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reaction mass of: trisodium 3-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate; trisodium 3-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate
EC number: 436-890-6 | 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
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:
- key study
- Study period:
- 1998-08-17 to 1998-09-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- -
- EC Number:
- 436-890-6
- EC Name:
- -
- Molecular formula:
- C27H18F3N10Na3O11S3
- IUPAC Name:
- hexasodium 3-(2-{5-[(2,6-difluoropyrimidin-4-yl)amino]-2-sulfophenyl}diazen-1-yl)-5-{[4-fluoro-6-(morpholin-4-yl)-1,3,5-triazin-2-yl]amino}-4-hydroxynaphthalene-2,7-disulfonate 3-(2-{5-[(4,6-difluoropyrimidin-2-yl)amino]-2-sulfophenyl}diazen-1-yl)-5-{[4-fluoro-6-(morpholin-4-yl)-1,3,5-triazin-2-yl]amino}-4-hydroxynaphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- see below
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann Gartenstr. 27; D-33178 Borchen
- Age at study initiation: approximately 7 weeks
- Weight at study initiation: M=34.6g; F=27.g
- Assigned to test groups randomly: yes, randomization schemes 98.0665 and 98.0666
- Fasting period before study:- Housing: in fully air-conditioned rooms in makrolon cages type 3 (five animals per cage) on soft wood granulate
- Diet (e.g. ad libitum): rat/mice diet ssniff RIM-H (V 1534), ad libitum ssniff GmbH, Postbox 2039, 59480 Soest
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3 degrees C
- Humidity (%): 50± 20%
- Light/dark cycles: 12 hours daily
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- deionized water
- Details on exposure:
- The test substance was administered once orally by gavage to the test animals at doses of 0 or 2000 mg per kg body weight. The vehicle, deionized water, was administered in the same way to the negative control groups. The study included a concurrent positive control using Endoxan, which was administered once orally by gavage at a dose of 50 mg per kg body weight. Following dosing, the animals were examined regularly for mortality and clinical signs of toxicity.
- Duration of treatment / exposure:
- According to the test procedure the animals were killed 24 or 48 hours after administration
- Frequency of treatment:
- once
- Post exposure period:
- 24 or 48h
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day
- No. of animals per sex per dose:
- Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- The study included a concurrent positive control using Endoxan, which was administered once orally by gavage at a dose of 50 mg per kg body weight.
Examinations
- Tissues and cell types examined:
- bone marrow cells
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
In a preliminary dose range finding study, oral administration of 2000 mg Reactive Red FC73270 per kg body weight did not cause any toxic effects in male and
female mice over an observation period of 7 days. This dose level was therefore the regularly limit dose, selected as the highest dose for the main study.
DETAILS OF SLIDE PREPARATION: Animals were killed by carbon dioxide asphyxiation 24 or 48 hours after dosing. For each animal, about 3 ml fetal bovine serum was poured into a centrifuge tube. Both femora were removed and the banes freed of muscle tissue. The proximal ends of the femora were opened and the bone marrow flushed into the centrifuge tube. A suspension was formed. The mixture was then centrifuged for 5 minutes at approx. 1200 rpm, after which almost all the supernatant was discarded. One drop of the thoroughly mixed sediment was smeared onto a cleaned slide, identified by project code and animal number and air-dried for about 12 hours.
Staining was performed as follows:
-5 minutes in methanol
-5 minutes in May-Grünwald' s solution
-brief rinsing twice in distilled water
-10 minutes staining in 1 part Giemsa solution to 6 parts buffer solution,
-pH 7.2 (Weise)
-rinsing in distilled water
-drying
-coating with Entellan
METHOD OF ANALYSIS:
2000 polychromatic erythrocytes were counted for each animal. The number of cells with micronuclei was recorded, not the number of individual micronuclei. In addition, the ratio of polychromatic erythrocytes to 200 total erythrocytes was determined. - Evaluation criteria:
- A substance is considered as positive if there is a significant dose-related increase in the number of micronucleated polychromatic erythrocytes for at least one of the time points compared with the concurrent negative control group. A test substance producing no significant dose-related increase in the number of micronucleated polychromatic erythrocytes is considered non-mutagenic in this system.
- Statistics:
- A one-sided Wilcoxon-Test was evaluated to check the validity of the study
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- All animals survived after treatment, no signs of toxicity were observed besides observingred-colored feces. Upon dissection there were no macroscopic findings.
Any other information on results incl. tables
Sex | Dose [mg/kg b.w.] |
killing time |
Number of animals |
Poly counted | Poly/Ery Mean |
Poly/Ery SD Mean |
Poly with MN Mean |
Poly with MN [%] Mean |
Poly with MN SD Mean |
Mut. I. |
pooled | 0 - Control | 24 h | 10 | 2000 | 0,50 | 0,07 | 2,00 | 0,1 | 0,04 | 1,0 |
pooled | 2000 | 24 h | 10 | 2000 | 0,49 | 0,05 | 1,70 | 0,1 | 0,05 | 0,9 |
pooled | 50 - Endoxan | 24 h | 10 | 2000 | 0,49 | 0,10 | 59.70* | 3,0 | 0,64 | 29,9 |
Mut. I. = Mutagenic Index Control = Vehicle (deionized water) * = significantly different from control (p < 0.05) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Reactive Red FC73270 did not lead to a substantial increase of micronucleated polychromatic erythrocytes and is not mutagenic in the micronucleus test under the conditions. - Executive summary:
In a NMRI mouse bone marrow micronucleus assay, 5 animals/sex/dose were treated via oral gavage with Reactive Red FC73270 at doses of 0 or 2000 mg/kg bw. Bone marrow cells were harvested at 24 or 48 hours post-treatment. The vehicle was deionized water.
There were no signs of toxicity during the study. Reactive Red FC73270 was tested at an adequate dose based on previous studies. The positive control induced the appropriate response. There was no significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow.
This study is classified as acceptable and satisfies the requirement for Test Guideline OECD 474 for in vivo cytogenetic mutagenicity data.
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