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Article ; Online: Gac Fruit Oils Encapsulated by Palm Oil-based Monoacylglycerols: The Effect of Drying Methods.

Nguyen, Viet / Nguyen, Ngan / Pham, Ly / Phung, Trinh / Nguyen, Phuong / Truong, Vinh

2023 Volume 73, Issue 1, Page(s) 65–71

Abstract: Lyotropic liquid crystals (LLCs) are interesting wall-materials for encapsulation technology, in which monoacylglycerols (MAGs) are considered as potential ingredient for LLC formulation. This study, therefore, applied palm oil-based MAGs to encapsulate ... ...

Abstract	Lyotropic liquid crystals (LLCs) are interesting wall-materials for encapsulation technology, in which monoacylglycerols (MAGs) are considered as potential ingredient for LLC formulation. This study, therefore, applied palm oil-based MAGs to encapsulate Gac fruit oils and compared the effect of two drying methods (freeze-drying and spray-drying) on the quality of products during storage. Wall-materials were prepared by ultrasound dispersing MAGs/water mixtures (40/60, w/w) into Pluronic solution (2%, w/w) to formulate LLC dispersions. Then, Gac fruit oils were encapsulated by freeze-drying and spray-drying. Various technologies were applied to characterize the properties of dispersions, the encapsulated powder morphology and the loading capacity. Obtained results showed that LLC dispersions made of palm oilbased MAG were micro- and nano-emulsions which were very convenient for encapsulating Gac fruit oils. For both drying methods, β-carotene of Gac fruit oils was successfully entrapped by MAGs with a high loading capacity (200 µg β-carotene/g powder). The degradation of encapsulated β-carotene after four storage weeks was 10 - 40% and freeze-dried samples showed a better protection effect in comparison to spray-dried samples.
MeSH term(s)	Fruit/chemistry ; beta Carotene/analysis ; Palm Oil/analysis ; Monoglycerides ; Powders ; Oils/chemistry ; Freeze Drying
Chemical Substances	beta Carotene (01YAE03M7J) ; Palm Oil (5QUO05548Z) ; Monoglycerides ; Powders ; Oils
Language	English
Publishing date	2023-12-14
Publishing country	Japan
Document type	Journal Article
ZDB-ID	2218264-0
ISSN	1347-3352 ; 1345-8957
ISSN (online)	1347-3352
ISSN	1345-8957
DOI	10.5650/jos.ess23172
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Comparison of threshold of toxicological concern (TTC) values to oral reference dose (RfD) values.

Pham, Ly L / Borghoff, Susan J / Thompson, Chad M

Regulatory toxicology and pharmacology : RTP

2020 Volume 113, Page(s) 104651

Abstract: Thousands of chemicals have limited, or no hazard data readily available to characterize human risk. The threshold of toxicological concern (TTC) constitutes a science-based tool for screening level risk-based prioritization of chemicals with low ... ...

Abstract	Thousands of chemicals have limited, or no hazard data readily available to characterize human risk. The threshold of toxicological concern (TTC) constitutes a science-based tool for screening level risk-based prioritization of chemicals with low exposure. Herein we compare TTC values to more rigorously derived reference dose (RfD) values for 288 chemicals in the U.S. Environmental Protection Agency's (US EPA) Integrated Risk Information System (IRIS) database. Using the Cramer decision tree and the Kroes tiered decision tree approaches to determine TTC values, the TCC for the majority of these chemicals were determined to be lower than their corresponding RfD values. The ratio of log10(RfD/TCC) was used to measure the differences between these values and the mean ratio for the substances evaluated was ~0.74 and ~0.79 for the Cramer and Kroes approach, respectively, when considering the Cramer Classes only. These data indicate that the RfD values for Cramer Class III compounds were, on average, ~6-fold higher than their TTC value. These analyses indicate that provisional oral toxicity values might be estimated from TTCs in data-poor or emergency situations; moreover, RfD values that are well below TTC values (e.g., 2 standard deviations below the log10(Ratio)) might be overly conservative and targets for re-evaluation.
MeSH term(s)	Administration, Oral ; Databases, Factual ; Dose-Response Relationship, Drug ; Hazardous Substances/administration & dosage ; Hazardous Substances/toxicity ; Humans ; No-Observed-Adverse-Effect Level ; Risk Assessment ; United States ; United States Environmental Protection Agency
Chemical Substances	Hazardous Substances
Language	English
Publishing date	2020-03-27
Publishing country	Netherlands
Document type	Comparative Study ; Journal Article
ZDB-ID	604672-1
ISSN	1096-0295 ; 0273-2300
ISSN (online)	1096-0295
ISSN	0273-2300
DOI	10.1016/j.yrtph.2020.104651
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Article ; Online: Assessment of the applicability of the threshold of toxicological concern for per- and polyfluoroalkyl substances.

Lea, Isabel A / Pham, Ly Ly / Antonijevic, Todor / Thompson, Chad / Borghoff, Susan J

Regulatory toxicology and pharmacology : RTP

2022 Volume 133, Page(s) 105190

Abstract: While toxicity information is available for selected PFAS, little or no information is available for most, thereby necessitating a resource-effective approach to screen and prioritize those needing further safety assessment. The threshold of ... ...

Abstract	While toxicity information is available for selected PFAS, little or no information is available for most, thereby necessitating a resource-effective approach to screen and prioritize those needing further safety assessment. The threshold of toxicological concern (TTC) approach proposes a de minimis exposure value based on chemical structure and toxicology of similar substances. The applicability of the TTC approach to PFAS was tested by incorporating a data set of no-observed-adverse-effect level (NOAEL) values for 27 PFAS into the Munro TTC data set. All substances were assigned into Cramer Class III and the cumulative distribution of the NOAELs evaluated. The TTC value for the PFAS-enriched data set was not statistically different compared to the Munro data set. Derived human exposure level for the PFAS-enriched data set was 1.3 μg/kg/day. Structural chemical profiles showed the PFAS-enriched data set had distinct chemotypes with lack of similarity to substances in the Munro data set using Maximum Common Structures. The incorporation of these 27 PFAS did not significantly change TTC Cramer Class III distribution and expanded the chemical space, supporting the potential use of the TTC approach for PFAS chemicals.
MeSH term(s)	Databases, Factual ; Fluorocarbons/toxicity ; Humans ; No-Observed-Adverse-Effect Level ; Risk Assessment
Chemical Substances	Fluorocarbons
Language	English
Publishing date	2022-06-01
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	604672-1
ISSN	1096-0295 ; 0273-2300
ISSN (online)	1096-0295
ISSN	0273-2300
DOI	10.1016/j.yrtph.2022.105190
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Article ; Online: Gram-negative bacteria act as a reservoir for aminoglycoside antibiotics that interact with host factors to enhance bacterial killing in a mouse model of pneumonia.

Wijers, Christiaan D M / Pham, Ly / Douglass, Martin V / Skaar, Eric P / Palmer, Lauren D / Noto, Michael J

FEMS microbes

2022 Volume 3, Page(s) xtac016

Abstract: ... In ... ...

Abstract	In vitro
Language	English
Publishing date	2022-05-13
Publishing country	England
Document type	Journal Article
ISSN	2633-6685
ISSN (online)	2633-6685
DOI	10.1093/femsmc/xtac016
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Article ; Online: Does Enhanced Structural Maturity of hiPSC-Cardiomyocytes Better for the Detection of Drug-Induced Cardiotoxicity?

Van de Sande, Dieter / Ghasemi, Mohammadreza / Watters, Taylor / Burton, Francis / Pham, Ly / Altrocchi, Cristina / Gallacher, David J / Lu, Huarong / Smith, Godfrey

Biomolecules

2023 Volume 13, Issue 4

Abstract: Human induced pluripotent stem cell derived cardiomyocytes (hiPSC-CMs) are currently used following the Comprehensive in vitro Proarrhythmic Assay (CiPA) initiative and subsequent recommendations in the International Council for Harmonization (ICH) ... ...

Abstract	Human induced pluripotent stem cell derived cardiomyocytes (hiPSC-CMs) are currently used following the Comprehensive in vitro Proarrhythmic Assay (CiPA) initiative and subsequent recommendations in the International Council for Harmonization (ICH) guidelines S7B and E14 Q&A, to detect drug-induced cardiotoxicity. Monocultures of hiPSC-CMs are immature compared to adult ventricular cardiomyocytes and might lack the native heterogeneous nature. We investigated whether hiPSC-CMs, treated to enhance structural maturity, are superior in detecting drug-induced changes in electrophysiology and contraction. This was achieved by comparing hiPSC-CMs cultured in 2D monolayers on the current standard (fibronectin matrix, FM), to monolayers on a coating known to promote structural maturity (CELLvo™ Matrix Plus, MM). Functional assessment of electrophysiology and contractility was made using a high-throughput screening approach involving the use of both voltage-sensitive fluorescent dyes for electrophysiology and video technology for contractility. Using 11 reference drugs, the response of the monolayer of hiPSC-CMs was comparable in the two experimental settings (FM and MM). The data showed no functionally relevant differences in electrophysiology between hiPSC-CMs in standard FM and MM, while contractility read-outs indicated an altered amplitude of contraction but not changes in time course. RNA profiling for cardiac proteins shows similarity of the RNA expression across the two forms of 2D culture, suggesting that cell-to-matrix adhesion differences may explain account for differences in contraction amplitude. The results support the view that hiPSC-CMs in both 2D monolayer FM and MM that promote structural maturity are equally effective in detecting drug-induced electrophysiological effects in functional safety studies.
MeSH term(s)	Humans ; Cardiotoxicity/diagnosis ; Cells, Cultured ; High-Throughput Screening Assays ; Induced Pluripotent Stem Cells/metabolism ; Myocytes, Cardiac/metabolism
Language	English
Publishing date	2023-04-14
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2701262-1
ISSN	2218-273X ; 2218-273X
ISSN (online)	2218-273X
ISSN	2218-273X
DOI	10.3390/biom13040676
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Reproducibility of organ-level effects in repeat dose animal studies.

Friedman, Katie Paul / Foster, Miran J / Pham, Ly Ly / Feshuk, Madison / Watford, Sean M / Wambaugh, John F / Judson, Richard S / Setzer, R Woodrow / Thomas, Russell S

Computational toxicology (Amsterdam, Netherlands)

2023 Volume 28, Page(s) 1–17

Abstract: This work estimates benchmarks for new approach method (NAM) performance in predicting organ-level effects in repeat dose studies of adult animals based on variability in replicate animal studies. Treatment-related effect values from the Toxicity ... ...

Abstract	This work estimates benchmarks for new approach method (NAM) performance in predicting organ-level effects in repeat dose studies of adult animals based on variability in replicate animal studies. Treatment-related effect values from the Toxicity Reference database (v2.1) for weight, gross, or histopathological changes in the adrenal gland, liver, kidney, spleen, stomach, and thyroid were used. Rates of chemical concordance among organ-level findings in replicate studies, defined by repeated chemical only, chemical and species, or chemical and study type, were calculated. Concordance was 39 - 88%, depending on organ, and was highest within species. Variance in treatment-related effect values, including lowest effect level (LEL) values and benchmark dose (BMD) values when available, was calculated by organ. Multilinear regression modeling, using study descriptors of organ-level effect values as covariates, was used to estimate total variance, mean square error (MSE), and root residual mean square error (RMSE). MSE values, interpreted as estimates of unexplained variance, suggest study descriptors accounted for 52-69% of total variance in organ-level LELs. RMSE ranged from 0.41 - 0.68 log
Language	English
Publishing date	2023-06-08
Publishing country	Netherlands
Document type	Journal Article
ISSN	2468-1113
ISSN	2468-1113
DOI	10.1016/j.comtox.2023.100287
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Article ; Online: High-Throughput Screening Assay for Detecting Drug-Induced Changes in Synchronized Neuronal Oscillations and Potential Seizure Risk Based on Ca

Lu, Hua-Rong / Seo, Manabu / Kreir, Mohamed / Tanaka, Tetsuya / Yamoto, Rie / Altrocchi, Cristina / van Ammel, Karel / Tekle, Fetene / Pham, Ly / Yao, Xiang / Teisman, Ard / Gallacher, David J

Cells

2023 Volume 12, Issue 6

Abstract: Drug-induced seizure liability is a significant safety issue and the basis for attrition in drug development. Occurrence in late development results in increased costs, human risk, and delayed market availability of novel therapeutics. Therefore, there ... ...

