Dipotassium hexachloropalladate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study preparation and single ocular application took place between 19 April and 24 April 1989.

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:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Remarks:

no significant deviations.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Remarks:

no significant deviations.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 003

Cas Number:

16919-73-6

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Potassium hexachloropalladate (IV)
- Substance type: Red powder
- Physical state: Solid
- Analytical purity: 26.8% Pd
- Impurities (identity and concentrations): no data
- Purity test date: Apparently 07 July 1989
- Lot/batch No.: 041368
- Expiration date of the lot/batch: no data
- Stability under test conditions: Stable
- Storage condition of test material: Kept desiccated in a fridge
- Other: slightly soluble in water.

Test animals / tissue source

Species:

rabbit

Strain:

other: White Russian (albino)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: ASTA Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 8 months (male)
- Weight at study initiation: 2.58 kg
- Housing: Stainless steel ASTA cages with grating floor, size 48.5(L)x40(B)x36.5(H) cm
- Diet (e.g. ad libitum): Approximately 120 g/day of Standard Diet ssniff K “Special Diet for Rabbits”, supplied by ssniff Spezialfutter GmbH, D-4770 Soest
- Water (e.g. ad libitum): ad libitum from Stadtwerke Beilefeld (Municipal Works)
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-23.5
- Humidity (%): 45-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 (6 am- 6 pm: artificial lighting; 6 pm-6 am: “natural light-dark-rhythm”)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: second eye of treated animals served as concurrent control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.09 g (volume of around 0.1 ml)

The test substance was applied to the conjunctival sac.

Duration of treatment / exposure:

Eyelids were briefly closed by gentle finger pressure, no subsequent washing to remove test substance.

Observation period (in vivo):

I hour

Number of animals or in vitro replicates:

One male

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was not rinsed

SCORING SYSTEM: Signs of irritation on the cornea, iris and conjunctiva should have been assessed qualitatively and quantitatively using the Draize scale following application of the test material into the eye, but weren't due to corrosive effects.

TOOL USED TO ASSESS SCORE: Cliptrix pencil light for examination in situ. Eye, lids and nictating membrane from treated eye were examined microscopically.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Reversibility:

other: reversibility was not assessed due to humane sacrifice of the animal one hour after application of the test substance.

Remarks on result:

other: An irritation index could not be determined because of the corrosive effects of the test substance.

Irritant / corrosive response data:

Corrosive effects were seen. The whole corneal area showed an easily discernible translucent opacity; detail of the iris were slightly obscured (grade 2) “without showing any alterations”; the nictating membrane was discoloured (yellow) and hardened and no reaction was seen on handling or mechanical opening of the palpebral fissure; discharge with moistening of considerable areas around the eye (grade 3).

Microscopic examination revealed severe superficial necrosis in the conjunctiva and deep acute coagulation necrosis in the nictating membrane. Slight to moderate oedema and slight inflammatory cell infiltration (predominantly neutrophilic granulocytes) were found in the conjunctiva and nictating membrane. In the cornea, acute coagulation necrosis of the corneal epithelium, focal complete loss of the necrotic corneal epithelium and hyalinization of superficial layers of the corneal stroma were seen.

See tables 1 and 2.

Other effects:

Systemic toxic effects were not observed.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

In an OECD Guideline study, to GLP, undiluted dipotassium hexachloropalladate (90 mg) produced severe irritation and corrosive effects following instillation into the eye of one male rabbit.

Executive summary:

In an OECD Guideline study, to GLP, undiluted dipotassium hexachloropalladate (90 mg) was instilled into one eye of one rabbit and both lids were briefly closed by gentle finger pressure. The other eye remained untreated and acted as the control. Following application of the test material, severe changes indicative of a corrosive effect were seen within one hour that necessitated humane sacrifice of the animal. These included opacity and necrosis of the cornea, profuse ocular discharge and swelling and necrosis in the conjunctiva and nictitating membrane. An irritation index could not be determined because of the corrosive effects. No systemic toxicity was seen.

 

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 appropriate to classify the test material for serious eye damage (Category 1), as the severe effects observed are not expected to be reversible.