[Study on the potential impact of bromomethane on medicinal products following simulated container fumigation]. / Untersuchungen zur möglichen Beeinflussung von Arzneimitteln nach einer simulierten Containerentwesung mittels Brommethan.

To protect against exotic forest pest, solid wood packing has to be treated before shipping. According to the international standard ISPM 15 containers are usually fumigated with bromomethane. During this quarantine treatment a chemical reaction of bromomethane with the transported goods can not principally be excluded. This study takes a look at the impact of bromomethane on selected potential sensitive active pharmaceutical ingredients during simulated container fumigation. Following a 24-hour exposure to 67-80 g bromomethane per cubic meter, up to 0.02% bromide has been confirmed in phenacetine. The bromide concentrations in other active pharmaceutical ingredients were below 0.002%. New reaction products have not been identified at a detection limit of 0.01-0.04%. The bromide residue detected in one active pharmaceutical ingredient does not represent a relevant impairment of quality according to the European Pharmacopoeia, nor does it lead to a relevant excess exposure compared to both the acceptable daily intake of bromide and to the actual daily uptake of bromide from other exposure paths, dominantly from food consumption.

Biomonitoring results and cytogenetic markers among harbour workers with potential exposure to river silt aerosols.

BACKGROUND: Workers on dredgers and lighters on rivers are potentially exposed to a variety of substances. AIMS: To determine the internal load of heavy metals and arsenic as well as levels of cytogenetic markers in workers exposed to river silt aerosols. METHODS: One hundred exposed workers were examined up to eight times within three years. Additionally, 100 control workers were studied once. Blood samples were analysed for lead, mercury, and cadmium. Additionally, micronuclei frequency and sister chromatid exchange (SCE) rates were determined. Urinary samples were analysed for cadmium, mercury, nickel, chromium, and arsenic. Information on potential confounders, such as smoking habits and consumption of fish were assessed. RESULTS: Apart from some increased concentrations of mercury in blood (maximum 14.6 microg/l) and arsenic in urine (maximum 356.5 microg/l) all measurements were within reference values. None of the exposure and effect markers were found to be significantly increased in exposed workers compared to non-exposed controls. In multiple linear regression models, mercury levels in blood as well as the concentration of arsenic in urine were strongly related to fish consumption. Cadmium levels in blood as well as urinary cadmium concentrations were strongly related to smoking habits. After adjusting for smoking habits, SCE rates were associated with cadmium levels in blood. CONCLUSION: Increased exposure levels or enhanced levels of cytogenetic markers were not found in workers exposed to river silt aerosols. However, cadmium exposure in blood was related to SCE frequency.

Lung function, biological monitoring, and biological effect monitoring of gemstone cutters exposed to beryls.

OBJECTIVES: Gemstone cutters are potentially exposed to various carcinogenic and fibrogenic metals such as chromium, nickel, aluminium, and beryllium, as well as to lead. Increased beryllium concentrations had been reported in the air of workplaces of beryl cutters in Idar-Oberstein, Germany. The aim of the survey was to study the excretion of beryllium in cutters and grinders with occupational exposure to beryls--for example, aquamarines and emeralds--to examine the prevalence of beryllium sensitisation with the beryllium lymphocyte transformation test (BeLT), to examine the prevalence of lung disease induced by beryllium, to describe the internal load of the respective metals relative to work process, and to screen for genotoxic effects in this particular profession. METHODS: In a cross sectional investigation, 57 out of 100 gemstone cutters working in 12 factories in Idar-Oberstein with occupational exposure to beryls underwent medical examinations, a chest radiograph, lung function testing (spirometry, airway resistance with the interrupter technique), and biological monitoring, including measurements of aluminium, chromium, and nickel in urine as well as lead in blood. Beryllium in urine was measured with a newly developed direct electrothermal atomic absorption spectroscopy technique with a measurement limit of 0.06 microgram/l. Also, cytogenetic tests (rates of micronuclei and sister chromatid exchange), and a BeLT were performed. Airborne concentrations of beryllium were measured in three factories. As no adequate local control group was available, the cutters were categorised into those with an exposure to beryls of > 4 hours/week (group A) and < or = 4 hours/week (group B). RESULTS: Clinical, radiological, or spirometric abnormalities indicating pneumoconiosis were detected in none of the gemstone cutters. Metal concentrations in biological material were far below the respective biological limit values, and beryllium in urine was only measurable in subjects of group A. Cytogenetic investigations showed normal values which were independent of the duration of beryllium exposure. In one subject, the BeLT was positive. Beryllium stimulation indices were significantly higher in subjects with detectable beryllium in the urine than in those with beryllium concentrations below the detection limit (p < 0.05). In one factory, two out of four measurements of airborne beryllium concentrations were well above the German threshold limit value of 2 micrograms/m3 (twofold and 10-fold), and all gemstone cutters working in this factory had measurable beryllium concentrations in urine. CONCLUSION: No adverse clinical health effects were found in this cross sectional investigation of gemstone cutters working with beryls. However, an improvement in workplace hygiene is recommended, accompanied by biological monitoring of beryllium in urine.