Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
neurotoxicity: chronic oral
Type of information:
experimental study
Adequacy of study:
key study
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:
1985

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trilead bis(carbonate) dihydroxide
EC Number:
215-290-6
EC Name:
Trilead bis(carbonate) dihydroxide
Cas Number:
1319-46-6
Molecular formula:
C2H2O8Pb3
IUPAC Name:
trilead bis(carbonate) dihydroxide

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 60 day old

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
1 year
Frequency of treatment:
ad libitum in diet
Doses / concentrations
Remarks:
Doses / Concentrations:
4 %
Basis:
nominal in diet
Control animals:
yes, plain diet

Examinations

Observations and clinical examinations performed and frequency:
OTHER: Both sciatic nerves
Time schedule: at 2, 4, 6, 8, 10, 12, 14 and 52 wk

Results and discussion

Results of examinations

Neuropathological findings:
effects observed, treatment-related
Details on results:
NEUROPATHOLOGY
The blood nerve-index (BNB) of rats exposed to lead was higher than that of pair-fed controls, and the difference increased within 52 wk

Any other information on results incl. tables

Because endoneurial protein changes are expected in lead neuropathy, it was important to determine if the elevated BNB-index was the result of a primary increase in endoneurial albumin concentration or of changes in endoneurial protein

Applicant's summary and conclusion

Conclusions:
It is clear that the elevated BNB-index was primarily the result of increased albumin concentration in the endoneurium of these lead-treated animals.The BNB-index can be used to evaluate blood-nerve barrier alterations quantitatively in animals models of neuropathy