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EC number: 203-468-6 | CAS number: 107-15-3 EDA
- 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:
- repeated dose toxicity: dermal
- Remarks:
- other: carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No data on guideline and GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Dermal Oncogenicity studies on ethylenediamine in male C3H mice.
- Author:
- DePass, L.R., Fowler, E.H. and Yang, R.S.H
- Year:
- 1 984
- Bibliographic source:
- Fundam. Appl. Toxicol. 4:641-645.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The maximum tolerated dose (for local effects) was applied to the back of 50 male mice three times weekly throughout their lifespan. Positive (3-methylcholanthrene) and negative (water) control groups (50 mice/group) were included.
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethylenediamine
- EC Number:
- 203-468-6
- EC Name:
- Ethylenediamine
- Cas Number:
- 107-15-3
- Molecular formula:
- C2H8N2
- IUPAC Name:
- ethane-1,2-diamine
- Details on test material:
- Substance no 1: Purity 99,91%, 0,07% ammonia
Substance no 2: Purity 99.1%;
Impurities:
0.54 % pyrazine,
0.08 % ammonia,
0.03 % water,
0.02 % monomethylamine,
0.02 % ethylamine,
0.02 % N-methyl-piperazine,
0.02 % methylpyrazine,
trace dimethylamine,
trace ethanol,
trace N-ethylpiperazine,
trace ethylpyrazine ,
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- C3H
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: C3H/HeJ mice from Jackson Laboratories, Bar Harbor, Maine
- Age at study initiation: 74 to 79 days of age
- Housing: Housed individually in stainless steel cages with wire mesh floors. All mice were housed in the same room with
controlled lighting
- Diet (e.g. ad libitum): Ziegler Bros. NIH 07 pellets (Gardners, Pa.)
- Water (e.g. ad libitum): water from an automatic watering system
Administration / exposure
- Vehicle:
- water
- Details on exposure:
- Mice were treated three times weekly for their complete life span with 25 µl per application of each substance. Substances were applied with an Eppendorf pipet to the back of each mouse from which the fur was clipped once weekly.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentrations verified monthly during the study
- Duration of treatment / exposure:
- complete life span
- Frequency of treatment:
- 3x/wk
Doses / concentrations
- Remarks:
- Doses / Concentrations:
25 μl of 1% aqueous solution/application
Basis:
- No. of animals per sex per dose:
- Treatment group singly housed: 50 mice
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Control group singly housed: 50 mice received distilled water. Control group housed 5/cage: 40 mice received water
- Positive control:
- Positive control group housed 5/cage: 40 mice received 0.1% 3-methylcholanthrene in acetone
Examinations
- Observations and examinations performed and frequency:
- All mice were examined daily, and the onset and progress of tumor growth were recorded monthly.
- Sacrifice and pathology:
- Ten mice from the EDA and individually housed water control groups were scheduled for sacrifice at 18 months to evaluate their tissues for possible pathologic changes. Complete necropsies were performed on all mice. The dorsal skin from all animals plus all gross lesions were examined histologically after sectioning and staining with hematoxylin and eosin. In addition, all livers, kidneys and lungs from the 18 month sacrifice were fixed for histopathologic examination.
- Statistics:
- The mean survival time of the EDA No. 2 group (598 days) was significantly (p < 0.05) shorter than that of the water controls (626 days) by the Mantel-Cox test but not by the Breslow test. The difference in these statistical results is understandable since the Breslow test gives greater weight to earlier observations. In this case, the survival curves did not differ for the first 600 days of the study. The survival comparisons included the mice sacrificed at 18 months.
The mean survival time of the group-housed water controls (488 days) was significantly reduced compared to the singly housed controls by the Breslow but not the Mantel-Cox test. Since these curves differed primarily in the first 600 days of the study, the difference was significant by the test that gave greater weight to early deaths.
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- other: 25μl 1% solution
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Mild fibrosis suggesting irritation to skin was noted
- Dose descriptor:
- NOAEL
- Effect level:
- 8.3 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Weight of male mice 0.03 kg
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Mean survival time of the exposure group for substance 2 (598 days) was shorter than that of the singly housed control group (626 days); no treatment-related macroscopic or histopathologic findings; one mouse of the exposure group had a dermal fibrosis at application site and another one had a mammary adenocarcinoma. One sebaceous adenoma of the skin of the thorax was noted in the control group individually housed.
In the exposure group for substance 1, 1 mouse had a myxosarcoma at the base of the tail, and 11 animals had mild to moderate dermal fibrosis, suggesting skin irritation. Survival time did not differ from negative control groups.
In the 3-methylcholanthrene group, 39 of 40 mice had skin tumors including 37 with confirmed squamous cell carcinomas.
Applicant's summary and conclusion
- Conclusions:
- The dermal repeated dose NOAEL was 8.3 mg/kg bw.
- Executive summary:
The dermal oncogenic potential of ethylenediamine (EDA) was assessed by applying 25 µ1 of a I% solution in deionized water to the skin of 50 male C3H/HeJ mice. This was the highest concentration not producing irritation or weight changes in a preliminary 2-week study. Two EDA samples (Nos. 1 and 2) from different production sources were tested. Applications were made thrice weekly until the death of the animals. A negative control group received deionized water only. This group and the EDA-treated groups were individually housed. A fourth group of 40 mice, housed 5 per cage, received 0.1% 3-methylcholanthrene (MC) in acetone as a positive control substance. A fifth group of 40 mice, housed 5 per cage, also received deionized water to determine the effect of group housing on survival. No skin tumors were observed in the EDA-treated groups. In the positive control group, however, 39 animals (98%) had skin tumors including 37 (92%) with confirmed squamous cell carcinomas. Eleven mice (22%) which received EDA No. 1 had dermal fibrosis indicative of probable skin irritation in this group; there was no such lesion in the controls.
No skin tumors were observed in the EDA treated animals. In the positive control group 98% of the animals had skin tumors.
Neither Ethylenediamine sample was oncogenic (carcinogenic) to the skin or systemically under the conditions of this study.
In a dermal carcinogenicity study, the maximum tolerated dose for local effects was applied to the back of 50 male mice three times weekly throughout their lifespan. There were no treatment-related systemic macroscopic or histopathologic findings
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