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EC number: 607-854-9 | CAS number: 2605-78-9
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- between 01 November 2007 and 28 February 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UK Department of Health Guidelines for Testing of Chemicals for Mutagenicity
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Schedule 1 (Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by 2004/0994))
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- N,N-dimethyl-N-octylhydroxylamine
- EC Number:
- 607-854-9
- Cas Number:
- 2605-78-9
- Molecular formula:
- CH3(CH2)7N(CH3)2O
- IUPAC Name:
- N,N-dimethyl-N-octylhydroxylamine
- Reference substance name:
- Dimethyl(octyl)amine
- EC Number:
- 230-939-3
- EC Name:
- Dimethyl(octyl)amine
- Cas Number:
- 7378-99-6
- Molecular formula:
- C10H23N
- IUPAC Name:
- N,N-dimethyloctan-1-amine
- Reference substance name:
- Methanol
- EC Number:
- 200-659-6
- EC Name:
- Methanol
- Cas Number:
- 67-56-1
- Molecular formula:
- CH4O
- IUPAC Name:
- Methanol
- Test material form:
- liquid: viscous
Constituent 1
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- - Analytical purity: 82.3%
- Purity test date: Not available
- Lot/batch No.: GN-8
- Expiration date of the lot/batch: Not available
- Appearance: Amber coloured, extremely viscous liquid
- Storage: In the dark at room temperature
- Additional information on test material used for the study: It was attempted to purify the substance to a purity of >80% by using an alternative synthetic route, as opposed to the usual commercial route of synthesis which results in a purity of the substance of approximately 40% in water. This alternative synthetic route generated the substance at 82.3% purity, however it also generated an impurity (methanol at 4.0%) which is not present in the commercial substance. Based on the classification and labelling of methanol, it is considered that this additional impurity would not have an influence on any of the endpoints discussed in this dossier other than the acute oral toxicity study. Therefore all studies (including the one covering this endpoint) contained in this dossier (other than the acute oral toxicity study) were conducted on the 82.3% pure substance containing the 4.0% methanol impurity. The acute oral toxicity study has been conducted on the commercially generated substance at a purity of approximately 40% in water.
Method
- Target gene:
- Total DNA
Species / strain
- Species / strain / cell type:
- lymphocytes: human
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction
- Test concentrations with justification for top dose:
- For the preliminary toxicity test, a range of concentrations of the test material were used, from 6.75 to 1730 µ/ml, also a set of parallel flasks were set up without whole blood to observe any precipitation within the concentration range. The concentrations of test material used in the main test were 108.13 to 1730 µg/ml.
- Vehicle / solvent:
- Dissolved in MEM (Minimal essential medium)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Solvent control
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- in the absence of S9 dissolved in MME Migrated to IUCLID6: Experiment 1: 0.4µg/ml, Experiment 2: 0.2µg/ml
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Vehicle control
- True negative controls:
- no
- Positive controls:
- no
- Positive control substance:
- no
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Solvent control
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- In the presence of S9 dissolved in dimethyl sulphoxide Migrated to IUCLID6: 5µg/ml in both experiments 1 and 2
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: dissolved in medium
DURATION
- Preincubation period: 48 hours for experiment 1 with and without metabolic activation.
- Exposure duration: Experiment 1: 4 hour exposure with and without S9 Experiment 2: 24 hour continuous exposure without S9 mix and a 4 hour exposure with S9 mix.
- Expression time (cells in growth medium): 20 hours
- Fixation time (start of exposure up to fixation or harvest of cells): Up to 24 hours
Selection agent: Not applicale for a chromosome aberration study
Spindle ihibitor: Demi-C
STAIN (for cytogenetic assays): 5% Gurrs Giesma
NUMBER OF REPLICATIONS: Duplicates cultures were used
NUMBER OF CELLS EVALUATED: 2000 per slide for mitotic index, 100 metaphases for aberrations
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; chromosome damage - Evaluation criteria:
- A positive response was recorded if the % cells with aberrations, excluding gaps, markedly exceed that of the concurrent control either with or without a clear dose-relationship. For modest increases a dose response relationship is required along with appropriate statistical tests.
- Statistics:
- The frequency of cells with aberrations excluding gaps and the frequency of polyploid cells was compared using the recommendations of the UKEMS (Richardson et al 1989) and where necessary with the concurrent vehicle control value using Fisher's Exact test.
Results and discussion
Test results
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- other: not applicable to this study
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No effects to pH with addition of test substance
- Effects of osmolality: No significant change in osmolality, no increase above 50mOsm
- Precipitation: No precipitation occured
RANGE-FINDING/SCREENING STUDIES: A preliminary toxicity test was conducted on the cells, some toxicity was observed within the 24 hour continiual exposure with metabolic activation
COMPARISON WITH HISTORICAL CONTROL DATA: Comparison of positive controls with historical control data - Remarks on result:
- other: other:
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Chormosome Aberration Test- Experiment 1 Without Metabolic Activation -S9
Chormosome Aberration Test- Experiment 1 With Metabolic Activation +S9
Chormosome Aberration Test- Experiment 2 Without Metabolic Activation -S9
Chormosome Aberration Test- Experiment 2 With Metabolic Activation +S9
Mean Frequency of Polyploid cells (%): Experiment 1
Mean Frequency of Polyploid cells (%): Experiment 2
Key for all tables: MMC = Mitomycin C CP = Cyclophosphamide NA = Not applicable - = Not assessed for mitotic index a = Slide evaluation terminated at 50 cells because approximately 50% cells with aberrations had been observed. *** = P0.001 * = P0.05 NM = No scorable metaphases
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
There were no significant toxicological increases in the frequency of cells with chromosome aberrations with or without activation. The test material is considered to be non-clastogenic to human lymphocytes in vitro. - Executive summary:
This report describes the results of an in vitro study for the detection of structural chromosome aberrations in cultured mammalian cells. It supplements microbial systems in so far as it identifies potential mutagens that produce chromosomal aberrations rather than gene mutations (Scott et al, 1990). The method used followed that described in the OECD Guidelines for tetsing of Chemicals (1997) No. 473 "Genetic Toxicology: Chromosome aberration Test" and Method B10 of Commission Directive 2000/32/EC. The study design also meets the requirements of the UK Department of Health Guidelines for Testing of Chemicals for Mutagenicity.
Methods:
Duplicate cultures of human lymphocytes, treated with the test material, were evaluated for chromosome aberrations at three dose levels, together with vehicle and positive controls. The test material dose levels used were selected using data from a preliminary toxicity test. Four treatment conditions were used for the study, i.e. In experiment 1, 4 hours in the presence of an induced rat liver homogenate metabolising system (S9), at a 2% final concentration with a cell harvest after a 20 - hour expression period and a 4 hours exposure in the absence of metabolic activation (S9) with a 20 -hour expression. In Experiment 2 , the 4 hours exposure with addition of S9 was repeated (using a 1% final S9 concentration), whilst in the absence of metabolic activation the exposure time was increased to 24 hours.
Results:
All vehicle (solvent) controls had frequencies of cells with aberrations within the range expected for normal human lymphocytes. All the positive control materials induced statistically significant increases in the frequency of cells with aberrations indicating the satisfactory performance of the test and of the activity of the metabolising system.
The test material was only moderately toxic and did not induce any toxicologically significant increases in the frequency of cells with aberrations, in either of two separate experiments when tested up to the 10 mM limit dose.
Conclusion:
The test material was considered to be non-clastogenic to human lymphocytes in vitro.
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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