prEN ISO 13977-1
(Main)Workplace atmospheres - Assessment of dermal exposure - Part 1: Framework for Dermal exposure assessment (ISO/DIS 13977‑1:2025)
Workplace atmospheres - Assessment of dermal exposure - Part 1: Framework for Dermal exposure assessment (ISO/DIS 13977‑1:2025)
This document describes a systematic approach to assess potential occupational risks related to the dermal exposure to chemical agents at the workplace. This approach provides guidance to identify hazards, exposure routes, exposed body parts and potential consequences of exposure with respect to skin uptake and local skin effects, using qualitative and quantitative approaches.
NOTE There is a relation between skin contamination and inadvertent ingestion.
This document is aimed at occupational hygienists, researchers and other safety professionals to assist recognition of potential dermal exposure and its potential consequences.
Arbeitsplatzatmosphäre - Beurteilung der Hautbelastung - Teil 1: Rahmen zur Beurteilung der Hautbelastung (ISO/DIS 13977‑1:2025)
Atmosphères des lieux de travail - Évaluation de l'exposition cutanée - Partie 1: Cadre pour l'évaluation de l'exposition cutanée (ISO/DIS 13977‑1:2025)
Zrak na delovnem mestu - Ocena dermalne izpostavljenosti - 1. del: Okvirno navodilo za oceno dermalne izpostavljenosti (ISO/DIS 13977-1:2025)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2025
Zrak na delovnem mestu - Ocena dermalne izpostavljenosti - 1. del: Okvirno
navodilo za oceno dermalne izpostavljenosti (ISO/DIS 13977-1:2025)
Workplace atmospheres - Assessment of dermal exposure - Part 1: Framework for
Dermal exposure assessment (ISO/DIS 13977-1:2025)
Arbeitsplatzatmosphäre - Beurteilung der Hautbelastung - Teil 1: Rahmen zur
Beurteilung der Hautbelastung (ISO/DIS 13977-1:2025)
Atmosphères des lieux de travail - Évaluation de l'exposition cutanée - Partie 1: Cadre
pour l'évaluation de l'exposition cutanée (ISO/DIS 13977-1:2025)
Ta slovenski standard je istoveten z: prEN ISO 13977-1
ICS:
13.040.30 Kakovost zraka na delovnem Workplace atmospheres
mestu
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.
DRAFT
International
Standard
ISO/DIS 13977-1
ISO/TC 146/SC 2
Workplace atmospheres —
Secretariat: ANSI
Assessment of dermal exposure —
Voting begins on:
Part 1: 2025-03-06
Framework for Dermal exposure
Voting terminates on:
2025-05-29
assessment
ICS: 13.100; 13.040.30
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Reference number
ISO/DIS 13977-1:2025(en)
DRAFT
ISO/DIS 13977-1:2025(en)
International
Standard
ISO/DIS 13977-1
ISO/TC 146/SC 2
Workplace atmospheres —
Secretariat: ANSI
Assessment of dermal exposure —
Voting begins on:
Part 1:
Framework for Dermal exposure
Voting terminates on:
assessment
ICS: 13.100; 13.040.30
THIS DOCUMENT IS A DRAFT CIRCULATED
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Published in Switzerland Reference number
ISO/DIS 13977-1:2025(en)
ii
ISO/DIS 13977-1:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Schematic overview of the framework for dermal exposure assessment . 3
5 Information gathering . 6
5.1 General .6
5.2 Substance-related information .6
5.3 Population at risk .8
5.4 Workplaces, tasks and / or processes at risk and RMMs in place .8
5.5 Identify similar exposure groups .9
6 Dermal risk assessment . 9
6.1 Dermal hazard assessment .9
6.2 Qualitative dermal exposure assessment .10
6.2.1 Outcome related to local corrosive/irritation effects .10
6.2.2 Outcome related to sensitizing effects .10
6.2.3 Outcome related to local carcinogenic and systemic effects .10
6.3 Quantitative dermal exposure assessment.11
6.3.1 Modelling dermal exposure .11
6.3.2 Measuring dermal exposure .11
7 Dermal risk assessment report .13
7.1 General section in the report . 13
7.2 Qualitative dermal exposure assessment . 13
7.3 Quantitative dermal exposure assessment.14
7.3.1 Modelled dermal exposure assessment .14
7.3.2 Measured dermal exposure assessment .14
8 Evaluation and periodic reassessment .15
Annex A (informative) Conceptual model .16
Annex B (informative) Local and systemic effects related to dermal exposure .18
Annex C (informative) Checklist for visiting workplaces .20
Annex D (informative) Kinney and Fine risk assessment method .24
Annex E (informative) Models and tools .26
Annex F (informative) Measurement of dermal exposure .29
Bibliography .34
iii
ISO/DIS 13977-1:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 146, Subcommittee SC 2, Workplace
atmospheres, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 137, Assessment of workplace exposure to chemical and biological agents, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 13977 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO/DIS 13977-1:2025(en)
Introduction
Dermal exposure assessment explores the dynamic interaction between environmental contaminants and
the skin. For thousands of chemicals in the workplace, the contribution of the dermal route to total-body
exposure has yet to be determined. Historically, the assessment of occupational exposure has focused
on inhalation of chemical agents. However, evidence from studies investigating the exposure pattern for
different occupational conditions indicates that dermal contact can serve as the primary route of exposure
for many chemical substances.
