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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

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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.
Justification for type of information:
refer to analogue justification provided in IUCLID section 13

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

Constituent 1
Chemical structure
Reference substance name:
Calcium hydrogenorthophosphate
EC Number:
231-826-1
EC Name:
Calcium hydrogenorthophosphate
Cas Number:
7757-93-9
Molecular formula:
CaHPO4
IUPAC Name:
calcium hydrogen phosphate

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system 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
gross pathology
mortality

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.