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Avis adoptés et consultations antérieures sur des demandes d’autorisation

Avis adoptés et consultations antérieures sur des demandes d’autorisation

 

This page provides further information on the applications for authorisation or review reports, which have undergone consultation. The applications for authorisation are in the opinion development phase until the final opinions of the Committees for Risk Assessment and Socio-economic Analysis have been adopted and sent to the European Commission. The European Commission's decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.

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Substance Details

Name
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
EC Number
-
CAS Number
-
Entry Nr in Annex XIV
42
Use name
Industrial use, as non-ionic surfactant, employed in the purification of antigens in in vitro diagnostics tests for infectious diseases, auto-immunity markers, bone metabolism, hepatitis and retrovirus, oncology and endocrinology.
Broad information on use applied for (conditions of use and function)
4-tert-OPnEO is used as a surfactant during the purification processes for the preparation of antigens, which will in turn be included into vitro diagnostic (IVD) reagents. The IVD kits are used to diagnose infectious diseases, auto-immunity markers, bone metabolism, hepatitis and retrovirus, oncology and endocrinology. The substance is not present any more in the IVD kits.
The purification processes are performed in biochemistry/biotechnology and biology laboratories and can be divided into two phases: the buffer preparation (including weighing and dilution) and the buffer application. The function of the substance, which is used in concentrations up to 10 % in aqueous buffers, is identified by the applicant as lysis of cells, lysis of cell paste, removal of contaminants (washing) and prevention from antigens unfolding, crystallisation or precipitation (storage).
The action of the 4-tert-OPnEO-buffer is aimed: to disrupt the bacterial wall cell; to remove possible contaminants bound to the protein of interest; to maintain, in solution, the purified proteins; to lyses of the eukaryote cell membranes. 4-tert-OPnEO-buffer is critical to allow the extraction of the cell proteins; to make available the protein of interest; to avoid aggregation and/or precipitation phenomena of proteins; to extract proteins from the cell nucleus.
Customers, mainly hospitals and laboratories, require the assays to be sensitive, specific, reproducible and stable over the shelf life. An alternative surfactant has to be:
- mild, non-ionic, thus it does not denature the tertiary structure of antigens and does not affect the immunological performance, in terms of sensitivity, specificity, reproducibility and stability
- selective towards contaminants to solubilise during and after lysis
- stable under operative conditions and removable from the sample without causing side-effects on the antigens, such as denaturation, aggregation or precipitation, in order to allow the following process steps. For instance, only traces of surfactants are compatible with column chromatography that is run for the purification of antigens.
Technical function: the specific function of 4-tert-OPnEO is surfactant.
Annual tonnage used: <10kg
Review period requested: 12 years
Use applied for number in application for authorisation
1
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): SU 0: Other: preparation of antigens which will be in turn included into IVDs
Environmental release category (ERC): 2, 4
Process category (PROC): 5, 9, 15
Product category (PC): 0: buffer
Article category related to subsequent service life (AC): n/a
Technical Function: Surfactant
Summary table of RMMs and OCs (non confidential)
Section 9 and 10 of the CSR (original and updated, if available) (non confidential)


Analysis of Alternatives (non confidential report)
Substitution Plan (non confidential summary)
Socio-Economic Analysis (non confidential report)
Joint Analysis of Alternatives and Socio-Economic Analysis (non confidential report)
Explanatory note
Additional information
ID
0181-01
Applicant(s)
DiaSorin S.p.A.
Application type
Initial
Status
Opinions adopted
Other consultations on the same/ similar use
Comments submitted to date
No comments received
Response to comments by applicant
Responses to RAC and SEAC requests by Applicant(s) (non confidential)
Compiled RAC and SEAC opinions
Minority positions
Adopted commission decision (OJ summary)
Authorisation decision

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