Registration Dossier
Registration Dossier
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EC number: 207-405-3 | CAS number: 468-28-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- 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. 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 irritation studies performed on this substance indicate that a preliminary classification of eye irritation category 2 is appropriate, pending the results of the study planned.
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:
- other: OECD 439
- Version / remarks:
- Weight of evidence to support study planned
- 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
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % tissue viability
- Remarks:
- Weight of evidence supporting study
- 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 (irritating to eyes) 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 irritation studies performed on this substance, together with a long history of use as a food ingredient, indicate that a preliminary classification of eye irritation category 2 is appropriate, pending the results of the study planned.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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