1、PUBLISHED DOCUMENT PD CEN/TR 15278:2006 Workplace exposure Strategy for the evaluation of dermal exposure ICS 13.100 PD CEN/TR 15278:2006 This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 June 2006 BSI 2006 ISBN 0 580 48272 3 National fore
2、word This Published Document is the official English language version of CEN/TR 15278:2006. Additional information The responsible BSI committee, EH/2/2, “Air quality Workplace atmospheres”, wishes to bring to the attention of users of this PD that the measurement principles and sampling strategies
3、described (clauses 3.4.2 and 3.4.3) are not applicable to assess risk from dermal absorption of vapours. Typically, exposure due to dermal absorption of vapours can be assumed to equate to 10 % of inhalation exposure at any given concentration. However, it can reach levels equivalent to 40 % of inha
4、lation exposure for workers operating in high humidity/high temperature ( 30 C) environments with chemicals that are readily absorbed by the skin. Risk from dermal exposure to vapours can be particularly significant for workers operating in confined spaces using respiratory apparatus. This risk can
5、be further exacerbated by heavy protective clothing, such as overalls, which can increase the temperature and humidity near the skin. Where the rate of chemical uptake into the skin is high, biological monitoring (if available) can be used as a check on all routes of exposure including dermal exposu
6、re to vapours. Its use should also be considered if the toxicity of the chemical is high, even if the rate of chemical uptake into the skin is expected to be low. Available biological monitoring methods include blood, urine and breath testing. Further information is available in HSE publication “Bio
7、logical Monitoring in the Workplace”, HSE www.hse.gov.uk. The UK participation in its preparation was entrusted by Technical Committee EH/2, Air quality, to Subcommittee EH/2/2, Workplace atmospheres, which has the responsibility to: A list of organizations represented on this subcommittee can be ob
8、tained on request to its secretary. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate t
9、hem in the UK. Summary of pages This document comprises a front cover, an inside front cover, page i, a blank page, the CEN/TR title page, pages 2 to 21 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publicat
10、ion Amd. No. Date CommentsPD CEN/TR 15278:2006 i Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Se
11、arch” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a Published Document does not of itself confer immunity from lega
12、l obligations.blankTECHNICALREPORT RAPPORTTECHNIQUE TECHNISCHERBERICHT CEN/TR15278 March2006 ICS13.100 EnglishVersion WorkplaceexposureStrategyfortheevaluationofdermal exposure ExpositionsurleslieuxdetravailStratgiepour lvaluationdelexpositiondermique ExpositionamArbeitsplatzStrategiezurBeurteilungd
13、er Hautbelastung ThisTechnicalReportwasapprovedbyCENon20September2005.IthasbeendrawnupbytheTechnicalCommitteeCEN/TC137. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembou
14、rg,Malta,Netherlands,Norway,Poland,Portugal, Romania, Slovakia,Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2006CEN Allrightsofexploitationinanyformandbyan
15、ymeansreserved worldwideforCENnationalMembers. Ref.No.CEN/TR15278:2006:ECEN/TR 15278:2006 2 Contents Page Foreword3 Introduction .4 1 Scope 5 2 Terms and definitions .5 3 Assessment of dermal exposure .7 4 Control 11 Annex A (informative) The conceptual model 12 Annex B (informative) Estimation and
16、Assessment of Substance Exposure (EASE)14 Annex C (informative) DeRmal Exposure Assessment Method (DREAM).16 Annex D (informative) Determinants of dermal exposure .18 Bibliography 20 CEN/TR 15278:2006 3 Foreword This Technical Report (CEN/TR 15278:2006) has been prepared by Technical Committee CEN/T
17、C 137 “Assessment of workplace exposure to chemical and biological agents”, the secretariat of which is held by DIN. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such
18、 patent rights. 4 Introduction Dermal exposure assessment explores the dynamic interaction between environmental contaminants and the skin. In contrast to inhalation exposure assessment, the assessment of dermal exposure remained a nascent field of scientific research and applied occupational hygien
19、e for most of the twentieth century, although multiple fatalities and occupational skin diseases due to dermal exposure have been described in literature. During the last decade, dermal exposure has received more attention, and one of the important results was the development of a conceptual model f
