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Survey and Health Assessment of Possible Health Hazardous Compounds in Proofing Sprays

Enclosure 1: Report from the Danish Poison Information Centre

Lung injuries from proofing sprays

Ole Lyngenbo, John Bang, Peter Jacobsen

Bispebjerg Hospital, Clinic for Occupational and Environmental Medicine and Danish Poison Information Centre.

Summary

Sprays for proofing of textile, ceramics and other surfaces can involve respiratory disease, ranging from slight irritation to diffuse pulmonary involvement with infiltrates on x-ray and reduced oxygenation. General malaises, non-specific symptoms from the central nervous system and gastro-intestinal tract are other common features.

84 cases were identified retrospectively through the Danish Poison Centres databases from the period January 1. 1991 till May 31. 2007. Analyses were largely descriptive and included frequencies, time trends and association between product types and severity.

Respiratory effect was present in most patients (92%). The majority of these also had general symptoms including fever, general malaise, gastrointestinal upset and symptoms from the central nervous system. In a large proportion of the patients symptoms did not start until some time after cessation of exposure, typically min.  up to one hour.

Reduced oxygen saturation was present in 19 out of 47 cases with available data. Pulmonary changes on x-ray were reported in 13 of 30 patients. The severity was estimated as moderate/severe for 58% of the cases, mild for 37% and as no poisoning for 4%. One case could not be classified. Severity was significantly associated with spraying of furniture (p=0,001). Follow up through hospital records was successful for 33 patients (39%), of these 20 were graded with moderate/severe and 13 with mild poisoning.

Conclusions: Aerosol sprays for surface coating have a potential for causing lung disease including severe morbidity. The cause and mechanism of this effect is not known and prevention of the problem is not straightforward. Future analytical and experimental studies should both consider the chemical composition and aerosol properties.

Introduction

Recommended use of ordinary consumer product does rarely cause serious harm. One exception is sprays for proofing of textile, ceramics and other surfaces, which for some decades regularly have been involved in outbreaks of acute pulmonary illness (1,2,3,4). Both small series and outbreaks with more than 100 victims associated to a single product have been reported (4,5,6). From Denmark information on 3 outbreaks with limited numbers of victims have been published (2,7,8).

Respiratory disease, ranging from slight irritation to diffuse pulmonary involvement with infiltrates on x-ray and reduced oxygenation has been the most common manifestation. General malaises, non-specific symptoms from the central nervous system and gastro-intestinal tract are other common features. Two cases with fatal course due to complicated respiratory illness have been reported (9,10).

Fluorcarbon polymers, silicone compounds, solvents and other components have been suggested to cause the pulmonary effect (7,11,12,13,14). However, none of these components have been present in all instances and usually the sprays do not induce harm. Thus, the cause and mechanisms of the diseases remains unknown and its also unknown why small changes in the composition of a product may change the associated risk (7,11).

The latest Danish outbreak involved 16 cases associated to use of a product based on Fluoracrylates and Cyclosiloxanes as active ingredients. The product had been sold for several years without apparent problems, and chemical analyses detected dodecyl acrylate (CAS: 2156-97-0) in high concentration. A component that could not be demonstrated in previous production series but on the other hand not has a strong potential for respiratory toxicity.

In order to obtain more information on the risks associated with proofing products the Danish EPA has initiated of studies on chemical composition and toxicology of the products and of disease associated with them. The present study represents the clinical epidemiology of pulmonary injuries associated with the use of proofing agents sold on the Danish market. It is based on data from the Danish Poisons Information Centre, which has poisoning surveillance as one of its aims.

Methods and data

Cases were identified retrospectively through the Danish Poison Centres databases from the period January 1. 1991 till May 31. 2007. After case identification the original records were retrieved and information was extracted from these. Additional information on clinical course and outcome of the poisoning was obtained through hospital discharge records when possible.

