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Toxicological information

Dermal absorption

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Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
validity restricted due to the use of high concentration inducing local toxic effects (corrosion at the high dose level) and exclusion of radioactivity in deeper skin layers for calculation of absorption (underestimation of absorption rate at low dose).

Data source

Reference
Reference Type:
publication
Title:
The in vitro permeability of human skin to benzene, ethylene glycol, formaldehyde, and n-Hexane
Author:
Loden M
Year:
1986
Bibliographic source:
Acta Pharmacol Toxicol 58: 382-389

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
yes
Remarks:
14C-formaldehyde

Test animals

Species:
human

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Duration of exposure:
15 h
Doses:
no data
concentration: 3.7% or 37%
No. of animals per group:
5 trials with skin samples for each concentration
Details on in vitro test system (if applicable):
Permeability of human skin to 14C-formaldehyde studied using excised full skin in a flow-through (5 mL/h) diffusion cell at 30°C. Radioactivity measured by scintillation counting. Resorption related to radioactivity in receptor fluid (radioactivity in skin not included) although radioactivity in tangential cryo-slices of the skin (thickness: 2 mm) was measured after 0.5 or 15 hours of exposure.

Results and discussion

Signs and symptoms of toxicity:
not specified
Dermal irritation:
not specified
Absorption in different matrices:
The dermal absorption was 16.7 µg/cm²/h using 3.7% formalin and 319 µg/cm²/h using 37% formalin (local corrosive effects assumed). Exclusion of radioactivity in deeper skin layers for calculation of absorption.
Total recovery:
no data

Applicant's summary and conclusion

Executive summary:

Comparable to Guideline study; validity restricted due to the use of high concentration inducing local toxic effects (corrosion at the high dose level) and exclusion of radioactivity in deeper skin layers for calculation of absorption (underestimation of absorption rate at low dose).

Permeability of human skin to 14C-formaldehyde studied using excised full skin in a flow-through (5 mL/h) diffusion cell at 30°C. The dermal absorption was 16.7 µg/cm²/h using 3.7% formalin and 319 µg/cm²/h using 37% formalin.