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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Remarks:
in vitro
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 methods predicting corrosivity. In combination with the in vitro irritation 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 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
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 human skin model, comprising at least a reconstructed epidermis with a functional stratum corneum.
Strain:
other: Skin model EST-1000
Details on test animals and environmental conditions:
Not applicable

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 minutes
Value:
0.5
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1 hour
Value:
< 0.1
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

The test item, Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts, was applied to the skin surface. Dulbecco’s phosphate buffered saline (D-PBS) was used as the negative control. 8 N KOH was used as the positive reference item. Two exposure times of 3 minutes or 1 hour were employed.

In comparison to the negative controls, the mean viability of cells exposed to the test item was 78.8% after a 3-minute exposure period and 74.9% after a 1-hour exposure. The OD540 values were well above the cut-off percentage cell viability values distinguishing corrosive from non-corrosive test items of <50% or <15% for a 3-minute or 1-hour treatment, respectively. Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin.

The mean viability of cells treated with the positive reference item 8 N KOH were 0.5% (3-minute incubation) and <0.1% (1-hour incubation) of the negative controls and were below the cut-off values. Hence, 8 N KOH caused pronounced corrosion in this skin model and is predicted to be corrosive to human skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the present test conditions the test itemapplied at two exposure times of 3 minutes or 1 hour was predicted non-corrosive to skin in an experiment employing 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 corrosion by test item to human skin, in an experiment with an artificial three-dimensional model of human skin. The EST-1000 model was employed. The test item was applied to the skin surface. Dulbecco’s phosphate buffered saline (D-PBS)was used as the negative control.8 N KOHwas used as the positive reference item.Two exposure times of 3 minutes or 1 hour were employed.

In comparison to the negative controls, the mean viability of cells exposed to the test item was 78.8% after a 3-minute exposure period and 74.9% after a 1-hour exposure.The OD540values were well above the cut-off percentage cell viability values distinguishing corrosive from non-corrosive test items of <50% or<15% for a 3-minute or 1-hour treatment, respectively.Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin.The mean viability of cells treated with thepositive reference item 8 N KOH was 0.5% (3-minute incubation) and <0.1% (1-hour incubation) of the negative controls and below the cut-off values. Hence, 8 N KOH caused pronounced corrosion in this skin model and is predicted to be corrosive to human skin.

Under the present test conditions the test item containing >95% active ingredient, tested at two exposure times of 3 minutes or 1 hour, was non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.