Dipotassium dodecenylsuccinate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dipotassium dodecenylsuccinate

EC Number:

260-612-0

EC Name:

Dipotassium dodecenylsuccinate

Cas Number:

57195-28-5

Molecular formula:

C16H26K2O4*H2O

IUPAC Name:

Dipotassium dodecenylsuccinate

Test material form:

liquid

Details on test material:

30 % aqueous solution
pure substance is solid (bulk/powder), but is only used as aqueous solution and blends it into mixture
Substance dissolves in water at 40wt%, then becomes gel and becomes solid, if mixed 61wt% with water

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkinTM –Small model (SM), reconstructed epidermis units (area: 0.38 cm2)
- Tissue batch number(s):
- Production date:
- Shipping date:
- Delivery date:
- Date of initiation of testing:

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After treatment, each treated epidermis unit was rinsed with 25ml sterile 0.01M PBS pH 7.4. After rinsing, the unit was placed on absorbent paper to remove the PBS solution from epidermal surface. Cotton-bud was used to sweep the surface carefully when necessary.

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/ml
- Incubation time: 3 hours
- Wavelength: 570nm

NUMBER OF REPLICATE TISSUES: 2

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability is < 35% after 3 min exposure OR ≥ 35% after 3 min exposure AND <35% after 60 min exposure OR ≥ 35% after 60 min exposure AND <35% after 240 min exposure.
- The test substance is considered to be non-corrosive to skin if the viability ≥ 35% after 240 min exposure.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

50 µl were dosed

Duration of treatment / exposure:

240 min

Number of replicates:

2

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1: 3 min exposure

Value:

106.7

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

2: 60 min exposure

Value:

38.7

Negative controls validity:

valid

Positive controls validity:

valid

Results 3

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3: 240 min exposure

Value:

11.2

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Based on the above results,

1. The OD mean value of the 2 epidermis units of the negative control substance (0.9% NaCl saline) are 1.009 at 3 min exposure, 0.920 at 60 min exposure and 0.883 at 240 min exposure, respectively; the OD mean values are≥0.6 and≤1.5 in each exposure time, i.e., meets the requirement of acceptance;

2. The mean viability of the 2 epidermis units of the positive control substance (glacial acetic acid) is 6.4% at 240 min exposure; the mean viability is≤20%, i.e., meets the requirement of acceptance;

3. In the range of 20-100% viability and for OD value≥0.3, the difference of viability between the 2 epidermis unit replicates are less than 30%, i.e., meets the requirement of acceptance;

4. The mean viability of the test item is 106.7% at 3 min exposure, 38.7% at 60 min exposure and 11.2% at 240 min exposure, respectively. Therefore, based on the prediction model for the EpiSkin^TMskin corrosion test method and associated with UN GHS classification system, the test item is considered as Corrosive, a combination of optional Sub-categories 1B-and-1C.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

Based on the prediction model for the EpiSkinTM skin corrosion test method and associated with CLP classification system, the test item - Dipotassium dodecenylsuccinate (aq. solution), Lot No: 170727 is considered as Corrosive, a combination of optional Sub-categories 1B-and-1C.