Batilol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vitro skin irritation and in vitro skin corrosion

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 January 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Batilol

EC Number:

208-874-7

EC Name:

Batilol

Cas Number:

544-62-7

Molecular formula:

C21H44O3

IUPAC Name:

3-(octadecyloxy)propane-1,2-diol

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Batch number: 8450
Appearance: White to pale yellow powder
Purity: ~99%
Expiry date: 28 March 2019

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

foreskin from multiple donors

Details on animal used as source of test system:

EPISKINTM(SM) kits are manufactured according to defined quality assurance procedures (certified ISO 9001). All biological components of the epidermis and the kit culture medium have been tested for the presence of viruses, bacteria and mycoplasma. The quality of the final product is assessed by undertaking a MTT cell viability test and a cytotoxicity test with sodium dodecyl sulphate (SDS).

Justification for test system used:

The EPISKIN TM(SM) model has been validated for corrosivity and irritation testing in an international validation study and its use is recommended by the relevant OECD guidelines for corrosivity and irritation testing (OECD No. 431 and OECD No. 439); therefore, it was considered to be suitable for this study.

Vehicle:

unchanged (no vehicle)

Details on test system:

-Pre-incubation :
The Maintenance Medium was pre-warmed to 37°C. The appropriate number of wells in an assay plate was filled with the pre-warmed medium (2 mL per well). The epidermis units were placed with the media below them, in contact with the epidermis into each prepared well and then incubated overnight at 37°C in an incubator with 5% CO2 in a > 95% humidified atmosphere.

Application :
The Assay Medium (corrosivity testing) and the Maintenance Medium (irritation testing) were pre-warmed to 37°C. The appropriate number of wells in an assay plate was filled with the pre-warmed medium (2 mL per well). The epidermis units were placed with the media below them, whereby each epidermis was in contact with the medium in the corresponding well underneath.

Test Item:
In case of the corrosivity testing, 20 mg of test item was applied evenly to each of two test units and each additional control skin units and then 100 µL physiological saline was added to the test item to ensure good contact with the epidermis in each case. In case of the irritation testing, first an appropriate amount (10 µL) distilled water was applied to the epidermal surface in order to improve further contact between test item and epidermis and then 10 mg of test item were applied evenly to each of three test units and each additional control skin units. The test item was spread gently on the skin surface with a pipette tip (or other appropriate tool) without damaging the epidermis. The amount was sufficient to cover the epidermal surface.

Control samples:

yes, concurrent no treatment

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

In case of the corrosivity testing, 20 mg of test item was applied evenly to each of two test units and each additional control skin units and then 100 µL physiological saline was added to the test item to ensure good contact with the epidermis in each case.

In case of the irritation testing, first an appropriate amount (10 µL) distilled water was applied to the epidermal surface in order to improve further contact between test item and epidermis and then 10 mg of test item were applied evenly to each of three test units and each additional control skin units. The test item was spread gently on the skin surface with a pipette tip (or other appropriate tool) without damaging the epidermis. The amount was sufficient to cover the epidermal surface.

Duration of treatment / exposure:

15 minutes incubation time for the irritation test
4 hours incubation time for the corrosivity test

Number of replicates:

two replicates per time point were used for test item (in case of corrosivity part of the test) and three replicates per time point were used for test item (in case of irritation part of the test)

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Corrosivity testing

Value:

ca. 75.4

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

irritation testing

Value:

ca. 83.6

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The in vitro skin irritation and corrosion was assessed accoding to the following guidelines:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

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

Based on these in vitro assays, the test item is considered as non-irritant, UN GHS Classification: No Category.