Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Version / remarks:
February, 04th, 2015
Principles of method if other than guideline:
The test item absorbs in the same wavelength as the MTT range. In order to assess a possible interference, control on the test item range of dilution was carried out under the same conditions as the test but the MTT was not added to the culture well.
GLP compliance:
yes (incl. certificate)
Type of study:
activation of keratinocytes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

In vitro test system

Details on study design:
The test consists in evaluating the activation of AKR1C2 in transformed keratinocytes (KeratinoSens™), by monitoring the induction of the luciferase gene fused to AKR1C2. The luciferase produced by the cells complexes with luciferin which, in the presence of ATP, produces light measured in relative light units (RLU).

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: Induction
Remarks:
of luciferase activity
Run / experiment:
two
Value:
0.79
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the retained experimental conditions RED STR 172 code ID-18/07953 may be classified as not sensitizer.