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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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-03-02 to 1987-10-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.11 (Mutagenicity - In Vivo Mammalian Bone-Marrow Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
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:
- liquid
- Details on test material:
- Batch: botteld on October 31st 1986
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- other: Han-Chinese
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Age: 3 to 4 months
- Source: Zentralinstitut für Versuchstierkunde, Hannover (Germany)
- Weight at study initiation: males 30 to 40 g; females 27 to 55 g
- No. of animals per dose: 5 males + 5 females
- Diet: Ssniff R pelleted diet, ad libitum
- Water: ad libitum, controlled visually
- Acclimation period: 4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21,5 C +- 1,5 C
- Humidity (%): 65 % +- 10 %
- Air changes (per hr): 16 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours daily from 7.00 a.m. to 7.00 p.m.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Details on exposure:
- ADMINISTRATION:
- Vehicle: water (aqua ad injectabilia); 10 ml/kg bw applied
- Duration of test: 24 hours; 22 hours after application: Treatment with 3.3 mg colcemid/kg bw
- Control groups and treatment:
Positive: 20 mg cyclophosphamide/kg bw
Negative: Vehicle - Duration of treatment / exposure:
- single dose
- Frequency of treatment:
- 1 time
- Post exposure period:
- 24 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3.75; 15; 60 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 20 mg cyclophosphamide/kg bw
Examinations
- Tissues and cell types examined:
- EXAMINATIONS:
Evaluation of 50 metaphase cells/animal (= 500/dose level)
Mitotic index determined from 1000 cells/animal - Details of tissue and slide preparation:
- Sampling times and number of samples: 24 hours after application: Killing by cervical dislocation, removal of femurs, dislocation of epiphysis,
rinsing with Hanks solution (37 °C) from diaphysis to obtain bone marrow, centrifugation, incubation for 20 minutes at 37 °C in 1 % trisodium
citrate, two times centrifugation / fixation in methanol/acetic acid (3:1), drying, staining with Giemsa. - Evaluation criteria:
- - Criteria for evaluating results: Significant increase of aberration rate (as compared with the negative control) with at least one dose level.
- Statistics:
- The mitotic index was statistically compared using a one factorial analysis of variance with subsequent Scheffe-test.
Group mean values might be compared employing the U-test of Mann-Whitney (chromosomale aberrations)
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Animals of the 60 mg/kg bw dose group showed transient and slight loss of activity.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- MORTALITY: No animal died at any dose level.
CLINICAL SIGNS: Animals of the 60 mg/kg bw dose group showed transient and slight loss of activity.
-------------------------------------------
MITOTIC INDEX AND CHROMOSOMAL ABERRATIONS (excl. gaps):
-------------------------------------------
Dose level % M.I. % C.A.
-------------------------------------------
neg. control 3.78 1.6
pos. control 1.88 p<0.05 3.8 *
3.75 mg/kg bw 4.02 1.0
15 mg/kg bw 3.30 1.0
60 mg/kg bw 3.98 0.6
* Borderline of significance; highly significant (p<0.001) result including gaps.
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The results of this study indicate that under the test conditions, the test substance 2,2,4(or 2,4,4)-trimethylhexamethylenediamine did not induce chromosome aberrations in the bone-marrow of male and female Chinese Hamster. - Executive summary:
2,2,4(or 2,4,4)-trimethylhexamethylenediamine was tested for its ability to induce in vivo chromosomal aberrations in the bone marrow of Chinese Hamsters. Each 5 male and 5 female Chinese Hamsters were exposed to 3.75, 15.0, and 60.0 mg/kg/bw by intraperitoneal injection. Bone marrow were collected 24 hours after single treatment and metaphase cells were examined microscopically for chromosomal aberrations. The analyse of metaphase cells showed that the test substance 2,2,4(or 2,4,4)- trimethylhexamethylene diamine did not induce chromosome aberration in the bone-marrow of Chinese Hamsters. Therefore, 2,2,4(or 2,4,4)-trimethylhexa methylenediamine is considered to be non-mutagenic in this chromosome aberration assay.
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