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Priority Existing Chemical Assessment Reports - Glutaraldehyde
Introduction Glutaraldehyde (CAS No. 111-30-8) was declared by the Minister for Industrial Relations as a priority existing chemical by notice in the Chemical Gazette of 2 March 1993. Importers of glutaraldehyde and products containing glutaraldehyde were obliged under section 55 of the Industrial Chemicals (Notification and Assessment) Act 1989 to apply for its assessment. Glutaraldehyde is not manufactured in Australia. Information for the assessment was obtained from the applicants for assessment, end-users of glutaraldehyde, State and Territory government departments and the scientific literature. Applicants
Chemical Identity Glutaraldehyde is listed on the Australian Inventory of Chemical Substances (AICS) as pentanedial. Its IUPAC name is 1,5-pentanedial. Trade names for products containing glutaraldehyde include the following: Actisan Uses Glutaraldehyde has the following uses in Australia:
In Australia, it is estimated that glutaraldehyde is disributed in end-use as follows:
Glutaraldehyde has also been reported to be used overseas as:
Physical And Chemical Properties Glutaraldehyde is a colourless oily liquid. In Australia it is commercially available only as an aqueous solution at concentrations up to approximately 50% w/w. In the vapour state, glutaraldehyde has a pungent odour, with an odour threshold of 0.04 ppm. Where information has been available, the physical and chemical properties for glutaraldehyde as a pure chemical and as a 50% w/w solution have been listed below. For some properties, data was available only for aqueous solutions of glutaraldehyde, for example, vapour pressure and partition coefficient. Physical Properties
(Note: n.a. = not applicable) Chemical PropertiesSolubility soluble in all proportions in water and ethanol; soluble in benzene and ether Hydrolysis stability decreases with increasing pH
Partition coefficient log P = -0.01 for a 50% Dissociation constant not applicable, as glutaraldehyde is non-toxic and would not be expected to dissociate in water Adsorption/desorption Test results indicate moderate sorption to, and moderate mobility in, sandy loam, silty clay loam, silt loam and loamy sand soils, grading to weak sorption and high mobility in sandy sediment. Desorption coefficients were not determined due to instability of glutaraldehyde under the test conditions. Little or no desorption occurred during a 24 hour desorption phase. Glutaraldehyde undergoes chemical reactions typical of aldehydes. It also cross-links with proteins and, in aqueous solutions, it partially polymerises to give oligomers. Health Effects Human Health EffectsHuman evidence has shown that glutaraldehyde is an irritant to the skin, eyes and respiratory system, with the effects consistent with those revealed in animal testing. Many cases of dermatitis have been reported for workers exposed to glutaraldehyde solutions, usually 2% or higher. Facial dermatitis has resulted from the use of glutaraldehyde in spray form. Irritation of the nose and throat and general tightness of the chest have been experienced by workers exposed to glutaraldehyde vapours. In a study of Swedish hospital workers, nose and throat irritation was experienced at vapour concentrations below 0.2 ppm. Human evidence indicates that skin and respiratory irritant effects are exacerbated on repeated exposure to glutaraldehyde. Human evidence and patch testing have shown that glutaraldehyde is a skin sensitiser. Photosensitisation testing on volunteers did not produce a phototoxic or photoallergic response. A number of reports of occupational asthma and/or rhinitis in workers exposed to glutaraldehyde have produced concern that glutaraldehyde may be a respiratory sensitiser. In the absence of adequate case reporting or an identified immune mechanism, it is difficult to say definitively that glutaraldehyde is a respiratory sensitiser, and there is debate on whether the symptoms are due to an irritant or an allergic respiratory response. However, in the United Kingdom, glutaraldehyde has been added to the indicative list of respiratory sensitisers. Further studies are required into the mechanism and cause of occupational asthma in workers exposed to glutaraldehyde. Limited epidemiological data is available on the long-term effects of glutaraldehyde, and only the irritant and skin sensitising effects of glutaraldehyde have been confirmed. There was no evidence of adverse reproductive health effects on exposure to glutaraldehyde, consistent with the results of animal testing. A mortality study did not reveal any increase incidence of cancer deaths. Results of Animal and In Vitro TestingAnimal studies indicate that the oral LD50 of glutaraldehyde in rats, mice and guinea-pigs is approximately 50 - 250 mg/kg, and that the acute dermal toxicity in rabbits, rats and mice is approximately 1000 - 4500 mg/kg, with skin absorption at high concentrations. Glutaraldehyde has a high acute inhalational toxicity in rats and mice, and lung