European Chemicals Agency Research Articles

Application of read-across methods as a framework for the estimation of emissions from chemical processes.

The read-across method is a popular data gap filling technique with developed application for multiple purposes, including regulatory. Within the US Environmental Protection Agency's (US EPA) New Chemicals Program under Toxic Substances Control Act (TSCA), read-across has been widely used, as well as within technical guidance published by the Organization for Economic Co-operation and Development, the European Chemicals Agency, and the European Center for Ecotoxicology and Toxicology of Chemicals for filling chemical toxicity data gaps. Under the TSCA New Chemicals Review Program, US EPA is tasked with reviewing proposed new chemical applications prior to commencing commercial manufacturing within or importing into the United States. The primary goal of this review is to identify any unreasonable human health and environmental risks, arising from environmental releases/emissions during manufacturing and the resulting exposure from these environmental releases. The authors propose the application of read-across techniques for the development and use of a framework for estimating the emissions arising during the chemical manufacturing process. This methodology is to utilize available emissions data from a structurally similar analogue chemical or a group of structurally similar chemicals in a chemical family taking into consideration their physicochemical properties under specified chemical process unit operations and conditions. This framework is also designed to apply existing knowledge of read-across principles previously utilized in toxicity estimation for an analogue or category of chemicals and introduced and extended with a concurrent case study.

Prezes Biura do Spraw Substancji Chemicznych

The subject of the analysis in this article is the legal status of the President of the Bureau for Chemical Substances. The President acts as the central government administration body responsible for chemical substances and their mixtures. Its functioning is justified by the threats to human life and health as well as the natural environment, which are associated with the production and trade of chemical substances. The article discusses, on the basis of relevant legal acts, the tasks of the President of the Bureau for Chemical Substances. In the author’s opinion, cooperation with international institutions, especially the European Commission and the European Chemicals Agency, is essential for the proper performance of the tasks by the President of the Bureau for Chemical Substances. Thanks to it, it is possible to take uniform actions to ensure chemical security within the European Union.

Predicted health and environmental hazards of liquid crystal materials via quantitative structure-property relationship modeling

Liquid crystal materials (LCMs) are considered as emerging contaminants with high persistent and bioaccumulative potentials, but their toxicological effects are not well understood. To address this issue, a list of 1431 LCMs commercially available in the market was established through literature reviews and surveys of LCM suppliers. Toxicological properties of 221 target LCMs were derived from the Classification and Labeling Inventory by the European Chemicals Agency. More than 80 % of target LCMs likely pose adverse effects on human health or aquatic ecosystems. Two quantitative structure-property relationship (QSPR) models developed from the toxicological properties of LCMs achieved approximately 90 % accuracy in external data sets. The probability-based approach was more efficient in defining the applicability domain for the QSPR models than a range- or distance-based approach. The highest accuracy was achieved for chemicals within the probability-based applicability domain. The QSPR models were applied to predict health and environmental hazards of 1210 LCMs that had not been notified to the Classification and Labeling Inventory, and 301 and 94 LCMs were recognized as posing potential hazards to human health and the environment, respectively. The present study highlights the potential detrimental effects of LCMs and offers a specific in silico technique for screening hazardous LCMs.

We Are What We Eat: The Association Between Ultra-Processed Food Consumption, Colon Cancer Risk and All-Cause Mortality

We Are What We Eat: The Association Between Ultra-Processed Food Consumption, Colon Cancer Risk and All-Cause Mortality

Inhalation exposure assessments under REACH – Problems encountered using the approach recommended by the ECHA guidance R.15

Consumers experience inhalation exposure events that are characterized by fluctuating substance air concentrations and typically exposure durations of less than 24 h. To assess the risk of such exposure events, a comparison with toxicological derived limits based on 24 h exposure duration per day is often necessary. Therefore, adjustments are needed to bridge the different time durations. One approach to handle this issue was recommended by the European Chemical Agency (ECHA) for consumer exposure. This approach is especially noteworthy, because it does not rely on the validity of Haber's law (which states that only total intake matters) but uses a modified Haber's law (with coefficient n = 3) as default. However, the proposed algorithm for its implementation can lead to the situation that increasing the exposure duration leads to lower predicted risk, which logically makes no sense. In this article, the correct way to implement the modified Haber's law is presented, which avoids logical fallacies. The presented algorithm has consequences for the sensitivity of the predicted risk regarding changes of exposure duration and ventilation rate, which are investigated in this article.