The penetration and permeation of substances through the skin can cause local and systemic effects,
respectively. Substances in contact with the skin may penetrate the stratum corneum to cause local effects
(irritation, corrosion or sensitization). Substances may also permeate through the skin reaching systemic
circulation leading to systemic effects, using different exposure pathways, namely 1) through sweat glands
and hair follicles, 2) the intercellular route (around the cells), or 3) the intracellular pathway (through the cells).
Observational studies show that the most highly exposed body parts are the hands. However, deposition of
airborne aerosols or direct contact with substances can also contaminate other body parts (e.g. forearms,
chest and forehead). Location of the exposure is of particular interest, since both the thickness of the
stratum corneum and the density of the hair follicles vary substantially between body locations. These are
important parameters with regard to potential penetration and local effects through the skin but also for
potential permeation and systemic effects. In addition to skin physiology, skin conditions and duration of
contact, the actual contact site may also be relevant for potential inadvertent oral exposure due to hand-to-
[1]
mouth contact.
[2]
The development of a conceptual model was a major milestone in assessing dermal exposure. The
multicompartment model systematically describes the transport of contaminant mass from the source of
exposure to the surface of the skin. The model consists of six compartments, eight mass transport processes
and two barriers ,and provides a structure for both qualitatively and quantitatively evaluating dermal
exposure. Many control banding tools, dermal exposure modelling tools and measurement methodologies
are described in scientific and grey literature using this basic concept.
No legally binding dermal limit values (DLVs) for dermal exposure are established at the time of the
[3]
publication of this document. However, Derived No Effect Levels (DNELs) for the dermal route of exposure,
[4]
Threshold Limit Value–Surface Limits (TLV–SLs) and skin notations exist for many substances and should
be considered in the risk assessment as prescribed in national regulations. For the assessment of, for
example, biocides and plant protection products, (internal) reference values are determined. These values,
namely the medium and long-term Acceptable Exposure Level (AEL) derived for biocides and the Acceptable
Operator Exposure Level (AOEL) derived for plant protection products, indicate the maximum acceptable
[5]
level of a substance in the body, independent of the pathways that lead to the exposure. As a common
practice, the whole-body exposure via all relevant routes is assessed , but for many substances and exposure
situations, one pathway (dermal, inhalation or ingestion) is typically dominant.
This document is aimed at industrial/occupational hygienists, human exposure scientists, researchers and
health and safety professionals to assist recognition, evaluation and control of dermal exposure and its
potential consequences.
This part of the document provides the framework introducing the approaches that can be applied to assess
the risks linked to dermal exposure in the workplace. In addition, it is the basis for future parts of this
document that will elaborate in more detail the methodologies and approaches that can be applied.
v
DRAFT International Standard ISO/DIS 13977-1:2025(en)
Workplace atmospheres — Assessment of dermal exposure —
Part 1:
Framework for Dermal exposure assessment
1 Scope
This document describes a framework introducing the approaches that can be applied to assess the risks
linked to dermal exposure to chemical substances in the workplace. It provides guidance on the different
steps to be taken when performing qualitative and quantitative dermal exposure assessments.