For the last five months in 2005 and the first five months in 2007 the retrospective case identification was substituted by active surveillance and expanded data collection through the poison centres ongoing activities. The background for this was an outbreak of lung injuries associated with aerosol sprays in 2005 and an effort to get better data for the present study.

Cases were defined as individuals presented to the poison centre with acute exposure to a product for surface proofing in an aerosol spray.

The databases were searched with phrases expected to identify this kind of products and substrings of the phrases in order to catch different spelling. Additional searches were performed using commercial names of identified brands and also using substrings of these names.

Information on product, exposure, demographic characteristics and clinical condition of the patient was extracted from the original record. Exposure was assessed using several parameters: Volume, number of containers used for proofing, object sprayed, time spraying, indoor/outdoor and ventilation.

However, this information had not been systematically collected, why an additional and simple exposure measure was constructed. In this exposure was classified as small when the treated object was small like shoes and when larger objects had been treated for short time (< 2 min. ) in good ventilation. All other exposures were classified as moderate/large or unknown.

The severity was classified as no poisoning when there was no indication of an effect, mild when symptoms were expected to disappear without treatment and moderate/severe when treatment was judged necessary. The basis for this classification was the original assessment and available clinical and Para clinical data. When follow up in hospital records with facts about the actual course was available, outcome was classified in the same groups.

Analyses were largely descriptive and included frequencies, time trends and association between product types and severity. As statistical test chi square test was applied with a 5% level for statistical significance.

Results

The search identified 126 potential cases. After exclusion of 42 cases with exposure to products not fulfilling the definition and cases that only had eye exposure, 84 cases remained for analyses.

Characteristics of the cases are shown in table 1. The majority were middle aged and young adults who had been exposed by their own spraying at home. Only one case had been exposed during professional work. Two puppets – the only non-human exposures - 4 children below 10 years and one adult had been exposed from other peoples work (passive exposure).  All cases were accidentally exposed, i.e. not by sniffing or other intended exposures.

Table 1. Main attributes of 84 cases with accidental poisoning from proofing sprays. Number of cases with available data in ( )

Information on the intended use of the products was available for 78 cases. Sprays for furniture proofing were by far most prevalent, table 2. Of these products 9 were meant for leather, 37 for textile surfaces and 7 were unclassifiable in this respect. Some information on composition was available for half of the products. Fluorinated carbon compounds were the most common active ingredients, but also silicone compounds and in some products both ingredients were used.

Table 2. Intended use of proofing sprays involved in accidental poisoning.

Brand names were available for 64 products. Three brands for furniture proofing included 47 of these products, appendix 1.

The available information on quantitative exposure is presented in, table 3. Only for type of object and indoor/outdoor exposure was information available in more than 50% of cases.

Table 3. Information on quantitative exposure to proofing sprays.

Following the constructed measure exposure was small for 10 cases, typically for proofing of shoes and clothes and moderate for 50 cases. Data were insufficient for a realistic exposure assessment for 24 cases.

Clinical effects

The clinical information is summarized in table 4. Respiratory effect was present in most patients (92%). The majority of these also had general symptoms including fever, general malaise, gastrointestinal upset and symptoms from the central nervous system. In a large proportion of the patients symptoms did not start until some time after cessation of exposure, typically min.  up to one hour.

Reduced oxygen saturation was present in 19 out of 47 cases with available data. Pulmonary changes on x-ray were reported in 13 of 30 patients, table 4.

Table 4. Clinical data on 84 cases accidentally exposed to proofing sprays.

The severity was estimated as moderate/severe for 58% of the cases, mild for 37% and as no poisoning for 4%. One case could not be classified. Severity was significantly associated with spraying of furniture (p=0,001). Follow up through hospital records was successful for 33 patients (39%), of these 20 were graded with moderate/severe and 13 with mild poisoning.

