Bavarian Health and Food Safety Authority


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Wollein U.,Bavarian Health and Food Safety Authority | Schramek N.,Bavarian Health and Food Safety Authority
European Journal of Pharmaceutical Sciences | Year: 2012

We report a specific, fast and feasible method for the simultaneous determination of methyl mesilate (MMS), ethyl mesilate (EMS), isopropyl mesilate (IMS), methyl besilate (MBS) and ethyl besilate (EBS) in finished drug products by GC/MS. Sample preparation was carried out by liquid extraction. The analytes were directly injected into the chromatographic system and quantified with the internal standard method using methyl tosylate (MTS) as internal standard (ISTD). The method gives excellent sensitivity for all the alkyl and aryl esters at typical target analyte level, according to the acceptance criteria that are described in the Guideline on the Limits of Genotoxic Impurities which has been issued in 2007 by the European Medicines Agency (EMA). The average recovery for methanesulfonic acid esters (mesilates) was not lower than 71 %, for benzenesulfonic acid esters (besilates) not lower than 94%. A linear range with R 2 ≥ 0.9998 has been established for concentrations between 0.01 and 1.33 μg/ml. Validation of the method was carried out on a sample matrix containing MMS, EMS, IMS, MBS and EBS at relevant levels and was further confirmed on finished products containing APIs as mesilate salts (Bromocriptine mesilate, Doxazosin mesilate). © 2011 Elsevier B.V. All rights reserved.

Volkel W.,Bavarian Health and Food Safety Authority | Kiranoglu M.,Bavarian Health and Food Safety Authority | Schuster R.,Bavarian Health and Food Safety Authority | Fromme H.,Bavarian Health and Food Safety Authority
Toxicology Letters | Year: 2014

Urine samples (n= 207) of 47 infants between 1- and 5-month of age were quantitated for 12 metabolites of 7 phthalates and compared with samples collected from the mothers of the infants at different time points. Median and 95-percentile were lower for all metabolites in urine samples of infants compared to mothers. For di-2-ethylhexyl phthalate (DEHP) the 95-percentile daily intake was 23.3. μg/kg b.w. for mothers and 5.4. μg/kg b.w. for infants and for di-isobutyl phthalate (DiBP) 10.1. μg/kg b.w. and 8.5. μg/kg b.w. Some values exceeded the corresponding tolerable daily intake (TDI) for DiBP for infants and mothers and for DEHP and di-n-butyl phthalate (DnBP) only for mothers. Both, infants and mothers are able to efficiently form phase II metabolites but infants with a slightly lower degree. Therefore, a distinguished risk assessment with respect to the formed toxic metabolites of phthalates would be necessary in combination with a reduction of the most toxic phthalates. © 2013 Elsevier Ireland Ltd.

Klostermann S.,Bavarian Health and Food Safety Authority | Bolte G.,Bavarian Health and Food Safety Authority | Bolte G.,University of Bremen
International Journal of Hygiene and Environmental Health | Year: 2014

Objective: Unprotected sun exposure especially during childhood is a risk factor for skin cancer. A combined use of sun protection measures is recommended to protect children. However, the prevalence and determinants for combined use have been scarcely studied in children. The objective of this study was to identify determinants of parental sun protection behaviour. Methods: A cross-sectional survey was performed in five regions in Bavaria (Germany) during school entrance health examination (2010/2011). Parents of 4579 children (47% female, aged 5-6 years) completed a self-administered questionnaire (response 61%). Results: Most children were regularly protected with single measures (shade (69%), clothes (80%), hat (83%), sunscreen (89%), sunglasses (20%)). However, regarding regular and combined use, >50% of children were inadequately protected. Larger family size, lower household equivalent income, darker skin and sunburn history were associated with inadequate use of different sun protection measures. The less frequent use of one sun protection measure was associated with less frequent use of the others. Child's sex, migration background, parental education and sun exposure showed inconsistent results regarding the different sun protection outcomes. Conclusion: Based on our results a regular, combined and correct use of multiple sun protection for children should be promoted independent of sociodemographic characteristics. Priority of shade, clothes and hat before sunscreen should be clarified. © 2013 Elsevier GmbH.

A vegetation study was carried out to investigate the carryover of Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS) from soil mixed with contaminated sewage sludge to potato, carrot, and cucumber plants. Analysis was done by liquid-extraction using acetonitrile with dispersive SPE cleanup and subsequent HPLC-MS/MS. In order to assess the transfer potential from soil, transfer factors (TF) were calculated for the different plant compartments: TF = [PFC] plant (wet substance)/[PFC] soil (dry weight). The highest TF were found for the vegetative plant compartments with average values for PFOS below those for PFOA: cucumber, 0.17 (PFOS), 0.88 (PFOA); potato, 0.36 (PFOS), 0.40 (PFOA); carrot, 0.38 (PFOS), 0.53 (PFOA). Transfer of PFOA and PFOS into potato peelings (average values of TF: PFOA 0.03, PFOS 0.04) exceeded the carryover to the peeled tubers (PFOA 0.01, PFOS < 0.01). In carrots, this difference did not occur (average values of TF: PFOA 0.04, PFOS 0.04). Transfer of PFOS into the unpeeled cucumbers was low and comparable to that of peeled potatoes (TF < 0.01). For PFOA, it was higher (TF: 0.03). © 2011 American Chemical Society.

Englund H.,Bavarian Health and Food Safety Authority | Campe H.,Bavarian Health and Food Safety Authority | Hautmann W.,Bavarian Health and Food Safety Authority
Epidemiology and Infection | Year: 2013

We estimated the vaccine effectiveness (VE) of trivalent and monovalent influenza vaccines, respectively, against laboratory-confirmed influenza infections in patients with influenza-like illness who visited physicians participating in the Bayern Influenza Sentinel in Bavaria, Germany during 2010/2011. Swab specimens were analysed for influenza A(H1N1)pdm09, A(H3) and B by PCR. VE was estimated using the test-negative case-control study design and logistic regression. In total, 1866 patients (790 cases, 1076 controls) were included. The VE of trivalent vaccines administered in season 2010/2011 against laboratory-confirmed infection with any influenza virus, adjusted for age group, sex, chronic illness and week of arrival of the specimen, was 67·8% [95% confidence interval (CI) 39·2-82·9)]. The adjusted VE of monovalent influenza vaccines administered in season 2009/2010 against laboratory-confirmed influenza A(H1N1)pdm09 infection in 2010/2011 was 38·6% (95% CI -70·0 to 77·8). This is the first VE study conducted in Bavaria. We concluded that the trivalent influenza vaccines were effective in our study population. Copyright © Cambridge University Press 2012.

Hogardt M.,Bavarian Health and Food Safety Authority | Heesemann J.,Ludwig Maximilians University of Munich
Current Topics in Microbiology and Immunology | Year: 2013

Pseudomonas aeruginosa is the leading pathogen of chronic cystic fibrosis (CF) lung infection. Life-long persistance of P. aeruginosa in the CF lung requires a sophisticated habitat-specific adaptation of this pathogen to the heterogeneous and fluctuating lung environment. Due to the high selective pressure of inflamed CF lungs, P. aeruginosa increasingly experiences complex physiological and morphological changes. Pulmonary adaptation of P. aeruginosa is mediated by genetic variations that are fixed by the repeating interplay of mutation and selection. In this context, the emergence of hypermutable phenotypes (mutator strains) obviously improves the microevolution of P. aeruginosa to the diverse microenvironments of the CF lung. Mutator phenotypes are amplified during CF lung disease and accelerate the intraclonal diversification of P. aeruginosa. The resulting generation of numerous subclonal variants is advantegous to prepare P. aeruginosa population for unpredictable stresses (insurance hypothesis) and thus supports long-term survival of this pathogen. Oxygen restriction within CF lung environment further promotes persistence of P. aeruginosa due to increased antibiotic tolerance, alginate production and biofilm formation. Finally, P. aeruginosa shifts from an acute virulent pathogen of early infection to a host-adapted chronic virulent pathogen of end-stage infection of the CF lung. Common changes that are observed among chronic P. aeruginosa CF isolates include alterations in surface antigens, loss of virulence-associated traits, increasing antibiotic resistances, the overproduction of the exopolysaccharide alginate and the modulation of intermediary and microaerobic metabolic pathways (Hogardt and Heesemann, Int J Med Microbiol 300(8):557-562, 2010). Loss-of-function mutations in mucA and lasR genes determine the transition to mucoidity and loss of quorum sensing, which are hallmarks of the chronic virulence potential of P. aeruginosa. Metabolic factors that are positively selected in response to the specific environment of CF lung include the outer membrane protein OprF, the microaerophilic oxidase Cbb3-2, the blue copper protein azurin, the cytochrome c peroxidase c551 and the enzymes of the arginine deiminase pathway ArcA-ArcD. These metabolic adaptations probably support the growth of P. aeruginosa within oxygen-depleted CF mucus. The deeper understanding of the physiological mechanisms of niche specialization of P. aeruginosa during CF lung infection will help to identify new targets for future anti-pseudomonal treatment strategies to prevent the selection of mutator isolates and the establishment of chronic CF lung infection. © Springer-Verlag Berlin Heidelberg 2011.