damage has been reported. Four-hour LC50 values of 23.5 and 40.1 ppm have been obtained for the male and female rat respectively, but the glutaraldehyde solution had to heated in order to generate glutaraldehyde vapour at high enough concentrations. Repeat acute inhalational toxicity studies at both ambient and elevated temperatures are being carried out. Glutaraldehyde is corrosive to the skin and eyes of rabbits at high concentrations, with signs of skin irritation evident at 2%, and eye irritation at 0.2%. Exposure to glutaraldehyde vapours resulted in nasal irritation and respiratory difficulties. Joint irritation was seen in rabbits after intra-articular administration. The skin sensitisation effect of glutaraldehyde was demonstrated in tests with guinea pigs. Short term (9-day or 2-week) repeated dose inhalational rat studies resulted in significant mortality at approximately 2 ppm v/v, and nasal irritation at levels down to approximately 0.2 ppm. Lesions of the nasal cavity and larynx were observed at 0.5 ppm and, in the 9-day study, atrophy of the liver was observed at 3.1 ppm. Signs of irritation included laboured breathing and discharge and encrustation around the eyes and nose. In two subchronic (13-14 weeks) rat studies, signs of nasal irritation were observed at lower concentrations, with a no-observed adverse effect level (NOAEL) of 125 ppb v/v in one study and signs of irritation at 49 ppb in the other. In corresponding 2-week and 13-week studies in mice, mortality occurred at 1.6 ppm and 500 ppb respectively, with signs of nasal irritation observed at the lowest dose (62.5 ppb) in the 13-week study. The results highlighted the toxicity and irritancy of glutaraldehyde by inhalation at low vapour concentrations, and the harmful effects of repeated or prolonged exposure to the vapours. A short-term dermal study showed that cumulative toxicity and mortality may occur by repeated skin contact to 25% to 50% glutaraldehyde, but there was no evidence of cumulative toxicity at 5% or less. A subchronic drinking water study in rats indicated some toxicity at 1000 ppm w/v, and a physiological response at 250 ppm. Reductions in food and water consumption and a dose-related effect in kidney weight were observed, but as drinking water studies at high concentrations are generally hampered by a natural aversion of the animals to the taste/odour of glutaraldehyde, the significance of these results is low. A 2-year drinking water study in rats resulted in an increased incidence of large granular lymphatic leukaemia (LGLL) in the liver and spleen of females only at all dose levels (50 - 1000 ppm), but the finding was not conclusive as the strain of rats used in the study has a high natural susceptibility to LGLL and variation in control data existed within the study laboratory. Repeated oral doses given during pregnancy to rabbits, rats and mice caused embryotoxicity and foetoxicity, but only at maternally toxic doses. No teratogenic effects were observed. Early mutagenicity studies were negative, but more recent studies have indicated that glutaraldehyde is mutagenic in vitro in bacterial assays and tests in mammalian cells. In vivo genotoxicity tests to date have proven negative. In view of the information gaps in the toxicity profile for glutaraldehyde, additional information is required in the following areas:
Occupational Health And Safety Assessment Occupational ExposureWorkers may be exposed to aqueous solutions of glutaraldehyde from 50% to less than 1% by skin contact and by inhalation of the vapours liberated from the solutions. Glutaraldehyde has a low vapour pressure over its aqueous solutions, but nonetheless adverse health effects have been observed. The risk of exposure to glutaraldehyde vapours is enhanced at higher temperatures and/or concentrations. A large number of workers are potentially exposed to glutaraldehyde in Australia, mostly in the health care industry, where workers such as endoscopy nurses and technical assistants in hospitals may be exposed to 1% and 2% solutions. Workers such as radiographers may be exposed to higher concentrations through the use of glutaraldehyde in x-ray film processing developers. It is estimated that approximately 75% of the glutaraldehyde use in Australia is in the health care industry. Occupational exposure to glutaraldehyde also occurs through its use in tanning, water treatment, animal housing and electron microscopy and through its use as a general biocide but, in general, the number of workers exposed in these industries is relatively low. FormulationMost of the glutaraldehyde products used in Australia are formulated here from 50% glutaraldehyde imported from overseas. The mixing of glutaraldehyde and other ingredients is usually carried out in a sealed system, but handling and packaging of the diluted product is usually more open and several workers may be involved Spillage is more likely to occur during this latter stage of the process. In general, the risk of adverse health effects in formulation is low due to enclosure of the process, the low number of