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EC number: 294-705-2 | CAS number: 91745-35-6
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Modern GLP study conducted in accordance with modern guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates
- EC Number:
- 294-705-2
- EC Name:
- Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates
- Cas Number:
- 91745-35-6
- Molecular formula:
- C72H140N2O3-C80H156N2O3
- IUPAC Name:
- Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates
- Details on test material:
- - Physical state: Solid
- Lot/batch No.: E0011-039E
- Storage condition of test material: Room temperature in the dark
Constituent 1
Method
- Target gene:
- The target genes in the Salmonella strains control the synthesis of histidine.
The target genes in the E. coli strain controls the synthesis of tryptophan.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from the livers of male Sprague-Dawley rats treated with phenobarbiton/beta-naphthoflavone
- Test concentrations with justification for top dose:
- 0, 50, 150, 500, 1500 and 5000 micrograms per plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tetrahydrofuran
- Justification for choice of solvent/vehicle: Based on prior experience with the test material, it was predicted to be soluble in tetrahydrofuran. Preliminary solubility checks confirmed the test material was fully soluble in tetrahydrofuran at 200 mg/ml.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tetrahydrofuran
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Migrated to IUCLID6: without S9 - TA100, TA1535, WP2uvrA-
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: without S9 - TA1537
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Migrated to IUCLID6: without S9 - TA98
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Migrated to IUCLID6: with S9 - TA98
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene: with S9 - TA100, TA1535, TA1537, WP2uvrA-
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
EXPOSURE/INCUBATION DURATION: Approximately 48 hours
NUMBER OF REPLICATIONS: Triplicate
- Evaluation criteria:
- There are several evaluation criteria for determining a positive result, such as a dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. Biological relevance is the first consideration. Statistical methods are used to aid evaluation, but statistical significance is not the only determining factor for a positive response.
- Statistics:
- In the absence of any indication of a positive response for the test material, the data were not subjected to statistical analysis.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH:
- Effects of osmolality:
- Evaporation from medium:
- Water solubility:
- Precipitation: Particulate precipitation was seen at and above 500 micrograms/plate, but this did not prevent scoring of revertant colonies
- Other confounding effects:
RANGE-FINDING/SCREENING STUDIES: The range-finding test was conducted at test material incorporation concentrations of 50, 150, 500, 1500 and 5000 micrograms/plate. The main test was also performed using these concentrations.
COMPARISON WITH HISTORICAL CONTROL DATA: Concurrent negative control data were within the historical control ranges.
ADDITIONAL INFORMATION ON CYTOTOXICITY: The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No significant increases in the frequency of revertant colonies were recorded for any of the bactrerial strains at any dose level, either with or without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
The test substance was evaluated for mutagenic potential in an Ames test, using the direct plate incorporation method, and conducted in accordance with OECD Test Guideline 471. Salmonella strains TA98, TA100, TA 1535 and TA1537, and E. coli strain WP2uvrA- were used in the test. The test material, in tetrahydrofuran vehicle/solvent was tested at concentrations of 0, 50, 150, 500, 1500 and 5000 micrograms/plate both in the presence and absence of exogenous (S9) metabolic activation. There was no evidence of cytotoxicity. Particulate precipitation of test material was seen at and above 500 micrograms/plate, but this did not prevent scoring of revertant colonies - manual counts were performed at 5000 micrograms/plate due to excessive precipitation. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains and any dose level, either with or without metabolic activation.
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