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Active Chlorine Released from Hypochlorous Acid

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Active Chlorine Released from Hypochlorous Acid Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products Evaluation of active substances Assessment Report ★ ★ ★ ★ * ★ * ★★ Active chlorine released from hypochlorous acid Product-type 1 (Human hygiene) July 2020 Slovak Republic Active chlorine released from Product-type 1 July 2020 hypochlorous acid CONTENTS 1. STATEMENT OF SUBJECT MATTER AND PURPOSE............................... 4 1.1. Procedure followed................................................................................................... 4 1.2. Purpose of the assessment report............................................................................ 4 2. OVERALL SUMMARY AND CONCLUSIONS............................................ 5 2.1. Presentation of the Active Substance.......................................................................5 2.1.1. Identity, Physico-Chemical Properties & Methods of Analysis..................................... 5 2.1.2. Intended Uses and Efficacy..................................................................................... 9 2.1.3. Classification and Labelling.................................................................................... 10 2.2. Summary of the Risk Assessment............................................................................10 2.2.1. Human Health Risk Assessment............................................................................. 10 2.2.1.1. Hazard identification and effects assessment.................................................... 10 2.2.1.2. Exposure assessment and risk characterisation.................................................14 2.2.1.3. Preliminary risk assessment for disinfection by-products (DBPs).........................15 2.2.2. Environmental Risk Assessment.............................................................................16 2.2.2.1. Hazard identification and effects assessment.....................................................16 2.2.2.2. Exposure assessment and risk characterisation................................................. 19 2.2.2.3. Fate and distribution in the environment.......................................................... 22 2.2.2.4. PBT and POP assessment................................................................................. 22 2.2.3. Assessment of endocrine disruptor properties.........................................................22 2.3. Overall conclusions.................................................................................................. 24 2.3.1. Overall conclusion of the evaluation including need for risk management measures ... 24 2.4. Requirement for further information related to the reference biocidal product ....24 2.5. List of endpoints.......................................................................................................24 APPENDIX I: LIST OF ENDPOINTS..................................................................... 25 Chapter 1: Identity, Physical and Chemical Properties, Classification and Labelling ....25 Chapter 2: Methods of Analysis....................................................................................... 30 Chapter 3: Impact on Human Health...............................................................................32 Chapter 4: Fate and Behaviour in the Environment...................................................... 41 Chapter 5: Effects on Non-target Species...................................................................... 43 Chapter 6: Other End Points........................................................................................... 45 APPENDIX II: LIST OF INTENDED USES.......................................................... 46 APPENDIX III: LIST OF STUDIES....................................................................... 47 2 Active chlorine released from Product-type 1 July 2020 hypochlorous acid APPENDIX IV: LIST OF ABBREVIATIONS......................................................... 77 3 Active chlorine generated from Product-type 1 July 2020 sodium chloride by electrolysis 1. STATEMENT OF SUBJECT MATTER AND PURPOSE 1.1. Procedure followed This assessment report has been established as a result of the evaluation of the active substance Active chlorine released from hypochlorous acid as product-type 1 (Human hygiene), carried out in accordance with Article 90(2) of Regulation (EU) No 528/2012, with a view to the possible approval of this substance. Active chlorine released from hypochlorous acid (CAS no. not applicable) was notified by PuriCore International Ltd, UK (Puricore International Ltd. transfers to PuriCore Europe Limited. PuriCore Europe Limited is a subsidiary of Realm Therapeutics PLC) and Forum Bioscience Holdings Ltd UK, (the subsequent change in the body of the applicant to company Aqualution Systems Ltd, UK because of the change of ownership), hereafter referred to as the applicants, in product-type 1. On 31st July 2007, SK competent authority received a dossier from PuriCore International Ltd, UK (Puricore International Ltd. transfers to PuriCore Europe Limited. PuriCore Europe Limited is a subsidiary of Realm Therapeutics PLC) and Forum Bioscience Holdings Ltd UK, (the subsequent change in the body of the applicant to company Aqualution Systems Ltd, UK because of the change of ownership). The Rapporteur Member State accepted the dossier as complete for the purpose of the evaluation on 31st January 2008. On 19st November 2010, the Rapporteur Member State submitted to the Commission and the applicants a copy of the evaluation report, hereafter referred to as the competent authority report. In 2019 PuriCore Europe Limited sold and transferred rights in the dossier to Aqualution Systems Ltd. In order to review the competent authority report and the comments received on it, consultations of technical experts from all Member States (peer review) were organised by the "Agency" (ECHA). Revisions agreed upon were presented at the Biocidal Products Committee and its Working Groups meetings and the competent authority report was amended accordingly. 1.2. Purpose of the assessment report The aim of the assessment report is to support the opinion of the Biocidal Products Committee and a decision on the approval of Active chlorine released from hypochlorous acid 1, and, should it be approved, to facilitate the authorisation of individual biocidal products. In the evaluation of applications for product-authorisation, the provisions of Regulation (EU) No 528/2012 shall be applied, in particular the provisions of Chapter IV, as well as the common principles laid down in Annex VI. For the implementation of the common principles of Annex VI, the content and conclusions of this assessment report, which is available from the Agency web-site, shall be taken into account. However, where conclusions of this assessment report are based on data protected under the provisions of Regulation (EU) No 528/2012, such conclusions may not be used to the benefit of another applicant, unless access to these data for that purpose has been granted to that applicant. 4 Active chlorine released from Product-type 1 July 2020 hypochlorous acid 2. OVERALL SUMMARY AND CONCLUSIONS 2.1. Presentation of the Active Substance 2.1.1. Identity, Physico-Chemical Properties & Methods of Analysis Active chlorine released from hypochlorous acid is an equilibrium mixture, with the exact composition dependent on pH. The active substance is generated by the electrolysis of a dilute aqueous solution of sodium chloride (NaCl). The passage of an electric current through sodium chloride in the electrolytic cell causes oxidation of the chloride ions (Cl-) to chlorine (Cl2). The chlorine undergoes rapid hydrolysis to form a range of different chlorine based constituents: hypochlorous acid (HOCl), chloride ions and hypochlorite ion (OCl-). 2 Cl- ^ Cl 2 + 2 e- Cl2 + H2O ^ HOCl + H+ + Cl- HOCl ^ H+ + OCl- Chlorine is available in three different forms: OCl-, HOCl and Cl2 . Thus, the term "Active Chlorine" covers all three forms of available chlorine. The precise concentration of the individual forms of available chlorine strongly depends on a number of parameters such as background electrolyte concentration, temperature and pH. Typically, at pH 6 - 8 the solution would contain primarily NaCl (not all the NaCl is converted to Active Chlorine), sodium hypochlorite (NaOCl), HOCl and other minor forms. HOCl is predominant between pH 3 and 7. At pH 7.5 the ratio OCl-/HOCl is in the proportion of one to one. At pH values higher than 10 the only constituent present is the OCl- . The generated solution is bottled and forms the product. Originally, the dossier for active chlorine released from hypochlorous acid was submitted under the Biocidal Products Directive as part of the dossier on active chlorine generated from sodium chloride by electrolysis. During the peer review it was conclude however that these are distinct active substances. Consequently, the original dossier was split in two: active chlorine generated from sodium chloride by electrolysis and active chlorine released from hypochlorous acid. Minimum content of hypochlorous acid (predominant in pH 3.0-7.4) is 0.0255% w/w (as dry weight min 90.87% w/w) 1. The individual chlorine based constituents are never isolated. Therefore, details on the constituents are presented for information only. Chlorine: CAS-No. 7782-50-5 EINECS-No. 231-959-5 Other No. (CIPAC, ELINCS) Not applicable 1 Reference specification is derived from the 5-batch analysis of the company Puricore
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