Hexachloroplatinic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 November 2002 - 20 December 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

No adjustment made for the specific gravity (2.07 g/ml) at the 25 mg/kg bw dose resulting in a 1.2% overdose which was considered to be within the experimental variation of oral dosing. Maximum 2% deviation from the minimum level for relative humidity.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexachloroplatinic acid

EC Number:

241-010-7

EC Name:

Hexachloroplatinic acid

Cas Number:

16941-12-1

Molecular formula:

Cl6Pt.2H

IUPAC Name:

platinum(4+) dihydrogen hexachloride

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Dihydrogen hexachloroplatinate (IV) solution
- Substance type: No data
- Physical state: liquid
- Analytical purity: 99.95%
- Impurities (identity and concentrations): not stated
- Purity test date: not stated
- Lot/batch No.: 4513936306
- Expiration date of the lot/batch: 12 September 2003
- Stability under test conditions: stable
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

other: Wistar strain Crl:(Wl) BR (SPF quality)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: young animals (approx. 8 weeks old)
- Weight at study initiation: 191-287 g
- Fasting period before study: max 20 hr
- Housing: Macrolon cages containing purified sawdust
- Diet (e.g. ad libitum): standard pelleted lab animal diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 70.8% by weight of the test substance

10 ml/kg bw for 25 mg/kg bw dose; 0.096 ml/kg bw (undiluted) for 200 mg/kg dose.

Doses:

25 and 200 mg/kg bw

No. of animals per sex per dose:

3 females dosed at 200 mg/kg bw; 3 males and 3 females dosed at 25 mg/kg bw

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily (mortality/viability); days 1 (pre-administration), 8 and 15 (body weights); daily (clinical signs)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 25 - < 200 mg/kg bw

Mortality:

2 at 200 mg/kg bw and remaining animal in distress and sacrificed. No mortality occurred at 25 mg/kg bw.

Clinical signs:

other: 200 mg/kg bw slight hunched posture seen immediately post-dosing. By 4 h post-dose severe lethargy; severe clonic spasms and tremor (1 animal). Slight clinical signs of slow breathing, piloerection, watery dischange from eyes and ptosis developed by 2-4 h

Gross pathology:

200 mg/kg bw: sStomach distended with gas in 2 animals. 25 mg/kg bw: no macroscopic findings.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category II

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 value of dihydrogen hexachloroplatinate was determined to be >25 mg/kg bw but <200 mg/kg bw in rats.

Executive summary:

The acute toxicity of dihydrogen hexachloroplatinate was investigated in Wistar rats, in an OECD Test Guideline 423 study (acute toxic class method), conducted according to GLP. Initially, a group of three females received the test material via oral gavage at a dose of 200 mg/kg bw. Subsequently, rats (3/sex) were gavaged at a dose of 25 mg/kg bw and observed for 14 days.

 

Two animals treated at 200 mg/kg bw died, and the third was sacrificed in distress, at 4 hours post treatment. No mortality or signs of systemic toxicity were observed at the lower dose. The investigators stated that the oral LD50 was established to be in the range of 25-200 mg/kg bw.

 

Based on the results of this study, it is prudent to classify the test material for acute oral toxicity (category 2) according to EU CLP criteria (EC 1272/2008).