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EC number: 240-012-5 | CAS number: 15876-58-1
- 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 / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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:
- Micronucleus Tests in Mice on 39 Food Additives and Eight Miscellaneous Chemicals
- Author:
- M. Hayashi, M. Kishi, T. Sofuni And M. Ishidate, Jr
- Year:
- 1 988
- Bibliographic source:
- Food Chem Toxicol., 26(6), 487-500
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Micronucleus test of Phloxine (Acid Red 92) in mice
- GLP compliance:
- not specified
- Type of assay:
- other: In vitro mammalian micronucleus assay
Test material
- Reference substance name:
- Dipotassium 3,6-dichloro-2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Cas Number:
- 6441-77-6
- Molecular formula:
- C20H6Br4Cl2O5.2K
- IUPAC Name:
- Dipotassium 3,6-dichloro-2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of the test material: Food Red No.104 (phloxine)
- IUPAC name: Dipotassium 3,6-dichloro-2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Molecular weight: 792.9646 g/mol
- Molceular Formula: C20H6Br4Cl2O5.2K
- Substance type: Organic
- Purity: No data
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material: CI Food Red 92
- IUPAC name: Dipotassium 3,6-dichloro-2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Molecular weight: 792.9646 g/mol
- Molceular Formula: C20H6Br4Cl2O5.2K
- Substance type: Organic
- Purity: No data
Test animals
- Species:
- mouse
- Strain:
- other: ddY
- Details on species / strain selection:
- No data
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Agriculture Cooperative Association for Laboratory Animals, Shizuoka
- Age at study initiation: 8 weeks
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): CE-2 food pellets, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimatization period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%): No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: Saline
- Justification for choice of solvent/vehicle: The test chemical was soluble in saline
- Concentration of test material in vehicle: 0, 30, 60 or 120 mg/Kg
- Amount of vehicle (if gavage or dermal): No data
- Type and concentration of dispersant aid (if powder): No data
- Lot/batch no. (if required): No data
- Purity: No data - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Prior to treatment, the test compound was dissloved in saline at dose levels of 0, 30, 60 or 120 mg/Kg
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Saline
- Concentration in vehicle: 0, 30, 60 or 120 mg/kg
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Duration of treatment / exposure:
- 24 hours (when exposed to only one injection) or 96 hours (when injected 4 times with 24 hrs apart)
- Frequency of treatment:
- Once ((when exposed to only one injection) or 4 times (with 24 hrs apart each injection)
- Post exposure period:
- No data available
Doses / concentrations
- Remarks:
- Doses/Concentrations: 0, 30, 60 or 120 mg/kg (when injected only once) or 60 mg/kg (when injected 4 times 24 hrs apart)
- No. of animals per sex per dose:
- Total: 30 mice
Control: 6 males
30 mg/kg: 6 males
60 mg/kg: 12 males
120 mg/kg: 6 males - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C
- Justification for choice of positive control(s): No data
- Route of administration: Intraperitoneal
- Doses / concentrations: 2.0 mg/Kg
Examinations
- Tissues and cell types examined:
- Femoral cells were observed for the presence of micronucleated polychromatic erythrocytes (MNPCEs)
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The maximum doses of the test compounds were determined by pilot experiments using the multisampling at multi-dose levels method. For some chemicals, which had not been subjected to the pilot experiments, the maximum dose levels were set at the supposed maximum tolerated dose referring to the LDs0
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 24 hrs or 96 hrs
DETAILS OF SLIDE PREPARATION: Femoral marrow cells were flushed out with foetal bovine serum and smeared on clean glass slides. Cells were fixed with methanol for 5 min, and stained with Acridine Orange for the pilot experiment and with Giemsa for the full-scale test.
METHOD OF ANALYSIS: The preparations were coded and analysed without any knowledge of the treatment. One thousand polychromatic erythrocytes per mouse were scored using a light microscope, with a high power objective (x 100), and the number of micronucleated polychromatic erythrocytes (MNPCEs) was recorded. The proportion of polychromatic erythrocytes (PCEs) among the total erythrocytes was also evaluated by observing 1000 erythrocytes on the same slide.
OTHER: No data - Evaluation criteria:
- One thousand polychromatic erythrocytes per mouse were scored using a light microscope, and the number of micronucleated polychromatic erythrocytes (MNPCEs) was recorded. The proportion of polychromatic erythrocytes (PCEs) among the total erythrocytes was also evaluated by observing 1000 erythrocytes on the same slide.
- Statistics:
- A two-stage statistical procedure was used. In the first step of the procedure, the frequency of MNPCEs in each treatment group was compared with the binomial distribution specified by historical control data from the laboratory where the test was performed. In the second step, the dose-response relationship was tested by the Cochran-Armitage trend test. A positive result was recorded only when one or more treatment group(s) showed a statistically significant difference from the spontaneous level of MNPCEs and the trend test indicated a positive dose response. This procedure was not applied to tests with multiple treatments which, in most cases, contained only one dose group. Such data were evaluated statistically using the first step only.
A Monte-Carlo simulation study showed that the probability of a type I error (the probability of a false positive), in this two-step procedure was, in general, closer to the nominal significance level than that of the usual conditional binomial testwhich has been widely used to evaluate micronucleus test data. Similarly, this method was a more powerful method of analysis than the conditional binomial test.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No mutagenic potential
- Additional information on results:
- No data
Any other information on results incl. tables
Table: Results of the micronucleus test using mouse bone marrow cells
Chemical |
Vehicle |
Route |
No. of doses |
Time between doses (hr) |
Sampllng time (hr) |
Dose level (mg/Kg) |
MNPCE (%) |
PCE (%) |
Mortality |
Trend test |
CI Food red 92 |
Saline |
ip |
1 |
|
24 |
0 |
0.20±0.13 |
56.9 ± 5.6 |
0/6 |
NS |
|
|
|
|
30 |
0,22 ± 0.18 |
55.3 ± 5.2 |
0/6 |
|||
|
|
|
|
60 |
0.23 ± 0.14 |
40.9 ± 16.5 |
0/6 |
|||
|
|
|
|
120 |
0.08±0.11 |
37.7 ± 7.0 |
0/6 |
|||
|
|
|
|
MMC 2.0 |
6.48 ± 1.87* |
37.8 ± 6.1 |
0/6 |
|||
ip |
4 |
24 |
24 |
60 |
0.25 ± 0.12 |
67.0 ± 5.5 |
0/6 |
Applicant's summary and conclusion
- Conclusions:
- Food Red 92 (Phloxine) is considered to be non-mutagenic in male ddY mice since no mutagenic effects were seen in a micronucleus test.
- Executive summary:
In the in vivo micronucleus test performed Acid Red 92 (Phloxine) was investigated in male ddY mice for mutagenicity. The test chemical was administered by intraperitoneal injection once (at doses 0, 30, 60 or 120 mg/kg) or 4 times 24 hours apart (at a dose of 60 mg/kg/injection). Femoral marrow cells were flushed out with foetal bovine serum and smeared on clean glass slides. Cells were fixed with methanol for 5 min, and stained with Acridine Orange for the pilot experiment and with Giemsa for the full-scale test. One thousand polychromatic erythrocytes per mouse were scored using a light microscope. After treatment, the number of micronucleated polychromatic erythrocytes (MNPCEs) was recorded and the proportion of polychromatic erythrocytes (PCEs) among the total erythrocytes was evaluated. Based on the results, no mutagenic effects could be detected. Therefore, Acid Red 92 is considered to be non-mutagenic when male ddY mice were exposed to the test chemical.
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