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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oktober 2017
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 defatted powder of Theobroma cacao (Malvaceae) by extraction with water and ethanol
EC Number:
948-068-9
Molecular formula:
not applicable
IUPAC Name:
Extract obtained from defatted powder of Theobroma cacao (Malvaceae) by extraction with water and ethanol
Test material form:
liquid
Details on test material:
Storage conditions: Ambient, 10 – 30°C

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:
1.33
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:
0.85
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:
1.1
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.