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EC number: 209-608-2 | CAS number: 587-98-4
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects Of Dyes (Indigo Carmine, Metanil Yellow, Fast Green FCF) And Nitrite In Vivo In Bone Marrow Chromosomes Of Mice
- Author:
- Ashok Kumar Giri, Tara Shankar Banerjee, Geeta Talukder And Archana Sharma
- Year:
- 1 986
- Bibliographic source:
- Cancer Letters, 30 (1986) 315-320
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- In vivo mammalian chromosome aberration assay was performed to determine the clastogenic nature of Metanil yellow
- GLP compliance:
- not specified
- Type of assay:
- other: In vivo mammalian bone marrow chromosome aberration assay
Test material
- Reference substance name:
- Sodium 3-(p-anilinophenylazo)benzenesulphonate
- EC Number:
- 209-608-2
- EC Name:
- Sodium 3-(p-anilinophenylazo)benzenesulphonate
- Cas Number:
- 587-98-4
- Molecular formula:
- C18H14N3O3S.Na
- IUPAC Name:
- sodium 3-(p-anilinophenylazo)benzenesulphonate
- Test material form:
- solid
- Details on test material:
- - Name of test material: Ext. D&C Yellow No. 1
- IUPAC name: sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Molecular formula: C18H15N3O3SNa
- Molecular weight: 375.383 g/mol
- Substance type: organic
- Physical state: solid
- Purity: No data available
- Impurities (identity and concentrations): no data available
Constituent 1
- Specific details on test material used for the study:
- Name of test material: Metanil yellow
- IUPAC name: sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Molecular formula: C18H15N3O3SNa
- Molecular weight: 375.383 g/mol
- Substance type: organic
- Physical state: solid
- Purity: No data available
- Impurities (identity and concentrations): no data available
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Remarks:
- Albino
- Details on species / strain selection:
- No data
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory bred animals were used for the study
- Age at study initiation: Between 90-100 days
- Weight at study initiation: 30 g approx..
- Assigned to test groups randomly: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%):No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Distilled water
- Justification for choice of solvent/vehicle: The chemical was soluble in distilled water
- Concentration of test material in vehicle: 0 or 2 mg/Kg bw
- Amount of vehicle (if gavage or dermal): 0.05mL
- Type and concentration of dispersant aid (if powder): No data
- Lot/batch no. (if required): No data
- Purity: No data - Details on exposure:
- For oral route
PREPARATION OF DOSING SOLUTIONS: Metanil yellow was dissolved in distilled water at dose level of 2 mg/Kg bw
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data - Duration of treatment / exposure:
- 30 days
- Frequency of treatment:
- Once, daily
- Post exposure period:
- No data
Doses / concentrations
- Remarks:
- 0 or 2 mg/Kg bw
- No. of animals per sex per dose:
- Total: 20
0 mg/Kg bw: 10 mice
2 mg/Kg bw: 10 mice - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- No data
Examinations
- Tissues and cell types examined:
- Bone marrow chromosomes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The dose in this experiment was calculated based on the idea that 200 ppm of the dye is allowed in food in India. The dose selected for dye depends on the assumption that a person can consume a maximum of about 100 mg of dye from foods every day. If a person weighing 50 kg consumes 100 mg of dye or nitrite per day then automatically the value comes to 2 mg/kg. These doses may appear a bit higher than normal human consumption, but
since the investigation was limited to only 30 days, it is conjectured that these doses were justified if the cumulative effects of these dyes on human beings for years was considered.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Afetr 30 days treatment with metanil yellow
DETAILS OF SLIDE PREPARATION: Colchicine (0.04%) was injected intraperitoneally at the rate of 1 ml/100 g body wt, 90 min before the animal was killed. For chromosome studies, flame dried preparations of bone marrow chromosomes were stained in Giemsa by the usual schedule
METHOD OF ANALYSIS: No data
OTHER: Chromosomal aberrations were scanned at the metaphase stage. - Evaluation criteria:
- Chromatid and chromosomal breaks, chromatid and chromosomal exchanges and cells with more than 10 aberrations were considered basically abnormal and hence scored accordingly.
The number of breaks per metaphase analysed Z/B, represents the fundamental index for comparison. In the Z/B category were the chromatid and chromosomal breaks, exchanges, dicentric chromosomes and cells with more than 10 aberrations. In qualitative evaluation the number of breaks were added in the following way: chromatid break, 1 break; chromosomal break, 1 break; chromosomal exchange, 2 breaks; dicentric chromosomes, 2 breaks; cells with more than 10 aberrations, 10 breaks. Gaps were not included - Statistics:
- No data
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- positive
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No data
Any other information on results incl. tables
TABLE 1
Chromosomal Aberrations Induced by Metanil yellow on Bone Marrow Cells of Mice
Substance |
Dose (mg/Kg bw) |
No. of animals |
na |
Aberrant cells |
Breaks |
Cells with 10 aberrations |
Z/Bb |
|
No. |
%`` |
|||||||
Distilled water (control) |
0 |
10 |
600 |
11 |
1.83 |
12 |
2 |
0.053 |
Metanil yellow |
2 |
10 |
600 |
89 |
14.83 |
44 |
55 |
0.990 |
an = number of cells analysed.
bZ/B = number of aberrations per cell
Applicant's summary and conclusion
- Conclusions:
- Metanil yellow induced chromosome aberrations in the bone marrow of Swiss albino male mice at a dose level of 2 mg/Kg bw and hence it is likely to be mutagenic in vivo.
- Executive summary:
In vivo mammalian chromosome aberration assay was performed to determine the clastogenic nature of Metanil yellow. Laboratory bred 10 Swiss albino male mice were given metanil yellow in distilled water by gavage at dose level of 0 or 2 mg/Kg bw once daily for 30 days.Controls were fed 0.05 ml of distilled water daily for 30 days. The animals were killed on the completion of 30 days treatment, starting from 0 day. Colchicine (0.04%) was injected intraperitoneally at the rate of 1 ml/100 g body wt, 90 min before the animal was killed.
For chromosome studies, flame dried preparations of bone marrow chromosomes were stained in Giemsa by the usual schedule. A total of 600 metaphase plates were scanned from the 10 animals killed in each set of experiments and the slides were observed for chromatid and chromosomal breaks, chromatid and chromosomal exchanges and number of breaks per metaphase was analysed by the Z/B ratio.
A significant increase in the frequency of the chromosomal aberrations (index Z/B) was found with metanil yellow treated series when compared with the controls.
Metanil yellow induced chromosome aberrations in the bone marrow of Swiss albino male mice at a dose level of 2 mg/Kg bw and hence it is likely to be mutagenic in vivo.
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