Abstract	Drug-induced seizure liability is a significant safety issue and the basis for attrition in drug development. Occurrence in late development results in increased costs, human risk, and delayed market availability of novel therapeutics. Therefore, there is an urgent need for biologically relevant, in vitro high-throughput screening assays (HTS) to predict potential risks for drug-induced seizure early in drug discovery. We investigated drug-induced changes in neural Ca
MeSH term(s)	Humans ; Induced Pluripotent Stem Cells ; Cells, Cultured ; High-Throughput Screening Assays ; Neurons ; Seizures/chemically induced
Language	English
Publishing date	2023-03-21
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2661518-6
ISSN	2073-4409 ; 2073-4409
ISSN (online)	2073-4409
ISSN	2073-4409
DOI	10.3390/cells12060958
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Article ; Online: Species differences in small intestinal exposure-related epithelial vacuolation in rats and dogs treated with a heteroaryldihydropyrimidine molecule.

Dai, Jieyu / Chen, Tao / Meng, Ryan / Jardi, Ferran / Kourula, Stephanie / Pham, Ly / De Jonghe, Sandra / De Smedt, Ann / Frisk, Anna-Lena / Xie, Jianxun

Journal of applied toxicology : JAT

2023 Volume 44, Issue 3, Page(s) 400–414

Abstract: Small intestinal epithelial vacuolation induced by a heteroaryldihydropyrimidine compound (HAP-1) was observed in rats but not in dogs at termination in screening toxicity studies, despite the plasma exposure being higher in dogs. To understand the ... ...

Abstract	Small intestinal epithelial vacuolation induced by a heteroaryldihydropyrimidine compound (HAP-1) was observed in rats but not in dogs at termination in screening toxicity studies, despite the plasma exposure being higher in dogs. To understand the species differences, investigational studies with multiple time points following single dose (SD) and 7-day repeated dose (RD) were conducted in both species at doses resulting in comparable plasma exposures. In rats, epithelial vacuolation in the duodenum and jejunum were observed at all time points. In dogs, transient vacuolation was noted at 8 h post-SD (SD_8h) and 4 h post-RD (RD_4 h), but not at termination (RD_24 h). Special stains demonstrated lipid accumulation within enterocytes in both species and intracytoplasmic inclusion bodies in rats. Transmission electron microscopy identified these inclusion bodies as endoplasmic reticulum (ER) membranous structures. Transcriptomic analysis on jejunal mucosa at SD_8 h and RD_24 h revealed perturbations of lipid metabolism-related genes at SD_8 h in both species, but not at RD_24 h in dogs. ER stress-related gene changes at both time points were observed in rats only. Despite comparable HAP-1 plasma exposures, the duodenum and jejunum tissue concentrations of HAP-1 and acyl glucuronide metabolite were >5- and >30-fold higher in rats than in dogs, respectively. In vitro, similar cytotoxicity was observed in rat and dog duodenal organoids treated with HAP-1. In conclusion, HAP-1-induced intestinal epithelial vacuolation was related to lipid metabolism dysregulation in both species and ER-related injuries in rats only. The species differences were likely related to the difference in intestinal exposure to HAP-1 and its reactive metabolite.
MeSH term(s)	Rats ; Dogs ; Animals ; Species Specificity ; Intestine, Small ; Pyrimidines
Chemical Substances	heteroaryldihydropyrimidine ; Pyrimidines
Language	English
Publishing date	2023-10-09
Publishing country	England
Document type	Journal Article
ZDB-ID	604625-3
ISSN	1099-1263 ; 0260-437X
ISSN (online)	1099-1263
ISSN	0260-437X
DOI	10.1002/jat.4550
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Article ; Online: ToxRefDB version 2.0: Improved utility for predictive and retrospective toxicology analyses.

Watford, Sean / Ly Pham, Ly / Wignall, Jessica / Shin, Robert / Martin, Matthew T / Friedman, Katie Paul

Reproductive toxicology (Elmsford, N.Y.)

2019 Volume 89, Page(s) 145–158

Abstract: The Toxicity Reference Database (ToxRefDB) structures information from over 5000 in vivo toxicity studies, conducted largely to guidelines or specifications from the US Environmental Protection Agency and the National Toxicology Program, into a public ... ...

Abstract	The Toxicity Reference Database (ToxRefDB) structures information from over 5000 in vivo toxicity studies, conducted largely to guidelines or specifications from the US Environmental Protection Agency and the National Toxicology Program, into a public resource for training and validation of predictive models. Herein, ToxRefDB version 2.0 (ToxRefDBv2) development is described. Endpoints were annotated (e.g. required, not required) according to guidelines for subacute, subchronic, chronic, developmental, and multigenerational reproductive designs, distinguishing negative responses from untested. Quantitative data were extracted, and dose-response modeling for nearly 28,000 datasets from nearly 400 endpoints using Benchmark Dose (BMD) Modeling Software were generated and stored. Implementation of controlled vocabulary improved data quality; standardization to guideline requirements and cross-referencing with United Medical Language System (UMLS) connects ToxRefDBv2 observations to vocabularies linked to UMLS, including PubMed medical subject headings. ToxRefDBv2 allows for increased connections to other resources and has greatly enhanced quantitative and qualitative utility for predictive toxicology.
MeSH term(s)	Animals ; Computational Biology/methods ; Computational Biology/trends ; Databases, Factual/trends ; Dose-Response Relationship, Drug ; Hazardous Substances/chemistry ; Hazardous Substances/classification ; Hazardous Substances/toxicity ; Models, Biological ; Software ; Toxicology/methods ; Toxicology/trends ; United States ; United States Environmental Protection Agency
Chemical Substances	Hazardous Substances
Language	English
Publishing date	2019-07-21
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	639342-1
ISSN	1873-1708 ; 0890-6238
ISSN (online)	1873-1708
ISSN	0890-6238
DOI	10.1016/j.reprotox.2019.07.012
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Article ; Online: Python BMDS: A Python interface library and web application for the canonical EPA dose-response modeling software.

Pham, Ly Ly / Watford, Sean / Friedman, Katie Paul / Wignall, Jessica / Shapiro, Andrew J

Reproductive toxicology (Elmsford, N.Y.)

2019 Volume 90, Page(s) 102–108

Abstract: Several primary sources of publicly available, quantitative dose-response data from traditional toxicology study designs relevant to predictive toxicology applications are now available, including the redeveloped U.S. Environmental Protection Agency's ... ...

Abstract	Several primary sources of publicly available, quantitative dose-response data from traditional toxicology study designs relevant to predictive toxicology applications are now available, including the redeveloped U.S. Environmental Protection Agency's Toxicity Reference Database (ToxRefDB v2.0), the Health Assessment Workspace Collaborative (HAWC), and the National Toxicology Program's Chemical Program's Chemical Effects in Biological Systems (CEBS). These resources provide effect level information but modeling these data to a curve may be more informative for predictive toxicology applications. Benchmark Dose Software (BMDS) has been recognized broadly and used for regulatory applications at multiple agencies. However, the current BMDS software was not amenable to modeling large datasets. Herein we describe development and use of a Python package that implements a wrapper around BMDS, a software that requires manual input in the dose-response modeling process (i.e., best-fitting model-selection, reporting, and dose-dropping). In the Python BMDS, users can select the BMDS version, customize model recommendation logic, and export summaries of the resultant BMDS output. Further, using the Python interface, a web-based application programming interface (API) has been developed for easy integration into other software systems, pipelines, or databases. Software utility was demonstrated via modeling nearly 28,000 datasets in ToxRefDB v2.0, re-creation of an existing, published large-scale analysis, and demonstration of usage in software such as CEBS and HAWC. Python BMDS enables rapid-batch processing of dose-response datasets using a modeling software with broad acceptance in the toxicology community, thereby providing an important tool for leveraging the publicly available quantitative toxicology data in a reproducible manner.
MeSH term(s)	Dose-Response Relationship, Drug ; Humans ; Internet ; Libraries, Digital ; Models, Biological ; Risk Assessment ; Software ; United States ; United States Environmental Protection Agency
Language	English
Publishing date	2019-08-12
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	639342-1
ISSN	1873-1708 ; 0890-6238
ISSN (online)	1873-1708
ISSN	0890-6238
DOI	10.1016/j.reprotox.2019.07.013
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