GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 20298-69-5
Chemical Name rel-(1R,2R)-2-tert-Butylcyclohexyl acetate
Substance ID R02-A-015-METI, MOE
Classification year (FY) FY2020
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
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)  
Model SDS by MHLW (External link)  
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 4
-
Warning
H227 P370+P378
P210
P280
P403
P501
A flash point was 89 deg C (closed-cup) for cis-2-tert-butylcyclohexyl acetate (ECHA (Accessed Aug. 2020)).
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 295 deg C for cis-2-tert-butylcyclohexyl acetate (ECHA (Accessed Aug. 2020)).
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)
-
-
- - 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 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) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" (Category 5 in UN GHS classification) from (1).

[Evidence Data]
(1) LD50 for rats: 4,600 mg/kg (REACH registration dossier (Accessed Aug. 2020))

1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rabbits: > 5,000 mg/kg (REACH registration dossier (Accessed Aug. 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]
Classification not possible due to lack of data.
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]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in a skin irritation test with rabbits (n = 7) (equivalent to OECD TG 404, semi-occlusive, 4-hour application, 72-hour observation), the mean score at 24/48/72 hours was 1.7 for erythema and 1.05 for edema, and the mean erythema score at 24/48/72 hours was 2.33 in one out of 7, but no other animal had the mean score exceeding 2.3 for erythema or edema. Skin reactions were not reversible within 72 hours, but effects were expected to disappear fully after 14 days (REACH registration dossier (Accessed Aug. 2020)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in an eye irritation test with rabbits (n = 4) (equivalent to OECD TG 405), no reactions were seen in any animal (corneal opacity score: 0/0/0/0, iritis score: 0/0/0/0, conjunctival redness score: 0/0/0/0, chemosis score: 0/0/0/0) (REACH registration dossier (Accessed Aug. 2020)).
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]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) It is reported that in a patch test in 101 persons, after induction by 9-time applications of a 10% solution over 3 weeks followed by challenge by 24-hour occlusive application of a 10% solution 2 weeks later, slight erythema was observed in one during the induction period (after the fifth application), but a positive rate was 0% (0/101) for both 24, 48 hours after challenge (REACH registration dossier (Accessed Aug. 2020)).
(2) It is reported that in a Buehler test with guinea pigs (n = 20) (equivalent to OECD TG 406, topical administration: undiluted), no sensitization reactions were seen in any animal (REACH registration dossier (Accessed Aug. 2020)).
5 Germ cell mutagenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

[Evidence Data]
(1) In a bacterial reverse mutation test (OECD TG471, GLP), the substance was negative (REACH registration dossier (Accessed Aug. 2020)).
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[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 feeding (OECD TG422, GLP, during a 10-week premating period, through a mating period, and until one day before necropsy (males); during a 10-week premating period, then through mating, gestation, and lactation periods, and until one day before necropsy (approx. day 4 of lactation) (females)), no reproduction toxicity was observed (REACH registration dossier (Accessed Aug. 2020)).
(2) It was reported that in a developmental toxicity study with rats dosed by feeding (OECD TG414, GLP, gestation days 0 to 21), at 7,700 mg/kg/day, reduced body weight gain and decreased food intake (palatability of the diet) were observed in parental animals, while only reduced fetal body weight and delayed ossification were observed in pups (REACH registration dossier (Accessed Aug. 2020)).

[Reference Data, etc.]
(3) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test for a mixture of cis- and trans- isomers of this substance used as the test substance with rats dosed by gavage (OECD TG422, for 42 days including a 14-day premating period and a mating period (males); during a 14-day premating period, through mating and gestation periods, until day 4 of lactation (for 41 to 46 days) (females)), at 500 mg/kg/day, deaths (4 females), salivation, clonic convulsion, reduced body weight gain, lower food consumption, higher water intake/urine volume, lower red blood cell count, and vacuolation of the adrenal cortex (females) were observed in parental animals, while only a tendency of lower body weight gain on postnatal days 0 to 4 was observed in pups (JECDB (2013)).
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was considered to be classified as "Not classified" in the oral and dermal routes, but there was no information on toxicity in the inhalation route. Therefore, classification was not possible due to lack of data.

