GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 32210-23-4
Chemical Name 4-tert-butylcyclohexan-1-yl acetate
Substance ID R02-A-017-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 Not classified
-
-
- - A flash point was 104 deg C (closed-cup) (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 Classification not possible
-
-
- - No data available.
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: about 3,370 mg/kg (males: about 3,885 mg/kg, females: about 3,323 mg/kg) (OECD TG 401) (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: > 4,680 mg/kg (OECD TG 402) (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), (2).

[Evidence Data]
(1) It is reported that in a skin irritation test with rabbits (n = 6) (occlusive, 24-hour application to abraded skin and intact skin, 72-hour observation), slight erythema and edema were observed in abraded skin and intact skin in two animals but completely disappeared within 72 hours (REACH registration dossier (Accessed Aug. 2020)).
(2) It is reported that in an in-vitro skin irritation test (OECD TG 439, GLP), cell viability, R = 62.6% (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 = 6) (equivalent to OECD TG 405, 7-day observation), chemosis with conjunctival redness was observed in 2 after 1 hour, and the other 4 showed slight eye irritation. After 24 hours, eye irritation effects were seen in 2, but the remaining 4 recovered, and all the animals fully recovered within 48 hours (mean corneal opacity score: 0.04, mean iritis score: 0, mean conjunctival redness score: 0.17, mean chemosis score: 0.04) (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 Category 1B


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
[Rationale for the Classification]
It was classified in Category 1B from (1).

[Evidence Data]
(1) It is reported that in a local lymph node assay (LLNA) with mice (n = 5/group) (OECD TG 429, GLP), stimulation index (SI values) was 1.39 (25%), 1.98 (50%), 3.61 (100%), and EC3 value was calculated as 81% (REACH registration dossier (Accessed Aug. 2020)).

[Reference Data, etc.]
(2) It is reported that in a patch test in 31 persons, a positive rate was 0% after induction by 5-time 48-hour occlusive applications of a solution of this substance (concentration: unknown) followed by challenge by 48-hour occlusive application of a solution of this substance (concentration: unknown) 14 days later (REACH registration dossier (Accessed Aug. 2020)).
(3) It is reported that in a patch test in 31 persons, a positive rate was 0% after induction by 5-time 18-hour occlusive applications of a solution of this substance (concentration: unknown) followed by challenge by 48-hour occlusive application of a solution of this substance (concentration: unknown) 10-14 days later (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, the substance was negative (JECDB (Accessed Aug. 2020)).
(2) In an in vitro mammalian cell chromosome aberration test, the substance was negative (JECDB (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." In (1), a decrease in dam's nursing behavior was observed, which occurred only in one litter each in the moderate and high dose groups and was not dose-related. In addition, the tendency of a decrease in viability index on postnatal day 4 in pups was not a significant change.

[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, GLP, for 42 days from 14 days before mating to one day before necropsy (males), from 14 days before mating to day 4 of lactation (for 42 to 51 days) (females)), at 300 mg/kg/day, general toxicity effects (such as reduced body weight gain and effects on the kidneys/adrenal glands) were observed in parental animals, death of all pups due to a decrease in nursing behavior (1/12 dams) and a tendency of lower viability index on postnatal day 4 (not significant) were observed in pups (JECDB (2014)).
(2) It was reported that in a developmental toxicity study with rats dosed by gavage (gestation days 7 to 20), at 640 mg/kg/day, sacrifice in emergency (1/25 cases), salivation, reduced body weight gain and reduced food consumption were observed in parental animals, while only slight effects (lower body weights, increased incidences of moderate enlargement of the renal pelvis, delays in ossification of the caudal vertebrae, fore- and hind-limb phalanges and hind-limb metatarsals) were observed in pups (REACH registration dossier (Accessed Aug. 2020)).
8 Specific target organ toxicity - Single exposure Category 2 (nervous system)


Warning
H371 P308+P311
P260
P264
P270
P405
P501
[Rationale for the Classification]
Based on (1), since hyperactivity and convulsions were observed within the range of Category 2, it was classified in Category 2 (nervous system).

[Evidence Data]
(1) It was reported that in an acute oral toxicity test with rats dosed by gavage (OECD TG 401), one female rat became hyperactive and showed limb twitching about 30 minutes after being dosed at 1,872 mg/kg (within the range for Category 2) and died within 24 to 48 hours after being dosed; tremors, convulsions, and chromorhinorrhea or chromodacryorrhea were observed at 2,340 mg/kg (in the range corresponding to "Not classified"); and deaths occurred at 4,212 mg/kg (in the range corresponding to "Not classified") (REACH registration dossier (Accessed Aug. 2020)).

[Reference Data, etc.]
(2) It was reported that in an acute dermal toxicity test with rabbits (OECD TG 402), no effects other than slight erythema were observed at 4,680 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), it was classified as "Not classified" in the oral route. However, there was not sufficient information available for classification in the other routes. Therefore, classification was not possible due to lack of data.

[Evidence Data]
(1) It was reported that in a reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 422, GLP) (males: for 42 days, females: for 42 to 51 days), kidney effects (higher weight, eosinophilic bodies of tubular epithelial cells (positive immunostaining for alpha 2mu-globulin)) were observed in males at and above 30 mg/kg/day (converted guidance value: 14 mg/kg/day, within the range for Category 2); adrenal effects (an increase of vacuoles in fasciculata cells) were observed in females at and above 100 mg/kg/day (converted guidance value: 46.7 mg/kg/day, within the range for Category 2); and reduced food consumption, reduced body weight gain (females), lower erythrocyte counts and higher MCV/MCH (females), liver effects (centrilobular hepatocyte hypertrophy (females), higher weight), kidney effects (granular casts (males)), adrenal effects (higher weight), reduced spontaneous activities, convulsions, and salivations were observed at 300 mg/kg/day (converted guidance value: 140 mg/kg/day, in the range corresponding to "Not classified") (JECDB (2014)).

[Reference Data, etc.]
(2) It was reported that in a 28-day oral toxicity study with rats dosed by feeding (OECD TG 407, GLP) performed using cis-4-tert-butylcyclohexyl acetate (CAS RN 10411-92-4) which is a geometric isomer (composition: the cis isomer: <80%, the trans isomer: >20%) of this substance, liver effects (an increase in relative weight) were observed at 300 mg/kg/day (converted guidance value: 93.3 mg/kg/day, within the range for Category 2), and thyroid effects (follicular epithelial hypertrophy (males: associated with hepatic enzyme induction)) and liver effects (an increase in relative weight, centrilobular hepatocyte hypertrophy (adaptive change)) were observed at 1,000 mg/kg/day (converted guidance value: 311 mg/kg/day, in the range corresponding to "Not classified") (REACH registration dossier (Accessed Aug. 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) Category 2
-
-
H401 P273
P501
It was classified in Category 2 from 48-hour EC50 = 5.3 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021).
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 as "Not classified" because it is not rapidly degradable (BIOWIN) and due to 72-hour ErC10 = 11 mg/L for algae (Desmodesmus subspicatus) (REACH registration dossier, 2021).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 because it is not rapidly degradable (BIOWIN) and due to 48-hour EC50 = 5.3 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021).
By drawing a comparison between 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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