Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 May - 01 June 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted similarly to OECD Guideline 431 with minor deviation: reference to historical data of the positive and negative controls not reported
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
yes
Remarks:
reference to historical data of the positive and negative controls not reported
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material: MEXORYL SCK
- Physical state: Beige powder
- Analytical purity: saponines content (determined by HPLC assay) 55.8 % w/w
- Lot/batch No.: R0069579A 003 P 001
- Shelf life/Retest date: April 2011
- Storage condition of test material: Stored at room temperature and away from light and moisture

Test animals

Species:
other: human skin
Strain:
other: not applicable
Details on test animals and environmental conditions:
Not applicable

Test system

Type of coverage:
other: not applicable
Preparation of test site:
other: not applicable
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg ± 2 mg applied onto the epidermis
- Concentration: Undiluted
Duration of treatment / exposure:
Application and post-treatment incubation time: 15 minutes ± 0.5 minute treatment at room temperature and incubated for 42 h ± 1 h (37 °C, 5 % CO2, 95 % humidity).
Observation period:
- At the end of the 42 h post-treatment incubation period: MTT test was performed and plates were incubated for 3 hours to 3 hours and 15 minutes (37 °C, 5 % CO2, 95 % humidity).
- At the end of the MTT incubation and extraction period: The optical density (O.D.) was measured at 570 nm versus acidified isopropanol (blank).
Number of animals:
Not applicable
Details on study design:
Preparation of the epidermis:
On Day 13, the kits were placed at room temperature protected from light. On Day 14, the color of the agar medium was checked. The epidermis were transferred onto 2 mL of the maintenance medium (at room temperature), and incubated for about 24 h (37 °C, 5 % CO2, 95 % humidity).

Negative and positive controls (reference substances) and raw material were tested in triplicate.
- Negative control: 10 µL of PBS.
- Positive control: 10 µL of 5 % aqueous solution of Sodium Dodecyl Sulfate

Results and discussion

In vivo

Irritant / corrosive response data:
See table 7.3.1/1
Other effects:
None

Any other information on results incl. tables

Table 7.3.1/1: RESULTS SUMMARY: % VIABILITY AND IL 1α CONCENTRATIONS

RAW MATERIAL

%viability

IL-1α (pg/mL)

Run 1

Run 2

Run 3

Mean

SD

Run 1

Run 2

Run 3

Mean

SD

MEXORYL SCK

(undiluted)

99.5

86.6

98.1

94.7

7.1

6.7

13.6

16.6

12.3

5.1

Reconstructed epidermis batch numbers

Run 1: batch No: 10-EKIN-017

Run 2: batch No: 10-EKIN-018

Run 3: batch No: 10-EKIN-019

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, MEXORYL SCK tested undiluted is considered as potentially non-irritant.
Executive summary:

An in vitro skin irritation study was performed similarly to the OECD Guideline 431 and in compliance with GLP, using the Episkin reconstituted skin model. Test item, MEXORYL SCK (10 mg ± 2 mg) was applied onto the epidermis. Application and post-treatment incubation time was 15 minutes ± 0.5 minute treatment at room temperature and 42 h ± 1 h (37 °C, 5 % CO2, 95 % humidity), respectively. Cell viability and IL-1α concentrations were determined. Negative (PBS) and positive (5 % aqueous solution of Sodium Dodecyl Sulfate) controls also included in this test.

RAW MATERIAL

%viability

IL-1α (pg/mL)

Run 1

Run 2

Run 3

Mean

SD

Run 1

Run 2

Run 3

Mean

SD

MEXORYL SCK

(undiluted)

99.5

86.6

98.1

94.7

7.1

6.7

13.6

16.6

12.3

5.1

 

Under the test conditions, MEXORYL SCK tested undiluted is considered as potentially non-irritant.