Registration Dossier

Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Deviations:
no
GLP compliance:
yes
Type of study:
activation of keratinocytes

Test material

Constituent 1
Reference substance name:
Extract obtained from the shell of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol
EC Number:
948-055-8
Molecular formula:
not applicable as it is a UVCB
IUPAC Name:
Extract obtained from the shell of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol
Test material form:
liquid
Remarks:
liquid to liquid viscous
Details on test material:
- Physical appearance: dark brown to black viscous liquid
- Storage conditions: in refrigerator (2-8°C) protected from light

In vitro test system

Details on the study design:
as per OECD guidelines

Results and discussion

Positive control results:
Cinnamic aldehyde is included as positive control. It is tested in each test plate at five concentrations from 4 – 64 µM.

In vitro / in chemico

Resultsopen allclose all
Key result
Run / experiment:
other: Rep 1
Parameter:
other: as per OECD guidelines
Value:
1.27
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation
Key result
Run / experiment:
other: Rep 2
Parameter:
other: As per OECD guidelines up to 200 ug/ml
Value:
0.93
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation
Key result
Run / experiment:
other: Rep 3
Parameter:
other: As per OECD guidelines at 200 ug/ml
Value:
1.24
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:
other: not a sensitizer
Conclusions:
In all three repetitions, no induction of the luciferase above the threshold of 1.5 was noted. According to the prediction model of the KeratinoSens™ assay, the test substance is rated as a non-sensitizer. This conclusion is also clearly supported by the analysis of the dose-response curve in Figure 4 with overall no induction of the luciferase reporter gene to be observed.
Executive summary:

In all three repetitions, no induction of the luciferase above the threshold of 1.5 was noted. According to the prediction model of the KeratinoSensassay, the test substance is rated as a non-sensitizer. This conclusion is also clearly supported by the analysis of the dose-response curve in Figure 4 with overall no induction of the luciferase reporter gene to be observed.