Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
2001
Report Date:
2001

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as the control.
Amount / concentration applied:
undiluted: Amount applied: 0.1 ml
Duration of treatment / exposure:
No data
Observation period (in vivo):
Eyes were examined at 1, 24, 48 and 72 hours after treatement. After recording the observations at 24 hours, the eyes of all rabbits were examined with the aid of fluorescein to further characterise corneal opacity.
Number of animals or in vitro replicates:
4
Details on study design:
Comment: not rinsed

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
Draize scoring system
Basis:
mean
Time point:
other: 1 hr
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 48 hr
Irritant / corrosive response data:
Corneal opacity : No corneal opacity was observed in any of the treated eyes at any of the observation periods. Iris : the iris response was normal in all treated eyes.Conjunctivae : slight conjunctival redness and chemosis were observed in all three treated eyes at the 1-hour observation point (grading score of 1). Conjunctival redness and chemosis persisted in 2 of 3 animals for 24 hours and was resolved by the 48 hour time point. In the third animal, all signs of irritation were resolved by the 24-hour observation point.
Other effects:
All of the animals exhibited an increase of body weight during the course of the study.

Any other information on results incl. tables

No overt sign of toxicity other than the ocular effects was evident during the course of the study in any of the animals.

No fluorescein staining was observed in any of the treated eyes at all observation points.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated informationCriteria used for interpretation of results: other: Used for data submission
Conclusions:
Classification: not irritating
Executive summary:

Used for data submission