Tripotassium orthophosphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute 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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: no data

Deviations:

not applicable

Principles of method if other than guideline:

The test compound was administered by oral gavage to 10 rats and observed for adverse effects and drug induced toxicity for 14 days. All animals were autopsied and observed for gross pathological changes.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tripotassium orthophosphate

EC Number:

231-907-1

EC Name:

Tripotassium orthophosphate

Cas Number:

7778-53-2

Molecular formula:

H3O4P.3K

IUPAC Name:

tripotassium orthophosphate

Test material form:

other: substance is stated as being solid

Details on test material:

- Name of test material: MCTR-7-75

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Zartman Farms, Douglassville, Pa.
- Age at study initiation: no data
- Weight at study initiation: 200 - 300 g
- Fasting period before study: fasted for approximately 24 h prior to dose administration.
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle: no data
- Justification for choice of vehicle:no data
- Lot/batch no.: no data
- Purity: no data


MAXIMUM DOSE VOLUME APPLIED: no data


DOSAGE PREPARATION: no data


CLASS METHOD
- Rationale for the selection of the starting dose: no data

Doses:

5 g/kg

No. of animals per sex per dose:

10 males

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 3, 6 and 24 h and daily thereafter for a total of 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weights.

Statistics:

No data

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD100

Effect level:

5 other: g/kg

Based on:

test mat.

Mortality:

See table

Clinical signs:

other: Loss of righting reflex, ptosis, respiratory depression and death occurred within the first 24 h post intubation.

Gross pathology:

Autopsies revealed no outstanding gross lesions.

Other findings:

No data

Any other information on results incl. tables

Table 1. Survival for the acute oral toxicity of MCTR-7 -75 in rats:

Dose (g/kg bw)	No. per group	Hour						Day
		1	3	6	24	48	72	4	5	6	7	8	9	10	11	12	13	14	Total
5.0	10	10	5	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Table 2. Observations for the acute oral toxicity of MCTR-7 -75 in rats:

Dose (g/kg bw)	Animal No.	Hour
		1	3	6	24	48	72
5.0	1	Rr-R PT	Rr-R PT	Death
	2	Rr-R PT	Death
	3	Rr-R PT	Death
	4	Rr-R PT	Death
	5	Rr-R PT	Death
	6	Rr-R PT	Death
	7	Rr-R PT	Rr-R PT	Rr-R PT	Death
	8	Rr-R PT	Rr-R PT	Rr-R PT	Death
	9	Rr-R PT	Rr-R PT	Death
	10	Rr-R PT	Rr-R PT	Rr-R PT	Death

PT - ptosis

R - respiratory depression

RR - loss of righting reflex

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The test substance when administered orally to Wistar-derived albino rats at a dose level of 5 mg/kg caused loss of rightling reflex, ptosis, respiratory depression and death. The LD50 is therefore considered to be <5g/kg bw.

This study does not meet the requirements for classification and labelling in accordance with Regulation (EC) No. 1272/2008, as only one dose level of 5 g/kg was tested (above for cut-off for classification under CLP). Therefore, for the purpose of the assessment of the acute oral toxicity of tripotassium orthophosphate this study has been disregarded.