Hexachloroplatinic acid

Endpoint summary

Description of key information

The acute oral LD50 value of dihydrogen hexachloroplatinate was determined to be >25 mg/kg bw but <200 mg/kg bw in rats (van Huygevoort, 2002).

 

No relevant acute dermal or inhalation toxicity data were identified. However, acute toxicity testing is not appropriate as hexachloroplatinic acid is considered corrosive.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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:

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

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.

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).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

50 mg/kg bw

Quality of whole database:

Overall, good-quality database which meets REACH Standard Information Requirements.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No relevant acute toxicity human data were identified.

 

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 (van Huygevoort, 2002). 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).

 

No relevant acute dermal or inhalation toxicity data were identified. However, acute toxicity testing by a second route is not appropriate as hexachloroplatinic acid is considered corrosive to the skin.

Justification for classification or non-classification

Based on the results of the available and reliable acute oral toxicity study in rats, it is prudent to classify hexachloroplatinic acid for acute oral toxicity (category 2) according to EU CLP criteria (EC 1272/2008).

 

No clear evidence of specific target organ toxicity was noted. As such, classification for STOT-SE is not considered appropriate.