Health Risk Assessment of Dermal Exposure to Polycyclic Aromatic Hydrocarbons from the Use of Infant Diapers.

In September 2021, the European Chemicals Agency evaluated a dossier for restricting polycyclic aromatic hydrocarbons (PAHs) in infant diapers and concluded that risks were not demonstrated, because of inconclusive exposure data. To fill this gap, we measured the 16 priority PAHs of the U.S. Environmental Protection Agency in the diaper core of four brands and in the sheets and fastening tapes of six brands of commercially available diapers. Health risks were conservatively assessed by assuming that dermally absorbed PAHs can cause both local (skin cancer) and systemic critical effects (neurobehavioral changes). Total concentrations of PAHs in the diaper core and top sheet, the only significant contributors to skin exposure, averaged 26.5 μg/kg and 66.6 μg/kg, respectively. Excess skin cancer risks and hazard quotients for neurobehavioral effects calculated with the daily dose of total PAHs from the combined diaper core and top sheet averaged 1.44 × 10-7 and 1.19 × 10-2, respectively. The median daily doses of total PAHs and of its benzo[a]pyrene-equivalent from breast milk estimated worldwide are 171 and 30 times greater than that from the combined diaper core and top sheet, respectively. Altogether, these findings indicate that trace levels of PAHs found in infant diapers are unlikely to pose health risks.

Magnetic Iron Nanoparticles: Synthesis, Surface Enhancements, and Biological Challenges

This review focuses on the role of magnetic nanoparticles (MNPs), their physicochemical properties, their potential applications, and their association with the consequent toxicological effects in complex biologic systems. These MNPs have generated an accelerated development and research movement in the last two decades. They are solving a large portion of problems in several industries, including cosmetics, pharmaceuticals, diagnostics, water remediation, photoelectronics, and information storage, to name a few. As a result, more MNPs are put into contact with biological organisms, including humans, via interacting with their cellular structures. This situation will require a deeper understanding of these particles’ full impact in interacting with complex biological systems, and even though extensive studies have been carried out on different biological systems discussing toxicology aspects of MNP systems used in biomedical applications, they give mixed and inconclusive results. Chemical agencies, such as the Registration, Evaluation, Authorization, and Restriction of Chemical substances (REACH) legislation for registration, evaluation, and authorization of substances and materials from the European Chemical Agency (ECHA), have held meetings to discuss the issue. However, nanomaterials (NMs) are being categorized by composition alone, ignoring the physicochemical properties and possible risks that their size, stability, crystallinity, and morphology could bring to health. Although several initiatives are being discussed around the world for the correct management and disposal of these materials, thanks to the extensive work of researchers everywhere addressing the issue of related biological impacts and concerns, and a new nanoethics and nanosafety branch to help clarify and bring together information about the impact of nanoparticles, more questions than answers have arisen regarding the behavior of MNPs with a wide range of effects in the same tissue. The generation of a consolidative framework of these biological behaviors is necessary to allow future applications to be manageable.

EFSA ‐ RACFC Chemical Contamination of Food Crisis Preparedness Training 2022 with Central and Eastern European Countries

