Registration Dossier
Registration Dossier
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EC number: 207-405-3 | CAS number: 468-28-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
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
- Molecular formula:
- No simple molecular formula for UVCB
- 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
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 5.65
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The study performed on hop extract is relevant for beta acids, since hop extract may contain up to ca. 64% beta acids, and the extract tested here contained 38% beta acids. Hop extract (Oil rich) is classfied as irritant to human skin.
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