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Diss Factsheets
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EC number: 248-502-0 | CAS number: 27503-81-7
- 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
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Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was approved by an independent ethical committee (Institutional Review Board) operating in accordance with the guidelines of the FDA. All phases of the clinical trial have been audited by the quality assurance unit.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
- Principles of method if other than guideline:
- The skin penetrating potential of phenylbenzimidazole sulfonic acid was investigated in humans using 14C-radiolabelled test item. Six healthy male volunteers (age: 51 – 63 years) were used for this single dose dermal application study. One gram of a gel containing 80 mg of the radiolabelled test item (1.86 MBq) was applied on 333 cm2 on one upper arm of each participant using a spatula. The skin was protected with a non-occlusive cover, not being in contact with the gel. After 6 hours the remaining gel on the skin was removed by skin washings with cotton wool plugs soaked with ether. Thereafter, the whole area of treated skin was stripped 10 times with adhesive films (Scotch® 3M). Blood samples were taken up to 120 hours after gel application. Urine and feces were collected up to 5 days after treatment. Plasma samples, urine, feces, methanol extracts of the cotton wool plugs, and adhesive films were analyzed for total radioactivity using Liquid Scintillation Counting (LSC).
- GLP compliance:
- no
- Remarks:
- in compliance with Good Clinical Practice (GCP) Guidelines for trials on medicinal products in the EU
Test material
- Reference substance name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
- EC Number:
- 248-502-0
- EC Name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
- Cas Number:
- 27503-81-7
- Molecular formula:
- C13H10N2O3S
- IUPAC Name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- human
- Sex:
- male
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: creme
- Doses:
- 80 mg per person
Results and discussion
- Total recovery:
- - Total recovery:
- Recovery of applied dose acceptable: yes
Percutaneous absorption
- Key result
- Dose:
- 80 mg
- Parameter:
- percentage
- Absorption:
- ca. 0.2 %
- Remarks on result:
- other: after five days
Applicant's summary and conclusion
- Conclusions:
- From the results of this study the author concluded that no noticeable absorption had taken place after the dermal application of Phenylbenzimidazole sulfonic acid. The low amount of radioactivity excreted in urine and feces within 5 days is in good agreement with the data from plasma measurements, which were always lower than two times the background radioactivity value, thus, confirming the fact that nearly no percutaneous absorption occurred.
- Executive summary:
Study Design
The skin penetrating potential of phenylbenzimidazole sulfonic acid was investigated in humans using 14C-radiolabelled test item. Six healthy male volunteers (age: 51 – 63 years) were used for this single dose dermal application study. One gram of a gel containing 80 mg of the radiolabelled test item (1.86 MBq) was applied on 333 cm2 on one upper arm of each participant using a spatula. The skin was protected with a non-occlusive cover, not being in contact with the gel. After 6 hours the remaining gel on the skin was removed by skin washings with cotton wool plugs soaked with ether. Thereafter, the whole area of treated skin was stripped 10 times with adhesive films (Scotch® 3M). Blood samples were taken up to 120 hours after gel application. Urine and feces were collected up to 5 days after treatment. Plasma samples, urine, feces, methanol extracts of the cotton wool plugs, and adhesive films were analyzed for total radioactivity using Liquid Scintillation Counting (LSC).
Results
In general, no maximal plasma levels of total radioactivity were reached. The plasma radioactivity values were below 0.01 µg eq/mL and always lower than two times the background value. In most of the volunteers no noticeable plasma levels of radioactivity were observed, indicating no penetration. Therefore, pharmacokinetic parameters could not be calculated. The recoveries are summarized in the following table:
Medium
Recoveries (of dose applied)
Skin washing with cotton plugs
43.409 – 70.587 %
Skin stripping 6 hrs after application
10.472 – 35.637 %
Skin stripping 5 days after appl.
0.023 – 0.370 %
Fecal excretion
0.028 – 0.046 %
Renal excretion
0.068 – 0.217 %
Total excretion
0.107 – 0.259 %
Conclusion
From the results of this study the author concluded that no noticeable absorption had taken place after the dermal application of Phenylbenzimidazole sulfonic acid. The low amount of radioactivity excreted in urine and feces within 5 days is in good agreement with the data from plasma measurements, which were always lower than two times the background radioactivity value, thus, confirming the fact that nearly no percutaneous absorption occurred.
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