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Pareri adottati e consultazioni precedenti sulle domande di autorizzazione

Pareri adottati e consultazioni precedenti sulle domande di autorizzazione

 

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 of 4-tert-OPnEO for its detergent properties in the process of cell lysing for the production of in-vitro diagnostic reagents (Asserachrom® HPIA, Asserachrom® HPIA–IgG and Asserachrom® PF4 and STA®-Néoplastine® R15 assays).
Broad information on use applied for (conditions of use and function)
Substance function
Triton™ X-100 is a non-ionic surfactant used in the production of a recombinant protein ( recombinant platelet factor 4 and recombinant tissue factor) used in the manufacture of Asserachrom® HPIA / Asserachrom® HPIA – IgG / Asserachrom® PF4 and STA ® - Néoplastine® R15, screening test used in the early ruling out of Heparin induced thrombocytopenia.

Under Use-1, Triton™ X-100 is used to permeabilise cell membranes so as to extract either tissue factor (STA®- Néoplastine® R15) or PF4 (Asserachrom® HPIA / Asserachrom® HPIA – IgG / Asserachrom® PF4).

The Main 4-tert-OPnEO sought after functional properties under Use- 1 include:
  • Detergent properties. In the presence of Triton ™X-100, the hydrophobic type interactions that allow the existence of the membrane are therefore non-existent. The intrinsic proteins, which interact with the hydrophobic zone of the membrane, are released.
  • Being a non-ionic surfactant in order to lyse cell membranes. This characteristic is necessary to eliminate issues related to the proteins denaturation in the absence of electrostatic interactions between proteins and ionic surfactants.
  • Solubilisation of membrane proteins by having an HLB (Hydrophilic-Lipophilic Balance) value higher than 13, to extract the protein of interest in an active form to obtain an aqueous solution containing the membrane protein complexed with detergents and lipids in a form suitable for purification and further analysis. By this property, Triton™ X-100 is used to recover membrane proteins because it has the ability to solubilize membranes without denaturing proteins.
Key elements of the conditions of use
  • 4-tert-OPnEO is used in Stago’s Franconville and Taverny sites, for the following maximum quantities: around 0,7 kg per year is used for the production of reagents.
  • 4-tert-OPnEO was included on Annex XIV of REACH for the impacts on the environment of its degradation products; as a consequence, impacts on human health are excluded of the context of the present application.
  • In the production the recombinant protein, releases of 4-tert-OPnEO are reduced to the maximum as all potential releases of the substance are collected and the only remaining release sources are residues in washed glassware.
  • In the production stage, Collection of all process effluents and solid wastes then disposed to a certified company.

Annual tonnage used: 0.0007 tonnes
Review period requested: 7 years
Use applied for number in application for authorisation
1
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 20, 24
Environmental release category (ERC): 2
Process category (PROC): 0, 5, 9, 15
Product category (PC): 21
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
0140-01
Applicant(s)
DIAGNOSTICA STAGO
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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