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EC number: 205-999-9 | CAS number: 280-57-9
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- 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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 1,4-diazabicyclooctane
- EC Number:
- 205-999-9
- EC Name:
- 1,4-diazabicyclooctane
- Cas Number:
- 280-57-9
- Molecular formula:
- C6H12N2
- IUPAC Name:
- 1,4-diazabicyclooctane
- Details on test material:
- - Name of test material (as cited in study report): Triethylenediamine - Physical state: solid- Analytical purity: > 97 %- Lot/batch No.: 2544 39 886, Fluka AG
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zentralinstitut fuer Versuchstierzucht, Hannover, F.R.G .
- Number of animals 108: 54 males (m) and 54 females (f)
- Number of animals treated per group (controls; test groups): 12 (6 m; 6 f)
- Number of animals analysed per group (controls; treated animals): 10 (5 m; 5 f)
- Age at study initiation: 2.5 - 4 months
- Assigned to test groups randomly: yes, under following basis: random selection within the sexes.
- Fasting period before study: the period of 18 h before administration of the test substance, positive and negative controls.
- Housing: Macrolon, type I, 1 animal per cage.
- Diet: ad libitum, ALTROMIN standard diet (ALTROMIN Tier-Labor Service, Lage, Germany)
- Water: ad libitum, water from the water supply of the Southern Hessian Gas and Water Board, Darmstadt, Germany)
- Acclimation period: two weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 40 - 60, not regulated
- Air changes (per hr): 10 changes of air per hour
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Amount of vehicle (if gavage or dermal): 10 mL/kg b.w. - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Solution prepared on day of administration
- Duration of treatment / exposure:
- 24 h, 48 h, 72 h after the treatment with the high dose. 24 h after the treatment with the medium and low dose.
- Frequency of treatment:
- Single dose
- Post exposure period:
- Rats were killed after 24, 48 and 72 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 90 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 900 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- CPA; Cyclophosphamide; 2-(Bis(2-chloroethyl)amino)tetrahydro (2H)-1,3,2-oxazophosphorine-2-oxid.
- Route of administration: oral (gavage), single
- Doses / concentrations: 30 mg/kg b.w. dissolved in 0.9 % NaCl-solution, Solution prepared on day of administration
- Volume 10 mL/kg b.w.
Examinations
- Tissues and cell types examined:
- bone marrow of the femora
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Dosing was chosen with regard to the results of pre-experiments.
In a first pre-experiment each of 2 males and 2 females received 1800; 1200; or 900 mg/kg bw of the test substance.
900 mg/kg b.w. was the highest non-lethal dose. With this dose the animals expressed toxic reactions: incomplete eyelid closure, abdominal position, reduction of spantaneous activity.
With higher doses of the sustance animals died: 1800 mg/kg b.w. dosing: 2 out of 4 treated animals died within 1 hour.
1200 mg/kg b.w. dosing: 2 out of 4 treated animals died within 1 hour.
In a second pre-experiment each 5 males and 5 females received 900 mg/kg b.w. of the test substance orally. None of the treated animals died within the observation period (72 hours).
DETAILS OF SLIDE PREPARATION:
The animals were killed by cervical dislocation. The femora were removed and freed from muscles and tissue. The epiphyses were cut off with scissors and the marrow was flushed out with 0.3 mL fetal calf serum, using a 1 mL syringe, into 5 mL fetal calf serum. The cell suspension was centrifuged at 1000 rpm for 5 minutes. The cell pellet was spread on a slide. The smear was air-dryed and then stained with May-Gruenwald/Giemsa. Cover slips were mounted with EUKITT (KINDLER, Freiburg, Germany), 3 slides were made from each animal.
METHOD OF ANALYSIS:
Analysing of the micronucleus rates was performed using Nikon microscopes with 100 x oil immersion objectives.
1000 polychromatic erythrocytes (PCE) were analysed per animal. The relationship of polychromatic and normochromatic erythrocytes was determined in cell samples containing 1000 polychromatic erythrocytes to obtain information on cytotoxic effects of the treatment. The analysis was performed with coded slides.
- Statistics:
- Not necessary to perform as all mean micronucleus rates in the groups treated with the test substance are in the range of the negative controls.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- (dose dependent decrease of PCE/NCE ratio)
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
-
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): There was no enhancement of the number of cells with micronuclei in the groups treated with the test substance as compared with the negative controls treated with the solvent.
Any other information on results incl. tables
Group |
Substance |
Dose (mg/kg) |
Sex |
post exposure period (h) |
PCE with micronuclei |
Ratio PCE/NCE |
1 |
solvent |
0 |
males/females |
24 |
0.07 |
2.08 |
2 |
solvent |
0 |
males/females |
48 |
0.13 |
1.04 |
3 |
solvent |
0 |
males/females |
72 |
0.04 |
1.61 |
4 |
CPA |
30 |
males/females |
24 |
0.8 |
2.70 |
5 |
test substance |
90 |
males/females |
24 |
0.13 |
1.51 |
6 |
test substance |
300 |
males/females |
24 |
0.07 |
1.36 |
7 |
test substance |
900 |
males/females |
24 |
0.09 |
1.31 |
8 |
test substance |
900 |
males/females |
48 |
0.02 |
1.04 |
9 |
test substance |
900 |
males/females |
72 |
0.08 |
1.59 |
PCE = polychromatic erythrocyts (1000 were scored for micronuclei)
NCE = normochromatic erythrocyts
The NCE/PCE ratio is based on the scoring of 1000 erythrocyts
Applicant's summary and conclusion
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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