[3-methoxycarbonyl-4-[6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carbonyl]oxy-phenyl] 6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carboxylate

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 439

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

[3-methoxycarbonyl-4-[6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carbonyl]oxy-phenyl] 6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carboxylate

Cas Number:

914918-26-6

Molecular formula:

C46H40O16

IUPAC Name:

[3-methoxycarbonyl-4-[6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carbonyl]oxy-phenyl] 6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carboxylate

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: human-derived epidermal keratinocytes

Vehicle:

physiological saline

Details on test system:

EpiDerm™ 200 kit:MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia containing: 24 EPI-200 tissues (reconstructed epidermis): surface 0.6 cm² cultured in Millicells®  1 cmAssay medium:EPI-100-NMM assay medium MTT diluent: Dulbecco's modified eagle's medium (DMEM) based medium used for diluting MTT (MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia / Sigma, Germany)Wash buffer:Dulbecco's phosphate buffered saline (PBS), w/o Ca 2+, Mg 2+ (MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia and Biochrom, Germany)Detection agent:3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) (MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia / Sigma, Germany), 1.0 mg / mL MTT diluentExtracting agent:Isopropanol p.a.

Control samples:

yes, concurrent vehicle

Amount/concentration applied:

single topical application of ca. 25 µL bulk volume (ca.12 mg) of the undiluted test substance to a reconstructed three dimensional human epidermis model (EpiDerm™)

Duration of treatment / exposure:

1h

Duration of post-treatment incubation (if applicable):

42h

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean

Value:

96.4

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The following results were obtained in the EpiDerm™ skin corrosion/irritation test:The test substance is not able to reduce MTT directly.The mean viability of the test-substance treated tissues determined after an exposure period of 1 hourwith about 42 hours post-incubationwas 96.4%.Based on the observed results and applying the evaluation criteria described in chapter3.8 it was concluded, that the test item does not show a skin irritation potential in the EpiDerm™ in vitro skin irritation and corrosion test strategy under the test conditions chosen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met