Registration Dossier
Registration Dossier
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EC number: 295-619-8 | CAS number: 92113-15-0
Skin irritation / corrosion
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:
- 2 018
- 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
- 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.
Constituent 1
- 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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