20、or dermal exposure (see 1). The model systematically describes the transport of contaminant mass from exposure sources to the surface of the skin. The model provides a structure for evaluating dermal exposure both qualitatively and quantitatively. The purpose of evaluating dermal exposure can differ
21、 substantially, as exposure analysis (to give guidance to control), risk assessment, and evaluation of exposure control can all be objectives to undertake assessments. In order to give guidance and to harmonise basic concepts and actions a strategy for evaluation of dermal exposure is proposed. CEN/
22、TR 15278:20065 1 Scope This Technical Report gives guidance on approaches for awareness and evaluation of dermal exposure in workplaces. This Technical Report describes strategies to evaluate exposure of the skin to chemical and biological agents qualitatively and quantitatively, e.g. to analyse exp
23、osure, as part of the risk assessment process, to investigate associations between exposure and diseases, and to evaluate control measures. The definitions and procedures given in this document are primarily related to dermal exposure to chemical substances. The specifications given in this Technica
24、l Report are not applicable to microbiological skin contaminants. 2 Terms and definitions For the purposes of this Technical Report, the following terms and definitions apply. NOTE The definitions are based on the implementation of exposure terminology by IPCS (see 2) and the conceptual model (see 1
25、), see also Annex A. 2.1 agent any chemical or biological entity on its own or admixed as it occurs in the natural state or as produced by any work activity, whether or not produced intentionally and whether or not placed on the market NOTE Adapted from EN 1540. 2.2 dermal contact volume volume cont
26、aining the mass of the agent that contacts the exposure surface NOTE 1 The dermal contact volume is given in litres (l). NOTE 2 The dermal contact volume is equivalent to the volume of the skin contaminant layer, and for practical reasons it is defined by the mass in kilograms (kg) of all substances
27、 contained in this compartment. 2.3 dermal exposure process of contact between an agent and human skin at an exposure surface over an exposure period 2.4 dermal exposure concentration exposure mass divided by the dermal contact volume or the exposure mass divided by the mass contained in the skin co
28、ntaminant layer NOTE The dermal exposure concentration is expressed in grams per liter (g/l) or grams per kilogram (g/kg) respectively. 2.5 dermal exposure loading exposure mass divided by the exposure surface NOTE For practical reasons it can be expressed as the time-averaged mass divided by area-a
29、veraged skin contaminant layer surface area in grams per square centimetre (g/cm 2 ). CEN/TR 15278:20066 2.6 dermal exposure mass mass of agent present in the dermal contact volume NOTE 1 For practical reasons it is defined by the amount of agent in grams (g) present in the skin contaminant layer. N
30、OTE 2 The outcome of the process of dermal exposure, i.e. the contact, can be expressed by different parameters of exposure. 2.7 dermal exposure surface skin surface area where an agent is present NOTE For practical reasons this is represented by a two dimensional representation of the skin contamin
31、ant layer in square centimetres (cm 2 ). 2.8 exposure period time the agent is present in the skin contaminant layer, i.e. contact time NOTE 1 The process by which an agent crosses an outer exposure surface of a target is called intake. In case of the concentration driven transport from the skin con
32、taminant layer into the skin, i.e. crossing the (exposure surface) interface between skin contaminant layer and the stratum corneum as an absorption barrier, the process is called uptake. Therefore, relevant for uptake would be the time- exposure concentration profile for an identified area of the s
33、kin contaminant layer over a defined period of time. NOTE 2 Other relevant types of time intervals, e.g. sampling time (B-C), immission or loading time (A-D), and post emission time (D-E), are illustrated in Figure 1. Key X time Y exposure loading A-E exposure/contact time A-D immission/loading time
34、 D-E post immission time B-C sampling time Figure 1 Different types of time intervals relevant in view of dermal exposure 2.9 immission transport of an agent from a defined source to the skin or outer clothing contaminant layer compartment CEN/TR 15278:20067 2.10 potential dermal exposure mass mass
