Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vitro test system

Test system:
human skin model
Remarks:
Episkin
Source species:
human
Cell type:
non-transformed keratinocytes
Justification for test system used:
The model is recommended by the OECD guideline.
Vehicle:
unchanged (no vehicle)
Details on test system:
Tissues used in this study were Reconstructed human Epithelia (Episkin), of a surface of 0.50 cm².
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
16 mg
Duration of treatment / exposure:
42 minutes
Duration of post-treatment incubation (if applicable):
41 hours and 50 minutes post-treatment incubation-period
Number of replicates:
3 living Reconstructed Human epidermis

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
mean
Value:
ca. 89.5
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Validity criteria were fulfilled.
There was no direct interaction between the test item and MTT and the test item did not interfere with the MTT assay.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In accordance with the Regulation EC No. 1272/2008, the test item Gamma Chrome has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required.