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Toxicological information

Skin irritation / corrosion

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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:
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 assays and on theI
Integrity Funktion 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. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
SAT 080004
Batch No.: Huc-Sa-9370-190
Purity: > 98% (NMR)

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 µl
Duration of treatment / exposure:
15 min
Observation period:
42 h
Number of animals:
0

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
0.85
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)
Irritation / corrosion parameter:
other:
Value:
104
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)

In vivo

Other effects:
no other effects

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 080004

15 min

0.8821

0.7955

0.8939

0.8571

0.0537

104.0

6.5

* Mean of two replicate wells after blank correction /

** relative absorbance [rounded values]:100 (absorbancetest item)/ (absorbancenegative 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 080004 is not irritant to skin.

This in vitro study was performed to assess the irritation potential of SAT 080004 by means of the Human Skin Model Test.

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

15 μL of the melted test item were applied to each tissue 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 hours 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 % variabilities 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 (see chapter 12).

After treatment with the test item SAT 080004 the mean relative absorbance value did not decrease (104.0%) 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 080004 is not irritant to skin.