Registration Dossier
Registration Dossier
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EC number: 406-030-4 | CAS number: 105812-81-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- other: extracted from ECHA database
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (-)-trans-4-(4'-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine
- EC Number:
- 406-030-4
- EC Name:
- (-)-trans-4-(4'-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine
- Cas Number:
- 105812-81-5
- Molecular formula:
- C13H18FNO
- IUPAC Name:
- (-)-trans-4-(4'-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- other: distilled water (0.5 ml)
- Amount / concentration applied:
- 5 mg
- Duration of treatment / exposure:
- 4 h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- Reversibility of any observed effect: changes not fully reversible within 14 days
- Other effects:
- Desquamation was noted in one animal at the 48 and 72 hours observations.
Haemorrhage of the dermal capillaries was observed in one treated animal (no.2). All treated skins had returned to normal by day 7, apart from desquamation or hyperkeratinisation.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
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