Registration Dossier
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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
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- Oxidation reduction potential
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
LD50/LC50 values are based on animal test data for acute toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10. Apr 1979 - 12. Jun 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented report which meets basic scientific principles.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 230 g (mean); female: 188 g (mean)
- Fasting period before study: 15 - 20 h before administration
- Diet (e.g. ad libitum): Herlian MRH, Eggersmann KG - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 3.16 - 14.70 %
MAXIMUM DOSE VOLUME APPLIED: 10 ml - Doses:
- 316, 464, 681, 825, 1000, 1210, 1470 mg/kg
- No. of animals per sex per dose:
- 316, 464, 681 mg/kg: 5
825, 1000, 1210, 1470 mg/kg: 10 - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: days 0, 3, 7, 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 866 mg/kg bw
- 95% CL:
- 762 - 946
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 841 mg/kg bw
- 95% CL:
- 683 - 943
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 893 mg/kg bw
- 95% CL:
- 750 - 943
- Mortality:
- 1470 mg/kg: all animals died within 24 h
1210 mg/kg: 8 males and females each died within 24 h. 1 further male died within 48 h.
1000 mg/kg: 7 males and 6 females died within24 h. 1 further male and female died within 48 h.
825 mg/kg: 5 males and females each died within 24 h. 1 further male died within 48 h.
681, 464, 316 mg/kg: no mortality occured. - Clinical signs:
- See detailed table in remarks on results.
- Body weight:
- Initially, animals in the 1210, 825 and 681 mg/kg dose group lost weight. See detailed table in remarks on results.
- Gross pathology:
- Dead animals:
Heart: acute dilatation on the right side; acute congestion;
Stomach: diffuse reddening of the glandular stomach;
Intestine: in individual animals diarrhoeic content; atonic; reddened in several cases;
Liver: in some animals individual focal necrosis;
Thymus: in individual animals extensive hemorrhages.
Sacrificed animals:
Stomach: in several animals wall of the forestomach slightly indurated. In individual cases adhesion of the forestomach to the liver. - Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Harmful Criteria used for interpretation of results: EU
- Conclusions:
- LD50 in an acute oral toxicity test to rats was 866 mg/kg bw.
- Executive summary:
In an acute toxicity test on rats, test groups consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior treatment and thereafter, day 3, day 7 and day 13 post-treatment. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. An LD50 value of 866 mg/kg was estimated on the basis of the observed mortalities.
Reference
Mortality:
Dose (mg/kg) | 1 h | 24 h | 48 h | 14 days | ||||
male | female | male | female | male | female | male | female | |
1470 | 0/10 | 0/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 |
1210 | 0/10 | 0/10 | 8/10 | 8/10 | 9/10 | 8/10 | 9/10 | 8/10 |
1000 | 0/10 | 0/10 | 7/10 | 6/10 | 8/10 | 7/10 | 8/10 | 7/10 |
825 | 0/10 | 0/10 | 5/10 | 5/10 | 6/10 | 5/10 | 6/10 | 5/10 |
681 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
464 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
316 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
Mean weight (g):
Dose (mg/kg) | gender | day 0 | day 2-4 | day 7 | day 13 | |
1470 | male | 140 | 154 | 196 | 235 | |
female | 175 | - | - | - | ||
1210 | male | 220 | 200 | 234 | 271 | |
female | 190 | 195 | 212 | 226 | ||
1000 | male | 250 | 221 | 247 | 281 | |
female | 195 | 175 | 186 | 204 | ||
825 | male | 220 | 214 | 230 | 271 | |
female | 190 | 166 | 192 | 212 | ||
681 | male | 300 | 298 | 327 | 349 | |
female | 210 | 212 | 227 | 205 | ||
464 | male | 300 | 305 | 340 | 370 | |
female | 220 | 226 | 240 | 249 | ||
316 | male | 180 | 205 | 244 | 290 | |
female | 160 | 172 | 189 | 204 |
Clinical signs: symptoms occured in the indicated time:
Dose | 1470 mg/kg | 1210 mg/kg | 1000 mg/kg | 825 mg/kg | 681 mg/kg | 464 mg/kg | 316 mg/kg |
Dyspnea | 15 min - 5 h | - 1 d | - 1 d | 15 min - 1 d | 30 min - 5 h | 5 h | - |
Spasmodic respiration | - | 15 min - 4 h | 2 h - 4 h | 2 h | - | - | - |
Apathy | 15 min - 1d | - 1 d | - 3 d | 15 min - 3 d | 15 min - 5 h | 1 h - 5 h | - |
Abnormal position | 5 h | - | - | - | - | - | - |
Staggering | 15 min - 5 h | - 4 h | 15 min - 1 d | 15 min - 1 d | 15 min - 1 d | 1 h - 5 h | - |