workers potentially exposed, and the low frequency of production. The risk is enhanced if the mixing process is not enclosed, especially if formulation is carried out at an elevated temperature. Cold DisinfectionGlutaraldehyde is used as an activated 1% or 2% aqueous solution for the disinfection of medical instruments such as endoscopes. The number of workers exposed is high, as virtually all the large hospitals and many other health care establishments use glutaraldehyde solutions in disinfection. The frequency of use is high in some workplaces and the degree of control measures in place in Australia to reduce exposure is extremely variable. Some workplaces have provided little in the way of efficient fume extraction, but others have introduced effective control measures such as fume cupboards and automatic instrument washing machines to significantly reduce exposure and the incidence of adverse health effects. X-Ray Film ProcessingExposure to glutaraldehyde in x-ray film processing is complicated by the simultaneous exposure of workers to other hazardous substances in the processing solutions. The frequency of exposure is high in many workplaces, the degree of control extremely variable, and workers may be exposed to solutions containing up to 50% w/v glutaraldehyde. The introduction of automatic film processors has reduced exposure, but the risk of adverse health effects is still significant for those workers involved in the mixing of solutions, due to exposure to high concentrations of glutaraldehyde and the poor level of control still apparent in many workplaces. The risk to workers handling the dilute working-strength solutions only is significantly lower. TanningA small number of tanneries use glutaraldehyde and few workers are potentially exposed, so the incidence of adverse health effects is low. However high concentration solutions are used, the tanning is often carried out at elevated temperatures, and the level of control is often poor, so the risk of adverse health effects for those workers involved is significant. Water TreatmentThe use of glutaraldehyde in water treatment is generally well-controlled, with few workers involved and solutions used in small quantities and generally at low concentrations. The most significant risk occurs during dilution of the concentrated glutaraldehyde stock solutions. Animal HousingThe total number of workers involved in the use of glutaraldehyde in the animal health industry is low, with the workers generally exposed to low concentration solutions of glutaraldehyde unless dilution is being carried out at the site of application. However the solutions may be used in spray form, significantly increasing the risk of exposure. Other usesOccupational exposure to glutaraldehyde in other areas is low and generally low strength solutions are used in small quantities, for example, in microscopy, in aircraft and portable toilet sanitation and in conveyor chain lubricants. The use of glutaraldehyde in aquaculture in Australia has been reported, but no information was available from the applicants. Public Health Assessment In general, public exposure to glutaraldehyde is minimal, with the public unlikely to be exposed during its routine importation, transportation and formulation, and during its use in x-ray film processing, tanning, water treatment and animal housing. Direct exposure is a possibility in health care establishments if cleaning and rinsing is inadequate and if spillage occurs in patient areas. Public exposure is also a possibility in premises after air duct disinfection if ventilation after the fogging process is inadequate. Environmental Assessment Environmental FateUse of glutaraldehyde entails exposure of aquatic and atmospheric compartments. Waste glutaraldehyde solutions are disposed of to sewer. This provides a route for glutaraldehyde to enter the aquatic environment when residues that may remain in treated sewage effluent are discharged to receiving waters. Glutaraldehyde's main application, as a cold disinfectant for use in such facilities as hospitals, surgeries and medical clinics, entails discharge of significant quantities to sewer as solutions that are disposed of retain at least 50% of their activity. Such disposal will occur predominantly in metropolitan areas. Smaller discharges to sewer will occur from x-ray film processing, water cooling treatment and tanneries use. Five-day biological oxygen demand and aquatic metabolism studies indicate that glutaraldehyde degrades readily. Accordingly, significant degradation is expected during passage through sewage treatment works. Reaction with proteins present in sewage effluent will also remove significant amounts from aqueous waste streams. Any glutaraldehyde that may enter receiving waters is likely to be rapidly diluted and undergo further biodegradation. Small amounts of glutaraldehyde will volatilise to the atmosphere. Glutaraldehyde used as a biocide in cooling systems will be entrained in water cooling tower drift. However, glutaraldehyde is not expected to persist in the atmosphere as it is subject