Registration Dossier
Registration Dossier
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EC number: 946-260-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
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 ambient 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.
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 10.6 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% | 0.00003% |
CONCLUSION:
Under environmental conditions (esp. high dilution and moderate pH) 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 given pH (see table above). Therefore test results in aqueous media from the unprotonated and protonated amine are equivalent.
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