[Name confidential or not available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ECVAM Skin Irritation Validation Study

Principles of method if other than guideline:

This study was conducted using a reconstruced human epidermis model and was in accordance with the following references:
- ECVAM international validation study on in vitro tests for acute skin irritation: Report on the validity of the EPISKIN and EpiDerm assys and on the Skin Integrity Function Test (Altern Lab Anim. 2007 Dec; 35(6): 559-601).
-European Commission: Institute for Health an Consumer Protection and European Centre for the Validation of Alternative Methods (ECVAM): Statement on the validity of in-vitro tests for skin irritation (2007)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test animals

Species:

other: Human Skin Model

Strain:

other: EpiSkin Standard Model

Test system

Type of coverage:

open

Preparation of test site:

other: not applicable

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

15 mg

Duration of treatment / exposure:

15 min

Observation period:

42 h

Number of animals:

0

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: Human Skin Model

Value:

ca. 0.78

Remarks on result:

other:

Remarks:

Basis: other: not applicable. Time point: 15 min. Max. score: 1.6. Reversibility: no data. Remarks: Score = optical density (OD). (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: Human Skin Model

Value:

95.5

Remarks on result:

other:

Remarks:

Basis: other: not applicable. Time point: 15 min. Max. score: 100.0. Reversibility: no data. Remarks: Score = Rel. Absorbance [% of Negative Control]. (migrated information)

Any other information on results incl. tables

Dose group	Treatment Interval	Absorbance 570 nm Tissue 1*	Absorbance 570 nm Tissue 2*	Absorbance 570 nm Tissue 3*	Mean Absorbance of 3 Tissues	Standard Deviation of 3 Tissues	Rel. Absorbance [% of Negative Control]**	Standard Deviation [%]
Negative Control	15 min	0.8909	0.8028	0.7786	0.8241	0.0591	100.0	7.2
Positive Control	15 min	0.1243	0.1320	0.1432	0.1331	0.0095	16.2	1.2
SAT 080003	15 min	0.7287	0.8381	0.7942	0.7870	0.0551	95.5	6.7

* Mean of two replicate wells after blank correction

** relative absorbance [rounded values]:100 (absorbance_{test item)} /  (absorbance_{negative control})

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification: not irritating

Executive summary:

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item SAT 080003 is not irritating to skin.

This in vitro study was performed to assess the irritation potential of SAT 080003 means of the Human Skin Test.

Three tissues of the human skin model EPISKIN were treated with either test item, the negative or positive control for 15 minutes.

Approx. 15 mg of the test item were applied to each tissue, each wetted with 15 µl deionised water and spread to match the tissue size.

15 µl of either the negative control (deionised water) or the positive control (5 % Sodium lauryl sulfate) were applied to each tissue.

The test item as well as the positive and negative controls were washed off the skin tissues after 15 minutes treatment. After further incubation for 42 hour the tissues were treated with the MTT solution for 3 hours following 72 hours 10 minutes extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.

After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD >= 0.6 for the 15 minutes treatment interval thus showing the quality of the tissues.

Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 15 minutes treatment interval thus ensuring the validity of the test system.

The standard deviations between the % variabilties of the test item, the positive and negative controls were below 18 % thus ensuring the validity of the study.

The control values are well in the range of our historical data.

After treatment with the test item SAT 080003 the mean relative absorbance value was slightly decreased (95.5%) compared to the negative control. This value is well above the threshold for irritancy of <= 50%. Therefore, the test item is not considered to possess an irritant potential.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item SAT 080003 is not irritant to skin.