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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: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- 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
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
- Reference Type:
- publication
- Title:
- No information
- Author:
- Zeller H et al.
- Year:
- 1 966
- Bibliographic source:
- Naunyn-Schmiedeberg's Arch. Exp. Path.Pharmak. 253: 98
- Reference Type:
- review article or handbook
- Title:
- Toxikologisch-Medizinische Begruendung von MAK-Werten.
- Author:
- Zeller, H. et al.
- Year:
- 1 970
- Bibliographic source:
- XV. Internat. Kongr. Arbeitsmed., Wien 1966; cited in: DFG, Gesundheitsschaedliche Arbeitsstoffe, Weinheim.
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
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: shaved rabbit back or nape (approx. 1 - 6 cm2)
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2-10 µL/kg bw - 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:
1.66, 4.15, and 8.3 mg/kg bw (2, 5, and 10 µL/kg bw) (Recalculation bsed on relative density at 24 °C = 0.83)
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 1 animal/dose regime
- Control animals:
- no
- Details on study design:
- Post-exposure period: 4 and 5 weeks, respectively (1.66 and 4.15 mg/kg bw, respectively)
- 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
- 8.3 mg/kg bw: 3/3 animals dead within 1-2 days
- 4.15 mg/kg bw: no lethality
- 1.66 mg/kg bw: no lethality
Local symptoms: edema and red-brown, widespread parchment-like necrosis with confluent blood discharge
BODY WEIGHT AND WEIGHT GAIN
- 8.3 mg/kg bw: body weight decreased
- 4.15 and 1.66 mg/kg bw: no effects
HAEMATOLOGY
Blood urea was increased and a slight leukocytosis observed.
URINALYSIS
Proteinuria was noted; both erythrocytes and leukocytes were detected in the urine sediment.
HISTOPATHOLOGY: NON-NEOPLASTIC
Renal papillary necrosis and necrosis of the medulla renalis in both kidneys
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
After repeated application of undiluted ethylenimine on the shaved rabbit back skin edema and red-brown, widespread parchment-like necrosis with confluent blood discharge.
Repeated (3-4 times) application of 8.3 mg/kg bw test substance led to lethality in 3/3 rabbits within 1-2 days. Blood urea was increased and a slight leukocytosis was observed. Proteinuria was noted; both erythrocytes and leukocytes were detected in the urine sediment. Necropsy revealed in all of the deceased rabbits renal papillary necrosis and necrosis of the medulla renalis in both kidneys.
Repeated dermal exposure (10 times) to doses of 4.15 mg/kg bw was survived by three rabbits. Slight proteinurea, leukocytes and to a lesser degree erythrocytes in urine were observed. Blood urea values were normal. All parameters returned to normal within the post-exposure period of 5 weeks. Necropsy revealed in one animal renal papillary necrosis; the other two animals were without finding.
Repeated applications of 1.66 mg/kg bw (10 times) did not lead to mortality, clinical signs of toxicity or changes in body weight and blood urea. Only leukocyte counts were decreased, and traces of protein and leukocytes were found in urine. After the post-exposure period of 4 weeks, the rabbits were sacrificed and subjected to gross-pathological examination. Necropsy did not reveal any abnormalities.
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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