Phosphoric acid, potassium salt (2:3), dihydrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Aug 2010 - 07 Sep 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study Analytical purity not given, responsibility of the sponsor.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

yes

Remarks:

Analytical purity not given, responsibility of the sponsor

GLP compliance:

yes (incl. QA statement)

Remarks:

Department of Health of the United Kingdom, 2009

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

tripotassium trihydrogen phosphate dihydrate

EC Number:

700-282-1

Cas Number:

66922-99-4

Molecular formula:

H304P.H20.3/2K

IUPAC Name:

tripotassium trihydrogen phosphate dihydrate

Details on test material:

- Name of test material (as cited in study report): HiPeaK
- Physical state: white powder
- Analytical purity: not given, responsibility of the sponsor
- Lot/batch No.: 9086
- Storage condition of test material: RT in the dark under nitrogen
- Expiry date: 23 Dec 2011

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 168 - 181 g
- Fasting period before study: overnight
- Housing: in groups of up to four
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/mL for pre-test and 200 mg/mL for main experiment
- Amount of vehicle (if gavage): 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the abscence of data regarding the toxicity, 300 mg/kg bw was chosen as starting dose for a preliminary experiment

Doses:

300 mg/kg bw for pre-test and 2000 mg/kg bw for main experiment

No. of animals per sex per dose:

pre-test 300 mg/kg bw: 1 animal
main experiment 2000 mg/kg bw: 5 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: cage side observations twice daily, weighing on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: 0.5, 1, 2 and 4 hours after dosing and daily thereafter

Results and discussion

Preliminary study:

300 mg/kg bw: no mortalities, hunched posture 0.5, 1 and 2 hours after dosing, no signs after 4 hours

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities

Clinical signs:

other: No signs of systemic toxicity

Gross pathology:

No abnormal findings

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 of HiPeaK was estimated to be >2000 mg/kg bw. Therefore no classification according to DSD or CLP is required.