to direct photochemical transformation and photo-oxidative degradation (reaction with hydroxyl radicals) in that compartment. In addition, the hydrophilicity of glutaraldehyde will ensure its removal through dissolution in rain. Environmental EffectsGlutaraldehyde loses biocidal activity at below 10 mg/L. Accordingly, impacts on sewage microbes are not expected provided that levels in sewage treatment works remain below this limit. However, glutaraldehyde must not be discharged into septic tanks as it may render essential bacteria inactive. Test reports indicate that glutaraldehyde is slightly to practically non-toxic to birds, slightly toxic to crabs, shrimp and sewage micro-organisms, slightly to moderately toxic to fish and Daphnia, moderately toxic to oyster larvae, and moderately to highly toxic to algae. Environmental HazardAs noted above, glutaraldehyde will undergo reaction with proteinaceous components of sewage effluent and biodegradation by sewage micro-organisms. With allowance for dilution by other waste streams, it is estimated that the concentrations of glutaraldehyde in sewage treatment plants will remain below 200 ug/L. Such levels do not constitute a significant environmental hazard, and will be reduced further by biodegradation during sewage treatment. Small amounts of glutaraldehyde will also be emitted to the atmosphere. Atmospheric hazard is low because of instability and a short residence time in this compartment. Conclusions
Recommendations Glutaraldehyde has a number of hazardous properties to justify its classification as a hazardous substance according to the Approved Criteria for Classifying Hazardous Substances (see below). Under the National Commission's Control of Workplace Hazardous Substances: National Model Regulations and National Code of Practice, duties are placed on suppliers, employers and employees regarding the provision of information, assessment of the workplace, and the implementation and operation of proper control measures. As all States and Territories are committed to adoption of the regulations for workplace hazardous substances, it is recommended that suppliers and employers fulfil their obligations under the regulations in a manner consistent with the recommendations in this report. The recommendations have been framed to assist with the implementation of these model regulations and therefore they cover matters such as information provision and suitable control strategies in the various industries where glutaraldehyde is used. Hazard Classification The classification of glutaraldehyde at various concentrations in accordance with the Approved Criteria is based on the assessment of the health effects of glutaraldehyde at those concentrations. Glutaraldehyde is commercially available in Australia at concentrations up to approximately 50% w/w, so the recommended classifications and corresponding risk phrases for these mixtures are tabled below. In the classification of glutaraldehyde products which contain other hazardous substances, for example, x-ray film processing solutions, the health effects of all the ingredients need to be taken into account. It is recommended that suppliers incorporate the health hazard information consistent with the classification of glutaraldehyde in their material safety data sheets (MSDS) and labels. The evidence for the respiratory sensitising effect of glutaraldehyde is not sufficient to recommend classification under the Approved Criteria, but it is recommended that the position be further reviewed, particularly when the criteria for respiratory sensitisation are amended by the EEC, and if evidence becomes available to confirm a respiratory sensitisation effect. Similarly, the acute inhalational toxicity classification should be reviewed when more data is available. It is recommended that the risk phrases determined from this assessment report be added to ASCC's List of Designated Hazardous Substances in order to assist implementation of the Model Regulations. Table - Classification at Various Concentrations
Hazard CommunicationLabels and Material Safety Data SheetsA survey of the labels and material safety data sheets (MSDS) of glutaraldehyde-containing products indicated that many were below the standard normally considered appropriate under the ASCC codes of practice. It is recommended that:
It is also recommended that the following statements be included on MSDS for glutaraldehyde products:
