Registration Dossier
Registration Dossier
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EC number: 800-172-4 | CAS number: 398141-87-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 March 1975 - 21 April 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study with limited details.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US 16 CFR 1500.42 Federal Hazardous Substances Act
- Deviations:
- not specified
- Principles of method if other than guideline:
- Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
- GLP compliance:
- no
- Remarks:
- Study predates GLP regulations.
Test material
- Reference substance name:
- Thiophene, tetrahydro-, 1,1-dioxide, 3-(C9-11-isoalkyloxy) derivs., C10-rich
- EC Number:
- 800-172-4
- Cas Number:
- 398141-87-2
- Molecular formula:
- Complex UVCB substance
- IUPAC Name:
- Thiophene, tetrahydro-, 1,1-dioxide, 3-(C9-11-isoalkyloxy) derivs., C10-rich
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
- Observation period (in vivo):
- 1, 2, and 3 days after administration (24, 48, and 72 hours)
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- A dose of 0.1 ml of the test material was instilled in the right eyes of six healthy young adult albino rabbits. The untreated left eyes served as controls. The treated eyes were examined at 1, 2, and 3 days following instillation of the test material in accordance with the Draize method.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: Conjunctival redness and chemosis were not differentiated but were just grouped as conjunctival scores. The maximum score for chemosis is 4.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for eye irritation.
- Executive summary:
The eye irritation potential of the test substance was evaluated in rabbits. A dose of 0.1 ml of the test material was instilled in the right eyes of six healthy young adult albino rabbits. The untreated left eyes served as controls. The treated eyes were examined at 1, 2, 3, 4, and 7 days following instillation of the test material in accordance with the Draize method. No corneal opacity, iritis, conjunctival irritation was observed in any animal at any observation period. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for eye irritation.
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