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Toxicological information

Skin irritation / corrosion

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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:
other: OECD 439
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

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