Butanedioic acid, sulfo-, 4-[2-[(2-hydroxyethyl)amino]ethyl] ester, N-C18-unsatd. acyl derivs., disodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2012-2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted according to GLP and valid methods and is considered relevant and reliable for classification. It is an in vitro study predicting skin irritation, which is considered adequate in combination with the in vitro corrosivity testing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of C18 unsatd. fatty acid diethanolamide and maleic anhydride, sulphonated, sodium salt

IUPAC Name:

Reaction product of C18 unsatd. fatty acid diethanolamide and maleic anhydride, sulphonated, sodium salt

Test material form:

other: lyophilisate

Details on test material:

- Name of test material (as cited in study report): butanedioic acid, sulfo-, 4-(2-((2-hydroxyethyl)amino)ethyl)ester, N-C18-unsatd. acyl derivs., disodium salts; Sulfosuccinate of Fatty Acid Diethanolamide, sodium salt ; Sulfosuccinate of Fatty Acid Diethanolamide 30% AS
- Physical state: Lyophilisate, light orange solid
- Analytical purity: 29.9% active ingredient
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: 2012-03-19
- Lot/batch No.: FL21-22-RS
- Expiration date of the lot/batch: March 2014
- Stability under test conditions: Stable
- Storage condition of test material: At +10°C to +25°C (0-40°C acceptable)
- Other: Manufacturer/supplier: TFL France S.A.S. , 4, rue de l’industrie, 68333 Huningue Cedex , France

Test animals

Species:

other: a three-dimensional human skin model

Strain:

other: The Skin model EST-1000 was used.

Details on test animals or test system and environmental conditions:

Not applicable

Test system

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 mg of the supplied test item were dissolved in 1 mL water for injection. 30 µL Butanedioic acid, sulfo-, 4-(2-((2-hydroxyethyl)amino)ethyl) ester, N-C18-unsatd. acyl derivs., disodium salts were applied to the skin model with a surface area of 0.6 cm2

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: cell viability test group

Value:

110.5

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 20 minutes, followed by 42h incubation . Remarks: % versus negative control group . (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: cell viability positive control group

Value:

1.3

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 20 minutes, followed by 42h incubation . Remarks: % versus negative control group . (migrated information)

Any other information on results incl. tables

The cell viability was measured by determining the optical density (OD) at a wavelength of 540 nm. An exposure time of 20 minutes was employed.

The test item, Butanedioic acid, sulfo-, 4 -(2 -((2 -hydrocyethyl)amino)ethyl)ester, N-C18 -unsatd. acyl derivs., disodium salts, was applied to the model skin surface. Water for injection was used as the negative control. 5% aqueous sodium dodecyl sulphate (SS) was used as the positive reference item.

The mean viability of the cells exposed to the test item was 110.5% of the mean negative control value. The OD₅₄₀ values were well above the cut-off percentage cell viability value (that distinguishes irritant from non-irritant test items) of >50% for a 20-minute exposure.

The test item was considered to be non-cytotoxic and predicted to be not irritant to skin.

The viability of cells treated with the positive reference item, 5% SDS,was 1.3% of the negative controls and below the 50% cut-off value. Hence, 5% SDS is predicted to cause pronounced skin irritation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the present test conditions Butanedioic acid, sulfo-, 4-(2-((2-hydroxyethyl)amino)ethyl) ester, N-C18-unsatd. acyl derivs., disodium salts, tested at an exposure time of 20 minutes, was non-cytotoxic and not irritant to skin in an experiment with an artificial three-dimensional model of human skin.

Executive summary:

The purpose of this study was to determine cytotoxic properties to skin cells, which might lead to irritation by Butanedioic acid, sulfo-, 4 -(2 -((2 -hydroxyethyl)amino)ethyl) ester, N-C-18 -unsatd. acyl derivs., disodium salts to human skin, in an experiment with an artificial three-dimensional model of human skin.

The EST1000 model was employed.

The cell viability was measured by determining the optical density (OD) at 540 nm. An exposure time of 20 minutes was employed.

The test item, Butanedioic acid, sulfo-, 4 -(2 -((2 -hydroxyethyl)amino)ethyl) ester, N-C18 -unsatd. acyl derivs., disodium salts, was applied to model skin surface. Water for injection was used as the negative control. 5% aqueous sodium dodecyl sulphate (SDS) was used as the positive reference item.

The mean viability of the cells exposed to the test item was 110.5% of the mean negative control value. The OD₅₄₀values were well above the cut-off percentage cell viability value (that distinguishes irritant from non-irritant test items) of >50% for a 20-minute exposure.

The test item was considered to be non-cytotoxic and predicted to be not irritant to skin.

The viability of cells treated with the positive reference item, 5% SDS,was 1.3% of the negative controls and below the 50% cut-off value. Hence, 5% SDS is predicted to cause pronounced skin irritation.