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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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).