Ann. occup. Hyg., Vol. 47, No. 8, pp. 599-607, 2003
© 2003 British Occupational Hygiene Society
Published by Oxford University Press
Determinants of Dermal Exposure Relevant for Exposure Modelling in Regulatory Risk Assessment
1 TNO Chemistry, Department of Chemical Exposure Assessment, PO Box 360, 3700 AJ Zeist, The Netherlands; 2 Health and Safety Laboratories, Broad Lane, Sheffield S3 7HQ, UK
Received 20 January 2003; in final form 29 May 2003
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODSRESULTSDISCUSSION AND CONCLUSIONSREFERENCES |
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Risk assessment of chemicals requires assessment of the exposure levels of workers. In the absence of adequate specific measured data, models are often used to estimate exposure levels. For dermal exposure only a few models exist, which are not validated externally. In the scope of a large European research programme, an analysis of potential dermal exposure determinants was made based on the available studies and models and on the expert judgement of the authors of this publication. Only a few potential determinants appear to have been studied in depth. Several studies have included clusters of determinants into vaguely defined parameters, such as ‘task’ or ‘cleaning and maintenance of clothing’. Other studies include several highly correlated parameters, such as ‘amount of product handled’, ‘duration of task’ and ‘area treated’, and separation of these parameters to study their individual influence is not possible. However, based on the available information, a number of determinants could clearly be defined as proven or highly plausible determinants of dermal exposure in one or more exposure situation. This information was combined with expert judgement on the scientific plausibility of the influence of parameters that have not been extensively studied and on the possibilities to gather relevant information during a risk assessment process. The result of this effort is a list of determinants relevant for dermal exposure models in the scope of regulatory risk assessment. The determinants have been divided into the major categories ‘substance and product characteristics’, ‘task done by the worker’, ‘process technique and equipment’, ‘exposure control measures’, ‘worker characteristics and habits’ and ‘area and situation’. To account for the complex nature of the dermal exposure processes, a further subdivision was made into the three major processes ‘direct contact’, ‘surface contact’ and ‘deposition’.
Keywords: dermal exposure; risk assessment; exposure model; exposure determinants
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSION AND CONCLUSIONSREFERENCES |
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Exposure assessment is an important part of the risk assessment process. When actual data are missing for the situation to be assessed, modelling is usually done. For dermal exposure, only a limited number of models exists, e.g. EASE (ECB, 1996), US EPA (US EPA, 1987), EUROPOEM (EUROPOEM, 1996), but the validity of these models has not been extensively studied. One of the goals of the European Union funded RISKOFDERM project (project QLK4-CT-1999-01107) is to make a predictive model on dermal worker exposure to be used in risk assessments. The project is being carried out by 15 groups in 10 member states of the European Union and consists of four interdependent work parts:
- 1. qualitative assessment of dermal exposure;
- 2. quantitative measurements of dermal exposure;
- 3. modelling of dermal exposure for risk assessment;
- 4. a toolkit for risk assessment and management of dermal exposure in small and medium-sized enterprises (SMEs).
- 2. quantitative measurements of dermal exposure;
The work presented here is in the third part. Together with the results from the first two work parts (RISKOFDERM, 2001, 2002), this work will lead to a model (set) that will be benchmarked in field studies. The results from work part 3 have also been used for the development of the modifiers used for the simple toolkit in work part 4.
This publication is the second in a series of four. The general framework of the toolkit is described by Oppl et al. (2003). The other publications in this series (Warren et al., 2003; Goede et al., 2003) further supplement the development of the toolkit for work part 4.
A more detailed version of this paper is available online.
Models depend on knowledge of the determinants of the modelled parameter. Unfortunately, only a few determinants of dermal exposure have actually been studied and evaluated. The aim of this paper is to describe the analysis of potential determinants of dermal exposure and their influence on dermal exposure, based on the available information and expert judgement. Based on this analysis, the parameters relevant for dermal exposure modelling in the regulatory risk assessment process will be further defined and models will be constructed in future work anticipated for work part 3.
