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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
Study period:
June 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to: OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, 11 December 2009, Vers. 4

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, 11 December 2009, Vers. 4
GLP compliance:
yes (incl. QA statement)

Test material

In vitro test system

Test system:
human skin model
Remarks:
EpiSkin
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
skin obtained from plastic surgery from multiple donors
Source strain:
not specified
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
10 µL
Duration of treatment / exposure:
15 min
Duration of post-treatment incubation (if applicable):
42 h
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: Mean rel. MTT absorbance
Run / experiment:
15 min treatment
Value:
104.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Remarks:
100.0
Positive controls validity:
valid
Remarks:
9.5
Other effects / acceptance of results:
After treatment with the test item SAT 090073 the mean relative absorbance value did not decrease (104.3%) compared to the negative control. Therefore, the test item is not considered to possess an irritant potential.

Any other information on results incl. tables

Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.

Table 1: Results after treatment with SAT 090073

 

Dose group

Treat-ment 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

0.857

0.936

0.896

0.896

0.039

100.0

4.4

Positive Control

15 min

0.061

0.087

0.107

0.085

0.023

9.5

2.6

SAT 090073

15 min

0.988

0.902

0.916

0.935

0.046

104.3

5.1

 *       Mean of two replicate wells after blank correction
**
      relative absorbance [rounded values]:

After treatment with the test item SAT 090073 the mean relative absorbance value did not decreas (104.3%) 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.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item SAT 090073 is not irritant to skin.
Executive summary:

This in vitro study was performed to assess the irritation potential of SAT 090073 by means of the Human Skin Model Test.

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

Approximately 10 µL of the neat test item were applied to each tissue and spread to match the tissue size.

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

After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD 0.6 and ≤ 1.5 for the15 minutes treatment interval thus showing the quality of the tissues and the specific batch of the tissue model.

Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 9.5% 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.

After treatment with the test item SAT 090073 the mean relative absorbance value did not decrease (104.3%) compared to the negative control. Therefore, the test item is not considered to possess an irritant potential.

According to the current prediction model no classification and labeling of SAT 090073 is necessary with respect to skin irritation under EU and UN classification.