SIST EN ISO 13977-1:2026

Workplace air - Assessment of dermal exposure - Part 1: Framework for dermal exposure assessment (ISO 13977-1:2026)

This document specifies a framework introducing the approaches that can be applied to assess the risks linked to dermal exposure to chemical substances in the workplace. This document provides guidance on the different steps to be taken when performing qualitative and quantitative dermal exposure assessments.
This document is not applicable to inhalation, oral, ocular and mucous membranes exposure, biological agents, wet work and mechanical stressors.

Luft am Arbeitsplatz - Beurteilung der Hautbelastung - Teil 1: Rahmen zur Beurteilung der Hautbelastung (ISO 13977-1:2026)

Dieses Dokument legt einen Rahmen für die Einführung der Ansätze fest, die zur Bewertung der Risiken im Zusammenhang mit Hautbelastungen durch chemische Stoffe am Arbeitsplatz angewendet werden können. Dieses Dokument bietet eine Anleitung zu den verschiedenen Schritten, die bei der Durchführung qualitativer und quantitativer Bewertungen der Hautbelastung zu befolgen sind.
Dieses Dokument ist nicht auf das Einatmen, die orale Exposition, die Exposition der Augen und Schleimhäute, biologische Wirkstoffe, Feuchtarbeit und mechanische Stressoren anwendbar.

Air des lieux de travail - Évaluation de l’exposition cutanée - Partie 1: Cadre pour l’évaluation de l’exposition cutanée (ISO 13977-1:2026)

Le présent document spécifie un cadre introduisant les approches qui peuvent être appliquées pour évaluer les risques liés à l’exposition cutanée à des substances chimiques sur le lieu de travail. Le présent document fournit des recommandations relatives aux différentes étapes à entreprendre lors de la réalisation d’évaluations qualitatives et quantitatives d’exposition cutanée.
Le présent document ne s’applique pas à l’exposition par inhalation, orale, par les membranes muqueuses et oculaires, aux agents biologiques, au travail en conditions humides ni aux facteurs de stress mécaniques.

Zrak na delovnem mestu - Ocena dermalne izpostavljenosti - 1. del: Okvirno navodilo za oceno dermalne izpostavljenosti (ISO 13977-1:2026)

Ta dokument določa okvir, ki uvaja pristope, ki jih je mogoče uporabiti za oceno tveganj, povezanih z dermalno izpostavljenostjo kemičnim snovem na delovnem mestu. Ta dokument zagotavlja smernice o različnih korakih, ki jih je treba sprejeti pri izvajanju kvalitativnih in kvantitativnih ocen dermalne izpostavljenosti.
Ta dokument ni uporaben za izpostavljenost z vdihavanjem, oralno, očesno in sluznicami, biološke dejavnike, mokro delo in mehanske stresorje.

General Information

• Status: Published
• Public Enquiry End Date: 02-May-2025
• Publication Date: 13-May-2026
• ICS: 13.040.30 - Workplace atmospheres
• ICS: 13.100 - Occupational safety. Industrial hygiene
• Technical Committee: KAZ - Air quality
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 28-Apr-2026
• Due Date: 03-Jul-2026
• Completion Date: 14-May-2026
• Ref Project: EN ISO 13977-1:2026 - Workplace air - Assessment of dermal exposure - Part 1: Framework for dermal exposure assessment (ISO 13977‑1:2026)

Relations

• Refers: SIST EN 1540:2022 - Workplace exposure - Terminology
• Effective Date: 06-May-2026
• Refers: SIST ISO 18158:2018 - Workplace air - Terminology
• Effective Date: 06-May-2026

Overview

SIST EN ISO 13977-1:2026: Workplace Air - Assessment of Dermal Exposure - Part 1: Framework for Dermal Exposure Assessment provides a comprehensive framework for assessing dermal exposure to chemical substances in workplace atmospheres. Developed through collaboration between CEN and ISO, this standard guides occupational health professionals, safety officers, and industrial hygienists in evaluating and managing risks associated with skin exposure to hazardous chemicals.

Focusing solely on the dermal route, this document offers structured guidance for conducting both qualitative and quantitative assessments, helping organizations recognize potential health risks and implement appropriate control measures. It is explicitly not applicable to inhalation, oral, ocular, or mucous membrane exposures, biological agents, wet work, or mechanical stressors.

Key Topics

• Framework for Dermal Exposure Assessment: The standard sets out a step-by-step process for identifying, evaluating, and reporting skin exposure to workplace chemicals.
• Information Gathering: Guidance on collecting detailed information about substances, the at-risk workforce, affected workplace areas and processes, and existing risk management measures (RMMs).
• Identification of Similar Exposure Groups (SEGs): Ensures systematic assessment by grouping workers with comparable exposure profiles based on activities and environments.
• Dermal Hazard Assessment: Evaluates substance-specific hazards by considering relevant health hazard classifications from safety data sheets (SDS), including corrosion, irritation, sensitization, and systemic effects.
• Qualitative and Quantitative Assessment: Differentiates when to apply observational, questionnaire-based approaches versus measurement and modeling methods for more precise exposure estimation.
• Establishment of Limit Values: Considers available dermal limit values (DLVs), Derived No Effect Levels (DNELs), and other substance-specific benchmarks for compliance and risk management purposes.
• Periodic Reassessment: Recommends regular review and updates of assessments, especially when workplace conditions change.

Applications

• Industrial Hygiene: Supports risk identification, hazard control, and reduction of chemical-related skin diseases in occupational settings such as manufacturing, chemical processing, and research laboratories.
• Regulatory Compliance: Assists organizations in meeting legal obligations for workplace health and safety under European and international regulations, particularly regarding assessment and documentation of dermal exposures.
• Control Measures Evaluation: Enables evaluation of the effectiveness of existing interventions (e.g., personal protective equipment, engineering controls) intended to minimize skin contact with hazardous substances.
• Epidemiological Studies: Facilitates the collection and analysis of exposure data for research into occupational skin diseases and chemical-related health effects.
• Risk Communication: Provides a standardized approach for communicating risks and preventive actions to stakeholders, including workers, management, and regulatory authorities.

Related Standards

• 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
• ISO 78-2: Chemistry - Layouts for standards - Methods of chemical analysis

These related documents provide definitions, measurement strategies, and procedural requirements that complement the dermal exposure assessment framework outlined in SIST EN ISO 13977-1:2026.

---

By implementing SIST EN ISO 13977-1:2026, organizations benefit from a harmonized, evidence-based approach to assessing workplace dermal exposure, supporting proactive management of occupational health risks and demonstrating commitment to worker safety and regulatory compliance. Use of this standard aligns with best practice in occupational hygiene and enhances workplace chemical safety management systems.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2026
Zrak na delovnem mestu - Ocena dermalne izpostavljenosti - 1. del: Okvirno
navodilo za oceno dermalne izpostavljenosti (ISO 13977-1:2026)
Workplace air - Assessment of dermal exposure - Part 1: Framework for dermal
exposure assessment (ISO 13977-1:2026)
Luft am Arbeitsplatz - Beurteilung der Hautbelastung - Teil 1: Rahmen zur Beurteilung
der Hautbelastung (ISO 13977-1:2026)
Air des lieux de travail - Évaluation de l’exposition cutanée - Partie 1: Cadre pour
l’évaluation de l’exposition cutanée (ISO 13977-1:2026)
Ta slovenski standard je istoveten z: EN ISO 13977-1:2026
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.

EN ISO 13977-1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2026
EUROPÄISCHE NORM
ICS 13.040.30; 13.100
English Version
Workplace air - Assessment of dermal exposure - Part 1:
Framework for dermal exposure assessment (ISO 13977-
1:2026)
Air des lieux de travail - Évaluation de l'exposition Luft am Arbeitsplatz - Beurteilung der Hautbelastung -
cutanée - Partie 1: Cadre pour l'évaluation de Teil 1: Rahmen zur Beurteilung der Hautbelastung (ISO
l'exposition cutanée (ISO 13977-1:2026) 13977-1:2026)
This European Standard was approved by CEN on 4 April 2026.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13977-1:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 13977-1:2026) has been prepared by Technical Committee ISO/TC 146 "Air
quality" in collaboration with Technical Committee CEN/TC 137 “Assessment of workplace exposure to
chemical and biological agents” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2026, and conflicting national standards shall
be withdrawn at the latest by October 2026.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 13977-1:2026 has been approved by CEN as EN ISO 13977-1:2026 without any
modification.
International
Standard
ISO 13977-1
First edition
Workplace air — Assessment of
2026-04
dermal exposure —
Part 1:
Framework for dermal exposure
assessment
Air des lieux de travail — Évaluation de l’exposition cutanée —
Partie 1: Cadre pour l’évaluation de l’exposition cutanée
Reference number
ISO 13977-1:2026(en) © ISO 2026

ISO 13977-1:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 13977-1:2026(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 . 5
5.1 General .5
5.2 Substance-related information .5
5.3 Population at risk .7
5.4 Workplaces, tasks and/or processes at risk and risk management measures in place .7
5.5 Identify similar exposure groups .8
6 Dermal risk assessment . 8
6.1 Dermal hazard assessment .8
6.2 Qualitative dermal exposure assessment .9
6.2.1 General .9
6.2.2 Risk characterization per endpoint and substance .9
6.2.3 Availability of a dermal limit value .10
6.3 Quantitative dermal exposure assessment.10
6.3.1 Modelling dermal exposure .10
6.3.2 Measuring dermal exposure .11
7 Dermal risk assessment report .12
7.1 General section in the report . 12
7.2 Qualitative dermal exposure assessment . 13
7.3 Quantitative dermal exposure assessment. 13
7.3.1 Modelled dermal exposure assessment . 13
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 .28
Bibliography .33

iii
ISO 13977-1:2026(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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, 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 www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 146, Air quality, 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 13977-1:2026(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 can penetrate the stratum corneum to cause local effects
(irritation, corrosion or sensitization). Substances can also permeate through the skin reaching systemic
circulation leading to systemic effects, using different exposure pathways, namely:
— through sweat glands and hair follicles,
— the intercellular route (around the cells), or
— 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 can 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 specifies 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 specified 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 level of a
[5]
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.
Dermal exposure 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 either local effects or systemic health
effects;
— for compliance purposes, where results are compared with DLVs, e.g. DNELs, recommendations from
scientific committees, TLV-SLs, action levels and in-house limit values;
— for epidemiological studies, requiring estimates of relevant exposure parameters.

v
ISO 13977-1:2026(en)
This document is aimed at industrial and 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 document is the basis for future parts of the ISO 13977 series that will elaborate in more detail on the
methodologies and approaches that can be applied.

vi
International Standard ISO 13977-1:2026(en)
Workplace air — Assessment of dermal exposure —
Part 1:
Framework for dermal exposure assessment
1 Scope
This document specifies a framework introducing the approaches that can be applied to assess the risks
linked to dermal exposure to chemical substances in the workplace. This document provides guidance on
the different steps to be taken when performing qualitative and quantitative dermal exposure assessments.
This document is not applicable to inhalation, oral, ocular and mucous membranes exposure, biological
agents, wet work and mechanical stressors.
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 18158, Workplace air — Terminology
EN 1540, Workplace exposure — Terminology
ISO/IEC GUIDE 98-3, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in
measurement (GUM: 1995) — Supplement 1: Propagation of distributions using a Monte Carlo method
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18158, EN 1540 and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
contaminant layer
compartments 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 (3.6)
Note 1 to entry: This theoretical term is equivalent to the volume of the skin contaminant layer (SCL) (3.14); however,
for practical reasons, it is defined by the mass (in g) of all substances present on the SCL.