Time trends

Figure 1 shows a non-regular distribution over the period with clustering in 2005 – 2007.  A smaller cluster around 1995 is also indicated. Figure 2 shows that the clusters largely are explained by cases associated with 3 brands. Also the group of other and unknown brands seems to increase in 2006 and 2007.

Figure 1. Time trend for poisoning with proofing sprays: Jan 1991 - May 2007. (Note: Only 5 months in 2007)

Figure 2. Time trend for poisoning with proofing sprays, distributed on brand and year: Jan. 1991- May 2007.

Discussion

The present study demonstrates that a wide range of spray products for surface proofing can cause lung injury and other health effects with ordinary use. Products for furniture dominate but this may have several interpretations: A greater exposure when treating such object or differences in chemical composition or physical properties of the products.

A toxicological interpretation is not possible with the lacking information on composition of the majority of products. A Fluorinated compound as active ingredient was present in most products for which information was available, but also products based on silicones alone was implicated.

Several different changes in chemical composition of spray products have increased the associated risk (7,11,12,13,14).  This could be interpreted in favour of a significant role for the products physical (aerosol) properties; interaction between chemical and physical properties of the sprays might be responsible for the increased risk.

The epidemiological characteristic of outbreaks was confirmed in this study ranging more than 16 years. Three different brands for furniture proofing were responsible for 45 of sixty-four cases for which the brand name was known. One of the brands was associated with a small increase in incidence in the mid nineties. The two other brands were involved in an outbreak that started abruptly in 2005 and seems still to be going on.

The outbreaks are related to sprays for furniture. However there may be a general increase in pulmonary injuries from sprays since 14 of twenty-four cases associated with product for other use than furniture proofing occurred within 2006 and 2007. Four cases caused by products for ceramic surfaces occurred in 2007.

The total number of inquires per year to the Danish Poison Centre has increased through the period under study from approximately 1500 in the early 1990ies to a little more than 2500 in 2005. In 2006 the number doubled by the change of the centre from a doctors only to a centre open to the general public in mid August 2006.

However adjusting for increase in contacts will not smooth the outbreaks out, especially not if particular brands are considered. The relative severity of the cases and their close association to the use of a consumer product makes contact to the poison centre likely both from the public and from physicians. Thus we find it reasonable to believe that the variations in poison centre cases represents true variations in incidence.

Although the occurrence in outbreaks indicates a significant role for the product as such other factors might also influence the incidence. Fore instance increase in use of the products or change in the purposes for which they are used. We have no information about these parameters, but statistics on sale of the products and information about recommended or suggested use from producers and dealers might help.

In this study more than one fifth of all cases had reduced oxygen saturation and one in six had pulmonary infiltrates or other changes on x-ray. Although the majority of cases only had a moderate or less severe course this indicates potential for more severe diseases in concordance with reports of ARDS and even deaths from other countries (14,15,16).

If prevention measures are not succeeded in short time, a shift to alternative forms of administration (others than spraying) must be considered and discussed. The non-professional use of aerosol sprays for surface coating of furniture must  - because of the risk for severe lung disease - be avoided.

Conclusions

• Aerosol sprays for surface coating have a potential for causing lung disease including severe morbidity.
• The cause and mechanism of this effect is not known and prevention of the problem is not straightforward.
• Future analytical and experimental studies should both consider the chemical composition and aerosol properties.

References

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       waterproofing sprays: Some UK experience. Thorax (online)

       http://thorax.bmj.com/cgi/eletters/59/6/541-a.

11.  Groot R de, Vries I de, Meulenbelt J. Sudden increase of acute respiratory illness after using a spray product to waterproff clothing and shoes. (Abstract 45, Eapcct congress Strasbourg 2004).

12.  Woo OF, Healey KM. Chest pain and hypoxemia from inhalation of a trichloroethane aerosol product. J Toxicol Clin Toxicol 1983; 20: 333-41.

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Version 1.0 October 2008, © Danish Environmental Protection Agency