Registration Dossier
Registration Dossier
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EC number: 203-492-7 | CAS number: 107-46-0
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 01.10.1999 to 30.06.2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Bronaugh Flow Through method
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexamethyldisiloxane
- EC Number:
- 203-492-7
- EC Name:
- Hexamethyldisiloxane
- Cas Number:
- 107-46-0
- Molecular formula:
- C6H18OSi2
- IUPAC Name:
- trimethyl[(trimethylsilyl)oxy]silane
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C-hexamethyldisiloxane (14C-HMDS)
Test animals
- Species:
- human
- Strain:
- other: N/A
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- Doses:
- Neat-14C-hexmethyldisloxane, 9 mg/cm2 of skin; radioactivity for each skin was 6 uCi.
- No. of animals per group:
- 5 males, 1 female
- Control animals:
- no
Results and discussion
Percutaneous absorption
- Dose:
- 9 mg/cm2
- Parameter:
- percentage
- Absorption:
- ca. 0.023 %
- Remarks on result:
- other: 24 hours
- Remarks:
- The majority (75%) of the absorbed dose was found in the skin, and the majority (98%) of the applied dose evaporated from the application site.
Any other information on results incl. tables
The statistical analysis of the data indicated that only 0.023% of the applied dose of neat HMDS was absorbed at the end of the assay (standard error of the mean =0.011% of applied dose). The majority of the absorbed HMDS (75.07%) was found in the skin. The percent of applied dose recovered from all analyzed samples for neat HMDS was 97.58 +/- 0.351%. The majority of the applied dose (97.51 +/- 0.357%) volatilised from the dosing site and was collected in the charcoal basket.
Applicant's summary and conclusion
- Conclusions:
- In a well conducted in vitro dermal absorption study conducted to GLP (reliability score 1), a statistical analysis of the data indicated that only
0.023% of the applied dose of hexamethyldisiloxane was absorbed through human cadaver skin. The majority of the dose volatilised from the application site (97.5%).
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