Registration Dossier
Registration Dossier
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EC number: 231-115-6 | CAS number: 7440-05-3
Acute Toxicity: oral
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:
- 1 975
- 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 palladium 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 substance name:
- Palladium monoxide
- EC Number:
- 215-218-3
- EC Name:
- Palladium monoxide
- Cas Number:
- 1314-08-5
- Molecular formula:
- OPd
- IUPAC Name:
- palladium monoxide
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): PdO
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system 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:
- > 4 900 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: CL was not determined
- Mortality:
- Palladium salts often kill 4-10 days after administration. An LD50 of >40 mmol/kg bw, using a molecular weight of approximately 122.42 g/mol, equates to >4896.8 mg/kg bw.
- Clinical signs:
- other: 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 4.9 g/kg bw was reported in male rats gavaged with palladium monoxide, and observed for up to 14 days.
- Executive summary:
In an acute oral toxicity study, groups of male Sprague-Dawley rats were administered palladium monoxide by stomach tube and observed for 14 days. Using the prescribed statistical method, the acute oral median lethal dose (LD50) was found to exceed 4.9 g/kg bw.
Based on the results of this study, palladium monoxide should not be classified for acute oral toxicity according to EU CLP criteria (EU 1272/2008).
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