Welcome to SIEF for tetradonium bromide

Contact

Chantale Julien
Senior Product Manager, Quats

Phone: +45 4029 7906
Email

Pre-SIEF

Step 1

Dear Madam, Dear Sir,
FeF Chemicals A/S has taken the role as SIEF Formation Facilitator (SFF) in the pre-SIEF for:

Tetradonium bromide, EINECS no. 214-291-9

for which you have also submitted a pre-registration.

DHI is managing the preSIEF discussions for FeF Chemicals A/S, Køge, Denmark and we are contacting you in the role as the SIEF Formation Facilitator (SFF).

The aim of this letter is to prepare an inventory of the foreseen activity level for each of participants within this SIEF and to reach agreement on the sameness of the substance.

For the purpose of facilitating the SIEF formation a preSIEF management portal has been established and we kindly ask you to log on this dedicated web portal:  http://presiefcon02.dhigroup.com/SIEFInfo.asp. For log on please enter your pre-registration number, and your password, which you will receive in a separate mail. Please be aware that the password is linked to one single pre-registration number.

Hereafter you are invited to fill in the questionnaire and submit it subsequently.

The roles to be taken in the SIEF are described by CEFIC and it was decided to follow these. See explanatory note below in this mail. For the substance identification please indicate your agreement or disagreement with the description given in the portal.

In view of the urgency in moving this forward, it is important that we receive the questionnaire by your submission as soon as possible and no later than 9 April 2009.

If you have problems using the preSIEF management portal please contact DHI at [email protected].

Please note that you may receive this e-mail for this substance several times if you have pre-registered the substance for different legal entities (LEOs). Please complete a separate questionnaire for each legal entity (LEO) represented by you.

 

Step 2

Dear Madam, Dear Sir,

DHI is contacting you on behalf of FeF Chemicals A/S, Køge, Denmark who is the SIEF Formation Facilitator (SFF) in the pre-SIEF for:

Tetradonium bromide, EINECS no. 214-291-9

This is the second step in the pre-SIEF for preparation of REACH registration of the substance. In the first step, contact was taken to all SIEF members for indication of roles and agreement on substance identification. The results from the inventory were as follows:
SIEF members’ role as involved, passive or dormant were indicated
No SIEF member besides FeF Chemicals A/S indicated to opt as leading registrant
No disagreements on the substance identification were identified.

The purpose of the second step is to get acceptance of FeF Chemicals A/S, Køge, Denmark as leading registrant and to identify the earliest registration deadline.

Please find the attached questionnaire covering the second step in the SIEF formation. The first questionnaire is also included in order to give SIEF members who did not respond to the first questionnaire the possibility to indicate their status and agreement with the substance ID. If you already have submitted the data you may ignore the two parts SIEF Code and Substance Identification of the questionnaire.

Please note that efficient communication is essential to organise the SIEF. Therefore we kindly ask you to fill in the relevant parts of the questionnaire and return it to [email protected] no later than 16 June 2009. Please be aware that if no reply is received by 16 June 2009 we will assume that you have taken the role as dormant and that you agree on FeF Chemicals A/S as the Lead registrant.

We encourage you to find general information on SIEF in ECHA’s fact sheet “Getting Started in SIEFs- Top Tips” using the link:
http://echa.europa.eu/doc/reach/reach_factsheet_siefs.pdf.

Step 3

Dear Madam, Dear Sir,

DHI is contacting you on behalf of FeF Chemicals A/S, Køge, Denmark who is the SIEF Formation Facilitator (SFF) in the pre-SIEF for:

Tetradonium bromide, EINECS no. 214-291-9

The results from Step 2 in the SIEF formation referring to our e-mail of 2 June 2009, are as follows:
– No disagreements with FeF Chemicals A/S acting as leading registrant for this substance were identified
– The registration deadlines for registration by the potential registrants were indicated to be 30 May 2013 and 30 May 2018
– The results from counting the number of SIEF members in the four SIEF code categories are as follows:
Leading: 1, Involved: 2 and Passive: 4. The remaining SIEF members are considered as dormant based on their response or based on the lack of response. The pre-SIEF counted 96 members.

