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Diss Factsheets
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EC number: 295-619-8 | CAS number: 92113-15-0
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: Published LD50 values for iso-alpha acids and rho-iso-alpha acids are cited in a company report and in a recent scientific publication.
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Data obtained from closely related molecules, on which from GRAS assessment
- GLP compliance:
- not specified
- Test type:
- other: Data obtained from GRAS assessment
- Species:
- other: rat data cited in GRAS assessment
- Key result
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 000 mg/kg bw
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Notes from attached justification: "Safety assessments of tetrahydroiso-α-acids were discussed in detail in company report BI/YYF/REACH/2007-001.1 In summary:
• The reduced derivatives are approved food additives for beer in the USA, under 21 CFR § 172.560.6 Safety assessments of these compounds have been performed.
• BI/YYF/REACH/2007-0011 provides discussions of acute dermal toxicity, acute inhalation toxicity, sub-acute toxicity studies, animal and human studies, mutagenicity and genotoxicity studies on iso-α-acids, rho-iso-α-acids, and tetrahydroiso-α-acids, which can be considered together using a read-across approach.
• The acute toxicity of tetrahydroiso-α-acids can be read across from LD50 values of 1,000 mg per kg for iso-α-acids and rho-iso-α-acids: see BI/YYF/REACH/2007-0011 and Karabin et al. (2016).
Since LD50 values for the closely-related iso-α-acids and rho-iso-α-acids have been quoted in the scientific literature, further animal studies are not warranted."
In addition: "Interestingly, the potassium salt of tetrahydroisohumulone has been tested as a potential drug for improving metabolism in prediabetic humans in a clinical research centre. .... Key points taken from the safety assessment detailed in the article are as follows:
• No cases of stopping the drug or of altering the dose
• All adverse effects were mild or moderate, and all resolved spontaneously
• The adverse effects were mostly gastrointestinal effects
• No evidence of greater toxicity with higher serum levels of KDT501
• No significant findings in clinical laboratory evaluations
• No evidence of liver, kidney or bone marrow toxicity"
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
Additional information
Justification for classification or non-classification
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.