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EC number: 281-928-5 | CAS number: 84066-92-2
- 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
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Formaldehyde, reaction products with ethylenediamine
- Type of composition:
- boundary composition of the substance
- State / form:
- solid: particulate/powder
- Reference substance:
- Formaldehyde, reaction products with ethylenediamine
- Reference substance:
- Formaldehyde, reaction products with ethylenediamine
- Reference substance:
- Formaldehyde, reaction products with ethylenediamine
- Reference substance:
- Formaldehyde, reaction products with ethylenediamine
- Name:
- Formaldehyde, reaction products with ethylenediamine
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: particulate/powder
- Related composition:
- Formaldehyde, reaction products with ethylenediamine
- Reference substance:
- Formaldehyde, reaction products with ethylenediamine
- Reference substance:
- Formaldehyde, reaction products with ethylenediamine
- Reference substance:
- Formaldehyde, reaction products with ethylenediamine
- Reference substance:
- Formaldehyde, reaction products with ethylenediamine
- PBT status:
- the substance is not PBT / vPvB
- Justification:
8.PBT AND vPvB ASSESSMENT
Assessment of PBT/vPvB properties
The assessment of PBT/vPvB properties has been done on the basis of the data available from the testing programme as well as from some calculated approaches.
Persistent assessment
To evaluate the persistence of formaldehyde, reaction products with ethylenediamine, a biodegradability study in saltwater has been carried out. In the experiment, the substance reached a degradation of 70% within 20 days therefore it can be considered biodegradable. Also a hydrolysis evaluation has been carried out, but the half life of the substance is 104 days at a temperature of 12°C, therefore, hydrolysis is not expected to be a relevant pathway of removal from the environment.
The logKoc for formaldehyde, reaction products with ethylenediamine is > 5 at pH 3.5 and < 1.5 at pH 9.5 and the pKa is 8.18. If released in sea, formaldehyde, reaction products with ethylenediamine may bind to sediment, because the seawater pH is about 8 and the logKoc value is expected to be near 5, while, if release in soil, formaldehyde, reaction products with ethylenediamine is expected to have a low to high mobility, depending on the soil pH.
If released in the atmosphere, formaldehyde, reaction products with ethylenediamine may be present, at a moderate extent, as vapour, basing on a vapour pressure of 2,176 Pa at 20°C (water: 3,200 Pa at 25°C).
As a result of the previous considerations, formaldehyde, reaction products with ethylenediamine does not meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Persistent”.
Bioaccumulation assessment
As a result of the low value of logKOW(< -2), and considering the low bioaccumulation potential (BCF: 1,41 L/kg ww) of formaldehyde, reaction products with ethylenediamine,the substanceis not expected to bioaccumulate in aquatic organisms.
On the basis of the above consideration, the substance is not expected to meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Bioaccumulative”.
Toxicity assessment
In acute toxicity studies with aquatic organism, the substance showed L(E)C50 values > than 1 mg/L and it is not of concern for its aquatic toxicity. The substance is classified neither as Toxic according to Directive 67/548/EEC nor as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1A, 1B or 2) according to Regulation 1272/2008/EC. Basing on the available data, the substance is not of concern for its chronic toxicity.
On the basis of the above consideration, it can be reasonably assumed that the substance does not meet the criteria ofAnnex XIII of Regulation EC 1907/2006 for the classification as “Toxic”.
Summary and overall conclusions on PBT or vPvB properties
On the basis of the available data, formaldehyde, reaction products with ethylenediamine, if released in the environment, will mainly distribute into the aquatic compartment, where it is expected to degrade through a biotic pathway, and in soil, depending on its pH. Moreover, the substance is not expected to bioaccumulate and it is of moderate toxicity for aquatic organisms, as indicated by the short-term ecotoxicity studies on fish, crustaceans and algae preformed in freshwater and in saltwater.
In conclusion, considering all the available data, the substance does not meet the criteria ofAnnex XIII of Regulation EC 1907/2006 for the classification as “Persistent”, “Bioaccumulative” and “Toxic”. Thereforeformaldehyde, reaction products with ethylenediamineis not considered to be neither a PBT nor a vPvB substance.
8.2. Emission characterization
Because the substance does not fulfil the PBT and vPvB criteria, no emission characterisation is performed. Furthermore on the basis of the risk characterisation, the risk is evaluated as adequately controlled during all steps of life cycle.
Referenceopen allclose all
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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