The European Food Safety Authority (EFSA) runs 2 crisis preparedness training events annually and selected chemical contamination as the scientific domain for its 2022 activities. The 4 specific exercise learning objectives of the 2022 EFSA and the Bulgarian Risk Assessment Center on Food Chain (RACFC) crisis preparedness workshop were: (a) to improve how and when collaboration takes place during a chemical contamination crisis response; (b) to understand individual roles and those of others in a chemical contamination crisis response; (c) to understand the purpose of selected EFSA tools and how to use them; and (d) to rehearse risk communication. Working with the RACFC and crisis training contractors Instinctif Partners, EFSA developed a 2.5-day programme of activities undertaken in working groups and plenary from 14-16 September 2022. In total there were 20 participants from 5 EU Member States and 2 EU candidate countries plus 2 observers from Bulgaria, 1 from the European Chemicals Agency (ECHA) and 1 from EFSA. Day One focused on briefings delivered in a combination of remote and in-person modes, covering areas such as applicable EU legislation, EFSA's and Bulgaria's responses to previous chemical contamination incidents, and crisis communication. Updates and training were provided on tools such as iRASFF, EFSA's Rapid Assessment of Chemical Exposure (RACE) tool and its OpenFoodTox database. An overview of cadmium toxicity anticipated the scenario used for a simulation exercise on Day Two. A detailed debrief on Day Three yielded 20 practical recommendations for improvement in the areas of (a) risk assessment; (b) EFSA tools; (c) risk communication; and (d) collaboration. The objectives of the event were achieved, based on recorded outcomes and feedback provided by participants in an evaluation survey.

Electrodeposition of Ni-W Alloy from Citric Acid Free Aqueous Electrolyte As a Substitute for Hard Chrome Coating and the Effect of Tungsten Content on Coating Hardness

In the industry, chrome coating is an important player in the functional layer application. Due to its high corrosion and wear resistance as well as high hardness [1], hard chrome plating is a popular choice in the automotive and aerospace industry. However, since September 2017, the application of chrome (VI) in surface treatment is banned by the European Chemical Agency (ECHA) due to chrome (VI) being toxic and environmentally hazardous [2]. Chrome (III) compound is a popular substitute for chrome (VI) due to it being less toxic compared to chrome (VI). However, chrome (III) coating has a lower corrosion resistance, and the electroplating process is more sensitive to metallic impurities.Many new innovations have since been developed such as the plasma electrolytic oxidation (PEO), extreme highspeed laser deposition (EHLA). Even established technologies such as physical vapour deposition (PVD), thermal spraying and case hardening process have tried to replace hard chrome coating with a degree of success. Admittedly, the above-mentioned technologies have their fair share of disadvantages. PEO, a green procedure [3], causes a metal substrate to develop a highly resistant oxide which is extremely strong and corrosion as well as wear resistant. The process however needs a high temperature and pressure, continuous replacement of electrolytes and consumes a great amount of power which made the process not feasible for a wide industrial application [4-6]. EHLA and thermal spraying on the other hand are restricted to rotational symmetric components. PVD is restricted to substrates that can handle high processing temperature like nitrable ferrous base materials. Lastly, case hardening processes requires long heat treatments which contribute to a higher process cost. [7]In our presentation, another alternative for chrome coating based on electrodeposition will be introduced. The element tungsten is considered in our experiments because tungsten not only has an excellent corrosion properties and high tensile strength at high temperature, but it also has a microhardness of 650 Vickers. However, it is not possible to deposit tungsten from an aqueous solution because tungstate cannot be directly reduced to metallic tungsten due to a very low overvoltage for hydrogen evolution on tungsten. Thus, an induced co-deposition mechanism is needed, and it is known that tungsten can be easily codeposited with iron group metal. [8-9]In this study a modified Watt’s bath is used as electrolyte to deposit NiW alloy. Our preliminary tests have shown that tungsten can also be deposited with nickel without the help of citric acid as complexing agent. The usage of citric acid does indeed inhibit the deposition of nickel but show no influence in the deposition of tungsten. Hence, in our study, experiments with the rotating disc electrode (RDE) will be done to see if tungsten content in the coating could be increased when the hydrodynamic and coating parameters are manipulated. The chemical composition of the layer is measured using SEM/EDX and the surface morphology is pictured using SEM. Metallographic cross-sections are made to see if there are any fissures in the layer and the hardness of the layer is measured using the microhardness test. The dependency of hardness on the tungsten content in the layer and the annealing parameter will also be shown in the presentation. XRD measurement is conducted for phase analysis and grain size calculation. Figure 1

Experiences and consequences of phasing out substances of concern in a multinational healthcare company