These assessments can be used for various purposes, such as:
— For the evaluation of exposure processes and pathways, in view of the human interface with workplace
processes;
— For the evaluation of control measures or interventions for effectiveness of exposure reduction;
— For risk assessment, identifying hazardous agents that exhibit local effects and/or systemic health
effects;
— For compliance purposes, where results are compared with existing or new established dermal OELVs;
— For epidemiological studies, requiring estimates of relevant exposure parameters.
NOTE Ocular and mucous membranes exposure, biological agents, wet work and mechanical stressors are outside the
scope of this document.
It is acknowledged that in practice, other pathways like inhalation or ingestion are considered as well.
There is a relationship between skin contamination and inadvertent ingestion.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 78-2, Chemistry — Layouts for standards — Part 2: Methods of chemical analysis
ISO 18158, Workplace air — Terminology
ISO 20581, Workplace air — General requirements for the performance of procedures for the measurement of
chemical agents
EN 689, Workplace exposure - Measurement of exposure by inhalation to chemical agents - Strategy for testing
compliance with occupational exposure limit values
EN 1540, Workplace exposure - Terminology
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18158and EN 1540, as well as the
following apply.
ISO/DIS 13977-1:2025(en)
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
contaminant layer compartment
layers that contain a contaminant or chemical agent
Note 1 to entry: The contaminant layer compartment is characterized by a volume of unknown depth.
Note 2 to entry: Compartments include source, air, surface, skin, inner and outer clothing contaminant layers (see
Annex A)
3.2
dermal contact volume
volume containing the mass of the chemical agent present on the dermal exposure surface area
Note 1 to entry: This theoretical term is equivalent to the volume of the skin contaminant layer (SCL) compartment;
however, for practical reasons, it is defined by the mass (in g) of all substances present on the SCL.
3.3
dermal exposure assessment
estimation (qualitative or quantitative) of the magnitude, frequency, duration,and extent of exposure to a
chemical agent via the dermal route
3.4
dermal exposure concentration
concentration of the chemical agent contained within the skin contaminant layer (SCL) compartment
Note 1 to entry: The dermal exposure concentration (in g/kg) is the dermal exposure mass divided by the dermal contact
volume or the dermal exposure mass divided by the mass contained in the skin contaminant layer (SCL) compartment.
3.5
dermal exposure loading
dermal exposure mass divided by the dermal exposure surface area
Note 1 to entry: For practical reasons, dermal exposure loading can be expressed as mass of the chemical agent in an
exposed part of the skin contaminant layer (SCL) compartment divided by the surface area of that part, expressed for
example in milligrams per centimetre squared.
3.6
dermal exposure mass
mass of chemical agent present in the dermal contact volume
Note 1 to entry: For practical reasons, dermal exposure mass is defined by the amount of the chemical agent present in
the skin contaminant layer (SCL) compartment
3.7
dermal exposure surface area
skin surface area where a chemical agent is present
Note 1 to entry: For practical reasons, the dermal exposure surface is represented by a two-dimensional representation
of the skin contaminant layer (SCL) compartment, expressed in centimetres squared
3.8
dermal hazard assessment
process to identify and characterize the adverse effects of a chemical agent to which individuals could be
exposed via the dermal route
Note 1 to entry: Effects should be assessed adverse only if they affect the viability and normal function of the organism
under test.
ISO/DIS 13977-1:2025(en)
3.9
dermal limit value (DLV)
level of exposure to the skin that is not expected to result in adverse biological effects
Note 1 to entry:
3.10
dermal risk assessment
overall process to identify potential risks based on a dermal hazard assessment and a dermal exposure
assessment
Note 1 to entry: A risk assessment usually includes risk mitigation, but this is outside the scope of this document
3.11
local dermal effect
effect that involves the skin (stratum corneum, epidermis and derma). It can be after acute or chronic
exposure
3.12
penetration
occurs when a substance enters into the skin
3.13
permeation
occurs when a substance pass through the skin
3.14
potential dermal exposure
dermal exposure expected to occur on the unprotected skin or clothes
Note 1 to entry: all substance mass that could reach the body without any exposure reducing methods being applied
3.15
skin contaminant layer (SCL) compartment
compartment on top of the stratum corneum of the human skin formed by sebum lipids, sweat and additional
water from transepidermal water loss, also including products from cornification and unshed corneocytes
Note 1 to entry: More information can be found in Annex A.
Note 2 to entry: The SCL compartment is characterized by a volume of unknown depth.
3.16
systemic dermal effect
systemic toxicity occurs when skin exposure contributes to the overall body burden, resulting in other
organ toxicities
[6]
[SOURCE: Andersen & Meade (2014) ]
3.17
uptake
concentration-driven transport of a chemical agent from the skin contaminant layer (SCL) compartmentinto
the skin, i.e. crossing the interface between the skin contaminant layer (exposure surface) and the stratum
corneum (absorption barrier)
Note 1 to entry: The time-exposure concentration profile for an identified area of the skin contaminant layer over a
defined period of time is relevant for uptake.
4 Schematic overview of the framework for dermal exposure assessment
The assessment of dermal occupational exposure to chemical agents starts with general substance
information gathering, identification of the population at risk, description of the workplace (e.g. Use of risk
management measures (RMMs)) and the identification of similar exposure groups (SEGs) Clause 5. This
ISO/DIS 13977-1:2025(en)
is followed by a dermal exposure risk assessment based on the classification of the product, substance or
agent Clause 6 and when required by a quantitative assessment when a method and DLV is available 6.3. The
dermal exposure assessments shall be documented and periodic reassessments shall be conducted when
significant changes occur at the workplace that may affect the dermal exposure and for evaluations where no
safe situation can be obtained. An annual interval for reassessment is recommended, whatever the outcome
is Clause 7. Figure 1 provides a schematic overview of the framework for dermal exposure assessment.
ISO/DIS 13977-1:2025(en)
NOTE DLV can be an OELV, DNEL, TLV, etc. and is used for evaluating the results
Figure 1 — Schematic overview of the framework for dermal exposure assessment
ISO/DIS 13977-1:2025(en)
5 Information gathering
5.1 General
Information shall be obtained to:
— List all products and their constituants used in the activities and process generated substances potentially
released during the activities so that toxicological endpoints for effect related to dermal exposure, skin
notations and/or DLVs can be identified.
— Determine the population at risk.
— Identify the workplaces, activities and / or processes at risk and the RMMs currently in place.
— Identify SEGs.
5.2 Substance-related information
The preparation of a list of all substances in the workplace and the relevant information concerned is an
essential step to the identification of the potential for exposure. The products’ safety data sheets (SDSs) and
other available information are useful to establish the list. The list shall include any of the following:
— raw materials, primary products, impurities, intermediates, final products, reaction and process
products and by-products, etc;
— the individual substances, identified with chemical registration numbers (e.g. Chemical Abstracts
Service Number, European Commission Number), including process generated emissions;
— classification and labelling, e.g. the health hazard (H) statements a shall be evaluated to identify those
which may be relevant;
— substance properties that affect dermal absorption and toxicokinetics, e.g octanol/water partition
[7]
coefficient (log Pow), molecular size, ionizatio and particle size / dustiness , as well as product
characteristics, e.g. vehicle used, dilution rate, and partitioning between vehicle and stratum corneum;
— appropriate limit values and additional notations (e.g. ‘skin’, ‘D’(dermal), ‘C’ (carcinogen), ‘M’ (mutagen), ‘Sk’
(skin), ‘DSEN’ (dermal sensitization notation)) and additional relevant toxicological endpoints for effect;
— additional information such as vapour pressure, temperature, saturation and concentration.
To determine whether any potential dermal exposure might be of concern, information regarding the
hazardous classification of the substances handled should be retrieved. The H statements as presented
in the products SDS should be reviewed to identify those which may be of relevant to the dermal route
(see Table 1, Table 2, Table 3).Due to local restrictions other statements may also be relevant, for instance
EUH statements (these being additional labelling information used in the European Union (EU)) related to
[8]
skin or allergic effects.
Table 1 — List of hazard statements relevant to dermal exposure – local corrosive/irritation effects
Code Hazard Statement
H314 Causes severe skin burns and eye damage
H315 Causes skin irritation
Table 2 — List of hazard statements relevant to dermal exposure – sensitizing effects
Code Hazard Statement
H317 May cause an allergic skin reaction
ISO/DIS 13977-1:2025(en)
Table 3 — List of hazard statements relevant to dermal exposure – systemic effects
Code Hazard Statement
H310 Fatal in contact with skin
H311 Toxic in contact with skin
H312 Harmful in contact with skin
H313 May be harmful in contact with skin
H340 May cause genetic defects
H341 Suspected of causing genetic defects
H350 May cause cancer
H351 Suspected of causing cancer
H360 May damage fertility or the unborn child
H360D May damage the unborn child
H360Df May damage the unborn child. Suspected of damaging fertility
H360F May damage fertility
H360FD May damage fertility. May damage the unborn child
H360Fd May damage fertility. Suspected of damaging the unborn child
H361 Suspected of damaging fertility or the unborn child
H361d Suspected of damaging the unborn child
H361f Suspected of damaging fertility
H361fd Suspected of damaging fertility. Suspected of damaging the unborn child
H362 May cause harm to breast-fed children
H370 Causes damage to organs
H371 May cause damage to organs
H372 Causes damage to organs through prolonged or repeated exposure
H373 May cause damage to organs through prolonged or repeated exposure
These shall then be checked in publicly available databases such as the “Information on Chemicals” platform
[9]
in the ECHA website.
Next, information regarding the potential of dermal absorption shall be retrieved in order to assess the
relevance of systemic exposure following the exposure via the dermal route. Measured dermal absorption
data is preferred to be used as an estimate of uptake but may not be available. In absence of this data, the
substance properties that affect dermal absorption can be evaluated, including the octanol/water partition
[7]
coefficient (log Pow), the molecular size, the ionisation and the particle size (e.g. for powders). It shall
be noted that the dermal absorption rate for a specific substance can differ significantly depending on the
vehicle that is used, the dilution rate, the partitioning between solvent and stratum corneum and workplace
factors, see 5.4
Considering the high relevance of dermal exposure for many products, such as pesticides and biocides, a high
number of in vitro and in vivo dermal absorption studies have been conducted during the last decades. Based
on these data, a significant impact of the substance concentration on dermal absorption and formulation
[10]
category has been reported for pesticides.
Additional characteristics, such as the physicochemical properties of the substances or products handled,
shall be considered on a case-by-case basis. For example, when handling liquid products at the workplace,
e.g. by means of stirring or spraying, droplets or aerosols can be formed. Depending on the volatility of
the substance, these droplets can easily evaporate or stay in the air for a relatively long period and can
[11]
even increase in volume over time due to condensation processes. When these droplets come into contact
with the skin (resulting in moistening of the skin), the chemical composition of the liquid, its skin-damaging
properties and percutaneous absorption characteristics shall be taken into account, regardless of the
droplets’ original dimensions.
ISO/DIS 13977-1:2025(en)
Furthermore, the existence of a DLV or skin notation for the substance under consideration shall be checked.
For dermal exposure, different limit values can be available and shall be identified. In the simplest case, a
DLV exists which can directly used for compliance testing, without considering other exposure pathways.
However, for pesticides and biocides reference values referring to an internal body burden are common.
These limit values are usually indicated as mass of substance per body weight and day, and considered
relevant for risk assessment related to systemic exposure resulting from all relevant exposure pathways,
i.e., inhalation, dermal and, if applicable, oral exposure. Similarly, for industrial chemicals limit values such
as DNELs exist, which can refer to different exposure pathways. In this case, for risk assessment purposes,
exposure indices (exposure divided by limit value) are calculated for all pathways and then summed
to conclude whether the exposure levels are acceptable (i.e. resulting sum is <1). For such limit values,
assessment of the dermal pathway according to this document requires that the exposure levels resulting
from all other relevant pathways shall be established. The acceptable exposure level remaining for the
dermal route shall then be derived and considered further as the relevant limit value for the this route.
5.3 Population at risk
The population at risk shall be identified. Pre-employment health questionnaires and company health
surveillance, if available, can help identify susceptible individuals or those with existing skin complaints. Any
occurrence of skin disease or health effects can indicate potential dermal exposures. For more information
on local and/or systemic dermal health effects, see Annex B.
Disruption of the skin decreases the barrier function of the stratum corneum and is thus important to
consider when establishing the population at risk. The integrity of stratum corneum and its damage due
to pre-existing disease and other work-related conditions (e.g. wet work and abrasion) can be assessed
relatively easily. Assessment of skin condition can be made by visual examination, which may include
[12]
questionnaires or scoring systems, like the Nordic Occupational Skin Questionnaire (NOSQ-2002) , the
[13] [14] [15]
Hand Eczema Severity Index (HECSI) , the Manuscore , the Osnabrück Hand Eczema Severity Index
[15] [13]
(OHSI) , and Hand Eczema Score for Occupational Screenings (HEROS). Furthermore, there are a
number of biophysical parameters that can be used to objectively assess skin condition, like transepidermal
[16]
water loss (TEWL) from the skin surface, skin hydration and quantitative measurement of skin colour.
It should be noted that what is observed at the individual worker level cannot be directly translated to an
assessment of skin disruption on a group level as it is. It is also important to take into account accidental
damage of the skin that might or might not be work-related. On the other hand, combining data generated on
an individual level may generate valuable information on a group level. It is advised to document and retain
these (anonymised) observations at company and/or industry level to be able to identify any group level
issues of concern .
5.4 Workplaces, tasks and / or processes at risk and RMMs in place
To determine if exposure via the dermal route is of relevance based on the workplace environment,
a description of all worker activities should be available, as well as details of how the worker directly or
[2]
indirectly interacts with the substance. The conceptual dermal model shall be used to identify the
processes by which substances from the source of exposure can be transported to the surface of the skin,
e.g. emission, deposition, transfer and removal. Further information on the conceptual model, is provided in
Annex A.
The work processes and procedures shall be evaluated to gauge the exposure and the exposure profile to
chemical agents by a detailed review of workplace factors, such as:
— work organization (job titles, activities, tasks, work shift system, job functions, etc.);
— processes and techniques (type of processes, temperature, pressure, etc.);
— amount and, if applicable, concentration of the substance that is used per shift/task/activity;
— workplace layout and configuration, including confined spaces, open air, etc.;
— safety precautions and procedures (restricted area, training, etc.);
— cleanliness and tidiness of workplace;
ISO/DIS 13977-1:2025(en)
— ventilation installations, other forms of engineering control and any information on their performance;
— emission sources and locations of high concentrations;
— periods, frequencies and durations of exposure, considering variation of exposure with time of day and
season of the year;
— work load;
— worker behaviour, or activity or production rate indicators;
— administrative controls and use of personal protective equipment (PPE).
Annex C provides a simple checklist of questions to be addressed and information to collect when visiting
the workplace to determine if dermal exposure is relevant. Information on engineering controls, protective
gloves and other PPE use is collected, as are details of the work practices and workers interaction with the
substances of concern.
5.5 Identify similar exposure groups
SEGs rely on grouping workers and assessing their health risks based on similar exposure conditions. When
determining SEGs consideration shall be given to various characteristics that influence exposure including,
e.g. tasks and activities undertaken and equipment used. Further information on assigning SEGs can be
found in EN 689, 5.2.1. However validation and constitution of SEG's might not be possible in all cases with
dermal exposure measurement results.
6 Dermal risk assessment
6.1 Dermal hazard assessment
The first step in the dermal hazard assessment is to identify whether the subtances under assessment may
produce any effects following exposure via the dermal route. The substance-related information retrieved
within 5.2 shall be reviewed in detail to conclude on the specific assessment required in relation to the
hazardous properties. The different cases are summarised below:
— All information gathered assigned to the substances under assessment present no relevant effects and
while there is also no DLV established; no further assessment is required .
— At least one of the H statements included in Table 1 or any other information gathered referring to
any local corrosive/irritation effects is assigned to the substance under assessment; an assessment is
required (see 6.2.2).
