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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January - March 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- The study was conducted according to the method described by Boller K & Schmid W (1970) for the Chinese hamster.
Boller K & Schmid W (1970). Humangenetik 11: 35 -53. - GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Ethylenimine
- IUPAC Name:
- Ethylenimine
- Details on test material:
- - Name of test material (as cited in study report): Aethylenimin
- Physical state: liquid
- Analytical purity: 100 % (stabilised by NaOH)
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: WIGA, Sulzfeld
- Age at study initiation: no data
- Weight at study initiation: 200 -250 g
- Housing: 3 animals/cage
- Diet (ad libitum): Altromin-R (Altrogge, Lage/Lippe)
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: none
- Duration of treatment / exposure:
- acute exposure (one application) / repeated dose exposure (5 applications)
- Frequency of treatment:
- 1 or 5 applications
- Post exposure period:
- not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.16 and 2.9 µl/kg bw (corresponding to approx. 0.96 and 2.41 mg/kg bw) (Recalculation based on relative density at 24 °C = 0.83)
Basis:
other: actually applied
- No. of animals per sex per dose:
- 3
- Control animals:
- yes, concurrent no treatment
- other: sodium chloride
- Positive control(s):
- As positive control mutagenic cytostatic Trenimon (= 2,3,5-tris-ethylenimino-benzochinon-1,4) was applied in the same way.
- Route of administration: intraperitoneal
- Doses / concentrations: 1 X 50 and 1 X 125 µg/kg bw (acute), and 5 X 50 and 5 X 25 µg/kg bw (repeated dose), respectively
Examinations
- Tissues and cell types examined:
- Femoral bone marrow cells were collected.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Dose selection was based on acute toxicity study by the intraperitoneal route.
TREATMENT AND SAMPLING TIMES:
After single application of the test substance, the rats were sacrificed 4, 24 or 48h after application. After repeated application (5 times) of the test substance, the rats were sacrificed 4h after the last application.
DETAILS OF SLIDE PREPARATION:
Femoral bone marrow cells were collected. Smears were prepared and stained according to May-Grünwald. 5000 erythrocytes and 500 nucleated cells were counted. - Evaluation criteria:
- No data
- Statistics:
- Statistical evaluation was done using the t-test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- positive
- Toxicity:
- no effects
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Animals sacrificed 4h after single injection:
No biological relevant increase in the frequency of micronuclei in erythrocytes was observed after injection of 0.96 or 2.41 mg/kg bw of the test substance.
Injection of 0.05 or 0.125 mg Trenimon/kg bw caused an increase in the number of micronuclei only in females.
Animals sacrificed 24h after single injection:
No significant increase in the frequency of micronuclei in erythrocytes was observed after injection of 0.96 or 2.41 mg/ kg bw of the test substance.
Injection of 0.05 or 0.125 mg Trenimon/kg bw caused an increase in the number of micronuclei in males, whereas in females only injection of 0.05 mg Trenimon/kg bw had a significant effect.
Animals sacrificed 48h after single injection:
After injection of 2.41 mg/kg bw of the test substance an increased number of micronuclei were observed in the erythrocytes of males and females.
No significant increase in the frequency of micronuclei in erythrocytes was observed after injection of 0.96 mg/kg bw of the test substance.
Injection of 0.125 mg Trenimon/kg bw caused an increase in the number of micronuclei in males, whereas injection of 0.05 mg Trenimon/kg bw caused an increased number of micronuclei containing erythrocytes both in males and females.
Animals sacrificed 4h after repeated application:
After 5 injections of 2.41 mg/kg bw of the test substance no increase in the number of micronuclei was observed. In males 5 injections of 0.96 mg/kg bw caused a significant increase in the number of micronuclei compared to the NaCl-treated control (P<0.005) and the untreated control (P<0.05).
Injection of 0.05 or 0.025 mg Trenimon/kg bw caused a significant increase in the number of micronuclei in males and females.
In conclusion, the test substance showed a chromosome damaging effect under the experimental conditions used.
