Registration Dossier
Registration Dossier
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EC number: 295-619-8 | CAS number: 92113-15-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- 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:
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
Test material
- Reference substance name:
- Hop, Humulus lupulus, ext.
- EC Number:
- 232-504-3
- EC Name:
- Hop, Humulus lupulus, ext.
- Cas Number:
- 8060-28-4
- IUPAC Name:
- Hop, Humulus lupulus, ext.
- Test material form:
- liquid: viscous
- Remarks:
- Depending on the extraction conditions and on the hop variety, the colour of the extract can vary from yellow to dark green. It is a semi-fluid paste at room temperature. The product becomes more fluid when heated.
Constituent 1
- Specific details on test material used for the study:
- Oil-rich hop extract, batch no. BI/YYF/1701
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: Prediction of sensitisation potential
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Together with endpoints 002 and 003, hop extract is classified as a sensitiser to human skin. The study performed on hop extract is relevant for tetrahydroisoalpha acids, since these are derived from hop extract.
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