In view of the differing labelling requirements for some products under the various codes and schedules, it is recommended that the relevant regulatory authorities use this assessment report on the hazards of glutaraldehyde as a basis for reviewing their labelling requirements. Such a review is particularly necessary in the case of the SUSDP where no warnings of sensitisation or corrosivity are currently required. A small number of glutaraldehyde-containing products are sometimes used in spray form, which significantly increases the risk of exposure unless proper precautions are taken. It is recommended that the use of glutaraldehyde-containing products in spray form be reduced as much as possible. However where spray use is still necessary, it is recommended that the product should carry an appropriate warning such as the following on the label: CAUTION: AVOID BREATHING SPRAY, and that the proper control measures and that should be implemented. Other Information For the health care industry, it is recommended that safe use guidelines, similar in style to those available in some States, be provided in each of the States and Territories. The guidelines should include information about the health effects of glutaraldehyde and detailed guidance on the control measures available to minimise exposure (see Control of Occupational Exposure below). It is also recommended that safe use guidance be provided for the use of glutaraldehyde in dentistry. In other industries, some end-users are not aware of the health effects of glutaraldehyde nor the hazards present during its use. Therefore industry specific safe use guidelines, similar in style to those available for the health care industry, are recommended for the tanning, animal housing and water treatment industries. For the other minor uses of glutaraldehyde, for example, in microscopy, in toilet sanitation and in air duct disinfection, guidance material from suppliers is recommended for availability at each workplace. For the sake of uniformity, it is recommended that wherever possible the guidelines be produced for use on a national basis. Training and EducationIn accordance with the national model regulations, workers potentially exposed to glutaraldehyde need to be trained in the safe work practices which are appropriate to their particular workplace, and that a record of training be kept. Because of the incidence of adverse health effects occurring in the past and the widespread use of glutaraldehyde in a number of different industries, the training should be as specific as possible. Use of information in the safe use guidelines for that industry is recommended to facilitate those training needs. Control of Occupational ExposureAs glutaraldehyde is a hazardous substance, it is recommended that worker exposure should be reduced as much as possible by the implementation of effective control measures in accordance with the hierarchy of control measures detailed in the National Model Regulations and Code of Practice for the Control of Workplace Hazardous Substances. Where the replacement of glutaraldehyde may be considered in some application, the health effects and hazards of any substitute need to be taken into account to ensure that glutaraldehyde is not being replaced by a more hazardous substance. Where possible, control measures, especially engineering controls, should be implemented at the design stage. Engineering controls such as ventilation should be installed by qualified professionals to ensure that specifications and Australian standards are met and that any new installation is compatible with existing systems. It is recommended that all workplaces handling glutaraldehyde employ safe work practices to minimise exposure during routine operations, and to quickly reduce exposure in the case of spillage or during maintenance. Good housekeeping and personal hygiene is required in all workplaces. Where other control measures are inappropriate or impractical, then personal protective equipment (PPE) must be used. If PPE is to be used, then it should be selected and maintained in accordance with the relevant Australian Standards. The type of personal protection must be appropriate to the concentration of glutaraldehyde in the product and to the particular use of the product. PPE must be properly stored and maintained. Recommended control measures by use and industry are detailed below. Formulation of Glutaraldehyde Products As glutaraldehyde is usually handled in large quantities and as a concentrate in the formulation of glutaraldehyde products, it is recommended that the process be enclosed, with the mixing vessel and glutaraldehyde transfer system sealed. The discharge of product, for example, to a filling line, should also be enclosed as much as possible. If this is not achievable, then local exhaust ventilation is required. Good dilution ventilation in accordance with Australian Standards is necessary in all production areas, with each ventilation rate having the capacity to be increased substantially in case of spillage. All ventilation systems must be regularly examined, tested and maintained. Total loss ventilation is recommended, but if the use of recirculated air cannot be avoided, filters, for example, carbon adsorption, must be used. If carbon filters are used, their performance must be monitored to ensure that they are replaced before chemical breakthrough occurs. In production areas, procedures must be in place to handle spills and leaks. If required, personal protective equipment (PPE) should consist of the items listed below for the use of glutaraldehyde as a disinfectant. If PPE is required in handling glutaraldehyde concentrate, then goggles, long gloves, overalls and respiratory