Furan-2,5-dicarboxylic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04-04-2011 to 11-04-2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EU method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test), adopted 24 August 2009

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guideline no. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, adopted 22 July 2010

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Furan-2,5-dicarboxylic acid

EC Number:

221-800-8

EC Name:

Furan-2,5-dicarboxylic acid

Cas Number:

3238-40-2

Molecular formula:

C6H4O5

IUPAC Name:

furan-2,5-dicarboxylic acid

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): FDCA
- Substance type: White to off-white powder

Test animals

Species:

human

Details on test animals or test system and environmental conditions:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37.1 - 37.4
- Humidity (%): 93-95

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amounts applied: 10.2 to 10.4 mg, 5 μl Milli-Q water to moisten skin.

NEGATIVE CONTOL:
- Amount applied: 25 µl phosphate buffered saline (PBS)

POSITIVE CONTROL
- Amount applied: 25 µl
- Concentration: 5% sodium dodecyl sulphate in PBS

Duration of treatment / exposure:

15 minutes

Details on study design:

TEST SITE
- EPISKIN Standard ModelTM (EPISKIN-SMTM, 0.38 cm2, Lot no.: 11-EKIN-014).This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded in 12-well plates on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days , which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.

REMOVAL OF TEST SUBSTANCE
- Washing: phosphate buffered saline
- Time after start of exposure: 15 minutes

POST INCUBATION PERIOD
- 42 hours

SCORING SYSTEM:
- Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

106

Vehicle controls validity:

valid

Remarks:

100%

Positive controls validity:

valid

Remarks:

6%

Other effects / acceptance of results:

Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with FDCA compared to the negative control tissues was 106%.

Any other information on results incl. tables

The test substance was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because no colour change was observed it was concluded that the test substance did not interact with MTT.

Mean tissue viability for the test substance was > 50%, therefore the test substance is considered not to be irritant to the skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

According to Regulation (EC) No 1272/2008

Conclusions:

The in vitro skin irritation test was conducted according to OECD 439 test guideline and GLP principles.
It is concluded that this test is valid and that FDCA is not irritating in the in vitro skin irritation test.

Executive summary:

In an in vitro skin irritation test using a human skin model ( EPISKIN Standard Model) performed according to OECD 439 guideline and GLP principles, the influence of the test substance on the viability of human skin was tested. The test substance was applied directly to 0.38 cm² cultured skin (10.2 to 10.4 mg, in presence of 5 μl Milli-Q water). After 15 minutes, the substance was removed and cells were cultured for 42 hours. The viability of the cells was tested by reduction of MTT. Survival of unexposed skin was set at 100%, the positive control had a mean cell viability of 6% whereas the test substance showed cell viability of 106%. Since the mean relative tissue viability after exposure to the test substance was above 50%, it can be concluded that FDCA is not irritating in the current in vitro skin irritation test.