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EC number: 214-946-9 | CAS number: 1222-05-5
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- Aquatic toxicity
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Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- September 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: SCCNFP in-vitro assessment of percutaneous absorption guidelines
- Version / remarks:
- SCCNFP/0167/99
- Deviations:
- not specified
- Principles of method if other than guideline:
- For the present human skin penetration study, 12 human epidermal membranes were clamped in dosage chambers. Permeation of HHCB was then measured over a 24 hrs period. The epidermal membranes were then tape stripped 10 times and the radiolabel content of the strips and remaining epidermis determined.
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran
- EC Number:
- 214-946-9
- EC Name:
- 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran
- Cas Number:
- 1222-05-5
- Molecular formula:
- C18H26O
- IUPAC Name:
- 4,6,6,7,8,8-hexamethyl-1H,3H,4H,6H,7H,8H-indeno[5,6-c]pyran
- Test material form:
- liquid: viscous
Constituent 1
- Radiolabelling:
- yes
Administration / exposure
- Duration of exposure:
- 24 hrs
- Doses:
- - Nominal doses: 20 uL/cm2 target dose of a 1% solution in ethanol
- Dose volume: 20 uL - Details on study design:
- VEHICLE
-Justification for use and choice of vehicle (if other than water): ethanol, because highest concentrations of test material are found in ethanolic products
SAMPLE PREPARATION
-Twelve active dosed chambers were prepared plus two control chambers.
ANALYSIS
-Determination of skin penetration: following application of the vehicles, 200 uL samples were taken from each receptor chamber at 1, 2, 6, 12 and 24 hrs. Each sample was placed into scintillation fluid and analysed for 14C. - Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Obtained from cosmetic surgery.
- Type of skin: Female breast and abdominal skin
- Preparative technique: Freshly obtained skin, was thawed for processing. Following removal of subcutaneous fat by blunt dissection, individual portions of skin were immersed in water at 60°C for 50 secs. The skin was then pinned, dermis side down, on a cork board and the epidermis (comprising stratum corneum and epidermis) gently removed from the underlying dermis. The latter was discarded and the epidermal membrane floated onto the surface of water and was taken up onto aluminium foil. The membranes were thoroughly dried and stored flat at -20°C until used. On the day of use, the epidermal membranes were floated onto water from the aluminium foil and taken onto 25 mm diameter filter paper supports, ensuring complete coverage of the filter paper. The membranes were then mounted onto the diffusion chambers. The skin samples were mounted in a exposure chamber with the stratum corneum facing the donor chamber. Controls: Two control chamber were prepared.
- Membrane integrity check: YES
PRINCIPLES OF ASSAY
- Diffusion chamber: Franz-type
- Receptor fluid: Water
- Static system: YES
- Test temperature: 32±1°C
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Total recovery:
- - Total recovery: Overall recovery of radioactive material was 92.1 +/- 0.8%.
- Recovery of applied dose acceptable: YES
Percutaneous absorption
- Key result
- Time point:
- 24 h
- Dose:
- 20 uL/cm2 1% HHCB
- Parameter:
- percentage
- Remarks:
- +/-0.59
- Absorption:
- ca. 5.16 %
- Remarks on result:
- other: Total HHCB in remaining stratum corneum plus epidermis, filter paper, and receptor fluid
Any other information on results incl. tables
Table 1: Distribution of HHCB in all compartments at 24 hrs (% of applied dose)
Surface wipe | Strip 1 | Strips 2 -3 | Strips 4 -6 | Strips 7 -10 | Remaining s kin | Receptor phase | Donor chamber | Filter paper | Total recovered | |
Mean | 58.2 | 2.15 | 2.04 | 1.07 | 0.578 | 4.52 | 0.397 | 22.9 | 0.245 | 92.1 |
SD | 6.5 | 0.86 | 1.21 | 0.58 | 0.315 | 1.96 | 0.197 | 4.8 | 0.108 | 2.7 |
Applicant's summary and conclusion
- Conclusions:
- The results of the present study indicated that the level of in-vitro percutaneous absorption of HHCB was quite low, with the majority of the applied HHCB remaining at the skin surface.
- Executive summary:
The dermal absorption (non-GLP, but with QA statement) of HHCB was determined over a 24-hr period according to the methodology of the SCCNFP. Radiolabeled HHCB (uniformly labelled in the aromatic ring – radiochemical purity 99.3%) was applied in 1% solution in ethanol (96% v/v) to human epidermal membranes (prepared from female breast or abdominal skin and assayed for integrity with tritiated water) supported on a piece of filter paper (for strength) in glass diffusion cells (n=12). The area of the membrane available for absorption was approximately 1 cm2 and the average applied dose was 20±0.2 µL/cm2. The amount of material absorbed into the receptor phase, 6% Volpo N20 (to enhance solubility) in pH 7.4 phosphate buffered saline, after 24 hr was 0.40±0.06% of the applied dose. The majority of applied HHCB (81±2% of the applied dose) was found in the 24-hr surface wipe and donor chamber wash plus wipe. The stratum corneum tape strips contained 5.8±0.8% of the applied dose and the remaining stratum corneum plus epidermis 4.5±0.6% of the applied dose. Levels of HHCB in the remaining stratum corneum plus epidermis, filter paper (on which the epidermis samples rested) and permeated HHCB were combined to produce a total absorbed dose value of 5.2±0.6% of the applied dose. Overall recovery of radioactivity was 92±0.8%.
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