BackgroundIn 2015, one of the largest healthcare companies in the world committed to phasing out from all its products and processes worldwide any substances declared by the European Chemicals Agency to be of very high concern. Since then, extended practical experience was gained in the phasing out of substances of concern.ResultsWe report in detail on a company-wide programme to phase out substances of concern, the challenges of and the approaches to the phase-out. The paper provides concrete ideas of how to address the legitimate urge to remove substances of concern from economic activities in a holistic way, taking into account the broad diversity of aspects of sustainability. The present paper also reviews the regulatory and societal environment in which substances of concern are being phased out. The paper attempts to contribute to the ongoing discussion of how to improve the chemicals policy in Europe and beyond.ConclusionsPhasing out substances of concern, substance selection for new products and processes, and the avoidance of regrettable substitutions while maintaining the pace of genuine innovation will stay a major challenge for our industry in the years ahead whereby not only toxicological and ecotoxicological hazards have to be considered in the selection and deselection of substances, but also other sustainability criteria characterising the entire life cycle will play an increasingly important role. Legislators and industry need to pay more attention to how this is implemented while avoiding slowing down innovation, making essential products unnecessarily more expensive, and further pushing material production out of highly regulated countries.

Integrated environmental risk assessment of rare earth elements mixture on aquatic ecosystems

Rare Earth elements (REE) have become essential in strategical sectors such as high- and green-technologies. Their increasing use in human activities worldwide leads to anthropogenic REE releases detectable in all compartments of the environment, transforming REE into emerging contaminants. However, their potential impacts on ecosystems are still poorly understood. In order to have a comprehensive understanding of REE ecotoxicology and to properly assess their environmental risk, we analysed the toxicity of three representative REE (neodymium Nd, gadolinium Gd, and ytterbium Yb). Following recommendations of the European Chemicals Agency, we assessed REE hazard by performing standard ecotoxicological tests on three freshwater species belonging to different trophic levels (algae, crustacean and fish). EC50 were calculated using different modes of expression of REE exposure concentration (based on nominal, measured total and dissolved concentrations) in order to more properly and accurately determine REE toxicity. In order to get closer to environmental conditions, we also tested the toxicity of REE in mixture because all of them occur naturally as such in the environment. Moreover, we added dissolved organic matter (DOM) in the test medium because DOM is ubiquitous and drives REE speciation in freshwater systems. The Results showed that DOM significantly reduced REE bioaccumulation and toxicity, probably by formation of non-bioavailable REE-DOM complexes. The algal species was the most sensitive to REE. Despite slight differences between Nd, Gd and Yb in behaviour and bioaccumulation, the three REE exhibited comparable toxicity and additive effects in mixture to all tested organisms. Thus, we considered REE as a uniform group and, for the first time, we used mixture toxicity values and environmental mixture concentrations to assess the risk of REE in freshwater (instead of considering different REE separately). The results revealed that the risk is currently limited to wastewater treatment plants, and industrial and mining activities, where released quantities of REE can induce severe damage to exposed freshwater organisms. However, the risks are likely more widespread in the future because anthropogenic REE releases are expected to increase.

Characterisation and analysis of key studies used to restrict substances under REACH

BackgroundUnderstanding how scientific studies are used in regulatory risk assessments is important since it influences the outcome of an assessment, and thus the level of protection of human health and the environment. Within the REACH legislation (Registration, Evaluation, Authorisation and Restriction of Chemicals, EC Nr. 1907/2006) hazard information on clearly defined (eco-)toxicological endpoints are submitted for the registration of substances, and this information is intended for concluding on potential hazards and risk as well as subsequent risk management measures such as restrictions. The present study aimed to (1) characterise key studies used by the European Chemicals Agency’s Committee for Risk Assessment to restrict hazardous substances; (2) analyse if the REACH registration database provided the key studies used in these restrictions, and (3) investigate potential expert disagreements related to the use of non-standard studies in the restrictions.ResultsOur analysis showed that 58% of the 53 scrutinised key studies were non-standard studies, all available by paying a fee or through open access. Sixteen (30%) of the key studies were consulted from external sources outside the REACH registration database by the Committee for Risk Assessment. Only one study of the 16 external key studies was a standard study. Further, 9% (5/53) of the key studies used by the Committee for Risk Assessment were inaccessible to third parties, all were standard studies. The uses of non-standard studies were (unsuccessfully) challenged for five substances during the public consultation.ConclusionsThese results suggest that non-standard studies contributed to the identification and management of substances of concern, that the REACH registration database may not be sufficient for the identification and management of uncontrolled hazards and risks, and that the transparency of the decisions made by the Committee for Risk Assessment was partially hampered due to the use of standard studies inaccessible to third parties.

