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
Study period:
May 1977 - June 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Conducted prior to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
Principles of method if other than guideline:
The methods employed in the testing, evaluation and in the grading of the test material are those described in Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973.
GLP compliance:
no
Remarks:
Conducted prior to GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Zinc Salt of 2-mercaptotolylimidazole.

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye remained untreated.
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
The test material was not washed from the eyes.
Observation period (in vivo):
7 days.
Number of animals or in vitro replicates:
Six.
Details on study design:
0.1 g of the experimental material was instilled into 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 at 1, 24, 48 and 72 hours and 5 and 7 days following instillation of the test material into the eyes.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
0
Irritation parameter:
other: Discharge
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
other: Discharge
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
other: Discharge
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
0
Other effects:
No effects.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
0/6 animals showed evidence of occular irritation in the study, therefore, ZMB2 is not classified as an irritant.