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5507987 
Journal Article 
Total Organic Carbon (TOC) in Parenteral Solutions Currently used in Brazil 
Madureira, PR; Jardim, WF; Sodre, FF 
2007 
1 
Clinical Toxicology
ISSN: 1556-3650
EISSN: 1556-9519 
45 
4 
348 
Objective: Human contamination due to the leaching of plasticizers used fa PVC bags fa parenteral solutions, specially di-(2-ethylhexyl)phthalate (DEHP) is well know in medical hospital procedures. Health risks associated to DEHP exposure like hepatotoxicity, endocrine disruption and reproductive toxicity has been addressed to recent literature. To evaluate the amount of exogenous organic carbon compounds fa parenteral solutions used in Brazil, TOC analysis was used as a rapid and reliable screening tool. Methods: From a total of 150 low density polyethylene (LDPE) and PVC bags containing water for injection and cristalloide parenteral solution used fa the University's Clinical Hospital (UNICAMP), 75 bags were analyzed for TOC by high temperature combustion followed by gas chromatography coupled mass spectroscopy (GC/MS) for confirmatory qualitative analysis. Chromatographic determinations were used for DEHP and possible metabolites to 2 samples with TOC values above 25 mgC/L. Results: TOC levels varied from 0.53 up to 54.4 mgC/L. Higher TOC values were obtained for PVC bags, whereas LDPE showed consistent lower values, independent of the fluid type held. Small volume containers presented higher TOC values most likely due to the area/volume ratio. GC/MS analysis showed the presence of 2-ethylhexanol, cyclohexanone and phthalates. Conclusion: Despite the fact that there are no TOC guidelines for parenteral solutions fa Brazil, both US and European Pharmacopeia establish the maximum of 0.5 mgC/L of TOC in water for parenteral use. Values above 0.5 mgC/L are likely to be due to leaching of sample walls as well as the printing ink used fa the PVC bags. Recent work found plasticizers contamination fa PVC bags from Australia, Europe and North America. Despite the fact that DEHP toxicity is not established, the tolerable daily intake (TDI) recommended by the European Union is 20-48 g/kg/day. Quantitative analysis of these plasticizers is currently under investigation. 
Health & Safety Science Abstracts; Toxicology Abstracts; Organic carbon; Toxicity; Containers; Combustion; North America; Metabolites; cyclohexanone; guidelines; phthalates; total organic carbon; Printing; Polyethylene; Plasticizers; endocrine disruptors; Mass spectroscopy; Leaching; Water temperature; Contamination; high temperature; Gas chromatography; Hospitals; European Union; hepatotoxicity; Australia; H 13000:Medical Safety; X 24350:Industrial Chemicals