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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	88-41-5
Chemical Name	2-tert-Butylcyclohexyl acetate
Substance ID	R02-A-091-METI
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)
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	It was classified in Category 4 based on a flash point of 89 deg C (closed cup) (cis form) (ECHA (Accessed Dec. 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 was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 295 deg C for cis form (ECHA (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" from (1). [Evidence Data] (1) LD50 for rats: 4,600 mg/kg (Fd. Chem. Toxicol., 46 (2008))
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 (Fd. Chem. Toxicol., 46 (2008))
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	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, scaling that was seen in (2) was not used for classification because it was impossible to judge if it persisted for 14 days. [Reference Data, etc.] (1) It is reported that in a skin irritation test in 25 persons (a preliminary test for a maximization test, 48-hour occlusive application of 4% of this substance), no skin irritation was seen (Fd. Chem. Toxicol., 46 (2008)). (2) It is reported that in a skin irritation test with rabbits (n = 10) (semi-occlusive, 4-hour application), slight to fairly distinct erythema and marginal to slight edema persisted for 72 hours, with marginal to fairly distinct cracking and scaling (Fd. Chem. Toxicol., 46 (2008)). (3) It is reported that in an acute dermal toxicity test with rabbits (n = 10), slight erythema in 6 out of 10 animals, moderate erythema in 4, slight edema in 3, and moderate edema in 7 were observed (Fd. Chem. Toxicol., 46 (2008)).
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) (24-hour observation), no eye irritation effects were seen after 24 hours (Fd. Chem. Toxicol., 46 (2008)).
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 skin sensitization test in 25 persons (maximization test, 4% in petrolatum), no sensitization was seen (Fd. Chem. Toxicol., 46 (2008)). (2) It is reported that in a patch test in 313 dermatitis patients, no sensitization reactions were observed (Fd. Chem. Toxicol., 46 (2008)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. [Reference Data, etc.] (1) In a bacterial reverse mutation test, negative results were reported (JECDB (Accessed Dec. 2020)). (2) In a chromosome aberration test using the cultured mammalian cells (CHL/IU), negative results were reported (JECDB (Accessed Dec. 2020)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible because there was no data available.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. In (1), no effect on fertility was observed, but there was no data available on developmental toxicity effects. [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 TG 422, GLP, for 42 days including 14 days prior to mating (males), for 41 to 46 days from 14 days before mating until day 4 of lactation (females)), at a dose at which apparent general toxicity effects (death (3/12 females in the mating group, 3/12 females in the non-mating group)) were observed in parental animals, reduced body weight gain, effects on the liver, kidney, thyroid, etc. were observed and only a tendency of lower body weight gain in pups on days 0 to 4 after birth was observed (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (2013)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. [Reference Data, etc.] (1) The LD50 of mice after the oral administration of this substance was 310 to 500 mg/kg. Concerning 16 kinds of cycloacetate compounds including this substance, it was reported that the symptoms such as lethargy and piloerection were observed after oral or dermal administration. In an acute oral toxicity test, irritative findings in some areas of the gastrointestinal tract, chromorhinorrhea and/or salivation were observed at necropsy (Fd. Chem. Toxicol., 46 (2008)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), the effects on the liver and thyroid were considered to be adaptive changes due to the induction of drug metabolic enzymes and the effects on the kidney were considered to be specific to male rats, and therefore, they were not adopted as the target organs. Although it could be classified as "Not classified" in the oral route, classification was not possible due to lack of data since there was no sufficient information available for classification in other routes. [Evidence Data] (1) In an oral toxicity test with rats dosed by gavage (OECD TG422, GLP, for 42 days including 14 days prior to mating (males, non-mating group), for 41 to 46 days (females)), at 50 mg/kg/day (converted guidance value: 23.3 mg/kg/day (males), 22.8 mg/kg/day (females), within the range for Category 2) and 150 mg/kg/day (converted guidance value: 70 mg/kg/day (males), 68.3 mg/kg/day (females), within the range for Category 2), liver effects (enlargements/increases in absolute and relative weight, centrilobular hepatocyte hypertrophy), kidney effects (increases in absolute and relative weight (males), eosinophilic bodies of tubular epithelial cells and regenerated renal tubules (males), higher relative weight (females)) and hypertrophy of thyroid follicular cells (males), etc. were observed. It was reported that the kidney effects were considered to be essentially attributed to the accumulation of alpha 2mu-globulin specific to male rats, and the liver effects (centrilobular hepatocyte hypertrophy) and the hypertrophy of thyroid follicular cells were considered to be attributed to the induction of drug metabolic enzymes judging from the morphology and development states of the symptoms (JECDB (Accessed Dec. 2020)).
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)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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