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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited but acceptable documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Method: other: in vivo eye irritation study (100 mg was placed into the conjunctival sac of 6 rabbits; 7-d observation period)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Bantex

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.8
Max. score:
110
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: slight erythema and slight to copious discharge
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
7.3
Max. score:
110
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: slight erythema, moderate to copious dischage
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
5.3
Max. score:
110
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: slight erythema, slight to moderate discharge

Any other information on results incl. tables

Immediate: discomfort

10 minutes: slight erythema, slight discharge

1 hour: slight erythema, moderate to copious discharge

24 hours: slight erythema, slight to moderate discharge

48 hours: all scored zero

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

The eye irritating potential of the test substance ZMBT was evaluated in an eye irritation study with six New Zealand albino rabbits. The finely ground test substance (100 mg) was placed into eyes of six rabbits. A 7-day observation period followed the application of the test substance. Eye response were scored in accordance with the Federal Hazardous substances Act (F.H.S.A.), 21 CFR, § 191.12 (1964).