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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 March 2018 - 30 March 2018
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 guideline
Qualifier:
according to
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Version / remarks:
adopted February, 2015
Deviations:
no
GLP compliance:
yes
Type of study:
activation of keratinocytes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material: 171116

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Dissolved in DMSO

Results and discussion

Positive control results:
EC1.5 of the positive control was between 5 and 125 µM (61 µM and 98 µM in experiment 1 and 2, respectively). A dose response was observed and the induction at 250 µM was higher than 2-fold (2.75-fold and 2.72-fold in experiment 1 and 2, respectively).

In vitro / in chemico

Resultsopen allclose all
Key result
Parameter:
other: Imax
Run / experiment:
Experiment 1
Value:
5.98
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
positive indication of skin sensitisation
Key result
Parameter:
other: Imax
Run / experiment:
Experiment 2
Value:
5.05
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
positive indication of skin sensitisation
Other effects / acceptance of results:
The luciferase activity induction obtained with the positive control, Ethylene dimethacrylate glycol, was above the threshold of 1.5-fold in at least one concentration.
The EC1.5 of the positive control was between 5 and 125 µM (61 µM and 98 µM in experiment 1 and 2, respectively). A dose response was observed and the induction at 250 µM was higher than 2-fold (2.75-fold and 2.72-fold in experiment 1 and 2, respectively).
The average coefficient of variation of the luminescence reading for the vehicle (negative) control DMSO was below 20% (8.8% and 14% in experiment 1 and 2, respectively).

Any other information on results incl. tables

Overview EC1.5, Imax, IC30and IC50Values

 EC1.5(µM)  Imax  IC30(µM)  IC50(µM)
Test item Experiment 1   <0.98  5.98  3.6  5.4
 Test item Experiment 2  <0.49  5.05  4.1  6.8
 Pos Control Experiment 1  61  2.75  N/A   N/A
 Pos Control Experiment 2  98  2.72   N/A  N/A 

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
In conclusion, the substance is classified as positive (activation of the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes) under the experimental conditions described.
Executive summary:

The ability of the substance to activate the antioxidant/electrophile responsive element (ARE)-dependent pathway was evaluated in the in vitro KeratinoSens assay. Two independent experiments were performed. 4,4’-Bis(diethylamino)benzophenone showed toxicity (IC30values of 3.6µM and 4.1µM and IC50values of 5.4µM and 6.8 µM in experiment 1 and 2, respectively). A biologically relevant, dose-related induction of the luciferase activity (EC1.5values of < 0.98µM and < 0.49µM in experiment 1 and 2, respectively) was measured in both experiments. The maximum luciferase activity induction (Imax) was 5.98-fold and 5.05-fold in experiment 1 and 2 respectively. The substance is positive in the KeratinoSensTMassay since positive results (>1.5-fold induction) were observed at test concentrations < 1000µM with a cell viability of >70% compared to the vehicle control.