Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Authoritative secondary source

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Approximately 100 pregnant female Long Evan rats received a diet containing 4% lead carbonate post partum. Offspring were sacrificed up to 71 days of age, having received 4% lead carbonate in the diet after cessation of suckling.
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:
tris(λ²-lead(2+)) dihydroxide dicarbonate

Test animals

Species:
rat
Strain:
Long-Evans

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
71 d
Frequency of treatment:
daily
Duration of test:
71 d
Doses / concentrations
Remarks:
Doses / Concentrations:
4%
Basis:
nominal in diet
No. of animals per sex per dose:
100 females post partum
Offsprings (number not reported)
Control animals:
not specified

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:not examined

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes

Details on embryotoxic / teratogenic effects:
Retardation in growth
At 23–29 days of age approximately 90% of the offspring developed paraplegia for up to 2 weeks, with about 85%–90% of these animals dying
Histopathological changes were seen in the cerebellum indicative of encephalo-myelopathy

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The substance was found to be neurotoxic to the offsprings at the concentration tested