Welcome to the registrant group for Reaction mass of C12 trimethylammonium bromide and C14 trimethylammonium bromide
Phone: +45 56671000
SIP – Boundary composition
Name and identifier, molecular and structural information
|Chemical name||Reaction mass of C12 trimethylammonium bromide and C14 trimethylammonium bromide|
|IUPAC name||Reaction mass of N,N,N-trimethyldodecan-1-aminium bromide and N,N,N-trimethyltetradecan-1-aminium bromide|
|EINECS number||To be determined|
|Molecular and structural formula||C17H38NBr and C15H34NBr|
|Recommendation for specification|
|Degree of purity (% w/w)||≥97.5|
|Impurities (% w/w)||≤2.5|
|C-Chain distribution (% w/w):|
|Free amine (Mwt 270) (% w/w)||≤10|
|Water (% w/w)||N/A|
|Sulphated ash (% w/w)||N/A|
|Methyl bromide (% w/w)||N/A|
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|
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 own registration.
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.