Registration Dossier
Registration Dossier
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EC number: 262-872-0 | CAS number: 61617-00-3
Eye irritation
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:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt
- EC Number:
- 262-872-0
- EC Name:
- 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt
- Cas Number:
- 61617-00-3
- Molecular formula:
- C8H8N2S.1/2Zn
- IUPAC Name:
- Zinc bis[4(or 5)-methyl-2-thioxo-2,3-dihydrobenzimidazol-1-ide]
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Zinc Salt of 2-mercaptotolylimidazole.
Constituent 1
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.
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