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EC number: 247-063-2 | CAS number: 25513-64-8
- 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:
- 1992-05-26 to 1992-09-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine
- EC Number:
- 247-063-2
- EC Name:
- 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine
- Cas Number:
- 25513-64-8
- Molecular formula:
- C9H22N2
- IUPAC Name:
- 2,2,4(or 2,4,4)-Trimethyl-1,6-hexanediamine
- Test material form:
- other: liquid
- Details on test material:
- 2,2,4-(2,4,4)-trimethyl-1,6-hexanediamine. Batch No. FB 508, purity not reported.
Actually the test substance is identified in the reference with CAS No. 25620-58-0. However, the production process has been yielding the 2,2,4 (or 2,4,4) isomer mixture (CAS No. 25513-64-8) all the time since the beginning of the production of this substance at this site. In previous years the substance was not identified with a precision sufficient for REACH. The correct CAS No. would have been 25513-64-8 all the time.
Constituent 1
Method
- Target gene:
- mammalian cell system( Chinese hamster Ovary cells)
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- CHO-K1 BH4
cell cycle length of 12 hours - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- male Sprague-Dawley rat liver S9 from Aroclor 1254 induced animals
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 0; 19.5; 39.1; 78.13; 156.25; 312.5; 625; 1250; 2500; 5000 mg/l
Experiment 1: 156.25; 312.5; 625 mg/l with and without S9
Experiment 2: 156.25; 312.5; 625 mg/l (without S9, 12 hour harvest); 312.5; 625; 937.5 mg/l (other) - Vehicle / solvent:
- Solvent Ham's Media
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Solvent Ham's Media
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- positive with metabolic activation: cyclophosphamide
Migrated to IUCLID6: without metabolic activation
- Details on test system and experimental conditions:
- SYSTEM OF TESTING
- Species/cell type: CHO-K1 BH4 cell line, cell cycle length 12 hours
- Metabolic activation system: male Sprague-Dawley rat liver S9 from Aroclor 1254 induced animals, lots Aro. S9/08/05/92 and Aro. S9/08/06/92
from British Industrial Biological Research Association
- No. of metaphases analyzed: first 100 consecutive from each culture if possible; mitotic index based on 1000 cell nuclei counted
ADMINISTRATION:
- Dosing:
Preliminary toxicity test: 0; 19.5; 39.1; 78.13; 156.25; 312.5; 625; 1250; 2500; 5000 mg/l
Experiment 1: 156.25; 312.5; 625 mg/l with and without S9
Experiment 2: 156.25; 312.5; 625 mg/l (without S9, 12 hour harvest); 312.5; 625; 937.5 mg/l (other)
Confirmatory experiment: 800, 937.5, 1000 mg/l with S9, both with and without Hepes buffer, evaluated for 937.5 mg/l, only 20 hour duration performed
- Number of replicates: 2
- Application: Solvent Ham's Media with S9: 4 hours exposure + 8 or 16 h culture period without S9: continuous for 12 or 20 hours
- Positive and negative control groups and treatment:
negative: solvent
positive with S9: cyclophosphamide, 10 mg/l (experiment 1, 12 hours) or 5 mg/l (other)
positive without S9: mitomycin C, 0.075 mg/l (experiment 1, 12 hours) or 0.05 mg/l (other) - Evaluation criteria:
- CRITERIA FOR EVALUATING RESULTS: significant increase in the frequency of aberrations, Fisher's Exact test
- Statistics:
- The frequency of cells with aberrations (both including and excluding gaps) and the frequency of polyploid cells was compared with the concurrent vehicle control value using Fisher's Exact Test for the hypothesis of equal means.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: complete at >= 1250 mg/l (with and without metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- GENOTOXIC EFFECTS:
- With metabolic activation: none
The increase in the frequency of cells with aberrations at 12 hours / 312.5 mg/l in experiment 1 was not considered to be toxicologically
significant because the frequency of cells with aberrations was well within historical ranges for this cell line and similar to the maximum vehicle
control value in this study. The increase at 20 hours / 937.5 mg/l in experiment 2 was investigated further in the confirmatory experiment and
identified to be an artefact caused by the interaction of a high pH value and the S9 metabolic activation system.