Spastic gait | 15 min - 1 d | - 1 d | 15 min - 3 d | 15 min - 3 d | 15 min - 1 d | 1 h - 1 d | - |
Urine (orange/yellow) | - | 1 d - 2 d | 4 h - 3 d | 1 d - 3 d | 4 h - 3 d | 4 h - 1 d | - |
Piloerection | 30 min - 2 d | - 1 d | 30 min - 3 d | 15 min - 3 d | 1 h - 5 h | 2 h - 5 h | - |
Diarrhea | 4 h - 5 h | 4 h - 1 d | 4 h - 1 d | 2 h - 1 d | 4 h - 1 d | 4 h - 5 h | - |
Cyanosis | 2 h - 4 h | - | - | - | - | - | - |
Exsiccosis | 4 h | 4 h - 1 d | 1 d | 2 h - 1 d | - | - | - |
Salivation | - | - | 2 h - 4 h | - | - | - | - |
Blood in feces | - | - | 5 h | - | 5 h | 5 h | - |
Poor general condition | 15 min - 1 d | - 1 d | - 3 d | 15 min - 3 d | 15 min - 1 d | 1 h - 5 h | - |
min: minute; h: hour; d: day
There is indication that the test substance causes local irritation to exposed tissues.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 866 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study which meets basic scientific principles.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 14 day mortality of rats exposed to metered concentrations of EDA vapor for 8h.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 8 h
- Concentrations:
- 2000 ppm corresponding to 4.9 mg/l and 4000 ppm corresponding to 9.8 mg/l
- No. of animals per sex per dose:
- 6 animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Sex:
- male
- Dose descriptor:
- LC0
- Effect level:
- 4.9 mg/L air
- Exp. duration:
- 8 h
- Sex:
- male
- Dose descriptor:
- LC100
- Effect level:
- 9.8 mg/L air
- Exp. duration:
- 8 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 7.35 mg/L air
- Exp. duration:
- 8 h
- Remarks on result:
- other: Geometric mean of LC0 and LC100
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 14.7 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: Back calculated from 8h exposure using Habers law
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute inhalation LC50 was 14.7 mg/l.
- Executive summary:
Rats were exposed to metered concentrations of EDA vapor for 8h. Six male rats per dose group were exposed to 2000 and 4000 ppm EDA vapour for 8h. Mortality of rats was observed for a 14 day period. No deaths were observed in the 2000 ppm dose group, and 100% mortality was observed in the 4000 ppm dose group. Taking the geometric mean as the LC50 value, and calculating back to 4h exposure gives an LC50 of 14.7 mg/l
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 14 700 mg/m³
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study which meets basic scientific principles.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Concentrated and 10% water solution was applied to clipped rabbit trunk under Vinylite sheeting.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 h
- Doses:
- 0.5 - 0063 - 0.795 - 1 mg/kg of concentrated sample
10% solutions 1.20 - 1.52 mg/kg - No. of animals per sex per dose:
- 10
- Control animals:
- no
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 560 mg/kg bw
- Sex:
- male
- Dose descriptor:
- approximate LD50
- Effect level:
- ca. 1 520 mg/kg bw
- Remarks on result:
- other: In 10% diluted solution
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 in an acute dermal toxicity test on rabbit was 560 mg/kg.
- Executive summary:
Rabbits were exposed to concentrated ethylene diamine (76%) and a 10% dilution in water under occlusive coverage for 24 h. With the concentrated substance, severe skin damage occurred. Congestion of the lungs and damage to the abdominal organs was noted on autopsy. LD50 was 560 mg/kg bw. For the diluted samples LD50 was approximately 1520 mg/kg bw.
Reference
Necrosis of the skin, congestion of the lungs and damage to the abdominal organs was noted on autopsy.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 560 mg/kg bw
Additional information
In an acute inhalation toxicity test, an 8h LC50 value was calculated as the geometric mean of LC0 and LC100 values. Back calculation using Habers law, C*t =k, gives the 4h LC50 value of 14.7 mg/L. This is supported by another study, with an 8h LC0 value of 11 mg/L.
Justification for selection of acute toxicity – oral endpoint
As a worst case the lowest LD50 was selected
Justification for selection of acute toxicity – inhalation endpoint
This is the only study where mortalities have been observed
Justification for classification or non-classification
A classification for Acute oral toxicity cat IV, acute dermal toxicity catIII and acute inhalation toxicity cat IV is proposed.
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