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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: 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:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Hop, Humulus lupulus, ext., isomerized, potassium salt
EC Number:
305-203-0
EC Name:
Hop, Humulus lupulus, ext., isomerized, potassium salt
Cas Number:
94349-84-5
Test material form:
solid
Remarks:
Resinous solid. Becomes flowable above 60 oC.
Specific details on test material used for the study:
Batch no. EXP 7

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
unchanged (no vehicle)

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Viability measured after 3 minutes
Value:
ca. 40.3
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Tissue viability measured after 1 hour
Value:
ca. 28.1
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Notes from study report: "After 3 min and 1h exposure on the surface of EpiDermTM reconstructed human epidermis, the viability of the tissues was assessed and compared to a negative control.
The percentage of viability obtained was 40.3% after 3 min and 28.1% after 1h and therefore:
Potassium Iso-Alpha Resin was classified as Corrosive, optional sub-category 1B/1C to human skin."

Since tetrahydroisoalpha acids are simply hydrogenated, with two side chain C=C double bonds converted to CH-CH, then it is appropriate to read across the classification from iso-alpha acids.

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