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Toxicological information

Dermal absorption

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Administrative data

dermal absorption
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994 - 1995
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP cmpliant study with valid study design and controls

Data source

Reference Type:
study report
Report date:

Materials and methods

Principles of method if other than guideline:
Skin permeability through porcine ear skin with 14C labelled substance
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)
EC Number:
EC Name:
Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)
Cas Number:
Molecular formula:
disodium 2,2'-(biphenyl-4,4'-diyldiethene-2,1-diyl)dibenzenesulfonate
Details on test material:
- Name of test material (as cited in study report): 14C-TINOPAL CBS
- Physical state: solid
- Analytical purity: 98%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date: November 01, 1994
- Lot/batch No.: R 108 h-l
- Expiration date of the lot/batch: November 10, 1995
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling): 12.72 µCi/mg
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: stable
- Storage condition of test material: Room temperature, protected from light
- Other: In water stable at least 5 days

Test animals

not specified
not specified
Details on test animals or test system and environmental conditions:
Porcine ears were obtained from a local slaughter-house on the day of slaughter and before the pigs were steam-cleaned. The outer ear region was washed and cleaned with cold water. After carefully shaving, the skin was removed by dissection.

Administration / exposure

Type of coverage:
Duration of exposure:
Samples (0.5 ml) were taken form the receptor chamber after 0, 0.5, 1, 4, 8, and 24 hours and analysed.
100, 10 and 1 µg/ml
No. of animals per group:
Control animals:
Details on study design:
For the determination of the absorption of the test article the skin was mounted in glass diffusion chambers with a diameter of 1.13 cm2 (area of skin) and a volume of 7 ml. These chambers are subdivided in an upper part (donor chamber) and in a lower part (receptor chamber). A recorded volume of physiological saline (0.9% NaCl-solution) was placed in the receptor chamber of each diffusion cell, followed by the application of 200 µl ofthe test article dissolved in aqua bidest. to the donor chambers. Three concentrations ofthe test article (100-, 10-, and 1 ng/ml chamber volume) where tested using 4 chambers at each concentration. The top of the donor chamber was covered with parafilm. The diffusion chambers were placed in an incubator at 37 °C. Samples (0.5 ml) were taken form the receptor chamber after 0, 0.5, 1, 4, 8, and 24 hours and analysed. The volume of the fluid in the receptor chamber was kept constant by the addition of 0.5 ml of fresh receptor fluid to the receptor chamber immediately after removal of each sample. By plotting the time dependent increase in concentration of the test article in the receptor chamber, the permeation rate was determined.
Details on in vitro test system (if applicable):
- Source of skin: Local slaughter house
- Type of skin: procine ear
- Preparative technique: The outer ear region was washed and cleaned with cold water. After carefially shaving, the skin was removed by dissection. The skin sample was then stored in a freezer until use (within a week).
- Thickness of skin (in mm): 2 - 3 mm
- Membrane integrity check: yes (use of 14C mannitose)
- Storage conditions: freezer
- Justification of species, anatomical site and preparative technique: Porcine skin is considered a suitable representative of human skin as indicated by the Opinion (23 June 1999) of the EU Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP).

- Diffusion cell: glass diffusion chambers with a diameter of 1.13 cm^ (area of skin) and a volume of 7 ml. These chambers are subdivided in an upper part (donor chamber) and in a lower part (receptor chamber).
- Receptor fluid: physiological saline (0.9% NaCl-solution)
- Solubility od test substance in receptor fluid: soluble
- Static system: yes
- Flow-through system: no
- Test temperature: 37°C
- Humidity: humid (see occlusion)
- Occlusion: The top ofthe donor chamber was covered with parafilm.
- Reference substance(s): 14C-Mannitol

Results and discussion

Signs and symptoms of toxicity:
not examined
Dermal irritation:
not examined
Absorption in different matrices:
For test substance exposed porcine skin, penetration to receptor fluid was not detected at any concentration tested in the time range up to 24 hours
Total recovery:
not applicable
Percutaneous absorption
0.1 mg/L
0 %
Remarks on result:
other: 24h
based on detection limit in receptor fluid

Any other information on results incl. tables

For the reference substance 14C-Mannitol, the value of Kp was determined to be 1.276 x 10(-4) cm/h.

Applicant's summary and conclusion