration hazard (Environmental Risk Assessment for Chemical Substance (Ministry of Environment, 2012), Patty (2012), HSDB in PubChem (Accessed Oct. 2021)).
(2) This substance is a hydrocarbon compound.
(3) It was reported that the viscosity was 625 Pa*s (25 deg C), and the density was 811 kg/m3 (20 deg C) (HSDB in PubChem (Accessed Oct. 2021), REACH registration dossier (Accessed Oct. 2021)). From the above, the kinematic viscosity was calculated to be 0.771 mm2/s.

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) Category 2
-
-
H401 P273
P501
It was classified in Category 2 from 48-hour EC50 = 2.1 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2000), SIAR, 2002, Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012)).
11 Hazardous to the aquatic environment Long term (Chronic) Category 2


-
H411 P273
P391
P501
If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2000)) and 21-day NOEC = 0.53 mg/L for crustacea (Daphnia magna) (SIAR, 2002).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (fish), then it is classified in Category 2 due to being not rapidly degradable and 96-hour LC50 = 5.8 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2000)).
From the above results, it was classified in Category 2.
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.
  • 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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