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METHODS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSION AND CONCLUSIONSREFERENCES |
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Dermal exposure depends on a complex set of processes. Determinants of exposure depend on the type of exposure process. To allow for this variability in exposure determinants, the mass transport processes in the conceptual model by Schneider et al. (1999) have been used to identify possible determinants for each of the processes of dermal exposure. The relevance of a determinant for dermal exposure depends, among other factors, on the process of mass transport through direct contact, deposition from the air and contact with contaminated surfaces. Contamination depends on the mass transport processes, although the underlying factors determining the amount of mass flow are not indicated in the conceptual model. The underlying factors are the actual determinants that can be observed in the workplace. These have been divided into six categories:
- substance and product characteristics;
- task done by the worker;
- process technique and equipment;
- exposure control measures;
- worker characteristics and habits;
- area and situation.
- task done by the worker;
An initial inventory of potential determinants was performed, using the conceptual model and the expert opinion and knowledge of experts in a brainstorming activity. The resulting long list of potential determinants is presented in an Appendix in the supplementary material to the online version of this paper. Published documents as well as unpublished reports were analysed for detailed information on the determinants. The analysis focused on the scientific evidence of the effect of a potential determinant and the direction of effect of the determinant. To structure the available information, all information on determinants was described with a focus on the following.
- The relation between the determinant and dermal exposure. Is it found to be significant or not, positive or negative, linear, exponential, logarithmic? Are there other influencing or confounding factors?
- The industries, processes and tasks that have been studied.
- The number of measurements performed and measurement method used.
- The duration of tasks and duration of measurements.
- The amount of substance handled or used during the task or process.
- The substance measured and possible physical or chemical properties that may influence dermal exposure.
- Any other factors that appeared to have influenced exposure.
- The industries, processes and tasks that have been studied.
The level of evidence for the influence of the determinants was described for each study. A description for each determinant was made, based on the presented strength and significance of the influence of a determinant and the power of the study. Combining this information with the experts’ opinion regarding scientific plausibility and the practicalities of obtaining relevant information led to a choice of parameters that should be included in a dermal exposure model. This final evaluation of relevant determinants of dermal exposure is used in the remainder of the RISKOFDERM project to build the dermal exposure model (set).
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RESULTS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSION AND CONCLUSIONSREFERENCES |
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A more detailed version of this section is available in the on-line supplementary material to this paper.
Some possible determinants or modifiers of dermal exposure have been studied relatively extensively. Others have received little attention so far. The results of the analysis of the literature and models can be summarized by category of determinants. In the process of summarizing, the participating experts have formulated conclusions regarding the relevance of potential determinants.
Substance and product characteristics
The effect of the physical state of a contaminant (i.e. is it a solid or liquid) on dermal exposure has clearly been demonstrated for a few activities, i.e. pouring and or mixing/loading of pesticides, or other direct contact exposure processes. For other processes the effect of physical state on dermal exposure is less clear, but should be considered carefully. Differences related to the physical state of a contaminant may have been incorporated into other characteristics, e.g. process or equipment. Only a few sources specifically compare exposure to solids and to liquids.
Only a few authors have studied the influence of percentage of the substance assessed (i.e. the concentration of the measured substance in a mixture that is used) on dermal exposure of either the specific substance or the product. In general, the percentage of the substance in a product has not been studied as a parameter as such, but has been used to calculate the total amount of substance handled. There is no strong evidence that the percentage of substance assessed has an important independent effect on exposure if its effect through the amount of substance used is already accounted for.
No data are available to draw conclusions on the influence of density of a product or substance on the level of dermal exposure.
Several aspects related to liquid characteristics, e.g. presence or absence of organic solvents, have been associated with the level of dermal exposure in a number of studies. Depending on the process of dermal exposure, organic solvent-based products tend to give higher exposure than water-based products (for aerosol deposition processes). For contact transfer processes higher viscosity resulted in higher exposure. For direct contact (immersion) such a difference was indicated, but not consistently. It is concluded that viscosity is a determinant of dermal exposure, but no clear indication can be given of the influence of liquid characteristics other than viscosity.
