Calcium hydrogenorthophosphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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 (either reagent grade dicalcium phosphate or dicalcium phosphate made from PCI superphosphoric acid) was dissolved in water and administered in single doses (2 dose levels) to fasted rats by means of a stomach tube. The animals were observed for 14 days post-treatment.

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 190-210 g
- Fasting period before study: 24 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL

Doses:

4640 mg/kg bw, 10000 mg/kg bw

No. of animals per sex per dose:

5 females/dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Substance tested: dicalcium phosphate reagent grade

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 7 940 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Substance tested: Dicalcium phosphate derived from PCI SPA

Mortality:

REAGENT GRADE DICALCIUM PHOSPHATE:
Dose level : 4,640 mg/kg bw
Mortality: 0/5

Dose level: 10,000 mg/kg bw
Mortality: 0/5

DICALCIUM PHOSPHATE DEERVIED FROM PCI SUPERPHOSPHORIC ACID:
Dose level : 4,640 mg/kg bw
Mortality: 0/5

Dose level: 10,000 mg/kg bw
Mortality: 4/5

Clinical signs:

other: No apparent signs of toxicity were produced from either sample when dosed at 4,640 mg/kg bw. The sample from Salt Lake (PCI SPA derived dical) produced acute depression and dyspnea at the 10,000 mg/kg dose level. Reagent grade dicalcium phosphate exhibit

Gross pathology:

The following abnormalities were observed in the animals dosed with 10,000 mg/kg of the Salt Lake sample when autopsied; stomach and upper gastro-intestinal tract erythemic with congestion of the liver, kidneys and adrenals.
Animals treated with reagent grade dicalcium phosphate at 10,000 mg/kg bw appeared grossly normal when autopsied 14 days after treatment.
Animals treated with reagent grade dicalcium phosphate and PCI dicalcium phosphate at 4,640 mg/kg bw appeared grossly normal when autopsied 14 days after treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Dicaclium phosphate Reagent grade and PCI dicalciumphosphate both gave acute oral LD50 vales of >5,000 mg/kg bw and thererfore under the conditions of this study are determined to be not acutely toxic via the oral route (according to EU CLP).

The results are sufficient in order to derive a reliable conclusion on classification and labelling in accordance with Regulation (EC) No.1272/2008 (EU CLP) and is therefore suitable for use as a key study.