5-(methoxymethyl)-2-furaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

other: in vitro (validated and accepted)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 26, 2010 - November 22, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has been performed according OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

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

Test guideline 2

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-(methoxymethyl)furan-2-carbaldehyde

EC Number:

700-511-5

Cas Number:

1917-64-2

Molecular formula:

C7H8O3

IUPAC Name:

5-(methoxymethyl)furan-2-carbaldehyde

Details on test material:

- Name of test material (as cited in study report): MMF
- Description: Clear yellow liquid
- CAS Number: 1917-64-2

Test animals

Species:

human

Details on test animals or test system and environmental conditions:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37.2-37.6
- Humidity (%): 75-89
- CO2 (%): 5.0 ± 0.5

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amounts applied: 10 μL (undiluted)

NEGATIVE CONTOL:
- Amount applied: 10 µl Phosphate buffered saline

POSITIVE CONTROL
- Amount applied: 10 µl
- Concentration: 5% (aq) Sodium dodecyl sulphate

Duration of treatment / exposure:

15 minutes

Details on study design:

TEST SITE
- EPISKIN Standard ModelTM(EPISKIN-SMTM, 0.38 cm^2, Lot no.: 10-EKIN-040). This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded 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. The test was performed on a total of 3 tissues per test substance, negative and positive controls.

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 vivo

Results

Irritation parameter:

other: mean tissue viability

Basis:

other: percentage of control

Time point:

other: 15 minutes

Score:

41

Remarks on result:

other: Negative control = 100%; Positive control = 34%

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.

- The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of 3 tissues treated identically was less than 18%.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The in vitro skin irritation test was conducted according to OECD 439 guideline and GLP principles. It is concluded that this test is valid and that the test substance is 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), the influence of the test substance on the viability of human skin was tested. The test substance was applied (10μl) directly to 0.38 cm2 cultured skin. 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 34% whereas the test substance showed cell viability of 41%. Since the mean relative tissue viability after exposure to the test substance was below 50%, it can be concluded that the test substance is irritating in the in vitro skin irritation test.