Registration Dossier
Registration Dossier
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EC number: 305-203-0 | CAS number: 94349-84-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: Published LD50 values for iso-alpha acids are cited and discussed in a GRAS assessment, and citred 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
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Data obtained from GRAS assessment
- GLP compliance:
- not specified
- Test type:
- other: Data obtained from GRAS assessment
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
Constituent 1
Test animals
- Species:
- other: rat data cited in GRAS assessment
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 000 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 values for iso-α-acids that have been reported in the scientific literature, from published and unpublished toxicity studies, were considered and summarised in a GRAS determination of hop iso-α-acids (2008). The LD50 value for isohumulone was reported in the scientific literature as 1,000 mg/kg body weight when administered to Sprague Dawley rats in a 50% corn-oil solution. The same value for LD50 is also quoted in a recent (2016) scientific review article by Karabin et al.*
Since LD50 values for iso-α-acids have been quoted in the scientific literature, further animal studies are not warranted.
* Karabin M, Hudcova T, Jelinek L and Dostalek P (2016) Biologically active compounds from hops and prospects for their use. Comprehensive Reviews in Food Science and Food Safety 15: 542-567. Accessed on 22 March 2017 on http://onlinelibrary.wiley.com/doi/10.1111/1541-4337.12201/pdf
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