α-d-Glucopyranoside, β-d-fructofuranosyl, mono, di, and tridodecanoate esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 22-25, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: flakes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Mitsubishi-Kagaku Foods Corporation, 6912911B
- Expiration date of the lot/batch: March 27, 2018

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: < 15 degrees C, protected from light
- Stability under test conditions: slightly hydroscopic

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: The test substance was crushed into a powder using a mortar and pestle.

FORM AS APPLIED IN THE TEST (if different from that of starting material): powder

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

The reconstructed human epidermis model closely mimics the biochemical and physiological properties of the human epidermis.

Vehicle:

other:

Remarks:

Dulbecco's phosphate buffered saline

Details on test system:

SKIN DISC PREPARATION
- Procedure used: Tissues were transferred to 6 well plates with 0.9 mL assay medium per well. The surface was dried, and incubated for 1 hr at 37 degrees C in 5% CO2. The tissues were transferred to new wells with 0.9 mL assay medium, and incubated for 18 hrs at 37 degrees C in 5% CO2.
- Quality control for skin discs: Visual inspection
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 degrees C
- Temperature of post-treatment incubation (if applicable): 37 degrees C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 19
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Wavelength: 570 nm
- Filter bandwidth: 30 nm

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg
- Concentration (if solution): 25 mg in 25 uL DPBS

VEHICLE
- Amount(s) applied (volume or weight with unit): 25 uL

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL DPBS


POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution): 5%

Duration of treatment / exposure:

42 hrs

Duration of post-treatment incubation (if applicable):

3 hrs

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

101.3

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

- OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no


ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LMDT is not irritating to skin.

Executive summary:

The skin irritation potential of LMDT was tested in an OECD Guideline 431 study using a human skin model. The test substance was placed on the human skin model for 1 hr, and then incubated for 42 hrs. LMDT did not show any evidence of skin irritation potential. LMDT is not classified as irritating to skin.