Welcome to the registrant group for Cetrimonium Bromide (CTAB)
Anne Rathmann Pedersen, MSC (Chem.Eng.) PhD
+45 4516 9370 (direct)
After signature of the LoA Agreement and receipt of payment for the access, we will provide the token for the joint registration.
Phone: +45 56671000
SIP – Boundary composition for cetrimonium bromide, EINECS no. 200-311-3
Name and identifier, molecular and structural information
|Chemical name||Cetrimonium bromide|
|IUPAC name||N,N,N-trimethylhexadecan-1-aminium bromide|
Cetyl trimethyl ammonium bromide
1-Hexadecanaminium, N,N,N-trimethyl-, bromide
|Molecular and structural formula||C19H42N.Br|
|Recommendation for specification|
|Degree of purity (% w/w)||>95|
|C-Chain distribution (% w/w):|
|Free amine (Mwt 270) (% w/w)||0-2|
|Amine Hydrobromides (Mwt 350) (% w/w)||0-2|
|Sulphated ash (% w/w)||0-1|
|Methyl bromide (% w/w)||0-1|
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 USP/NF Pharmacopoeia||General identification and identification of the bromide ion|
Cetrimonium bromide, EINECS no. 200-311-3
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.