[Evidence Data]
(1) It was reported that in an acute oral toxicity test with rats, ataxia and piloerection were observed at 3,200 mg/kg (in the range corresponding to "Not classified") (REACH registration dossier (Accessed Aug. 2020)).
(2) It was reported that in an acute dermal toxicity test with rabbits, diarrhea was observed in one animal and skin irritation symptoms (redness, edema) were observed in all animals at 5,000 mg/kg (in the range corresponding to "Not classified") (REACH registration dossier (Accessed Aug. 2020)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was considered to be classified as "Not classified" in the oral route, but there was no information on toxicity in the other routes. Therefore, classification was not possible due to lack of data.

[Evidence Data]
(1) It was reported that in a 90-day repeated oral dose toxicity test with rats dosed by feeding (OECD TG 408, GLP), at and above 800 ppm (37 mg/kg/day (males), 43 mg/kg/day (females), within the range for Category 2), an increase in relative weight of the kidneys and histological changes (such as hyaline droplets accumulation, granular casts, basophilic tubules) were observed only in males, and since an immunocytochemical staining of alpha 2mu-globulin showed positive results, the observed symptoms were considered to be male rat-specific renal pathological changes. No other effects were observed at doses up to the highest dose of 7,500 ppm (423 mg/kg/day (males), 457 mg/kg/day (females), in the range corresponding to "Not classified") (REACH registration dossier (Accessed Aug. 2020)).
(2) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by feeding (OECD TG 422, GLP, males: during a 10-week premating period, then through a mating period, and until one day before necropsy, females: during a 10-week premating period, then through mating, gestation, and lactation periods and until one day before necropsy (approx. day 4 of lactation)), a rise of urea nitrogen and an increase of hyaline droplets (an increase of eosinophilic hyalin droplets in the proximal tubular cells, dilated tubuli filled with eosinophilic cell debris) were observed at 75 mg/kg/day (converted guidance value: 58.3 mg/kg/day (males), 61.7 mg/kg/day (females), within the range for Category 2), an increase in relative kidney weight was observed in males at and above 200 mg/kg/day (converted guidance value: 156 mg/kg/day (males), 164 mg/kg/day (females), in the range corresponding to "Not classified"), and based on positive staining for alpha 2mu-globulin, the observed symptoms were judged as male rat-specific alpha 2mu-globulin nephropathy. No other effects were observed at doses up to the highest dose of 500 mg/kg/day (converted guidance value: 389 mg/kg/day (males), 411 mg/kg/day (females), in the range corresponding to "Not classified") (REACH registration dossier (Accessed Aug. 2020)).

[Reference Data, etc.]
(3) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test for a mixture of cis- and trans- isomers of this substance with rats dosed by gavage (OECD TG 422, GLP, males: for 42 days, females: for 41 to 46 days), kidney effects were observed in males at 50 mg/kg/day (converted guidance value: 22.8 mg/kg/day (males), 25.6 mg/kg/day (females), within the range for Category 2), and liver effects (centrilobular hepatocyte hypertrophy (males and females)) and thyroid effects (follicular cell hypertrophy (males)) were observed mainly at and above 150 mg/kg/day (converted guidance value: 68.3 mg/kg/day (males), 76.7 mg/kg/day (females), within the range for Category 2) (JECDB (2013)).
10 Aspiration hazard Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

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 72-hour EC50 = 4.2 mg/L for algae (Desmodesmus subspicatus) (REACH registration dossier, 2021).
11 Hazardous to the aquatic environment Long term (Chronic) Category 2


-
H411 P273
P391
P501
It was classified in Category 2 because it is not rapidly degradable (BIOWIN) and due to 21-day NOEC = 0.39 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021).
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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