Registration Dossier

Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
other: publication
Adequacy of study:
supporting study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The data concern a literature study; human neonatal foreskin is isolated and placed in a diffusing chamber. The integrity of the cell layers is only checked histologically; the experiment contains no sufficient positive control on integrity of the cell layer.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1983
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Freshly human neonatal foreskin was prepared to form a layer between two compartments. *MOCA was added to the upper compartment, samples were taken at t = 1, 2, 3, and 4 hours.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
yes
Remarks:
14C

Test animals

Species:
human
Strain:
other: neonatal foreskin

Administration / exposure

Duration of exposure:
t = 1, 2, 3, and 4 hr.
Details on in vitro test system (if applicable):
SKIN PREPARATION
- Source of skin: neonatal foreskin
- Membrane integrity check: solely histologically

Results and discussion

Applicant's summary and conclusion

Conclusions:
The authors suggest that *MOCA is rapidly absorbed through the human foreskin. Since, the integrity of the cell layer is not sufficiently controlled, the data may be considered as doubtful.