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EC number: 203-041-4 | CAS number: 102-60-3
- 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
Endpoint summary
Administrative data
Description of key information
Repeated dose oral (non-guideline study): 90-days feeding study in Harlan Albino rats, 70-3770 mg/kg bw test substance; NOEL = 720 mg/kg bw (Hilltop Research Institute E-151, 1956)
Repeated dose oral (non-guideline study): 90-days feeding study in Sprague-Dawley rats, 500 mg/kg bw test substance; NOAEL = 500 mg/kg bw (MJ Dunphy, 1991)
Repeated dose oral (GLP & OECD 422): gavage study in Wistar rats, 0-1000 mg/kg bw test substance; NOAEL = 300 mg/kg bw (BASF SE 95R0628/04108; 2009)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
To assess toxicity of ethylenediamine, +4PO upon subacute oral exposure, Wistar rats of both sexes were administered with 0, 100, 300, 1000 mg/kg bw test substance (vehicle: water) by gavage for 30 (males) or 49 (females) days in a GLP and OECD 422 guideline study (BASF, 95R0628/04108, 2009). Adverse effects were exclusively seen in the high dose group. All animals treated with 1000 mg/kg bw ethylenediamine, +4PO displayed vacuolisation of the epithelial cells of the choroid plexus of the lateral ventricles in the brain. Detailed behavioural and neurological examinations of these animals did not reveal any physiological consequences of this vacuolisation. Although the further impact of the observed phenomenon in the choroid plexus is unclear, it is considered to be an adverse effect. However, similar effects were not recorded for the other dose groups. No mortalities occured and parameters of clinical chemistry and haematology did not show treatment related changes. No gross lesions were reported during necropsy. Thus, under the study conditions chosen, a NOAEL of 300 mg/kg bw was derived for general sytemic toxicity.
In a 90-days repeated dose feeding study, Harlan strain Albino rats were administered with 70, 210, 720, 2170 and 3770 mg/kg bw ethylenediamine, +4PO (Hill Top Research Institute E-151; 1955). At higher dose levels (≥ 2170 mg/kg bw) rats displayed cellular degeneration and necrosis in the liver. The NOEL is 720 mg/kg bw. In an additional 90-days feeding study, Sprague-Dawley rats were dosed with 500 mg/kg bw ethylenediamine, +4PO (MJ Dunphy, 1991). No adverse observations were reported. Thus, a NOAEL of 500 mg/kg bw was determined. However, in none of the 90 -days studies, the brain was examined during necropsy or histopathology. Taking into account this limitation, the results of the Hill Top study and the report of MJ Dunphy are in line with the BASF repeated dose study 95R0628/04108.
Justification for classification or non-classification
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC and 1272/2008/EEC. In conclusion, ethylenediamine, +4PO does not require classification.
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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