GHS Classification Result

Chemical Name：tetrahydrothiophene-1,1-dioxide; sulpholane
CAS：126-33-0

Result：
ID: 20A2192
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government （Sep, 2008）

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 molecules.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solid Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Classification not possible - - - - No data available.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - Its autoignition point is 528degC (Chemical Risk Information Platform (CHRIP) (accessed in November 2008)), which is above 70degC.
11 Self-heating substances and mixtures Classification not possible - - - - No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified - - - - The substance is stable in contact with water.
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Classification not possible - - - - No data available.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Not classified - - - - Its rat LD50 values were 2489 mg/kg for male and 2324 mg/kg for female in one study (SIDS (accessed in November 2008)), and they were 2006 mg/kg for male and 2130 mg/kg for female in other study (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council), accessed in November 2008). All these LD50 values fall under the "Not classified" category using the JIS classification criteria (Category 5 in the United Nations classification).
1 Acute toxicity （Dermal） Not classified - - - - Its rat LD50 of > 2000 mg/kg and rabbit LD50 values of 12600 mg/kg (SIDS (accessed in November 2008)) and 4897 mg/kg (SIDS (accessed in November 2008)) all fall under the "Not classified" category.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Not classified - - - - Its rat LC50 values obtained in inhalation tests: 12 mg/L/4h and 3.6 mg/kg/17.5h (15.75 mg/kg/4h) (SIDS (accessed in November 2008)), fall under the "Not classified" category
2 Skin corrosion/irritation Not classified - - - - Rabbit and guinea pig studies found the substance not irritating (SIDS (accessed in November 2008)). Similarly, other rabbit tests found the substance mildly irritating, or according to the EC classification, not irritating as it was graded 2 on a scale of 1 to 10 (IUCLID, 2000). Based on these results, the substance was classified into the "Not classified" category.
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. 		A rabbit test (US Federal Register 29 FR 13009 (1964)) found the substance not irritating (mild conjunctivitis was noted but healed in several hours). A rabbit Draize test found the substance slightly irritating (corneal opacity, and iridial and conjunctival irritation were noted but were healed quickly; all treated animals showed complete recovery 7 days after application) (SIDS (accessed in November 2008)). A different rabbit test found the substance moderately irritating (SIDS (accessed in November 2008)). Overall, since the Draize test found the substance slightly irritating, it was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Since guinea pig maximization tests found the substance not sensitizing (SIDS (accessed in November 2008), IUCLID (2000)), it was classified into the "Not classified" category.
5 Germ cell mutagenicity Classification not possible - - - - Classification is not possible due to lack of in vivo mutagenicity test results as well as positive results in in vitro mutagenicity tests using several indices. Regarding in vitro mutagenicity tests, Ames tests and chromosomal aberration tests gave negative results while mouse lymphoma assays gave positive results (SIDS (accessed in November 2008)).
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In a preliminary reproduction toxicity screening test using rats that underwent oral administration, decreased number of estrous cases before mating, decreased birth index, decreased live birth index, and death of neonates were noted at doses that caused body weight loss and decreased amount of food consumption (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council), accessed in November 2008). Thus, the substance was classified into Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In 27-day inhalation exposure tests using rats, guinea pigs, dogs, or monkeys (dose: 0.495 mg/L, 8 hour/day and 5 days/week), liver and lung inflammation in rats, lung inflammation in guinea pigs, dogs, and monkeys were noted at 0.495 mg/L, which is above Category 2 guidance values (SIDS (accessed in November 2008)). In 90 to 110-day inhalation exposure tests (23 hours/day) using rats, NOAEL was 0.02 mg/L (equivalent to Category 2 guidance values) and LOAEL was not obtained. In 85 to 110 day inhalation exposure tests (23 hours/day) using guinea pigs, NOAEL was 0.159 mg/L, which is above Category 2 guidance values, and fatty vacuolization in the liver was detected at 0.2 mg/L (given that the saturated vapour pressure concentration is 0.04 mg/L, the study was presumably carried out in a mist state) (SIDS (accessed in November 2008)). In 90 to 110-day inhalation exposure tests (23 hours/day) using dogs, NOAEL was 0.02 mg/L and chronic pulmonary inflammation was detected at 0.2 mg/L. In 90 to 110-day inhalation exposure tests (23 hours/day) using monkeys, NOAEL was 0.02 mg/L and chronic pleuritis was found at 0.2 mg/L (SIDS (accessed in November 2008)). Since all NOAELs obtained in different animal tests are above Category 2 guidance values, the substance presumably has no effects at doses that are within the range of guidance values. These results indicate that the substance falls under the "Not classified" category (inhalation); however, since its effects through other administration routes are unclear, the substance was classified into the "Classification not possible" category. As additional background information, in a 28-day oral exposure test using rats that received 60, 200, or 700 mg/kg (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council), accessed in November 2008), increased hyaline droplets and acidophilic bodies in the proximal renal tubular epithelium were found in male rats at 200 mg/kg (the 90-day conversion value falls under Category 2 guidance values). However, these changes were considered to be specific to male rats, so we did not evaluate this study.
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） Not classified - - - - Its 96-hour LC50 is > 100 mg/L for fish (medaka), 48-hour EC50 = 852 mg/L for crustaceans (Daphnia magna), and 72-hour EbC50 = 500 mg/L for algae (Pseudokirchneriella subcapitata). Based on these results, the substance was classified into "Not classified".
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Since it is water soluble (water solubility: 1000000 mg/L (PHYSPROP Database, 2008)), and its classification for acute toxicity is the "Not classified" category, the substance was classified into "Not classified".


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