NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	828-00-2
Chemical Name	6-Acetoxy-2,4-dimethyl-1,3-dioxane
Substance ID	m-nite-828-00-2_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)	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.	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	Although the test method of obtained flash point data 52 degC (Chemical Risk Information Platform (CHRIP) (Access on June. 2010); Original literature: Aldrich reagent catalogs) was unknown, it was judged that its flash point is > 23 degC and <= 60 degC for the closed-cup flash point measurement, and the substance was 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 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	- -	-	-	The two LD50 values for rats of > 2000 mg/kg bw (EPA test guideline compliant) (EPA RED (1996)) and 1930 mg/kg (NTP TR354 (1989)). The substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 or "Not classified" category in the UN-GHS classification), by adopting the test data complying with the EPA test guideline.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the rat LD50 value of > 2000 mg/kg bw (EPA test guideline compliant) (EPA RED (1996)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 or "Not classified" category in the UN-GHS classification)	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	- -	-	-	The rat LC50 value of > 4.0 mg/L/4hrs (EPA test guideline compliant) (EPA RED (1996)) was documented. Since this value did not provide the basis for the classification, the classification was not possible. The test concentration (4.0 mg/L) was higher than the saturated vapor pressure concentration (1.33 mg/L), the criterion values for dust/mist were adopted.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	The substance was classified as "Not classified" (corresponding to Category 3 in the GHS classification) based on the documented case of "slight irritation" (EPA RED (1996)) resulted from the rabbit test in which the substance caused slight erythema, but irritation disappeared in all animals except one within 48 hours.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	The substance was classified as Category 2B based on the documented case of "mild transient ocular irritation" resulted from the rabbit test (EPA RED (1996)).	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	In the sensitization test using guinea pig, the substance caused strong sensitization (EPA RED (1996)), and allergic contact dermatitis was reported in textile workers who was the occupationally exposed to the substance (NTP TR354 (1989)). Based on these documents, the substance was classified as Category 1.	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 Ames test (EPA RED (1996)), positive results only in TA100 strain with S9 and negative results in other bacterial strains in another Ames test (NTP TR354 (1989)), and positive results in the chromosome aberration test using CHO cells (NTP TR354 (1989)), were reported.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	The classification was concluded "Classification not possible" based on the criterion of "Group 3" by the IARC carcinogenicity assessment (IARC Suppl.7 (1987)). In addition, there were 2-year oral administration studies in rats and mice, and it was reported that there was no evidence of carcinogenicity for both sexes in rats. However, in mice, the incidence of squamous papilloma of the forestomach increased without statistically significance in high dose group and squamous carcinoma was also observed in males. Therefore, it was concluded that, for mice, no evidence of carcinogenicity in females and ambiguous in males (NTP TR354 (1989)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In the developmental toxicity study in rats by oral administration during the organogenetic period, in the highest dose level (900 mg/kg/day), maternal toxicity such as reduced body weight gain and reduced food consumption were observed. Because the NOEL for developmental toxicity was 900 mg/kg/day, the highest dose tested (EPA RED (1996)), therefore, it was considered that there was no developmental toxicity. However, due to insufficient data regarding the effects on sexual functions and fertility in parental animals, 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 13-week oral toxicity studies in rats and mice, treatment-related toxic effects were seen, but limited to the forestomach lesions which consisted of thickening of stratified squamous epithelium, hyperkeratosis, ulceration and inflammation (NTP TR354 (1989)). These lesions were observed at 500 mg/kg/day in both species, and were not observed at doses at the dose levels of 31 mg/kg/day or lower for males and at 125 mg/kg/day or lower for females in rats, while in mice, no lesions were observed at the dose levels of 250 mg/kg/day or lower (NTP TR 354 (1989)). In addition, it was also reported that incidences of any forestomach lesions were not increased at the dose levels equivalent to the guidance values in the 15-month oral toxicity studies with rats or mice (NTP TR 354 (1989)). Thus, the classification was suitable to "Not classified" in oral route. On the other hand, in the 3-month dermal toxicity study in rats, increased incidence of hepatic changes, containing necrosis, inflammation and hemorrhage was reported in the dose range of 300 to 1000 mg/kg/day. Because the NOEL was 100 mg/kg/day (EPA RED (1996)), the classification was also applicable to "Not classified "in dermal route. However, because no data were available for inhalation route and toxic effects was unknown, the classification as this hazard class 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)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	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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