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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:
key study
Study period:
19 February to 16 March, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline-compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Calcium fluoride, batch identification F1510740 834, purity > 98%, described as a white solid. The test material was homogenous by visual inspection. The stability under storage conditions was guaranteed by the sponsor. The material was stored at room temperature; hygroscopic.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
The animals were nulliparous and non-pregnant female Wistar rats of the Crl:WI (Han) strain. They were obtained from Charles River Wiga GmbH (Germany) and were approximately 10 weeks old at the start of the study. They were allowed an acclimatisation period of at least 5 days before the beginning of the experimental phase. Individuals were identified by cage cards and tail markings.
The rats were housed in fully air-conditioned rooms, maintained at a temperature of 22±3°C and 30-70% relative humidity. Light was provided on a 12 hour light/dark cycle. The rats were singly housed in Makrolon type III cages, with bedding and enrichment provided. They were fed VRF1(P) diet (SDS, Germany), and tap water was available ad libitum.

Feed, drinking water, bedding and enrichment analyses were conducted.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
doubly distilled
Details on oral exposure:
Each rat received a single oral administration by gavage.
The dosing preparation (suspension) was produced for each test group shortly before administration by stirring with a magnetic stirrer. The homogeneity of the preparation during application was ensured by stirring with a magnetic stirrer.
Doubly distilled water was chosen as the vehicle as an aqueous formulation corresponds to the physiological medium. The administration volume was 10 ml/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Two groups of 3 females.
Control animals:
no
Details on study design:
A starting dose of 2000 mg/kg be was chosen in the first step with 3 females. No animals died, so 2000 mg/kg bw was administered to another group of 3 females. As no animal died in the second step the study was termination.
Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum. Dosing took place in the morning. The rats were observed for 14 days after dosing.
Individual body weights were obtained shortly before administration (day 0), weekly thereafter and on the last day of observation. Clinical signs were erecorded several times on the day of administration, and at least once daily thereafter each workday. A check for dead or moribund animals was made at least once each workday. Rats were sacrificed at the end of the observation period by exposure to increasing concentrations of CO2. Necropsy with gross pathology was performed.
Statistics:
A formal statistical analysis was nto required.

Results and discussion

Preliminary study:
No preliminary study available.
Effect levels
Sex:
female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths at the limit dose
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs were observed in the first adminstration group. Clinical observations in the second group revealed reduced impaired general state, piloerection, diarrhoea and dyspnoea in one out of three animals from hour 2 until hour 5 after administration.
Body weight:
The mean body weight of the test groups increased throughout the study period within the normal range.
Gross pathology:
There were no macroscopic pathological findings.
Other findings:
No other findings reported.

Any other information on results incl. tables

No further information on results.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 in rats was estimated to be >2000 mg/kg bw.
Executive summary:

The acute oral toxicity of calcium fluoride was evaluated according to the Acute Toxic Class method. Calcium fluoride was administered as a suspension in doubly distilled water, by gavage, to two groups of 3 female Wistar rats at a dose of 2000 mg/kg bw.

No mortality ccurred in the six females. No clinical signs were observed in the first adminstration group. Clinical observations in the second group revealed reduced impaired general state, piloerection, diarrhoea and dyspnoea in one out of three animals from hour 2 until hour 5 after administration. The mean body weight of the test groups increased throughout the study period within the normal range. There were no macroscopic pathological findings.

The acute oral LD50 in rats was estimated to be >2000 mg/kg bw.