Registration Dossier
Registration Dossier
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EC number: 268-717-3 | CAS number: 68133-90-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 April - 10 October 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Dihydrogen hexahydroxyplatinate, compound with 2-aminoethanol (1:2)
- EC Number:
- 268-717-3
- EC Name:
- Dihydrogen hexahydroxyplatinate, compound with 2-aminoethanol (1:2)
- Cas Number:
- 68133-90-4
- Molecular formula:
- C2H7NO.1/2H6O6Pt.H
- IUPAC Name:
- dihydrogen hexahydroxyplatinate, compound with 2-aminoethanol (1:2)
- Details on test material:
- - Name of test material (as cited in study report): DIhydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2) CAS 68133-90-4
- Substance type:
- Physical state: Liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: A-198-01
- Expiration date of the lot/batch: At least 6 months after analysis
- Stability under test conditions:
- Storage condition of test material: Opaque plastic bottle. In a dessicator at 4 deg C
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy, S.r.l., 33049 San Pietro al Natisone (UD), Italy
- Age at study initiation: approx. 5-6 weeks
- Weight at study initiation: 126-150 g
- Fasting period before study: overnight
- Housing: polycarbonate cages with stainless steel mesh lid and floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5%
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: not stated
- Lot/batch no. (if required): not stated
- Purity: not stated
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual): dissolution/suspension - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2 and 4 hours after dosing and then daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- None
- Clinical signs:
- other: Not applicable - no clinical signs observed
- Gross pathology:
- No adverse effects observed
- Other findings:
- No adverse events detected for either sex
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 value of dihydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2) was determined to exceed 2000 mg/kg bw following gavage administration in rats.
- Executive summary:
In an OECD Test Guideline 423 study, to GLP, dihydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2) was studied for acute toxicity after single oral administration in Sprague-Dawley rats.
The test substance was administered by stomach tube at a dose of 2000 mg/kg bw to groups of rats (3/sex). No mortality was observed and there were no clinical signs or body weight changes at the end of the 14-day observation period. Subsequent necropsy revealed no gross abnormalities.
The acute oral LD50 value of dihydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2) was determined to exceed 2000 mg/kg bw.
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