Tetraammineplatinum dinitrate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 to 27 July 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tetraammineplatinum dinitrate

EC Number:

243-929-9

EC Name:

Tetraammineplatinum dinitrate

Cas Number:

20634-12-2

Molecular formula:

H12N4Pt.2NO3

IUPAC Name:

tetraaminoplatinumbis(ylium) dinitrate

Test material form:

other: Clear colourless liquid

Details on test material:

- Name of test material (as cited in study report): Tetraamineplatinum dinitrate
- Substance type: Technical product
- Physical state: Liquid
- Analytical purity: No data
- Impurities (identity and concentrations): Chloride: less than 0.1%, K: 232 ppm/metal basis
- Composition of test material, percentage of components: 3.320% Pt (wt/wt)
- Isomers composition: No data
- Purity test date: 11 May 2012
- Lot/batch No.: CPI-15003
- Expiration date of the lot/batch: 1 February 2013
- Stability under test conditions: Not specified
- Storage condition of test material: Room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:Harlan Laboratories UK Ltd, Leicestershire, UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.64 to 3.02 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23oC
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 to 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

VEHICLE
Not applicable

Duration of treatment / exposure:

Eyes were held closed for 1 second after instillation

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 (Initially one animal, after consideration of the ocular response two additional animals were treated).

Details on study design:

REMOVAL OF TEST SUBSTANCE
Eyes were unwashed after treatment

SCORING SYSTEM: Ocular irritation evaluated through scoring of the conjunctivae, iris and cornea according to the Draize numerical scale.

TOOL USED TO ASSESS SCORE: Standard opthalmoscope as light source

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

110

Reversibility:

other: not applicable since no effects seen

Results 2

Irritation parameter:

overall irritation score

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

110

Reversibility:

other: not applicable since no effects seen

Results 3

Irritation parameter:

overall irritation score

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

110

Reversibility:

other: not applicable since no effects seen

Irritant / corrosive response data:

Minimal transient conjuctival redness was noted in one treated eye one hour after treatment

Other effects:

No signs of toxicity were noted during the study and all animals showed expected bodyweight gain.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an OECD Test Guideline 405 eye irritation study, conducted to GLP, tetraammineplatinum dinitrate was not irritating to rabbit eyes following instillation of the test material (0.1 ml) into the right eye of 3 animals.

Executive summary:

In an in vivo eye irritation study carried out in accordance with OECD Test Guideline 405, and to GLP, a 0.1 ml aliquot of undiluted tetraammineplatinum dinitrate was instilled into the conjunctival sac of the right eye of three male New Zealand White rabbits. The left eye was untreated to serve as a control. Following instillation the eyelids were held closed for 1 second. The ocular response was assessed at 1, 24, 48 and 72 hours. Corneal opacity, effects on the iris and conjunctival redness, chemosis and discharge were scored according to the Draize numerical scale. Any clinical signs of toxicity were noted and body weights were also recorded.

 

No corneal or iris effects were observed throughout the study. The only effect to be noted was minimal transient conjunctival redness in one treated eye one hour after treatment. No signs of toxicity were noted during the study and all animals showed expected bodyweight gain.

 

Based on the results of this study, tetraammineplatinum dinitrate should not be classified for eye irritation under EU CLP criteria (EC 1272/2008).