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
Study period:
November 18, 1976 - December 29, 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
The method employed was similar to that described in Section 1500.42. - Hazardous Substances and Articles , Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
Six healthy young adult albino rabbits were used in this study. 0.1 ml of the experimental material was instilled in to the right eyes of the test animals while the other eyes remained untreated to serve as controls . The test material was not washed from the eyes.
The treated eyes were examined a t 1, 24, 48 & 72 hrs. as well as 5 & 7 days following instillation of the test material into the eyes. Interpretation of the results was made in accordance with the grading system outlined in the "Illustrated Guide for Grading Eye lrritation By Hazardous Substances".
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
DABCO TMR-2

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Remarks:
Albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
The test material was not washed from the eyes.
Observation period (in vivo):
1, 24, 48 & 72 hrs. as well as 5 & 7 days following instillation
Number of animals or in vitro replicates:
Six rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: all animals
Time point:
other: all time points 1, 24, 48 & 72 hrs, 5 & 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
other: all animals
Time point:
other: all time points 1, 24, 48 & 72 hrs, 5 & 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 5 days
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
The tested substance is a mild ocular irritant with effects fully reversible after 7 days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The tested substance is a mild ocular irritant with effects fully reversible after 7 days.