Registration Dossier
Registration Dossier
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EC number: 238-851-7 | CAS number: 14782-75-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 December to 12 December 2003.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Aluminium ethyl acetoacetate neopentyl glycol complexes
- Cas Number:
- 569319-64-8
- Molecular formula:
- C11H19AlO5
- IUPAC Name:
- Aluminium ethyl acetoacetate neopentyl glycol complexes
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Free access to food and mains drinking water.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Arachis oil BP
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 0.5 g test material moistened with 0.5 mL arachis oil.
- Duration of treatment / exposure:
- Four hours
- Observation period:
- 72 hours.
- Number of animals:
- 3
- Details on study design:
- 2.5 x 2.5 cotton gauze was secured in position with surgical adhesive tape, and wrapped in an elasticated corset.
Four hours after application the corset and patches were revoved from the animal and residual test material removed by swabbing with cotton wool soaked in distilled water.
Examination of the test site occured 1, 24, 48 and 72 hour after exposure.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- PII = 0.5 (mild irritant)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 4 h semi-occluded exposure to rabbit skin produced no evidence of skin irritation.
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