ISO 13977-1:2026(en)
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 loading
dermal exposure mass (3.5) divided by the dermal exposure surface area (3.6)
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) (3.14) divided by the surface area of that part, expressed, for example,
in milligrams per centimetre squared.
3.5
dermal exposure mass
mass of chemical agent present in the dermal contact volume (3.2)
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) (3.14).
3.6
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) (3.14), expressed in centimetres squared.
3.7
dermal hazard assessment
process to identify and characterize the adverse effects of a chemical agent, via the dermal route, based on
substance properties that are reflected in hazard statements (H-statements) and similar information
Note 1 to entry: Effects should be considered adverse only if they affect the viability and normal function of the
organism under test.
3.8
dermal limit value
DLV
level of exposure to the skin that is not expected to result in adverse biological effects
3.9
dermal risk assessment
overall process to identify potential risks based on a dermal hazard assessment (3.7) and a dermal exposure
assessment (3.3)
Note 1 to entry: A risk assessment usually includes risk mitigation, but this is outside the scope of this document.
3.10
local effect
adverse health effect that occurs at the site of contact with a substance
3.11
penetration
process that occurs when a substance enters the skin
3.12
permeation
process that occurs when a substance passes through the skin

ISO 13977-1:2026(en)
3.13
potential dermal exposure
dermal exposure that can occur on the unprotected skin or clothes
Note 1 to entry: All substance mass that can reach the body without applying any risk management measures (RMMs).
3.14
skin contaminant layer
SCL
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.
3.15
systemic effect
adverse health effect that occurs in a part of the body distant from the initial point of contact with a
substance
3.16
uptake
concentration-driven transport of a chemical agent from the skin contaminant layer (SCL) (3.14) into 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
RMMs] and the identification of similar exposure groups (SEGs) described in Clause 5. This is followed by a
qualitative dermal exposure risk assessment based on the classification of the product, substance or agent,
as defined in 6.2, and when required by a quantitative assessment when a method and DLV is available as per
6.3. The dermal exposure assessments shall be documented, and periodic reassessments shall be conducted
when significant changes occur at the workplace that can affect the dermal exposure and for evaluations
where no safe situation can be obtained. An annual interval for reassessment is recommended, whatever
the outcome, as defined in Clause 7. Figure 1 provides a schematic overview of the framework for dermal
exposure assessment.
ISO 13977-1:2026(en)
ISO 13977-1:2026(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
5 Information gathering
5.1 General
Information shall be obtained to:
— List all products and their constituents 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 or DLVs can be identified.
— Determine the population at risk.
— Identify the workplaces, activities and/or processes and the RMMs currently in place where workers can
be at risk.
— Identify SEGs.
5.2 Substance-related information
The preparation of a list of all substances in the workplace is an essential step to the identification of
the potential for exposure. The products’ safety data sheets (SDSs) and other available data are useful to
establish the list, which shall include the following information, if relevant:
— 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.

ISO 13977-1:2026(en)
— Classification and labelling, e.g. the health hazard (H) statements shall be evaluated to identify those
which can be relevant to the dermal route (see Table 1, Table 2 and Table 3). Due to local restrictions,
other statements can also be relevant, for instance EUH statements [these being additional labelling
[6]
information used in the European Union (EU)] related to skin or allergic effects .
— Substance properties that affect dermal absorption and toxicokinetics, e.g. octanol/water partition
[7]
coefficient (log P ), molecular size, ionization and particle size/dustiness, as well as product
ow
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.
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 Can cause an allergic skin reaction
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 Can be harmful in contact with skin
H340 Can cause genetic defects
H341 Suspected of causing genetic defects
H350 Can cause cancer
H351 Suspected of causing cancer
H360 Can damage fertility or the unborn child
H360D Can damage the unborn child
H360Df Can damage the unborn child. Suspected of damaging fertility
H360F Can damage fertility
H360FD Can damage fertility. Can damage the unborn child
H360Fd Can 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 Can cause harm to breast-fed children
H370 Causes damage to organs
H371 Can cause damage to organs
H372 Causes damage to organs through prolonged or repeated exposure
H373 Can cause damage to organs through prolonged or repeated exposure

