ethanol water extract from husk of Chenopodium quinoa, Chenopodiaceae

Skin irritation / corrosion

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

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

Test material information

Constituent 1

Reference substance name:

ethanol water extract from husk of Chenopodium quinoa, Chenopodiaceae

IUPAC Name:

ethanol water extract from husk of Chenopodium quinoa, Chenopodiaceae

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 or test system 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.