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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 March 1995 - 17 May 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with no protocol deviations

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 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Potassiumhexachloroplatinate(IV)

- Substance type:
- Physical state: Powder
- Analytical purity: >99.9%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: 8833 / June 23, 1994
- Expiration date of the lot/batch:

- Stability under test conditions: According to information from sponsor, test substance stable throughout experimental period
- Storage condition of test material: Closed container in refrigerator
- Other:

Test animals / tissue source

Species:
rabbit
Strain:
other: White Russian (Albino)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ASTA Medica AG, D-33790 Halle/Westfalen
- Age at study initiation: 34 months
- Weight at study initiation: 2.81 Kg
- Housing: Stainless steel cage with grating floor
- Diet (e.g. ad libitum): Approx. 120 g/day standard diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5
- Humidity (%): 53-69
- Air changes (per hr) not stated:
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
99.5 mg
Duration of treatment / exposure:
Substance applied to conjunctival sac of left eye and both lids briefly closed by gentle finger pressure. The treated eye was not rinsed.
Observation period (in vivo):
1 and 24 hours after application
Number of animals or in vitro replicates:
1 male
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable

SCORING SYSTEM: Draize scale. An irritation index was not determined because of corrosive effects

TOOL USED TO ASSESS SCORE: Cliptrix pencil light

Results and discussion

In vivo

Results
Remarks on result:
positive indication of irritation
Remarks:
Irritation index not determined because of corrosive effects
Irritant / corrosive response data:
Cornea: at 1 hour - no corneal opacity (degree 0, area 0); at 24 hours - corneal opacity (degree 4, area 4)
Iris: at 1 hour - no iridial irritation (0); at 24 hours - iris not discernible

Conjunctiva: at 1 hour - redness 2, chemosis 1, discharge 3; at 24 hours - redness 3 (diffuse beefy redness), chemosis 4 (swelling with lids more than half closed), discharge 3 (moistened considerable areas around the eye)

Eye filled with white mucus; eye, including nictitating membrane, discoloured (grey)

1 animal affected; due to the severity of the symptoms, no additional animals were tested.
Due to the severity of the symptoms at 24 hours, the tested animal was humanely killed.
Other effects:
Eye processed for microscopic examination: revealed evidence of inflammation in the iris, uvea and sclera, anterior chamber, cornea, ocular muscles and eyelids; pronounced corrosive effects leading to ulcerations, coagulation necrosis and inflammatory changes.

No systemic toxic effects detected.

No changes were seen in the untreated eye.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guideline study, to GLP, potassium hexachloroplatinate produced corrosive effects following instillation into the eye of a single male rabbit.
Executive summary:

In an OECD Test Guideline 405 study, conducted according to GLP, potassium hexachloroplatinate (99.5 mg) wasinstilled into the conjunctival sac of the left eye ofa single male White Russian rabbit.The other eye was untreated to serve as a control. Following instillation the eyelids were held closed by gentle finger pressure.The ocular response was assessed at 1 and 24 hr after instillation; corneal opacity, effects on the iris and conjunctival redness, chemosis and discharge were scored according to the Draize numerical scale. The treated eye as well as eye lids and nictitating membrane were assessed microscopically.

 

Corrosive effects were noted following instillation of the test material. The cornea was opaque and the iris was not discernible through the opacity. The conjunctiva showed diffuse beefy redness and swelling with lids more than half to completely closed. Discharge moistened considerable areas around the eye. The histological findings revealed a pronounced corrosive potential. The animal was humanely killed after 24 hr and no additional animals were tested due to the severity of the symptoms.No evidence of systemic toxicity was observed.

 

As the results were based on only one rabbit, it is not possible to give a definitive interpretation according to EU CLP criteria (EC 1272/2008). However, it is considered prudent to classify the test material for serious eye damage (Category 1), as the severe effects observed are not expected to be reversible.