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EC number: 207-405-3 | CAS number: 468-28-0
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Intragastric administration of lupulone. Publication useful for assessment since it contains data for experiments on rats, rabbits, guinea pigs and monkeys. In view of all of these animal experiments having been published, further animal studies are not warranted.
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicology and Pharmacology of Lupulon
- Author:
- Y-C Chin and HH Anderson
- Year:
- 1 950
- Bibliographic source:
- Arch. int. pharmacodyn (1950) LXXXII, No. 1, pp. 1-15
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Subacute intragastric toxicity was studied in young male rats, with lupulone administered once daily fo 12 days. All surviving animals were sacrificed and specimens were investiagted for pathology. Similar studies were made in rabbits, guinea pigs and monkeys, but no monkey was sacrificed.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3,5-dihydroxy-2,6,6-tris(3-methylbuten-2-yl)-4-(3-methyl-1-oxobutyl)cyclohexa-2,4-dien-1-one
- EC Number:
- 207-405-3
- EC Name:
- 3,5-dihydroxy-2,6,6-tris(3-methylbuten-2-yl)-4-(3-methyl-1-oxobutyl)cyclohexa-2,4-dien-1-one
- Cas Number:
- 468-28-0
- Molecular formula:
- C26-H38-O4
- IUPAC Name:
- Lupulone
Constituent 1
- Specific details on test material used for the study:
- Lupulone was suspended in 6% gum acacia in proper concentrations.
Test animals
- Species:
- rat
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Tests were also made on rabbits, guinea pigs and monkeys.
Administration / exposure
- Route of administration:
- other: Intragastric
- Duration of treatment / exposure:
- 12 days
- Frequency of treatment:
- Once per day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 150 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 450 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 6
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Stated in the publication: "Only one rat fed 300 mg per kg bw per day died on the twelfth day. Grossly there were no observable lesion in any animal."
Also: "Rats, rabbits, guinea pigs and monkeys tolerated repeated daily intragastric doses for 2 weeks without showing apparent ill effects. The growth of the rats receiving the top two doses was reduced in the second week. Laboratory findings showed no significant changes. The pathologic sections of about half the animals revealed a spotty mononuclear-leukocytic infiltration in the lungs, usually around bronchi and bronchioles."
Effect levels
- Key result
- Dose descriptor:
- dose level: Only one rat fed 300 mg per kg bw per day died on the twelfth day. Grossly there were no observable lesion in any animal. The growth of the rats receiving the top two doses was reduced in the second week. Laboratory findings showed no significant changes.
- Effect level:
- ca. 300 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The publication shows that rats, rabbits, guinea pigs and monkeys tolerated daily intragastric doses of lupulone for two weeks without showing apparent ill effects.
The dose rate for rats was 1/4, 1/6 and 1/12 of the LD50.
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