Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 305-203-0 | CAS number: 94349-84-5
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- This academic paper, although published in 1953, is well reported and the studies were carefully executed. Many experiments were performed to (i) investigate the sedative effect of hop extracts on goldfish, (ii) to distinguish between toxic and sedative effects, and (iii) to determine which components of the hop extract were responsible for which effects. Since toxicity to fish was clearly noted in several instances, and since this carefully-conducted study is available in the public domain, further animal studies are not warranted. It is possible from the published results to derive a defensible estimate of lowest toxic dose, and so it would not be right to conduct further experiments on living fish. Furthermore, the Daphnia appear to be more sensitive than the fish (see relevant endpoints) which further argues against the need to do more animal studies.
- Qualifier:
- according to guideline
- Guideline:
- other: The article refers to a method by Fauconnet on investigation of sedative drugs in fish
- Principles of method if other than guideline:
- Carefully conducted studies on goldfish, with nine sets of observations
- GLP compliance:
- not specified
- Remarks:
- Well-conducted and reported 1953 study
- Test organisms (species):
- Carassius auratus
- Key result
- Duration:
- 15 min
- Dose descriptor:
- other: Lowest dose causing adverse effects
- Effect conc.:
- ca. 80 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- behaviour
- Sublethal observations / clinical signs:
Only the aqueous extract had no effect on the fish.This is not surprising, as the alpha and beta acids, and the essential oils, are not soluble in water. For the purposes of establishing toxicity, the following two sets of extract were particularly relevant:
1. Acetone extract,which will contain alpha, beta and essential oils,re-dissolved in ethanol, at 40% concentration. This was very toxic to fish at 5 cm3per litre: violent spasms, the fish went onto one side, and died in 6-7 minutes.
· The same results were observed when the extract was dosed at 1 cm3per litre.
· When the extract was dosed at 0.2 cm3per litre, the fish were removed from the test water when they started to go onto one side, and were re-placed into fresh, running water. The fish then revived.
2. A dry extract was re-worked as 5% in ethanol. A dry extract would be expected to containalpha, beta and essential oils. When dosed at 5 cm3per litre, this had slight sedative effects on the fish, and caused some spams and some equilibrium problems. No death reported.
A 0.2 cm3per litre dose of a 40% acetone extract is equivalent to0.08 g per litre hop extract, i.e.80 mg per litre. At this dose, adverse effects started to be observed.
A 5 cm3per litre of a 5% extract is equivalent to0.125 g per litre hop extract, i.e.125 mg per litre. This caused some adverse effects, but not lethal.
Attempts to de-toxify the extracts by further solvent extractions/fractionations were not successful, apart from removal of essential oils. The essential oils seemed to be responsible for sedative activity, but not toxicity. The residue of a hop extract, once essential oils had been removed by steam distillation, and which was then re-dissolved in ethanol and dosed at 5 cm3per litre, was very toxic.
The toxic principles are thus found in the hop extract apart from essential oils. These are most likely to be the alpha and beta acids, and potentially the other resins too, since these contain oxidised alpha and beta acids.The fats and waxes are very insoluble and not known to be toxic.
- Conclusions:
- For the acetone extract of lupulin, 400 mg per litre hop extract (1 cm3 per litre of the 40% extract) and 2,000 mg per litre (5 cm3 dose) were highly toxic, but 80 mg per litre gave reversible effects. Taking a safety factor of 10, it seems reasonable that a dose of 8 mg per litre could be considered as a level which would have little effect on the fish. Furthermore, hop extract is highly insoluble. Tween 20 was used in these experiments to assist with solubility. In the Daphnia tests, a limit of solubility of approximately 2.2 mg per litre was noted. Thus, it is not likely that hop extract could accumulate in water to reach a concentration of toxicity towards fish.
The study performed on hop extract is relevant for iso-alpha acids, since iso-alpha acids are derived from hop extract.
Reference
Description of key information
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 8 mg/L
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.