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Mono-n-hexyl phthalate: exposure estimation and assessment of health risks based on levels found in human urine samples

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Titel: Mono-n-hexyl phthalate: exposure estimation and assessment of health risks based on levels found in human urine samples
Autoren: Ralph Pirow, Ulrike Bernauer, Annegret Blume, Adrian Cieszynski, Gabriele Flingelli, Astrid Heiland, Matthias Herzler, Bettina Huhse, Christian Riebeling, Esther Rosenthal, Moustapha Sy, Thomas Tietz, Achim Trubiroha, Andreas Luch
Quelle: Arch Toxicol
Verlagsinformationen: Springer Science and Business Media LLC, 2024.
Publikationsjahr: 2024
Schlagwörter: Adult, Male, 0301 basic medicine, Human biomonitoring data, Plasticizers/toxicity [MeSH], Female [MeSH], Phthalic Acids/urine [MeSH], Tolerable daily intake, Environmental Exposure/adverse effects [MeSH], Risk Assessment [MeSH], Adult [MeSH], Humans [MeSH], Animals [MeSH], Phthalic Acids/toxicity [MeSH], Environmental Pollutants/toxicity [MeSH], Di-n-hexyl phthalate, Male [MeSH], Germany [MeSH], Reverse dosimetry, Environmental Pollutants/urine [MeSH], Benchmark dose modelling, Child [MeSH], Mono-n-hexyl phthalate, Pregnancy [MeSH], Environmental Exposure/analysis [MeSH], Regulatory Toxicology, Phthalic Acids, Environmental Exposure, Risk Assessment, 01 natural sciences, 03 medical and health sciences, Plasticizers, Pregnancy, Germany, Humans, Animals, Female, Environmental Pollutants, Child, 0105 earth and related environmental sciences
Beschreibung: Mono-n-hexyl phthalate (MnHexP) is a primary metabolite of di-n-hexyl phthalate (DnHexP) and other mixed side-chain phthalates that was recently detected in urine samples from adults and children in Germany. DnHexP is classified as toxic for reproduction category 1B in Annex VI of Regulation (EC) 1272/2008 and listed in Annex XIV of the European chemical legislation REACH; thereby, its use requires an authorisation. Health-based guidance values for DnHexP are lacking and a full-scale risk assessment has not been carried out under REACH. The detection of MnHexP in urine samples raises questions about the sources of exposure and concerns of consumer safety. Here, we propose the calculation of a provisional oral tolerable daily intake value (TDI) of 63 µg/kg body weight/day for DnHexP and compare it to intake levels corresponding to levels of MnHexP found in urine. The resulting mean intake levels correspond to less than 0.2% of the TDI, and maximum levels to less than 5%. The TDI was derived by means of an approximate probabilistic analysis using the credible interval from benchmark dose modelling of published ex vivo data on reduced foetal testosterone production in rats. Thus, for the dose associated to a 20% reduction in testosterone production, a lower and upper credible interval of 14.9 and 30.0 mg/kg bw/day, respectively, was used. This is considered a conservative approach, since apical developmental endpoints (e.g. changed anogenital distance) were only observed at higher doses. In addition, we modelled various scenarios of the exposure to the precursor substance DnHexP from different consumer products, taking measured contamination levels into account, and estimated systemic exposure doses. Of the modelled scenarios including the application of sunscreen (as a lotion or pump spray), the use of lip balm, and the wearing of plastic sandals, and considering conservative assumptions, the use of DnHexP-contaminated sunscreen was highlighted as a major contributing factor. A hypothetical calculation using conservative assumptions for the latter resulted in a margin of safety in relation to the lower credible interval of 3267 and 1007 for adults and young children, respectively. Most importantly, it was found that only a fraction of the TDI is reached in all studied exposure scenarios. Thus, with regard to the reported DnHexP exposure, a health risk can be considered very unlikely.
Publikationsart: Article
Other literature type
Sprache: English
ISSN: 1432-0738
0340-5761
DOI: 10.1007/s00204-024-03835-x
Zugangs-URL: https://pubmed.ncbi.nlm.nih.gov/39153032
https://repository.publisso.de/resource/frl:6503577
Rights: CC BY
Dokumentencode: edsair.doi.dedup.....4aca2849d99d16f5af232087d59233b4
Datenbank: OpenAIRE
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  Data: Mono-n-hexyl phthalate: exposure estimation and assessment of health risks based on levels found in human urine samples
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  Data: Mono-n-hexyl phthalate (MnHexP) is a primary metabolite of di-n-hexyl phthalate (DnHexP) and other mixed side-chain phthalates that was recently detected in urine samples from adults and children in Germany. DnHexP is classified as toxic for reproduction category 1B in Annex VI of Regulation (EC) 1272/2008 and listed in Annex XIV of the European chemical legislation REACH; thereby, its use requires an authorisation. Health-based guidance values for DnHexP are lacking and a full-scale risk assessment has not been carried out under REACH. The detection of MnHexP in urine samples raises questions about the sources of exposure and concerns of consumer safety. Here, we propose the calculation of a provisional oral tolerable daily intake value (TDI) of 63 µg/kg body weight/day for DnHexP and compare it to intake levels corresponding to levels of MnHexP found in urine. The resulting mean intake levels correspond to less than 0.2% of the TDI, and maximum levels to less than 5%. The TDI was derived by means of an approximate probabilistic analysis using the credible interval from benchmark dose modelling of published ex vivo data on reduced foetal testosterone production in rats. Thus, for the dose associated to a 20% reduction in testosterone production, a lower and upper credible interval of 14.9 and 30.0 mg/kg bw/day, respectively, was used. This is considered a conservative approach, since apical developmental endpoints (e.g. changed anogenital distance) were only observed at higher doses. In addition, we modelled various scenarios of the exposure to the precursor substance DnHexP from different consumer products, taking measured contamination levels into account, and estimated systemic exposure doses. Of the modelled scenarios including the application of sunscreen (as a lotion or pump spray), the use of lip balm, and the wearing of plastic sandals, and considering conservative assumptions, the use of DnHexP-contaminated sunscreen was highlighted as a major contributing factor. A hypothetical calculation using conservative assumptions for the latter resulted in a margin of safety in relation to the lower credible interval of 3267 and 1007 for adults and young children, respectively. Most importantly, it was found that only a fraction of the TDI is reached in all studied exposure scenarios. Thus, with regard to the reported DnHexP exposure, a health risk can be considered very unlikely.
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