The Construction Material Pyramid - Integrating health and toxicity parameters

This article investigates how hazardous substances and toxicity information can be integrated into the Construction Material Pyramid [Pyramid] in order to showcase the potential health impacts of material choices in architecture. The current Pyramid indicates different materials’ upfront environmental impacts in the initial life phase of a building product, specifically in the Life Cycle Assessment phases A1-A3. The success of the Pyramid hinges on its communicative strength of conveying complex data in a simple format, easily understood by architects and planners. Can other aspects of material impacts be conveyed with a similar graphic ease to provide a more complete material assessment? Material health and toxicity is notoriously difficult to assess, as data is insufficient and hard to acquire due to proprietary concerns from manufacturers and lack of proper legislation to ensure transparency. The Pyramid has not yet dealt with health and toxicity as a parameter and there exists no predefined method as to how these problems can be included in a comparative model such as the Pyramid. This article’s first line of inquiry is to discuss a suitable methodology to disclose the potential health impacts of construction materials and their associated, often invisible, chemical products applied for mounting, finishing, mold or fire resistance. The Swedish Chemicals Agency’s and the European Chemicals Agency’s evaluation of substances will inform the framework for a comparative system. Secondly, the article will address how the model can graphically convey the potential health and environmental impacts from the production and construction phases of prime and associated materials. This augmentation of the Pyramid would enable architects and designers to more easily obtain information regarding potential health impacts resulting from hazardous chemical content and could provide incentives for selecting less-toxic alternatives. By drawing on H-phases and SundaHus’s product assessment, a ‘stop-sign method’ is used to indicate hazard levels of construction materials.

Influence of CeO2 and TiO2 Particles on Physicochemical Properties of Composite Nickel Coatings Electrodeposited at Ambient Temperature.

The Ni-TiO2 and Ni-CeO2 composite coatings with varying hydrophilic/hydrophobic characteristics were fabricated by the electrodeposition method from a tartrate electrolyte at ambient temperature. To meet the requirements of tight regulation by the European Chemicals Agency classifying H3BO3 as a substance of very high concern, Rochelle salt was utilized as a buffer solution instead. The novelty of this study was to implement a simple one-step galvanostatic electrodeposition from the low-temperature electrolyte based on a greener buffer compared to traditionally used, aiming to obtain new types of soft-matrix Ni, Ni-CeO2, and Ni-TiO2 coatings onto steel or copper substrates. The surface characteristics of electrodeposited nickel composites were evaluated by SEM, EDS, surface contact angle measurements, and XPS. Physiochemical properties of pure Ni, Ni-CeO2, and Ni-TiO2 composites, namely, wear resistance, microhardness, microroughness, and photocatalytic activity, were studied. Potentiodynamic polarization, EIS, and ICP-MS analyses were employed to study the long-term corrosion behavior of coatings in a 0.5 M NaCl solution. Superior photocatalytic degradation of methylene blue, 96.2% after 6 h of illumination, was achieved in the case of Ni-TiO2 composite, while no substantial change in the photocatalytic behavior of the Ni-CeO2 compared to pure Ni was observed. Both composites demonstrated higher hardness and wear resistance than pure Ni. This study investigates the feasibility of utilizing TiO2 as a photocatalytic hydrophilicity promoter in the fabrication of composite coatings for various applications.

Development of an environmental hazard-based rating assessment for defence-related chemical compounds in ecological soil systems.

