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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: see 'Remark'
Remarks:
p-Phenylenediamine hydrochloride will dissociate in situ, to the chloride ion and its corresponding cation. p-Phenylenediamine will also dissociate in situ to form the corresponding cation. In view of the species being the same regardless of whether the test substance is in its salt form or not, p-phenylenediamine hydrochloride is therefore representative of the substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Principles of method if other than guideline:
An experiment was conducted to compare the absorption of varying doses of 14C-labelled test material through male rat skin.
GLP compliance:
not specified

Test material

Constituent 1
Details on test material:
- Purity: ≥98%
Radiolabelling:
yes
Remarks:
14C-PPD dihydrochloride

Test animals

Species:
rat
Strain:
other: Charles River CD®
Sex:
male

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: ethanol-artificial "sweat solution" (NaCl, KCl, and NaHCO3 in distilled water, pH adjusted to 7.0 with NaOH or HCl)
Duration of exposure:
Single dose
Doses:
38, 190, 12000 µg
No. of animals per group:
3 males
Control animals:
no

Results and discussion

Percutaneous absorptionopen allclose all
Remarks on result:
other: Only trace amounts of the test substance were present in blood at any time and comparatively little was eliminated in the urine and faeces, particularly at the low dose.
Remarks on result:
other: At the high dose (12 mg), however, the amount of the test substance or its metabolites present in blood, urine, and faeces increased considerably.
Remarks on result:
other: This indicates that the test substance changes the skin permeability (enhances its own absorption and elimination)

Any other information on results incl. tables

Only trace amounts of the test substance were present in blood at any time and comparatively little was eliminated in the urine and faeces, particularly at the low dose. At the high dose (12 mg), however, the amount of the test substance or its metabolites present in blood, urine, and faeces increased considerably. This indicates that the test substance changes the skin permeability (enhances its own absorption and elimination).

Applicant's summary and conclusion

Executive summary:

An experiment was conducted to compare the absorption of varying doses of 14C-labeled test material through male rat skin at doses of 38, 190, and 12000 µg. Only trace amounts of the test substance were present in blood at any time and comparatively little was eliminated in the urine and faeces, particularly at the low dose. At the high dose, however, the amount of test substance or its metabolites present in blood, urine, and faeces increased considerably. This further indicates that the test substance changes the skin permeability. In this case, the test substance enhances its own absorption and elimination.

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