3-ethoxy-4,6-difluoro-7-(pentyloxy)dibenzo[b,d]furan

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-06-17 - 2016-08-12

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Skinethic skin irritation test -42bis Standard operating procedure (SOP) 2009

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

3-ethoxy-4,6-difluoro-7-(pentyloxy)dibenzo[b,d]furan

EC Number:

942-871-8

Cas Number:

1799569-89-3

Molecular formula:

C19H20F2O3

IUPAC Name:

3-ethoxy-4,6-difluoro-7-(pentyloxy)dibenzo[b,d]furan

Specific details on test material used for the study:

Designation: Art. 201386
Synonym: B-2O-O5
Batch: EF13004186
Purity (HPLC): 100.0%
Appearance: White, solid
Expiry date: April 30, 2018
Storage: Tightly closed, dark at room temperature (15 to 25°C)

The test item was applied neat to the tissues.

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

foreskin from a single donor

Justification for test system used:

standard model

Vehicle:

unchanged (no vehicle)

Remarks:

No vehicle used; Test item was applied neat to the tissues

Details on test system:

CELL CULTURE
- Supplier: Episkin/SkinEthic Laboratories, Lyon, France
- Source: human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation
- Format: 24 well plate
- Batch: 16-RHE-073
- Expiration date: 2016-07-18

Control samples:

yes, concurrent negative control

Amount/concentration applied:

TEST MATERIAL
- Amount applied: 16 mg per tissue

NEGATIVE CONTROL
- Amount applied: 16 µL per tissue (Dulbecco`s Phosphate-Buffered Saline)

POSITIVE CONTROL
- Amount applied: 16 µL per tissue
- Concentration: 5% aqueous solution of sodium dodecyl sulfate in deionised water

Duration of treatment / exposure:

42 min (± 1 minute)

Duration of post-treatment incubation (if applicable):

42 hours (± 1 hour)

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Experiment 1 / Run 1

Value:

97.48

Vehicle controls validity:

not applicable

Remarks:

The Test item was applied neat to the tissues

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Acceptability of the Quality Control Data of the Skin Model with Reference to Historical Batch Data:
The negative control OD values were 1.802, 1.909 and 1.903 and, thus, in the range of ≥0.8 and ≤3.0.

Acceptability of the Positive and Negative Control Data:
After treatment with the negative control (DPBS-buffer) the mean OD was 1.871 (standard deviation: 3.91%) and, thus, higher than the historically established threshold of 1.423.
After treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) the mean viability value was 1.33% (standard deviation: 6.71%) and, thus, lower than the historically established threshold of 3.21%.

Variability of the Data:
The standard deviation between the three tissues replicates treated with the test item was 6.18% and, thus, ≤18%. The standard deviations between the three tissue replicates of the negative control and the positive control were 3.19% and 6.71%, respectively, and, thus, ≤18%.

The study met all acceptance criteria.

Any other information on results incl. tables

Group	Time / [min]	Mean OD	Mean Relative viability [%]
Negative Control	42	1.871	100.00
Positive Control	42	0.025	1.33
Test Material	42	1.824	97.48

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

UN GHS: No Category (according to OECD TG 439)

Conclusions:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. Under the conditions of the present study, the test item Art. 201386 (B-2O-O5) is not considered to possess an irritant potential to skin (UN GHS: No Category).

Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. Under the conditions of the present study, the test item Art. 201386 (B-2O-O5) is not considered to possess an irritant potential to skin (UN GHS: No Category).