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Diss Factsheets
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EC number: - | 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 cell study: DNA damage and/or repair
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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)
- Deviations:
- yes
- Remarks:
- limited given data
- GLP compliance:
- yes
- Remarks:
- HAZLETON LABORATORIES AMERICA, INC.
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex
- EC Number:
- 400-720-9
- EC Name:
- Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex
- Cas Number:
- 126851-40-9
- Molecular formula:
- C22H11FeN6NaO10S.H2O
- IUPAC Name:
- Monosodium aqua-[(5-((E)-(5-((Z)-(3,5-dinitro-2-oxidophenyl)diazenyl)-2-hydroxy-4-oxidophenyl)diazenyl)naphthalene-2-sulfonate)ferrate(-)]
- Test material form:
- solid: particulate/powder
1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc.
- Age at study initiation: adult
- Weight at study initiation: 150 - 300 g
- Assigned to test groups randomly: yes
- Diet (e.g. ad libitum): Purina Certified Rodent Chow (Formula 5002); ad libitum
- Water (e.g. ad libitum): water; ad libitum
- Acclimation period: minimum of 5 days prior to use
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Amount of vehicle (if gavage or dermal): 9 ml/kg bw - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Fresh preparations of test article in vehicle were used for any testing purpose. - Duration of treatment / exposure:
- 4 h
- Frequency of treatment:
- single application
- Post exposure period:
- 4 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1000, 2000, 4000 mg/kg bw
Basis:
nominal in water
- No. of animals per sex per dose:
- 3 animals/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Dimethylnitrosamine (DMN)
- Justification for choice of positive control(s): known to induce UDS in vivo in rat hepatocytes
- Route of administration: intraperitoneal
- Doses / concentrations: ca. 10 mg/kg bw
Examinations
- Tissues and cell types examined:
- hepatocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
In the preliminary study to determine dose and perfusion time, an attempt was made to gavage two animals with 5000 mg/kg, but the test material formed a sludge in CMC that could not be forced through a syringe. The highest dose that could be administered was between approximately 3200 mg/kg and 3400 mg/kg although one animal died due to gavage back up. The amount administered was not exact because the sludge was difficult to measure. One rat was sacrificed (liver perfusion) approximately 4.5 hours later and the other approximately 15 hours later and slides were prepared for UDS. Microscopic examination of the slides prepared at the two time points indicated that they were similar. It was decided that the UDS assay would be performed approximately 4 hours after administration of a single dose of the test material.
DETAILS OF SLIDE PREPARATION:
UDS based on the procedures in rats described by Williams (1980) and Mirsalis, Tyson and Butterworth (1982): Briefly, isolated hepatocytes were cultured for 1.5 to 2 hours at 37°C in a humidified atmosphere containing 5 % C02. Three of the replicate cultures from each animal were used for the UDS assay, thus labeld and fixed with acetic acid : ethanol (1:3) and dried for at least 24 hours.
METHOD OF ANALYSIS:
The cells were examined microscopically at approximately 1500x magnification under oil immersion and the field was displayed on the video screen of an automatic counter. UDS was measured by counting nuclear grains and subtracting the average number of grains in three nuclear-sized areas adjacent to each nucleus (background count). This value is referred to as the net nuclear grain count. The coverslips were coded to prevent bias in grain counting. The net nuclear grain count was determined for 50 randomly selected cells on each coverslip. Only nuclei with normal morphologies were scored, and any occasional nuclei blackened by grains too numerous to count were excluded as cells in which replicative DNA synthesis occurred rather than repair synthesis. The mean net nuclear grain count was determined from the triplicate coverslips (150 total nuclei) for each treatment condition. Occasionally, a coverslip is recounted at a later date or by a different technician. Since a different cell population will generally be scored, the average count for 50 cells was used in the calculation of the mean for the triplicate treatment. - Evaluation criteria:
- The test material is considered active in the UDS assay at applied concentrations that cause:
- an increase in the mean net nuclear grain count to at least six grains per nucleus after subtraction of the concurrent negative control value, and/or
- an increase in the percent of nuclei having 6 or more net grains to at least 10% of the analyzed population after subtraction of the concurrent negative control value, and/or
- the percent of nuclei with 20 or more grains to reach or exceed 2% of the analyzed population
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 3200 - 5000 mg/kg bw
- Solubility: material formed a sludge in CMC that could not be forced through a syringe at 5000 mg/kg bw
Any other information on results incl. tables
Results:
Test condition | Dose Level | Animal | UDS grains/nucleus | Average* % nuclei with | |
>= 6 grains | >= 20 grains | ||||
water | - | 1 | 0.45 ± 0.18 | 0.7 | 0.0 |
2 | -0.43 ± 0.10 | 0.7 | 0.0 | ||
3 | -0.163 ± 1.59 | 0.7 | 0.0 | ||
DMN | 10 mg/kg bw | 1 | 25.22 ± 8.79 | 94.7 | 64.7 |
2 | 15.47 ± 2.65 | 83.3 | 41.3 | ||
3 | 17.2 ± 7.8 | 84.0 | 41.3 | ||
Saeurebraun 6229 | 4000 mg/kg bw | 1 | 0.36 ± 0.52 | 2.0 | 0.0 |
2 | -0.08 ± 0.73 | 0.0 | 0.0 | ||
3 | 0.08 ± 0.66 | 0.7 | 0.0 | ||
2000 mg/kg bw | 1 | -1.32 ± 0.50 | 0.7 | 0.0 | |
2 | -1.00 ± 0.76 | 0.0 | 0.0 | ||
3 | -1.03 ± 1.02 | 0.7 | 0.0 | ||
1000 mg/kg bw | 1 | -1.49 ± 0.57 | 0.0 | 0.0 | |
2 | -1.11 ± 0.88 | 5.3 | 0.0 | ||
3 | -0.57 ± 0.60 | 0.0 | 0.0 | ||
5000 mg/kg bw | 1 | -0.20 ± 0.20 | 1.3 | 0.0 | |
2 | -1.18 ± 0.39 | 0.0 | 0.0 | ||
3 | -0.92 ± 0.75 | 1.3 | 0.0 |
UDS: Average of net nuclear grain counts on triplicate coverslips (150 total cells), ± standard deviation between coverslips
*: Average values for triplicate coverslips
Applicant's summary and conclusion
- Conclusions:
- The substance was tested for genotoxicity following OECD 486. The tets substance was inactive in the in-vitro/in-vivo Rat Epatocyte UDS Assay over a dosing range of about 500 to 4000 mg/kg.
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