ISO 13977-1:2026(en)
These shall then be checked in publicly available databases (e.g. the “Information on Chemicals” platform
[8] [9]
in the ECHA website , PubChem (US National Institutes of Health) or Annex VI of the CLP Regulation
[10]
(Regulation (EC) No. 1272/2008 ).
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 will not always be available. In absence of these
data, the substance properties that affect dermal absorption can be evaluated, including the log P , the
ow
[7]
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
[11]
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
[12]
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.
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 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, and the extent of that 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 can include questionnaires or scoring systems, like the Nordic Occupational Skin Questionnaire
[13] [14],[15] [16]
(NOSQ-2002), the Hand Eczema Severity Index (HECSI), the Manuscore, the Osnabrück Hand
[16] [14]
Eczema Severity Index (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 water loss (TEWL) from the skin surface, skin hydration and quantitative
[17]
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. It is also important to
take into account accidental damage of the skin that will or will possibly not be work-related. On the other
hand, combining data generated on an individual level can generate valuable information on a group level. It
is advised to document and retain these (anonymised) observations at company or industry level to be able
to identify any group level issues of concern.
5.4 Workplaces, tasks and/or processes at risk and risk management measures 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.
ISO 13977-1:2026(en)
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;
— 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
[18]
found in EN 689:2018+AC: 2019, 5.2.1. However, validation and constitution of SEG's will not always be
possible in all cases with dermal exposure measurement results, e.g. due to a potential high variability in
measurement results.
6 Dermal risk assessment
6.1 Dermal hazard assessment
The first step in the dermal hazard assessment is to identify whether the substances under assessment can
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 6.2.2).

ISO 13977-1:2026(en)
— 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 6.2.2).
— No H statement is assigned to the substance under assessment but local carcinogenic effects are identified
(see B.2.3), an assessment is required (see 6.2.2).
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.
When multiple H statements are assigned to the substances under assessment, it is possible that multiple
endpoints need to be evaluated in the hazard assessment.
6.2 Qualitative dermal exposure assessment
6.2.1 General
Once the hazard assessment 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.
[19]
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
[20]
to Health (COSHH) Essentials and Système d’évaluation et d’information sur les risques chimiques en
[21]
milieu professionnel (Seirich) 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
[22]
or exposure classes (low, medium, high), are the Einfaches Maßnahmenkonzept Gefahrstoffe (EMKG),
[23] ®1)[24]
Dermal Risk Assessment Method (DRAM), Stoffenmanager and DeRmal Exposure Assessment
[25]
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.
6.2.2 Risk characterization per endpoint and substance
If the hazard assessment has local corrosive or irritant, sensitizing, local carcinogenic and/or systemic
effects as an endpoint for one or more substances, the assessment continues with a qualitative dermal
exposure assessment for each relevant endpoint per substance.
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 for this endpoint.
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
after its implementation. When elimination or substitution is not feasible, appropriate (further) RMMs shall
be implemented. RMMs are only considered adequate if it can be demonstrated to the RMMs effectively ®
1) Stoffenmanager is a trademark of a product supplied by Cosanta B V. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO.

ISO 13977-1:2026(en)
reduce or suppress dermal exposure in the situation that is assessed, for example, prevention of direct hand
contact or formation of splashes that can hit body or face. Then the risk characterisation is acceptable, and
the assessment shall be terminated and documented for this endpoint.
When no adequate RMMs are available, the assessment continues w
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