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EC number: 203-183-7 | CAS number: 104-19-8
- 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 / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the genotoxic potential of alkyleneamines
- Author:
- Leung
- Year:
- 1 993
- Bibliographic source:
- Mutation Research, 320 (1994) 31-43
Materials and methods
- Principles of method if other than guideline:
- The assay (Heddle et al., 1983) was based on the procedures developed by Schmid et al. (1975) to screen chemicals for clastogenic potential (See section References)
- GLP compliance:
- no
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 2-piperazin-1-ylethylamine
- EC Number:
- 205-411-0
- EC Name:
- 2-piperazin-1-ylethylamine
- Cas Number:
- 140-31-8
- Molecular formula:
- C6H15N3
- IUPAC Name:
- 2-(piperazin-1-yl)ethan-1-amine
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6-8 weeks old
Administration / exposure
- Route of administration:
- intraperitoneal
- Frequency of treatment:
- single administration
- Post exposure period:
- Sampling times:
30h post administration
48h post administration
72h post administration
Doses / concentrationsopen allclose all
- Dose / conc.:
- 175 mg/kg bw/day (nominal)
- Dose / conc.:
- 350 mg/kg bw/day (nominal)
- Dose / conc.:
- 560 mg/kg bw/day (nominal)
- Control animals:
- yes
- Positive control(s):
- Triethylenemelamine at 0.3 mg/kg bw
Examinations
- Tissues and cell types examined:
- Micronuclei in peripheral, polychromatic erythrocytes from blood samples collected from the tail vein
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Test doses were selected from a preliminary range-finding test to determine approximate toxicity of the test materials.
DETAILS OF SLIDE PREPARATION: Micronuclei in peripheral, polychromatic erythrocytes were stained with Furr's R-66 Giemsa diluted in phosphate buffer (Gallupudi and Kamra, 1974). Slides were coded and read blindly to prevent bias. The polychromatic : normochromatic erythrocytes ratio for approximately 1000 total cells was calculated.
- Evaluation criteria:
- A positive result was concluded if at least one statistically significant increase above vehicle control was observed with an indication of a dose-related effect.
- Statistics:
- Data were compared for significant differences using the Fisher's Exact Test.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- at 30, 48 and 72h sampling times
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- With AEP, there was no increase at either the 48- or 72-h sample periods. Of the 3 dose levels, only the middle one (350 mg/kg), and only at the 30-h post-injection sample interval, produced a single statistically significant increase in the number of micronuclei.
Any other information on results incl. tables
INDUCTION OF MICRONUCLEUS IN PERIPHERAL ERYTHROCYTES OF SWISS-WEBSTER MICE INJECTED INTRAPERITONEALLY WITH ALKYLENEAMINES
|
Water |
TEM |
AEP |
||
|
10 |
0.3 |
175 |
350 |
560 |
|
mg/kg |
mg/kg |
mg/kg |
||
30 hours post dosing |
|||||
Male |
4.2±1.6 |
24.0±6.4b |
3.0±1.4 |
5.0±1.6 |
2.8±1.8 |
Female |
1.4±1.7 |
17.0±5.3b |
2.0±1.6 |
4.0±1.9 a |
1.8±1.3 |
48 hours post dosing |
|||||
Male |
2.4±0.9 |
- |
3.8±3.4 |
2.0±1.4 |
1.2±1.6 |
Female |
1.8±0.8 |
- |
2.8±1.1 |
2.8±0.8 |
1.4±2.0 |
72 hours post dosing |
|||||
Male |
2.4±2.2 |
- |
4.2±2.5 |
2.0±1.2 |
2.2±1.3 |
Female |
1.2±1.3 |
- |
1.8±1.6 |
1.6±0.9 |
2.2±1.8 |
TEM, triethylenemelamine.
Statistical analysis employed the Fisher's Exact text (1-tailed):ap < 0.01; b p < 0.001.
Applicant's summary and conclusion
- Conclusions:
- In this micronucleus study with Swiss-Webster mice, no clastogenic activity was observed with AEP in male and female mice.
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