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EC number: 609-904-5 | CAS number: 41263-74-5
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 4-(methylamino)-3-nitrobenzoic acid
- EC Number:
- 609-904-5
- Cas Number:
- 41263-74-5
- Molecular formula:
- C8 H8 N2 O4
- IUPAC Name:
- 4-(methylamino)-3-nitrobenzoic acid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Frequency of treatment:
- single
- No. of animals per sex per dose:
- 5 male and female per dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test item BIBR 1048 Aminoacido
did not induce structural and/or numerical chromosomal damage in the immature erythrocytes of the mouse.
Therefore, the test item BIBR 1048 Aminoacido is considered to be nonmutagenic with respect to clastogenicity and/or aneugenicity in the
Mammalian Erythrocyte Micronucleus Test. - Executive summary:
This study was performed to investigate the potential of BIBR 1048 Aminoacido to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the mouse, which is the endpoint of this test to assess genotoxicity. The test item was prepared with Cottonseed oil. The volume administered ip was 10 mL/kg bw. Peripheral blood samples were collected for micronuclei analysis
44 h and 68 h after a single application of the test item. A pre-experiment was performed as range finding study based on the OECD guideline 474 and other relevant documents. A dose of 500 mg/kg bw was selected as maximum tolerable dose (MTD). Signs of toxicity were noted. In the main experiment three dose levels were used covering a range from the maximum tolerable dose to slight/or no toxicity. The following dose groups were selected based on the toxicity observed in the pre-experiment:
Doses Concentration [mg/kg bw] 1 MTD 500 mg/kg bw 0.05 MTD 250 mg/kg bw 0.02 MTD 100 mg/kg bw The animals treated with a dose of 0.2 MTD and 0.5 MTD showed slight signs of systemic toxicity. The animals treated with a dose of 1 MTD showed signs of systemic toxicity. The signs of toxicity noted were reduction of spontaneous activity, palpebral closure, prone position, constricted opisthosoma and change of the skin colour. For all dose groups, including positive and negative controls, 10000 polychromatic erythrocytes per animal were scored for incidence of micronuc1eated immature erythrocytes. The negative controls (44 h, 68 h) were within the range of the historicallabour control data. The mean values noted for the dose groups which were treated with the test item (44 h, 68 h) were within or decreased compared to the negative control data range. No biologically relevant increase of micronuclei was found after treatment with the test item in any of the dose groups evaluated.
The nonparametric Mann-Whitney test was perfonned to verify the results. No statistically significant enhancement (p<0.05) of cells with micronuclei was noted in any dose group of the test item evaluated (Table 12).Cyclophosphamide (40 mg/kg bw) administered ip was used as positive control which induced a significant increase in micronucleus frequency. This demonstrates the validity of the assay.
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