[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 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 corrosivity, which is considered adequate in combination with the in vitro irritation testing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18 unsaturated alkyl) tetrasodium salts

EC Number:

939-704-6

Cas Number:

867040-07-1

Molecular formula:

Molecular formula cannot be given as the substance is a mixture

IUPAC Name:

Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18 unsaturated alkyl) tetrasodium salts

Test material form:

other: liquid

Test animals

Species:

other: a three-dimensional reconstructed human epidermis model

Strain:

other: The EST1000 model was employed.

Details on test animals or test system and environmental conditions:

Not applicable

Test system

Details on study design:

TEST SITE
- Area of exposure: skin model with a surface area of 0.6 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Dulbecco’s phosphate buffered saline (D-PBS)

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

positive control, 1 h

Value:

12.3

Vehicle controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

positive control, 3 min.

Value:

21.6

Vehicle controls validity:

valid

Positive controls validity:

valid

Results 3

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

test substance, 1 h

Value:

74.1

Vehicle controls validity:

valid

Positive controls validity:

valid

Results 4

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

test substance, 3 min.

Value:

92.2

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

The test item, Aspartic acid, N-(3 -carboxy-1 -oxo-sulfopropyl)-N-(C16 -C18(even numbered), C18unsaturated alkyl) tetrasodium salts, was applied to the skin surface. Water for injection was used as the negative control. 8N 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 92.2% after a 3-minute exposure period and 74.1% 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 21.6% (3-minute incubation) and 12.3% (1-hour incubation) of the negative controls and were below the cut-off values and well within the range of historical background data of 3.3 – 47.4% (3-minute incubation) and 0.2 – 4.9% (1-hour incubation) of the negative controls (the last 6 experiments, not audited by the LPT QAU-department). 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:

other: predicted non-corrosive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the present test conditions Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts 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.

Executive summary:

The purpose of this study was to determine cytotoxic properties to skin cells which might lead to corrosion by Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts to human skin, in an experiment with an artificial three-dimensional model of human skin. The EST-1000 model was employed.

The test item, Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts, was applied to the skin surface. Water for injection 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 92.2% after a 3-minute exposure period and 74.1% after a 1-hour exposure.The OD₅₄₀values were well above the cut-off percentage cellviability 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 21.6% (3-minute incubation) and 12.3% (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.