Registration Dossier

Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1979
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
The testmaterial retention on the skin surface was measured
GLP compliance:
no
Remarks:
pre-dates GLP regulation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Radiolabelling:
no

Test animals

Species:
other: human
Sex:
male

Administration / exposure

Type of coverage:
open
Vehicle:
other: 70 % aqueous iso-propanol
Duration of exposure:
10 Mintutes, 6, 24, 48, 72 hours
Doses:
- Actual concentration: 0,001 mol/L = 35 mg/100 mL
- Dose volume: 20 µL
No. of animals per group:
10
Control animals:
no
Details on study design:
Twenty µL each of a 0.001 molar solution of the test material (35 mG/100 mL) were applied to 5 cm² skin of in inner forearm of 1o male human volunteers. Each volunteer had 5 applications which were left for 10 minutes or 6, 24, 48, or 72 hours (open condition).
Afterwards the testmaterial remaining in the upper layers of the skin was recovered and measured by a tape stripping method using the measurement of diffuse reflection of light.

Results and discussion

Signs and symptoms of toxicity:
no effects
Dermal irritation:
not specified
Total recovery:
- Total recovery: 79 to 99 % were found in the epidermis; i.e. not absorbed through skin.
- Recovery of applied dose acceptable: yes
- Results adjusted for incomplete recovery of the applied dose: Yes
- Limit of detection (LOD): no data
Conversion factor human vs. animal skin:
1

Any other information on results incl. tables

The stability of the colorant under test conditions was determined as 81 to 95 % in three volunteers. Thus, the recovery indicates no absorption at all.

Applicant's summary and conclusion

Conclusions:
The test material was practically not absorbed through skin in human volunteers.
Executive summary:

After application of the test material to the skin of the inner forearms of ten male human volunteers for 10 minutes to 72 hours practically the complete dose was recovered by tapestripping of the treated skin several times. Recovered amounts were comparable to samples exposed to light for an equal length of time.

The test material was practically not absorbed through skin in human volunteers.