Registration Dossier
Registration Dossier
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EC number: 204-934-1 | CAS number: 129-17-9
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data available from study report.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Scientific Opinion on the re-evaluation of Patent Blue V (E 131) as a food additive
- Author:
- European Food Safety Authority (EFSA), Parma, Italy
- Year:
- 2 013
- Bibliographic source:
- EFSA Journal 2013;11(3):2818
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Data is from study report
- Principles of method if other than guideline:
- The DNA damaging capabilities of Patent Blue V was assessed in the in vivo single cell gel/Comet assay in rats.
- GLP compliance:
- not specified
- Type of assay:
- other: In vivo bone marrow micronucleus assay
Test material
- Reference substance name:
- Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
- EC Number:
- 204-934-1
- EC Name:
- Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
- Cas Number:
- 129-17-9
- Molecular formula:
- C27H32N2O6S2.Na
- IUPAC Name:
- hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
- Details on test material:
- - Name of test material: Patent Blue V (E131)- Molecular formula: C27H31N2O6S2.NaC27H32N2O6S2.Na - Molecular weight: 566.672 g/mol- Substance type: Organic- Physical state: Solid- Purity: 90%- Impurities: No data available
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Details on test animals and env conditionsTEST ANIMALS- Source: No data available- Age at study initiation: 8 weeks old- Weight at study initiation: 30 g body weight- Assigned to test groups randomly: [no/yes, under following basis: No data available- Fasting period before study: No data available- Housing: caged individually- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): Standard- Humidity (%):Standard- Air changes (per hr): Standard- Photoperiod (hrs dark / hrs light): StandardIN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Vehicles- Vehicle(s)/solvent(s) used: Sterile Distilled water of injectable grade- Justification for choice of solvent/vehicle: No data available- Concentration of test material in vehicle: 500, 1000, 2000 mg/kg/bw - Amount of vehicle (if gavage or dermal): No data available- Type and concentration of dispersant aid (if powder): No data available- Lot/batch no. (if required): No data available- Purity: No data available
- Details on exposure:
- No data
- Duration of treatment / exposure:
- No data
- Frequency of treatment:
- Twice
- Post exposure period:
- 3-4 hrs
Doses / concentrations
- Remarks:
- Doses / Concentrations:500, 1000, 2000 mg/kg/bw Basis:no data
- No. of animals per sex per dose:
- Total: 15500 mg/Kg bw: 5 mice/dose1000 mg/Kg bw: 5 mice/dose2000 mg/Kg bw: 5 mice/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Ethylmethanesulphonate (EMS)
Examinations
- Tissues and cell types examined:
- Patent Blue V (E 131) was examined for genotoxic properties by evaluating the induction of DNA damage in cell suspensions isolated from liver, jejunum/ileum and peripheral blood of rats
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The highest dose level represents the maximum dose level to be used for non-toxic compoundsTREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): No data availableDETAILS OF SLIDE PREPARATION: Peripheral blood and cell suspensions isolated from liver and jejunum/ileum were embedded in agarose gel on microscope slides
- Evaluation criteria:
- Changes in tail moment and tail intensity values were detected
- Statistics:
- No data
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No data
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negativePatent Blue V E131 fails to induce gene mutation in vivo in the Sprague Dawley male rats.
- Executive summary:
- The DNA damaging capabilities of Patent Blue V (E 131) were assessed in the in vivo single cell gel/Comet assay in rats. Patent Blue V (E 131) was examined for genotoxic properties by evaluating the induction of DNA damage in cell suspensions isolated from liver, jejunum/ileum and peripheral blood of rats after in vivo treatment using the alkaline (pH>13) version of the Comet Assay.
In the main experiment, only male animals were treated since no substantial inter-sex differences in toxicity were observed. Groups of 5 Sprague-Dawley male rats were treated twice at 24 hour intervals with the vehicle only (sterile distilled water of injectable grade), or Patent Blue V (E 131) at the dose levels of 500, 1000 and 2000 mg/kg/day. Ethyl methanesulphonate (EMS), at 200 mg/kg/day served as positive control. Animals were sacrificed approximately 3-4 hours after the second dosing.
Peripheral blood and cell suspensions isolated from liver and jejunum/ileum were embedded in agarose gel on microscope slides. No statistically significant increases in tail moment and tail intensity values compared with the vehicle control values were observed at any dose-level in the treated groups.
Patent Blue V (E 131) does not induce any effect on DNA migration in rat liver, jejunum/ileum and peripheral blood.
The given test material gives negative gene toxicity in vivo response on the Sprague Dawley male rats and hence is not likely to classify for gene mutation in vivo.
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