A positive linear relationship has been observed in a number of studies for direct contact processes between moistness of the soil and soil adherence. Particle size distribution affects dermal exposure. In direct contact processes an inverse relationship between dermal exposure and particle size has been shown. The same holds true for surface transfer processes. For aerosol deposition processes it has been shown that large particles show higher deposition velocities (potentially leading to higher exposures) compared with small particles. However, there is a very poor relationship between particle size of a product and particle size distribution of the aerosol generated by the dust generating process.
Tasks done by the worker
It is obvious that dermal exposure is determined by the tasks done by the workers. Many studies show that exposures vary with task. The differences between tasks are manifold and can be found in a variety of potential determinants of dermal exposure. Therefore, the fact that different tasks in general lead to different dermal exposure levels is not very helpful in constructing dermal exposure models, unless the underlying determinants that relate to the task and to dermal exposure can be found. Unfortunately, these underlying determinants have often not been studied.
For many exposure scenarios dermal exposure has been associated with the amount of substance handled. From the underlying studies it is obvious that a strong correlation exists between the amount of substance handled and duration of the task, and often also with other parameters. No studies have been identified that relate dermal exposure to amount of substance while keeping other parameters constant. Where the amount of substance handled and duration of the task are highly correlated, their effects cannot easily be separated. In these cases probably only one of these parameters should be included in an exposure model. Most of the reviewed studies show a better correlation with dermal exposure for amount of substance handled than for duration of task. Some of the studies indicate that for some exposure processes there is a non-linear relation between exposure and duration (of exposure), but most exposure models assume a linear relationship.
It is concluded that the amount of substance handled is not a relevant parameter as such for contact transfer processes. However, for some exposure scenarios, e.g. pesticide re-entry work, it will determine the level of contamination of the surface (dislodgeable foliar residue) and thus dermal exposure indirectly.
In several studies for aerosol spraying processes, spray volume, i.e. the amount of liquid sprayed, and the area treated have been suggested as determinants of exposure. These factors are closely related to the amount of substance handled and were found to contribute to the explained variation in multiple regression models. It is unknown whether these parameters are independent determinants of dermal exposure as such, if their effect on the amount of substance handled is already accounted for.
Intensity of contact has been identified frequently as a determinant of exposure, however, in many cases this was concluded based on the fact that different activities (that result in different dermal exposures) were assumed to differ in intensity of contacts. In such cases the difference can only truly be related to differences in tasks. In a few exposure scenarios related to direct contact or contact transfer processes, i.e. collection of bags, dumping of bags, numbers of crops harvested and direct contact, the frequency (or number) of contacts or events has been shown to be correlated with the level of dermal exposure. In several studies the numbers of treated objects handled, as a surrogate of frequency of contact, has been correlated with exposure for handling of treated (mostly sprayed) objects.
Duration of contact and exerted force were identified as relevant parameters for surface contact transfer processes, but only in experimental situations.
For contact transfer processes, e.g. pesticide re-entry activities, it has been shown in many studies that dermal exposure is (partly) determined by the level of contamination of the surface.
Some indications can be derived from a few studies that the size and the sort of material of the treated objects or area determine dermal exposure during spraying processes. However, size of objects seems to be related to (paint) spray technique, so no clear view can be achieved for the influence of size as an independent determinant of exposure. Similar considerations exist for the influence of the type of material that is often related to other potential determinants as well.
Process, technique and equipment
In general, many studies indicate that dermal exposure resulting from direct contact and deposition of aerosols is associated with the process and type of equipment or technique used. In most cases, however, this is based on the conclusion that process, equipment or technique A resulted in a different exposure than process, equipment or technique B. It is clear that this determinant is a very general and crude denominator of many underlying factors that cannot easily be specified.
Level of automation is obviously a probable determinant of dermal exposure. However, this was studied for only one exposure scenario where manual harvesting was compared with a partly automated process.
Orientation of the worker in relation to the application in a few studies has been shown to be a determinant of exposure during the aerosol deposition process, but does not appear to have been studied for other processes. Proximity of the worker to the source has not been extensively studied. However, it is obvious that this can be an important determinant of dermal exposure.
Since there is a relationship between spray pressure and initial aerosol diameter distribution generated during spraying processes and given the relationship observed between deposition velocity of aerosols and diameter, there are strong indications that spray pressure is a relevant parameter for dermal exposure for aerosol deposition processes. The limited results regarding spray pressure support these indications.