Kopp E.K.,Bavarian Health and Food Safety Authority | Fromme H.,Bavarian Health and Food Safety Authority | Volkel W.,Bavarian Health and Food Safety Authority
Journal of Chromatography A | Year: 2012

Brominated flame retardants (BFRs) are persistent and widespread chemicals. Therefore human beings are exposed to BFRs. House dust may be one source of exposure and contains a lot of xenobiotics in relatively high concentrations. In contrast to common GC-MS based methods here an online LC-MS/MS method is presented to quantify 16 BFRs in dust using ultrasonic solvent extraction as a single sample work up step. LOQ from 0.6 (tetrabromobisphenol A) to 80 (polybrominated diphenylethers (BDE 28) ng/g dust were achieved. Data for accuracy, precision and recovery are presented and are comparable to common LC-MS/MS methods in different matrices. In addition 5 real house dust samples were analyzed with high concentration (535. ng/g) for bis(2-ethyl-1-hexyl)tetrabromophthalate which is a novel alternative BFRs to replace common BDE's. © 2012 Elsevier B.V.

Scharte M.,Bavarian Health and Food Safety Authority | Bolte G.,Bavarian Health and Food Safety Authority
European Journal of Public Health | Year: 2013

Background: Adverse effects of single parenthood on children's health have been reported before. Socio-economic difficulties are discussed as mediating factors. As child health also depends on environmental conditions, we investigated the impact of environmental exposures and socio-economic factors on differences in health outcomes of children with single mothers vs. couple families. Methods: Data on 17 218 pre-school children (47% female) from three cross-sectional surveys conducted during 2004-07 in Germany were analysed. Health and exposure assessment were primarily based on parental report. Effects of socio-economic indicators (maternal education, household income) and environmental factors (traffic load at the place of residence, perceived environmental quality) on associations of four health outcomes (parent-reported health status, asthma, overweight, psychological problems) with single parenthood were determined by logistic regression analyses. Results: Children with single mothers showed an increased risk regarding parent-reported poor health status [boys: odds ratio (OR) 1.39 (95% confidence interval (CI): 1.06-1.82), girls: 1.73 (1.28-2.33)], psychological problems [boys: 1.90 (1.38-2.61), girls: 1.58 (1.03-2.42)], overweight [only boys: OR 1.23 (1.01-1.50) and asthma [only girls: OR 1.90 (1.15-3.15)]. Adjusting for socio-economic factors attenuated the strength of the association of family type with child health. Although environmental factors were associated with most health outcomes investigated and children of single mothers were more often exposed, these environmental factors did not alter the differences between children with single mothers and couple families. Conclusions: The increased health risks of children from single-mother families vs. couple families are partly explained by socio-economic factors, but not by the environmental exposures studied. © 2012 The Author. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Volkel W.,Bavarian Health and Food Safety Authority | Kiranoglu M.,Bavarian Health and Food Safety Authority | Fromme H.,Bavarian Health and Food Safety Authority
Environmental Research | Year: 2011

Infants may be particularly sensitive regarding hormonally active compounds such as Bisphenol A (BPA), which is widely distributed and exhibits weak oestrogenic activity. Since only free (unconjugated) BPA exhibits endocrine activity, both free and total (after hydrolysis of conjugates) BPA were determined in urine samples of infants to support valid risk assessments. Free BPA was observed above the LOQ in only 3 of 91 (3%) samples from 47 infants. As total BPA was observed in only 38 (42%) urine samples, with concentrations between

Ehling-Schulz M.,University of Veterinary Medicine Vienna | Messelhausser U.,Bavarian Health and Food Safety Authority
Frontiers in Microbiology | Year: 2013

The highly heterogeneous genus Bacillus comprises the largest species group of endospore forming bacteria. Because of their ubiquitous nature, Bacillus spores can enter food production at several stages resulting in significant economic losses and posing a potential risk to consumers due the capacity of certain Bacillus strains for toxin production. In the past, food microbiological diagnostics was focused on the determination of species using conventional culture-based methods, which are still widely used. However, due to the extreme intra-species diversity found in the genus Bacillus, DNA-based identification and typing methods are gaining increasing importance in routine diagnostics. Several studies showed that certain characteristics are rather strain-dependent than species-specific. Therefore, the challenge for current and future Bacillus diagnostics is not only the efficient and accurate identification on species level but also the development of rapid methods to identify strains with specific characteristics (such as stress resistance or spoil age potential), trace contamination sources, and last but not least discriminate potential hazardous strains from non-toxic strains. © 2013 Ehling-Schulz and Messelhäusser.

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