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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:
1993-08-04 to 1993-08-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: In principle well documented GLP-study, but no information on test item purity was provided.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): silver powder CAP 9
- Physical state: grey powder
- Storage condition of test material: room temperature, white plastic container
- Particle size: <40 µm

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, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.2 - 2.52 kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: ad libitum (RABMA Rabbit Diet, Special Diet Services Ltd., Witham, Essex, U.K.)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 62 - 68
- Air changes (per hr): 15
- Photoperiod: 12 hours dark/light cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used for control purposes.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test material was placed into the conjunctival sac of the right eye.
Duration of treatment / exposure:
1 second
Observation period (in vivo):
Immediately after administartion of the test material, an assessment of the initial pain reaction was made.
Number of animals or in vitro replicates:
3 rabbits: After consideration of the ocular response produced in the first treated animal, two additional animals were treated.
Details on study design:
REMOVAL OF TEST SUBSTANCE
no data

SCORING SYSTEM: Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation from DRAIZE 1959.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by use of the light source from a standard opthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
, opacity
Basis:
mean
Time point:
other: up to 72 hours after treatment
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: up to 72 hours after treatment
Score:
0
Max. score:
1
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
mean
Time point:
other: up to 72 hours after treatment
Score:
0
Max. score:
0
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study.
No ocular effects were noted 24, 48 or 72 hours after treatment.
Other effects:
Residual test material was noted around the treated eye of all animals during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was classified as non-irritant according to EEC labelling regulations.