Diammonium hexachloropalladate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4 September 1989 – 4 September 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to a company standard protocol designed to comply with the recommendations of OECD guideline No. 405

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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:

Reference substance 001

Cas Number:

19168-23-1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): ammonium hexachloropalladate (IV)
- Substance type: red coloured powder
- Physical state: solid
- Lot/batch No.: 042011
- Stability under test conditions: not determined
- Storage condition of test material: room temperature

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, UK
- Age at study initiation: approx. 12-16 wk
- Weight at study initiation: 2.95 kg
- Housing: individually in a suspended metal cages
- Diet: ad libitum Rabbit Diet supplied by Preston Farmers Limited, New Leake, Boston, Lincolnshire, UK
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 61
- Air changes (per hr): approx. 15/hr
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 100 mg

Duration of treatment / exposure:

1 hr

Observation period (in vivo):

1 hr

Number of animals or in vitro replicates:

One male

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: Eye damage/irritation was assessed 1 hr following treatment according to Draize, 1959 and the numerical values corresponding to each tissue were recorded to give the total score for the conjunctivae (redness, chemosis and discharge), iris and cornea (degree and area of opacity). Using the numerical data obtained, the ocular irritancy potential was assessed by a modified version of the system described by Kay and Calandra, 1962.

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 1 hr

Score:

<= 106

Reversibility:

not specified

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1 hr

Score:

80

Max. score:

80

Reversibility:

not specified

Remarks on result:

other: Total corneal opacity noted 1 hr after treatment.

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 hr

Score:

<= 10

Reversibility:

not specified

Remarks on result:

other: Corneal opacity precluded evaluation of the iridial damage.

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 hr

Score:

<= 16

Reversibility:

not specified

Remarks on result:

other: Yellow-coloured staining of the nictitating and conjunctival membranes precluded evaluation of the conjunctival redness. Severe swelling of the conjunctival membranes was also noted.

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1 hr

Score:

4

Max. score:

4

Reversibility:

not specified

Irritant / corrosive response data:

Severe ocular reactions were produced 1 hr after treatment. Total corneal opacity was noted 1 hr after treatment and this precluded evaluation of the iridial damage. Severe swelling of the conjunctival membranes was noted, however yellow-coloured staining of the nictitating and conjunctival membranes precluded evaluation of the conjunctival redness.

Other effects:

The animal showed signs of distress and was killed, for humane reasons, 1 hr after treatment.

Applicant's summary and conclusion

Interpretation of results:

Category I

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a GLP eye irritation study, equivalent to OECD Test Guideline 405, undiluted diammonium hexachloropalladate (100 mg) produced very severe eye irritation following instillation into the eye of one male rabbit.

Executive summary:

In a GLP study, equivalent to OECD Test Guideline 405, undiluted diammonium hexachloropalladate (100 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. The treated eye was then assessed, after 1 hr, using the Draize scale for signs of irritation on the cornea, iris and conjunctiva.

Due to signs of distress, the animal was killed, for humane reasons, 1 hr after treatment and no further animals were tested. The scores were combined using a modified version of the system described by Kay and Calandra to give an ocular irritancy potential of ≤106. Diammonium hexachloropalladate was, therefore, considered a very severe irritant in this test system.

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