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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	24851-98-7
Chemical Name	Methyl(2-pentyl-3-oxocyclopentyl)acetate
Substance ID	R02-A-068-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 about 150 deg C (Closed cup) (GESTIS (Accessed Sep. 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 259 deg C (GESTIS (Accessed Sep. 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) - (4). [Evidence Data] (1) LD50 for rats (cis-: trans-isomer (about 10: 90)): > 5,000 mg/kg (REACH registration dossier (Accessed Oct. 2020)) (2) LD50 for rats (cis-: trans-isomer (about 10: 90)): > 10 mL/kg (> about 10,000 mg/kg) (REACH registration dossier (Accessed Oct. 2020)) (3) LD50 for rats (cis-: trans-isomer (about 30: 70)): about 10 mL/kg (about 10,000 mg/kg) (REACH registration dossier (Accessed Oct. 2020)) (4) LD50 for rats (cis-: trans-isomer (about 70: 30)): < 10 mL/kg (< about 10,000 mg/kg) (REACH registration dossier (Accessed Oct. 2020)) [Reference Data, etc.] (5) Specific gravity (20 deg C): 1.005 (REACH registration dossier (Accessed Oct. 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 (cis-: trans-isomer (about 10: 90)): > 5,000 mg/kg (REACH registration dossier (Accessed Oct. 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)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LC50 for rats (4 hours): > 4.93 mg/L (measured value, no dead animals) (OECD TG 403, GLP) (REACH registration dossier (Accessed Oct. 2020))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) It is reported that in a patch test in 111 persons, no skin irritation reactions were seen by a 20% solution of this substance (cis-: trans-isomer (about 10-12%: 88-90%)) (REACH registration dossier (Accessed Oct. 2020)). (2) It is reported that in a patch test in 100 persons, no skin irritation reactions were observed by a 20% solution of this substance (cis-: trans-isomer (about 75%: 25%)) (REACH registration dossier (Accessed Oct. 2020)). (3) It is reported that in a skin irritation test with rabbits (n = 3) on this substance (cis-: trans-isomer (about 30%: 70%)) (OECD TG 404, GLP, occlusive, 4-hour application, 72-hour observation), no skin irritation reactions were found in any animal (erythema/eschar score: 0/0/0, edema score: 0/0/0) (REACH registration dossier (Accessed Oct. 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 = 3) on this substance (cis-: trans-isomer (about 10-12%: 88-90%)) (OECD TG 405, GLP, 72-hour observation), all the animals showed conjunctival redness after 1 hour but fully recovered within 48 hours (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 0/0.3/0.3, chemosis score: 0/0/0) (REACH registration dossier (Accessed Oct. 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) - (4). [Evidence Data] (1) It is reported that in a patch test in 111 persons, no skin sensitization reactions were seen by a 20% solution of this substance (cis-: trans-isomer (about 10-12%: 88-90%)) (REACH registration dossier (Accessed Oct. 2020)). (2) It is reported that in a patch test in 100 persons, no skin sensitization reactions were observed by a 20% solution of this substance (cis-: trans-isomer (about 75%: 25%)) (REACH registration dossier (Accessed Oct. 2020)). (3) It is reported that in a maximization test with guinea pigs (n = 10) on this substance (cis-: trans-isomer (about 30%: 70%)) (OECD TG 406, GLP, intradermal administration: 6.25% solution), a positive rate was 0% (0/10) after a challenge with a 50% or 100% solution (REACH registration dossier (Accessed Oct. 2020)). (4) It is reported that in a local lymph node assay (LLNA) with mice (n = 5/group) on this substance (cis-: trans-isomer (about 75%: 25%)) (OECD TG 429, GLP), stimulation index (SI values) did not exceed 3 at any concentration (REACH registration dossier (Accessed Oct. 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (6), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test of this substance (a mixture of a cis isomer, ca. 10 to 12% and a trans isomer, ca. 86 to 88/88 to 90%) using the mouse bone marrow cells (OECD TG 474, GLP, intraperitoneal injection), negative results were reported (REACH registration dossier (Accessed Oct. 2020)). (2) In unscheduled DNA synthesis (UDS) tests with the hepatocellular from rats (OECD TG 486, GLP, intraperitoneal injection), negative results were reported (REACH registration dossier (Accessed Oct. 2020)). (3) In a bacterial reverse mutation test of this substance (a mixture of isomers with a composition ratio of 7:1) (OECD TG 471, GLP), negative results were reported (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (2013)). (4) In an in vitro mammalian cell chromosome aberration test (OECD TG 473, GLP), negative results were reported (JECDB (2013)). (5) In a reverse mutation test of this substance (a mixture of a cis isomer, ca. 10 to 12% and a trans isomer, ca. 86 to 88/88 to 90%) (OECD TG 471, GLP), negative results were reported (REACH registration dossier (Accessed Oct. 2020)). (6) In a gene mutation test with the L5178Y mouse lymphoma cells (OECD TG 476, GLP), negative results were reported (REACH registration dossier (Accessed Oct. 2020)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was 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 gavage (OECD TG422, GLP, for 42 days from 14 days before mating until the day before necropsy (males), for 41 to 46 days from 14 days before mating until day 4 of lactation (females)), at 1,000 mg/kg/day, reduced body weight gain and effects on the liver, kidney, blood system, etc. were observed in parental animals; and lower body weight on day 0 after birth was only observed in pups (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (2013)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage (OECD TG 414, GLP, days 7-20 of gestation), no developmental toxicity was observed (REACH registration dossier (Accessed Oct. 2020)).
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1), this substance was considered to produce irritation to nasal mucous membranes at high doses near the upper limit of Category 2 and it was classified in Category 3 (respiratory tract irritation). [Evidence Data] (1) It was reported that in an acute inhalation (dust/mist) toxicity test with rats (OECD TG 403, GLP, 4 hours), at 4.93 mg/L (within the range for Category 2), there was no death case, and an increase in respiratory rate, hunched posture, piloerection, wet fur, red and brown stains around the snout, and respiratory murmur in some cases were observed (REACH registration dossier (Accessed Oct. 2020)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" in the oral route. However, classification was not possible due to lack of data since there was not sufficient information available for classification in other routes. (1) It was reported that in an oral toxicity study of this substance (a mixture of isomers with a composition ratio of 7:1) with rats dosed by gavage (OECD TG422, GLP, for 42 days (males), for 41 to 46 days (females)), no effect was observed at 100 mg/kg/day (converted guidance value: 46.7 mg/kg/day (males), 45.6 mg/kg/day (females), within the range for Category 2); and effects on the liver, kidney and blood system were observed at or above 300 mg/kg/day (converted guidance value: 140 mg/kg/day (males), 137 mg/kg/day (females), in the range corresponding to "Not classified") (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (2013)). (2) It was reported that in a 90-day oral toxicity study of this substance (a mixture of a cis isomer, ca. 10 to 12% and a trans isomer, ca. 88 to 90%) with rats dosed by feeding (OECD TG408, GLP), no effect was observed at 100 mg/kg/day (within the range for Category 2) (REACH registration dossier (Accessed Oct. 2020), EFSA (2016)).
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 = 8.25 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	It was classified in Category 3 because it was rapidly degradable (a 28-day degradation rate by BOD: 98% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2009)) and due to 21-day NOEC = 0.79 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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