Male rats:
Test substance |
Time of sacrifice [h] |
Dose [mg/kg bw] |
Micronuclei in polychrom. eryth. [%] |
Micronuclei in normochrom. eryth. [%] |
Micronuclei in total eryth. [%] |
Ethylenimine |
4 |
1 X 2.41 |
4.63 |
1.73 |
6.37 ** |
4 |
1 X 0.96 |
3.93 |
1.23 |
5.17 |
|
24 |
1 X 2.41 |
6.23 |
2.74 |
8.70* |
|
24 |
1 X 0.96 |
4.63 |
0.67 |
5.30 |
|
48 |
1 X 2.41 |
5.83 |
0.47 |
6.30*** |
|
48 |
1 X 0.96 |
2.40 |
1.13 |
3.53* |
|
4 |
5 X 2.41 |
4.80 |
0.63 |
5.43 |
|
4 |
5 X 0.96 |
7.27 |
2.00 |
9.27*** |
|
Trenimon |
4 |
1 X 0.125 |
3.57 |
3.10 |
6.67** |
4 |
1 X 0.05 |
4.50 |
1.70 |
6.20** |
|
24 |
1 X 0.125 |
9.07 |
2.93 |
12.0*** |
|
24 |
1 X 0.05 |
17.80 |
4.27 |
22.67*** |
|
48 |
1 X 0.125 |
4.53 |
4.67 |
9.20*** |
|
48 |
1 X 0.05 |
5.57 |
1.77 |
7.33*** |
|
4 |
5 X 0.05 |
12.73 |
7.11 |
19.84*** |
|
4 |
5 X 0.025 |
10.47 |
4.70 |
15.17*** |
|
Sodium chloride |
4 |
1 X 5.0 mL/kg |
4.22 |
1.77 |
5.98** |
24 |
1 X 5.0 mL/kg |
3.40 |
1.50 |
4.90 |
|
48 |
1 X 5.0 mL/kg |
3.32 |
1.17 |
4.48 |
|
4 |
5 X 5.0 mL/kg |
3.48 |
0.90 |
4.38 |
|
Untreated |
4 |
- |
2.84 |
0.80 |
3.64 |
24 |
- |
4.23 |
0.89 |
5.13 |
|
48 |
- |
3.12 |
0.85 |
3.97 |
|
4 |
- |
3.93 |
1.24 |
5.18 |
* Statistical significance compared to NaCl control
** Statistical significance compared to untreated control
*** Statistical significance compared to both controls
Female rats:
Test substance |
Time of sacrifice [h] |
Dose [mg/kg bw] |
Micronuclei in polychrom. eryth. [%] |
Micronuclei in normochrom. eryth. [%] |
Micronuclei in total eryth. [%] |
Ethylenimine |
4 |
1 X 2.41 |
4.07 |
1.30 |
5.37 |
4 |
1 X 0.96 |
3.33 |
1.30 |
4.60 |
|
24 |
1 X 2.41 |
3.67 |
0.97 |
4.63* |
|
24 |
1 X 0.96 |
3.87 |
0.77 |
4.63* |
|
48 |
1 X 2.41 |
5.80 |
1.63 |
7.43*** |
|
48 |
1 X 0.96 |
1.90 |
2.43 |
4.33 |
|
4 |
5 X 2.41 |
4.63 |
1.20 |
5.83** |
|
4 |
5 X 0.96 |
3.50 |
1.53 |
5.03 |
|
Trenimon |
4 |
1 X 0.125 |
11.93 |
5.47 |
17.40*** |
4 |
1 X 0.05 |
6.37 |
2.93 |
9.30*** |
|
24 |
1 X 0.125 |
3.53 |
1.60 |
5.13 |
|
24 |
1 X 0.05 |
10.53 |
3.20 |
13.73*** |
|
48 |
1 X 0.125 |
3.03 |
2.60 |
5.63 |
|
48 |
1 X 0.05 |
7.33 |
3.00 |
10.33*** |
|
4 |
5 X 0.05 |
7.80 |
4.45 |
12.25*** |
|
4 |
5 X 0.025 |
8.97 |
5.27 |
14.23*** |
|
Sodium chloride |
4 |
1 X 5.0 mL/kg |
3.70 |
1.40 |
5.10 |
24 |
1 X 5.0 mL/kg |
3.90 |
2.02 |
5.92** |
|
48 |
1 X 5.0 mL/kg |
3.18 |
1.68 |
4.87 |
|
4 |
5 X 5.0 mL/kg |
3.60 |
1.45 |
5.05** |
|
Untreated |
4 |
- |
2.91 |
1.33 |
4.24 |
24 |
- |
2.78 |
0.98 |
3.76 |
|
48 |
- |
2.82 |
1.40 |
4.22 |
|
4 |
- |
2.76 |
0.84 |
3.60 |
* Statistical significance compared to NaCl control
** Statistical significance compared to untreated control
*** Statistical significance compared to both controls
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
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