Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study, GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
5-chloro-o-toluidine
EC Number:
202-452-6
EC Name:
5-chloro-o-toluidine
Cas Number:
95-79-4
Molecular formula:
C7H8ClN
IUPAC Name:
5-chloro-2-methylaniline

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan

Test system

Vehicle:
other: Sesam oil and no vehicle
Amount / concentration applied:
0,1 ml
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6

Results and discussion

Any other information on results incl. tables

After conjunctival application of 0.1 ml 5 - chloro-o-toluidin slight redding and swelling was observed. The cornea showed clouding up to seven days. All irritations were reversible within 14 days.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA