Substance Information

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Substance Infocard

IC

Salts of 4,4'-oxydianiline

EC / List no.: -

CAS no.: -

Mol. Formula:

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Key datasets

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Regulatory context

Here you can find all of the regulations and regulatory lists in which this substance appears, according to the data available to ECHA. This substance has been found in the following regulatory activities (directly, or inheriting the regulatory context of a parent substance):

Active Implantable Medical Devices Directive-repealed
  • Active Implantable Medical Devices Directive - Hazardous Substances
    EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007

    This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Construction Products Regulation
  • Construction Product Regulation - Annex I (3) - Hazardous Substances
    EU. Hazardous Substances for Purposes of Annex I (3) (Requirements for Construction Works), Regulation 305/2011/EU on Marketing of Construction Products, amended by Regulation 574/2014/EU, 28 May 2014

    This list contains a non-exhaustive inventory of substances taken from: (1) Table 3 of Annex VI to CLP; (2) the Candidate List of SVHCs; (3) Annex XIV of REACH (Authorisation List); (4) Annex XVII of REACH (Restrictions List); (5) F-gases subject to emission limits/reporting per Regulation 517/2014/EU; and (6) volatile organic compounds (VOCs) listed in the Ambient Air Directive 2008/50/EC. The basis of the list is Annex I(3) of the Construction Products Regulation 305/2011/EC, which stipulates that construction works must not have a high impact on human health or the environment as a result of: giving off toxic gas; emissions of dangerous substances, volatile organic compounds (VOC), greenhouse gases or dangerous particles into indoor or outdoor air; release of dangerous substances into drinking water, ground water, marine waters, surface waters or soil.

  • Construction Product Regulation - Article 6(5) - SDS and Declaration
    EU. Hazardous Substances Subject to Declaration (Article 6(5)), Regulation 305/2011/EU on Marketing of Construction Products, amended by Regulation 574/2014/EU, 28 May 2014

    This list contains a non-exhaustive inventory of substances originating from: (1) Table 3 of Annex VI to CLP (i.e., the list of harmonised substances); (2) the Candidate List of Substances of Very High Concern (SVHCs); and REACH Annex XIV (Authorisation List). This list is compiled on the basis of Article 6(5) of Regulation 305/2011/EC on Marketing of Construction Products. This provision requires SDSs and information on hazardous substances (i.e., SVHCs) contained in construction products be provided with the declaration of performance.

Cosmetic Products Regulation
  • Cosmetic Products Regulation, Annex II - Prohibited Substances
    EU. Prohibited Substances: Annex II, Regulation 1223/2009/EC on Cosmetic Products, as amended by Regulation (EU) 2024/996, OJ L of 4 April 2024

    This list contains substances which are banned from use in any cosmetic products marketed for sale or use in the European Union.

EU Ecolabel Regulation
  • Ecolabel - Restrictions for Hazardous Substances/Mixtures
    EU. Hazardous Substances which may Preclude Goods from the Ecolabel Award as per Article 6(6) of Regulation 66/2010/EC, L 27/1, 30 January 2010

    This list contains a non-exhaustive inventory of substances based on the list of hazardous substances with harmonised classification and labelling (i.e. Table 3 of Annex VI to the CLP Regulation), and the Candidate List of substances of very high concern (SVHCs). Pursuant to Article 6(6) of the EU Ecolabel Regulation, the ecolabel must not be awarded to goods containing substances or mixtures classified according to the CLP as toxic; hazardous to the environment; and carcinogenic, mutagenic, or toxic for reproduction (CMRs). Nor are products allowed the ecolabel award when they contain SVHCs (per Article 57 of REACH). While the CLP's harmonised list contains many such substances, other ones not listed in Table 3 may also meet the criteria specified for classification under the CLP.

General Product Safety Directive
  • General Product Safety Directive - Hazardous Substances
    EU. Hazardous Substances for Purposes of General Product Safety Directive (2001/95/EC), 15 January 2002, amended by Reg 596/2009/EC, 18 July 2009

    This list contains a non-exhaustive inventory of substances that fall within the European Union's hazardous substance definitions, as provided on: (1) Table 3 of Annex VI to the CLP Regulation 1272/2008/EC; (2) Annex III of Directive 2000/54/EC (Biological Agents); Candidate List of SVHCs; and REACH Annexes XIV and XVII (Authorisation and Restriction lists). They can be considered hazardous for purposes of the General Product Safety Directive 2001/95/EC.

In Vitro Diagnostic Medical Devices Directive-repealed
  • In Vitro Diagnostic Medical Devices Directive - Hazardous Substances
    EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

    This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

In Vitro Diagnostic Medical Devices Regulation
  • In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances
    EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019

    This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).

Marine Environmental Policy Framework Directive
  • Marine Environmental Policy Framework Directive - Hazardous Substances
    EU. Hazardous Substances for Purposes of Directive 2008/56/EC (Marine Strategy Framework Directive), 25 June 2008, amended by Directive 2017/845/EU, 18 May 2017

    This list contains a non-exhaustive inventory of hazardous substances for purposes of the Marine Strategy Framework Directive, especially as it concerns Art. 3(8), and Annexes I and III. The listed substances meet the European Union's definitions as hazardous, as provided on: (1) Table 3 of Annex VI to the CLP Regulation (1272/2008/EC); (2) Annex III of Directive 2000/54/EC (Biological Agents); Candidate List of SVHCs; and REACH Annex XIV (Authorisation List).

Medical Devices Directive-repealed
  • Medical Devices Directive - Hazardous Substances
    EU. Hazardous Substances for Purposes of Medical Devices Directive 93/42/EEC, 12 July 1993, amended by Directive 2007/47/EC, 21 September 2007

    This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Medical Devices Regulation
  • Medical Devices Regulation - Hazardous Substances
    EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

    This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).

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Substance names and other identifiers

Regulatory process names
4,4'-oxydianiline and its salts; p-aminophenyl ether
Active Implantable Medical Devices Directive - Hazardous Substances, In Vitro Diagnostic Medical Devices Directive - Hazardous Substances, Medical Devices Directive - Hazardous Substances
Salt of 4,4'-Oxydianiline
Construction Product Regulation - Annex I (3) - Hazardous Substances, Construction Product Regulation - Art. 6(5) - SDS and Declaration, EU Ecolabels - Restrictions for Hazardous Substances/Mixtures, In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances, Marine Environmental Policy Framework Directive - Hazardous Substances, Medical Devices Regulation - Hazardous Substances, General Product Safety Directive - Hazardous Substances
Salts of 4,4'-oxydianiline
Cosmetic Products Regulation, Annex II - Prohibited Substances, Other