Environmental hazard-based methods are commonly used to categorise the severity of chemical contamination to ecological soil systems, although a traffic-light approach (green, amber, red) has never been used to assess these consequences. A traffic light approach is an easy to interpretate data as it has a clear visual display which can provide an early warning approach for stakeholders to identify areas that require further investigation. This approach should be underpinned by extensive research data and systematic methods of development. However, the extent of reliable data available for specific chemicals can be limited and therefore decision making may rely on expert judgement. Therefore, in this study, an environmental hazard-based rating methodology was developed by combining the guidelines from the European Chemical Agency (ECHA) and the USEPA for Predicted Non-effect Concentration (PNEC) and Ecological Soil Screening Levels (Eco-SSL) for defence-related chemicals (2,4,6-trinitrotoluene (TNT), 1,3,5-trinitro-1,3,5-triazinane (RDX), cypermethrin, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS)). The developed hazard-based rating assessment was design to categorise the chemicals into low, medium and high environmental hazards priority to inform and ease the decision-making process for contaminated areas to ensure that sustainable operations are carried out.

Melamine targeted for possible EU regulation

Germany will propose that the European Union consider melamine for strict regulation, the European Chemicals Agency (ECHA) announced in late June . Melamine is used to make plastic dinnerware, fertilizers, colorants, flame retardants, and other items. It made headlines in 2007 when it sickened dogs and cats that ate pet food tainted with the chemical . In 2008, the Chinese government discovered that manufacturers were adding the substance to milk powder even though melamine has not been approved for use in foods. Six infants died and hundreds of thousands of babies fell ill after consuming melamine. ECHA indicates that Germany will file a submission in August describing why the EU should classify melamine as a substance of very high concern and containing data to support its claims. According to the agency, Germany intends to argue that the substance can have serious adverse effects on the environment. Compounds classified as being

Identification of substances with a carcinogenic potential in spray-formulated engine/brake cleaners and lubricating products, available in the European Union (EU) – based on IARC and EU-harmonised classifications and QSAR predictions

Spray-formulated engine/brake cleaners and lubricating agents are widely used to maintain machines. The occupational exposure to their aerosols is evident. To assess the carcinogenic potential of these products, we identified such products available in the European Union (EU). We built a database with CAS numbers of 1) mono-constituent substances, and 2) multi-constituent-substances, and unknown-or-variable-composition,-complex-reaction-products-and-biological-materials (multi-constituent/UVCBs). The compositions of multi-constituent/UVCBs were unravelled with European Chemicals Agency (ECHA) registration dossiers. To identify carcinogenic potentials, we searched for 1) International Agency for Research on Cancer (IARC) classification; 2) Harmonised classifications in Annex VI to the EU classification, labelling and packaging (CLP) Regulation; and 3) whether they had a Danish Environmental Protection Agency advisory CLP self-classification based on quantitative structure-activity relationships (QSARs) for genotoxicity and carcinogenicity in the Danish (Q)SAR Database. In 82 products, we identified 332 mono-constituent substances and 44 multi-constituent/UVCBs. Six substances were either IARC 1 or 2B classified. Twelve mono-constituent substances and 22 multi-constituent/UVCBs had harmonised classifications as Carcinogenic Category 1A, 1B or 2, while nine substances fulfilled the QSAR-based advisory self-classification algorithms for mutagenicity or carcinogenicity. At the product level, 39 products contained substances of carcinogenic concern by either IARC, harmonised classification or QSAR. We conclude that in the investigated EU marketed spray-formulated engine/brake cleaners and lubricants, 24 of 332 mono-constituent substances and 28 of 44 multi-constituent/UVCBs had a carcinogenic potential. At the product level, 39 of 82 contained substances with an identified carcinogenic potential. Regulators and manufacturers can use this determination of carcinogenic potential to decrease occupational risk.