Based on these results, FeF Chemicals A/S, Køge will take the role as the lead registrant in the registration of tetradonium bromide. FeF Chemicals A/S will hereafter prepare the joint submission of the registration dossier for tetradonium bromide at the earliest registration deadline which is 30 May 2013.

In case that you do not agree with the earliest registration deadline of 30 May 2013 i.e. if your annual tonnage of manufacture or import of the substance is or expected to be 100 tonnes or more, please react to this e-mail as soon as possible and no later than 31 August by sending information on your identity and expected tonnage band and deadline to [email protected].

For the work in the SIEF, FeF Chemicals A/S has the intention to follow the CEFIC model for a SIEF agreement among the SIEF members. This implies that a bilateral contractual agreement will be made between the lead registrant and the individual SIEF members with the SIEF code 1-3 i.e. leading, involved and passive members.

Please be aware that if your role is dormant (SIEF code 4) no agreement will be made with you. However, you will be informed about the registration process occasionally. If you change your status from dormant to either passive, involved or leading, please react to this e-mail by sending information on your identity, SIEF code and expected tonnage band and deadline to [email protected]. Hereafter, a contractual agreement will be made with you in order for you to be able to be part of the joint submission.

We encourage you to find general information on the SIEF work and SIEF agreement in CEFIC’s guidance sheets using the link:
http://www.cefic.org/templates/shwPublications.asp?HID=750&S=33

Step 3

Dear Madam, Dear Sir,

DHI is contacting you on behalf of FeF Chemicals A/S, Køge, Denmark who is the SIEF Formation Facilitator (SFF) in the pre-SIEF for:

Cetrimonium bromide, EINECS no. 200-311-3

The results from Step 2 in the SIEF formation referring to our e-mail of 2 June 2009, are as follows:
– No disagreements with FeF Chemicals A/S acting as leading registrant for this substance were identified
– The registration deadlines for registration by the potential registrants were indicated to be 30 May 2013 and 30 May 2018
– The results from counting the number of SIEF members in the four SIEF code categories are as follows:
Leading: 1, Involved: 2 and Passive: 13. The remaining SIEF members are considered as dormant based on their response or based on the lack of response. The pre-SIEF counted 132 members

Based on these results, FeF Chemicals A/S, Køge will take the role as the lead registrant in the registration of cetrimonium bromide. FeF Chemicals A/S will hereafter prepare the joint submission of the registration dossier for cetrimonium bromide at the earliest registration deadline which is 30 May 2013.

In case that you do not agree with the earliest registration deadline of 30 May 2013 i.e. if your annual tonnage of manufacture or import of the substance is or expected to be 100 tonnes or more, please react to this e-mail as soon as possible and no later than 31 August by sending information on your identity and expected tonnage band and deadline to [email protected].

For the work in the SIEF, FeF Chemicals A/S has the intention to follow the CEFIC model for a SIEF agreement among the SIEF members. This implies that a bilateral contractual agreement will be made between the lead registrant and the individual SIEF members with the SIEF code 1-3 i.e. leading, involved and passive members.

Please be aware that if your role is dormant (SIEF code 4) no agreement will be made with you. However, you will be informed about the registration process occasionally. If you change your status from dormant to either passive, involved or leading, please react to this e-mail by sending information on your identity, SIEF code and expected tonnage band and deadline to [email protected]. Hereafter, a contractual agreement will be made with you in order for you to be able to be part of the joint submission.

We encourage you to find general information on the SIEF work and SIEF agreement in CEFIC’s guidance sheets using the link:
http://www.cefic.org/templates/shwPublications.asp?HID=750&S=33

You may receive this e-mail for this substance several times if you have pre-registered the substance for different legal entities.

We appreciate your support and look forward to an effective and efficient collaboration with you.

 

Step 4
Non-dormant members

Dear Madam, Dear Sir,
DHI is contacting you on behalf of Fef Chemicals A/S, Køge, Denmark regarding the SIEF for:

Tetradonium bromide, EINECS no. 214-291-9

Based on the results from Step 2 in the SIEF formation, FeF Chemicals A/S, Køge has taken the role as the lead registrant in the registration of Tetradonium bromide. FeF Chemicals A/S has the intention to prepare the joint submission of the registration dossier for Tetradonium bromide at the earliest registration deadline which is 30 May 2013.

