Registration Dossier
Registration Dossier
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EC number: 443-460-1 | CAS number: 188199-50-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 443-460-1
- EC Name:
- -
- Cas Number:
- 188199-50-0
- Molecular formula:
- C16H28O2
- IUPAC Name:
- (1R,2S,2'S,4R)-1,7,7-Trimethylbicyclo (2.2.1)heptane-2-spiro-4'-(2'-isopropyl-1',3'-dioxane)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24, 48, 72 h. 7, 10 and 14 days
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), Belambre is considered to be "R38-irritating to skin"
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