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EC number: 211-470-3 | CAS number: 646-24-2
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-08-17 to 2012-09-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- Thymidine Kinase (TK+/-)
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: complete growth medium F10P [Dulbecco’s modified Eagle’s Medium (DMEM) with 4 mM L-glutamine adjusted to contain 1.5 g/L sodium bicarbonate and 4.5 g/L glucose supplied with 0.1 % Pluronic, 90 % and Fetal bovine serum, 1 0%]. Treatment medium F5P [Dulbecco’s modified Eagle’s Medium (DMEM) with 4 mM Lglutamine adjusted to contain 1.5 g/L sodium bicarbonate and 4.5 g/L glucose supplied with 0.1 % Pluronic, 95 % and Fetal bovine serum, 5 %].
- Metabolic activation:
- with and without
- Metabolic activation system:
- A co-factor supplemented postmitochondrial fraction (S9) from the liver of Aroclor 1254 induced Sprague- Dawley rats.
- Test concentrations with justification for top dose:
- 0.40 mg/ml, 0.20 mg/ml, 0.10 mg/ml and 0.05 mg/ml
- Vehicle / solvent:
- distilled water
- Untreated negative controls:
- yes
- Remarks:
- sterile distilled water
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 13 days
SELECTION AGENT (mutation assays): Trifluorothymidine (TFT)
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: 3 x 10e6
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- The total number of colonies per TFT plate were determined for those cultures with > = 10 % total growth.
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Cytotoxic effect of cell growth inhibition was observed at 2.5 µg/ml and above.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: none
RANGE-FINDING/SCREENING STUDIES: The concentrations of the test substances for the study were selected based on the results of preliminary range-finding test using L5178Y/TK+/- mouse lymphoma cells. In the range-finding test, cytotoxic effect of cell growth inhibition was observed at 0.4 mg/ml and above. - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- From the above study, the test item nonamethylenediamine (NMDA) is non-mutagenic to the L5178Y TK+/- clone, both in the absence and presence of S9 metabolic activation system.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Information is available from reliable studies for all required in vitro endpoints. The results of the studies are in agreement. 1,9-nonanediamine has been tested in a bacterial reverse mutation assay according to OECD 471, in a mammalian cell gene mutation assay according to OECD 476 and in an in vitro mammalian chromosome aberration test according to OECD 473 to determine the genetic toxicity of the substance. The results show that the substance does not induce mutations in bacterial or mammalian cells, nor chromosome aberrations in mammalian cells.
Justification for selection of genetic toxicity endpoint
Data are available from reliable studies for all the required in vitro endpoints. No mutagenic effects were observed in all of the tests.
Justification for classification or non-classification
The available information for the substance indicates that 1,9 -nonanediamine does not induce mutations in bacterial or mammalian cells, nor chromosome aberrations in mammalian cells. Therefore it is considered that classification for mutagenicity is not required.
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.
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