Diammonium hexachloroplatinate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 Dec 1993 - 10 Jan 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study carried out in accordance with OECD and EU guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

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

Test material

Test material information

Constituent 1

Reference substance name:

Diammonium hexachloroplatinate

EC Number:

240-973-0

EC Name:

Diammonium hexachloroplatinate

Cas Number:

16919-58-7

Molecular formula:

Cl6Pt.2H4N

IUPAC Name:

diammonium hexachloroplatinate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Ammonium hexachloroplatinate(IV)
- Substance type: yellow powder
- Physical state: solid
- Analytical purity: “99.9% purity of the metal used for production of this compound”
- Lot/batch No.: 231/08-91
- Stability under test conditions: “stable throughout the experimental period”
- Storage condition of test material: Kept dry in a container in a refrigerator

Test animals / tissue source

Species:

rabbit

Strain:

other: White Russian (albino)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Breeder: ASTA Medica AG, D-33790, Halle/Westfalen
- Age at study initiation: Male 14 months; females 15 months
- Weight at study initiation: Male 2.31 kg; females 2.35 and 3.18 kg
- Housing: Stainless steel cages with grating floor, one animal/cage
- Diet (e.g. ad libitum): Approx. 120 g/day standard diet (“ssniff K”)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-20
- Humidity (%): 58-70
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs artificial light

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): 89.1-94.4 mg (volume of about 0.1 ml)

Duration of treatment / exposure:

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

Observation period (in vivo):

1, 24, 48 and 72 hours after application, thereafter once daily. 2 animals were observed for 7 days after application, then killed because of the severe effects observed. The remaining animal was observed for 21 days.

Number of animals or in vitro replicates:

3 (1 male, 2 females)

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 were assessed quantitatively and qualitatively using the Draize scale (see attachment 3 for details) assessed at 1, 24, 48, and 72 hrs (and daily thereafter) following application of the test material into the eye.

TOOL USED TO ASSESS SCORE: Cliptrix pencil light

Results and discussion

In vivo

Results

Irritation parameter:

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

Reversibility:

not fully reversible within: 7 days in two of the animals

Remarks on result:

positive indication of irritation

Remarks:

An irritation index could not be determined because of the corrosive effects

Irritant / corrosive response data:

Corrosive effects seen in the treated eyes of two rabbits, marked (but reversible) irritation in the third (see Tables 1a and 1b for details).

Other effects:

The only systemic effects observed were a very slight loss of body weight detected in the two animals showing corrosive eye damage.

Applicant's summary and conclusion

Interpretation of results:

Category I

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a guideline study, to GLP, instillation of ammonium hexachloroplatinate (0.1 ml) into one eye of each of three rabbits caused severe irritation and corrosion.

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 ammonium hexachloroplatinate was instilled into the conjunctival sac of the right eye of three White Russian rabbits (one male, two females). The left 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, 24, 48 and 72 hours and thereafter once daily for up to 21 days. 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. The treated eye as well as eye lids and nictitating membrane were assessed microscopically.

 

A number of severe (and often irreversible) effects were observed, including opacity and necrosis of the cornea, moderate circumcorneal hyperaemia of the iris, diffuse redness of the conjunctiva, swelling of the eyelids, as well as ocular discharge and the formation of a white mucus over the eyes. Two animals were killed 7 days after application because of the severe effects observed. The histopathological examination revealed a pronounced irritation potential of the test material, leading to very severe coagulation necrosis after conjunctival application. An irritation index could not be determined because of the corrosive effects. No systemic toxicity was observed other than a very slight reduction in body weight in the two rabbits showing corrosive effects.

 

Based on the results of this study, the test material should be classified for serious eye damage (Category 1) according to EU CLP criteria (EC 1272/2008).