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EC number: 470-130-4 | CAS number: 697235-49-7
- 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
- Study period:
- 2004-04-14 to 2004-05-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 1997-07-21
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- , 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2003-07-01
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 470-130-4
- EC Name:
- -
- Cas Number:
- 697235-49-7
- Molecular formula:
- Hill formula: C16H15NO4 CAS formula: C16H15NO4
- IUPAC Name:
- 2-((3-(4-Hydroxyphenyl)propanoylamino)benzoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: white powder
- Molecular formula: C16H15NO4
- Molecular weight: 285.3 g/mole
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 prepared from Sprague-Dawley male rats (8-10 weeks old) induced with Aroclor 1254 (500 mg/kg body weight)
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500 and 5000 µg/plate (with and without metabolic activation)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- Positive control with metabolic activation: dissolved in DMSO; concentrations: 0.8, 0.9 and 1.7 µg/plate; strains: all strains
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Positive control without metabolic activation: dissolved in distilled water; concentration: 50 µg/plate; strain: TA1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Positive control without metabolic activation: dissolved in distilled water; concentration: 0.15 µg/plate; Strain TA 102
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Positive control without metabolic activation: dissolved in DMSO; concentration: 2.5 µg/plate; strain: TA98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Positive control without metabolic activation: dissolved in distilled water; concentration: 0.7 µg/plate; strains: TA100 and TA1535
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
Tests were performed with and without liver homogenate activation. To each culture tube containing 2 mL of top agar 0.1mL of bacteria was added followed by the test solution and 0.5 mL of S9-mix or phosphate buffer in the assays without metabolic activation. The test components were mixed thoroughly with a vortex and immediately poured onto coded minimal agar plates and carefully spread to achieve an uniform distribution of the top agar on the surface of the plate. The minimal agar plates contain 20 to 25 mL of 1.5 % agar in Vogel-Bonner medium E with 2 % glucose. Three parallel plates were prepared for each experimental point. Plates were kept for 48 to 72 h at 37°C in the dark and then examined. Besides the counting of the number of revertant colonies (his+ revertants), the plates were examined for the existence of a normal background lawn and/or precipitates and microscopically for microcolony growth. A reduction in the number of revertant colonies and/or a diminution of the background lawn was taken as an indication of bacteriotoxicity.
The experiment was repeated in full alter an interval of at least 3 days. - Evaluation criteria:
- not stated
- Statistics:
- Estimation of the statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level was conducted using a X2-test (Mohn and Ellenberger, 1977)*.
*Reference
- Mohn G.R., and J. Ellenberger (1977), The use of E. coli K12/343/113 (lambda) as a multi-purpose indicator strain in various mutagenicity testing procedures, in: B.J. Kilbey (Ed.), Handbook of mutagenicity test procedures, Elsevier, Amsterdam, pp. 95-118
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- please refer to "Additional information on results below"
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The test compound failed to induce a significant increase in the mutation frequency of the tester strains in the absence and presence of a metabolic activation system. Similarly, the estimation of the statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level did not reveal a significant effect at any one of the test points.
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation of the test compound on the plates was not observed.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the absence of S9-mix the test item was bacteriotoxic towards the strains TA100 and TA1537 at 5000 µg/plate. In the presence of S9-mix the test item was bacteriotoxic towards the strain TA102 at 5000 μg/plate. - 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
In conclusion, these results indicate that the test item under the experimental conditions described is not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolizing system.
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