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 |
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 |
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. |
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. |
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 | - |
- |
- | - | - |
|