Cyclohexyldimethoxymethylsilane

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02.03.2006 to 03.03.2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 428 (Skin Absorption: In Vitro Method)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexyldimethoxymethylsilane

EC Number:

402-140-1

EC Name:

Cyclohexyldimethoxymethylsilane

Cas Number:

17865-32-6

Molecular formula:

C9H20O2Si

IUPAC Name:

cyclohexyldimethoxymethylsilane

Test material form:

liquid

Radiolabelling:

no

Test animals

Species:

human

Strain:

other: Not applicable

Sex:

female

Details on test animals or test system and environmental conditions:

Not applicable

Administration / exposure

Type of coverage:

other: Not applicable

Vehicle:

unchanged (no vehicle)

Duration of exposure:

Receptor vessels were changed after 4, 8 and 12 hours.

Doses:

40 microlitres (equivalent to 37.6 mg test substance)

No. of animals per group:

8 samples tested

Control animals:

no

Details on in vitro test system (if applicable):

SKIN PREPARATION
- Source of skin: from cosmetic surgery
- Ethical approval if human skin: No data
- Type of skin: Female human abdominal origin
- Preparative technique: Split skin (approx. 500 micrometres) was prepared with a dermatome and comprised the stratum corneum, the epidermis and part of the dermis. With a punch (10 mm diameter) skin slices were produced for use in the diffusion cell.
- Thickness of skin (in mm): 0.5
- Membrane integrity check: Checked microscopically, then tritiated water in diffusion cell.
- Storage conditions: <=-15oC
- Justification of species, anatomical site and preparative technique: None given

PRINCIPLES OF ASSAY
- Diffusion cell: The Bioservice diffusion cell is designed with a PTFE-donator and -acceptor part of the flow through diffusion cell horizontal exposure of the skin surface. Skin exposure area was about 20 mm2.
- Receptor fluid: Phosphate buffered saline was used (degassed)
- Solubility of test substance in receptor fluid: No data
- Test temperature: 32oC
- Humidity: No data
- Occlusion: None

Results and discussion

Absorption in different matrices:

- Receptor fluid: <0.2% of applied dose
- Skin preparation (in vitro test system): Not determined
- Stratum corneum (in vitro test system): (i.e tape strips): Not determined

Total recovery:

- Total recovery: No data
- Recovery of applied dose acceptable: No data
- Results adjusted for incomplete recovery of the applied dose: No data
- Limit of detection (LOD): No data
- Quantification of values below LOD or LOQ: No data

Percutaneous absorption

Dose:

37.6 mg

Parameter:

percentage

Absorption:

0.2 %

Remarks on result:

other: 12 hours

Remarks:

Essentially zero absorption

Applicant's summary and conclusion

Conclusions:

In an in vitro dermal absorption study conducted to OECD 428 and to GLP (reliability score 1) the dermal absorption of cyclohexyldimethoxymethylsilane was less than 0.2% of the applied dose over 12 hours.