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Toxicological information

Skin irritation / corrosion

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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:
2017
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

Constituent 1
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.
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:
Hop extract (Oil rich) is classfied as irritant to human skin

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