3,5-bis(2,4-dimethylcyclohex-3-en-1-yl)polyheterocycle

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:

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

Test material information

Constituent 1

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 Sa 57 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 Sa 57

 

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
Sa 57	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 Sa 57 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 Sa 57 is not irritant to skin.

Executive summary:

This in vitro study was performed to assess the irritation potential of Sa 57 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 Sa 57 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 Sa 57 is necessary with respect to skin irritation under EU and UN classification.