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EC number: 604-603-5 | CAS number: 147769-93-5
- 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 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:
- 17.11.1998 - 24.02.1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and in accordance with an OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- AG-EE 623 (S)-amine
- IUPAC Name:
- AG-EE 623 (S)-amine
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): AG-EE 623 (S)-amine
- Physical state: Light yellow viscous
- Purity test date: August 28, 1998
- Lot/batch No.: WB 501
- Expiration date of the lot/batch: August 31, 2000
- Storage condition of test material: At room temperaturein the dark (ambient humidity)
- Other:
Constituent 1
Method
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 mix
- Test concentrations with justification for top dose:
- Five concentration Ievels of 1, 3, 10, 30 and 100µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- Plate Incorporation:
0.1 ml of a bacterial shaking culture (6 hr, exponential phase), 0.1 ml vehicle or test article solution
and 0.5 ml phosphate buffer or S9-mix were added to 2 ml soft agar. After vortexing, these mixtures
were overlaid immediately onto minimal medium plates in triplicate (control: 6 plates).
Preincubation
The results were confirmed in an independent experiment using the preincubation technique. 0.1 ml
vehicle or test article solution, 0.5 ml phosphate buffer or S9-mix and 0.1 ml of a bacterial culture
were preincubated and shaken for 20 min at 37°C. Then 2 ml soft agar were added to the mixture and
after vortexing overlaid onto minimal medium plate.
All tests were performed in the presence or absence ofrat liver microsomal enzymes. Finally, the titer
of the initial bacterial suspension was determined with appropriated culture plates (5 replicates),
respectively. - Evaluation criteria:
- Revertant his + colonies were counted using the automatic colony counter IPI Analyser 982 B after
incubation at 37°C for 2 days (TA 102: 3 days). For all replicate platings, the mean number of
revertants per test concentration was calculated.
The condition of the background bacterial lawn (residual growth by histidine residues) was evaluated
macroscopically for evidence of bacteriotoxicity due to the test article. If extreme thinning or complete
lack of the microcolony lawn compared to the vehicle control plates was observed, no revertants were
counted. Evidence of macroscopic test article precipitate in the agar overlay was recorded.
Evaluation Criteria
A reproducible, concentration-dependent increase in the number of revertants of at least one tester
strain over the vehicle control value andlor outside the historical control range is indicative of
genotoxic activity. Since the results were unequivocal, no detailed statistical evaluationwas
performed.A reproducible, concentration-dependent increase in the number of revertants of at least one tester
strain over the vehicle control value andlor outside the historical control range is indicative of
genotoxic activity. Since the results were unequivocal, no detailed statistical evaluation was
performed.
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:
- >= 10µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Solubility and Toxicity:
The test article AG-EE 623 (S)-amine was tested in a concentration range of 1-100 µg/plate. Higher concentrations caused strong toxicity. A weak strain- and concentration-dependent toxicity, as seen by a reduced background lawn and/or a decrease of absolute revertant numbers, was observed at the higher concentrations >= 10 µg/plate in the presence and absence of liver enzymes. The strain S. typhimurium TA 102 was most sensitive.
Mutagenicity:
The mean number of bacteria tested varied between 0.2 and 2.0 x 108/plate AG-EE 623 (S)-amine. In the repeat experiment no titer was determined in the strains S. typhimurium TA 1537 and TA 98.
Control plates (vehicle control) showed spontaneaus revertant colonies for the tester strains of S. typhimurium at frequencies similar to those described in the Iiterature and within the historical control range for our laboratory. The number of revertants was not increased after treatrnent with concentrations ranging from 1 to 100 µg/plate AG-EE 623 (S)-amine in all tester strains (plate technics). Addition of liver homogenates from rats pretreated with Aroclor 1254 had no influence on mutation induction. The negative results were qualitatively confirmed by the repeated experiment using preincubation. In the nonactivation system, however, the number of spontaneaus revertants for S. typhimurium TA 1535 exceeded the historical baseline following preincubation. Due to the fact that the positive control showed the known response the assay is regarded valid and no repetition was clone.
Positive Controls:
The diagnostic mutagen NaN3, 9-AA, 2-NF and MMC in the absence and 2-AA in the presence of mammalian liver enzymes showed the expected strain specific responses. The results with the indirect mutagen confirmed the metabolic activation capacity of the S9 fractions used.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on these results it is concluded, that AG-EE 623 (S)-amine, when tested up to toxic
concentrations, caused neither base-pair substitutions nor frameshift mutations in bacteria. No
evidence of genotoxic activity was observed in different strains of S. typhimurium in the absence and
presence of metabolic activation when tested to the limits of toxicity. The test compound is, therefore,
classified as "Ames negative".
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