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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented and corresponded to the requirements of the recommended Annex V Test Guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
acute toxic class method

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
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source: Forschungsinstitut fur Versuchstierzucht, A-2325 Himberg
Age at study initiation: approx. 8 weeks at time of administration
Acclimation period: 6 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
Maximum dose volume applied: 10 ml per kg body weight
Doses:
"NAFTOVIN T2" was administered once perorally to 5 male and 5 female Him:OFA rats. The test substance, suspended in Arachis oil, was applied once at a dose of 2000 mg per kg body weight by stomach intubation.
No. of animals per sex per dose:
5 male and 5 female
Statistics:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Behavior, reactions and physical signs of the animals were observed 10, 30 min, 1, 2, 4 and 6 hours after administration (p.a.) and then at least once a day for a total of 2 weeks. Body weight was determined before administration, 7 days p.a. and 14 days p.a.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None.
Clinical signs:
All animals were normal during the whole study. No toxic signs were noted.
Body weight:
Body weight gain of the animals was inconspicuous.
Other findings:
No sex differences between males and females were noted in the response to the test substance.

Applicant's summary and conclusion

Interpretation of results:
other: practically nontoxic
Remarks:
Migrated information The LD50 for both male and female rats is higher than 2000 mg/kg of lead basic carbonate. Criteria used for interpretation of results: other: OECD-Guideline 401, "Acute Oral Toxicity, Limit-Test," 1987
Executive summary:

The observations in life revealed no toxic signs. 9/10 animals were normal at post mortem examination. Alterations of the 10th rat are not attributed to the action of the test substance, as similar changes are known to occur spontaneously with a low incidence in untreated rats of the strain used, and due to the single occurence in this study. No differences between the sexes were noted in the response to the test substance. All animals survived until termination. Therefore, LD50 (oral) for both male and female rats is higher than 2000 mg lead basic carbonate per kg body weight.