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EC number: 201-663-0 | CAS number: 86-30-6
- 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Dose-response curves for liver DNA fragmentation induced in rats by sixteen N-nitroso compounds as measured by viscometric and alkaline elution analyses
- Author:
- Brambilla G, Carlo P, Finollo R, Sciaba L.
- Year:
- 1 987
- Bibliographic source:
- Cancer Research 47, 3485-3491, July 1
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A new viscometric technique, capable of detecting DNA strand breaks and alkali-labile sites by monitoring time-dependent changes of DNA-reduced viscosity, has been used to analyse dose-response curves for the induction of DNA damage in liver of rats treated with single p.o. doses.
The contemporary measurement of liver DNA fragmentation by the alkaline elution technique revealed hat in the experimental conditions higher doses are needed to produce statistically significant increase of DNA elution rate. This suggests that the viscometric method is capable of detecting smaller levels of N-nitroso compound induced DNA fragmentation. - GLP compliance:
- no
- Type of assay:
- other: DNA fragmentation
Test material
- Reference substance name:
- Nitrosodiphenylamine
- EC Number:
- 201-663-0
- EC Name:
- Nitrosodiphenylamine
- Cas Number:
- 86-30-6
- Molecular formula:
- C12H10N2O
- IUPAC Name:
- N-nitroso-N-phenylaniline
Constituent 1
- Specific details on test material used for the study:
- Abbreviation in the publication : NDPHA
molecular weight : 198.2 g/mol
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 160-180g
- Assigned to test groups randomly: yes
- Fasting period before study: 12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Nitrosodiphenylamine was suspended in distilled water with 1% carboxymethyl cellulose
- Details on exposure:
- A single dose was administered by gavage in 0.01 ml of vehicle/g of body weight.
- Duration of treatment / exposure:
- only one treatment
- Frequency of treatment:
- only one treatment
- Post exposure period:
- Rats were sacrified 3h after treatment.
Doses / concentrations
- Dose / conc.:
- 540 mg/kg bw/day
- Remarks:
- corresponding of one-third of LD50
- No. of animals per sex per dose:
- Control groups : 20 rats
Treated groups : 3 rats - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- no
Examinations
- Tissues and cell types examined:
- Liver cells
- Details of tissue and slide preparation:
- Liver cell nuclei of treated and control rats were obtained by liver perfusion, and analyzed viscometrically in alkaline conditions (pH 12.5) at high ionic strength (I = 1.08). The cells harvested with the procedure used were predominantly of the lobular prenchyma. The number of nuclei lysed in the circular channel of the viscometer ranged from 6 to 7 x 10^7.
Results are expressed as reduced viscosity that is the viscosity of DNA solution for conentration units of DNA, determined at the end of each experiment.
To obtain quantitative parameters, viscosity measurements were performed at 20 and 40-min intervals.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Additional information on results:
- Fragmentation of rat liver DNA :
DNA damage was absent in the liver of rats given 540 mg/kg of nitrodiphenylamine.
% DNA eluted from the filter : 19.2 +/-6.3
DNA elutation rate over controls : 0.0020
Effet of nitrosodiphenylamine on viscometric behavior of rat liver DNA :
The time required for DNA reduced viscosity to reach 95% = T95 = 1411 min +/-88 min
Reduced viscosity at 95% = 3.05 +/-0.11 (x10-2 dl/g)
Slope = 0.22 +/- 0.03 x 10-2
Applicant's summary and conclusion
- Conclusions:
- DNA damage was undetectable in liver of rats treated with 540 mg/kg of nitrosodiphenylamine, that exhibited a plateau effect.
- Executive summary:
A new viscometric technique, capable of detecting DNA strand breaks and alkali-labile sites by monitoring time-dependent changes of DNA-reduced viscosity, has been used to analyse dose-response curves for the induction of DNA damage in liver of rats treated with single p.o. doses.
The contemporary measurement of liver DNA fragmentation by the alkaline elution technique revealed hat in the experimental conditions higher doses are needed to produce statistically significant increase of DNA elution rate. This suggests that the viscometric method is capable of detecting smaller levels of N-nitroso compound induced DNA fragmentation.
With both techniques, DNA damage was undetectable in liver of rats treated with 540 mg/kg of nitrosodiphenylamine, that exhibited a plateau effect.
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