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Diss Factsheets
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EC number: 272-727-3 | CAS number: 68909-99-9
- 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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
Skin Sensitisation:
Only one Buehler Test of validity 1 (BASFSE.32H0402/042325) is available, which was conducted with a surrogate of the registered substance, N,N'-bis(3-aminopropyl)ethylenediamine (CAS No. 10563-26-5).
The surrogate test substance was tested positive in the Buehler Test, conducted according to the OECD Guideline 406 (Skin Sensitization) in guinea pigs (Hartley). The test-substance concentrations for the main test were selected based on the results of a pretest. All inductions were performed with a 10% test-substance preparation in doubly distilled water and for the challenge a 5% test-substance preparation in doubly distilled water was chosen. 1 control group and 1 test group were used. The inductions were performed on days 0, 7 and 14, and a challenge was carried out 14 days after the last induction.
The inductions caused discrete or patchy to intense erythema, swelling and eczematous skin changes in all test group animals. For the 3rd induction the test patch was moved to the middle of the flank in one test group animal because of severe skin irritation effect. After the challenge discrete or patchy to moderate and confluent erythema was observed in the test group animals 24 and 48 hours after removal of the patches. Whereas no animal showed positive reaction 24, and 48 hours after challenge in the negative control group, 12/10 after 24 hours and 16/20 animals after 48 hours (for a total of 16/20 animals) showed a positive reaction after challenge treatment.
Based on the results of this study and applying the evaluation criteria for a Buehler test, it was concluded that N,N'-bis(3-aminopropyl)ethylenediamine has a sensitizing effect on the skin of the guinea pig in the Buehler Test under the test conditions chosen.
Migrated from Short description of key information:
No skin sensitisation studies of registered substance were available. The registered substance is a complex reaction mixture, containing N,N'-bis(3-aminopropyl)ethylenediamine (CAS No. 10563-26-5) and N-(2-aminoethyl)-1,3-propanediamine (CAS No. 13531-52-7) among others as majors components. One of these two components were used as surrogate to evaluate the skin sensitisation potential of the registered substance. For read across justification please refer to IUCLID chapter 13.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
Respiratory sensitisation:
There are no data available for N3/N4-amine. However, the mixture will be classified and labeled as a respiratory sensitiser due to the presence of ethanediamine (CAS No. 107-15-3) as a secondary constituent.
Migrated from Short description of key information:
No data
Justification for classification or non-classification
Based on the above described studies and considering the worst case assumption that the test substance contains 100% of its most toxic surrogate the test substance could be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 as follows:
skin sensitising (GHS cat. 1)
Moreover, the mixture will be classified and labeled as respiratory sensitising (GHS cat. 1) due to the presence of ethanediamine (CAS No. 107-15-3) as a secondary constituent.
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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