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Reaction mass of 1,5-Naphthalenedisulfonic acid, 3,3'-[(4-methyl-1,2-phenylene)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino[2-(acetylamino)-5-methoxy-4,1-phenylene]-2,1-diazenediyl]]bis-, sodium salt (1:4) and 1,5-Naphthalenedisulfonic acid, 3,3'-[(3-methyl-1,2-phenylene)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino[2-(acetylamino)-5-methoxy-4,1-phenylene]-2,1-diazenediyl]]bis-, sodium salt (1:4)
EC number: 947-857-5 | CAS number: -
- 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
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Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
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
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Yellow 138:1 Na/K
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ICI Barriered Animal Breeding Unit (BABU), Alderley Park, Macclesfield.
- Age at study initiation: 6-8 weeks
- Assigned to test groups randomly: the animals were allocated according to the order in which they were removed from the stock cage
- Housing: 5/cage
- Diet (e.g. ad libitum): Porton Combined Diet , ad libitum
- Water (e.g. ad libitum): Filtered tap water, ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- The vehicle for the test agent and negative control substance was deionised water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: For dosage,the test substance was dispersed in deionised water by homogenisation. Concentrations prepared for UDS assay were 125 and 200mg/mi. All dosing preparations were administered at a volume of 10 mL/kg bw.
2-AAF was prepared as a 2.5mg/mi suspension in 0.5% hydroxypropylmethyl cellulose in 0.1% aqueous PS80 (HPMC) by high speed homogenisation. DMH.2HCl was dissolved at 3 mg/mL in deionised water by hand shaking. All dose solutions were used within a day of preparation. - Duration of treatment / exposure:
- Preparation of hepatocytes took place 2 or 16 hours after dosage.
- Frequency of treatment:
- Single dose
- Post exposure period:
- 2 and 16 h
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- preliminary study: 5 (treatment group only)
5 males/dose in treatment groups
2 males/group in vehicle and positive control groups - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Positive control substances were 2-acetylaminofluorene (2-AAP) for 16 hour treatments and dimethylhydrazine dihydrochloride (DMH.2HCl) for 2 hour treatments.
Examinations
- Tissues and cell types examined:
- Hepatocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Based on a preliminary study, in which the acute MTD for the test substance was >2000 mg/kg
DETAILS OF SLIDE PREPARATION: Hepatocytes were prepared from treated animals by a two stage collagenase perfusion technique. Hepatocyte cultures were prepared by allowing cells to attach to plastic coverslips.
Medium was removed from the dishes and replaced with fresh medium containing [3H] thymidine. After approximately 4 hours incubation at 37°C within a 5% CO2/95% (v/v) air atmosphere, the medium was removed, the cells washed three times and the cultures incubated overnight with medium containing an excess of unlabelled thymidine.
Cultures were fixed and coverslips mounted onto microscope slides. Slides were coated with photographic emulsion and left for 14 days 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. Slides were scored under code.
Coded hepatocyte preparations were examined for the induction of UDS using a microscope-mounted image analyser linked to a computer for data analysis
METHOD OF ANALYSIS: The number of silver grains over the nucleus [N] was determined. Then an equivalent area of cytoplasm tangential to the nucleus and with the highest apparent number of silver grains was scored [C]. The difference between these two values [N-C] was the net nuclear grain count. Appendix C shows the total number of cells scored for each animal.
Normally 60 cells were scored from each animal using two slides. The third slide was not normally read, unless a total of 60 cells could not be obtained from the first two slides examined. - 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:
- orange discolouration of urine and internal organs served as proof for exposure
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
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:
The test substance was tested for the ability to induce unscheduled DNA synthesis (UDS) in an in vivo rat hepatocyte assay incorporating an autoradiographic technique. Male rats were given a single oral dose by gavage at 1250 or 2000 mg/kg body weight. The highest test treatment, 2000 mg/kg, was the limit dose for this assay. Two sampling times were used, 2 hours and 16 hours following administration of the chemical. Two independent experiments were carried out at each time point, validated by concurrent control treatments of rats with the vehicle and with the carcinogens 2-acetylaminofluorene (2-AAF) or dimethylhydrazine dihydrochloride (DMH.2HCl).
Hepatocytes from treated rats were assessed for the induction of UDS at both dose levels, 1250 and 2000 mg/kg bw. Examination of the mean net nuclear grain count and percentage of cells in repair showed that the test substance did not induce DNA repair, as measured by UDS, at either dose level or time point.
It is concluded that, when tested up to a limit dose of 2000 mg/kg, the test substance did not induce DNA repair in the liver of the rat in vivo.
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