Registration Dossier
Registration Dossier
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EC number: 941-432-8 | CAS number: 1085706-46-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 28th, 2007 to July 6th, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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
Test material
- Reference substance name:
- tert-butyl (2S)-2-[5-(4'-{2-[(2S)-1-[(tert-butoxy)carbonyl]pyrrolidin-2-yl]-1H-imidazol-5-yl}-[1,1'-biphenyl]-4-yl)-1H-imidazol-2-yl]pyrrolidine-1-carboxylate
- EC Number:
- 941-432-8
- Cas Number:
- 1085706-46-2
- Molecular formula:
- C36 H44 N6 O4
- IUPAC Name:
- tert-butyl (2S)-2-[5-(4'-{2-[(2S)-1-[(tert-butoxy)carbonyl]pyrrolidin-2-yl]-1H-imidazol-5-yl}-[1,1'-biphenyl]-4-yl)-1H-imidazol-2-yl]pyrrolidine-1-carboxylate
- Test material form:
- solid: crystalline
- Details on test material:
- Off white crystalline solid stored at room temperature in the dark.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Accredited supplier
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Certified Rabbit Diet
- Water (e.g. ad libitum): Drinking water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): At least 15 changes
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: June 28th, 2007 To: July 6th, 2007
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: distilled water
- Controls:
- other: contralateral zone of same animal
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- Site: 1, 2, 2
Duration: 3 min., 1 hr., 4 hrs. - Observation period:
- 1hr, 24hr, 48hr and 72hr after removal of the patches
- Number of animals:
- 3
- Details on study design:
- - Duration of observation period following administration: 3 days
- Frequency of observations and weighing: Approximately one hour following the removal of the patches, and 24, 48, and 72 hours later, the test sitewere examined for evidence of primary irritation and scored according to the scale.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 0)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 0)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 0)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 0)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 0)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 0)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritant / corrosive response data:
- The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification
scheme. No corrosive effect were noted. - Other effects:
- There were no signs of dermal effects.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was classified as non-irritant to the skin. The test material did not meet the criteria for classification as irritant or corrosive
according to the EU labelling regulations Commission Directive 2001/59/EC.
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