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Toxicological information

Dermal absorption

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Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
year of publication: 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Deviations:
not applicable
Principles of method if other than guideline:
in vitro investigation on skin permeability using a Franz Diffusion Cell and living human skin from female donors
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
N-butyl acetate
EC Number:
204-658-1
EC Name:
N-butyl acetate
Cas Number:
123-86-4
Molecular formula:
C6H12O2
IUPAC Name:
butyl acetate
Details on test material:
- Name of test material (as cited in study report): butyl acetate
- Analytical purity: highest commercially available quality
Radiolabelling:
no

Administration / exposure

Details on in vitro test system (if applicable):
SKIN PREPARATION
- Source of skin: Healthy females who underwent plastic surgery of the breast
- Ethical approval if human skin: no data
- Type of skin: breast skin
- Thickness of skin: final thickness in cell (after stretching of skin): 300 to 600 µm
- Membrane integrity check: yes, by measuring skin permeation of [3H] water
- Storage conditions and preparative conditions: Skin samples were stored in Dulbecco's medium (with gentamicin) at 4°C until thinned (- area of exposed skin in the cell: 0.64 cm2

PRINCIPLES OF ASSAY
- Diffusion cell: Franz Diffusion cell
- Receptor fluid: isotonic, nourished, saline solution (Dulbecco's medium [Gibco 141-12430M] with gentamycin [50 µg/mL])
- Solubility of test substance in receptor fluid: no data; solubility in water: > 100 mg/L; no solubilizing agents were added
- Static system: fresh receptor fluid was added to replace the amount used for analysis
- Test temperature: water temperature: about 37°C which resulted in a skin temperature of about 34°C
- Humidity: no data
- Occlusion: no
- Reference substance(s): a series of solvents including DMSO were tested

Results and discussion

Any other information on results incl. tables

- using three skin samples from the same donor the following permeability constant was determined for n-butyl acetate: 1.98 +/- 0.25 g/m2*h (un-normalized) and 1.58 +/- 0.09 g/m2*h (normalized with respect of the mean permeability constant of [3H] water)

- 1.6 +/- 0.1 g/m2*h correspond to 1.8 +/+ 0.1 cm3/m2*h

Applicant's summary and conclusion

Conclusions:
In vitro investigations on skin permeability of n-butyl acetate indicate that the test item has only a low tendency to penetrate the skin.
Executive summary:

Skin permeability of n-butyl acetate was investigated in vitro using a Franz-Diffusion cell and viable skin from female human donors. The permeability constant for n-butyl acetate was 1.6 +/- 0.1 g/m2*h (1.8 +/+ 0.1 cm3/m2*h), indicating that the test item has only a low tendency to penetrate the skin (Ursin et al., 1995).

The study is reliable with restrictions (RL2).