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SIP – Boundary composition for Tetradonium Bromide EINECS no. 214-291-9
Name and identifier, molecular and structural information
|Chemical name||Tetradonium bromide|
|IUPAC name||N,N,N-trimethyltetradecan-1-aminium bromide|
|Synomyms||Tetradecyl trimethyl ammonium bromide|
Trimethyl tetradecyl ammonium bromide
1-Tetradecanaminium, N,N,N-trimethyl-, bromide
Myristyl trimethyl ammonium bromide
|Molecular and structural formula||C17H38N.Br|
|Recommendation for specification|
|Degree of purity (% w/w)||≥99|
|Impurities (% w/w)||≤1|
|C-Chain distribution (% w/w):|
|Free amine (Mwt 270) (% w/w)||<10|
|Other alkyltrimethyl ammonium bromides (C12, C16) (% w/w)||<10|
|Sulphated ash (% w/w)||≤0.5|
|Solvent – unidentified (% w/w)||≤0.5|
|Conc. (ppm)||< 500|
Recommended Analytical Information
For the analytical information to be included in the company specific dossier, it is recommended to have the following analyses done:
|Spectral data||FT-IR, UV, NMR- MS||Identification|
|Chromatograms||GC-MS||Purity, quantification (chain length distribution for the starting material)|
|Supplementary tests recommended||Identification test A-E from the current European Pharmacopoeia or A-C from the current British Pharmacopoeia||General identification and identification of the bromide ion|
Tetradonium Bromide, EINECS no. 214-291-9
Background on the registration process
Novo Nordisk Pharmatech A/S was accepted in the role as lead registrant in 2009.
The roles to be taken in the SIEF were described by CEFIC and it was decided to follow these.
Novo Nordisk Pharmatech’s SIEF, now LOA agreement is based on a CEFIC template and is
a bilateral contractual agreement made between the lead registrant and the individual SIEF members.
Through a SIEF group formed in 2009, Novo Nordisk Pharmatech has ensured the registration of
Cetrimonium bromide. Our external consultant DHI has been managing the preSIEF formation,
aiming to prepare an inventory of the foreseen activity level for each of participants within the SIEF
group and to reach agreement on the sameness of the substance.
Through a questionnaire to all preSIEF members in 2009 the substance identification was decided upon.
Please find substance identification information in the SIP section on this webpage.
In 2010 Novo Nordisk Pharmatech took steps to planning a SIEF meeting to ensure data availability survey
between SIEF members before registration of the substance, however, no other SIEF members showed interest.
In 2013 Novo Nordisk Pharmatech informed all preSIEF members about the approaching registration deadline
and invited preSIEF members to inform Novo Nordisk Pharmatech about their uses.
The mapping of the identified uses serves as the basis for exposure scenarios to be developed and included in the
registration for this substance. For the identified uses, a risk characterization was carried out in order to demonstrate
that risk to human health and the environment is controlled with the implementation of risk management measures.
The exposure scenarios and the risk characterization is part of the chemical safety report included in the registration.
Any registrant intending to register this substance in annual volumes above 10 t/yr shall pay attention to the list of
identified uses. The registrant shall be aware of uses, outside the list of identified uses, which must be added to their
In 2013 Novo Nordisk Pharmatech prepared the joint submission of the registration dossier for Cetrimonium bromide in
the tonnage band of 100-1000 ton/year and registered before the deadline 30 May 2013. No SIEF members indicated a need
for an earlier registration deadline.
Please pay attention to the list of registered uses attached. Kindly be aware that the number of uses included in the registration
differs from the number of identified uses communicated previously. Any registrant intending to register the substance in
annual volumes above 10 ton/year shall be aware that uses outside the list of registered uses must be added to own registration.