NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	6485-40-1
Chemical Name	L-Carvone
Substance ID	m-nite-6485-40-1_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	It was classified in Category 4 because it is estimated to be > 60 degrees C and <= 93 degrees C in a prescribed test from data as 88 degrees C (Lange (16th, 2005)) and 92 degrees C (GESTIS (Access on June. 2011)) in unknown test methods.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group present in the molecule associated with a self-reactive property (unsaturated bond), but the classification is not possible due to no data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for liquid substances.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain fluorine or chlorine but contains oxygen which is not chemically bonded to elements other than carbon.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain -O-O- structure.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	On the basis of an LD50 value of 1640 mg/kg for rats (JECFA 718 (1991)), it was classified in Category 4.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	It is a liquid at normal temperatures (Merck (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Lack of data. Besides, a 48-hour closed patch test in which humans were exposed to concentrations of 1 % (-)-carvone in petrolatum reports that no irritation was observed (JECFA 718 (1991)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1B	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1B. Also, based on the new evaluation report and findings, the classification result was changed. [Evidence Data] (1) It was reported that, in a Local Lymph Node Assay (LLNA) (OECD TG 429, GLP) with mice (n=4), the Stimulation Index (SI) values were 1 (2.5%), 1.5 (5%), 2.9 (10%), 5 (25%), and 5.7 (50%), and the EC3 value was calculated to be 10.7% (REACH registration dossier (Accessed Dec. 2021)). (2) Several case studies were available in which patch tests for L-carvone were positive. In addition, it was reported that patch tests for L-carvone were positive in 15 out of 541 patients with contact allergy, who had used spearmint toothpaste, spearmint chewing gum, or shampoo with a mint scent (CLH Report (2012)). [Reference Data, etc.] (3) It was reported that, in a Freund's complete adjuvant test (intradermal induction: 5% solution) with guinea pigs (n=15), erythema was observed in 13 animals at 48 hours after challenge and in 15 animals at 72 hours after challenge (ECHA RAC Opinion (2013)). (4) It was reported that, in a Maximization test using carvone with guinea pigs (n=19) (OECD TG 406, intradermal induction: 5% solution), slight to moderate erythema was observed in 47% (9/19 animals) at 24 hours after challenge and 5% (1/19 animals) at 48 hours after challenge in the group challenged with 50% solution. In the group challenged with 75% solution, 53% (10/19 animals) at 24 hours after challenge and 5% (1/19 animals) at 48 after challenge showed slight to moderate erythema (CLH Report (2012), ECHA RAC Opinion (2013)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, in vitro test results as "negative" in an Ames test and "equivocal" in a chromosomal aberration test using Chinese hamster ovary cells are reported (JECFA 944 (1999)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	Lack of data. Besides, a carcinogenicity test in which mice were given d-carvone for 2 years reports that no increases in tumor incidences were observed in mice administered d-carvone (NTP TR 381 (1990)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	Lack of data. Besides, some reports serum cholesterol and triacylglycerol increases in oral administration of 500 mg/kg/day to rats for 14 days (converted to a 90-day equivalent: 78 mg/kg/day) (JECFA 718 (1991)), growth depression and testicular atrophy in diet administration of 1.0 % (500 mg/kg/day) for 16 weeks (JECFA 718 (1991)), and no adverse effects in diet administration of 0.25 % (125 mg/kg) for 1 year (JECFA 718 (1991)), but it was classified as "Classification not possible" because L-body or D-body is unknown about the test substance and details of results are unknown.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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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