N-butyl acetate

Dermal absorption

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

Test material information

Constituent 1

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).