{"title":"Chlorinated biphenyls: MAK Value Documentation, addendum - Translation of the German version from 2025.","authors":"Andrea Hartwig","doi":"10.34865/mb0cbphpcbe11_1ad","DOIUrl":"10.34865/mb0cbphpcbe11_1ad","url":null,"abstract":"<p><p>The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) derived a concentration in workplace air for chlorinated biphenyls (PCBs) [1336-36-3] which is without risk to the developing foetus (corresponding to Pregnancy Risk Group C). The derivation is based on the prerequisite for the classification in Pregnancy Risk Group C at 3.5 μg/l plasma for the sum of the 6 indicator congeners (6IC) PCB 28, PCB 52, PCB 101, PCB 138, PCB 153 and PCB 180. Assuming a background concentration of 2 μg 6IC/l plasma for women up to 45 years of age with data from about 2010, an increment of 1.5 μg 6IC/l plasma is thus tolerable. This increment was estimated to correspond to a total PCB concentration in air of 0.0008 mg/m<sup>3</sup> measured as the sum of the 6IC multiplied by 5. This concentration represents a rather conservative estimate, as the background concentration in plasma has reduced since and a respiratory volume of 10 m<sup>3</sup> has been assumed, which might overpredict the exposure at workplaces in PCB-contaminated office or public buildings. Additionally, age and duration of exposure are important determinants for the inner exposure. These factors should be considered when evaluating the measurement results.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"11 1","pages":"Doc007"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13502079/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148815072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"1,2-Dichloro-1,1,2,2-tetrafluoro-ethane: MAK Value Documentation, addendum - Translation of the German version from 2024.","authors":"Andrea Hartwig","doi":"10.34865/mb7614e11_1ad","DOIUrl":"https://doi.org/10.34865/mb7614e11_1ad","url":null,"abstract":"<p><p>1,2-Dichloro-1,1,2,2-tetrafluoroethane [76-14-2] and other partly halogenated chloro-fluorocarbons (H-CFCs) are no longer approved in the European Union or in Germany. The derivation of the previous MAK value (maximum concentration at the workplace) of 1,2-dichloro-1,1,2,2-tetrafluoroethane by the German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) does not correspond to the current approach of the Commission. There are no new studies that would allow the MAK value to be revised. The Commission decided that a new evaluation is not of high priority. The MAK value and the other classifications are therefore suspended and the substance is listed in the Section II c of the List of MAK and BAT Values for substances no longer evaluated.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"11 1","pages":"Doc009"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13502072/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148815480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura Kuhlmann, Elisabeth Eckert, Christine Höllerer-Mittelmaier, Thomas Göen, Veronika Spindler, Gerhard Scherer, Craig Sams, Kate Jones, Andrea Hartwig
{"title":"Tri-(2-ethylhexyl)trimellitat – Bestimmung von 1-MEHTM, 2-MEHTM, 5OH-1-MEHTM, 5OH-2-MEHTM, 5cx-1-MEPTM und 5cx-2-MEPTM in Urin mittels LC-MS/MS: Biomonitoring-Methode.","authors":"Laura Kuhlmann, Elisabeth Eckert, Christine Höllerer-Mittelmaier, Thomas Göen, Veronika Spindler, Gerhard Scherer, Craig Sams, Kate Jones, Andrea Hartwig","doi":"10.34865/bi331931d10_4or","DOIUrl":"10.34865/bi331931d10_4or","url":null,"abstract":"","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 4","pages":"Doc069"},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064901/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Glaswolle, Halbwertszeit < 40 Tage (faserförmige und granuläre Bestandteile): MAK-Begründung.","authors":"Andrea Hartwig","doi":"10.34865/mb0244gwd10_4or","DOIUrl":"10.34865/mb0244gwd10_4or","url":null,"abstract":"","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 4","pages":"Doc059"},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064889/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lutz Nitschke, Adela Frenzen, Dietmar Breuer, Ralph Hebisch, Uta Lewin-Kretzschmar, Andrea Hartwig
{"title":"4-Methyl-3-penten-2-one - Determination of 4-methyl-3-penten-2-one (mesityl oxide) in the workplace air using high-performance liquid chromatography (HPLC-DAD): Air Monitoring Method - Translation of the German version from 2025.","authors":"Lutz Nitschke, Adela Frenzen, Dietmar Breuer, Ralph Hebisch, Uta Lewin-Kretzschmar, Andrea Hartwig","doi":"10.34865/am14179e10_4or","DOIUrl":"10.34865/am14179e10_4or","url":null,"abstract":"<p><p>The working group \"Air Analyses\" of the German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) developed and verified the presented analytical method. It is used to determine the levels of 4-methyl-3-penten-2-one [141-79-7] that occur in the workplace air. The method covers concentrations in the range from one tenth up to twice the current occupational exposure limit value (OELV) of 8.1 mg/m<sup>3</sup>. The method is also suitable for verifying the short-term exposure limit (STEL; excursion factor 2). Samples are collected by drawing a defined volume of air through a sampling tube filled with silica gel using a flow regulated pump at a volumetric flow rate of 0.5 l/min. Exposure during the shift is measured with a sampling period of 2 hours and the short-term exposure with a period of 15 minutes. The 4-methyl-3-penten-2-one adsorbed to the silica gel is extracted by liquid extraction with methanol and analysed by high-performance liquid chromatography using diode array detection. The quantitative determination is based on multiple-point calibrations with external standards. A relative limit of quantification (LOQ) of 0.06 mg/m<sup>3</sup> is obtained for an air sample volume of 60 litres. As the LOQ for a sample volume of 30 litres is 0.03 mg/m<sup>3</sup>, the STEL can also be measured. The recovery is approx. 100% and the expanded uncertainty is 14% for a sampling period of 2 hours and below 16% for a period of 15 minutes.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 4","pages":"Doc067"},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cadmium and its inorganic compounds - Addendum: re-evaluation of the BLW: Assessment Values in Biological Material - Translation of the German version from 2025.","authors":"Ernst Hallier, Hans Drexler, Andrea Hartwig","doi":"10.34865/bb744043e10_4ad","DOIUrl":"10.34865/bb744043e10_4ad","url":null,"abstract":"<p><p>The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) re-evaluated the data for cadmium [7440-43-9] to derive a biological guidance value (BLW) for its systemic non-carcinogenic end points. Relevant studies were identified from a literature search. Exposure to cadmium dust can cause nasal inflammation and anosmia, bronchitis and pneumonia, which are recognised as local effects. Tubular kidney damage was identified as the most sensitive end point of systemic toxicity, which results in excretion of low molecular weight proteins such as α1 and β2-microglobulins and retinol binding protein (RBP) in the urine. Recent studies on workers occupationally exposed to cadmium revealed a NOEL (no observed effect level) and a BMDL5 (benchmark dose lower limit) for tubular proteinuria at approximately 3 to 5 µg cadmium/g creatinine in ever-smokers, whereas this threshold is higher in never-smokers. Therefore, a BLW of 2 µg cadmium/g creatinine is set for cadmium in urine.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 4","pages":"Doc066"},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064887/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura Kuhlmann, Elisabeth Eckert, Christine Höllerer-Mittelmaier, Thomas Göen, Veronika Spindler, Gerhard Scherer, Craig Sams, Kate Jones, Andrea Hartwig
{"title":"Tri-(2-ethylhexyl) trimellitate - Determination of 1-MEHTM, 2-MEHTM, 5OH-1-MEHTM, 5OH-2-MEHTM, 5cx-1-MEPTM, and 5cx-2-MEPTM in urine by LC-MS/MS: Biomonitoring Method - Translation of the German version from 2025.","authors":"Laura Kuhlmann, Elisabeth Eckert, Christine Höllerer-Mittelmaier, Thomas Göen, Veronika Spindler, Gerhard Scherer, Craig Sams, Kate Jones, Andrea Hartwig","doi":"10.34865/bi331931e10_4or","DOIUrl":"10.34865/bi331931e10_4or","url":null,"abstract":"<p><p>The working group \"Analyses in Biological Materials\" of the German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) developed and verified this biomonitoring method for the measurement of six specific metabolites of the plasticiser tri‑(2‑ethylhexyl) trimellitate (TEHTM) in urine. Specifically, this method determines two monoester isomers as primary hydrolysis products of TEHTM, 1‑mono-(2‑ethylhexyl) trimellitate (1‑MEHTM) and 2‑mono-(2‑ethylhexyl) trimellitate (2‑MEHTM), as well as the oxidatively formed secondary derivatives, namely 1‑mono-(2‑ethyl-5‑hydroxyhexyl) trimellitate (5OH‑1‑MEHTM), 2‑mono-(2‑ethyl-5‑hydroxyhexyl) trimellitate (5OH‑2‑MEHTM), 1‑mono-(2‑ethyl-5‑carboxypentyl) trimellitate (5cx‑1‑MEPTM), and 2‑mono-(2‑ethyl-5‑carboxypentyl) trimellitate (5cx‑2‑MEPTM). Determination is carried out after enzymatic hydrolysis of the urine sample as well as enrichment of the analytes by online SPE. Via integrated, automatic column-switching, the analytes are transferred onto the analytical column in backflush mode, separated by liquid chromatography, and quantified by tandem mass spectrometry. Calibration is performed using calibration standards prepared in pooled urine and processed analogously to the samples to be analysed. The following isotope-labelled substances are added to the urine samples as internal standards: D<sub>5</sub>‑1‑MEHTM, D<sub>5</sub>‑2‑MEHTM, D<sub>5</sub>‑5OH‑1‑MEHTM, D<sub>5</sub>‑5cx‑1‑MEPTM, and D<sub>5</sub>‑5cx‑2‑MEPTM. The method provides reliable and accurate analytical results, as shown by the good precision data with standard deviations no greater than 8%. Good accuracy data were obtained with mean relative recoveries in the range of 97-109%. The method is both selective and sensitive, and provides quantitation limits in the range of 0.04-0.12 μg/l.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 4","pages":"Doc070"},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cadmium und seine anorganischen Verbindungen – Addendum: Reevaluierung des BLWs: Beurteilungswerte in biologischem Material.","authors":"Ernst Hallier, Hans Drexler, Andrea Hartwig","doi":"10.34865/bb744043d10_4ad","DOIUrl":"10.34865/bb744043d10_4ad","url":null,"abstract":"","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 4","pages":"Doc065"},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Synthetic amorphous silica: MAK Value Documentation, addendum - Translation of the German version from 2023.","authors":"Andrea Hartwig","doi":"10.34865/mb763186e10_4ad","DOIUrl":"10.34865/mb763186e10_4ad","url":null,"abstract":"<p><p>The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) has re-evaluated the occupational exposure limit value (maximum concentration at the workplace, MAK value) of synthetic amorphous silica [7631-86-9] considering all toxicological end points. Relevant studies were identified from a literature search and also unpublished study reports were used. The critical effects are the inflammatory effects in the lungs. A NOAEC cannot be established for these effects. In a 90-day study, one form of nanoscale synthetic amorphous silica induced inflammatory effects in the lungs of rats at the lowest concentration tested of 0.5 mg/m<sup>3</sup> and above. Based on this LOAEC, a maximum concentration at the workplace (MAK value) of 0.02 mg/m<sup>3</sup> has been derived for the respirable fraction and the substance has been classified in Peak Limitation Category II with an excursion factor of 8. The NOAEL for developmental or perinatal toxicity in rats was 1000 mg/kg body weight and day after gavage; this corresponds to concentrations of 1750 or 2450 mg/m<sup>3</sup> at the workplace. As the margins between these values and the MAK value are sufficiently large, synthetic amorphous silica has been assigned to Pregnancy Risk Group C. Studies in animals did not show a carcinogenic potential of synthetic amorphous silica, which is relevant for humans. Synthetic colloidal amorphous silica is not mutagenic in vitro or in vivo. The DNA strand breaks and micronuclei that were observed in vitro were not confirmed by the results in vivo. Synthetic colloidal amorphous silica is not absorbed through the skin in toxicologically relevant amounts and there is no evidence that it induces contact sensitization.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 4","pages":"Doc062"},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064888/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Tetrabromobisphenol A: MAK Value Documentation - Translation of the German version from 2023.","authors":"Andrea Hartwig","doi":"10.34865/mb7994e10_4or","DOIUrl":"10.34865/mb7994e10_4or","url":null,"abstract":"<p><p>The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) has evaluated the data for tetrabromobisphenol A [79-94-7] considering all toxicological end points. Relevant studies were identified from a literature search, epidemiological studies of tetrabromobisphenol A are not available. After repeated administration by gavage, the target organs of toxicity were the endocrine system in male and female rats with decreased total T4 concentrations and the kidneys in male mice with cytoplasmic changes in the tubules. Tetrabromobisphenol A induces uterine tumours in female Wistar-Han rats and hepatoblastomas and haemangiosarcomas in male B6C3F1/N mice. Due to its non-genotoxic mechanism of action, it is assumed that a NAEL (no adverse effect level) can be determined for carcinogenic effects. Therefore, tetrabromobisphenol A could be classified in Carcinogen Category 4. However, there are no data that can be used to establish a NOAEL for atypical hyperplasia (preneoplasia) in the endometrium, to clarify whether the observed uterine tumours are specific to the strain, and to further characterize the mechanism of tumourigenesis. Therefore, a maximum concentration at the workplace (MAK value) cannot be established and tetrabromobisphenol A has been classified in Carcinogen Category 2 and given the footnote \"Prerequisite for Category 4 in principle fulfilled, but insufficient data available for the establishment of a MAK or BAT value\". Tetrabromobisphenol A is not mutagenic in bacteria or clastogenic in mammalian cells. In vivo data do not provide evidence of genotoxic effects in soma cells, even at concentrations that cause systemic toxicity. In vivo studies suggest that transdermal uptake may be relevant. As tetrabromobisphenol A has been classified as a Category 2 carcinogen and no threshold for the carcinogenic effects can be established at present, the substance has provisionally been designated with \"H\". Data for humans, animals and from in vitro studies show no sensitizing potential.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 4","pages":"Doc063"},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064891/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}