Registration Dossier
Registration Dossier
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EC number: 948-068-9 | CAS number: -
Skin sensitisation
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:
- 2 017
- 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
- 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
Constituent 1
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 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.
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