NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	97-53-0
Chemical Name	Eugenol
Substance ID	m-nite-97-53-0_v1
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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified	- -	-	-	Although measurement method of the flash points 104 degC (HSDB (2010)) and > 110 degC (Gangolli (2nd, 1998)) is unknown, it is estimated that the flash point measured by the closed-cup method is > 93 degC. Therefore, the substance is classified as "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	It contains chemical groups (unsaturated bond) associated with self-reactive properties in the molecule. Since no test results are available, classification is not possible.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2010	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)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen which is chemically bonded only to carbon or hydrogen.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2010	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	Two LD50 values for rats of 1930 mg/kg and 2680 mg/kg were reported (IARC 36 (1985)). Since one is equivalent to Category 4, and the other is equivalent to "Not classified" of the JIS classification criteria. Selecting the category of greater hazard, the substance was classified as Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Insufficient data were available. Although the LC50 value of > 2.58 mg/L/4hrs was reported in RTECS (2010), which was the "List 3" information source designated in the GHS classification guidance for the Japanese government, the classification was not possible from the result. Since the test concentration (2.58 mg/L) was higher than the saturated vapor pressure concentration (0.20 mg/L), the criterion values for mist were adopted.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	The substance was classified as Category 2 because primary skin irritation index value of rabbits was 2.92 (ECETOC TR 66 (1995)) in the test that 0.5 mL of undiluted test substance was applied for 4 hours (OECD TG 404, GLP-compliant).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Positive results were reported in the guinea pig maximization test, mouse local lymph node assay (LLNA test), and guinea pig optimization tests (ECETOC TR 77 (1999)). In the clinical patch test for 155 subjects who complained dermatitis from using cosmetics, positive reaction was found in 4 subjects (ECETOC TR 77 (1999)). And in another patch test with 18 dental patients, 16 were found to be positive (ECETOC TR 77 (1999)). The substance was concluded as a skin sensitizer for humans and animals (ECETOC TR 77 (1999)). Based on these documents, the substance was classified as Category 1. As relevant notes, the substance was also listed as a sensitizer in the literature (Contact Dermatitis, Frosch, 4th (2006)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	The classification was concluded as "Not classified" based on the negative results in the micronucleus test using bone marrow obtained from mice after intraperitoneally administered (in vivo mutagenicity test in somatic cells) (NTP DB (Access on Oct. 2010)). As relevant information, the results of the chromosome aberration test using bone marrow cells by the intraperitoneal administration in mice (in vivo mutagenicity test in somatic cells) were equivocal, and the results of sister chromatid exchange test were positive (NTP DB (Access on Oct. 2010)). As for in vitro studies, negative results in the Ames test, negative to weakly positive results in the chromosome aberration test and positive results in the mouse lymphoma assay were reported (NTP DB (Access on Oct. 2010)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	The classification was concluded as "Classification not possible" based on the criterion of "Group 3" in the carcinogenicity assessment by the IARC (IARC Supplement 7 (1987)). As relevant information, in the 2-year dietary administration test using rats and mice, no evidence of carcinogenicity in relation to the administration was found in both sexes of rats. On the other hand, in mice, the incidences of liver carcinomas and adenomas in males of the low dose group increased and the total incidences of hepatocellular carcinomas or adenomas in females significantly increased, suggesting an equivocal evidence for carcinogenicity (NTP TR 223 (1983)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the 13-week feeding studies in rats and mice treated up to the highest doses of 12500 ppm (625 mg/kg/day) and 6000 ppm (900 mg/kg/day), respectively, no treatment-related toxic effects were observed in both species except for a slight reduction in the body weight in rats at 12500 ppm (NTP TR 223 (1983)). In the 28-day feeding study in rats, there were no effects at the dietary concentration of 2% (converted dose level as that of 90-day study: 622 mg/kg/day) (JECFA WHO FAS 56 (2006)). And no effects were also confirmed in another 19-week feeding study in rats at the dietary concentration of 10000 ppm (500 mg/kg/day) (JECFA WHO FAS 56 (2006)). As stated above, no effects were noted up to the doses over the range of the guidance values, and consequently classification was considered to be equivalent to "Not classified" category for oral route. However, the effects for the other routes were unknown due to no available data. Therefore, the classification for specific target organ toxicity (repeated exposure) was concluded as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	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)	Category 3	- -	H402	P273 P501	Classified into Category 3 from its 96h-LC50 = 24.0 mg/L for fish (Pimephales promelas) (AQUIRE, 2011).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	Classified into Category 3 since its acute toxicity is Category 3 and it is not rapidly degradable (BIOWIN).	FY2010	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.	FY2010	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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