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Toxicological information

Dermal absorption

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Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well designed and conducted. No guideline followed. Not GLP compliant.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1987

Materials and methods

Principles of method if other than guideline:
Comparison of the skin absorption of the test substance in guinea pigs using a variety of patch test systems.
GLP compliance:
no

Test material

Constituent 1
Details on test material:
- Specific activity (if radiolabelling): 6.25 μCi/mg
- other: formulated as 1% pet., USP
- The radiolabelled material was provided by Leszek Wolfram of Clairol, Inc.
Radiolabelling:
yes
Remarks:
14C-PPD

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
petrolatum
Duration of exposure:
48 hours
Doses:
A concentration of 2 mg/mm2, normalized to equal surface area; 14C-PPD was formulated as 1% in USP petrolatum.
No. of animals per group:
3
Control animals:
yes
Remarks:
animals administered with ip injection of 14C-PPD dissolved in propylene glycol

Results and discussion

Signs and symptoms of toxicity:
not specified
Dermal irritation:
not specified
Percutaneous absorptionopen allclose all
Remarks on result:
other: A statistically significant difference in absorption was observed due to test patch systems. There was a 6-fold difference in the range of absorption.
Remarks on result:
other: In decreasing order, percent absorption from the various systems were: Hill-Top chamber > Teflon Patch > Small-Finn chamber with paper disc insert > Small-Finn chamber > Large Finn chamber) > AL test.

Any other information on results incl. tables

A statistically significant difference in absorption was observed due to test patch systems. There was a 6-fold difference in the range of absorption. In decreasing order, percent absorption from the various systems were: Hill-Top chamber (53.4±20.6) > Teflon Patch (48.6±9.3) > Small-Finn chamber with paper disc insert (34.1±9.8) > Small-Finn chamber (29.8±9.0) > Large Finn chamber (23.1±7.3) > AL test (8.0±0.8).

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, a 6-fold difference in the range of skin absorption of 1% test substance from different test patch chambers was observed in guinea pigs; the differences in absorption due to test patch system was statistically significant.
Executive summary:

Comparison of the skin absorption of the test substance in guinea pigs was made using a variety of patch test systems. A statistically significant difference in absorption was observed due to test patch systems. There was a 6-fold difference in the range of absorption; the differences in absorption due to test patch system was statistically significant (P< 0.02). In decreasing order, percent absorption from the various systems were: Hill-Top chamber (53.4±20.6) > Teflon Patch (48.6±9.3) > Small-Finn chamber with paper disc insert (34.1±9.8) > Small-Finn chamber (29.8±9.0) > Large Finn chamber (23.1±7.3) > AL test (8.0±0.8).