Registration Dossier

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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: No separate control animals were included. Only one eye was treated per animal and the other eye remaining untreated, serves as reference control.
Amount / concentration applied:
49mg (a volume of approximately 0.1ml)
Duration of treatment / exposure:
about one second
Observation period (in vivo):
Observations were made:
- mortality: twice daily
- toxicity: at least once daily
- body weight: day of treatment prior to instillation
- irritation: 1, 24, 48 and 72h after instillation.
Number of animals or in vitro replicates:
3 of one sex

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean 24 - 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Irritation of the conjunctivae was seen as redness, chemosis and discharge.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean 24 - 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Treatment with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean 24 - 72 hours
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU