Platinum

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study, to GLP, on a related compound

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Platinum dioxide

EC Number:

215-223-0

EC Name:

Platinum dioxide

Cas Number:

1314-15-4

Molecular formula:

O2Pt

IUPAC Name:

Platinum dioxide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Platinum (IV) oxide Type D
- Substance type:
- Physical state: powder
- Analytical purity: not stated
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: CC0198
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material: grey plastic tub; room temperature
- Other:

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.75 - 3.29 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 48 - 58
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye untreated and served as control

Amount / concentration applied:

100 mg/eye

Duration of treatment / exposure:

Test material placed into conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyball. Upper and lower eyelids were held together for about one second immediately after application and then released. Test material was not washed out.

Observation period (in vivo):

Grading timepoints: 1, 24, 48 and 72 hours
Reversibility assessed at 7 days

Number of animals or in vitro replicates:

One animal treated initially. After consideration of ocular response, two additional animals were treated.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable

SCORING SYSTEM:
Quantitative, using Draize scale (cornea: degree of opacity 0-4, area affected 1-4; iris 0-2; conjunctiva: redness 0-3, chemosis 0-4, discharge 0-3).
Interpretation using modified Kay and Calandra scheme (0-8 point irritation scale)

TOOL USED TO ASSESS SCORE: light source from standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 8

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

1.7

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 9

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Corrosive:No

Irritation Score: Cornea/Iris:
Cornea: at 24 and 48 hours - diffuse corneal opacity in 2/3 eyes (degree 1, area 1); no other corneal effects.
Iris: at 1 hour - iridial inflammation (1) in 3/3 eyes; 24 hours - iridial inflammation (1) in 2/3 eyes; no other iridial effects.

Irritation Score: Conjunctivae (Redness/Chemosis):
Conjunctivae: at 1 hour - moderate conjunctival irritation in 3/3 eyes (redness 2, chemosis 2, discharge 2); at 24 hours - minimal to moderate conjunctival irritation in 3/3 eyes (redness 2, chemosis 1-2, discharge 0-3); at 48 hours - minimal conjunctival irritation in 3/3 eyes (redness 1-2, chemosis 0-1, discharge 0); at 72 hours - minimal conjunctival irritation in 1/3 eyes (redness 1, chemosis 0, discharge 0); no other conjunctival effects.

Overall Irritation Score:
Highest overall irritation score 17.0, with group mean score at 72 hours >0; Kay and Callandra class 5, moderate irritant

Any other information on results incl. tables

3/3 animals affected.

Scores were reduced over time.

Effects were reversible.

Residual test material was found around the treated eye.

For Kay and Callandra classification, group mean scores (3 animals) for each timepoint:

1 hour - 17.0 (individual scores 17, 17, 17)

24 hours - 16.7 (individual scores 6, 24, 20)

48 hours - 7.3 (individual scores 2, 11, 9)

72 hours - 0.7 (individual scores 0, 2, 0)

7 days - 0 (1 animal)

Highest overall irritation score 17.0, with group mean score at 72 hours >0, placing the test material in class 5, moderate irritant.

For EC classification, mean scores (24, 48 and 72 hours) for individual animals:

Corneal opacity - 0.0, 0.7, 0.7

Iridial inflammation - 0.0, 0.3, 0.3

Conjunctival redness - 1.0, 1.7, 1.0

Conjunctival chemosis - 0.3, 1.0, 1.0

Test material does not meet the limits required by the EC regulation for hazard labelling.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a guideline study, to GLP, instillation of platinum dioxide (0.1 g) produced moderate irritation in three rabbits after a 72-hr observation period. The substance would not be classified under EU CLP criteria.

Executive summary:

In an OECD Test Guideline 405 study, conducted to GLP, the potential of platinum dioxide to cause eye irritation was assessed in rabbits. The test material (0.1 g) was instilled into the conjunctival sac of the right eye of each of three New Zealand White rabbits, without irrigation. Diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation were observed during the 72-hr observation period; only conjunctival redness had not reversed during this period (though it had lessened in severity). The test material produced a maximum group mean score of 17.0 and was classified as a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. However, no classification for eye irritation is required based on EU CLP criteria (EC 1272/2008).