Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 308-208-6 | CAS number: 97925-95-6
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-10-14 - 2004-11-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.
- EC Number:
- 308-208-6
- EC Name:
- Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.
- Cas Number:
- 97925-95-6
- Molecular formula:
- Not applicable - multiconstituent substance
- IUPAC Name:
- Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.
Constituent 1
Method
- Target gene:
- Histidine operon for TA-1535, TA-1537, TA-98, TA-100 and tryptophan operon for WP2 uvrA (pKM101)
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 pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix purchased from MolTox Inc.
- Test concentrations with justification for top dose:
- For initial dose finding experiments: 100, 200, 500, 1000, 2500, 5000 µg/plate with and without S9-Mix
For main experiment: 2, 5, 10, 20, 50, 100 µg/plate with and without S9-Mix
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulfoxid (DMSO), water for sodium azide positive control only
- Justification for choice of solvent/vehicle: Solubility of substances
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO 10 µL/mL culture volume
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA), 1 µg/plate for TA-98 and TA-100, 2 µg/plate for TA-1535 and TA-1537
- Remarks:
- with S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO 10µL/mL culture volume
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9-mix Migrated to IUCLID6: 5 µg/plate for WP2 uvrA(pKM 101)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO 10 µL/mL culture volume
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9-mix Migrated to IUCLID6: 2 µg/plate for TA-100 and TA-1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO 10 µL/mL culture volume
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Acridine Mutagen ICR191, 2 µg/plate for TA-1537
- Remarks:
- without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO 10 µL/mL culture volume
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- no
- Remarks:
- without S9-mix Migrated to IUCLID6: Daunomycin Hydrochloride (DR), 1 µg/plate for TA-98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO 10 µL/mL culture volume
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9-mix Migrated to IUCLID6: 1 µg/plate for WP2 uvrA(pKM 101)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation),
DURATION
- Preincubation period: 1 h
- Exposure duration: 3 days
NUMBER OF REPLICATIONS: two independent experiments, in triplicates each
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth by colony count - Evaluation criteria:
- A positive response in a (valid) individual experiment is achieved when one or both of the following criteria are met: a) a significant, dose-related increase in the mean number of revertants is observed; b) a two-fold or greater increase in the mean number of revertant colonies (over that observed for the concurrent solvent control plates) is observed at one or more concentrations
A negative result in a (valid) individual experiment is achieved when: a) there is no significant dose-related increase in the mean number of revertant colonies per plate observed for the test substance; and b) in the absence of any such dose response, no increase in colony numbers is observed (at any test concentration) which exceeds 2x the concurrent solvent control. - Statistics:
- All derived calculations (i.e. mean colony count/plate; standard deviation, etc.) were carried out by computer, no further specification of methods
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:
- cytotoxicity
- Remarks:
- ≥200 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥200 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- - RANGE-FINDING/SCREENING STUDIES: In an initial experiment, significant toxicity was observed at concentrations of 200 µg/plate and above.
- The positive controls for each experiment induced the expected responses, indicating the strains were responding satisfactorily in each case. - COMPARISON WITH HISTORICAL CONTROL DATA: Data of positive and vehicle controls is range of experiments done between 12/1997 and 06/2004
Any other information on results incl. tables
In two subsequent experiments with each tester strain, the test substance did not induce any significant, reproducible increases in the observed numbers of revertant colonies with any of the tester strains in the presence or absence of S9-mix.
It is concluded that, under the conditions of this assay, ATMER 163 gave a negative, i.e. non-mutagenic, response in S. typhimurium strains TA1535, TA1537, TA98 and TA100 and E. coli strain WP2 uvrA (pKM101) in both the presence and absence of S9-mix.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.