For the collaboration among the SIEF members, FeF Chemicals A/S has drafted a bilateral SIEF agreement to be entered between the lead registrant and each individual non-dormant SIEF member.  Please, find the draft SIEF agreement attached this email (pdf and word-format). Your comments to the draft SIEF agreement are welcome, no later than September 1st, 2010.  

A SIEF meeting will be requested early fall, for discussions on the cooperation in the SIEF as well as the agreement. The budget for the preparation of the lead registration dossier will be elaborated in due time before the meeting in order to allow discussions on the budget as well during the SIEF meeting. The final SIEF agreement should be prepared immediately after the meeting and signed by the lead registrant and each potential registrant.
Please read the drafted SIEF agreement and send you comments to [email protected] or as reply to this email, no later than September 1st, 2010.

Step 4
Non-dormant members

Dear Madam, Dear Sir,
DHI is contacting you on behalf of Fef Chemicals A/S, Køge, Denmark regarding the SIEF for:

Cetrimonium bromide, EINECS no. 200-311-3

Based on the results from Step 2 in the SIEF formation, FeF Chemicals A/S, Køge has taken the role as the lead registrant in the registration of Cetrimonium bromide. FeF Chemicals A/S has the intention to prepare the joint submission of the registration dossier for Cetrimonium bromide at the earliest registration deadline which is 30 May 2013.

For the collaboration among the SIEF members, FeF Chemicals A/S has drafted a bilateral SIEF agreement to be entered between the lead registrant and each individual non-dormant SIEF member.  Please, find the draft SIEF agreement attached this email (pdf and word-format). Your comments to the draft SIEF agreement are welcome, no later than September 1st, 2010.  

A SIEF meeting will be requested early fall, for discussions on the cooperation in the SIEF as well as the agreement. The budget for the preparation of the lead registration dossier will be elaborated in due time before the meeting in order to allow discussions on the budget as well during the SIEF meeting. The final SIEF agreement should be prepared immediately after the meeting and signed by the lead registrant and each potential registrant.
Please read the drafted SIEF agreement and send you comments to [email protected] or as reply to this email, no later than September 1st, 2010.
We appreciate your support and are looking forward to an effective and efficient collaboration with you.

Step 4
Dormant members

Dear Madam, Dear Sir,
DHI is contacting you on behalf of Fef Chemicals A/S, Køge, Denmark regarding the SIEF for:

Tetradonium bromide, EINECS no. 214-291-9

Based on the results from Step 2 in the SIEF formation, FeF Chemicals A/S, Køge has taken the role as the lead registrant in the registration of Tetradonium bromide. FeF Chemicals A/S has the intention to prepare the joint submission of the registration dossier for Tetradonium bromide at the earliest registration deadline which is 30 May 2013.

For the collaboration among the SIEF members, FeF Chemicals A/S has drafted a bilateral SIEF agreement to be entered between the lead registrant and each individual non-dormant SIEF member.  Please, find the draft SIEF agreement attached this email for your information

Please, be aware that if your role is dormant (SIEF code 4) no agreement will be made with you. However, you will be informed about the registration process occasionally. If you change your status from dormant to either passive, involved or leading, please react to this e-mail by sending information on your identity, SIEF code and expected tonnage band and deadline to [email protected]. Hereafter, a contractual agreement will be made with you in order for you to be able to be part of the joint submission.

Step 4
Dormant members

Dear Madam, Dear Sir,
DHI is contacting you on behalf of Fef Chemicals A/S, Køge, Denmark regarding the SIEF for:

Cetrimonium bromide, EINECS no. 200-311-3

Based on the results from Step 2 in the SIEF formation, FeF Chemicals A/S, Køge has taken the role as the lead registrant in the registration of Cetrimonium bromide. FeF Chemicals A/S has the intention to prepare the joint submission of the registration dossier for Cetrimonium bromide at the earliest registration deadline which is 30 May 2013.