— At least the H statement included in Table 2 or any other statement or skin notation referring to sensitizing
effects is assigned to the substance under assessment; an assessment is required (see 6.2.3).
— At least one of the H statements included in Table 3 or any other statement or skin notation referring to
potential health effects related to dermal exposure, following absorption in the systemic circulation is
assigned to the substance under assessment; an assessment is required (see 6.2.4).
— no H statement is assigned to the substance under assessment but local carcinogenic effects are identified
(see B.1.3); an assessment is required. (see 6.2.4).
The relevance of systemic effects is also indicated by the existence of reference/limit values for the chemical
agent/product under assessment, independently of the classification.
It is noted that multiple statements can be assigned to the substances under assessment and thus multiple
exposure risk assessments can be required, e.g. an assessment for both local and systemic effects may be
required.
ISO/DIS 13977-1:2025(en)
6.2 Qualitative dermal exposure assessment
Once the hazard evaluation has been performed, the qualitative dermal exposure assessment shall be
performed in cases where effects relevant to dermal exposure have been identified. The qualitative
exposure assessment shall consider workplace factors, workers tasks and the physical-chemical properties
of the agent. This assessment can be performed on product, substance or process level. When the qualitative
exposure assessment indicates that the risk characterisation result is not acceptable then an investigation of
the possibilities for elimination or substitution shall be performed. If elimination or substitution is possible,
the situation shall be reassessed, if not, a quantitative exposure assessment shall be performed to identify
the exposure risk.
For the purposes of the qualitative dermal exposure assessment, several methods/tools are available
depending on the level of detail needed to perform the analysis. These include approaches which require
minimal information where easy to use spreadsheets can be used, to more sophisticated tools.
[17]
A typical, simplistic approach is based on the Kinney and Fine risk assessment method , which can be
easily performed in a spreadsheet (see Annex D). Other examples are Control of Substances Hazardous to
[18]
Health (COSHH) Essentials , Système d’évaluation et d’information sur les risques chimiques en milieu
[19] [20]
professionnel (Seirich) , and Einfaches Maßnahmenkonzept Gefahrstoffe (EMKG) which are freely
available. The lack of consideration of the exposed skin surface is the major disadvantage of these tools.
Examples of tools which take into account the exposed skin surface and where results are expressed as
categorical estimates of exposure, e.g. ever-never, yes-no or exposure classes (low, medium, high), are the
[21] ® [22]
Dermal Risk Assessment Method (DRAM) , Stoffenmanager and DeRmal Exposure Assessment
[23]
Method (DREAM).
Consideration shall be given to applying the method/tool most suitable for the exposure situation being
assessed. See Annex E for further information on available tools.
6.2.1 Outcome related to local corrosive/irritation effects
If the hazard assessment has local corrosive or irritant effects as endpoint, appropriate (further) RMMs shall
be implemented, after which the assessment for this endpoint is terminated and documented. For example,
when working with corrosive acids, a closed system shall be installed or acid-resistant gloves shall be worn
to prevent exposure.
6.2.2 Outcome related to sensitizing effects
If the hazard assessment has sensitizing effects as an endpoint, the assessment continues with a qualitative
exposure assessment. When susceptible individuals in the population are exposed to specific sensitizing
agents, additional RMMs shall be implemented for these individuals. The assessment continues for local
carcinogenic and systemic effects. (see 6.2.4)
6.2.3 Outcome related to local carcinogenic and systemic effects
If the hazard assessment has local carcinogenic or systemic effects as an endpoint, the assessment continues
with a qualitative dermal exposure assessment.
If the conclusion of the qualitative assessment is no exposure, for example if a substance is only present in a
closed system which is confirmed to be effective, the risk characterisation is acceptable and the assessment
shall be terminated and documented.
When the risk characterisation is not acceptable the assessment continues with an investigation if elimination
or substitution is feasible. When elimination or substitution is feasible, reassessment is required. When
elimination or substitution is not feasible the assessment continues with a quantitative exposure assessment
(see 6.3). An important consideration is to investigate if there is a DLV available to compare the quantitative
results against. When no published DLV exists, it shall be investigated if an own DLV can be established. An
example is the
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