Butanedioic acid, sulfo-, C-C16-18-alkyl esters, disodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to GLP and valid testing guidance. In combination with the in vitro corrosion test, it is considered relevant, adequate and reliable for classification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts

EC Number:

290-836-4

EC Name:

Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts

Cas Number:

90268-36-3

Molecular formula:

C12 - C18 C16 H30 O7 S 2Na - C22 H42 O7 S 2Na

IUPAC Name:

Butanedioic acid, sulfo-, 1-C12-18 (even numbered)-alkyl esters, disodium salts

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts
- Physical state: White powder
- Analytical purity: >95%
- Composition and impurities of test material, percentage of components: See confidential details
- Purity test date: 2012-07-03
- Lot/batch No.: 008249628
- Expiration date of the lot/batch: 2014-03-20
- Stability under test conditions: stable
- Storage condition of test material: At +10° to +25°C
- Other: Manufacturer/supplier: BASF Personal Care and Nutrition GmbH

Test animals

Species:

other: three-dimensional reconstructed human epidermis model

Strain:

other: EST1000

Details on test animals or test system and environmental conditions:

Not applicable

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: cell viability test group

Value:

98.3

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 viabilitypositive control group

Value:

1.2

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 viabilitywas measured by determining theoptical density (OD) at a wavelength of 540 nm. An exposure time of 20 minutes was employed.

The test item, Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts,was applied to the 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 98.3% 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 1.2% 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:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the present test conditions the test item, applied 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 the test item 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 a wavelength of 540 nm. An exposure time of 20 minutes was employed. The test item was applied to the 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 98.3% 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 1.2% of the negative controls and below the 50% cut-off value. Hence,5% SDS is predicted to cause pronounced skin irritation.