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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 221-067-4 | CAS number: 2997-01-5
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 2017-07-11 - 2017-08-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3,3'-ethylenedioxybis(propylamine)
- EC Number:
- 221-067-4
- EC Name:
- 3,3'-ethylenedioxybis(propylamine)
- Cas Number:
- 2997-01-5
- Molecular formula:
- C8H20N2O2
- IUPAC Name:
- 3-[2-(3-aminopropoxy)ethoxy]propan-1-amine
- Test material form:
- liquid
- Details on test material:
- - Density: 0.98 g/cm3 (25 degrees Celcius)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 903-2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, protected from light
- Solubility of the test substance in the solvent/vehicle: The test substance formed a clear solution in water at a concentration of approximately 50 mg/mL in the solubility test conducted at BioReliance.
Method
- Target gene:
- The Salmonella strains contain mutations in the histidine operon, thereby imposing a requirement for histidine in the growth medium. These strains contain the deep rough (rfa) mutation, which deletes the polysaccharide side chain from the lipopolysaccharides of the bacterial cell surface. This increases cell permeability of larger substances. The other mutation is a deletion of the uvrB gene, which codes for a protein of the DNA nucleotide excision repair system, resulting in an increased sensitivity in detecting many mutagens. This deletion also includes the nitrate reductase (chi) and biotin (bio) genes (bacteria require biotin for growth). Tester strains TA98 and TA100 contain the R-factor plasmid, pKM101. These strains are reverted by a number of mutagens that are detected weakly or not at all with the non-R-factor parent strains. pKM101 increases chemical and spontaneous mutagenesis by enhancing an error-prone DNA repair system, which is normally present in these organisms. The tester strain Escherichia coli WP2 uvrA carries the defect in one of the genes for tryptophan biosynthesis. Tryptophan-independent mutants (revertants) can arise either by a base change at the site of the original alteration or by a base change elsewhere in the chromosome so that the original defect is suppressed. This second possibility can occur in several different ways so that the system seems capable of detecting all types of mutagens, which substitute one base for another. Additionally, the strain is deficient in the DNA nucleotide excision repair system.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Cytokinesis block (if used):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- In the preliminary toxicity assay, the dose levels tested were 6.67, 10.0, 33.3, 66.7, 100, 333, 667, 1000, 3333 and 5000 µg per plate. The top dose is determined per the guidelines and solubility of the test substance.Based upon these results, the maximum dose tested in the mutagenicity assay was 5000 µg per plate. In the mutagenicity assay, the dose levels tested were 15.0, 50.0, 150, 500, 1500 and 5000 µg per plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water for the test substance; all positive controls were diluted indimethyl sulfoxide (DMSO) except for sodium azide, which was diluted in sterile water.
- Justification for choice of solvent/vehicle: Water was the vehicle of choice based on the solubility of the test substance and compatibility with the target cells.
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
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS: 1 in the preliminary toxicity assay; 3 in the mutagenicity assay
NUMBER OF CELLS EVALUATED: 1.6 to 3.9 x10E8 cells per plate.
DETERMINATION OF CYTOTOXICITY
- Method: other: Counting of revertant colony numbers and evaluation of the condition of the bacterial background lawn. - Evaluation criteria:
- The revertant colony numbers were determined for each plate (counted either manually or by automatic colony counter).
The mean and standard deviation of the number of revertants per plate were calculated and reported.
For the test substance to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test substance as specified below:Strains TA1535 and TA1537Data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 3.0-times the mean vehicle control value and above the corresponding acceptable vehicle control range.Strains TA98, TA100 and WP2 uvrAData sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 2.0-times the mean vehicle control value and above the corresponding acceptable vehicle control range.An equivocal response is a biologically relevant increase in a revertant count that partially meets the criteria for evaluation as positive.
This could be a dose-responsive increase that does not achieve the respective threshold cited above or a non-dose responsive increase that is equal to or greater than the respective threshold cited.
A response was evaluated as negative if it was neither positive nor equivocal. - Statistics:
- According to the test guidelines, the biological relevance of the results is the criterion for the interpretation of the results, and a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Sterility Results
No contaminant colonies were observed on the sterility plates for the vehicle control, the test substance dilutions or the S9 and Sham mixes.
Preliminary Toxicity Assay
The maximum dose of 5000 μg per plate was achieved using a concentration of 50.0 mg/mL and a 100 μL plating aliquot. Neither precipitate nor toxicity was observed.
Mutagenicity Assay
Based upon the results of the preliminary toxicity assay, the dose levels selected for the mutagenicity assay were 15.0, 50.0, 150, 500, 1500 and 5000 μg per plate. Neither precipitate nor toxicity was observed.
