Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 March 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline test. Available as an unpublished report. Single animal tested for welfare reasons. Acceptable without restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

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:
other: white crystalline powder
Details on test material:
- Name of test material (as cited in study report): Potassium dicyanoaurate(I)
- Physical state: White crystalline powder
- Stability under test conditions: Stable throughout the experiment period
- Storage condition of test material: Desiccated in a closed container in refridgerator

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-4802 Halle-Künsebeck
- Age at study initiation: 12 months
- Weight at study initiation: 2.42 kg
- Housing: Stainless steel cage with grating floor, type ASTA, size: 48.5x40x36.5
- Diet (e.g. ad libitum): ssniff K, Special diet for rabbits. Approx: 120 g/day.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: One day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 22.0°C
- Humidity (%): 50 - 55%
- Photoperiod (hrs dark / hrs light): 6 a.m. - 6 p.m. CET artificial lighting, 6 p.m. - 6 a.m. CET darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.101 g in one eye.
Duration of treatment / exposure:
Single application of test substacnce applied
Observation period (in vivo):
5 hours after treatment (animal was found dead at 7 hours after treatment)
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
None

SCORING SYSTEM:
DRAIZE scale as well as qualitative assessments.

TOOL USED TO ASSESS SCORE: Cliptrix pencil light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Time point:
other: 1 hour after treatment
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Remarks:
area of cornea involved
Basis:
animal #1
Time point:
other: 1 hour after treatment
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 hour after treatment
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 1 hour after treatment
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
animal #1
Time point:
other: 1 hour after treatment
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #1
Time point:
other: 1 hour after treatment
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritant / corrosive response data:
All DRAIZE scores were at maximum 1 hour after treatment. No reversability occured - the animal was found dead 7 hours after treatment.
Severe hypokinesia and lacrimation at the non-treated eye 5 hours after treatment
Other effects:
Microscopial examination of the treated eye showed severe ulceration, moderate to severe coagulation necrosis and inflammatory cell infiltration in cornea and eyelids. Anterior eye chamber was filled with fibrinous masses and the iris exhibited moderate hypermia and severe edema.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Application of potassium dicyanoaurate to the eye of a rabbit caused severe changes 1 hour after treatment. The animal was found dead 7 hours after treatment.
Executive summary:

In a GLP, guideline test application of potassium dicyanoaurate to the eye of a rabbit caused severe changes 1 hour after treatment. The animal was found dead 7 hours after treatment. The test substance is therefore considered to be corrosive to the eye of the rabbit.