Registration Dossier

Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
year of publication: 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Fate of water-insoluble and water-soluble dichlorobenzidine-based pigments in Fischer 344 rats
Author:
Decad GM, Snyder, CD, Mitoma C
Year:
1983
Bibliographic source:
Journal of Toxicology and Environmental Health 11: 455-465
Report Date:
1983

Materials and methods

Principles of method if other than guideline:
testing of absorption, distribution and excretion after single dermal application

GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
yes
Remarks:
14-C labelled, 11 µCi/µmol

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Emulphor EL-620:ethanol (1:1, v/v)
Duration of exposure:
24 hours
Doses:
- 2.57-2.95 µCi/rat
No. of animals per group:
>/= 3 (no further information)
Control animals:
no
Details on study design:
- region of exposure: mid dorsal area
- pretreatment: shaved with an electric clipper on the day before experiment
- area: 4 x 4 square centimeter

Results and discussion

Signs and symptoms of toxicity:
not specified
Dermal irritation:
not specified
Total recovery:
- 112 +/- 3% of the administered dose
Percutaneous absorption
Dose:
2.57-2.95 µCi/rat
Parameter:
percentage
Absorption:
0 %
Remarks on result:
other: 24 hours
Remarks:
1.9 +/- 0.4 µCi were detectable in skin samples

Any other information on results incl. tables

- No radioactivity above background levels were detectable in blood, urine and liver.

- The total dermally administered dose could be accounted for by the radioactivity at the site of application and on the patch and pipet tip.

Applicant's summary and conclusion

Conclusions:
The test item was not absorbed by rats after dermal application.
Executive summary:

Radioactive labelled test item was applied to male rats on the shaved skin of the mid-dorsal area for 24 hours under occlusive conditions. No test item was detected in blood, urine and liver on the first day after exposure. Radioactivity detected at the site of application and on the patch and pipet tip accounted for the entire applied dose. These data indicate, that the test item is not absorbed by rats after dermal application.