Alkenes, C11-14, hydroformylation products, distn. residues, reaction products with maleic anhydride and sodium bisulfite, sodium salts

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: According to: OECD Guideline for the Testing of Chemicals 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (Original Guideline adopted July 22, 2010)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline for the Testing of Chemicals 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (Original Guideline adopted July 22, 2010)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C11-14, hydroformylation products, distn. residues, reaction products with maleic anhydride and sodium bisulfite, sodium salts

EC Number:

938-654-2

Molecular formula:

not applicable

IUPAC Name:

Alkenes, C11-14, hydroformylation products, distn. residues, reaction products with maleic anhydride and sodium bisulfite, sodium salts

Details on test material:

Identity: Alkenes, hydroformylated sulfosuccinates, sodium salt
Batch-No.: Rif. 7018
Purity: 100%; active ingredient: 78%; dose calculation will not be adjusted to purity
Appearance: Solid (waxy), yellowish
Stability in Solvent: Not relevant
Storage: In the freezer at ≤ - 18°C
Expiration Date: May 31, 2013

Test system

Amount / concentration applied:

Each approximately 10 mg of the neat test item were applied to three EPISKIN (Skinethic) tissues. Addtionally, the tissues were wetted with 15 µL of deionised water.

Duration of treatment / exposure:

The skin equivalents were exposed to the test item for 15 minutes. After completion of the treatment the test item was rinsed off and the skin equivalents were incuated for further 42 hours.

Details on study design:

Each approximately 10 mg of the neat test item and 10 µl of the negative control (deionised water) and the positive control (5% SLS) were applied to each three EPISKIN (Skinethic) tissues. Additionally, the test item treated skin equivalents were wetted with 15 µL of deionised water. The test item as well as the controls were rinsed off after 15 minutes treatment. After further 42 hours incubation the tissues were treated with the MTT solution for 3 hours following approximately 72 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at a wavelength of 570 nm.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

93

In vivo

Irritant / corrosive response data:

After treatment with the test item Alkenes hydroformylated, sulfosuccinates, sodium salt the mean relative absorbance value was reduced to 93.0%. This value is well above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.

Any other information on results incl. tables

Results after treatment with Alkenes hydroformylated, sulfosuccinates, sodium salt and controls

 

Dose group	Treatment Interval	Absorbance 570 nm Tissue 1*	Absorbance 570 nm Tissue 2*	Absorbance 570 nm Tissue 3*	Mean Absorbance of 3 Tissues	Relative Absorbance [%] Tissue 1, 2 + 3**	Standard Deviation [%]	Rel. Absorbance [% of Negative Control]***
Negative Control	15 min	1.106	0.909	1.011	1.009	109.6 90.1 100.2	9.8	100.0
Positive Control	15 min	0.242	0.297	0.193	0.244	24.0 29.5 19.1	5.2	24.2
Test Item	15 min	0.922	0.946	0.947	0.938	91.4 93.8 93.9	1.4	93.0

*       Mean of two replicate wells after blank correction

**      relative absorbance per tissue [rounded values]:
***    relative absorbance per treatment group [rounded values]:

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

The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 93.0% (threshold for irritancy:≤50%), consequently the test item was notirritant to skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Alkenes hydroformylated, sulfosuccinates, sodium salt is not irritant to skin.

Executive summary:

This in vitro study was performed to assess the irritation potential of Alkenes hydroformylated, sulfosuccinates, sodium salt by means of the Human Skin Model Test.

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

Prior to the test the test item was thawed at 37 ± 1 °C and homogenised. Since the test item was very pasty afterwards, it was applied with a measuring spoon. Approximately 10 mg of the test item were applied to each tissue, wetted with 15 µL of deionised water, and spread.

The test item and the positive and negative controls were washed off the skin tissuesafter 15 minutes treatment. After further incubation for about 42 hours the tissues were treated with the MTT solution for 3 hours following approximately 72 hours extraction of the colorant from the cells. The amount of extracted colorant was determinedphotometrically at 570 nm.

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 of greater or equal than 0.6 till less or equval 1.5 for the15 minutes treatment interval thus showing the quality of the tissues.

Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 24.2% 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 10% (threshold of the "OECD TG 439 Guideline for the Testing of Chemicals 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method”: 18%), thus ensuring the validity of the study.

After treatment with the test item Alkenes hydroformylated, sulfosuccinates, sodium salt the mean relative absorbance value was reduced to 93.0%. This value is well above the threshold for irritancy of≤50%. Therefore, the test item is not considered to possess an irritant potential.