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EC number: 204-783-1 | CAS number: 126-33-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- The inhalation toxicity of sulfolane (tetrahydrothiophene-1,1-dioxide).
- Author:
- Andersen, ME, Jones, RA, Mehl, RG, Hill, TA, Kurlansik, L, and Jenkins, Jr, LJ
- Year:
- 1 977
- Bibliographic source:
- Toxicology and Pharmacology 40: 463-472.
Materials and methods
- Principles of method if other than guideline:
- No further information is available.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Sulfolane
- IUPAC Name:
- Sulfolane
- Reference substance name:
- Tetrahydrothiophene 1,1-dioxide
- EC Number:
- 204-783-1
- EC Name:
- Tetrahydrothiophene 1,1-dioxide
- Cas Number:
- 126-33-0
- Molecular formula:
- C4H8O2S
- IUPAC Name:
- 1λ⁶-thiolane-1,1-dione
- Details on test material:
- - Name of test material (as cited in study report): sulfolane
- Analytical purity: not stated
- Minor constituent: 3% water (added to prevent freezing)
Constituent 1
Constituent 2
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 295 – 460 g
- Diet: Commercial prepared dry chow ad libitum except during exposure
- Water: ad libitum except during exposure.
IN-LIFE DATES: From:
Administration / exposure
- Route of administration:
- other: inhalation, aerosol (200, 159 and 20 mg/m3 exposure concentrations); inhalation, gas (4.0 and 2.8 mg/m3 exposure concentrations)
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: water
- Remarks on MMAD:
- MMAD / GSD: No information is available.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Rochester-type chambers were used for the whole body exposures. Airflow was maintained at 1 m3/min with constant temperature (25 + 1oC) and relative humidity (50%).
For the three highest exposure concentrations, sulfolane was pumped from a reservoir into a high-pressure spray nozzle, dispersed into an aerosol, pumped through laminar flow tubing and a drum impactor, and diluted with input air before entering into the chamber. Input concentration could be varied by altering the amount of sulfolane to the aerosolizer, by changing the pressure at the spray nozzle, and the amount of sulfolane in the reservoir with distilled water.
At the two lower exposure concentrations, air was bubbled through a sulfolane solution and then mixed with chamber input air. Concentrations were adjusted by changing the flow rate of air into the reservoir. Since sulfolane freezes at 27.5oC, the reservoir and input lines were wrapped with heat tape and maintained above room temperature. Exposure was discontinued for approximately one hour each day to feed the animals.
TEST ATMOSPHERE
Atmospheric sulfolane concentrations were determined by drawing known volumes of chamber air first through an impinger and then through a bubbler containing distilled water. The aerosolized sulfolane trapped by the impinger was dissolved in distilled water. Sulfolane in these aqueous solutions was determined by gas-liquid chromatography with flame ionization detection. Samples were taken every 6 hours during the exposures. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- No information is available.
- Duration of treatment / exposure:
- 90-110 days (90, 85, 95, 110, and 90 days for the 200, 159, 20, 4.0 and 2.8 mg/m3 exposure concentrations, respectively)
- Frequency of treatment:
- 23 hours/day, 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2.8 mg/m³ air (analytical)
- Remarks:
- +1.4
- Dose / conc.:
- 4 mg/m³ air (analytical)
- Remarks:
- +1.0
- Dose / conc.:
- 20 mg/m³ air (analytical)
- Remarks:
- +6.7
- Dose / conc.:
- 159 mg/m³ air (analytical)
- Remarks:
- +68
- Dose / conc.:
- 200 mg/m³ air (analytical)
- Remarks:
- +48
- No. of animals per sex per dose:
- 15 animals/sex for the 200 mg/m3 group; 24 animals/sex for the 159 mg/m3; 8 males and 7 females for the 20 mg/m3 group; 15 males/group for the 4.0 and 2.8 mg/m3 groups.
- Control animals:
- yes, sham-exposed
- Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- Effects on general toxicity, hematology, clinical chemistry, and urinalysis were evaluated.
