Registration Dossier

Toxicological information

Repeated dose toxicity: other routes

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: 4e: Documentation insufficient for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rabbit eyes were treated twice daily for 20 days with 1 mg per eye.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: ocular
Details on exposure:
Test substance was administered undiluted (crystals).
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
twice a day, 5 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
1 mg/eye
No. of animals per sex per dose:
no data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Haematological findings:
no effects observed
Details on results:
No clinicals findings, no haematological or biochemical parameters and no anatomo-pathological abnormalities were found. Furthermore, no deaths occured during the study.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion