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Analyse von Schadstoffen in Humanproben im Rahmen der Deutschen Umweltstudie zur Gesundheit von Erwachsenen (GerES V/VI), Teil 1 - DINCH und DEHTP

a) Zielstellung Der Schutz der Bevölkerung vor Belastungen mit chemischen und anderen Schadstoffen setzt voraus, dass gesundheitlich problematische Belastungen rechtzeitig erkannt und die Wirksamkeit von Begrenzungsmaßnahmen überwacht werden. Die in GerES VI gewonnenen HBM-Proben der Erwachsenen sollen auf Schadstoffe analysiert werden, die besondere Gesundheitsrelevanz aufweisen und denen die erwachsene Bevölkerung ausgesetzt ist. Darüber hinaus sollen die Substanzen, die von BMUB/VCI zukünftig benannt wurden, in den HBM-Proben sowohl des aktuellen GerES VI (DINCH und DEHTP) als auch in den archivierten HBM-Proben von GerES V analysiert werden: b) Output Zusammen mit den Ergebnissen der Befragung der teilnehmenden Personen liefern die Analysen der Blut- und Urinproben wesentliche Informationen zur Belastung der in Deutschland lebenden Bevölkerung mit zahlreichen gesundheitsrelevanten Substanzen. Mit diesen Erkenntnissen können Standardwerte für Expositionsanalysen und Risikoschätzungen abgeleitet werden

Human Biomonitoring - Pilotphase des 5. Umwelt-Surveys - Schadstoffbelastung in Urin

In Umweltsurveys (US) werden seit mehreren Jahrzehnten repräsentative Daten zur Belastung der Bevölkerung mit Schadstoffen erhoben. Die letzte Datenerhebung endete 2006. Jetzt gilt es den nächsten Survey in Kooperation mit dem RKI vorzubereiten, d.h. eine Pilotphase zur Testung der methodischen Aspekte durchzuführen und erste Einblicke in die Verteilung der Belastungen der Bevölkerung mit chemischen, biologischen und physikalischen Noxen zu erhalten. Durch dieses geplante Teilvorhaben (2) sollen in Urinproben der Probandinnen und Probanden folgende Stoffe qualitätsgesichert bestimmt werden: Creatinin, Cotinin, Quecksilber, Cadmium, Arsen, Metabolite von Phthalaten inkl. DPHP und Hexamoll® DINCH®, Metabolite von polyzyklischen aromatischen Kohlenwasserstoffen (PAK) und Organophosphaten, Parabene. Außerdem sollen die Pyrrolidone NMP und NEP sowie das Benzothiazol 2-MBT bestimmt werden. Damit werden die ersten im Rahmen des BMU/VCI-Projekts zum HBM entwickelten neuen Nachweismethoden für bisher in Spurenbereichen nicht messbare Chemikalien erstmals eingesetzt. BMU hat sich verpflichtet, die Belastung der Bevölkerung mit diesen Chemikalien anhand der neuen Methoden zu untersuchen.

Anwendung von neuen HBM-Analyse-Methoden an ausgewählten Kollektiven zur Bestimmung der Belastung der Allgemeinbevölkerung und damit zur Unterstützung von REACH; Teilprojekt 1: Biomonitoring von fünf Parabenen, DINCH, DPHP

BMU hat in 2009 eine Initiative gestartet, bei der in Kooperation mit dem VCI neue analytisch-chemische Methoden zur Bestimmung von Schadstoffen mit dem Human-Biomonitoring (HBM) entwickelt werden. Dabei geht es um gesundheitlich potentiell bedenkliche Stoffe, die aber bisher im menschlichen Körper nicht gemessen werden können. Ohne HBM-Daten liegen keine verlässlichen Informationen vor, ob und in wieweit die Bevölkerung mit diesen Stoffen belastet ist und Regelungsbedarf gegeben ist. VCI wird jährlich für bis zu fünf dieser Stoffe quantitative Nachweismethoden entwickeln. BMU/UBA werden sicherstellen, dass diese neuen Methoden zur Anwendung gebracht und so die Belastung der Bevölkerung mit diesen Stoffen festgestellt wird. Der Lenkungsausschuss des Kooperatitionsprojekts hat im Mai 2010 - auf der Basis von Vorschlägen eines zur Thematik einberufenen Expertenkreises - die ersten fünf Stoffe bzw. Stoffgruppen ausgewählt, die jetzt von Seiten der Industrie einer Methodenentwicklung zugeführt werden. Die Bestimmung der Belastung der Bevölkerung mit diesen Stoffen/Stoffgruppen wird über den UFOPLAN 2010 sichergestellt. Ab dem Frühjahr 2010 werden jährlich jeweils 5 weitere Stoffe/Stoffgruppen ausgewählt: von 2010 bis 2013 somit insgesamt 20 Stoffe/Stoffgruppen. In der Laufzeit dieses Teilvorhabens von 2011 bis 2012 sollen fünf Parabene (Methyl-, Ethyl-, Propyl-, Butyl- und Benzylparaben) in 600 möglichst repräsentativen Humanproben sowie DINCH und DPHP in je 120 Humanproben analysiert und gleichzeitig ein Konzept für eine größere bevölkerungsrepräsentative Untersuchung der Belastung mit den Stoffen entwickelt werden. Damit sollen Aussagen zur Belastung der Bevölkerung und bestimmter Bevölkerungsgruppen mit diesen Stoffen/Stoffgruppen ermöglicht werden.

Human-Biomonitoring von 'neuen' Schadstoffen (GUB), Teilvorhaben 1: Erstellung von Stoffdosiers für fünf Stoffe/Stoffgruppen

BMU hat in 2009 eine Initiative gestartet, bei der in Kooperation mit dem VCI neue analytisch-chemische Methoden zur Bestimmung von Schadstoffen mit dem Human-Biomonitoring (HBM) entwickelt werden. Dabei geht es um gesundheitlich potentiell bedenkliche Stoffe, die aber bisher im menschlichen Körper nicht gemessen werden können. Ohne HBM-Daten liegen keine verlässlichen Informationen vor, ob und in wieweit die Bevölkerung mit diesen Stoffen belastet ist und Regelungsbedarf gegeben ist. VCI wird jährlich für bis zu fünf dieser Stoffe quantitative Nachweismethoden entwickeln. BMU/UBA werden sicherstellen, dass diese neuen Methoden zur Anwendung gebracht und so die Belastung der Bevölkerung mit diesen Stoffen festgestellt wird. Der Lenkungsausschuss des Kooperationsprojekts hat im Mai 2010 - auf der Basis von Vorschlägen eines zur Thematik einberufenen Expertenkreises - die ersten fünf Stoffe bzw. Stoffgruppen ausgewählt, die jetzt von Seiten der Industrie einer Methodenentwicklung zugeführt werden. Die fünf Stoffe sind: di(2-propyl-heptyl)phthalat (DPHP); DINCH; Hexabromocyclododecane (HBCD); 2,2',6,6'-Tetra-tert-butyl-4,4'-methylendiphenol; Dodecylphenol. BMU/UBA werden veranlassen, dass diese Stoffe in repräsentativen Humanproben analysiert werden. Als Basis für eine Bewertung der dann vorliegenden Analysenergebnisse ist es erforderlich Kenntnisse über Toxizität und Vorkommen dieser Stoffe/Stoffgruppen in der Umwelt (Stoffdossiers) zusammenzustellen. Die Bewertung der Analysendaten stellt eine wichtige Grundlage für die Durchführung und Weiterentwicklung der Stoffregelungen unter REACH dar.

Time trend of exposure to the phthalate plasticizer substitute DINCH in Germany from 1999 to 2017: Biomonitoring data on young adults from the Environmental Specimen Bank (ESB)

Kasper-Sonnenberg, Monika; Koch, Holger M.; Apel, Petra; Rüther, Maria; Pälmke, Claudia; Brüning, Thomas; Kolossa-Gehring, Marike International Journal of Hygiene and Environmental Health (2019), online 1. August 2019 DINCH (cyclohexane-1,2-dicarboxylic acid-diisononyl ester) is a phthalate plasticizer substitute introduced into the market in 2002. It is increasingly used especially in the production of toys, food contact materials and medical devices. In this measurement campaign on 24-h urine samples of young adults (20–29 years) from the German Environmental Specimen Bank (ESB) collected in 2010, 2011, 2013, 2015 and 2017 (in total 300 samples, 60 samples/year) we analyzed three specific, oxidized DINCH metabolites (OH-MINCH: cyclohexane-1,2-dicarboxylic acid-mono(hydroxy-isononyl) ester; cx-MINCH: cyclohexane-1,2-dicarboxylic acid-mono(carboxy-isooctyl) ester, oxo-MINCH: cyclohexane-1,2-dicarboxylic acid-mono(oxo-isononyl) ester). We merged these data with earlier data of the ESB from the years 1999-2012 and are now able to report levels and time trends of internal DINCH exposure from 1999 to 2017. After first detections of the major oxidized DINCH metabolite OH-MINCH in 2006 (6.7%) detection rates rapidly increased to 43.3% in 2009, 80% in 2010 and 98.3% in 2011 and 2012. From the year 2013 on we could detect OH-MINCH in every urine sample analyzed. The median concentrations of OH-MINCH rapidly increased from 0.15 μg/L in 2010 to twice the concentration in 2011 (0.31 μg/L) with further increases in 2013 (0.37 μg/L), 2015 (0.59 μg/L) and 2017 (0.70 μg/L). Similar increases, albeit at lower detection rates and concentration levels, could be observed for cx-MINCH and oxo-MINCH. All metabolites strongly correlate with each other. For the ESB study population, DINCH exposures are still far below health based guidance values such as the German Human Biomonitoring Value (HBM-I; 4,500 μg/L for the sum of OH-MINCH and cx-MINCH) or the tolerable daily intake (TDI) of EFSA (1 mg/kg bw/d). The median daily DINCH intake (DI) calculated for 2017 was 0.23 μg/kg bw/d, thus 4,310-times lower than the TDI. The maximum DI calculated for one individual in 2012 (42.60 μg/kg bw/d) was a factor of more than 20 below the TDI. The ongoing increase in DINCH exposure needs to be closely monitored in the future, including populations with potentially higher exposures such as children. This close monitoring will enable timely exposure and risk reduction measures if exposures reached critical levels, or if new toxicological data lead to lower health based guidance values. DINCH belongs to the European Human Biomonitoring Initiative (HBM4EU) priority substances for which policy relevant questions still have to be answered. doi: 10.1016/j.ijheh.2019.07.011

Trends for plasticizers in German freshwater environments – Evidence for the substitution of DEHP with emerging phthalate and non-phthalate alternatives

Nagorka, Regine; Koschorreck, Jan Environmental Pollution 262 (2020), 114237; online 20. Februar 2020 Plasticizers are marketed in high volumes and Di(2-ethylhexyl) phthalate (DEHP) is frequently detected in the environment and human populations. Industry had largely relied on DEHP until regulation started to restrict its marketing in 1999 due to environmental and human health concerns. The aim of this study was to obtain spatial-temporal trends for DEHP and its substitutes in German rivers. We have investigated suspended particulate matter (SPM) samples from the German Environmental Specimen Bank (ESB) for the presence of 23 plasticizers, i.e. 17 phthalates and 6 non-phthalates. The samples were collected in the last 10 years at 13 sites in large river basins in Germany such as the Rhine, Elbe and Danube. A decrease in DEHP concentrations was observed at all sampling sites between the mid-2000s and 2017. The maximum concentration for DEHP was determined in 2006 in samples from Rehlingen/Saar (6720 ng/g dry weight (dw)). By 2017, the DEHP concentration in Rehlingen had dropped to 2080 ng/g dw. Currently, Diisononyl phthalate (DINP) is the plasticizer with the highest levels in the SPM samples (maximum value 4150 ng/g dw in Rehlingen/Saar). Our results show that novel plasticizers such as Diisononylcyclohexane-1,2-dicarboxylate (DINCH) spread rapidly in surface waters after their market introduction. We have found several plasticizers of emerging concern in the environmental samples, the further use of which is currently under review under the EU chemicals regulation (REACH, registration, evaluation, authorisation and restriction of chemicals). In particular for Di(2-propylheptyl) phthalate (DPHP) a significant increase in concentration was observed at almost all sites between the mid-2000s and 2017, for example in Prossen/Elbe from 24 ng/g dw (2005) to 1380 ng/g dw (2017). doi: 10.1016/j.envpol.2020.114237

Entering markets and bodies: increasing levels of the novel plasticizer Hexamoll® DINCH® in 24 hr urine samples from the German Environmental Specimen Bank

Schütze, André; Kolossa-Gehring, Marike; Apel, Petra; Brüning, Thomas; Koch, Holger M. International Journal of Hygiene and Environmental Health (2013), online 16. August 2013 DINCH (diisononylcyclohexane-1,2-dicarboxylate) was introduced into the world market in 2002 as a non-aromatic plasticizer and phthalate substitute. We analyzed 300 urine samples (24 h voids) of the German Environmental Specimen Bank (ESB for Human tissues, ESB Hum) for specific DINCH metabolites by on-line HPLC-MS/MS with isotope dilution quantification. Urine samples of the ESB Hum were from the years 1999, 2003, 2006, 2009 and 2012, chosen to investigate the appearance and a possible trend of DINCH exposure since its market introduction. No DINCH metabolites were detected in the 1999 and 2003 samples. From 2006 on, the percentage of samples with DINCH metabolites above the LOQ increased significantly over the years (7% in 2006, 43% in 2009 and 98% in 2012). The cyclohexane-1,2-dicarboxylic acid-mono(hydroxy-isononyl) ester (OH-MINCH) was the predominant metabolite. Median (and 95th percentile) concentrations (in μg/L) increased from <LOQ (0.09) in 2006, to <LOQ (1.02) in 2009 to 0.39 (2.09) in 2012. All oxidized DINCH metabolites (OH-MINCH, cx-MINCH, oxo-MINCH) correlated strongly among each other (ρ>0.75, p < 0.001). The median (95th percentile) DINCH intake in 2012 was calculated to be 0.14 (1.07) μg/kg body weight/day which is considerably below daily intakes currently deemed tolerable. DINCH is regarded to have a preferred toxicological profile over certain anti-androgenic phthalates. The continuation of DINCH measurements in the ESB Hum and other human biomonitoring studies like the German Environmental Survey (GerES) allows tracking the development of DINCH body burdens, the distribution of exposure levels and daily intakes, providing basic data for future toxicological assessment and further epidemiological studies. doi:10.1016/j.ijheh.2013.08.004

Urinary excretion of phthalates and the substitutes DINCH and DEHTP in Danish young men and German young adults between 2000 and 2017 - a time trend analysis

Over the last twenty-five years it has become evident that exposure to several phthalates can have adverse effects on human health, such as endocrine disruption. This led to a series of EU regulations that resulted in a decrease in the production volumes of the restricted phthalates and an increased production of substitutes. The current study describes the impact of regulations and changes in production and use of phthalates and their substitutes on internal exposure patterns in two European populations since the beginning of the 2000'ies. Using harmonised data from young adults in Denmark (Danish Young Men Study, n = 1,063, spot urine) and Germany (Environmental Specimen Bank, n = 878, 24-h urine) with repeated cross-sectional design (3-11 cycles per biomarker) we applied Locally Estimated Scatterplot Smoothing (LOESS) and Generalized Linear Models (GLMs) to estimate time trends and the role of covariates on the trend (e.g. age, BMI). Time trends of daily excretion (mikrog/24h) are comparable between the two samples for the regulated (DEHP, BBzP, DiNP, DnBP, DiBP, DiDP/DPHP) as well as the non-regulated substances (DMP, DEP, DINCH, DEHTP) although the rate of change differ for some of the compounds. GLM results indicate that the daily excretion of the most regulated phthalates has decreased over time (DEHP yearly about 12-16%, BBzP 5%, DnBP 0.3-17%, and DiBP 4-12%). Interestingly, also the non-regulated phthalates DMP and DEP decreased by 6-18% per year. In sharp contrast, the phthalate substitutes DINCH and DEHTP show very steep annual increases (~10-68% and ~100%, respectively) between 2009 and 2017. We did not find an effect of age, sex, BMI, or education on the time trend. The present study provides comparable insights into how exposure to phthalates and two of their substitutes have changed over the last two decades in Germany and Denmark. © 2022 The Authors

Time trend of exposure to the phthalate plasticizer substitute DINCH in Germany from 1999 to 2017: Biomonitoring data on young adults from the Environmental Specimen Bank (ESB)

