Sodium 4-propoxycarbonylphenoxide

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given.

Data source

Reference

Reference Type:

publication

Title:

Effects of Skin Metabolism on Percutaneous Penetration of Lipophilic Drugs

Author:

Bando, H. et al.

Year:

1997

Bibliographic source:

Journal of Pharmaceutical Sciences, 86, 6, 759-761

Materials and methods

Principles of method if other than guideline:

The test substance was applied to rat skin for 12 h. The penetration amount, the permeability coefficient and the lag time were determined.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Propyl 4-hydroxybenzoate

EC Number:

202-307-7

EC Name:

Propyl 4-hydroxybenzoate

Cas Number:

94-13-3

Molecular formula:

C10H12O3

IUPAC Name:

propyl 4-hydroxybenzoate

Details on test material:

- Name of test material (as cited in study report): propylparaben
- Analytical purity: no data

Radiolabelling:

no

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Administration / exposure

Type of coverage:

open

Vehicle:

other: phospate buffered saline (PBS)

Doses:

20% test substance in PBS

No. of animals per group:

not applicable

Control animals:

no

Details on study design:

DOSE PREPARATION
- Method for preparation of dose suspensions: The suspension was prepared by stirring PBS and the test substance for 24 h at 37 °C.

TEST SITE
- Preparation of test site: The fullthickness abdominal skin of rats was excised after removal of the hair with an electric clipper. After the underlying adipose tissue was removed, the skin was punched out into a 3 cm diameter disk and mounted on a flow through type diffusion cell with the epidermal side facing the donor cell. The apparatus was thermostated at 37 °C in a water bath throughout the experiment. A 2 mL aliquot of 20% (w/v) propylparaben suspension in PBS was applied. The dermal side of the skin was continuously washed with PBS containing streptomycin sulfate and penicillin G potassium salt which flowed at a rate of 5 mL/h. The receptor fluid was collected every 60 min for 12 h.
- Area of exposure: 3.14 cm²

ANALYSIS
- Method type(s) for identification: HPLC-UV

Results and discussion

Any other information on results incl. tables

After 12 h, total amounts of about 200 µg test substance and 400 µg p-hydroxybenzoic acid were recovered in the receptor fluid. Permeability coefficients (Kp) of 10.6 ± 5.6 x 10³cm/h and 25.0 ± 5.9 x 10³cm/h were calculated for the intact paraben and its metabolite p-hydroxybenzoic acid. The lag time for the test substance was 1.49 ± 0.44 h and the lag time for its metabolite was 2.46 ± 0.15 h.