35、retrieved from (outer and inner clothing contaminant layer and exposure mass, i.e. mass retrieved from the covered and uncovered by clothing) parts of the skin contaminant layer compartment NOTE For practical reasons related to sampling methodology and strategy the term potential exposure mass has b
36、een introduced. It refers to the agent mass that has the potential the reach the skin (contaminant layer) since it has landed on the clothing and the agent mass that has actually reached the skin. The conceptual model distinguishes between outer and inner clothing contaminant layer compartment, resp
37、ectively, and characterises the clothing itself as a buffer layer. 2.11 skin contaminant layer compartment compartment on top of the stratum corneum of the human skin NOTE The skin contaminant layer compartment is formed by sebum lipids, sweat and additional water from transepidermal water loss, res
38、t products from cornification and unshed corneocytes, and is given by its three dimensional volume. 2.12 workplace the defined area or areas in which the work activities are carried out EN 1540:1998, 3.36 3 Assessment of dermal exposure 3.1 General Sampling strategies provide general guidelines to a
39、pproach dermal exposure issues systematically. This approach is according to the conceptual model illustrated in Figure A.1. The conceptual model structures the process of dermal exposure to chemicals and assists in evaluating the performance of sampling methods. Basically, the model systematically
40、describes the transport of contaminant mass from the source onto the surface of the skin. Six compartments, i.e. three environmental compartments (air, surface and source) and three personal compartments (outer and inner clothing, and skin contaminant layer) and eight mass transport processes onward
41、s and from the compartments are distinguished and their mutual relationship is outlined. 3.2 Objectives In general, five objectives for assessing dermal exposure can be distinguished: a) evaluation of exposure processes and pathways Evaluation of exposure processes and pathways is an important tool
42、for selecting an adequate sampling strategy and for effective risk management. b) evaluation of exposure control measures or interventions Evaluation of control measures is relevant in view of effectiveness of exposure reduction and post-intervention surveillance. c) risk assessment Results for risk
43、 assessment purposes should be linked to results of hazard assessment. Hazardous agents that show local effects are distinguished from hazardous agents that show systemic health effects after uptake (see 3). For the first group of agents, quantitative exposure assessment seems to be very difficult,
44、however some data are available on effect and dosage and duration. CEN/TR 15278:20068 d) epidemiological investigations To investigate possible associations between exposure and health effects by epidemiological investigations estimates of relevant parameters of exposure are needed. e) compliance Co
45、mpliance sampling is relevant in case exposure limits have been set. At the present time no such limits have been set by National Authorities or other International Bodies. However, in-company exposure limits are used as action levels or references for compliance. Such limits may be at the level of
46、any parameter of dermal exposure, i.e. exposure mass, exposure loading, exposure surface area, or at the level of determinants of exposure, e.g. surface contamination in case of transfer, or at the level of intake by aggregated exposure routes including the dermal route, e.g. biological monitoring l
47、imit values. The last two types of limit values, however, are beyond the scope of this document. 3.3 Models and semi quantitative estimates 3.3.1 Objectives Most models provide estimates of the likelihood of skin exposure or skin contamination that can be used as a first tier in exposure assessment
48、processes. Application of the models is analogous to the first two steps, i.e. initial appraisal and basic survey, of a tiered approach as given for airborne contamination by EN 689. The estimates provided by the models can be used for an initial evaluation of the exposure process, initial exposure
49、assessment in view of risk assessment processes, and estimation of exposure levels for epidemiological studies. Moreover, the results will be helpful to select an appropriate sampling strategy for quantitative exposure assessment and to prioritise control measures. 3.3.2 Methods Categorical estimates, e.g. ever-never, yes-no or exposure
