Registration Dossier

Diss Factsheets

Toxicological information

Dermal absorption

Currently viewing:

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: Test method is not according to any guideline. No GLP.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1974

Materials and methods

Principles of method if other than guideline:
The permeability of human skin to terpenes was studied by Römmelt et al., who demonstrated percutaneous absorption from 30 -min full baths (Kneipp) containing pine oil additives by measuring camphene and other terpene components in the expired air of one human subject. The results of dermal absorption were calculated with respect to the values obtained from the elimination of camphene through the lungs after IV administration.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Camphene
EC Number:
201-234-8
EC Name:
Camphene
Cas Number:
79-92-5
Molecular formula:
C10H16
IUPAC Name:
2,2-dimethyl-3-methylidenebicyclo[2.2.1]heptane
Details on test material:
- Name of test material (as cited in study report): Camphene
Radiolabelling:
not specified

Test animals

Species:
human
Strain:
other: not applicable
Sex:
not specified
Details on test animals or test system and environmental conditions:
In all experiments, the water and the bath temperature were kept constant.
The subject breathed through a breathing mask with double valve.

Administration / exposure

Type of coverage:
open
Vehicle:
water
Duration of exposure:
30 minutes
Doses:
150 mL pine bath oil in 450 L water
The exact dose was controlled by a pressure reducer in the stock tank and a diving bell spirometer, which functioned as a variable reservoir.
No. of animals per group:
One human subject (no data on sex)
Control animals:
no
Details on study design:
Observation period: 24 hours

Results and discussion

Signs and symptoms of toxicity:
no effects
Dermal irritation:
no effects
Total recovery:
A human subject immersed in a bath containing pine needle oil, exhaled terpenes, including 0.67 µL camphene, within 5 hr.
A constant of 81 µL/cm2/hr was calculated for the percutaneous absorption of camphene from the bath.
The total quantity of Kneipp pine oil extract absorbed through the skin of an adult person from a 30-min full bath containing 150 mL pine bath oil in 450 L water bath water was estimated to be 0.04 mg, which must be considered to be within a range capable of producing therapeutic effects.

Any other information on results incl. tables

The test subject exhaled terpenes, including 0.67 µL camphene, within 5 hr. A constant of 81 µL/cm2/hr was calculated for the percutaneous absorption of camphene from the bath.

Applicant's summary and conclusion

Conclusions:
The test subject exhaled terpenes, including 0.67 µL camphene, within 5 hr. A constant of 81 µL/cm2/hr was calculated for the percutaneous absorption of camphene from the bath.
Executive summary:

The permeability of human skin to terpenes was studied by Römmelt et al., who demonstrated percutaneous absorption from 30 -min full baths (Kneipp) containing pine oil additives by measuring camphene and other terpene components in the expired air of one human subject. The results of dermal absorption were calculated with respect to the values obtained from the elimination of camphene through the lungs after IV administration.

The test subject exhaled terpenes, including 0.67 µL camphene, within 5 hr. A constant of 81 µL/cm2/hr was calculated for the percutaneous absorption of camphene from the bath.