For the collaboration among the SIEF members, FeF Chemicals A/S has drafted a bilateral SIEF agreement to be entered between the lead registrant and each individual non-dormant SIEF member. Please, find the draft SIEF agreement attached this email for your information

Please, be aware that if your role is dormant (SIEF code 4) no agreement will be made with you. However, you will be informed about the registration process occasionally. If you change your status from dormant to either passive, involved or leading, please react to this e-mail by sending information on your identity, SIEF code and expected tonnage band and deadline to [email protected] Hereafter, a contractual agreement will be made with you in order for you to be able to be part of the joint submission.

 

Progress on registration

October 2010, in total 7 non-dormant members were registered.

Step 5 
Non-dormant SIEF members & Data holders

15 October 2010. Meeting announcement and data information request were sent to non-dormant SIEF members. The data information request was also sent to data holders.

Dear Madam, Dear Sir,
DHI is contacting you on behalf of the lead registrant Fef Chemicals A/S, Køge, Denmark regarding the SIEF for:

Tetradonium bromide, EINECS no. 214-291-9

Meeting announcement
As you have taken an involved or passive role in the registration process of Tetradonium bromide, FeF Chemicals A/S invites you to a SIEF meeting. The meeting will be held at Hamburg airport on the 19th  November 2010. More details on the meeting including the agenda will be sent to you in due time before the meeting. The purpose of the meeting is to present the registration process and to discuss the cooperation in the SIEF and the SIEF agreement which was send to you 2nd July 2001.

Please, reserve the day 19th November 2010 for the SIEF meeting at Hamburg Airport.

Data information request

A data availability survey for registration of Tetradonium bromide is undergoing in order to prepare for the registration with the earliest registration deadline of 30th May 2013.

Please find attached the data information request. DHI kindly ask you to fill out the form with information to be used in the data availability survey for registration of Tetradonium bromide. Please, return the filled form no later than 8th November 2010 to DHI at [email protected].

 

Step 6
Non-dormant SIEF members & All SIEF members

16 November 2010. Cancellation of Meeting 19 November – SIEF Tetradonium bromide EC 214-291-9 and information on website was sent to non-dormant SIEF members.

Dear Madam, Dear Sir,
Due to lack of interest from the SIEF members, FeF chemicals A/S has decided to postpone the SIEF meeting planned for 19th November in Hamburg. With registration deadline by 2018, members of the SIEF for Tetradonium bromide do not intend to participate in a SIEF meeting at this time and therefore we decided to cancel the meeting. A SIEF meeting will be planned closer to the registration deadline.

FeF chemicals is the only company with registration deadline in 2013, so the registration process will proceed. The registration progress can be followed at the website for the SIEF for Tetradonium bromide using this link: http://tetradoniumbromide.sief.dhigroup.com

 

23 August 2010. Substance specification for Cetrimonium bromide EC 200-311-3 was sent to non-dormant SIEF members.

Dear Madam, Dear Sir,
DHI is contacting you on behalf of Fef Chemicals A/S, Køge, Denmark regarding the SIEF for:

Tetradonium bromide, EINECS no. 214-291-9

The registration process for tetradonium bromide is ongoing with FeF Chemicals A/S as the lead registrant. FeF Chemicals A/S will prepare the joint submission of the registration dossier for tetradonium bromide with registration deadline of 30 May 2013.

The registration progress can be followed at the SIEF website for tetradonium bromide using the link: http://tetradoniumbromide.sief.dhigroup.com

At the SIEF website, you will also find information on the preSIEF activities. If you are dormant and want to change your role, please contact the SIEF using the contact information on the SIEF website.

Step 7 
Non-dormant SIEF members

23 August 2010. Substance specification for Tetradonium bromide EC 214-291-9 was sent to non-dormant SIEF members.

Dear Madam, Dear Sir,
DHI is contacting you on behalf of the lead registrant FeF Chemicals A/S, Køge, Denmark regarding the SIEF for:

Tetradonium bromide, EINECS no. 214-291-9

FeF Chemicals is preparing for registration in 2013 and have prepared the substance specification for the registration dossier. Please find attached the proposed substance specification for Tetradonium bromide.

