CEN/TS 15279:2006

Workplace exposure - Measurement of dermal exposure - Principles and methods

This Technical Specification establishes principles and describes methods for the measurement of dermal exposure in workplaces. It gives guidance on the commonly used approaches to the measurement of dermal exposure, their advantages and limitations and how these might be assessed in specific circumstances for specific compounds.
This Technical Specification should enable users of dermal sampling methods to adopt a consistent approach to method validation and provide a framework for the assessment of method performance.
This Technical Specification describes the requirements against which sampling methods need to be assessed. It will then indicate methods for agreement with these requirements. Requirements include specification of the following:
NOTE   Not all requirements are applicable to all methods.
-   sampling efficiency;
-   recovery efficiency;
-   sample stability;
-   maximum capacity;
-   bias, precision, overall uncertainty;
-   core information;
-   contextual information.

Exposition am Arbeitsplatz - Messung der Hautbelastung - Grundsätze und Verfahren

Diese Technische Spezifikation stellt Grundsätze auf und beschreibt Verfahren für die Messung der Hautbelastung (sog. dermale Exposition) am Arbeitsplatz. Sie gibt eine Anleitung zu den üblicherweise angewendeten Vorgehensweisen für die Messung der Hautbelastung, deren Vorteilen und Einschränkungen und wie diese Verfahren unter spezifischen Bedingungen für spezifische Verbindungen beurteilt werden könnten.
Diese Technische Spezifikation soll die Anwender von Verfahren zur Probenahme an der Haut(oberfläche) in die Lage versetzen, einen einheitlichen Ansatz zur Verfahrensvalidierung zu übernehmen und einen Rahmen für die Beurteilung der Leistungsfähigkeit von Verfahren liefern.
Diese Technische Spezifikation beschreibt die Anforderungen, denen gegenüber Probenahme¬verfahren beurteilt werden müssen. Sie wird dann Verfahren zur Übereinstimmung mit diesen Anforderungen aufzeigen. Zu den Anforderungen gehören Festlegungen zu folgenden Punkten:
ANMERKUNG   Nicht alle Anforderungen sind auf alle Verfahren anwendbar.
   Wirksamkeit der Probenahme;
   Wirksamkeit der Wiederfindung von Substanzen;
   Stabilität der Proben;
   Höchstkapazität des Messgeräts;
   systematische Abweichung, Präzision, Messunsicherheit;
   Kerninformationen;
   zugehörige Informationen.

Exposition sur les lieux de travail - Mesurage de l'exposition cutanée - Principes et méthodes

La présente Spécification technique établit les principes et décrit les méthodes de mesurage de l'exposition par voie cutanée sur les lieux de travail. Elle donne les lignes directrices relatives aux approches généralement utilisées pour le mesurage de l'exposition par voie cutanée, à leurs avantages et à leurs limites ainsi qu'à la manière dont elles peuvent être évaluées dans des circonstances particulières pour des composés spécifiques.
Il convient que la présente Spécification technique permette aux utilisateurs des méthodes d'échantillonnage destinées à mesurer l'exposition cutanée d'adopter une approche cohérente pour valider ces méthodes et qu'elle propose un cadre pour l'évaluation des performances de ces méthodes.
La présente Spécification technique décrit les exigences requises pour l'évaluation des méthodes d'échantillonnage. Elle indique ensuite quelles méthodes satisfont à ces exigences. Ces exigences comprennent la vérification des éléments suivants :
NOTE   Toutes les exigences ne sont pas applicables à la totalité des méthodes.
-   l'efficacité d'échantillonnage ;
-   le taux de récupération ;
-   la stabilité de l'échantillon ;
-   la capacité maximale ;
-   le biais, la fidélité, l'incertitude globale ;
-   les informations fondamentales ;
les informations contextuelles.

Izpostavljenost na delovnem mestu – Merjenje dermalne izpostavljenosti kože – Načela in metode

General Information

• Status: Published
• Publication Date: 14-Mar-2006
• ICS: 13.100 - Occupational safety. Industrial hygiene
• Technical Committee: CEN/TC 137 - Assessment of workplace exposure
• Drafting Committee: CEN/TC 137/WG 6 - Dermal Exposure
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 12-Jun-2015
• Ref Project: SIST-TS CEN/TS 15279:2006 - Workplace exposure - Measurement of dermal exposure - Principles and methods

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2006
,]SRVWDYOMHQRVWQDGHORYQHPPHVWX±0HUMHQMHGHUPDOQHL]SRVWDYOMHQRVWLNRåH±
1DþHODLQPHWRGH
Workplace exposure - Measurement of dermal exposure - Principles and methods
Exposition am Arbeitsplatz - Messung der Hautbelastung - Grundsätze und Verfahren
Exposition sur les lieux de travail - Mesurage de l'exposition cutanée - Principes et
méthodes
Ta slovenski standard je istoveten z: CEN/TS 15279:2006
ICS:
13.100 Varnost pri delu. Industrijska Occupational safety.
higiena Industrial hygiene
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

TECHNICAL SPECIFICATION
CEN/TS 15279
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
March 2006
ICS 13.100
English Version
Workplace exposure - Measurement of dermal exposure -
Principles and methods
Exposition sur les lieux de travail - Mesurage de l'exposition Exposition am Arbeitsplatz - Messung der Hautbelastung -
cutanée - Principes et méthodes Grundsätze und Verfahren
This Technical Specification (CEN/TS) was approved by CEN on 22 November 2005 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 15279:2006: E
worldwide for CEN national Members.

