Registration Dossier

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Scientifically sound study. However, as the study was only conducted for 14 days it is not sufficient for use as a key study for the endpoint repeated dose toxicity and therefore the data is only submitted as a supporting study to show that calcium phosphates are not considered to be systemically toxic.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test material was administered to male rats by means of a stomach tube daily for 14 days. 24 hours after the final dose animals were autopsied and observed for pathological changes.
GLP compliance:
no
Remarks:
Study pre-dates GLP
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 220-240 g
- Fasting period before study: 24 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
No data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
14 days
Frequency of treatment:
daily
Doses / concentrations
Dose / conc.:
214 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle
Details on study design:
- Dose selection rationale: The dose level of 214 mg/kg bw is equivalent to the 0.15 lb/head/day level fed to cattle as a food additive.
Positive control:
No

Examinations

Observations and examinations performed and frequency:
No data
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
Other examinations:
No data
Statistics:
No data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No signs of toxicity were reported for either dicalcium phosphate sample.
Mortality:
no mortality observed
Description (incidence):
0/10 animals died during the study
Body weight and weight changes:
not examined
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Description (incidence and severity):
All animals appeared grossly normal when necropsied following termination of the experiment
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined

Effect levels

Dose descriptor:
NOAEL
Effect level:
>= 214 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
clinical signs
mortality
gross pathology

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
No adverse effects of administration of dicalcium phosphate (reagent grade and PIC SPA derived) were noted at a dose level of >214 mg/kg bw in rats under the conditions of the study.