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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- toxicokinetics
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Qualifier:
- according to guideline
- Guideline:
- other: National Toxicology Program
- GLP compliance:
- no
Test material
- 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
- Test material form:
- liquid
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Remarks:
- /N
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 25.2-30.5 g for male mice and 18.6-21.7 g for female mice.
- Fasting period before study: not specified
- Housing: Individual metabolism cages with ability to separately collect urine, faeces and expired air.
- Individual metabolism cages: yes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least one week's quarantine before initiating of the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 35-65 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h /12 h
IN-LIFE DATES: not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
All dose formulations contained [14C]sulfolane and an appropriate amount of unlabeled sulfolane to achieve the final desired sulfolane concentration and specific activity. The target radioactivity per animal was ~ 10 μCi/rat. Oral dose formulations were prepared in water; a single dose was administered in a volume of 10 mL/kg by intragastric gavage. - Duration and frequency of treatment / exposure:
- single exposure
Doses / concentrations
- Dose / conc.:
- 100 other: mg/kg bw
- No. of animals per sex per dose / concentration:
- 1
- Control animals:
- no
- Positive control reference chemical:
- No
- Details on study design:
- - Dose selection rationale: Randomised
- Rationale for animal assignment: Randomised - Details on dosing and sampling:
- TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, blood, plasma, cage washes,
- Time and frequency of sampling: 24 h and 48 h
- Other:
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine, faeces, tissues, cage washes
- Time and frequency of sampling: 24 h and 48 h
- From how many animals: 2
- Method type(s) for identification: HPLC; LC-MS; NMR
- Limits of detection and quantification: not specified - Statistics:
- Standard deviation, nothing else specified
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- Sulfolane was well-absorbed
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- In total was ≥ 89.5 % of the dose absorbed.
- Details on distribution in tissues:
- The total radioactivity remaining in mouse tissue was ~ 7% 24 h post administration of 100 mg/kg bw. After 48 and 72 h, the radioactivity decreased to ~ 2% regardless of administered dose. The highest detected concentrations of [14C] sulfolane were in blood, liver, lung and kidney. Higher levels observed in the bladder are likely to have occurred due to contamination from urine.
- Details on excretion:
- In total was 28.7 – 98.5 % of the administered dose excreted in the urine whereas 0 – 61.6% of the administered dose was excreted by the faeces.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Treatment of urine with β-glucuronidase, sulfatase, or acylase resulted in no change to the profile, indicating that conjugates are not present. Furthermore, the presence of 3-hydroxysulfolane was confirmed in several different metabolomic tests.
Any other information on results incl. tables
Table 1. Disposition of radioactivity following a single oral of [14C]sulfolane in male and female B6C3F1/N mice
Sample |
Collection Interval (h) |
Male, 100 mg/kg (% of dose recovered) |
Female, 100 mg/kg (% of dose recovered) |
Urine |
0-8 |
ND |
1.3 ± 2.3 |
Urine |
8-24 |
66.9 ± 8.4 |
16.4 ± 24.4 |
Urine |
24-48 |
1.3 ±1.2 |
3.4 ± 3.7 |
Urine |
Sub Total |
68.2 ± 8.2 |
21.0 ± 22.4 |
Cage Rinse |
0-8 |
2.6 ± 3.7 |
38.3 ± 34.0 |
Cage Rinse |
8-24 |
13.8 ± 3.2 |
12.9 ± 9.6 |
Cage Rinse |
24-48 |
1.8 ± 1.0 |
1.1 ± 1.2 |
Cage Rinse |
Sub Total |
17.6 ± 3.6 |
42.7 ± 27.3 |
Total Urine + Cage Rinse |
0-72 |
85.8 ± 4.8 |
63.6 ± 34.9 |
Faeces |
0-24 |
6.6 ± 4.4 |
30.0 ± 30.7 |
Faeces |
24-48 |
1.2 ± 0.8 |
0.6 ± 0.5 |
Faeces |
Sub Total |
7.8 ± 4.9 |
30.5 ± 31.1 |
GI Tract Contents |
- |
0.01 ± 0.01 |
0.02 ± 0.01 |
Tissues |
- |
0.7 ± 0.0 |
0.6 ± 0.1 |
Total Dose Recovered |
- |
94.3 ± 0.3 |
94.8 ± 5.2 |
ND – not detected
Applicant's summary and conclusion
- Conclusions:
- Following oral administation of 100 mg/kg bw sulfolane to mouse, ≥ 89.5 % of the dose was absorbed. Moreover, the main excretion route in male and female mouse was by the urine (86 % and 64 %) followed by the faeces (8 % and 31 %) respectively. Nevertheless, the variability was significant at different time-points. Radioactivity was observed in all examined blood and tissues where the highest concentrations were detected in blood, liver, lung, kidney, thyroid and skin.
- Executive summary:
In an in vivo oral toxicokinetic study which was performed according to a similar approach as in OECD guideline 417, however, not in accordance to GLP, reported that following a single oral dose of 100 mg/kg bw sulfolane to one female and one male mouse respectively, ≥ 89.5 % of the dose was absorbed. Furthermore, the main excretion route in male mouse was by the urine (86 %) followed by the faeces (8 %). The main excretion route in female mouse was also by urine (64 %), however, more excretion had occurred in female mouse by the faeces (31 %) compared to the male mouse. Nevertheless, the variability was significant at different time-points.
Following oral ingestion of 100 mg/kg bw of the test substance in male mouse, radioactivity was observed in all examined blood and tissues where the highest concentrations were detected in blood, liver, lung, kidney, thyroid and skin. No sex differences could be identified between the two tested mice.
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