No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Historical control Data:
Historical Negative and positive control values 2015 revertants per plate | |||||||||||
Activation | |||||||||||
None | Rat Liver | ||||||||||
Strain | Control | Mean | SD | Min | Max | 95% CL | Mean | SD | Min | Max | 95% CL |
TA 98 (2015) | Neg | 16 | 5 | 6 | 43 | 6 -26 | 23 | 7 | 5 | 53 | 9 -37 |
TA 98 (2015) | Pos | 190 | 191 | 42 | 2468 | 329 | 176 | 51 | 1786 | ||
TA 100 (2015) | Neg | 90 | 12 | 62 | 233 | 66 -114 | 98 | 15 | 63 | 157 | 68 -128 |
TA 100 (2015) | Pos | 697 | 172 | 239 | 1767 | 671 | 284 | 138 | 2692 | ||
TA 1535 (2015) | Neg | 13 | 5 | 2 | 35 | 3 -23 | 13 | 5 | 3 | 33 | 3 -23 |
TA 1535 (2015) | Pos | 624 | 196 | 50 | 2509 | 137 | 110 | 24 | 1060 | ||
TA 1537 (2015) | Neg | 7 | 3 | 1 | 20 | 1 -13 | 9 | 3 | 2 | 23 | 3 -15 |
TA 1537 (2015) | Pos | 392 | 292 | 24 | 2887 | 73 | 53 | 19 | 574 | ||
WP2 uvrA (2015) | Neg | 25 | 8 | 7 | 73 | 9 -41 | 28 | 8 | 10 | 96 | 12 -44 |
WP2 uvrA (2015) | Pos | 336 | 112 | 89 | 10126 | 352 | 117 | 78 | 1409 | ||
SD=standard deviation; Min=minimum value; Max=maximum value; 95% CL = Mean ±2 SD (but not less than zero); Neg=negative control (including but not limited to deionized water, dimethyl sulfoxide, ethanol and acetone); Pos=positive control |
Metabolic activation | Test substance | Dose level (μg/plate) | Revertant Colony Counts (mean +/- SD) | ||||
TA 98 | TA 100 | TA 1535 | TA 1537 | WP2 uvrA | |||
Without metabolic activation | water | 100 μL/plate | 16 ± 4 | 87 ± 4 | 14 ± 0 | 10 ± 3 | 25 ± 3 |
Without metabolic activation | Jeffamine EDR 176 | 15.0 | 19 ± 2 | 86 ± 12 | 15 ± 1 | 9 ± 5 | 28 ± 3 |
Jeffamine EDR 176 | 50.0 | 18 ± 5 | 89 ± 11 | 12 ± 3 | 7 ± 1 | 26 ± 8 | |
Jeffamine EDR 176 | 150 | 14 ± 2 | 83 ± 7 | 11 ± 6 | 6 ± 1 | 25 ± 6 | |
Jeffamine EDR 176 | 500 | 20 ± 4 | 92 ± 2 | 17 ± 2 | 9 ± 5 | 25 ± 2 | |
Jeffamine EDR 176 | 1500 | 16 ±2 | 85 ± 6 | 12 ± 2 | 8 ± 1 | 20 ± 5 | |
Jeffamine EDR 176 | 5000 | 16 ±2 | 86 ± 7 | 15 ± 3 | 6 ± 2 | 29 ± 4 | |
2NF | 1.00 | 131 ±33 | |||||
SA | 1.00 | 644 ±45 | 686 ± 47 | ||||
9AAD | 75.0 | 609 ±96 | |||||
MMS | 1000 | 324 ± 28 | |||||
With metabolic activation | water | 100 μL/plate | 19 ± 4 | 98 ± 6 | 12 ± 5 | 9 ± 4 | 27 ± 8 |
With metabolic activation | Jeffamine EDR 176 | 15.0 | 17 ±6 | 89 ± 7 | 14 ± 2 | 10 ± 4 | 30 ± 6 |
With metabolic activation | 50.0 | 19 ± 5 | 108 ± 13 | 15 ± 7 | 9 ± 2 | 27 ± 3 | |
150 | 23 ± 7 | 114 ± 27 | 11 ± 2 | 8 ± 8 | 28 ± 8 | ||
500 | 21 ± 2 | 112 ± 17 | 15 ± 6 | 8 ± 2 | 32 ± 9 | ||
1500 | 16 ±1 | 96 ± 5 | 11 ± 5 | 9 ± 4 | 27 ± 6 | ||
5000 | 17 ± 1 | 91 ± 7 | 13 ± 3 | 7 ± 6 | 31 ± 6 | ||
1.00 | 248 ±85 | 77 ± 14 |
|
|
|||
|
|
2.00 |
|
612 ±79 |
|
64 ±33 |
|
|
|
15.0 |
|
|
|
|
288 ± 26 |
Key to Positive Controls
SA: sodium azide
2AA: 2-aminoanthracene
9AAD: 9-Aminoacridine
2NF: 2-nitrofluorene
MMS: methyl methanesulfonate
Applicant's summary and conclusion
- Conclusions:
- All criteria for a valid study were met as described in the protocol. The results of the Bacterial Reverse Mutation Assay indicate that, under the conditions of this study, the test substance did not cause a positive mutagenic response with any of the tester strains in either the presence or absence of Aroclor induced rat liver S9. The study was concluded to be negative without conducting a confirmatory (independent repeat) assay because the results were clearly negative; hence, no further testing was warranted.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)