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EC number: 274-828-8 | CAS number: 70729-65-6
- 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 cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 20. June to 28. Oct 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- GLP compliance:
- yes
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- Methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
- EC Number:
- 274-828-8
- EC Name:
- Methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
- Cas Number:
- 70729-65-6
- Molecular formula:
- C22H24N6O9
- IUPAC Name:
- methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Disperse Red 311
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zeneca Barriered Animal Breeding Unit (BABU), Alderley Park, Macclesfield
- Diet (e.g. ad libitum): Porton Combined Diet , ad libitum
- Water (e.g. ad libitum): Filtered tap water, ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: 0.5% (w/v) hydroxy propyl methyl cellulose in 0.1% aqueous polysorbate 80
- Justification for choice of solvent/vehicle: Forms good suspension
- Concentration of test material in vehicle: 125 and 200 mg/mL
- Amount of vehicle: 10 mL/kg bw - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dosing suspensions of the test substance were prepared in 0.5% (w/v) hydroxy propyl methyl cellulose in 0.1% aqueous polysorbate 80
A solution of dimethylhydrazine dihydrochloride was prepared in deionised water. - Duration of treatment / exposure:
- 16 h
- Frequency of treatment:
- Single dose
- Post exposure period:
- 2 and 16 h after treatment
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 250 mg/kg bw (total dose)
- Dose / conc.:
- 2 000 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 5 males/dose in treatment groups
2 males/experiment in vehicle and positive control group - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Dimethylhydrazine dihydrochloride
- Route of administration: oral, gavage
- Doses / concentrations: 30 mg/kg bw (3 mg/mL)
Examinations
- Tissues and cell types examined:
- Hepatocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Based on acute oral toxicity study in rats (recently conducted study in same lab), in which the acute MTD for the test substance was >2000 mg/kg
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Single oral dose by oral gavage. Slides from the animals were subsequently analysed. Of the two positive and two vehicle control animals in each experiment, only one of each was scored for induction of UDS
DETAILS OF SLIDE PREPARATION: Preparation of hepatocytes were made 2 or 16 h after dosage. Hepatocytes were prepared from treated animals by a two stage collagenase perfusion technique. Hepatocyte cultures were prepared by allowing cells to attach to plastic cover slips. Medium was removed from the dishes and replaced with fresh medium containing [3H] thymidine. After 4 h incubation at 37 °C within a 5% CO2/95% air (v/v) atmosphere, the medium was removed, the cells washed three times with medium containing unlabelled thymidine and the cultures incubated overnight with the same medium. Cultures were fixed and coverslips mounted onto microscope slides. Slides were coated with photographic emulsion and left for 14 d at 4 °C in the dark. The emulsion was developed, fixed and the cell nuclei and cytoplasm stained with Meyers haemalum and eosin Y phloxine.
Slides were examined microscopically for signs of undue cytotoxicity to enable selection of those to be examined for UDS.
METHOD OF ANALYSIS: Prior to microscopic assessment, all slides were furnished with code numbers, so that the counting was blind. The following counts were made:
- 30 morphologically normal cells/slide and a total of 60 cells/animal.
- The nuclear count (the number of silver grains over the nucleus) and the cytoplasmic count (the number of grains in an adjacent, nuclear sized, most heavily labelled area of cytoplasm) were measured using an automated image analyser (AMS 40-10) and the data captured directly into a computer.
- The mean net grain count (nuclear count - cytoplasmic count), the mean nuclear count and cytoplasmic counts and the percent of cells in repair (net grain count of 5 or greater) to be calculated. - Evaluation criteria:
- Criteria for a positive response:
- A mean animal net nuclear grain count [N-C] value of greater than zero represents a biologically significant departure from normal.
- The radiolabelling of the nucleus exceeds that of the cytoplasm, indicating of a real net synthesis of nuclear DNA
Criteria for a negative response:
- The mean net nuclear grain count of all test substance treated animals is less than 0.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- Colouration of the urine was observed in animals dosed with Disperse Red 311
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: >2000 mg/kg in acute oral study
RESULTS OF DEFINITIVE STUDY
- Animal Toxicity: No significant signs of acute toxic effects.
Others:
Treatments with Disperse Red 311 in no case resulted in a mean net nuclear grain count greater than zero, at either time point investigated.
Colouration of the urine was observed in animals dosed with Disperse Red 311, which clearly indicates that the test material was absorbed following administration via the oral route.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test substance did not induce DNA repair in rat liver in vivo up to a limit dose of 2000 mg/kg bw
- Executive summary:
Disperse Red 311 was tested for the ability to induce unscheduled DNA synthesis (UDS) in an in vivo rat hepatocyte assay. Male Alpk:APfSD rats were treated with a single oral dose of Disperse Red 311 by gavage at dose levels of 1250 or 2000 mg/kg bodyweight. The latter dose level is the limit dose level for this assay. Animals were killed and hepatocytes isolated and prepared two and sixteen hours after dosing. Two independent experiments were carried out for each time point.
Hepatocytes from treated rats were exposed to [3H]-thymidine and the amount of radioactivity incorporated into the nucleus and an equal area of cytoplasm determined by autoradiography. The cytoplasmic grain count was subtracted from that of the nucleus. The value obtained, the mean net nuclear grain count [N-C], is an index of UDS activity. In this laboratory no negative control animal has shown a mean net nuclear grain count of greater than zero. An [N-C] value of greater than zero is therefore considered indicative of a UDS response.
Each experiment was validated by concurrent control treatments of rats with 0.5% (w/v) hydroxy propyl methyl cellulose in 0.1% aqueous polysorbate 80, the vehicle for Disperse Red 311 and with the carcinogen dimethylhydrazine dihydrochloride [DMH.2HC1]. Vehicle-treated rats gave rise to mean net nuclear grain counts of less than zero, whilst hepatocytes from DMH.2HC1-treated animals had mean net nuclear grain counts of greater than +5. These data show that the Background levels of UDS in this study were normal and that the test animals were responsive to a known carcinogen requiring metabolic activation for the demonstration of genotoxic activity.
Hepatocytes from Disperse Red 311 treated animals were assessed for UDS at both dose levels tested. Treatments with Disperse Red 311 in no case resulted in a mean net nuclear grain count greater than zero, at either time point investigated.
Colouration of the urine was observed in animals dosed with Disperse Red 311, which clearly indicates that the test material was absorbed following administration via the oral route.
It is concluded that, when tested up to a limit dose level of 2000 mg/kg, the test sample of Disperse Red 311 did not induce DNA repair (as measured by unscheduled DNA synthesis) in rat liver.
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