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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
2012
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:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation / corrosion parameter:
other:
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)
Irritation / corrosion parameter:
other:
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 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.

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.