In order to facilitate the SIEF work and the generation of the registration dossier, we ask you to agree on the proposed specification. In case you do not agree, please indicate the modifications in the attached document, and we will do our best to include the modifications in the registration dossier.

DHI kindly ask you to respond to this communication no later than September 6, 2011 by email to [email protected].

Step 8
Non-dormant SIEF members

6 November 2012. Information on identified uses was sent to non-dormant SIEF members.

Dear Madam, Dear Sir,

DHI is contacting you on behalf of the lead registrant FeF Chemicals A/S, Køge, Denmark regarding the SIEF for:

Tetradonium bromide, EINECS no. 214-291-9

FeF Chemicals is preparing for registration in 2013. In this regard, a mapping of the identified uses to be included in the registration of Tetradonium bromide has been done.

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 characterisation will be 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 characterisation will be part of the chemical safety report to be 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. Please find attached the list of identified uses.

The registration progress can be followed at the website for the SIEF for Tetradonium bromide using this link: http://tetradoniumbromide.sief.dhigroup.com

Step 9
Non-dormant SIEF members
4 July 2013. Information on REACH registration of Tetradonium bromide EC 214-291-9 was sent to non-dormant SIEF members.

Dear Madam, Dear Sir,

We are pleased to inform you that

Tetradonium bromide, EINECS no. 214-291-9

was successfully registered by the lead registrant FeF Chemicals A/S, Køge, Denmark.

The substance has been registered for the tonnage band of 100-1000 ton/year. The letter of access will be available on requests.

Please contact Chantale Julien, FeF Chemicals A/S by phone: +45 5667 1006 (direct); +45 4029 7906 (mobile) or by sending an email to [email protected]

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.

Details on the registration are found at: http://tetradoniumbromide.sief.dhigroup.com

For Joint Registrants

Please find information relevant for joint registration of the substance cetrimonium bromide, EC 200-311-3.

For Letter of Access (LoA) price and application, please contact the lead registrant:
Chantale Julien at [email protected] and Camilla Maria Højer Knudsen at [email protected] with CC to [email protected].

After signature of the SIEF Agreement and purchase of the LoA, the lead registrant will provide the token for the joint registration.

SIP – Boundary composition for cetrimonium bromide, EINECS no. 200-311-3

Name and identifier, molecular and structural information

Chemical nameTetradonium bromide
IUPAC nameN,N,N-trimethyltetradecan-1-aminium bromide
EINECS number214-291-9
CAS number1119-97-7
SynomymsTetradecyl trimethyl ammonium bromide
Trimethyl tetradecyl ammonium bromide
1-Tetradecanaminium, N,N,N-trimethyl-, bromide
Myristyl trimethyl ammonium bromide
Myrtrimonium bromide
N,N,N-Trimethyl-1-tetradecanaminium bromide
Cetrimide
Molecular and structural formulaC17H38N.Br
SMILES notation[Br-].CCCCCCCCCCCCCC[N+](C)(C)C
InChlInChI=1/C17H38N.BrH/c1-5-6-7-8-9-10-11-12-13-14-15-16-17-18(2,3)4;/h5-17H2,1-4H3;1H/q+1;/p-1
Molecular weight 336.3943

Composition

Recommendation for specification
Degree of purity (% w/w)=95
Impurities (% w/w)=5
Constituents
C-Chain distribution (% w/w):
C19
C12=25
C14=65
C16=10
C18
Impuritites 
Free amine (Mwt 270) (% w/w) =2.5
Water (% w/w)=2
 Sulphated ash (% w/w)=1
Methyl bromide (% w/w) =1
Additives
Conc. (ppm)< 5000*
 Name/nature Acetone

Recommended Analytical Information

For the analytical information to be included in the company specific dossier, it is recommended to have the following analyses done:

AnalysisRationale
Spectral dataFT-IR, UV, NMR- MSIdentification
ChromatogramsGC-MSPurity, quantification (chain length distribution for the starting material)
Supplementary tests recommendedIdentification test A-E from the current European Pharmacopoeia or A-C from the current British PharmacopoeiaGeneral identification and identification of the bromide ion