Registration Dossier
Registration Dossier
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EC number: 636-196-5 | CAS number: 6902-77-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Negative in the Ames when tested as an isolated substance snd as an unrefined plant extract
In in-vitro SCE study, there was a slightly significant increase in SCE frequency in all doses tested compared with the solvent control. It should be noted that a similar increase was seen for the crude plant extract assays reported as part of the same research.
Link to relevant study records
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Sister chromatid exchange (SCE)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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-clinical research when considering use of genipin in medical and food products.
Data from peer-reviewed publication
Methodology not provided in detail - Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 479 (Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells)
- Principles of method if other than guideline:
- Methodology details lacking in publication, but following principles of OECD 473
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 (induction unspecified)
- Test concentrations with justification for top dose:
- Up to 10 μg/ml.
Maximum tolerated concentration - Vehicle / solvent:
- DMSO - details not specified
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- not specified
- Remarks:
- No details of controls were provided, other than untreated cultures
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- not applicable
- Genotoxicity:
- ambiguous
- Remarks:
- Genipin induced a slightly significant increase in SCE frequency in all doses tested compared with the solvent control
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- 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.
Genipin induced a slightly significant increase in SCE frequency in all doses tested compared with the solvent control - Conclusions:
- Considered equivocal.
Genipin induced a slightly significant increase in SCE frequency in all doses tested compared with the solvent control. It should be noted that a similar increase was seen for the crude plant extract assays reported as part of the same research. - 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 - 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
- Specific details on test material used for the study:
- Crude plant extract tested
- 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.
- 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
- 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.
- Conclusions:
- Considered negative, but potentially toxic to the bacteria at highest concentrations
Due to known reactivity with proteins, the result is not unexpected.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
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.
