Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2013
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

Constituent 1
Chemical structure
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
Constituent 2
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

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.