Contents Page
Foreword.3
Introduction .4
1 Scope .5
2 Terms and definitions .6
3 Principles and methods .9
4 Quality issues.10
5 Report .11
Annex A (informative) Interception methods.13
Annex B (informative) Hand wash methods .18
Annex C (informative) Wipe methods.22
Annex D (informative) Tape-stripping method .26
Annex E (informative) In-situ methods.31
Bibliography .38

Foreword
This Technical Specification (CEN/TS 15279:2006) has been prepared by Technical Committee CEN/TC 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 patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden,
Switzerland and the United Kingdom.
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 hygiene 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 for 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 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 measurements, requirements and test methods for measurement
of dermal exposure are proposed.
1 Scope
This Technical Specification establishes principles and describes methods for the measurement of dermal
exposure in workplaces. It gives guidance on the commonly used approaches to the measurement of dermal
exposure, their advantages and limitations and how these might be assessed in specific circumstances for
specific compounds.
This Technical Specification should enable users of dermal sampling methods to adopt a consistent approach
to method validation and provide a framework for the assessment of method performance.
This Technical Specification describes the requirements against which sampling methods need to be
assessed. It will then indicate methods for agreement with these requirements. Requirements include
specification of the following:
NOTE Not all requirements are applicable to all methods.
 sampling efficiency;
 recovery efficiency;
 sample stability;
 maximum capacity;
 bias, precision, overall uncertainty;
 core information;
 contextual information.
2 Terms and definitions
For the purposes of this Technical Specification, the following terms and definitions apply.
NOTE The definitions are based on CEN/TR 15278.
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
bias
consistent deviation of the measured value from the value of the air quality
characteristic itself or the accepted reference value
[ISO 6879:1995, 5.2.3.1]
2.3
dermal contact volume
volume containing 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 contained in this compartment.
2.4
dermal exposure
process of contact between an agent and human skin at an exposure surface over an exposure period
2.5
dermal exposure concentration
exposure mass divided by the dermal contact volume or the exposure mass divided by the mass contained in
the skin contaminant layer
NOTE The dermal exposure concentration is expressed in grams per litre (g/l) or grams per kilogram (g/kg)
respectively.
2.6
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-averaged skin
contaminant layer surface area in grams per square centimetre (g/cm ).
2.7
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.
NOTE 2 The outcome of the process of dermal exposure, i.e. the contact, can be expressed by different parameters of
exposure.
2.8
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 contaminant layer in
square centimetres (cm ).
2.9
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 contaminant layer into the skin, i.e. crossing the (exposure surface) interface
between SCL 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 skin 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
D-E post immission time
B-C sampling time
Figure 1 — Different types of time intervals relevant in view of dermal exposure
2.10
immission
transport of an agent from a defined source to the skin or outer clothing contaminant layer compartment
2.11
limit of detection
LOD
background level plus three times estimated standard deviation of measured blank substrate mass
NOTE Adapted from ISO 15767.
2.12
limit of quantitation
LOQ
background level plus ten times estimated standard deviation of measured blank substrate mass
NOTE Adapted from ISO 15767.
2.13 overall method efficiency
2.13.1
overall method efficiency
sampling efficiency multiplied by recovery efficiency
2.13.2
overall method efficiency
mass of agent detected divided by mass of agent in analysed contact volume
NOTE Mass of agent detected either directly or indirectly by use of a tracer.
2.14
overall uncertainty
quantity used to characterise as a whole the uncertainty of
the result given by an apparatus or measuring procedure
NOTE It is expressed, as a percentage, by a combination of bias and precision usually according to the formula:
x − x + 2s
ref
x
ref
where
x is the mean value of results of a number (n) of repeated measurements;
x is the true or accepted reference value of concentration;
ref
s is the standard deviation of the measurements.
[EN 1540:1998, 3.17]
2.15
potential dermal exposure mass
mass 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
been 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, respectively, and characterises the clothing itself as a
buffer layer.
2.16
precision
the closeness of agreement between independent test results obtained under stipulated conditions
[ISO 6879:1995, 5.2.16]
2.17
quality control sample
blank substrate that undergoes the same handling as the sampling substrate and can either be fortified with
the agent or not
2.18
recovery efficiency
mass of agent recovered from collection substrate divided by mass of
agent present on the substrate immediately after collection
NOTE For in situ methods recovery efficiency is not applicable.
2.19 sampling efficiency
NOTE For in situ methods sampling efficiency is not applicable.
2.19.1
sampling efficiency
mass of agent on collection substrate at end of sampling divided by immission of
agent to sampled area integrated over sampling time
2.19.2
sampling efficiency
mass of agent on collection substrate divided by dermal exposure loading by agent
times sampled area
2.20
skin contaminant layer compartment
compartment on top of the stratum corneum of the human skin
NOTE The skin contaminant l
...