protection are essential. Use as Cold Disinfectant All instruments and equipment must be thoroughly cleaned before disinfection with glutaraldehyde. Elimination or Substitution The use of glutaraldehyde in general surface disinfection, for example, the cleaning of bench-tops, is not recommended, so it should be eliminated where possible by more thorough cleaning with soap and water or replaced by a non-hazardous substance. The substitution of glutaraldehyde should be approached with caution, as many of the alternatives are hazardous substances and/or less efficacious against micro-organisms. Enclosure Where possible, it is recommended that the disinfection of instruments such as endoscopes be fully enclosed, for example, by the use of automatic washers. Automatic equipment must be properly maintained in accordance with the manufacturer's specifications and instructions. Engineering Controls Where the purchase of automatic equipment cannot be justified, good local exhaust ventilation (LEV) is essential to minimise exposure. LEV for fixed work stations should consist of properly constructed and maintained fume cupboards. Mobile units must have lids or covers and be fitted with vapour extractors and carbon adsorption filters, which must be monitored to ensure that they are replaced before chemical breakthrough occurs. Good dilution ventilation to a standard consistent with the relevant Australian Standards is essential in all work areas. Safe Work Practices The following safe work practices are recommended for the use of glutaraldehyde as a disinfectant:
Personal Protective Equipment Personal protective equipment recommended for the use of glutaraldehyde disinfectant solutions are:
Use in X-ray Film ProcessingEnclosure Operations involving glutaraldehyde in x-ray film processing should be enclosed. Automatic mixers and automatic processors with exhaust outlets should be used where possible. Engineering Controls The exhaust air from automatic processors must be completely removed from the work area by connection to an exhaust ventilation system independent of the dilution ventilation system. Discharge should be to atmosphere at a safe location. If the use of an automatic mixer and/or processor is impractical or unjustifiable on economic grounds, then all mixing and processing operations involving glutaraldehyde must be carried out with effective local exhaust ventilation, preferably in a fume cupboard. Effective dilution ventilation is essential in all work areas, with the area under slightly negative pressure to prevent the escape of chemical vapours to adjacent work areas. To minimise evaporation of the chemicals, including glutaraldehyde, the dark room temperature and the processing temperature should be kept as low as possible whilst attaining the desired photographic results. Safe Work Practices Recommended safe working practices for the use of glutaraldehyde in x-ray film processing include:
Personal Protective Equipment Personal protective equipment (PPE) is required when filling, emptying or maintaining automatic mixers and processors and when working with solutions during manual operations. Eye protection and gloves should be worn at all times and respiratory protection is required during spillage and maintenance of equipment. The recommended PPE for the handling of x-ray processing solutions is:
Use in TanningControl measures similar to those used in the manufacture of glutaraldehyde products are required for the use of glutaraldehyde in tanning (see section 11.3.1 above). Mixing vessels should be covered and sealed if possible to minimise vapour generation. The transfer of glutaraldehyde to the mixer should proceed via a sealed system, and all operations should be carried out with good ventilation. Procedures for handling spills must be in place, and personal protective equipment (see 11.3.2 above) should be worn during all operations involving possible exposure to glutaraldehyde. Use in Water TreatmentThe addition of glutaraldehyde solutions to cooling water systems is generally carried out in the field. If automatic feed systems are used, then the proper safe handling procedures should be followed in filling and emptying the containers and connecting them to the dosing system. Manual dosing should be carried out wearing the proper personal protective equipment, that is, goggles, gloves, overalls and protective footwear. Respiratory protection is required if glutaraldehyde vapours are generated. The dilution of concentrated glutaraldehyde solutions should be carried out under proper local exhaust ventilation rather than at the site of water treatment. Use in Animal Housing The application of glutaraldehyde solutions in animal housing is generally carried out in the field, with the solutions used in spray form (see Training and Education above), as a wash, or as a foam. Recommended safe work practices for the use of glutaraldehyde as a wash or foam in animal housing are:
The following personal protective equipment to be worn during application as a wash or foam:
