Registration Dossier

Administrative data

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

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

Principles of method if other than guideline:
Epidermal membranes from human abdominal skin (2.5 cm²) were supported in a glass cell and the amount of m-cresol passsing to the receptor vessel was measured spectrophotometrically at room temperature . The test was conducted twice
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
m-cresol: not further specified
Radiolabelling:
no

Test animals

Species:
other: human epidermis in vitro
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
No. of animals per group:
in vitro study

Results and discussion

Any other information on results incl. tables

the permaeability coefficient of m-cresol ws 2.54 x 10(exp)-4 cm/min and

the lag time for a 0.4 %w/v solution was 15 min

the threshold concentration for damage i.e. the aqueous concentration at which

the permeability coefficient began to increase waa 1.0 %w/v

Applicant's summary and conclusion