Registration Dossier

Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Urinary lead content of rats was measured with epicutaneous application of four lead compounds: lead sulfate, lead oxide, lead powder, and lead stearate.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
petrolatum
Doses:
0.4g of test substance
Control animals:
yes

Results and discussion

Percutaneous absorption
Dose:
100 mg
Parameter:
percentage
Absorption:
ca. 16.7 %
Remarks on result:
other: 12 days
Conversion factor human vs. animal skin:
Based on Stauber et al. estimated absorption rate and the assumption of equal to or more permeability in rat skin as compared with human skin, the total absorption of lead sulfate was calculated to be about 4.8% within 24 hours of a 4.4mg application to the human skin.

Any other information on results incl. tables

Lead sulphate was absorbed more easily through rat skin. the animal model experiment showed that skinexposure to all kinds of lead compounds, including elemental lead, organic acids, and inorganic acid salts of lead, increased the amount of lead excreted in urine, that is, lead burden assuming that kidney function is normal.

Applicant's summary and conclusion

Conclusions:
In the condition of the study, lead sulphate was found partially water soluble and easily absorbable through the skin.