Registration Dossier
Registration Dossier
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EC number: 611-084-9 | CAS number: 54041-17-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14.- 21. January 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-(4-fluorophenyl)-2-hydroxy-N-(propan-2-yl)acetamide
- EC Number:
- 611-084-9
- Cas Number:
- 54041-17-7
- Molecular formula:
- C11H14FN
- IUPAC Name:
- N-(4-fluorophenyl)-2-hydroxy-N-(propan-2-yl)acetamide
Constituent 1
- Specific details on test material used for the study:
- Purity: 99.2 %
Identity/Stability: guaranteed for the study period
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 µl, equivalent to app. 61 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.88
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.22
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Moderately irritating to the eye (exposure period: 24 hrs).
Reactions of the mucous membranes and effects of the cornea and discharge were evident in all animals. The iris was also transiently affected in one animal. These signs proved to be fully reversible within 7 days. Non-ocular lesions and other signs of toxicity were not observed. - Executive summary:
The irritant/corrosive potential of the test substance was studied on the skin and eye of the rabbit in accordance with the OECD Guidelines Nos. 404 and 405 for Testing of Chemicals. Whilst considering OECD Interpretation Guides results were interpreted in conjunction with the nature, intensity, and reversibility of the responses observed.
Exposure of the test substance to the eye caused reactions of the mucous membranes and effects of the cornea and discharge in all animals. The iris was also transiently affected in one animal. These signs proved to be fully reversible within 7 days. Non-ocular lesions and other signs of toxicity were not observed. This evidence indicates that the product may be considered as moderately irritating to the eye.
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