DINCH (cyclohexane-1,2-dicarboxylic acid-diisononyl ester) is a phthalate plasticizer substitute introduced into the market in 2002. It is increasingly used especially in the production of toys, food contact materials and medical devices. In this measurement campaign on 24-h urine samples of young adults (20-29 years) from the German Environmental Specimen Bank (ESB) collected in 2010, 2011, 2013, 2015 and 2017 (in total 300 samples, 60 samples/year) we analyzed three specific, oxidized DINCH metabolites (OH-MINCH: cyclohexane-1,2-dicarboxylic acid-mono(hydroxy-isononyl) ester; cx-MINCH: cyclohexane-1,2-dicarboxylic acid-mono(carboxy-isooctyl) ester, oxo-MINCH: cyclohexane-1,2-dicarboxylic acid-mono(oxo-isononyl) ester). We merged these data with earlier data of the ESB from the years 1999-2012 and are now able to report levels and time trends of internal DINCH exposure from 1999 to 2017. After first detections of the major oxidized DINCH metabolite OH-MINCH in 2006 (6.7%) detection rates rapidly increased to 43.3% in 2009, 80% in 2010 and 98.3% in 2011 and 2012. From the year 2013 on we could detect OH-MINCH in every urine sample analyzed. The median concentrations of OH-MINCH rapidly increased from 0.15 (Mü)g/L in 2010 to twice the concentration in 2011 (0.31 (Mü)g/L) with further increases in 2013 (0.37 (Mü)g/L), 2015 (0.59 (Mü)g/L) and 2017 (0.70 (Mü)g/L). Similar increases, albeit at lower detection rates and concentration levels, could be observed for cx-MINCH and oxo-MINCH. All metabolites strongly correlate with each other. For the ESB study population, DINCH exposures are still far below health based guidance values such as the German Human Biomonitoring Value (HBM-I; 4,500 (Mü)g/L for the sum of OH-MINCH and cx-MINCH) or the tolerable daily intake (TDI) of EFSA (1mg/kg/bw/d). The median daily DINCH intake (DI) calculated for 2017 was 0.23 (Mü)g/kg bw/d, thus 4,310-times lower than the TDI. The maximum DI calculated for one individual in 2012 (42.60 (Mü)g/kg bw/d) was a factor of more than 20 below the TDI. The ongoing increase in DINCH exposure needs to be closely monitored in the future, including populations with potentially higher exposures such as children. This close monitoring will enable timely exposure and risk reduction measures if exposures reached critical levels, or if new toxicological data lead to lower health based guidance values. DINCH belongs to the European Human Biomonitoring Initiative (HBM4EU) priority substances for which policy relevant questions still have to be answered. © 2019 Elsevier GmbH. All rights reserved.

Hexamoll® DINCH and DPHP metabolites in urine of children and adolescents in Germany. Human biomonitoring results of the German Environmental Survey GerES V, 2014-2017

The production and use of the plasticisers Hexamoll® DINCH (di-(iso-nonyl)-cyclohexane-1,2-dicarboxylate) and DPHP (di-(2-propylheptyl) phthalate) have increased after both chemicals were introduced into the market in the early 2000s as substitutes for restricted high molecular weight phthalates. During the population representative German Environmental Survey (GerES) of Children and Adolescents (GerES V, 2014-2017), we collected urine samples and measured the concentrations of DINCH and DPHP metabolites in 2228 and in a subsample of 516 participants, respectively. We detected DINCH and DPHP metabolites in 100% and 62% of the 3-17 years old children and adolescents, respectively. Geometric means of DINCH metabolites were 2.27 myg/L for OH-MINCH, 0.93 myg/L for oxo-MINCH, 1.14 myg/L for cx-MINCH and 3.47 myg/L for DINCH (Sigma of OH-MINCH + cx-MINCH). Geometric means of DPHP metabolites were 0.30 myg/L for OH-MPHP, 0.32 myg/L for oxo-MPHP and 0.64 myg/L for DPHP (Sigma of OH-MPHP + oxo-MPHP). The 3-5 years old children had almost 3-fold higher DINCH biomarkers levels than adolescents (14-17 years). Higher concentrations of DPHP biomarkers among young children only became apparent after creatinine adjustment. Urinary levels of DINCH but not of DPHP biomarkers were associated with the levels of the respective plasticisers in house dust. When compared to HBM health-based guidance values, we observed no exceedance of the HBM-I value of 1 mg/L for DPHP (Sigma of OH-MPHP + oxo-MPHP). However, 0.04% of the children exceeded the health based guidance value HBM-I of 3 mg/L for DINCH (Sigma of OH-MINCH + cx-MINCH). This finding shows that even a less toxic replacement of restricted chemicals can reach exposures in some individuals, at which, according to current knowledge, health impacts cannot be excluded with sufficient certainty. In conclusion, we provide representative data on DINCH and DPHP exposure of children and adolescents in Germany. Further surveillance is warranted to assess the substitution process of plasticisers, and to advise exposure reduction measures, especially for highly exposed children and adolescents. Providing the results to the European HBM Initiative HBM4EU will support risk assessment and risk management not only in Germany but also in Europe. © 2019 The Authors. Published by Elsevier GmbH

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