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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Principles of method if other than guideline:
KeratinoSens method
GLP compliance:
yes
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

Constituent 1
Chemical structure
Reference substance name:
(1E)-1-(2H-1,3-benzodioxol-5-yl)-4,4-dimethylpent-1-en-3-one
EC Number:
604-446-2
Cas Number:
144850-45-3
Molecular formula:
C14H16O3
IUPAC Name:
(1E)-1-(2H-1,3-benzodioxol-5-yl)-4,4-dimethylpent-1-en-3-one
Test material form:
solid: particulate/powder

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Key result
Group:
test chemical
Run / experiment:
mean
Parameter:
other: viability IC70
Value:
23.71 µM
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Group:
test chemical
Run / experiment:
mean
Parameter:
EC 1.5 [442D]
Value:
3.3 µM
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
mean
Parameter:
other: EC1.5 Lin/Log
Value:
3.2 µM
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
mean
Parameter:
Imax [442D]
Value:
692.1
Positive controls validity:
valid
Remarks on result:
other: value without unit
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.