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EC number: 800-526-8 | CAS number: 1273322-45-4
- 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
SUMMARY OF THE MOST RELEVANT AQUATIC ECOTOXICITY DATA FOR THE REGISTRATION SUBSTANCE
For all relevant trophic levels - fish, daphnia and algae as well as microorganisms - acute ecotoxicity values are available with Daphnia as the most sensitive species. Fish is the least sensitive species and therefore and for animal welfare reasons no chronic fish tests were carried out. Chronic tests are available for daphnia (21d Reproduction test) and algae (EC10 growth rate). In the table below the most relevant ecotoxicity data for the registration substance and read-across substances are given:
Primary alkyl amines & Salts | |||||||
C16-18 | C16-18, 18u | C18 | C16-18 (sat.&unsat.) | C12-18, 18u | |||
Fish | OECD 203 | LC50 (96h) mg/L | 0.88 | 0.25 | - | 4.21 (RW) | 0.84 (RW) |
Daphnia | OECD 202 | EC50 (48h) mg/L | 0.04 | 0.23 | 0.13 | 0.98 (RW) | 0.32 (RW) |
Algae | OECD 201 | ErC50 (72h) mg/L | 0.12 | 0.39 (RW) | 0.46 (RW) | 0.16 (RW) | |
Bacteria | OECD 209 | EC10 (3h) mg/L | - | 7 | - | - | 5.5 |
Bacteria | OECD 209 | EC20 (3h) mg/L | 214 | - | - | 62.5 | - |
Bacteria | OECD 209 | EC50 (3h) mg/L | 490 | 32 | - | 222 | 14 |
Daphnia | OECD 211 | NOEC repro (21d) mg/L | - | 0.013 (RW) | - | 0.013 (RW) | 0.013 (RW) |
Algae | OECD 201 | ErC10 (72h) mg/L | 0.029 | 0.13 (RW) | - | 0.15 (RW) | 0.06 (RW) |
RW=River water test |
Daphnia has the lowest chronic NOEC and this value from a river water test is selected for the derivation of the PNEC freshwater according the Bulk approach (see Category Approach for Primary alkyl amines under REACH and Existing Substances Regulation 93/793/EEC).
Additional information
Category Approach for Primary alkyl amines and their salts e.g. Acetates
Primary alkyl amines and acetate salts are characterized by the hydrophobic aliphatic alkyl chain as well as a hydrophilic amine/ammonium group. They are mostly protonated under physiological or environmental conditions (pH 4-9). The degree of protonation is exclusively determined by the pKa and the pH and therefore it is irrelevant if the amine itself or its salt is considered.
Considering these characteristics and that primary alkyl amines and primary alkyl amines acetates have a close structural relationship and share common functionalities as well as metabolic pathways, they can be considered as chemically and biologically equivalent. It is therefore imperative to use read-across principles in the assessment of primary alkyl amines and acetate salts. The read-across data from non neutralized amine compounds is used without molecular weight correction, where it is assumed that the acetate counterion does not contribute to the toxicity. Therefore the 1:1 read-across-approach can be seen as worst-case approach from a scientifically point of view.
Primary alkyl amines were already assessed for their environmental and human health hazards and risks under the EU Existing Chemicals Regulation 793/93/EEC. Industry has provided a justification for the category approach to the German rapporteur BAuA on 2001-04-07. This justification was accepted as basis for the EU Risk assessment and is used for the REACH registration as well.
Speciation of Primary alkyl amines
In aqueous medium the unprotonated and the protonated amine are in equilibrium. The percentage of the unprotonated and the protonated amine is determined by the acid constant pKa and the given pH. In the table the percentages are given as function of pH and the pKa of 10.5 for Primary alkyl amines.
pH | Percentage Protonated amine (N+) | Percentage Unprotonated amine (N) |
9 | 97.5% | 2.5% |
7 | 99.975% | 0.025% |
4 | 99.99997% | 0.000003% |
CONCLUSION:
Under environmental conditions it is not relevant if the unprotonated or the protonated amine will be introduced in an aquatic medium. The composition of the protonated and unprotonated amine is solely determined by the pKa and the ambient pH (see table above). Therefore aquatic test results from the unprotonated and protonated amine are equivalent.
River water tests, Mitigation factor, PECbulk, PNECbulk
For the primary fatty amines and acetates under consideration short-term studies are available for fish, aquatic invertebrates and algae. Long-term data are available for aquatic invertebrates and algae.
The standard tests submitted were conducted using synthetic growth media. These tests do not take into account particulate matter and dissolved organic carbon (DOC). Since primary fatty amines and acetates are positively charged under environmental conditions, they might adsorb on surfaces such as test vessels or organic material (e.g. test organisms such as algae). The results of ecotoxicity testing might be influenced by these secondary effects. In order to reduce the influence of secondary effects modifications such as river water tests or tests in the presence of humic acids) are introduced as more realistic conditions and used as higher tier studies.
For the aquatic risk assessment of strongly sorbing substances the current REACH Guidance Documents do not provide sufficient guidance concerning both effects and exposure assessment. An alternative for strongly sorbing substances can be the PEC/PNECaquatic bulk approach (ECETOC 2003). This approach is based on a PNECaquatic bulk which is derived from a modified ecotoxicity test using humic acid, natural water or effluent and a PEClocal, aquatic bulk which represents the total aquatic concentration (dissolved and sorbed = bulk). The risk quotient for the aquatic compartment is calculated by using nominal concentrations.
Testing primary fatty amines under more realistic conditions in the presence of humic acids or in river water indicate that bioavailability is lower compared to studies using standard media. Following the reasoning above, tests conducted under environmentally realistic conditions (i.e. in river water) will be used for effects assessment of primary fatty amines.
The ecotoxicity is mitigated due to sorption but this kind of tests at least ensures that all added test substance is present in the test system and available for the exposure of the organism in dissolved or sorbed form. Mitigation can be taken into account by a factor of 10 applied to the ecotoxicity result (L(E)C50) for C&L. For risk assessment purposes these ecotoxicity results can be compared with the total or bulk concentration in surface water.
Additional Literature
ECETOC (2003): Environmental Risk Assessment of Difficult
Substances. Technical Report No. 88
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