Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published study to non-standard guidelines (Stratmann et al, 1979); results are also summarised in later papers by Stratmann (1979) and Stratmann & Eifinger (1981).
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
[Teratological aspects of CaF2 medication]
Author:
Stratmann KR, Eifinger FF & Köhler F
Year:
1979
Bibliographic source:
Deutsche Zahnarztliche Zeitschrift 1979, Feb; 34(2):124-6
Reference Type:
publication
Title:
[TOXICOLOGICAL THRESHOLD VALUES OF VARIOUS FLUORIDE COMPOUNDS]
Author:
STRATMANN KR & EIFINGER FF
Year:
1981
Bibliographic source:
KARIESPROPHYLAXE 3:15-17,1981
Reference Type:
publication
Title:
[Comparison of embryotoxic effects of inorganic fluorides]
Author:
Stratmann KR
Year:
1979
Bibliographic source:
Deutsche Zahnarztliche Zeitschrift 1979, Jun; 34(6):484-6

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The acute intraperitoneal toxicity of the substance in the mouse was investigated as a range-finding study for a study of developmental toxicity.
GLP compliance:
no
Remarks:
: published study, pre-dates GLP
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No additional details are reported

Test animals

Species:
mouse
Strain:
ICR
Sex:
female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Doses:
0 (control), 25, 50, 100, 200, 400, 800, 1600, 3200 or 6400 mg/kg bw
No. of animals per sex per dose:
5-15 pregnant females per dose level
Control animals:
yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
2 778 mg/kg bw
Remarks on result:
other: gravid
Mortality:
Deaths occurred at 3200 mg/kg bw (8/9) and at 6400 mg/kg bw (5/7).

Any other information on results incl. tables

The acute intraperitoneal LD50 of calcium fluoride in gravid female mice was calculated to be 2778 mg/kg bw

Applicant's summary and conclusion

Conclusions:
The test substance was shown to be of low toxicity under the conditions of this study.
Executive summary:

A single dose of calcium fluoride was administered by intraperitoneal injection to gravid female mice on day 9 of gestation at dose levels of between 25 and 6400 mg/kg bw. The acute intraperitoneal LD50 of calcium fluoride in gravid female mice was calculated to be 2778 mg/kg bw under the conditions of this study. The intraperitoneal LD50 of calcium fluoride in gravid female mice is additionally reported in a later paper by the same authors to be 2638.27 mg/kg bw; this valeu may represent a re-interpretation of the same data.