Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 236-216-9 | CAS number: 13241-33-3
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative mutagenesis of plant flavonoids in microbial systems
- Author:
- Hardigree AA, Epler JL
- Year:
- 1 978
- Bibliographic source:
- Mutation Research,58: 231-239
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not applicable
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hesperidin
- EC Number:
- 208-288-1
- EC Name:
- Hesperidin
- Cas Number:
- 520-26-3
- IUPAC Name:
- 5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4-oxo-3,4-dihydro-2H-chromen-7-yl 6-O-(6-deoxy-alpha-L-mannopyranosyl)-beta-D-glucopyranoside
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
Hesperidin used in this investigation was acquired from Sigma.
OTHER SPECIFICS:
- Name of test material (as cited in study report): hesperidin
- Molecular formula (if other than submission substance): C28H34O15
- Molecular weight (if other than submission substance): 610.5606
- Smiles notation (if other than submission s.): CC1C(O)C(O)C(O)C(OCC2C(O)C(O)C(O)C(Oc3cc4c(c(O)c3)C(=O)CC(c3ccc(OC)c(O)c3)O4)O2)O1
- InChl (if other than submission substance): InChI=1/C28H34O15/c1-10-21(32)23(34)25(36)27(40-10)39-9-19-22(33)24(35)26(37)28(43-19)41-12-6-14(30)20-15(31)8-17(42-18(20)7-12)11-3-4-16(38-2)13(29)5-11/h3-7,10,17,19,21-30,32-37H,8-9H2,1-2H3
- Structural formula attached as image file (if other than submission substance): see Fig. attached.
Method
- Target gene:
- Salmonella typhimurium histidine (his) reversion system;
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- courtesy of Dr. Bruce Ames, Berkeley, Calif
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, rfa, missense
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- courtesy of Dr. Bruce Ames, Berkeley, Calif
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, rfa, missense plus R factor
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- courtesy of Dr. Bruce Ames, Berkeley, Calif
- Additional strain / cell type characteristics:
- other: hisC3076, uvrB, rfa, frameshift
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- courtesy of Dr. Bruce Ames, Berkeley, Calif
- Additional strain / cell type characteristics:
- other: hisD3052, uvrB, rfa, frameshift
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- courtesy of Dr. Bruce Ames, Berkeley, Calif
- Additional strain / cell type characteristics:
- other: his D3052, uvrB, fra, frameshift plus R factor
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 25-2000 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulfoxide(DMSO)
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: quercetin
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: pour-plate assays with and without metabolic activation were used according to the method originally reported by Ames. The compound to be tested was dissolved in DMSO and, in general, concentration of the compound was varied over a range of 25 - 2000 μg added per plate. In assays requiring metabolic activation, standard rat liver S-9 preparations from untreatedrats and from rats whose liver enzymes were induced with Aroclor 1254, methylcholanthrene, or sodium phenobarbital were used.
DURATION
- Exposure duration: 48h
DETERMINATION OF CYTOTOXICITY
- Method: not specified. - Evaluation criteria:
- Compounds which show a consistent dose response and a value of greater than 0.1 revertants per nanomole as mutagenic.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- In this investigation also Hesperetin, the aglycone of hesperidin, has been investigated for mutagenicity and also was found to be negative with all strains (with and without metabolic activation).
Any other information on results incl. tables
Table 1. Dose-Response values with strain TA98 with or without activation (Aroclor-induced).
Compound |
his+ revertants/100 μg (a) |
|
-S9 |
+S9 |
|
Quercetin |
260 (0.79) |
750 (2.27) |
Hesperetin |
0 (0) |
9 (0.03) |
Hesperidin |
4 (0.02) |
4 (0.02) |
* Numbers in parenthesis refer to number of revertants/plate. (a) Slope determination from dose-response curve.
Applicant's summary and conclusion
- Conclusions:
- Under test conditions, the test substance hesperidin, as well as its aglycone hesperetin, were non mutagenic, with and without metabolic activation.
- Executive summary:
The potential mutagenic activity of the test item was studied using the method of Ames, similar to OECD 471. Five histidine requiring strains of Salmonella typhimurium (TA1535, TA1537, TA1538, TA98 and TA 100) were exposed to six different concentrations of test item, up to 2000 μg/plate, with and without S9 metabolic activation (Kanechlor KC-400-induced rat liver microsome fraction), based on the results of a preliminary citotoxicity study.Vehicle and untreated controls were run in parallel, other substances tested served as positive controls. Under test conditions,the test item did not induce an increase in the number of revertants in any strainat any dose level. Therefore, the test item was found to be non mutagenic.
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.