Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not stated
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only a 1-page study report, no data on guideline/GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
5 rats/sex were given a single oral dose of tetrammine platinous chloride at 15.1 g/kg bw, and observed for mortality.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): tetrammine platinous chloride.
- Substance type: white powder
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: 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
- Other: Sponsor’s code no. CB 13

Specific details on test material used for the study:
- Name of test material (as cited in study report): tetrammine platinous chloride.
- Substance type: white powder
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: 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
- Other: Sponsor’s code no. CB 13

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: “young adult”
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

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: From: To:

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: no data

DOSAGE PREPARATION (if unusual): no data

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:
15.1 g/kg bw
No. of animals per sex per dose:
5/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: no data
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: no data

Results and discussion

Preliminary study:
1/sex dosed at 0.001, 0.05, 0.5 or 15 g/kg bw. No deaths, no other findings reported.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 100 mg/kg bw
Mortality:
None
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to a brief report, the acute oral LD50 value for tetrammine platinous chloride in rats is >15.1 g/kg bw.


Executive summary:

In a brief report of an acute oral toxicity test, in which 5 rats/sex were given a single oral dose of tetrammine platinous chloride at 15.1 g/kg bw, there were no deaths. The acute oral LD50 is therefore >15.1 g/kg bw. No other findings were reported (but the extent of examination and observation is unclear).

The study report notes that, according to the tabulation of toxicity classes incorporated in the American NFPA No. 704M labelling system, the acute oral LD50 of CB 13 is likely to fall within Class 0 – “relatively harmless”.

Based on the results of this study, tetraammineplatinum dichloride does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).