REACH – Applications for authorisation AFA021-01 OPEO

Overview

Public consultation on alternatives

Reference: AFA021-01

Applicant: Becton Dickinson U.K. Limited

Application type: Initial

Substance name: 4-(1,1,3,3 tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))

• 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
  • EC Number: 618-344-0
  • CAS Number: 9002-93-1
• 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
  • EC Number: 618-541-1
  • CAS Number: 9036-19-5

Proposed use: Use of 4-(1,1,3,3 tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)) for the lysis of different types of cells in order to release the cell contents for subsequence analysis in diagnostics

Broad information on use applied for (conditions of use and function): Becton Dickinson imports into the UK and distributes the diagnostics from their distribution centre outside the UK directly to the DU as required, to hospitals, blood banks CROs, and doctors’ surgeries across the UK. Once at these locations the diagnostics are used in the analysis of a number of end points. These end points include; Infectious disease tests (including screening of cancer causing viruses and SARS-CoV-2); DNA genotyping & analysis; and White blood cell counting in blood products for transfusion. OPnEO is used within the diagnostics for the solubilisation of hydrophobic proteins and lipids, specifically the lysis of different types of cells where OPnEO is used to disrupt cell membranes (mammalian and bacterial) to release cell contents and maintain protein solubility for subsequent analysis in BD diagnostic systems.

Technical function: OPnEO is a key constituent of these imported diagnostics for the purpose of the lysis of different types of cells (mammalian and bacterial) in order to release the cell contents for subsequent analysis in BD diagnostic systems.

An alternative must have the following key properties:

• Water solubility
• Should not denature the proteins being assessed
• High purity available (Molecular Grade)
• Amphipathic Character
• Low Critical Micelle Concentration value
• Stability

List of descriptors:

• Sector of end use (SU): 20 
• Sector of end use (SU): 24 
• Product category: 21 – Laboratory chemicals
• Environmental release category (ERC): 8a 
• Process category (PROC): 15 – Use as laboratory reagent
• Article category related to subsequent service life (AC): N/A

Technical Function: Surfactant

Annual tonnage used:  <1 tonne per year

Review period requested: 12 year review period

How to submit comments

Provide some basic information on possible alternative(s) in the online survey below but more detailed information should be provided in document(s) prepared using the commenting templates in the related section below. A “public version” should always be completed and will be published after the consultation has closed. If you want to include confidential information in your submission, please additionally complete a “confidential version” and submit both versions as attachments.

The consultation lasts for 8 weeks (unless otherwise specified) and closes at 23:59 London time (BST).