Registration Dossier

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
KeratinoSens method
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Principles of method if other than guideline:
KeratinoSens method
GLP compliance:
not specified
Type of study:
other: KeratinoSens method
Justification for non-LLNA method:
The test method described in this Test Guideline can be used to support the discrimination between skin sensitisers (i.e. UN GHS Category 1) and non-sensitisers in the context of IATA. The level of reproducibility in predictions that can be expected from the test method is in the order of 85% within and between laboratories. The accuracy (77% -155/201), sensitivity (78% -71/91) and specificity (76% -84/110) of the KeratinoSensTM for discriminating skin sensitisers (i.e. UN GHS Cat. 1) from non-sensitisers when compared to LLNA results were calculated by considering all of the data submitted to EURL ECVAM for evaluation and peer-review of the test method.

Test material

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

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Key result
Parameter:
other: viability IC70
Run / experiment:
mean
Value:
23.71
Positive controls valid:
yes
Key result
Parameter:
other: linear EC1.5
Run / experiment:
mean
Value:
3.3
Positive controls valid:
yes
Key result
Parameter:
other: EC1.5 lin/log
Run / experiment:
mean
Value:
3.2
Positive controls valid:
yes
Key result
Parameter:
other: Imax
Run / experiment:
mean
Value:
692.1
Positive controls valid:
yes
Other effects / acceptance of results:
Repartition Imax is hiher than 1.5.
EC1.5 is lower than 1000 µM
EC 1.5 concentration viability is higher than 70%

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Repartition Imax is hiher than 1.5; EC1.5 is lower than 1000 µM and EC 1.5 concentration viability is higher than 70%.
Under the retained experimental conditions, the test item can be classified as sensitizer.
Executive summary:

The sensitization potential is evaluated according OECD 442D.

Repartition Imax is hiher than 1.5; EC1.5 is lower than 1000 µM and EC 1.5 concentration viability is higher than 70%.

Under the retained experimental conditions, the test item can be classified as sensitizer.