Potential endocrine disruption properties of biocides
Dr Michael Werner , managing director of Prosacon , shares some insights into the assessment of potential endocrine-disrupting properties of biocidal active substances and biocidal products , including the regulatory implications
The hazard identification and hazard characterisation process in the area of toxicology spans many endpoints , from acute toxicity , primary irritation and sensitisation to higher tier endpoints , such as repeated dose toxicity , carcinogenicity , mutagenicity and reproductive toxicity ( CMR ). The long-debated endocrine disruption ( ED ) endpoint has gained more attention in the past few years and has now become an integral part in the hazard identification process under different legislation . With the publication of Commission Delegated Regulation ( EU ) 2017 / 2100 , setting out scientific criteria for the determination of endocrine-disrupting properties under the Biocidal Products Regulation ( BPR ), a new data requirement entered the biocides arena . The delegated regulation entered into force on 7 June 2018 , which meant at the same time that the biocides regime has been the first to apply the criteria . Whereas 2017 / 2100 focuses on the ED criteria , the tools on how to assess potential ED properties of an active substance used in biocidal or plant protection products in practice are defined in the ECHA / EFSA ‘ Guidance for the identification of endocrine disruptors in the context of Regulations ( EU ) No 528 / 2012 and ( EC ) No 1107 / 2009 ’ which was adopted on the same day . 1 The latter defines the procedure ( s ) and data needed to perform hazard identification for ED properties of active substances under the BPR and the Plant Protection Products Regulation ( PPPR ). In this article , the procedure for the determination of the potential ED properties is briefly summarised , distinguishing between biocidal active substances and biocidal products .
ED assessment of biocidal active substances
With the entry into force and application of the ECHA / EFSA ED guidance document , the evaluation of potential ED properties became a mandatory data requirement before a final conclusion on the approval or non-approval of a biocidal active substance can be drawn . Determining potential ED properties of biocidal active substances is based on the WHO definition of an endocrine disruptor . 2 According to this definition , a substance shall be considered as having ED properties that may cause adverse effect in humans if it meets all of the following criteria , unless there is evidence demonstrating that the adverse effects identified are not relevant to humans :
• Observation of an adverse effect in an intact organism or its progeny ( change in the morphology , physiology , growth , development , reproduction or lifespan of an organism , system or ( sub- ) population that results in an impairment of functional capacity , an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences )
• Identification of an endocrine mode of action ( MoA ), altering the function ( s ) of the endocrine system
• The adverse effect is a consequence of the endocrine MoA The document focuses on ED properties based on ‘ estrogen , androgen , thyroid and steroid ( EATS ) -mediated effects ’. To date , these endpoints are best understood from the mechanistic point of view . Standardised in vitro / in vivo test methods and guidelines are available on them , with broad scientific agreement on the interpretation of the effects observed on the investigated parameters . The available test methods are provided for in the OECD Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption ( GD 150 ), which includes the OECD Conceptual Framework for Testing & Assessment of Endocrine Disruptors . This groups the studies into five levels according to the kind of information provided . To assess the potential ED properties of an active substance , a grouping is performed in the evaluation of the scientific evidence when identifying such substances . It comprises the following parameters :
34 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981