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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-236-4 | CAS number: 104-78-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-aminopropyldiethylamine
- EC Number:
- 203-236-4
- EC Name:
- 3-aminopropyldiethylamine
- Cas Number:
- 104-78-9
- Molecular formula:
- C7H18N2
- IUPAC Name:
- (3-aminopropyl)diethylamine
- Details on test material:
- - Name of test material (as cited in study report): Diethylaminopropylamine
- Physical state: liquid
- Analytical purity: 99.83%
- Purity test date: 25/04/1988
- Lot/batch No.: 8804193
- Expiration date of the lot/batch: no data
- Storage condition of test material: no data
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100, TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 mix from rats induced with PCB (Pentachlorobiphenyle)
- Test concentrations with justification for top dose:
- 50, 100, 500, 750, 1000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
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
- Details on test system and experimental conditions:
- DETERMINATION OF CYTOTOXICITY (preliminary range-finding test)
- Test: in TA 98 and TA 100 strains, with or without S9 mix ; 4 dose-levels (three plates/dose level): 100, 500, 750, 1000, 5000 and 10000µg/plate
- Method: relative total growth (decrease in the number of revertant colonies and/or a thinning of the bacterial lawn);
EXPERIMENTS
Number of independent experiments: 2.
METHOD OF APPLICATION:
* Preincubation:
DURATION
- Preincubation period: 20 min 37°C
- Exposure duration: 48H
NUMBER OF REPLICATIONS: triplicates for all tested doses. Duplicates for positive controls.
CONTROLS
* Without S9 mix
- 5 µg/plate Sodium azide (NAN3) for TA 1535; TA 100 strains
- 100 µg/plate 9-Aminoacridine (9AA) for TA 1537 strain
- 5 µg/plate 2-Nitrofluorene (2NF) for TA 98 strain and TA 1538
* With S9 mix:
- 5 µg/plate 2-Aminoacridine (2AA) for all strains - Evaluation criteria:
- Reproducible increase in the number of revertant colonies (2-fold for TA98, TA100, TA 1535 and TA 1537) compared with vehicle controls at any dose-level and/or evidence of a dose-relationship.
Reference to historical data and consideration to biological relevance may also be taken into account.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 750 AND 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 750 and 1000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 750 AND 1000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 750 and 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 750 and 1000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING STUDY:
- Results on cytotoxicity: Cytotoxicity has been highlighted at 750µg/plate and above.
- Selection of doses for experiment: 50, 100, 500, 750, 1000µg/plate
CYTOTOXICITY: during the main study, cytotoxicty has been observed at 750 and 1000µg/plate (same as in the range-findings study)
Applicant's summary and conclusion
- Conclusions:
- DEAPA did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.
- Executive summary:
The potential of 3 -aminopropyldiethylamine (DEAPA) to induce reverse mutation in Salmonella typhimurium (strains: TA 1535, TA 1537, TA 98, TA 100 and TA 1538) was evaluated in accordance with the international guidelines (OECD 471, Commission Directive No. B13/14) in compliance with the Principles of Good Laboratory Practice. The test item was tested in two independent experiments, with and without a metabolic activation system, both performed according to the preincubation method (20 min at 37°C). Bacterias were exposed to the test item at five dose-levels (three plates/dose-level) selected from a preliminary toxicity test: 50, 100, 500, 750 and 1000 µg/plate. After 48 hours of incubation at 37°C, the revertant colonies were scored. The test item did not induce any noteworthy increase in the number of revertants, both with and without S9 mix, in any of the five strains. Under these experimental conditions, DEAPA did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.
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.