Registration Dossier

Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: A scientific publication.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982

Materials and methods

Principles of method if other than guideline:
Percutaneous absorption determined by radiolabelled substances.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
yes

Test animals

Species:
mouse
Sex:
male

Administration / exposure

Duration of exposure:
1st experiment: 40 min
2nd experiment: 10 min
Doses:
3.18 mcg/mL per 3 cm2
No. of animals per group:
60 animals:
1 st experiment: 3 animals
2nd experiment: 3 animals/skin surface

Results and discussion

Any other information on results incl. tables

1st experiment: after 10-min absorption time, maximum blood levels of all terpenes were reached. After 20 min, a decrease of terpene concentrations was observed in the blood. For isobornylacetate, the resutls were as follows: after 10 min, approximately 60 ng isobornyl acetate / mL blood (maximum), after 40 min, approx. 15 ng / mL.

2nd experiment: the terpene concentrations in the blood increase linearly with the size of the exposed skin.

Applicant's summary and conclusion

Conclusions:
Maximum blood levels were achieved after 10 minutes the onset of the percutaneous absorption and this was a direct function of the size of the skin area involved.
Executive summary:

The percutaneous absorptions of isobornyl-acetate as a constituent of a foam bath was measured on animals using radioactively labelled ingredients. Pharmacokinetic measurements showed maximum blood levels 10 min after the onset of percutaneous absorption. Blood levels of all ingredients after 10 min of percutaneous absorption were a direct function of the size of the skin area involved.