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EC number: 269-887-1 | CAS number: 68385-96-6
- 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 somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 08 Oct - 25 Nov 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- N-[2-[(2,6-dicyano-p-tolyl)azo]-5-(diethylamino)phenyl]methanesulphonamide
- EC Number:
- 269-887-1
- EC Name:
- N-[2-[(2,6-dicyano-p-tolyl)azo]-5-(diethylamino)phenyl]methanesulphonamide
- Cas Number:
- 68385-96-6
- Molecular formula:
- C20H22N6O2S
- IUPAC Name:
- N-[2-[(2,6-dicyano-p-tolyl)azo]-5-(diethylamino)phenyl]methanesulphonamide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals used were young adult male and virgin female mice, bred and supplied by F. Winkelmann, Borchen. They initially weighed 29-40 g, and were thus approximately 8 to 12 weeks of age.
The bread's state of health is regularly spot-checked for the major specific pathogene.
On the day of arrival, (Sept 27, 1991), the health of the animals was appraised before acclimatising them to the housing conditions for a period of at least one week. Only healthy animals without symptoms were used in the study.
They were kept in the group of a maximum of three to five mice, separated by sex and test group, in makrolon type I and II cages, using bedding of soft wood granules type S 8/15.
Husbandry was standardized, with twelve hours of electrical lighting daily (6.00 am to 6.00 pm), 21 - 23 °C room temperature, and 51 - 55 % mean relative humidity.
Setting for the animal room.22 ± 2 °C (rising with outside temperature above 24 °C).
At least 50 % humidity (rising with high absolute outside humidity), and air change at least ten times per hour.
Fixed-formula feed was Altromin 1324 standard Diet.
Water: drinking water quality.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- suspension in 0.5 % aqueous Cremophor emulsion
- Duration of treatment / exposure:
- treatment: 24, 48 and 72 hrs
controls: 24 hours - Frequency of treatment:
- once
Doses / concentrations
- Dose / conc.:
- 10 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Positive control: Cyclophosphamide
- Route of administration: i.p.
- Doses / concentrations: 20 mg/kg bw
Examinations
- Tissues and cell types examined:
- bone marrow (from femur)
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
The selection of the test item was based on a pilot test, in which groups of five animals, including both males and females, were intraperitoneally administered 5000 mg/kg and 10000 mg/kg. No animals died. In addition the following symptoms were recorded, starting at 5000 mg/kg: apathy, roughened fur, staggering gait, spasm and reddish discoloured urine. Based on these results, 10000 mg/kg was chosen for the main test. - Evaluation criteria:
- Assessment criteria:
A test was considered positive if, at any of the intervals, there was relevant and significant increase in the number of polychromatic erythrocytes showing micronucleated in comparison to the negative control.
A test was considered negative if there was no relevant or significant increase in rats of micronucleated polychromatic erythrocytes at any time.
In addition, a test was considered equivocal if there was an increase of micronucleated polychromatic erythrocytes above the range of attached historical negative controls, provided the increase was not significant. A test was also considered equivocal if there was a significant increase in that rate which, according to the laboratory's experience was within the range of negative controls. In either case, a second test had to be performed at the most sensitive interval.
Assay Acceptance criteria:
An assay was considered acceptable if the figures of negative and positive controls were within the expected range, in accordance with the laboratory's experience.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Apathy, roughened fur, staggering gait, spasm, reddish discoloured urine
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no mortality
- Additional information on results:
- Assessment:
Normally, cells with micronuclei (Howell-Jolly bodies) occur in polychromatic erythrocytes with an incidence of up 2.5/1000. The increase in the polychromatic erythrocytes, due for example, to chromosome breaks or spindle disorders, is the criterion for clastogenic effects in this test model.
The results with the test item gave no relevant indications of clastogenic effects after a single intraperitoneal treatment with 10000 mg/kg bw.
Furthermore the known mutagen and clastogen cyclophosphamide, had a clear clastogenic effect at an intraperitoneal dose of 20 mg/kg bw. The number of micronucleated polychromatic erythrocytes increase to a biological relevant degree.
Applicant's summary and conclusion
- Conclusions:
- In a GLP study according to OECD test guideline 474, no indication of a clastogenic effect of 10000 mg/kg bw in the micronucleus test on the mouse was observed. The substance is not considered to be a clastogen in mammalia.
- Executive summary:
The micronucleus test was used in order to investigate the test item in male and female mice for a possible clastogenic effect on the chromosomes of bone-marrow erythroblasts. The known clastogen and cytostatic agent; i.e. cyclophosphamide, served as positive control.
The treated animals received a single intraperitoneal administration of either the test item or cyclophosphamide. The femoral marrow of groups treated with the test item was prepared 16, 24 and 48 hours after administration. All negative and positive control animals were sacrificed after 24 hours. The dose of the test item and the positive control, cyclophosphamide, were 10000 and 20 mg/kg body weight, respectively.
The animals treated with the test item, showed some symptoms of toxicity after administration. However all animals survived until the end of the test. There was an altered ratio between polychromatic and monochromatic erythrocytes.
No indications of a clastogenic effect of the test item were found after a single intraperitionael treatment with 10000 mg/kg bw. Furthermore the known mutagen and clastogen cyclophosphamide, the positive control, had a clear clastogenic effect at an intraperitoneal dose of 20 mg/kg bw as is shown by the biologically relevant increase in polychromatic erythrocytes with micronuclei. The ratio of polychromatic to monochromatic erythrocytes was not altered.
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