NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	470-82-6
Chemical Name	1,3,3-Trimethyl-2-oxabicyclo[2.2.2]octane; 1,8-Epoxy-p-menthane
Substance ID	m-nite-470-82-6_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	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Since its flash point reported 48 degC (closed-cup) (Merck (14th, 2006)) is >= 23 degC and <= 60 degC, the substance is classified into Category 3.	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	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	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 (but not fluorine or chlorine) 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)	Not classified	- -	-	-	Three LD50 values for rats of 1680 mg/kg bw (Reference: Brownlee (1940)), 2480 mg/kg bw (Reference: Bär & Greipentrog (1967)) and 2480 mg/kg bw (Reference: Jenner et al. (1964)) (all of the above: JECFA FAS 52 (2004)) were reported. One is equivalent to Category 4, and the other two are equivalent to "Not classified" of JIS classification criteria. Since the number of data equivalent to "Not classified" category was more numerous than that equivalent to Category 4, the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 in the UN-GHS classification).	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	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data were available. As relevant notes, in the skin irritation tests using rabbit (OECD TG 404), the primary skin irritation index value (PII) of 1,4-Epoxy-p-menthane, isomer of the substance, was 2.25 (ECETOC TR66 (1995)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data were available. As relevant notes, contact of the liquid with human eyes causes severe pain and blepharospasm (HSDB (2002)).	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	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification was not possible due to lack of in vivo test data. As relevant information, as for in vitro studies, negative results in the Ames test and in the chromosome aberration test using Chinese hamster ovary cells were reported (NTP DB (Access on Oct. 2010)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	Insufficient data were available. As relevant information, in the 80-week oral study in male mice at the dose levels of 8 or 32 mg/kg/day, the incidences and severities in tumors of liver, lung and kidney, or malignant lymphoma in the dose groups of this substance were not significantly different from those in the control groups (JECFA FAS 52 (2004)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In the developmental toxicity study in which rats were orally administered with the mixture containing this substance on the days 9 - 14 of gestation, at the highest dose, there were significant reductions in maternal body weight, placental weight, fetal and newborn body weight compared with controls. However, there were no external, visceral or skeletal anomalies, and there was no significant difference in the incidence of fetal malformations in the treated group by comparison with that in controls. Thus, no teratogenic effect was observed (JECFA FAS 52 (2004)). However, since sexual functions and fertility of parental animals were unknown due to no data, the substance was classified as "Classification not possible".	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 28-day gavage or feeding studies in rats and mice, centrilobular vacuolation and fatty changes of hepatocytes were found in male rats at all dose levels (converted dose level as that of 90-day study: 58.3 - 467 mg/kg/day) in the feeding study and at 600 mg/kg/day (converted dose level as that of 90-day study: 187 mg/kg/day) or more in the gavage study. In addition, cytoplasmic alterations of the renal tubular epithelium and parotid salivary gland were observed in male rats at the dose levels of 750 mg/kg/day (converted dose level as that of 90-day study: 233 mg/kg/day) or more in the feeding study (JECFA FAS 52 (2004)). Moreover, it was also reported in the feeding study in mice that increased relative liver weight was observed accompanied by centrilobular hypertrophy of hepatocytes at the dose levels of more than 1125 mg/kg/day (JECFA FAS 52 (2004)). It was described that the liver changes in rats were not dose-related, and that these were typical of adaptive metabolic changes in the liver resulted from continuous exposure to high doses of test substance (JECFA FAS 52 (2004)). As mentioned above, because no adverse effects were seen not only within but over the guidance values in the 28-day repeated oral dose toxicity studies in rats and mice, the classification was equivalent to "Not classified" category for oral route. However, due to no available data for the other routes, the classification for specific target organ toxicity (repeated exposure) was determined 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)	Not classified	- -	-	-	Classified as "Not classified" from its 96h-LC50 = 102 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)	Not classified	- -	-	-	Classified as "Not classified" since its acute toxicity is "Not Classified" and it is not non-water soluble (water solubility: 3500 mg/L (PHYSPROP Database, 2011)).	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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