- Without metabolic activation: none
- Positive controls: highly significant response
CYTOTOXIC CONCENTRATION:
- With metabolic activation: observed at >= 625 mg/l nearly total absence of metaphase cells at >= 1250 mg/l
- Without metabolic activation: observed at >= 156.25 (20 hour culture) or 312.5 (12 hour culture) mg/l total absence of metaphase cells
at >= 1250 mg/l
- A dose-related increase of cytotoxicity was noted. A color change observed in the culture medium indicated that the test substance caused a
dose-related increase in the pH. Since addition of a buffer in the confirmatory experiment reduced toxicity, pH seems to be decisive for
cytotoxicity. - Remarks on result:
- other: strain/cell type: CHO (Chinese hamster ovary) cells
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
MITOTIC INDEX: mean of 2 replicate cultures each
- With metabolic activation:
------------------------------------------
Experiment Concn. 12 hours 20 hours
------------------------------------------
No. 1 0 8.15 7.75
No. 1 156.25 9.55 8.1
No. 1 312.5 8.45 11.2
No. 1 625 6.05 10.1
No. 1 pos. control 2.7 6.3
No. 2 0 9.9 9.25
No. 2 312.5 7.55 8.45
No. 2 625 6.9 7.15
No. 2 937.5 3.3 4.55
No. 2 pos. control 1.35 10.6
Confirm. 0 with buffer 10.3
Confirm. 937.5 with buffer 17.2
Confirm. 0 without buffer 12.2
Confirm. 937.5 without buffer 2.85
------------------------------------------
- Without metabolic activation:
------------------------------------------
Experiment Concn. 12 hours 20 hours
------------------------------------------
No. 1 0 9.4 3.4
No. 1 156.25 8.45 2.2
No. 1 312.5 9.55 4.15
No. 1 625 7.65 8.0
No. 1 pos. control 3.05 2.5
No. 2 0 8.45 4.1
No. 2 156.25 10.6 7.5
No. 2 312.5 9.9 8.0
No. 2 625 4.1 1.6
No. 2 pos. control 6.05 4.8
------------------------------------------
Higher concentrations (see test conditions) are reported for 20 hours without metabolic activation in Experiment No. 2. The increase of the mitotic index observed at higher concentrations particularly in the 20-hour cultures may indicate a certain degree of treatment induced cell-cycle synchrony.
------------------------------------------
CHROMOSOMAL ABERRATIONS (cells with aberrations excluding gaps): mean of 2 replicates each
- With metabolic activation:
------------------------------------------
Experiment Concn. 12 hours 20 hours
------------------------------------------
No. 1 0 0.5 % 0.5 %
No. 1 156.25 2.5 % 0.5 %
No. 1 312.5 3.5 % * 1.0 %
No. 1 625 4.0 % 2.0 %
No. 1 pos. control 9.5 % *** 11.5 % ***
No. 2 0 3.5 % 1.5 %
No. 2 312.5 3.0 % 2.0 %
No. 2 625 0.5 % 2.5 %
No. 2 937.5 1.5 % 7.5 % **
No. 2 pos. control 12.5 % *** 21.3 % ***
Confirm. 0 with buffer 1.5 %
Confirm. 937.5 with buffer 0.0 %
Confirm. 0 without buffer 1.5 %
Confirm. 937.5 without buffer 12.4 % **
------------------------------------------
- Without metabolic activation:
------------------------------------------
Experiment Concn. 12 hours 20 hours
------------------------------------------
No. 1 0 2.5 % 1.5 %
No. 1 156.25 1.0 % 0.0 %
No. 1 312.5 0.0 % 1.0 %
No. 1 625 1.0 % 3.0 %
No. 1 pos. control 11.0 % *** 14.5 % ***
No. 2 0 0.5 % 1.0 %
No. 2 156.25 3.0 % 1.5 %
No. 2 312.5 0.0 % 2.0 %
No. 2 625 1.4 % 3.0 %
No. 2 pos. control 10.5 % *** 20.0 % ***
------------------------------------------
*** p<0.001; ** p<0.01; * p<0.05
Higher concentrations (see test conditions) are reported for 20 hours without metabolic activation in Experiment No. 2.
------------------------------------------
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance 2,2,4-(2,4,4)-trimethyl-1,6-hexanediamine was shown to be non-clastogenic to CHO cells in vitro. - Executive summary:
The substance 2,2,4-(2,4,4)-trimethyl-1,6-hexanediamine was tested for its ability to induce structural chromosome aberrations in an in vitro mammalian cell system (CHO Chinese hamster ovary cells). Two independent experiments were carried out with and without the addition of Arochlor 1254 -induced rat liver S9 mix. 2,2,4-(2,4,4)-trimethyl-1,6-hexanediamine produced a highly statistically significant increase in the frequency of cells with chromosome aberrations both including and excluding gaps in 20-hour with metabolic activation treatment group at the maximum dose level only, in Experiment 2. However, this was demonstrated to be an artefact caused by the interaction of a high ph value and the S9 metabolic activation systhem. 2,2,4-(2,4,4)-trimethyl-1,6-hexanediamine is therefore considered to be non-clastogenic to CHO cells in vitro.
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