3,5-di(undecan-2-yl)heteropolycycle

Skin irritation / corrosion

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:

guideline study

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 assays and on the Integrity Funktion Test (Altern Lab Anim. 2007 Dec; 35 (6): 559-601.
- European Commission: Institute for Health and 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

Reference

Name:

Unnamed

Type:

Constituent

In vitro test system

Test system:

human skin model

Remarks:

EpiSkin Standard Model

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:

15 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

Results 1

Irritation / corrosion parameter:

other: Optical density (OD)

Run / experiment:

Time point: 15 min

Value:

0.85

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Remarks:

0.82

Positive controls validity:

valid

Remarks:

0.13

Remarks on result:

other:

Remarks:

Max. score: 1.6

Results 2

Irritation / corrosion parameter:

other: Rel. Absorbance

Run / experiment:

Time point: 15 min.

Value:

104

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Remarks:

100.0

Positive controls validity:

valid

Remarks:

16.2

Other effects / acceptance of results:

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
Sa 190	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 (absorbance_{test item)}/ (absorbance_{negative control})

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

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 Sa 190 is not irritant to skin.

This in vitro study was performed to assess the irritation potential of Sa 190 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 Sa 190 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 Sa 190 is not irritant to skin.