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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:
experimental study
Adequacy of study:
weight of evidence
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:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 and environmental conditions:
Not applicable

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
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)
Irritation / corrosion parameter:
other:
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 viability was 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 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 1.2% 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
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 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 1.2% of the negative controls and below the 50% cut-off value. Hence, 5% SDS is predicted to cause pronounced skin irritation.