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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:
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 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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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).