REACH – Applications for authorisation AFA018-01 OPEO

Closes 1 Dec 2022

Opened 6 Oct 2022

Overview

Public consultation on alternatives

Reference: AFA018-01

Applicant: Siemens Healthcare Diagnostics Products GmbH

Application type: Initial 

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

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

Proposed use: Use of IVD kit reagents on diagnostic analyser systems by professional users 

Broad information on use applied for (conditions of use and function): Octylphenolethoxylates (OPE) are used as cell lysis agents, detergents and stabilisers in IVD-kits.

Conditions of use: To perform an assay for a specific disease or condition, the customer is essentially running a ‘ready to use’ IVD-kit on a compatible analyser system. After use OPE-containing solutions are mainly discharged to the sewage and communal STP.

OPEs have to contribute to fulfil two main parameters in the IVD kits:

  • Specificity (the potential of the kit to detect a certain protein with a high accuracy) and
  • Sensitivity (the degree to which a test does detect a target protein)
  • Stability (IVD kits are required to have a long shelf-life)

List of descriptors: 

  • Sector of end use (SU): 20 
  • Product category (PC): 21 - Laboratory chemicals   
  • Environmental release category (ERC): 8a
  • Process category (PROC): 8b - Transfer of substance or mixture (charging and discharging) at dedicated facilities 
  • Process category (PROC): 15 - use as laboratory reagent   
  • Process category (PROC): 21 - Low energy manipulation of substances bound in materials and/or articles    
  • Article category related to subsequent service life (AC): N/A 
  • Technical Function: Surfactant  

Annual tonnage used:  <1 tonne per year 

Review period requested: 12 years

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).

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Audiences

  • Applications for authorisation

Interests

  • Registration, Evaluation, Authorisation & restriction of CHemicals (REACH)