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EC number: 500-035-6 | CAS number: 25214-63-5 (>1 <8.5 mol PO)
- 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
A 28 -day oral (gavage) repeated dose NOAEL for (male/female) >= 1000 mg/kg b. w. /d is available for the substance (OECD 422).
Read across from testing with ethylenediamine, ethoxylated and propoxylated for the 90-day subchronic endpoint: a 90 -day oral (gavage) repeated dose guideline study (OECD 408) resulted with a NOEL for systemic toxicity of 300 mg/kg/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Results 'read across' from study on ethylenediamine, ethoxylated and propxylated, as permitted by Annex XI para 1.5, based on the justification in the report by Paul Illing Consultancy Services Ltd and Marlin Consultancy (Illing and Barratt, 2009). The report identifies that ethylenediamine ethoxylated and propoxylated is the most bioavailable of the ethylenediamine NLP polyols linked by an amine group, and the lack of toxicity seen for it and and the toxicity/lack of toxicity for both components (ethylenedimaine and propane-1,2-diol) of ethylenediamine, propoxylated should be considered representative of the lack of toxicity of the amine linked polyol.
Thus, on animal welfare grounds this test should not be undertaken on ethylenediamine, propoxylated. For further details concerning the grouping, consult Illing and Barratt, 2009 and the read-across document, both contained in Section 13.
A 28-day oral (gavage) repeated dose toxicity study following the OECD guideline 422 is available for the endpoint. There were no adverse effects observed up to the highest concentration tested and the NOAEL for both sexes for both systemic toxicity and reproductive/developmental toxicity was concluded as 1000 mg/kg b.w./d ( based on nominal).
A 28-day oral (gavage) repeated dose toxicity study following the OECD guideline 407 is available for the read-across substance ethylenediamine ethoxylated and propoxylated. There were no adverse effects observed up to the highest concentration tested and the NOAEL for both sexes was concluded as 1000 mg/kg b.w./d ( based on nominal).
For the highest dose group, MCH was increased in females and MCHC was increased in both sexes. This effect was considered as non adverse. The NOEL for both sexes was concluded as 300 mg/kg b.w./d (based on nominal).
For the repeated dose toxicity endpoint, read-across for the subchronic toxicity study with EDA EO PO is utilized. A 90 -day oral gavage repeated dose guideline study (OECD 408) tested ten male and ten female F344/DuCrl rats per group were administered 0, 100, 300, or 1000 milligrams Ethylenediamine, ethoxylated and propoxylated (>1 - <8.5 mol of EO and PO) per kilogram body weight per day (mg/kg/day) in ultrapure water via oral gavage for at least 90 days to evaluate the potential for systemic toxicity. Based on the treatment-related point-of-contact irritative lesions in the nasal tissues that were present in some males and females from all treated dose levels, the overall no observed- effect level (NOEL) for F344/DuCrl rats of either sex was not determined. However, the only treatment-related effects indicative of systemic toxicity were lower red blood cell counts, hemoglobin concentrations and hematocrits in males and females administered 1000 mg/kg/day, with compensatory increased erythrocytic extramedullary hematopoiesis of the spleen in males administered 1000 mg/kg day. Therefore, the NOEL for systemic toxicity was 300 mg/kg/day Ethylenediamine, ethoxylated and propoxylated (>1 - <8.5 mol of EO and PO).
A prenatal developmental toxicity guideline study (OECD 414) was conducted for Ethylenediamine, ethoxylated and propoxylated (>1-<8.5 mol of EO and PO) in Crl:CD(SD) rats following repeated gavage administration. Gavage administration of Ethylenediamine, ethoxylated and propoxylated (>1-<8.5 mol of EO and PO) up to, and including the limit dose of 1000 mg/kg/day, resulted in no treatment-related maternal toxicity and no indication of embryo/fetal toxicity or teratogenicity. Therefore, under the conditions of this study, the no-observed-effect level (NOEL) for maternal toxicity and developmental toxicity was the limit dose of 1000 mg/kg/day.
Justification for classification or non-classification
On the basis of 'read across' from ethylenediamine, propoxylated and ethoxylated, the findings in the available studies do not warrant classification according to the EU criteria.
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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