Dipotassium tetrachloroplatinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 November 1981 to 27 November 1981 & 01 December 1981 to 03 December 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study not carried out in accordance with the relevant guidelines, but appears scientifically acceptable and well reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1982

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

After a range-finding study involving ten rats, five rats/sex were given 50 mg/kg bw and observed for signs of toxicity for 14 days.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dipotassium (II) tetrachloroplatinate

Cas Number:

10025-99-7

IUPAC Name:

Dipotassium (II) tetrachloroplatinate

Details on test material:

- Name of test material (as cited in study report): Potassium tetrachloroplatinate (II)
- Substance type: Orange/brown powder
- Physical state: Solid
- Analytical purity: no data
- Lot/batch No.: 031440A
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Tuck & Sons Ltd, Battlesbridge, Essex
- Age at study initiation: no data
- Weight at study initiation: 151-261 g or (in additional study) 218-332 g
- Fasting period before study: 16-20 hours
- Housing: Maximum of 5 rats (of one sex) per polypropylene cage (solid floor, furnished with softwood sawdust)
- Diet (e.g. ad libitum): ad libitum “Rat Diet” from Nottingham University, School of Agriculture, Sutton Bonington, Near Loughborough, Leics, UK.
- Water (e.g. ad libitum):ad libitum, from mains tap
 Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): no data
- Air changes (per hr): 20 (minimum)
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

A single dose was administered by gavage using an all-metal stomach tube.

VEHICLE
- Concentration in vehicle: 100 mg/ml
- Amount of vehicle (if gavage): 0.25, 0.5, 2.0, 5.0 or 20 ml/kg bw (range-finding study); 0.5 ml/kg bw (main study); 2.0 ml/kg bw (additional study)
- Justification for choice of vehicle: no data
- Purity: “B.P.”

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

Doses:

In the range-finding study, male and female rats were administered test substance at doses of 25, 50, 200, 500 or 2000 mg/kg bw (as a suspension in arachis oil). In the main study, male and female rats were administered 50 mg/kg bw. In an additional study, a dose of 200 mg/kg bw was given to rats of both sexes.

No. of animals per sex per dose:

One rat/sex (range-finding study) and 5 rats/sex (main study and additional study)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 5 days (range-finding study); up to 14 days (main study and additional study) they died within 2 days in the additional study (but intention was to observe for 14 .
- Frequency of observations and weighing: a half, one and four hours post-dosing, then daily for up to 14 days (main study and additional study)
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs

Statistics:

Acute oral median lethal dose (LD50)

Results and discussion

Preliminary study:

In the range-finding study, and in an additional (single dose-level) study, all rats given 200, 500 and 2000 mg/kg bw died within 2 days. In the main study, no deaths were seen at 50 mg/kg bw and below.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 50 - < 200 mg/kg bw

Mortality:

In the range-finding study, and in an additional (single dose-level) study, all rats given 200 mg/kg bw or more died within one or two days. No deaths were seen at the lower dose levels of 50 and 25 mg/kg bw in the range-finding study. In the main study, none of the ten treated rats given 50 mg/kg bw died within 14 days.

Clinical signs:

other: Subdued activity and hair standing on end were seen in all rats immediately after dosing with 50 mg/kg bw in the main study. No clinical signs were apparent after 24 hours. In the additional study, further symptoms of laboured breathing followed by colla

Gross pathology:

Not reported.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The acute oral median lethal dose (LD50) of dipotassium tetrachloroplatinate in the rat was shown to be between 50 and 200 mg/kg bw.

Executive summary:

The acute oral toxicity of dipotassium tetrachloroplatinate was assessed in rats. In a range finding study, groups of Sprague-Dawley rats (1/sex/group) were administered the test item at doses of 25, 50, 200, 500 or 2000 mg/kg bw (in arachis oil) by stomach tube. All rats given 200 mg/kg bw or more died within one day, but no deaths were seen within 5 days at the lower dose levels of 50 and 25 mg/kg bw. Therefore, in the main study, five rats/sex were given 50 mg/kg bw (the highest dose causing no deaths in the range-finding study). All of these animals survived the 14-day observation period. The only clinical symptoms reported were reduced activity and hair standing on end, which ceased to be apparent within 24 hours of dosing. In an additional study, 5 rats/sex given 200 mg/kg bw all died within 2 days. As well as the clinical signs already mentioned, laboured breathing, collapse, eye closure, tremors and diarrhoea preceded death.

 

Considering the results of the range-finding investigation, a more appropriate dose for the additional study would have been between 50 and 200 mg/kg bw.

 

The authors conclude that the acute oral median lethal dose (LD50) of dipotassium tetrachloroplatinate is between 50 and 200 mg/kg bw. Based on the results of this study, dipotassium tetrachloroplatinate should be classified for acute oral toxicity (category 3) according to EU CLP criteria (EC 1272/2008).