Registration Dossier
Registration Dossier
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EC number: 700-095-5 | CAS number: 203448-76-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according OECD / EU guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(4-methylpentan-2-yl)aniline
- EC Number:
- 700-095-5
- Cas Number:
- 203448-76-4
- Molecular formula:
- C12 H19 N
- IUPAC Name:
- 2-(4-methylpentan-2-yl)aniline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Crl:KBL(NZW)BR
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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