Characterization of synthetic turf rubber granule infill in Japan: Polyaromatic hydrocarbons and related compounds

Although the health effects of artificial turf fillings have been investigated in Europe and the United States, the actual situation in Japan is unclear. To address this issue, the concentrations of 46 polyaromatic hydrocarbons (PAHs) and related compounds in rubber infills were analyzed prior to their use in synthetic turf fields in Japan. Based on information obtained from the sample suppliers, the investigated samples were divided into five categories: discarded tires, industrial rubber, combinations of these products or unidentified components (mixture/unknown), synthetic rubber specifically manufactured for synthetic turf, and special-purpose thermoplastic elastomers (TPEs). The industrial rubber samples were mixtures of styrene butadiene rubber, natural rubber, and ethylene propylene diene rubber (EPDM). The synthetic rubber samples consisted only of EPDM. A few or none of the PAHs were detected in the synthetic rubber and TPE samples. However, in the discarded tire and industrial rubber samples, benzo[a]pyrene, cyclopenta[cd]pyrene, and 30 other compounds were detected. A comparison between these two categories indicated that the discarded tire samples exhibited higher concentrations of the target compounds than the industrial rubber samples. This finding can be attributed to the presence of EPDM in almost all of the industrial rubber samples, which were not present in the discarded tire samples. The maximum PAH concentrations obtained in the present study were equivalent to or lower than the previously reported PAH concentrations. The total concentrations of the eight PAHs included in the European Chemical Agency (ECHA) assessment of health risks were lower in the present study than those reported by the ECHA. Furthermore, elution testing was performed with four simulated biofluids (gastric and intestinal juices, saliva, and perspiration). The actual elution amounts of all compounds were less than the limits. This report provides basic data for the risk assessment of PAHs in rubber infills.

Unnecessary use of additional animals for determination of sexual maturation in the EOGRTS

The Extended-One-Generation Study [EOGRTS, OECD 443] is a study in which the toxic effects of test substances on reproduction (Cohort 1), neurodevelopment (Cohort 2), and development of the immune system (Cohort 3) in rats are evaluated. The latter two Cohorts are not always required according to the European Chemicals Agency (ECHA) based on data from previously performed toxicity studies. Although the Cohorts for developmental neurotoxicity (DNT) and developmental immunotoxicity (DIT) are often omitted, the F1-animals normally required for these Cohorts are still maintained for evaluation of sexual maturation since three F1-animals/sex/litter/group are required according to OECD Guidance Document (GD) No. 151. This review investigates whether two F1-animals/sex/litter/group would suffice for this endpoint by investigating the rationale provided by the GD and by comparing results of eighteen EOGRTSs in which three versus two F1-animals/sex/litter/group were evaluated. After a comprehensive literature research, we concluded that the rationale in the GD does not substantiate the decision to use three F1-animals/sex/litter/group. The scientific papers provided as rationale focused on male observations and the observations discussed do not match the observations for sexual maturation mentioned by the guidelines. The investigation using data from eighteen EOGRTSs showed that the toxicological conclusions, whether the test substance affected sexual maturation or not, matched when comparing data of two F1-animals/sex/litter/group to three F1-animals/sex/litter/group. To conclude, two F1-animals/sex/litter/group would suffice for the evaluation of sexual maturation, which negates the requirement for a so called “Cohort 1 C” (i.e. 160 animals (80 males and 80 females)) per EOGRTS, as well as the number of regulated procedures that need to be performed.

Netherlands seeks EU controls on perfluoroheptanoic acid

The European Union should classify perfluoroheptanoic acid (PFHpA) and its salts as candidates for strict regulation, the Dutch government has proposed. The chemicals are per- and polyfluoroalkyl substances (PFAS) , a category of synthetic, industrial compounds that persist in the environment. Some PFAS are toxic, especially those like PFHpA that have carboxylic acid groups or other chemically active components. PFHpA and its salts are persistent, bioaccumulative, and toxic, the European Chemicals Agency (ECHA) says in a May 18 announcement about the Dutch plan . The Netherlands is expected to submit details of its proposal in August, ECHA indicates. PFHpA is registered in the EU for production or import levels of between 1 and 10 metric tons . It is unclear how it and its salts are used. According to the US-based Environmental Working Group, an advocacy organization, PFHpA is a breakdown product of stain- and grease-proof coatings on food packaging,