Registration Dossier
Registration Dossier
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EC number: 451-000-6 | CAS number: -
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF, Japanese Test Guidelines, November 2000, including the most recent partial revisions
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- benzene, 1,4-bis[2-[3,5-dimethoxy-4-(1- methylpropoxy)phenyl]ethenyl]-
- Cas Number:
- 586410-55-1
- Molecular formula:
- C34 H42 O6
- IUPAC Name:
- benzene, 1,4-bis[2-[3,5-dimethoxy-4-(1- methylpropoxy)phenyl]ethenyl]-
- Details on test material:
- Read-across from CASRN586410-55-1 to the substance defined in section 1 allowed by belgian authority.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- 3 males (at least 6 weeks old and body weights at least 1.0kg)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- other: Milli-U water.
- Controls:
- not required
- Amount / concentration applied:
- 500 mg moistened with 1ml of the vehicle
- Duration of treatment / exposure:
- 4 h
- Observation period:
- mortality/viability: twice daily
toxicity: at least once daily
body weight: day of treatment (prior to application) and at termination
irritation: +/- 1, 24, 48 and 72 hours after the removal of the dressings and test substance - Number of animals:
- 3
- Details on study design:
- No control animals required as adjacent areas of the untreated skin of each animal served as controls.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- individual score
- Time point:
- other: at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- individual score
- Time point:
- other: at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- individual score
- Time point:
- other: at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- individual score
- Time point:
- other: at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- individual score
- Time point:
- other: at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- individual score
- Time point:
- other: at 1, 24, 48 and 72 h
- Score:
- 0
- Other effects:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: OECD (1998) and EC (67/548/EEC)
- Conclusions:
- not classified
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