GHS Classification Result

Chemical Name：6-Acetoxy-2,4-dimethyl-1,3-dioxane
CAS：828-00-2

Result：
ID: 22A4049
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Liquid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Liquid (GHS definition)
5 Gases under pressure Not applicable - - - - Liquid (GHS definition)
6 Flammable liquids Category 3 Warning H226: Flammable liquid and vapour P303+P361+P353: IF ON SKIN （or hair）: Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against static discharge.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ... 		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.
7 Flammable solids Not applicable - - - - Liquid (GHS definition)
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Classification not possible - - - - No data available.
10 Pyrophoric solids Not applicable - - - - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to liquid substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases 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).
13 Oxidizing liquids Not applicable - - - - The substance is an organic compound containing oxygen which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
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.
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)
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
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.
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.
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling. 		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)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... 		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.
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.
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)).
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".
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
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".
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Classification not possible - - - - No data available.
11 Hazardous to the aquatic environment （Long-term） Classification not possible - - - - No data available.
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

To GHS Information