Exposure control measures
The use of personal protective equipment (PPE), i.e. (protective) clothing and gloves, decreases the level of (actual) dermal exposure substantially, as has been extensively shown in several exposure situations. It is obvious that PPE can only protect those areas of the skin that are covered by PPE. Therefore, although it has hardly been specifically studied, it is clear that the skin area covered by (protective) clothing and gloves is an important determinant of dermal exposure.
(Protective) Clothing and glove material have been proven to affect the level of protection afforded by the PPE, though mostly in experimental situations. Roughness of clothing affects the deposition of aerosols from air, but this observation has limited value for skin exposure.
An influence of maintenance, cleaning and changing of (protective) clothing or gloves on dermal exposure is to be expected, but no studies were found that looked at this aspect of clothing and glove use.
Technical control measures for spray processes, e.g. segregation and ventilation, have been shown to be determinants of exposure due to deposition of aerosols, but the data are limited. The available data are too limited to draw conclusions on local exhaust ventilation (LEV) as a parameter of exposure.
The level of contamination of crops with pesticides depends on the interval between application of the pesticide and measurement of the contamination. This indicates that organization of work can be a tool for exposure control in pesticide re-entry exposure scenarios. Timing of application affected both the level of contamination of the treated objects (area) and the transfer efficiency of the contaminant from surface to skin. In a more generic terminology, for the exposure process of contact with contaminated surfaces, this could be called the interval between the event of contamination and contact.
Worker characteristics and habits
Accuracy of working as a result of experience (and training) is indicated in a few studies as an important characteristic that affects dermal exposure. However, it is not clear whether it is the experience per se or another factor that influences dermal exposure. It is, for example, possible that experienced workers do not perform exactly the same tasks as less experienced workers.
It is to be expected that the posture or position of the worker may influence the dermal exposure levels. However, there is hardly any information on the influence of this aspect and no conclusion can be drawn.
Skin characteristics, roughness and electrical chargeability are strongly related to the aerosol deposition process, but the actual relation with dermal exposure is unclear, whereas moistness of the skin may determine the adherence of the contaminant to the skin for direct contact and surface contact transfer processes. The information on these parameters is too limited to draw conclusions.
Personal care and personal manner of work, including the manner in which gloves are used, are other factors that were identified by some authors to affect dermal exposure. It is highly probably that the correct use of gloves leads to lower dermal exposure than inadequate use of gloves.
Area and situation
In a limited number of outdoor studies, weather conditions, such as temperature and wind speed, were identified as potential modifiers of dermal exposure. Wind speed was shown to influence dermal exposure during spray generating processes, but the direction of the influence depends on the position of the worker and the source relative to the wind direction. Temperature was associated with dermal exposure in a single study.
Indications exist that crop height partly determines the exposure level in pesticide re-entry work. The information is too limited to draw clear conclusions.
Similarly, it has been suggested that work in confined spaces will lead to relatively higher dermal exposure levels. However, the available data for this aspect are also too limited.
Whether a task is performed indoors or outdoors may be a determinant of dermal exposure, as suggested by some studies. The actual influence of this aggregate determinant may result from factors such as orientation of worker, wind speed, humidity and rainfall.
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DISCUSSION AND CONCLUSIONS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSION AND CONCLUSIONSREFERENCES |
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Only a few of the parameters have been identified with little doubt to be independent determinants of exposure. Modelling dermal exposure has largely been based on commonsense rather than knowledge of the underlying processes or the results of experimental studies. The existing models, such as EASE and EUROPOEM, generally try to categorize work situations in a few, rather broad, categories of parameters. By using measured data from the categorized situations (EUROPOEM) or by using limited experimental data to fit into the structure (EASE) the models come to ranges of exposure in a kind of matrix of situations. Some of the determinants mentioned in this work are also included in these models, e.g. the percentage of active ingredient or the use rate. Other parameters in EASE are very unclear and not related to the process of dermal exposure (e.g. ‘use category’, which is divided into ‘non-dispersive use’ and ‘wide dispersive use’). One aim of the RISKOFDERM project is to provide a model (set) which is more based on actual determinants of exposure and which is more evidence based. Another aim is to provide a simple toolkit for risk assessment and management by SMEs. By considering the process of dermal exposure as a basis for determinants, a more general approach is possible compared with the rough categorization of tasks or unclear situations that is seen in some other models. The DREAM model, developed in The Netherlands, uses a similar approach (Van Wendel-de-Joode et al., 2003). However, DREAM results in relative and qualitative ‘values’ of dermal exposure and does not attempt to reach quantitative results that can be used in the scope of regulatory risk assessments. This work attempts to select parameters whose influence on dermal exposure can be used quantitatively in a model or model set.
