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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Justification for type of information:
An eye irritation study according to OECD test guideline 492 has been commissioned and an update will be made once results are available. The skin corrosion studies performed on this substance indicate that a preliminary classification of eye damage category 1 is appropriate, pending the results of the study planned.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 431: skin corrosion study used as supporting evidence for classification
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

Test system

Vehicle:
unchanged (no vehicle)

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: % tissue viability 3 minutes
Value:
ca. 40.3
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
other: % tissue viability 1 hour
Value:
ca. 28.1
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
An eye irritation study according to OECD test guideline 492 has been commissioned and an update will be made once results are available. The skin corrosion studies performed on this substance indicate that a preliminary classification of eye damage category 1 is appropriate, pending the results of the study planned.

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.