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EC number: 664-406-5 | CAS number: 277319-62-7
- 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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted as Ames II test under non GLP-conditions. The Ames II assay is a high throughput version showing a high correlation with the traditional Salmonella assay. At the date of this dossier the method still is not included in the OECD 471 guideline. The documentation is sufficient for evaluation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- The Ames II assay is a high throughput version showing a high correlation with the traditional Salmonella assay. Concurrently with positive and negative (vehicle) controls, the test article was tested over a concentration range from 1 to 5000 μg/mL medium with and without microsomal rat liver enzymes (Aroclor 1254-induced). The bacterial tester strains S. typhimurium TA Mix (TA 7001, TA 7002, TA 7003, TA 7004, TA 7005, TA 7006 sensitive to base-pair substitution) and TA 98 (susceptible to frameshift mutagens) are histidine-auxotrophic and were exposed for 90 minutes. Using the liquid fluctuation technique revertant growth was quantified colorimetrically in 384-well plates after 48 hrs at 37°C.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-amino-N-hydroxybenzene-1-carboximidamide
- EC Number:
- 664-406-5
- Cas Number:
- 277319-62-7
- Molecular formula:
- C7 H9 N3 O
- IUPAC Name:
- 4-amino-N-hydroxybenzene-1-carboximidamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA Mix (TA 7001- 7006)
- Additional strain / cell type characteristics:
- other: sensitive to base-pair substitution
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: susceptible to frameshift mutagens
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 rat liver
- Test concentrations with justification for top dose:
- 1 to 5000 μg/mL
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- The assay was performed according to the instruction manual for the Ames II (Xenometrix, Boulder/USA). Vehicle, test substance or positive
control in a volume of 0.01 mL were incubated with 0.24 mL bacterial overnight culture (ca 107/mL)/exposure medium in 24-well plates for 90 min at 37°C and 250 rpm. With metabolic activation 0.2 mL strain mixture and 0.04 mL S9-mix (30%) were used. After 90 min the exposed cultures
were diluted with pH indicator medium lacking histidine and aliquoted into 48 wells of a 384-well plate (3 replicates) using an 8-channel pipettor.
The plates were incubated for 48 hrs at 37°C. To confirm the sensitivity of the tester strains and the metabolic capacity of the S9 fractions, the
diagnostic mutagens 2-nitrofluorene (2-NF), 4-nitroquinoline-N-oxide (4-NQO) and 2-aminoanthracene (2-AA) were used, respectively. - Evaluation criteria:
- The pH indicator bromocresol purple turns the colour of the cultures from blue to yellow as the pH drops due to the accumulation of catabolites
from the metabolic activity of revertant cells. The number of positive wells (yellow) out of a total of 48 wells is an indication of the frequency of
reversion per replicate per dose and was compared to the number of spontaneous revertant wells of the solvent control. Each test point contains
48 wells of a 384-well plate. In each 48-well section, the wells were scored for the number of revertant wells (yellow) and the mean value of the
triplicates was calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA Mix (TA 7001- 7006)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- The test substance did neither precipitate nor show bacteriotoxicity up to the highest concentration.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation.
BIBR 1048 ABA did not consistently increase the number of positive wells in the different tester strains neither in presence nor absence of a
metabolic system as compared to the vehicle control. The negative control showed a mean number of positive wells for S. typhimurium TA Mix
(TA 7001-7006) and TA 98 similar to those described in the literature (≤8/48 wells).
As expected, the positive controls (2-NF, 4-NQO and 2-AA, respectively) showed a clear mutagenic response demonstrating the validity of the study.
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