Registration Dossier

Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: in-vitro test

Data source

Reference
Reference Type:
publication
Title:
Permeability of human epidermis to the phenolic compounds
Author:
Roberts MS, Anderson RA, Swarbrick J
Year:
1977
Bibliographic source:
J Pharm Pharmac 29: 677-683

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Human abdominal skin (2.5 cm²) used as epidermal membranes were supported in a glass cell and the amount of the test substance passsing to the receptor vessel was measured spectrophotometrically at room temperature. The test was performed twice.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
no

Test animals

Species:
other: human epidermis in vitro
Strain:
other: not applicable
Sex:
not specified
Details on test animals and environmental conditions:
in vitro study

Administration / exposure

Type of coverage:
other: in vitro study
Vehicle:
water
Duration of exposure:
up to 250 minutes
Doses:
not indicated
No. of animals per group:
in vitro study

Results and discussion

Any other information on results incl. tables

Roberts et al. (1977) used human abdominal epidermal membranes and a number of aqueous concentrations of the test substance, in vitro, to determine a Kp of 2.62 x 10 cm/minute (= 1.57 x 10 cm/hour).

Applicant's summary and conclusion