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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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption 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
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 417
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 427 (Skin Absorption: In Vivo Method)
- Deviations:
- no
- 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
- Remarks:
- [2,5-14C]sulfolane (14[C]sulfolane, 58.2 mCi/mmol)
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 (°C): 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
- Type of coverage:
- other: A metal mesh tissue capsule (placed immediately after dose administration) was used to protect the dose site from grooming.
- Vehicle:
- ethanol
- Duration of exposure:
- 48 hours
- Doses:
- - Actual doses: 100 mg/kg bw
- No. of animals per group:
- 2
- Control animals:
- no
- Details on study design:
- DOSE PREPARATION
- Method for preparation of dose suspensions: Approximately 24 h prior to dermal dosing, each mouse was anesthetized with isoflurane.
- Method of storage: not specified
APPLICATION OF DOSE:
VEHICLE
- Justification for use and choice of vehicle (if other than water): not specified
- Amount(s) applied (volume or weight with unit): not specified
- Concentration (if solution): 95 %
- Lot/batch no.: not specified
- Purity: not specified
TEST SITE
- Preparation of test site: Fur was clipped from each animal’s back and wiped with water. Following the cleaning, examination for nicks were performed and an outline of the dose area, 1 cm2 (1 x 1 cm), was inscribed on backs of each animal with a permanent-type felt tip marker. A single dose was applied to the dose area in a volume of 1 mL/kg using a syringe with a ball tipped feeding needle and spread evenly over the dose site.
- Area of exposure: on the back of the animal
- % coverage: not specified but an area of 1 cm2 (1 x 1 cm)
- Type of cover / wrap if used: immediately after the application of the test material, a metal mesh tissue capsule was placed to protect the dose site.
- Time intervals for shavings or clipplings: not specified
SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: n/a
REMOVAL OF TEST SUBSTANCE
- Removal of protecting device: following termination and blood collection, the metal appliance was removed with acetone to enable that cyanoacrylate adhesive (which were used to secure the metal appliances) was dissloved properly.
- Washing procedures and type of cleansing agent: acetone
- Time after start of exposure: 48 hours
SAMPLE COLLECTION
- Collection of blood: yes
- Collection of urine and faeces: yes
- Collection of expired air: yes
- Terminal procedure: the animals were euthanized by asphyxiation with CO2 and blood was collected via cardiac puncture and added to tubes containing K2EDTA.
- Analysis of organs: liver, kidney, heart, lung, spleen, brain, bladder, thyroid, pancreas, testes or uterus and ovaries, small intestine, large intestine, cecum and stomach (all gastrointestinal (GI) tract tissues were collected without contents) and samples of muscle (hind leg), abdominal skin and adipose (perirenal).
SAMPLE PREPARATION
- Storage procedure: All samples were stored at -20 °C until analysis.
- Preparation details: The GI tract tissues were rinsed with deionized water and the rinsate was collected separately. Tissues were divided into 2-4 aliquots (depending on tissue weight) and weighed. Liver was minced and 4 aliquots were weighed for analysis. GI tract tissues, GI contents, skin, and carcass were digested in 2N ethanolic NaOH. Triplicate faeces and tissue aliquots were digested in Soluene®-350; after digestion, samples (requiring bleaching) were decolorized with 70% perchloric acid and hydrogen peroxide. Triplicate aliquots of GI tract tissue, GI contents, skin and tissues digests and duplicate aliquots of urine, VOC and CO2 trapping solutions, plasma, cage rinse, and GI tract rinsates were added to vials containing Ultima Gold™ scintillation cocktail. All samples were analysed for radioactivity content.
ANALYSIS
- Method type(s) for identification: HPLC; LC-MS; NMR
- Liquid scintillation counting results (cpm) converted to dpm as follows: not specified
- Validation of analytical procedure: not specified
- Limits of detection and quantification: not specified
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- In total was ≥ 63.5 % of the dose absorbed.
- Total recovery:
- The total dose recovered was between 63.5 – 87.3 % in mouse following dermal application of the test substance.
Any other information on results incl. tables
Table 1 - Disposition of radioactivity following a single dermal application of 100 mg/kg
[14C]sulfolane in male and female B6C3F1/N mice
Sample |
Collective Interval (h) |
Male - Percent of dose recovered |
Female – Percent of Dose Recovered |
Urine |
0-8 |
No sample |
No Sample |
Urine |
8-24 |
25.9 ±17.3 |
17.0 ± 8.0 |
Urine |
24-48 |
3.18 ± 2.0 |
2.7 ± 1.6 |
Urine |
Sub Total |
43.7 ± 20.2 |
19.7 ± 9.6 |
Cage rinse |
0-8 |
11.1 ± 2.6 |
32.1 ± 15.4 |
Cage rinse |
8-24 |
5.8 ± 4.1 |
12.7 ± 8.0 |
Cage rinse |
24-48 |
1.4 ± 0.8 |
4.9 ± 2.9 |
Cage rinse |
Sub Total |
18.3 ± 6.9 |
49.7 ± 9.6 |
Total Urine + Cage Rinse |
0-48 |
62.0 ± 16.8 |
69.4 ± 2.0 |
Faeces |
0-24 |
6.2 ± 5.5 |
7.8 ± 4.6 |
Faeces |
24-48 |
1.2 ± 1.0 |
1.5 ± 0.9 |
Faeces |
Sub Total |
7.4 ± 6.5 |
9.4 ± 5.1 |
GI Tract Contents |
- |
0.02 ± 0.01 |
0.04 ± 0.02 |
Tissues |
- |
0.8 ± 0.3 |
1.7 ± 1.5 |
Total Absorbed Dose |
- |
70.2 ± 12.0 |
80.4 ± 3.5 |
Dose Site Skin |
- |
1.4 ± 1.4 |
0.9 ± 0.6 |
Gauze |
- |
1.2 ± 0.9 |
1.1 ± 0.7 |
Dermal Appliance |
- |
2.6 ± 3.1 |
1.4 ± 1.1 |
Dose Site Skin Rinse |
- |
0.1 ± 0.1 |
0.2 ± 0.1 |
Total Unabsorbed Dose |
- |
3.9 ± 2.9 |
2.7 ± 1.9 |
Total Dose Recovered |
- |
75.5 ± 11.8 |
84.0 ± 2.3 |
Applicant's summary and conclusion
- Conclusions:
- Following dermal application of 100 mg/kg bw of sulfolane to mice, 70 % and 80 % of the applied dose was absorbed to male and female respectively. The total recovered dose recovered in males and females were 76 % and 84 % respectively.
- Executive summary:
In an in vivo dermal absorption study which was performed according to a similar approach as described in the OECD guideline 427, however, not in accordance to GLP, reported that following dermal application of 100 mg/kg bw of sulfolane to the back, ≥ 63.5 % was absorbed in male and female mice respectively. The majority of the recovered dose were in the urine (62 % / 70 %); faeces (7 % / 9 % and tissue (<1 % / 2 %) to male and female respectively. The total recovered dose recovered in males and females were between 63.5 – 87.3 %.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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