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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:
2001
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

Constituent 1
Chemical structure
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:

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.