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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: inhalation
Administrative data
- Endpoint:
- chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 June 1970 - 30 May 1972
- 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:
- 1 978
- Report date:
- 1978
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
- Principles of method if other than guideline:
- The aim of the study was to investigate the effects of chronic inhalative exposure to the test substance. Reversibility of the effects was tested in the post exposure observation period.
One group of 35 rats/sex was exposed to 5 ppm of the test substance 5 hours per day, 5 days per week for 27 weeks (129 exposures) and observed until their spontaneous death. Another group of 40 rats/sex was exposed to 5 ppm of the test substance 5 hours per day, 5 days per week until all animals of the group were dead (332 exposures). The corresponding control groups were exposed to air. - GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Aziridine
- EC Number:
- 205-793-9
- EC Name:
- Aziridine
- Cas Number:
- 151-56-4
- Molecular formula:
- C2H5N
- IUPAC Name:
- aziridine
- Details on test material:
- - Name of test material (as cited in study report): Ethylenimine
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Willi Gassner (WIGA), D-8741 Sulzfeld
- Age at study initiation: no data
- Mean weight at study initiation: males 223 g, females 178 g
- Housing: 5 animals/cage
- Diet (ad libitum): Altromin R (Firma Altromin, D-4937 Lage/Lippe)
- Water (ad libitum): tap water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
no data
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 1300 L chamber - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The nominal test substance vapour concentrations were verified by chemical analysis and by means of DRAEGER test tubes. 118 analytical measurements and 76 measurementy by Draeger tubes were conducted during 332 exposures, respectively. Mean measurements were 2.5 ppm by chemical analysis and 3 ppm by Draeger test tubes, respectively.
- Duration of treatment / exposure:
- 27 weeks or until death (approx. 66 weeks)
- Frequency of treatment:
- 5 hours/day, 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5 ppm (corresponding to approx. 8.9 µg/L)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 35 (subchronic) and 40 (chronic), respectively
- Control animals:
- yes, sham-exposed
- Details on study design:
- Post-exposure period: until death (subchronic satellite group)
- 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: once/week
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 18 times during the study
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 15
- Parameters: hemoglobin, hematocrit, number of erythrocytes and leukocytes.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 18 times during the study
- Animals fasted: No data
- How many animals: 15
- Parameters: differential blood count, glutamate-pyruvate-transaminase, urea and kreatinine.
URINALYSIS: Yes
- Time schedule for collection of urine: 18 times during the study
- Parameters: pH, protein, saccharose, urobilinogene, sediment: leukocytes, erythrocytes, cristals, fat, bacteria, cylinder, epithelia: squamous epithelium, tubular epithel cells and renal epithelium.
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
-Organ weights: liver, spleen, kidneys, heart, testes
HISTOPATHOLOGY: Yes
- Organs: central nervous system, pituitary gland, heart, lungs, skin, trachea, thyroid gland, liver, kidneys, adrenal glands, spleen, pancreas, mesenteric lymph nodes, stomach, intestinal tract, urinary bladder, and genitals.
- All abnormalities. - Statistics:
- no data
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
After exposure to the test substance no symptoms were observed except sporadic sneezing of single animals.
The test substance exposed group showed a shortened average survival time compared to the control group. Lethality was increased during exposure to the test substance.
BODY WEIGHT AND WEIGHT GAIN
The animals of both test substance exposed groups showed no reduction in body weight compared to the corresponding control groups.
HAEMATOLOGY
No changes of the measured parameters were observed compared to the control group.
CLINICAL CHEMISTRY
No changes of the measured parameters were observed compared to the control group.
URINALYSIS
No changes of the measured parameters were observed compared to the control group.
´
ORGAN WEIGHTS
no data
HISTOPATHOLOGY: NON-NEOPLASTIC and NEOPLASTIC
In the kidneys of the male animals of the test groups papillary necroses and oedema were observed. In addition, inflammatory and hyperregenerative changes of the trachea were described in test animals. The incidence of squamous epithelial metaplasia was noticeably increased in test animals compared to control animals (control group/ test group: males 1/35; females 0/2). In one female rat (test group) the formation of polyps was diagnosed. In the lungs of control and test animals squamous epithelial metaplasia accumulated. In one male test animal an adenocarcinoma of the lung was observed.
A higher incidence of breast tumours (control group/test group 32/60) in females and skin tumours in males (control group/test group 1/11) indicated a correlation with the exposure to the test substance. 5 male animals from the subchronic dose group showed carcinomas. The incidence of skin tumours in females was lower: in the test group 3 tumours including one carcinoma, in the control group 2 tumours including one carcinoma.
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 5 ppm
- Remarks on result:
- not determinable
- Remarks:
- no NOAEC identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
In conclusion, exposure to the test substance caused reduced lifespan of the rats, histopathological changes in kidney and trachea and an increased incidence of tumours in trachea, lung, skin and breast.
