Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 March-12 April 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline, to GLP, with a minor deviation (humidity) that would not be expected to affect results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Relative humidity was below the protocol-stated range twice (for around 1 hour)
Qualifier:
according to
Guideline:
other: EEC Guideline 92/32/EEC
Deviations:
yes
Remarks:
Relative humidity was below the protocol-stated range twice (for around 1 hour)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): hexahydroxoplatinum(IV) acid
- Note: According to ChemIDPlus, the CAS in this study report corresponds to "diaquatetrahydroxyplatinum". The name dihydrogen hexahydroxyplatinate (synonym hexahydroxoplatinum(IV) acid) corresponds to CAS 51850-20-5. This apparent discrepancy within the study report between CAS and name is inconsequential as these are equivalent from a toxicological perspective.
- Molecular formula (if other than submission substance): No data
- Molecular weight (if other than submission substance): No data
- Smiles notation (if other than submission substance): No data
- InChl (if other than submission substance): No data
- Structural formula attached as image file (if other than submission substance): No data
- Substance type: Product
- Physical state: Powder
- Analytical purity: >99.9%
- 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.: 8188
- Expiration date of the lot/batch: 1999
- Stability under test conditions: Stable throughout the experimental period
- Storage condition of test material: In a closed container in a refrigerator

Test animals

Species:
rat
Strain:
other: HsdCpb: WU
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, D-33176 Borchen
- Age at study initiation: 9 weeks (males); 10 weeks (females)
- Weight at study initiation: 218-225 g (males); 159-170 g (females)
- Fasting period before study: Approximately 16 hours
- Housing: Macrolon cages, type II
- Diet (e.g. ad libitum): ssniff R special diet for rats (ad libitum)
- Water (e.g. ad libitum): From Stadtwerke Halle (utility service provider), using an automatic drinking water system with drinking nipples or drinking bottles (ad libitum)
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 34-61
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
Aqueous CMC 0.5% (Registered trademark name Tylose; Tylopur C 1000 P)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 215 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: None given
- Lot/batch no. (if required): E 11430100
- Purity: No data

DOSAGE PREPARATION: Suspension, prepared using a homogenizer
Doses:
2150 mg/kg bw (males and females)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed continuously for 4-6 hours after administration; then once/day
- Necropsy of survivors performed: yes
- Other examinations performed: mortality and clinical signs (at least once/day), body weight (days 0, 7, 14)

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 150 mg/kg bw
Based on:
test mat.
Remarks on result:
other: CL not applicable
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 150 mg/kg bw
Based on:
test mat.
Remarks on result:
other: CL not applicable
Mortality:
None
Clinical signs:
Stilted gait (seen between 55 minutes and 1 day after administration) in 1 male and 3 females.
Sunken sides (seen between 55 minutes and 1 day after administration) in 1 male and 4 females.
Body weight:
No significant effects
Gross pathology:
No significant findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guideline GLP study, the acute oral LD50 value of hexahydroxoplatinum(IV) acid was determined to exceed 2150 mg/kg bw (limit test) in rats.
Executive summary:

In a well-conducted acute oral toxicity test, conducted in accordance with OECD Test Guideline 401 and to GLP, HsdCpb: WU rats (5/sex) were gavaged with hexahydroxoplatinum(IV) acid (as a suspension in aqueous carboxymethyl cellulose) at a limit dose of 2150 mg/kg bw and observed for 14 days.

 

Transient clinical signs of stilted gait and sunken sides were apparent in some animals. No deaths were observed within the observation period. The oral LD50 (and indeed the LD0) was therefore determined to exceed 2150 mg/kg bw in male and female rats.

 

Based on the results of this study, no classification for acute oral toxicity is required according to EU CLP criteria (EC 1272/2008).