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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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited information on test procedure. Study was not conducted according to the OECD principle of Good Laboratory Practive (GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Register, April 1974
Deviations:
yes
Remarks:
The test was conducted with three rabbits instead of six
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
White powder
Specific details on test material used for the study:
The test was conducted with a white powder diluted in distilled water to 1.12 % (w/w)

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF-Russian strain
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Versuchstierzuchtanstalt WIGA, D-8741 Sulzfeld
- Weight at study initiation: 1750-1800 g
- Housing: Single cages, 45x90 cm with a floor of wire netting
- Diet: free access to feed pellets (green rabbit KFK 7112)
- Water: free access to fresh water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19±2
- Humidity (%): 50±10

Test system

Vehicle:
water
Controls:
other: only the right eyes were treated. The left eye remained untreated and served as a control.
Amount / concentration applied:
0.1 mL of 1.12% w/w teradonium bromide in destilled water
Duration of treatment / exposure:
0.1 mL of the test material was placed in the right eye and the lid held together for one second. Eyes were washed with 20ml 0.9% saline solution after 24 hours.
Observation period (in vivo):
6 days
Number of animals or in vitro replicates:
3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
Score after 72h = 0
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks:
Score after 72 h = 0
Irritation parameter:
conjunctivae score
Remarks:
Rednes
Basis:
animal: #1, #2, #3
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks:
Score after 6 days = 0
Irritation parameter:
chemosis score
Basis:
animal: #1, #3
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks:
Score after 6 d = 0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Remarks:
Score after 6 d = 0
Other effects:
No other effects reported

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Under the experimental conditions described in the report the testing revealed a positive reaction in all the three rabbits. Therefore the preparation must be designated as eye irritant.
Executive summary:

3 albino male rabbits (SPF-Russian strain) were treated in the right eye with 0.1 mL of the test material. Left eye remained untreated and served as a control. The lid was held gently together for a second and the eye examined 1 h, 24 h, 48 h, 72 h and 6 days after treatment. The reaction was scored according to grades of occular lessions. Highest scores were given for "conjunctiva chemosis". Effects were observed after 1 hour and decreased over time. After 6 days all scores were 0