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Diss Factsheets
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EC number: 232-504-3 | CAS number: 8060-28-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Referenceopen allclose all
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
- Reference Type:
- review article or handbook
- Title:
- Hagers Handbuch der Pharmazeutischen Praxis. Drogen E—O. Chapter H
- Author:
- F. von Bruchhausen, G. Dannhardt, S. Ebel, A. W. Frahm, E. Hackenthal, R. Hänsel et al.
- Year:
- 1 993
- Bibliographic source:
- https://doi.org/10.1007/978-3-642-57993-6
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Data obtained from Handbook, and cited in EMEA assessment of hop extracts
- GLP compliance:
- not specified
- Test type:
- other: Data obtained from Handbook, and cited in EMEA assessment of hop extracts
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
Test animals
- Species:
- mouse
- Details on test animals or test system and environmental conditions:
- Rat and mouse data cited in Handbook
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: 1,000 - 2,300 mg/kg bw for beta-acid-enriched hop extract
Applicant's summary and conclusion
- Conclusions:
- Hop extracts are widely used as ingredients for beer. They are generally regarded as safe (GRAS) according to USA law 21 CFR 182.20. Within the European Union, an assessment report of Humulus lupulus by the European Medicines Agency (EMEA) in 2014 is available on the web. Section 3.3 of that report states: “Hops have been used in the brewing industry for centuries without any known adverse effect to the health of consumers. Thus, given the history of long-term and present use in humans with no significant adverse effects, it is considered that hops are safe (Chadwick et al., 2006).” LD50 values are quoted in Section 3.3.1 of that report as follows:
• Ethanolic hop extract: LD50 3,500 mg/kg/b.w. p.o., 1,200 mg/kg/b.w. s.c. (mice); LD50 2,700 mg/kg/b.w. p.o. (rats).
• Methylisobutylketone-hop extract: LD50 2,700 mg/kg/b.w. p.o. (mice); LD50 415 mg/kg/b.w. p.o. (rats).
This suggests an expected LD50 for oral administration >2,000 mg per kg bw for most hop extracts, i.e. not triggering a hazard classification under Regulation (EC) 1272/2008.
2. β-ACID-ENRICHED HOP EXTRACT
An LD50 of ca. 700 mg per kg bw was estimated for β-acids (see attached report Hop Extract_Data Summary.pdf). Thus a β-acid-enriched hop extract, containing 30 – 70% β-acids, could potentially have an LD50 value of 1,000 – 2,300 mg per kg bw. This would potentially place certain extracts (>35% β-acids) under Category 4 for Acute Toxicity according to Regulation (EC) 1272/2008, section 3.1.2.1, with the Signal Word “Warning”, and the Hazard Statement “H302: Harmful if swallowed”.
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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