Registration Dossier

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:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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.