Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Conducted prior to standard OECD/EU test guidelines and GLP. While there is somewhat limited reporting of methods and results, the study appears scientifically acceptable.

Data source

Reference
Reference Type:
publication
Title:
Studies on the evaluation of the toxicity of various salts of lead, manganese, platinum and palladium
Author:
Holbrook DJ, Washington ME, Leake HB and Brubaker PE
Year:
1975
Bibliographic source:
Environmental Health Perspectives 10, 95-101

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In the lethal dose experiments, male Sprague-Dawley rats received the tested platinum salt by gavage and were observed through a 14-day period. The LD50 values were calculated by the method of Litchfield and Wilcoxon. The exact dosing strategy is unclear and no details on pathological assessment are given.
GLP compliance:
no
Remarks:
(prior to GLP)
Test type:
other: No data
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): PtO2
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: No data
- 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
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 100-110 g
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): Presumably ad libitum
- Water (e.g. ad libitum): Presumably ad libitum
- Acclimation period: 1-1.5 weeks

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:
No data
Doses:
No data
No. of animals per sex per dose:
No data
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No data
Statistics:
The LD50 values were calculated by the method of Litchfield and Wilcoxon.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 3 400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: CL was not determined
Mortality:
Soluble platinum (IV) salts cause mortality early, usually within the first 1-2 days after administration. An LD50 of >15 mmol/kg bw for platinum dioxide, using a molecular weight of approximately 227.08 g/mol, equates to >3406.2 mg/kg bw (equivalent to 2926.2 mg/kg bw as platinum, based on MWt differences).
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study, an LD50 of greater than 3.4 g/kg bw was reported in male rats gavaged with platinum dioxide, and observed for up to 14 days.
Executive summary:

In an acute oral toxicity study, groups of male Sprague-Dawley rats were administered platinum dioxide by stomach tube and observed for 14 days. Using the prescribed statistical method, the acute oral median lethal dose (LD50) was found to exceed 3.4 g/kg bw (equivalent to >2.9 g/kg bw as platinum, based on MWt differences).

 

Based on the results of this study, platinum dioxide should not be classified for acute oral toxicity according to EU CLP criteria (EC 1272/2008).