Registration Dossier
Registration Dossier
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EC number: 611-084-9 | CAS number: 54041-17-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- 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 %;
stability in water not tested
(pulverized compound and patch moistened with water)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not irritating to the skin (exposure period: 4 hrs)
- 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. The results of the exposure of the test substance to the skin did not show any signs of irritation in the animals. Toxic signs were not observed. This evidence indicates no hazard potential to the skin and the test substance may therefore be regarded as not irritating to the skin.
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