Mean life span:
|
Subchronic |
Chronic |
||||||
|
Control |
5 ppm |
Control |
5 ppm |
||||
Mean life span (d) |
m |
f |
m |
f |
m |
f |
m |
f |
|
557 |
553 |
444 |
439 |
449 |
464 |
334 |
345 |
Lethality:
|
Subchronic |
Chronic |
||||||
|
Control |
5 ppm |
Control |
5 ppm |
||||
Dead animals |
m |
f |
m |
f |
m |
f |
m |
f |
|
6 |
3 |
15 |
6 |
7 |
3 |
18 |
7 |
Tumour localisation and classification:
|
Subchronic |
Chronic |
||||||
|
Control |
5 ppm |
Control |
5 ppm |
||||
Tumour |
m |
f |
m |
f |
m |
f |
m |
f |
Mamma: |
|
|
|
|
|
|
|
|
adenoma |
- |
5 |
- |
2 |
- |
7 |
- |
10 |
adenofibroma |
- |
- |
- |
4 |
- |
4 |
- |
7 |
fibroadenoma |
- |
4 |
- |
7 |
- |
6 |
2 |
12 |
fibroma |
- |
2 |
- |
- |
- |
- |
4 |
1 |
cystadenoma papilliferum |
- |
- |
- |
3 |
- |
- |
- |
3 |
cystadenoma (papilliferum) + degeneration |
- |
- |
- |
4 |
- |
4 |
- |
2 |
carcinoma |
- |
- |
- |
4 |
- |
- |
- |
1 |
Epidermis: |
|
|
|
|
|
|
|
|
epithelioma malherbe |
- |
- |
- |
- |
1 |
- |
4 |
- |
basalioma |
- |
- |
- |
1 |
- |
- |
- |
- |
syringoma |
- |
- |
- |
- |
- |
1 |
1 |
- |
keratocanthoma invasivum |
- |
- |
- |
1 |
- |
- |
- |
- |
keratocanthoma invasivum + degeneration |
- |
- |
- |
- |
- |
- |
1 |
- |
carcinoma |
- |
1 |
5 |
- |
- |
- |
- |
1 |
Dental origin: |
|
|
|
|
|
|
|
|
adamantinoma |
- |
- |
- |
- |
- |
- |
- |
1 |
Thyroid gland: |
|
|
|
|
|
|
|
|
adenoma |
3 |
- |
- |
- |
4 |
6 |
4 |
2 |
carcinoma |
1 |
1 |
- |
- |
2 |
6 |
- |
2 |
Adrenal glands: |
|
|
|
|
|
|
|
|
adenoma of the adrenal cortex |
4 |
- |
2 |
1 |
2 |
- |
1 |
1 |
chromaffinoma |
- |
- |
- |
- |
2 |
- |
1 |
- |
neuroblastoma/sympathoblastoma |
3 |
- |
- |
- |
4 |
1 |
- |
1 |
carcinoma |
- |
- |
- |
- |
- |
1 |
1 |
- |
Pituitary gland: |
|
|
|
|
|
|
|
|
adenoma |
1 |
5 |
- |
* |
* |
11 |
2 |
* |
carcinoma |
- |
- |
- |
- |
- |
2 |
- |
1 |
Pancreas: |
|
|
|
|
|
|
|
|
adenoma |
1 |
- |
- |
- |
1 |
- |
- |
- |
Lungs: |
|
|
|
|
|
|
|
|
carcinoma |
- |
- |
- |
- |
- |
- |
1 |
- |
Brain/ meninges: |
|
|
|
|
|
|
|
|
meningenoma |
- |
- |
- |
- |
- |
- |
2 |
- |
malign neurinoma |
- |
- |
- |
- |
- |
- |
- |
1 |
gliablastoma |
- |
- |
- |
- |
2 |
1 |
1 |
3 |
Uterus/vagina: |
|
|
|
|
|
|
|
|
carcinoma |
- |
- |
- |
2 |
- |
3 |
- |
3 |
sarcoma |
- |
1 |
- |
1 |
- |
1 |
- |
6 |
Intestines: |
|
|
|
|
|
|
|
|
carcinoma |
- |
- |
- |
- |
1 |
- |
1 |
- |
sarcoma |
- |
- |
- |
- |
- |
- |
- |
1 |
Kidneys: |
|
|
|
|
|
|
|
|
nephroblastoma |
- |
1 |
2 |
2 |
- |
1 |
- |
1 |
Epididymis: |
|
|
|
|
|
|
|
|
sarcoma |
- |
- |
- |
- |
- |
- |
2 |
- |
Liver: |
|
|
|
|
|
|
|
|
hepatocellular adenoma |
- |
- |
- |
- |
- |
1 |
- |
- |
Subcutis: |
|
|
|
|
|
|
|
|
sarcoma |
- |
- |
2 |
- |
- |
- |
2 |
1 |
Mediastinum: |
|
|
|
|
|
|
|
|
sarcoma |
- |
1 |
1 |
- |
- |
1 |
1 |
- |
Abdominal region: |
|
|
|
|
|
|
|
|
lipoma |
- |
- |
- |
- |
- |
- |
- |
1 |
sarcoma |
- |
- |
- |
- |
- |
- |
1 |
- |
Heart: |
|
|
|
|
|
|
|
|
endocardial fibroma |
- |
- |
- |
- |
- |
- |
1 |
- |
Ovaries: |
|
|
|
|
|
|
|
|
cystoma |
- |
- |
- |
2 |
- |
- |
- |
- |
carcinoma |
- |
- |
- |
- |
- |
- |
- |
1 |
sarcoma |
- |
- |
- |
- |
- |
- |
- |
1 |
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.