Registration Dossier
Registration Dossier
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EC number: 207-405-3 | CAS number: 468-28-0
Toxicological information
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Remarks:
- See experimental details and the weight of evidence data in the background material.
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 90 days
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Referenceopen allclose all
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 960
- Report date:
- 1960
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Version / remarks:
- The experiment has been cited, discussed and referred to as evidence for low toxicity in Chappel et al. (1998) Food Chem. Toxicol. volume 36, pp. 915-922 and in Gerhauser C (2005) Eur. J. Cancer vol. 41, pp. 1941-1954.
- Principles of method if other than guideline:
- 90-day subactue toxicity feeding study set up using 1, 0.1 and 0.01% of hop iso-alpha acids in corn oil, plus a negative control, fed to 21-day-old Sprague-Dawley rats. Histopathological examinations of tissues including reproductive tissues.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3,4-dihydroxy-5-(3-methylbut-2-enyl)-2-(3-methyl-1-oxobutyl)-4-(4-methyl-1-oxopent-3-enyl)cyclopent-2-en-1-one
- EC Number:
- 247-072-1
- EC Name:
- 3,4-dihydroxy-5-(3-methylbut-2-enyl)-2-(3-methyl-1-oxobutyl)-4-(4-methyl-1-oxopent-3-enyl)cyclopent-2-en-1-one
- Cas Number:
- 25522-96-7
- Molecular formula:
- C21H30O5
- IUPAC Name:
- (4S,5S)-3,4-dihydroxy-2-(3-methylbutanoyl)-5-(3-methylbut-2-enyl)-4-(4-methylpent-3-enoyl)cyclopent-2-en-1-one
- Reference substance name:
- 3,4-dihydroxy-5-(3-methylbut-2-enyl)-4-(4-methyl-1-oxopent-3-enyl)-2-(2-methyl-1-oxopropyl)cyclopent-2-en-1-one
- EC Number:
- 246-780-8
- EC Name:
- 3,4-dihydroxy-5-(3-methylbut-2-enyl)-4-(4-methyl-1-oxopent-3-enyl)-2-(2-methyl-1-oxopropyl)cyclopent-2-en-1-one
- Cas Number:
- 25269-20-9
- Molecular formula:
- C20H28O5
- IUPAC Name:
- 3,4-dihydroxy-5-(3-methylbut-2-enyl)-4-(4-methyl-1-oxopent-3-enyl)-2-(2-methyl-1-oxopropyl)cyclopent-2-en-1-one
- Reference substance name:
- 3,4-dihydroxy-5-(3-methylbut-2-enyl)-2-(2-methyl-1-oxobutyl)-4-(4-methyl-1-oxopent-3-enyl)cyclopent-2-en-1-one
- EC Number:
- 246-967-4
- EC Name:
- 3,4-dihydroxy-5-(3-methylbut-2-enyl)-2-(2-methyl-1-oxobutyl)-4-(4-methyl-1-oxopent-3-enyl)cyclopent-2-en-1-one
- Cas Number:
- 25422-83-7
- Molecular formula:
- C21H30O5
- IUPAC Name:
- 3,4-dihydroxy-5-(3-methylbut-2-enyl)-2-(2-methyl-1-oxobutyl)-4-(4-methyl-1-oxopent-3-enyl)cyclopent-2-en-1-one
- Test material form:
- liquid
- Details on test material:
- Isomerized hop extract present as 50% suspension in corn oil
1
2
3
- Specific details on test material used for the study:
- Isomerized hop extract present as a 50% suspension in corn oil. This will be an extract enriched in hop iso-alpha acids.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Details on exposure:
- Rats provided with test ration and water ad libitum
- Duration of treatment / exposure:
- 90 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- Iso-alpha acids present at 0, 0.01, 0.1 and 1% in the study design
- Dose / conc.:
- 100 ppm
- Remarks:
- Iso-alpha acids present at 0, 0.01, 0.1 and 1% in the study design
- Dose / conc.:
- 1 000 ppm
- Remarks:
- Iso-alpha acids present at 0, 0.01, 0.1 and 1% in the study design
- Dose / conc.:
- 10 000 ppm
- Remarks:
- Iso-alpha acids present at 0, 0.01, 0.1 and 1% in the study design
- No. of animals per sex per dose:
- 10
Examinations
- Parental animals: Observations and examinations:
- Animals weighed and their food consumption measured weekly. Periodic check for abnormal blood elements and urine elements made on high level groups and control.
- Postmortem examinations (parental animals):
- Certain organs weighed (body, liver, heart, spleen, kidneys, gonads); certain organs examined microscopically (heart, lung, spleen, liver, pancreas, stomach and intestine, mesenteric lymph nodes, salivary glands, thyroid, kidney, urinary bladder, ovary or testis, uterus or prostate, bone and bone marrow)
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced weight gain at the highest level (1%), but no changes in weights of liver, heart, spleen, kidneys or gonads, and no histopathological changes. The reduced weight gain is likely to be due to the unpalatibility of teh bitter iso-alpha acids.
Details on results (P0)
Reduced weight gain at the highest level (1%), but no changes in weights of liver, heart, spleen, kidneys or gonads, and no histopathological changes. The reduced weight gain is likely to be due to the unpalatibility of teh bitter iso-alpha acids.
Effect levels (P0)
- Key result
- Dose descriptor:
- dose level: NOAEL can be estimated from effects at highest dose level
- Effect level:
- ca. 10 000 ppm
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Results: F1 generation
Effect levels (F1)
- Key result
- Dose descriptor:
- other: F1 offspring not tested in this experiment
- Remarks:
- Histopathological examination of reproductive tissues in parents only
- Generation:
- other: F1 offspring not tested in this experiment
- Effect level:
- 0 other: Histopathological examination of reproductive tissues in parents only
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: F1 offspring not tested in this experiment
- Remarks on result:
- other: See the attached background material that gives an analysis of existing data. Further animal studies are not warranted.
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- not specified
- Lowest effective dose / conc.:
- 10 000 ppm
- Treatment related:
- yes
Applicant's summary and conclusion
- Conclusions:
- See the attached background material that gives an analysis of existing data. Further animal studies are not warranted.
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