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: no data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: no data
BODY WEIGHT: Yes
- Time schedule for examinations: prior to exposure; after 30 and 60 exposure-days; and at study termination.
FOOD CONSUMPTION: No
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 30 and 60 exposure days, and at study termination (also at 20 exposure days for the 200 mg/m3 group only).
- Anaesthetic used for blood collection: no data, except at termination (lethal dose of pentabarbital)
- Animals fasted: no data
- How many animals: 5 animals/sex per timepoint for the 200, 159, 20, 4.0 and 2.8 mg/m3 dose groups; 8 males and 7 females for the 20.0 mg/m3 dose group. In addition, 8 males and 2 females were bled after 20 exposures in the 200 mg/m3 group.
- Parameters examined: total and differential leucocyte counts, hemoglobin concentrations, and hematocrit.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 30 and 60 exposure days, and at study termination.
- Anaesthetic used for blood collection: Yes (lethal dose of pentabarbital)
- Animals fasted: Yes
- How many animals: 5 animals/sex per timepoint for the 200, 159, 20, 4.0 and 2.8 mg/m3 dose groups; 8 males and 7 females for the 20.0 mg/m3 dose group.
- Parameters examined: creatinine, urea nitrogen, cholesterol concentrations; alkaline phosphatase, lactate dehydrogenase, aspartate aminotransferase, and alanine aminotransferase activity.
URINALYSIS: Yes
- Time schedule for collection of urine: At study termination.
- Metabolism cages used for collection of urine: no data
- How many animals: 5 animals/sex for the 200, 159, 20, 4.0 and 2.8 mg/m3 dose groups; 8 males and 7 females for the 20.0 mg/m3 dose group.
- Parameters examined: estimation of pH, protein, sugar, ketone bodies, and occult blood.
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: No data
ORGAN WEIGHTS: No data
HISTOPATHOLOGY: Yes. Tissues examined: lung, bronchus, heart, kidney, bile duct, liver, spleen, stomach, intestine, pancreas, cerebellum, esophagus, thyroid, trachea, lymph node, bladder and aorta. - Other examinations:
- None
- Statistics:
- A students t-test was used.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- HAEMATOLOGY
White blood cell counts were significantly lower in the 200 mg/m3 group at exposure days 20, 30 and at study termination.
CLINICAL CHEMISTRY
No effects considered to be treatment-related.
GROSS PATHOLOGY
In the 200 mg/m3 group, several of the livers appeared fatty.
HISTOPATHOLOGY: NON-NEOPLASTIC
200 mg/m3: all of the guinea pigs in the 30-day termination group had chronic pleuritis. Histopathogical examination of the liver showed that 4/5 animals at day 30, 6/7 at day 60, and 4/5 at study termination had fatty vacuolization.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- LOAEC
- Effect level:
- 200 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Leukopenia; hemorrhagic, inflamed lungs; fatty vacuolation of the liver.
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 159 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- haematology
- histopathology: non-neoplastic
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Guinea pigs were exposed by inhalation to sulfolane either as a vapor/aerosol (20, 159 or 200 mg/m3) or as a vapor (2.8 and 4.0 mg/m3) for 90-110 days. At 200 mg/m3, animals exhibited chronic pleuritis, leukopenia (decreased white blood cells), and fatty vacuolization of the liver. At 159 mg/m3 or lower, there were no treatment-related effects. A NOAEC of 159 mg/m3 was established.
- Executive summary:
Guinea pigs were exposed by inhalation to sulfolane either as a vapor/aerosol (20, 159 or 200 mg/m3) or as a vapor (2.8 and 4.0 mg/m3) for 90-110 days. At 200 mg/m3, animals exhibited chronic pleuritis, leukopenia (decreased white blood cells), and fatty vacuolization of the liver. At 159 mg/m3 or lower, there were no treatment-related effects. A NOAEC of 159 mg/m3 was established.
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