Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 Oct 2017 to 05 Dec 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The MalTek EpiDerm™ MTT Viability Assay has been demonstrated to be a quantitative method for assessing potential skin hazards.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
White powder

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
other: not specified
Cell source:
other: not specified
Source strain:
not specified
Justification for test system used:
The MatTek EpiDerm™ MTT Viability Assay has been demonstrated to be a quantitative method for assessing potential skin hazards.
Vehicle:
unchanged (no vehicle)
Details on test system:
EpiDerm™ Tissue Samples
EpiDerm™ tissues, Lot 27154 Kit R, were received from MatTek on 10 Oct 2017 and refrigerated at 2-8ºC. Before use, the tissues were incubated (37oC ± 1oC, 5% ± 1% CO2) with assay medium (MatTek) for a one-hour equilibration. Equilibration medium was replaced with fresh medium before dosing.
Control samples:
yes, concurrent no treatment
yes, concurrent positive control
Amount/concentration applied:
100mg
Duration of treatment / exposure:
For 0.5, 4, and 24 hours.
Number of replicates:
3 different doses, but no replicates per dose

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
0.5 hours
Value:
43.8
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1.0 hours
Value:
39.2
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
4.0 hours
Value:
31.9
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
ET50 score of <0.5 hours

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test articles provided by Merck & Co., Inc. were tested using the MatTek EpiDerm™ MTT Viability Assay. At the request of the Sponsor, the test articles were dosed neat. The ET50 scores were converted to an irritancy classification. The ET50 score of the positive control, 1% Triton® X-100, was 6.0 hours, which met MatTek's acceptance criterion of 4.8-8.7 hours.
The summarized data and irritation classifications are as follows:
Test and Control Article Identity ET50 (hr) Irritancy Classification
L-006266209-000K003 <0.5 Severe, Probable Corrosive
1% Triton® X-100 (Positive Control) 6.0 Within Range (4.8 - 8.7)