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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:
12-13 October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
yes
Remarks:
the epidermis units were incubated with MTT for 2 hours 1 minute instead of 3 hours (± 15 min)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: Adult humanderived epidermal keratinocytes are seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen
Details on test system:
Kit Contents
Units: EPISKINTM(SM) plate containing up to 12 reconstructed epidermis units (area: 0.38 cm2) each reconstructed epidermis is attached to the base of a tissue culture vessel with an O-ring set and maintained on nutritive agar for transport.
Plate: 12-well assay plate
Punch: EPISKINTM(SM) biopsy punch for easy sampling of epidermis
Medium: A flask of sterile “Maintenance Medium” (Batch No.: 17 MAIN3 043; Exp. Date: 18 October 2017)
A flask of sterile “Assay Medium” (Batch No.: 17 ESSC 040; Exp. Date: 18 October 2017)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
50 μL
Duration of treatment / exposure:
4 hours
Duration of post-treatment incubation (if applicable):
4 hours
Number of replicates:
2 replicates each for test item, negative control and positive control

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
88
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is non-corrosive to the skin
Executive summary:

The skin corrosivity has been assessed using the EPISKIN model test according to the OECD 431. The tissue viability was 88% and the substance is therefore non-corrosive.