Registration Dossier
Registration Dossier
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EC number: 604-437-3 | CAS number: 144690-92-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 7 November 2012 to 12 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (5-methyl-2-oxo-2H-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-({2'-[1-(triphenylmethyl)-1H-1,2,3,4-tetrazol-5-yl]-[1,1'-biphenyl]-4-yl}methyl)-1H-imidazole-5-carboxylate
- EC Number:
- 604-437-3
- Cas Number:
- 144690-92-6
- Molecular formula:
- C48H44N6O6
- IUPAC Name:
- (5-methyl-2-oxo-2H-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-({2'-[1-(triphenylmethyl)-1H-1,2,3,4-tetrazol-5-yl]-[1,1'-biphenyl]-4-yl}methyl)-1H-imidazole-5-carboxylate
- Reference substance name:
- Tritil-olmesartan-medoxomil
- IUPAC Name:
- Tritil-olmesartan-medoxomil
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test article identification: Tritril-olmesartan-medoxomyl
Test article description: Powder
Test article lot/batch: 2U003
Cartificate of analysis: Dated 11 September 2012
Storage confitions bulk material: room temperature
Purity: 99.7 %
Retest or expiry date: April 2013
Constituent 1
Constituent 2
Test animals
- Species:
- human
- Strain:
- other: Reconstructed human Epidermis
Test system
- Duration of treatment / exposure:
- 15 minutes
The post-treatment incubation is approximately 42h, 37 +/- 2°C; 5 +/- 1% CO2. - Observation period:
- The viability is assessed after approximately a 3-hour incubation with MTT solution in a 12-well plate.
- Details on study design:
- Positive control (PC): Sodium Dodecyl Sulphate (SDS), 5%
Negative control (NC): Phosphate buffered saline (D-PBS)
Results and discussion
In vitro
Results
- Remarks on result:
- other:
- Remarks:
- Remarks: Mean viability and mean OD of Reconstructed human Epidermis.. (migrated information)
In vivo
- Irritant / corrosive response data:
- With Tritil-olmesartan-medoxomil, the mean viability was higher than 50% which indicated a non-irritant potential.
Any other information on results incl. tables
The experiment was validated as all the acceptance criteria were fulfilled.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these experimental conditions, the mean viability was higher than 50% which indicated a non-irritant potential of the test article Tritil-olmesartan-medoxomil.
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