Registration Dossier
Registration Dossier
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EC number: 207-317-5 | CAS number: 461-82-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June to October 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- first version adopted 1981
- Deviations:
- yes
- Remarks:
- Exposure period was 8 to 24 hours; dressing type used not specified; testing performed on the ear
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-(trifluoromethoxy)aniline
- EC Number:
- 207-317-5
- EC Name:
- 4-(trifluoromethoxy)aniline
- Cas Number:
- 461-82-5
- Molecular formula:
- C7H6F3NO
- IUPAC Name:
- 4-(trifluoromethoxy)aniline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, England
- Weight at study initiation: 3-4 kg
- Housing: Individually housed in standard rabbit cages
- Diet: rabbit food provided ad libitum
- Water: provided ad libitum
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: ear, fur removed
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated skin of each animal served for control
- Amount / concentration applied:
- 0.5 g applied to small cellulose patches
- Duration of treatment / exposure:
- 8 to 24 hours
- Observation period:
- 7 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: ear
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: no
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- other: data not provided
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- other: data not provided
- Irritant / corrosive response data:
- No skin changes were observed after the dressings were removed or during the post-treatment observation period. Thus, the test item was not a skin irritant under the test conditions used.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
- Conclusions:
- In a study conducted in principle similar to OECD TG 404, the test item was not found to be a skin irritant.
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