Registration Dossier
Registration Dossier
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EC number: 636-196-5 | CAS number: 6902-77-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Non regulatory study
- Justification for type of information:
- Study performed as part of pre-clincal research when considering use of genipin in medical and food products.
Data from peer-reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity Assessment of Gardenia Yellow using Short-term Assay
- Author:
- Chung, Y et al
- Year:
- 2 009
- Bibliographic source:
- Mol Cel Toxicol. 2009;5(3):257-264.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Academic (non-regulatory) study with lack of details from methods in relation to compliance with guidelines. Suitable as Weight of Evidence data
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methyl (1S,4aS,7aS)-7-(hydroxymethyl)-1-{[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-1,4a,5,7a-tetrahydrocyclopenta[c]pyran-4-carboxylate
- Cas Number:
- 24512-63-8
- Molecular formula:
- C17 H24 O10
- IUPAC Name:
- Methyl (1S,4aS,7aS)-7-(hydroxymethyl)-1-{[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-1,4a,5,7a-tetrahydrocyclopenta[c]pyran-4-carboxylate
Constituent 1
- Specific details on test material used for the study:
- Crude plant extract tested
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 (induction unspecified)
- Test concentrations with justification for top dose:
- Top dose 5000 ug/plate.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Remarks:
- No details of controls were provided, other than untreated cultures
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity noted, but not apparent in which strains
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity noted, but not apparent in which strains
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity noted, but not apparent in which strains
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity noted, but not apparent in which strains
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity noted, but not apparent in which strains
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Treatment level resulting in toxicity not specified. Only noted that highest concentrations were toxic.
Applicant's summary and conclusion
- Conclusions:
- Considered negative, but potentially toxic to the bacteria at highest concentrations
Due to known reactivity with proteins, the result is not unexpected.
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