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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
Endpoint summary
Administrative data
Description of key information
Acute oral LD50 (rat): 2068 mg/kg
Acute dermal LD50 (rat): >2000mg/kg
Acute inhalation LC50 (rat, 4-hr): >12,000 mg/m3
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- No further information available.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5 weeks of age
- Weight at study initiation: 122-138 g for males; 107-120 g for females - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No information is available.
- Doses:
- 892, 1204, 1626, 2195, 2963, and 4000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was weighed immediately prior to treatment, the day and thereafter 1, 3, 7 and 14 days after treatment. The rats were observed periodically during the two-week post-treatment observation period.
- Necropsy of survivors performed: yes - Statistics:
- LD50 was calculated by Van der Waerden method
- Preliminary study:
- No information is available.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 006 mg/kg bw
- Remarks on result:
- other: 1783 – 2256
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 130 mg/kg bw
- Remarks on result:
- other: 1844 - 2460
- Mortality:
- Males: 4/5, 5/5, and 5/5 at 2195, 2963, and 4000 mg/kg, respectively. Females: 3/5, 5/5, and 5/5 at 2195, 2963 and 4000 mg/kg, respectively.
- Clinical signs:
- other: Males at >/=1626 mg/kg: convulsions, decreased locomotor activity, ptosis, salivation, piloerection, chromodacryorrhea and perineal region soiling with urine. [CONFIRM THAT THESE EFFECTS REFER TO MALES] Females at >/= 1626 mg/kg: decreased locomotor act
- Gross pathology:
- Dead animals showed hemorrhagic black spots in their glandular stomach mucosa at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 in male and female rats were 2006 and 2130 mg/kg, respectively.
- Executive summary:
A single oral dose of sulfolane was administered to rats by gavage at doses of 0, 892, 1204, 1626, 2195, 2963, and 4000 mg/kg. The acute oral LD50 in male and female rats were established at 2006 and 2130 mg/kg, respectively.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 068 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute 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
- Guideline:
- other: Other: Andersen et al. (1977)
- Principles of method if other than guideline:
- No further information available.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 260 – 480 g
- Diet: Commercial prepared dry chow ad libitum except during exposure
- Water: ad libitum except during exposure. - Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole-body inhalation system: cylindrical glass battery jar supported in a Plexiglas frame.
- Exposure chamber volume: 30 Liter
- Method of holding animals in test chamber: The animals were kept singly in compartmentalized wire cages
- Aerosols were generated using a glass nebulizer and final chamber concentrations were varied by altering the drop rate of test material into the nebulizer. Particle size distribution analysis of the aerosol was between 1 and 4 um in mean particle size diameter. Exposures were made at various concentrations, all of which were below the aerosol concentration which caused wetting of the animals and chamber surfaces (Approximately 12,000 mg/m3).
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 test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Approximately 12,000 mg/m3
- No. of animals per sex per dose:
- Not reported.
- Control animals:
- not specified
- Details on study design:
- Duration of observation period following administration: 2 weeks
- Statistics:
- Not necessary.
- Preliminary study:
- No information is available.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 12 000 other: mg/m³ aerosol/vapor
- Exp. duration:
- 4 h
- Remarks on result:
- other: no mortality
- Mortality:
- No mortality.
- Clinical signs:
- other: Not reported.
- Body weight:
- Not reported.
- Gross pathology:
- Not reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LC50 of sulfolane aerosol/vapor was >12,000 mg/m3 in male and female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 12 000 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Principles of method if other than guideline:
- Directive 84/449/EEC. No further information available.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:CD.BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K., Ltd.
- Age at study initiation: At least 7-8 weeks
- Weight at study initiation: mean Not reported
- Fasting period before study: Overnight
- Housing: 1-3 rats in stainless steel wire-mesh cages
- Diet: LAD 1, Special Diets Services, Ltd. ad libitum, except for pre-dose fast
- Water: Tap water ad libitum
- Acclimation period: at least seven days
ENVIRONMENTAL CONDITIONS
- Temperature: 19 – 23°C
- Humidity: 30 – 70%
- Air changes (per hr): Not reported
- Photoperiod: 12 hrs dark / 12hrs light
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Test Site
- Type of wrap if used: a gauze dressing (approx. 6 x 8 cm) covered with waterproof adhesive tape.
Removal of Test Substance
- Washing (if done): with warm dilute detergent solution
- Time after start of exposure: 24 hours
Test Material
- Amount(s) applied (volume or weight with unit): 1.59 mL/kg
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations made at least six times on the day of dosing and twice daily thereafter for the remainder of the study. Body weights were measured prior to dosing, and thereafter on Day 1, 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- Not needed
- Preliminary study:
- No information is available.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths.
- Clinical signs:
- other: The majority of rats showed staining (yellow) of the anogenital fur and one rat showed an unkempt appearance on Day 2 only. Erythema or discoloration (yellow) of the sites of application of the test material were common after removal of the dressings on D
- Gross pathology:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal rat LD50 of sulfolane was greater than 2000 mg/kg. No deaths were observed.
- Executive summary:
Undiluted sulfolane at a dose of 2000 mg/kg was applied to the skin of male and female Sprague-Dawley rats for 24 hours by an occlusive patch. There were no deaths. The acute dermal LD50 of sulfolane in rats is greater than 2000 mg/kg.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute Oral
The Japan MHW (1996) reported an OECD TG 401 study with sulfolane. The oral LD50 in male and female rats were 2006 and 2130 mg/kg, respectively. In male rats, the mortality rate was 0%, 0%, 0%, 80%, 100% and 100% at 892, 1204, 1626, 2195, 2963 and 4000 mg/kg. At >1626 mg/kg, there were convulsions, decreased locomotor activity, ptosis, salivation, piloerection, chromodacryorrhea and perineal region soiling with urine. In females, the mortality rate was 0%, 0%, 0%, 60%, 100% and 100% at 892, 1204, 1626, 2195, 2963 and 4000 mg/kg. At >1626 mg/kg, there was decreased locomotor activity. A t>2195 mg/kg, there was convulsions, ptosis, salivation, piloerection, chromodacryorrhea, perineal soiling with urine.
Hazleton (1983a) reported oral rat LD50 values of 2739, 2108 and 2363 mg/kg in males, females and both sexes combined, respectively.
Acute Inhalation
Andersen et al. (1977) exposed male and female Sprague-Dawley rats for four hours to approximately 12,000 mg/m3 of an aerosol/vapor mixture of sulfolane. There were no deaths. The 4-hr rat LC50 is >12,000 mg/m3.
Acute Dermal
SRC (1993) reported the acute dermal rat LD50 of sulfolane to be >2000 mg/kg. Undiluted sulfolane at a dose of 2000 mg/kg was applied to the skin of male and female Sprague-Dawley rats for 24 hours by an occlusive patch. There were no deaths. The majority of rats showed staining (yellow) of the anogenital fur and one rat showed an unkempt appearance on Day 2 only. Erythema or discoloration (yellow) of the sites of application of the test material were common after removal of the dressings on Day 2. All dermal changes resolved by Day 4.
Justification for classification or non-classification
Acute Oral
Classification proposal regarding acute oral toxicity: GHS/CLP: None (Category 5).
Acute Inhalation
Classification proposal regarding acute inhalation toxicity: GHS/CLP: None.
Acute Dermal
Classification proposal regarding acute dermal toxicity: GHS/CLP: None.
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