Item | Information |
---|---|
CAS RN | 123-91-1 |
Chemical Name | 1,4-Dioxane |
Substance ID | H30-C-011-MHLW |
Classification year (FY) | FY2018 |
Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW) |
New/Revised | Revised |
Classification result in other fiscal year | FY2009 FY2006 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
UN GHS document (External link) | UN GHS document |
Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
Model Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | eChemPortal |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Explosives | - |
- |
- | - | - |
2 | Flammable gases (including chemically unstable gases) | - |
- |
- | - | - |
3 | Aerosols | - |
- |
- | - | - |
4 | Oxidizing gases | - |
- |
- | - | - |
5 | Gases under pressure | - |
- |
- | - | - |
6 | Flammable liquids | - |
- |
- | - | - |
7 | Flammable solids | - |
- |
- | - | - |
8 | Self-reactive substances and mixtures | - |
- |
- | - | - |
9 | Pyrophoric liquids | - |
- |
- | - | - |
10 | Pyrophoric solids | - |
- |
- | - | - |
11 | Self-heating substances and mixtures | - |
- |
- | - | - |
12 | Substances and mixtures which, in contact with water, emit flammable gases | - |
- |
- | - | - |
13 | Oxidizing liquids | - |
- |
- | - | - |
14 | Oxidizing solids | - |
- |
- | - | - |
15 | Organic peroxides | - |
- |
- | - | - |
16 | Corrosive to metals | - |
- |
- | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | - |
- |
- | - | - |
1 | Acute toxicity (Dermal) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Gases) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Vapours) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Dusts and mists) | - |
- |
- | - | - |
2 | Skin corrosion/irritation | - |
- |
- | - | - |
3 | Serious eye damage/eye irritation | - |
- |
- | - | - |
4 | Respiratory sensitization | - |
- |
- | - | - |
4 | Skin sensitization | - |
- |
- | - | - |
5 | Germ cell mutagenicity | - |
- |
- | - | - |
6 | Carcinogenicity | Category 1B |
Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] As for carcinogenicity, there is no sufficient report indicating carcinogenicity in humans. As for the oral route, in multiple tests conducted according to appropriate test guidelines and GLP standards, (1) and (2), increased incidences of tumors including malignant tumors were observed in multiple sites of two animal species. In rats, tumors similar to those in the oral route were also observed in the inhalation route as written in (3). On top of the above, on the basis that EPA classified it L on the similar rationale as described in (4), it was classified in Category 1B. Besides, the same test results as for the previous classification were used for the classification this time. However, the category was revised by putting importance on the fact that the substance was judged to be carcinogenic in animals in Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare), and that guidelines were issued by the ministry from concerns on carcinogenicity after discussions in the small committee of hazard evaluation. [Evidence Data] (1) In a carcinogenicity test in rats (2-year drinking water administration), increased incidences of malignant tumors (mainly squamous cell carcinoma) in the nasal cavity and hepatocellular adenoma and carcinoma were observed in male and female dosed groups, and an increased incidence of mesothelioma in the peritoneum was also observed in a male dosed group (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 1990)). (2) In a carcinogenicity test in mice (2-year drinking water administration), increases in hepatocellular carcinoma were observed in male and female dosed groups (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 1990)). (3) In a test in which male F344 rats were exposed by inhalation of the vapour of this substance for 2 years, increased incidences of squamous cell carcinoma in the nasal cavity, hepatocellular adenoma, mesothelioma in the peritoneum were observed (OEL Documentations (Japan Society For Occupational Health, 2015), IRIS (2013); a test commissioned by Ministry of the Environment: Kasai et al. (2009)). (4) As for classification results by domestic and international organizations, it was classified in Group 2B by IARC (IARC 71 (1999)), in Carc. 2 in EU CLP, in R by NTP (NTP RoC (14th, 2016)), in L (Likely to be carcinogenic to humans) by EPA (IRIS (2013)), in A3 by ACGIH (ACGIH (7th, 2001)), in 2B by Japan Society for Occupational Health (JSOH) (OEL Documentations (Japan Society For Occupational Health, 2015)). [Reference Data, etc.] (5) In NTP's carcinogenicity tests in rats and mice (drinking water administration) that increased incidences of nasal cavity tumors hepatocellular adenoma in rats and hepatocellular carcinoma in mice are also reported (NTP TR80 (1979)). (6) Based on paragraph (3) of Article 28 of the Industrial Safety and Health Act, this substance is subject to guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare (Public announcement on guidelines in order to prevent the impairment of worker's health, No. 23, Oct 10, 2012). |
7 | Reproductive toxicity | - |
- |
- | - | - |
8 | Specific target organ toxicity - Single exposure | - |
- |
- | - | - |
9 | Specific target organ toxicity - Repeated exposure | - |
- |
- | - | - |
10 | Aspiration hazard | - |
- |
- | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment (Acute) | - |
- |
- | - | - |
11 | Hazardous to the aquatic environment (Long-term) | - |
- |
- | - | - |
12 | Hazardous to the ozone layer | - |
- |
- | - | - |
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