Registration Dossier
Registration Dossier
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EC number: 202-947-7 | CAS number: 101-50-8
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity Testing of the Food Colours Amaranth and Tartrazine
- Author:
- Aparajita Das and Anita Mukherjee
- Year:
- 2 004
- Bibliographic source:
- Int J Hum Genet, 4(4): 277-280 (2004)
Materials and methods
- Principles of method if other than guideline:
- Chromosome aberration assay was performed to evaluate the mutagenic nature of the test compound tartrazine.
- GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- EC Number:
- 217-699-5
- EC Name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Cas Number:
- 1934-21-0
- IUPAC Name:
- trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Reference substance name:
- trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo) pyrazole-3-carboxylate
- IUPAC Name:
- trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo) pyrazole-3-carboxylate
- Details on test material:
- - Name of test material (as cited in study report): Tartrazine- Molecular formula (if other than submission substance): C16-H12-N4-O9-S2.3Na.C16-H9-N4-O9-S2.3Na- Molecular weight (if other than submission substance): 534.3681 g/mol- Substance type: Organic- Physical state: No data availablePurity No data available- Impurities (identity and concentrations): No data available
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: No data available- Age at study initiation: 8-10 weeks- Weight at study initiation: 20-25 g- Assigned to test groups randomly: [no/yes, under following basis: ] No data available- Fasting period before study: No data available- Housing: No data available - Diet (e.g. ad libitum): Commercial diet ad libitum- Water (e.g. ad libitum): Water ad libitum- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): Ambient room temperature- Humidity (%): Relative - Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: distilled water- Justification for choice of solvent/vehicle: No data available- Concentration of test material in vehicle: 50,100 and 200 mg/kg body weight- 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:
- 18 hrs
- Duration of treatment / exposure:
- No data available
- Frequency of treatment:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:50,100 and 200 mg/kg bwBasis:
- No. of animals per sex per dose:
- Total : 160 mg/kg bw: 4 male mice50 mg/kg bw: 4 male mice100 mg/kg bw: 4 male mice200 mg/kg bw: 4 male mice
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Positive controls cyclophosphamide CP- Justification for choice of positive control(s): No data available - Route of administration: No data available- Doses / concentrations: 20 mg/Kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The selection of dose was based on the permitted dose of the dyes being 100mg/kg of the prepared food.TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): DETAILS OF SLIDE PREPARATION: Bone marrow cells were routinely processed by the standard procedure and slides were coded and stained in diluted GiemsaMETHOD OF ANALYSIS: For chromosomal aberration analysis, four animals were used per point. Hundred well spread metaphase plates were scored per animal (400 metaphase plates per treatment set) at random.OTHER: All aberrations (chromatid gaps, isochromosome gaps, chromatid breaks and rearrangements) were considered equal- regardless of the number of breakages involved. The percentages of damaged cells (% DC) and chromosomal aberrations per cell (CA/cell) values were calculated excluding gaps.
- Evaluation criteria:
- Chromatid gaps, isochromosome gaps, chromatid breaks and rearrangements were noted
- Statistics:
- ANOVA test was performed at 0.05 level
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No data available
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negativeThe test compound tartrazine is not mutagenic in the chromosomal aberration study conducted using Swiss albino mouse isolated bone marrow cells.
- Executive summary:
Chromosome aberration assay was performed to evaluate the mutagenic nature of the test compound tartrazine.
The study was conducted on male Swiss albino mice, 8-10 weeks old and weighing 20-25 g. Four animals per dose were administered intraperitoneally with the different doses of the tartrazine (50,100 and 200 mg/kg body weight).
The animals were killed after 18 hr. For bone marrow chromosome analysis, animals were injected with 0.1 ml colchicine solution (4mg/10ml distilled water /10g body weight, 90 minutes before they were killed. Bone marrow cells were routinely processed by the standard procedure and slides were coded and stained in diluted Giemsa.
For chromosomal aberration analysis, four animals were used per point. Hundred well spread metaphase plates were scored per animal (400 metaphase plates per treatment set) at random. The types of aberrations were scored. The percentages of damaged cells (% DC) and chromosomal aberrations per cell (CA/cell) values were calculated excluding gaps.
The test compound tartrazine is not mutagenic in the chromosomal aberration study conducted using Swiss albino mouse isolated bone marrow cells.
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