Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: Non GLP-Study, but well documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified

Results and discussion

Any other information on results incl. tables

RESULTS AND DISCUSSION

The rabbit with unwashed eyes pawed the treated eye after instillation of the test substance. The

test substance produced moderate conjunctival redness and minimal discharge in the treated

unwashed rabbit eye. Minimal discharge was observed in the eye washed after treatment.

Fluorescein stain examinations were negative for corneal injury in the treated eyes of both

rabbits. The treated washed eye was normal by 1 day, and the treated unwashed eye was normal

by 2 days after instillation. No clinical signs were observed, and no body weight loss occurred

during the study.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test substance was a moderate eye irritant. If these test scores are to be used for EEC/OECD classification, according to the guide to the labeling of dangerous substances published in the Official Journal of European Communities
(67/548/EEC), the test substance probably should not be classified as irritant unless additional testing
proves otherwise.