In the application of glutaraldehyde solutions in spray form, all the above safe work practices need to be followed, with additional care in the clearing of the work area of other workers and animals and birds. In addition to the PPE stipulated above, long-sleeved overalls and respiratory protection, for example, a half-face cartridge respirator, are required, with the type of respiratory protection dependent on the duration of application. The use of glutaraldehyde on animals or birds is not recommended. Atmospheric MonitoringWhere an assessment of the workplace indicates that there is a significant risk of exposure to glutaraldehyde, it is recommended that an atmospheric monitoring program for glutaraldehyde be implemented as a means of measuring occupational exposure and as a monitor of the effectiveness of control measures in the workplace. The program should be in proportion to the risk of exposure, taking into account the quantity and concentration of glutaraldehyde used, the frequency of use and the number of workers potentially exposed. Where the level of exposure to glutaraldehyde is not known, a small number of analyses is required initially to establish a baseline for assessment of the workplace and to determine whether improved control measures and/or regular monitoring are necessary. For example, no atmospheric monitoring results for exposure to glutaraldehyde in the tanning industry were available during the PEC assessment period. Where atmospheric monitoring is required, both personal and fixed-point monitoring should be carried out using proven analytical procedures. The frequency of monitoring required will also depend on the results obtained. Once control measures have been shown to be effective, then the frequency can be reduced. Emergency Response PlanIt is recommended that a written emergency response plan be provided in all workplaces where significant quantities of glutaraldehyde are used. DisposalIt is recommended that no special environmental controls beyond those that currently prevail across Australia are considered necessary. Spent solutions disposed of to sewer should be flushed with copious amounts of water. Glutaraldehyde must not be discharged to surface waters, storm water drains or septic systems. Regulatory Controls Exposure StandardThe current Australian exposure standard for glutaraldehyde, set by the National Commission, is 0.2 ppm v/v (0.82 mg/m3) as a peak limitation and with a sensitiser notation. The standard, which is based on the irritant effect of glutaraldehyde on the upper respiratory tract, has been listed for review since 1991. In view of the results of animal testing and the human experience, where irritant effects have been observed at or below the current exposure standard, particularly after repeated exposure, it is recommended that the following exposure limits for glutaraldehyde be considered by the ASCC Exposure Standards Expert Working Group in their review:
with a skin sensitiser notation. Health Surveillance It is not recommended that glutaraldehyde be added to Schedule of the National Model Regulations to Control Workplace Hazardous Substances, but under the regulations, employers will need to provide health surveillance in workplaces where the assessment shows that exposure to glutaraldehyde may result in a substance-related health effect such as contact dermatitis. As early diagnosis of glutaraldehyde-induced health effects is important, it is recommended that workers potentially exposed to glutaraldehyde should undergo a pre-placement medical check as a baseline to assist in identifying future signs of skin or respiratory disease. If the workplace assessment indicates that that health surveillance is required, then it is recommended that the following medical tests should be considered by occupational physicians:
So that an adequate record of occupational disease is compiled, it is recommended that cases of skin and respiratory disease in workers exposed to glutaraldehyde be fully evaluated and that the case studies be reported in the scientific and/or medical literature. Available case reports should be sent to Worksafe. Aquaculture Although not reported by any of the applicants during the assessment period, there is some evidence that glutaraldehyde may be used in aquaculture in Australia. It is recommended that the National Registration Authority for Agricultural and Veterinary Chemicals use the health and environmental effects information in this report to assist with any review of the use of glutaraldehyde in aquaculture. Further TestingIn carrying out the assessment of glutaraldehyde, some items of toxicological, ecotoxicological and technical information were unavailable, either because testing was not completed or because testing had not been carried out. It is recommended that testing be carried out, or completed, in the following areas:
Secondary Notification In the case of glutaraldehyde, secondary notification may be required if:
significant new information about the health and/or environmental effects of glutaraldehyde becomes available.
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