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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was not conducted in compliance with GLP, but is well documented and sufficient to cover this endpoint (conduction similar to OECD 405).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 1%
Duration of treatment / exposure:
single treatment, not washed out
Observation period (in vivo):
1, 2, and 8 hours and 1, 2,3 and up to 7 days
Number of animals or in vitro replicates:
6
Details on study design:
All eyes were examined prior to testing by the fluorescin method and only those that were grossly normal were used. 0.1 ml of the diluted test
material was placed into the conjunctival sac of the left eye while the remaining eye served as control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Under described conditions within 24 hours after application all animals showed a slight redness and swelling of conjunctiva and a slight
hypersecretion. 48 hours after application all symptoms were absent.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under described conditions within 24 hours after application all animals showed a slight redness and swelling of conjunctiva and a slight
hypersecretion. 48 hours after application all symptoms were absent. Based on this result the test substance is considered to be not irritating to the eye.