Some of the proposed determinants are interdependent and they should not be included together in one model. The information on some determinants that are potentially relevant for mass transport to the skin may in practice be difficult, if not impossible, to obtain in an objective manner. Therefore, it is not feasible to include these determinants in a predictive model, unless more objective factors are included that correlate well with the determinant. Relevant determinants to be used in modelling of dermal exposure for risk assessment are indicated in Table 1. The choice of these determinants is based on a combination of objective evidence (from the analysed studies) and expert opinion. It is not possible to base the choice of determinants solely on objective information because only a few of the potentially highly relevant determinants have been studied extensively. Other potentially highly relevant determinants have not been studied in depth or these determinants could not be studied independently of other, related, determinants. Some of the ‘determinants’ mentioned in this publication are not at all well defined. They are mere terms used to indicate groups of complex interacting factors that could not be easily distinguished. A very clear example is the general determinant ‘task done by the worker’. It is evident that the task is a very important determinant of exposure. However, the actual influence is due to several parameters related to the task in all of the major categories of determinants. Several studies only compare ‘tasks’, without presenting information on the relevant parameters underneath. The influence of the actual determinants incorporated at the ‘task’ level cannot be determined for these studies. This clustering of real determinants under vague categories also occurs in several other situations, e.g. when processes or techniques are compared or when the influence of cleaning and maintenance of protective clothing is studied. The true determinants cannot be extracted from these studies. This is the reason for including some of the vague terms in the group or relevant determinants for modelling.
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Another rather complex issue is the most appropriate metric of dermal exposure. Proposed metrics have been: ‘mass’, ‘mass/unit of time’, ‘mass/skin surface area’ and ‘mass/unit of time/skin surface area’. For model results to be used quantitatively in comparison with toxicological limits a metric has to be chosen. Based on the evaluation of duration of a task as one of the determinants of dermal exposure there is no clear evidence that time is in general a determinant of exposure, as the metric mass/unit of time suggests. On the other hand, total mass recovered from the skin at a certain moment does not necessarily relate to dermal uptake over time, due to the complex processes of transfer to and from the skin as described by Schneider et al. (1999). A complicating factor is the measurement technique used to measure dermal exposure. All of the available methods measure a somewhat different parameter. A surrogate skin sampler may gather all contaminants over the period of sampling, although transfer of contamination from the sampler to other surfaces may also occur. Skin washing can only measure the amount that is still on the outside of the skin and not the amount that has already penetrated into or through the skin. This complicating factor may well have an important influence on the results of studies regarding the time-related aspects of dermal exposure. No simple solutions to these problems exist. It is therefore necessary that for each method and model of dermal exposure assessment at least the metric used is clearly defined and that the reasons for choosing that metric are explained. However, it can be expected that longer duration of a task will lead to higher exposure than shorter duration of the same task. Therefore, the pragmatic choice is to present dermal exposure levels as time-dependent by using metrics such as mg/cm2/h.
Acknowledgements—This study was supported by the EU Project QLK4-CT-1999-01107 RISKOFDERM in the Fifth Framework Programme and by the Dutch Ministry of Social Affairs and Employment.
Readers are referred to the more detailed version of this paper on-line for an analysis of the majority of the papers mentioned in this reference list (supplementary data).
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FOOTNOTES |
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* Author to whom correspondence should be addressed. Tel: +31-30-6944-733; fax: +31-30-6944-926; e-mail: marquart{at}chemie.tno.nl
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