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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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
Principles of method if other than guideline:
None
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 1.5 to 2 kgs
- Housing: Housed individually in metal cages
- Diet: NAFAG, Gossau SG ad libitum
- Water: Water, ad libitum
- Acclimation period: 4 days


ENVIRONMENTAL CONDITIONS

- Temperature: 22 + 1°C
- Humidity: 55 + 5 %
- Photoperiod: 10 hour light cycle

Test system

Vehicle:
not specified
Controls:
other: untreated right eye
Amount / concentration applied:
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
Unwashed eye: unspecified (not rinsed after single instillation)
Washed eye: 30 sec
Observation period (in vivo):
The rabbits were examined for day 1, 2, 3, 4 and 7 d after application of the test.
Number of animals or in vitro replicates:
Six animals (Three males and three females)
Details on study design:
PROCEDURE:
The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for one second.
The right eye was not treated and served as an untreated control.

REMOVAL OF TEST SUBSTANCE
In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water.

SCORING SYSTEM: The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit . The primary eye irritation index represents the sum of the mean values for cornea, iris and conjunctivae. This procedure was carried out separately for unrinsed and rinsed eyes
respectively.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
5.3
Remarks on result:
other: Unrinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
0
Remarks on result:
other: Unrinsed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
3.3
Remarks on result:
other: Unrinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
0
Remarks on result:
other: Rinsed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
0
Remarks on result:
other: Rinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
0
Remarks on result:
other: Rinsed
Irritant / corrosive response data:
no data
Other effects:
Not available

Any other information on results incl. tables

  Unrinsed Eyes Rinsed Eyes
Days after Appl. Rabbit 1 (Male) Rabbit 2 (Male) Rabbit 3 (Male) Rabbit 4 (Female) Rabbit 5 (Female) Rabbit 6 (Female)
Cornea Iris Conjuctiva Cornea Iris Conjuctiva Cornea Iris Conjuctiva Cornea Iris Conjuctiva Cornea Iris Conjuctiva Cornea Iris Conjuctiva
1 0 0 12 10 0 12 10 0 12 0 0 0 0 0 0 0 0 0
2 0 0 6 10 0 10 10 0 8 0 0 0 0 0 0 0 0 0
3 0 0 6 5 0 8 5 0 6 0 0 0 0 0 0 0 0 0
4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
7 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Cornea: 3.3 Iris: 0 Conjuctivae: 5.3 Cornea: 0 Iris: 0 Conjuctivae: 0

effect of rinsing R = unrinsed eyes 2.9

rinsed eyes 0

Applicant's summary and conclusion

Interpretation of results:
other: Minimla irritant
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
Under the study conditions, the test substance was considered to be an minimal overall eye irritant to rabbits.
Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance in rabbits according to procedure "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).

The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the six rabbits. The eyelids were then held closed for 1 second. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit.

In the present experiments the irritation index was established as 1.7 for the cornea, 0 for the iris and 2.6 for the conjunctivae. The test material caused therefore a minimal overall eye irritation to rabbits.