NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	97-54-1
Chemical Name	Isoeugenol
Substance ID	m-nite-97-54-1_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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	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)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified	- -	-	-	From a flash point of > 93 degrees C judged from a flash point of > 100 degrees C [closed cup] (NFPA (13th, 2006)), it was classified as "Not classified."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	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)	- -	-	-	"Liquids" according to GHS definition.	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 contains oxygen which is not chemically bonded to elements other than carbon or hydrogen.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	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	From LD50 values of 1560 mg/kg (PATTY (5th, 2001)) and 1290 to 1880 mg/kg (NTP TR 551 (2010)) for rats, it was classified in Category 4.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	From an LD50 value of 1912 mg/kg bw for rabbits (HERA (2005), corresponding to List 2), it was classified in Category 4.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	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	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	From "severely irritating" concluded by 24-hour occlusive application with undiluted this substance to rabbit or guinea pig skin (HERA (2005)), it was classified in Category 2. Besides, in human, a 48-hour occlusive application test with 32% solution of this compound in acetone in adult males reported that 1 out of 50 men showed moderately irritating. (HERA (2005))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	After application of 1% or 1.25% solution of this substance in alcohol into rabbit eyes, mild conjunctival irritation in 1% and intense conjunctival irritation accompanied by chemosis and discharge in 1.25% were observed, and eyes became normal after four and seven days respectively. (HERA (2005)) It was classified in Category 2A because severe irritation is expected if undiluted this substance is used (HERA (2005)).	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 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Positive results were obtained in both a maximization test in guinea pigs and a local lymph node test in mice. (ECETOC TR 77 (1999), NTP TR 551 (2010)) In human, incidences in allergic contact dermatitis are increasing by use of cosmetics and detergents including this substance (NTP TR 551 (2010)), and many cases of a positive response in a patch test in patients who have sensitization or dermatitis to cosmetics and so on were published. Therefore, it was concluded that this substance is a skin sensitizer both in human and animal. (ECETOC TR 77 (1999)) Furthermore, this substance is included in a list of sensitizing substances recognized by the Japanese Society for Dematoallergology and Contact Dermatitis (Japanese standard allergens 2008, corresponding to List 1) and is also listed as a contact allergy substance in Contact Dermatitis (Frosch) (Contact Dermatitis (Frosch) (4th, 2006), corresponding to List 1). From the above knowledge, it was classified in Category 1.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	A micronucleus test using peripheral blood after 90-day oral administration to mice (in vivo somatic cell mutagenicity test) showed a negative in males and a positive in females. (NTP DB (Access on June 2011)) But the positive result was judged not to have biological significance from whose significant difference, which was only found in the highest dose group, was attributed to a low incidence of micronucleus in a control group. Therefore, it was classified as "Not classified" from the negative result in males. Besides, as in vitro tests, both an Ames test and a chromosomal aberration test using CHO cells reported negatives. (NTP DB (Access on June 2011))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	In a 2-year oral administration carcinogenicity test in rats and mice, no evidence of carcinogenicity was found in female rats, but increased incidences of rarely occurring thymoma and mammary gland carcinoma in male rats and an increased incidence of histiocytic sarcoma in female mice were considered to be equivocal evidence of carcinogenicity. On the other hand, hepatocellular adenoma and hepatocellular carcinoma were found in male mice. (NTP TR 551 (2010)) It was classified as "Classification not possible" because the liver tumors found in male mice, which were the only clear evidence of carcinogenicity, were not sufficient to prove apparent carcinogenicity of this substance from the above.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In a three-generation reproductive test in oral administration in rats (70 to 700 mg/kg/day), manifestations of general toxicity such as hyperkeratosis and hyperplasia in forestomach at all doses and decreased body weight at doses of 230 mg/kg/day or higher, and a decrease in male pups number per litter at 700 mg/kg/day in F0 generation were reported. (NTP RACB 97004 (2002)) But due to insufficient evidence to show apparent reproductive toxicity from limited effects to F0 generation, and description of "mild reproductive toxicity" in the main text (NTP RACB 97004 (2002)), it was classified as "Classification not possible." Besides, in a development toxicity test in oral administration on day 6 to 19 of gestation in rats (250 to 1000 mg/kg/day), decreased weight gains at all doses, and as effects on the development of the offspring, only decreased fetal body weights and delayed ossification of sternebra but no teratogenicity were observed. (NTP TER 97006 (1999))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In oral administration to rats, an LD50 of 1560 mg/kg, comatose state and persistent weakness, and deaths within a week were observed. (PATTY (5th, 2001)) In addition, in intraperitoneal administration in rats, anesthetic and anticonvulsant effects at doses near to LD50 values (261 to 309 mg/kg) were reported. (HERA (2005)) There is information that eugenol of related substance reduces peripheral nerve activity at a low dose and causes neurotoxicity at a high dose (HSDB (2010)). Because the LD50 value in oral corresponded to Category 2 in Guidance values from the above signs after exposure, it was classified in Category 2 (nervous system).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (nasal cavity)	Warning	H373	P260 P314 P501	In a 2-year repeated oral administration test dosed 75, 150, or 300 mg/kg/day to mice, incidences of respiratory metaplasia, atrophy, and hyaline droplet accumulation in the olfactory epithelium of nasal cavity in all dose groups increased significantly than those in a vehicle control group, and incidences of minimal to marked hyperplasia of Bowman’s gland also increased significantly. (NTP TR 551 (2010)) In a 2-year repeated oral administration test dosed 75, 150, or 300 mg/kg/day to rats, increased incidences of respiratory metaplasia and atrophy at doses of 150 mg/kg/day or higher and olfactory epithelium degeneration at 300 mg/kg/day were also reported. (NTP TR 551 (2010)) It was classified in Category 2 (nasal cavity) because the dose of 75 mg/kg/day at which the above effects on olfactory epithelium in mice were reported corresponds to Category 2 in Guidance values. Besides, in a 14-week repeated oral administration test in rats and mice, atrophy of olfactory epithelial tissue and nerve bundles were also reported at a dose above the upper limit of a range of Guidance values. (NTP TR 551 (2010))	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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