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:
the permeability of p-cresol was measured across epidermal membranes from human abdominal skin in vitro
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: p-cresol, purity: reagent grade
Radiolabelling:
not specified

Test animals

Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
see section: any other information on material and method"

Administration / exposure

Type of coverage:
other: in vitro
Vehicle:
unchanged (no vehicle)
Duration of exposure:
250 minutes
Doses:
see section" additional information on materials and methods"
No. of animals per group:
in vitro study
Details on study design:
see section "any other information on materials and methods"
Details on in vitro test system (if applicable):
see section "any other information on materials and methods"

Results and discussion

Signs and symptoms of toxicity:
not specified
Remarks:
in vitro examination
Dermal irritation:
not specified
Remarks:
in vitro examination
Absorption in different matrices:
see section "executive summary"
Total recovery:
see section "executive summary"
Percutaneous absorption
Dose:
see section "executive summary"
Remarks on result:
other: see section "executive summary"
Remarks:
in vitro test: see section "executive summary"
Conversion factor human vs. animal skin:
no data

Any other information on results incl. tables

see section "executive summary"

Applicant's summary and conclusion

Executive summary:

the permeability efficient of p-cresol (in vitro human abdominal skin) was 2.92 x 10[exp-4] cm/min and the lag time for a 0.4 %w/v solution was 16 min. The threshold concentration for damage i.e. the aquous concentration at which the permeability coefficient began to increase was 8.85 %w/v