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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
5 treatments during gestation
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Since lithium benzoate will dissociate in biological systems, it is considered valid to assess separately lithium and benzoate ions

Data source

Reference
Reference Type:
publication
Title:
EVIDENCE ON THE DEVELOPMENTAL AND REPRODUCTIVE TOXICITY OF Bromacil Lithium Salt
Author:
Reproductive and Cancer Hazard Assessment Section Office of Environmental Health Hazard Assessment California Environmental Protection Agency
Year:
2003
Bibliographic source:
Reproductive and Cancer Hazard Assessment Section Office of Environmental Health Hazard Assessment California Environmental Protection Agency 2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Principles of method if other than guideline:
Mated female CD-1 mice were treated with lithium carbonate by gavage at 0 or 400 mg/kg/d for gestation day 8-12. Mice were allowed to give birth and nurse to postnatal day 3. There were 30 control females, and 25 in each lithium carbonate group. Two types of lithium formulation were administered.
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium carbonate
EC Number:
209-062-5
EC Name:
Lithium carbonate
Cas Number:
554-13-2
Molecular formula:
CH2O3.2Li
IUPAC Name:
dilithium carbonate
Specific details on test material used for the study:
There were two lithium carbonate groups: one in which the lithium carbonate suspension was treated with a “Polytron” (presumably sonicated), the other not.

Test animals

Species:
mouse
Strain:
CD-1

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
Not specified; treatment started post-mating
Duration of treatment / exposure:
Gestation days 8 - 12
Duration of test:
Terminated Day 3 postnatal
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
400 mg/kg bw/day
Remarks:
As Lithium carbonate
No. of animals per sex per dose:
50 treated with lithium carbonate; two types of formulation applied, with 25 in each group (one being an emulsion to mimic theraputic deliver methods)
Control animals:
yes, concurrent vehicle

Examinations

Maternal examinations:
Yes
Fetal examinations:
Yes

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
no effects observed
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not examined
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Other effects:
not specified

Maternal developmental toxicity

Number of abortions:
no effects observed
Pre- and post-implantation loss:
no effects observed
Total litter losses by resorption:
no effects observed
Early or late resorptions:
not specified
Dead fetuses:
no effects observed
Changes in pregnancy duration:
not specified
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed
Changes in number of pregnant:
no effects observed
Description (incidence and severity):
In the control group, 12 out of 30 animals were pregnant, with two maternal deaths reported. Of the treated group, 33 out of 50 animals were pregnant, with no maternal mortality and all giving birth
Details on maternal toxic effects:
No treatment related toxicity

Effect levels (maternal animals)

Key result
Dose descriptor:
NOAEL
Effect level:
> 400 mg/kg bw/day (nominal)
Based on:
test mat.

Maternal abnormalities

Key result
Abnormalities:
no effects observed

Results (fetuses)

Fetal body weight changes:
no effects observed
Description (incidence and severity):
Mean weight of treated group 1.81 - 1.83 g; control weights 1.69 g
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): Pups from treated mothers showed slightly higher growth than control group.
Reduction in number of live offspring:
no effects observed
Description (incidence and severity):
Apparant reduction in numbers of pups born in one of the treated groups, but pup weight and viabilty unchanged
Changes in sex ratio:
not specified
Changes in litter size and weights:
no effects observed
Description (incidence and severity):
Slight reduction in litter size in one of the treated groups. Reported as statistically significant, but group size two small to make firm conclusionTaking bother treated groups as a whole, no significant effects
Changes in postnatal survival:
no effects observed
External malformations:
no effects observed
Skeletal malformations:
no effects observed
Visceral malformations:
no effects observed
Other effects:
not specified

Effect levels (fetuses)

Key result
Dose descriptor:
NOAEL
Effect level:
> 400 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female

Fetal abnormalities

Key result
Abnormalities:
no effects observed

Overall developmental toxicity

Key result
Developmental effects observed:
no

Any other information on results incl. tables

Only a summary report, but used by California State EPA as part of assessment of pesticide review

Applicant's summary and conclusion

Conclusions:
At 400 mg/kg/day, no adverse maternal or developmental toxicity observed.
Executive summary:

Only a summary report, but used by California State EPA as part of assessment of pesticide review

Chernoff N, Kavlock RJ (1982). An in vivo teratology screen utilizing pregnant mice. J Toxicol Environ Health 10(4-5):541-50.