Toxicological evaluation and limit values for Methyl-tertiary-butyl ether (MTBE), Formaldehyde, Glutaraldehyde, Furfural 1. General description1.1 Identity
1.2 Physical / chemical properties
1.3 Production and use Glutaraldehyde is synthesised in a two-step process: ethyl or methyl vinyl ether is reacted with acrolein to produce ethoxy or methoxy dihydropyran, respectively, which is then hydrolysed to produce glutaraldehyde and ethanol or methanol, respectively (CIR 1996). Next to formaldehyde, glutaraldehyde is the most used aldehyde. It has widespread uses as a bactericide, a tanning agent, a fixative for electron microscopy, as a preservative in cosmetics (maximum 0.1% in EU) and in sterilising surgical, endoscopic, anaesthetic, and dental instruments. In the US, it has many additional uses, e.g. as a direct and indirect food additive, and in packaging materials for food (CIR 1996). Glutaraldehyde has also been used to treat a number of skin disorders, including epidermolysis bullosa, hyperhydrosis, herpes zoster, herpes simplex, dyshidrosis, onychomycosis, and warts (Beauchamp et al. 1992). 1.4 Environmental occurrence Glutaraldehyde does not appear to occur naturally. It may be formed in air by the reaction between cyclic alkenes and ozone and hydroxyl radicals (Beauchamp et al. 1992), however, no concentrations are given. 1.5 Environmental fate Air No information has been found. Water/ waste water In the DOC die-away-test carried out according to EU guideline, there was a 90-100% biodegradation of glutaraldehyde after 28 days (IUCLID 1996). The elimination rate of glutaraldehyde in industrial sewage was concentration dependent with 30-60 mg/l being eliminated 100% after 5 hours and 300 mg/l being eliminated < 20% after 7 days (IUCLID 1996). Bioaccumulation In a test for bioaccumulation using Escherichia coli and incubation for 30 minutes at pH = 4 and concentrations of 0.1-0.4 mg/l of glutaraldehyde, the bioaccumulation was linear with 0.03 mg/mg (dry weight) at the lower concentration of 0.1 mg/l and 0.13 mg/mg (dry weight) at the concentration of 0.4 mg/l. (IUCLID 1996). 1.6 Human exposure Humans can be exposed to glutaraldehyde in numerous clinical and occupational settings, as indicated by its many different uses. In Germany, exposure to glutaraldehyde was determined in hospital operating and patients rooms, where cleaning solutions containing glutaraldehyde were used. When a cleaning solution containing 0.025% glutaraldehyde was used, the TLV (0.2 ppm, 0.8 mg/m3) was not exceeded. However, when a cleaning solution containing 0.15% glutaraldehyde was used, 0.57 ppm (2.4 mg/m3) glutaraldehyde was detected in the air. (Binding & Witting 1990 - quoted from Beauchamp et al. 1992). In two Swedish hospitals, where a 2% alkaline glutaraldehyde solution was used to disinfect equipment, the exposure levels ranged from <0.01 to 0.57 mg/m3, with most of the measurements being in the range of 0.02 to 0.14 mg/m3 (Norbäck 1988).
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