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Diss Factsheets
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EC number: 205-793-9 | CAS number: 151-56-4
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
- Reference Type:
- publication
- Title:
- No information
- Author:
- Schilling, B.V. et al.
- Year:
- 1 966
- Bibliographic source:
- Naunyn-Schmiedeberg's Arch. Exp. Path. Pharmak. 253, 82
- Reference Type:
- publication
- Title:
- No information
- Author:
- Schilling, B.V. et al.
- Year:
- 1 966
- Bibliographic source:
- Verh. Dtsch. Ges. Path., 50. Tagung Heidelberg, 429
Materials and methods
- Principles of method if other than guideline:
- BASF-Test (internal BASF method)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Ethylenimine
- IUPAC Name:
- Ethylenimine
- Details on test material:
- - Name of test material (as cited in study report): Aethylenimin rein
- Analytical purity: pure (no further data)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.01 - 0.05 % aqueous solution - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- see "Any other information on material and methods incl. tables"
- Frequency of treatment:
- up to 5 times a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.42, 0.83, 1.66, 3.32, 4.15 mg/kg bw (0.5, 1, 2, 5 µL/kg bw) as 0.01-0.05 % aqueous solution (Recalculation bsed on relative density at 24 °C = 0.83)
Basis:
- No. of animals per sex per dose:
- 1 animal/dose regime
- Control animals:
- no
- Details on study design:
- Post-exposure period: no data
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: no data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: no data
BODY WEIGHT: Yes
- Time schedule for examinations: before test start, during test, and at test termination
HAEMATOLOGY: Yes
- Time schedule for collection of blood: no data
- How many animals: all animals
- Parameters examined: leukocytes, lymphocytes, erythrocytes, granulocytes
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: no data
- How many animals: all animals
- Parameters examined: urea, serum-glutamate-pyruvate-transaminase
URINALYSIS: Yes
- Time schedule for collection of urine: no data
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- no data
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
- 4.15 mg/kg bw: 4/4 rabbits dead
- 1.66 mg/kg bw: 4/4 rabbits dead
- 0.83 mg/kg bw: 5/7 rabbits dead
- 0.42 mg/kg bw: 3/4 rabbits dead
Anorexia, atony, apathy, laboured respiration, and shortly before death abdominal and lateral position
BODY WEIGHT AND WEIGHT GAIN
Decrease of body weights
HAEMATOLOGY
Decrease in lymphocytes down to 10-15 % of normal, and an increase in granulocytes. All other values were normal.
URINALYSIS
Proteinuria was observed; both erythrocytes and, to a lesser extend, leukocytes were detected in the urine. Urea in blood was generally increased in the treated rabbits.
HISTOPATHOLOGY: NON-NEOPLASTIC
Renal papillary necrosis, hyperemia in the medulla renalis
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The repeated administration of ethylenimine to rabbits caused at doses of 0.83 mg/kg bw or higher anorexia, atony, and apathy, laboured respiration, and shortly before death abdominal and lateral position.
Repeated dosing (3-8 times) with 4.15 and 1.66 mg/kg bw led to the death of the treated rabbits. Haematology (haemoglobin, erythrocyte and leukocyte counts) appeared to be normal. But the differential blood count showed a decrease in lymphocytes down to 10-15 % of normal, and an increase in granulocytes. Proteinuria was observed; both erythrocytes and, to a lesser extend, leukocytes were detected in the urine. Blood ureawas generally increased in the treated rabbits. Necropsy revealed in all of the deceased rabbits of both dose groups (4.15 and 1.66 mg/kg bw ) renal papillary necrosis.
The repeated gavage administration of 0.83 mg/kg bw caused proteinurea, increased blood urea and to the excretion of erythrocytes and leukocytes in urine. Haematology (haemoglobin, erythrocyte and leukocyte counts) appeared to be normal. The repeated application of 0.83 mg/kg bw resulted in renal papillary necrosis and in one case hyperemia in the medulla renalis.
2 rabbits survived 31 gavage administrations with substance doses of 0.83 mg/kg bw without clinical signs of toxicity. After increasing the dose to 1.66 and 3.32 mg/kg bw respectively, symptoms of renal toxicity were observed.
The lowest dose (0.42 mg/kg bw) was lethal to 3/4 rabbits. Haematology was within normal ranges, except for a decrease of lymphocytes accompanied by an increase of granulocytes. Again, erythrocytes were found in urine sediment. Pathology revealed hyperemia of the medulla renalis.
Applicant's summary and conclusion
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