Registration Dossier
Registration Dossier
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EC number: 266-719-9 | CAS number: 67564-91-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Acute dermal irritation / corrosion in rabbits
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.2010 - 12.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Umweltministerium Baden-Württemberg
Test material
- Reference substance name:
- cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine
- EC Number:
- 266-719-9
- EC Name:
- cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine
- Cas Number:
- 67564-91-4
- Molecular formula:
- C20H33NO
- IUPAC Name:
- (2R,6S)-4-[3-(4-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL(NZW)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: Ca. 5 months
- Weight at study initiation: 3.93 - 4.23 kg
- Housing: single housing
- Diet: STANRAB (P) SQC, not specified if ad libitum or not
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 30 - 70 %
- Air changes: not specified
- Photoperiod: 12 h / 12 h (6.00 a.m. - 6.00 p.m. / 6.00 p.m. - 6.00 a.m.)
IN-LIFE DATES:
- From: 2010-10-26
- To: 2010-11-30
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL of the undiluted liquid test item
NEGATIVE CONTROL : untreated skin sites of the same animal
- Amount(s) applied (volume or weight): not applicable
- Concentration (if solution): not applicable
POSITIVE CONTROL : not applicable - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Flank
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: semi occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: The test item was removed with Lutrol E 400 and Lutrol / water (1:1)
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
Immediately after removal of the patch, approx. 1, 24, 48 and 72 hours after removal and then in weekly intervals up to day 14.
SCORING SYSTEM:
- Method of calculation: For evaluation the mean values of erythema and edema for readings at 24, 48 and 72 hours were calculated. Additionally, reversibility of the observed findings was evaluated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: within 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- - Erythema beyond the application area was observed in all animals during the course of the study
- Edema beyond the application area was noted in one animal immediatly after removal of the patch and at the 1 hour reading
- Scaling occured in all animals from day 7 to the study termination
- The test item shows a skin irritating potential under the test conditions chosen
Applicant's summary and conclusion
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