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EC number: 282-199-6 | CAS number: 84144-79-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Justification for type of information:
- The attached document provides evidence generated for a testing proposal for developmental toxicity (OECD 414) using weight of evidence from structurally similar substances, identified using validated QSAR models.
The substance 1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether is a multiconstituent substance which predominantly consists of secondary aliphatic amines, with the exception of one CGE dimer.
Various QSAR models were run on the identified constituents of the substance. Predictions with the CAESAR model revealed some positive predictions for developmental toxicity. The DART model profiler showed positive results of the unspecific category Known precedent reproductive and developmental toxic potential; Toluene and small alkyl toluene derivatives (8a) for all structures of the substance. And in the CAT-SAR system, for Human Developmental Toxicity the CGE-DIMER revealed equivocal results for developmental toxicity.
On the basis of positive indication for developmental effects from the various QSAR models it is proposed to conduct an OECD 414 Prenatal Developmental Toxicity Study (Annex IX 8.7.2) in order to clarify specifically this concern.
Thus, an OECD 421 Reproductive and Developmental Toxicity Screening Test would provide less information and is therefore waived in accordance with column 2 of REACH Annex VIII 8.7.1.
Alternative approaches are excluded based on the following considerations:
• Available GLP studies There is no experimental GLP- study regarding toxicity on reproduction or teratogenicity available
• Available non-GLP studies There is no experimental study regarding toxicity on reproduction or teratogenicity available
• Grouping and read-across Due to the concern from the QSAR calculations and the complexity of an multiconstituent read across is not further considered
• Historical human data Not available
• (Q)SAR Data provided, see above, in attached document and endpoint entries
• In vitro methods Due to the concern from the QSAR calculations and the complexity of an multiconstituent in in vitro systems, in vitro testing is not further considered
• Weight of evidence Data generated using QSAR raise a concern for developmental toxicity, which should be clarified by the proposed OECD 414 study, there is no further data available for a weight of evidence approach
• Substance-tailored exposure
driven testing [if applicable] Not applicable. In order to clarify the concern, the OECD study 414 is considered appropriate
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- rats
Test material
- Reference substance name:
- 1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether
- EC Number:
- 282-199-6
- EC Name:
- 1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether
- Cas Number:
- 84144-79-6
- Molecular formula:
- C14H26N3O2
- IUPAC Name:
- 1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether
- Details on test material:
- 1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether as generic entry for a waiver or QSAR
Constituent 1
Test animals
- Species:
- rat
Results and discussion
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.