Registration Dossier
Registration Dossier
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EC number: 269-927-8 | CAS number: 68391-08-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-06-26 to 1984-06-29
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Perfluoralkylethanol
- IUPAC Name:
- 2-Perfluoralkylethanol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 min to 60 min, 24 h, 48 h and 72h after removing of patch
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2,5 x 2,5 cm plaster
- Type of wrap if used: semiocclusive wrap
REMOVAL OF TEST SUBSTANCE
- the test substance was carefully removed
- after exposure period of 4 h
SCORING SYSTEM: DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Irritation parameter:
- overall irritation score
- Time point:
- other: 24, 48 and 72h
- Score:
- 0.11
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test the test substance is considered to be "not irritant" to rabbit skin.
- Executive summary:
The acute dermal irritating potential of the test item was investigated in three New Zealand White rabbits. 0.5 mL of the undiluted test substance was applied to the shaved skin and covered semi occlusive for a 4 hour exposure. Observation periods were approximately 1h, 24 h, 48 h and 72h after removing of the patch. The overall irritation score was determined to be 0.11. Based on the results of the test the test substance has not to be classified.
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