Registration Dossier
Registration Dossier
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EC number: 208-762-8 | CAS number: 540-97-6
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-04-02 to 2--2-04-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Principles of method if other than guideline:
- Recommended Protocol for in vitro Percutaneous Absorption Rate Studies (Federal Register, April 3, 1996, Vol 61, No. 65, pp 14773-14778).
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dodecamethylcyclohexasiloxane
- EC Number:
- 208-762-8
- EC Name:
- Dodecamethylcyclohexasiloxane
- Cas Number:
- 540-97-6
- Molecular formula:
- C12H36O6Si6
- IUPAC Name:
- dodecamethylcyclohexasiloxane
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- human
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 h
- Doses:
- 6 mg/cm2
- No. of animals per group:
- epidermis samples from 6 cadavers; 3 met barrier integrity test
Results and discussion
- Total recovery:
- After 24-hour semi-occluded contact, 46.4% applied D6 was found on the skin; 40% was volatilized; 3% was found in the skin; virtually none (0.003%) penetrated the skin. Total recovery from all analyzed samples was 89.5%. A further wash at 24 h indicated that D6 present in the skin did not penetrate the skin but continued to evaporate. Under the conditions of this in vitro study D6 did not penetrate human epidermis.
Applicant's summary and conclusion
- Conclusions:
- A well conducted guideline in vitro study found no penetration by D6 through samples of human skin in 24-hour semi-occluded contact.
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