exposure scenario conference oslo exposure … scenario conference –oslo exposure models in reach...

Exposure Scenario Conference – Oslo

Exposure models in REACH

24 October 2014

Stefano Frattini

Risk Management Identification D2

Overview

• Purpose of Chemical Safety Assessment (CSA)

• Worker exposure assessment

• Consumer exposure assessment

• Environmental exposure assessment

• Chemical Safety Assessment tool (Chesar)

10/27/2014INTERNAL 2

Purpose of the Chemical safety Assessment (CSA)


When is a CSA required?

• If the substance manufactured or imported at 10 tonnes or more per year a CSA is required.

• The CSA includes exposure assessment and risk characterisation for all the identified hazards, if• one of the criteria is met to classify the substance as hazardous

• the substance is to be treated as PBT/vPvB

• information requirements are adapted based on exposure considerations according to Annex XI (3)

• Identified hazards = adverse effects observed

• Annex I of REACH sets out the general provision for the assessment


Purpose of the CSA process

• Describe the conditions ensuring control of risks arising from manufacture and use(s) of a substance

• The set of information describing the operational conditions and risk management (if needed) for a use is called exposure scenario

• Identify where further information is needed (exposure data or testing the substance).

• Inform users of the substance on the conditions of safe use (via exposure scenario attached to the SDS)

• Document the assessment in a CSR for the companies’ own documentation.

• Submit CSR to the authorities (ECHA and MS)


Assessment workflow

Fulfil information requirements for the

various endpoints

Derive hazard assessment conclusions (DNELs,

PNECs, CnL);

Describe the uses of the sub-stance; compile information on

the existing conditions of use

Exposure scenario building, exposure estimation, risk

characterisation

Communicate information on substance properties and conditions of safe use via

extended SDS

CSR to authorities


Exposure estimation

• Role of exposure estimation

• Enable the calculation of Risk Characterization Ratio (RCR) when (semi)quantitative assessment is needed (DN(M)EL, PNEC)

• Can be used to support qualitative assessment as well

• Exposure estimation can be achieved by:

• Modelling tools

• Measured data

• Exposure estimation follows from conditions of use reported in the exposure scenario

Exposure estimation - Workers


Workers - Routes of exposure

• Inhalation• Dust

• Gas

• Vapour

• Liquid aerosol

• On the skin and via the skin

• Inadvertent ingestion?

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How to assess exposure – Empirical models

• Tier 1

•Supposed to be screening tools

•Often no access to original data

•May be issues over validity of data

•Generic but may be off the mark (domain of applicability)

•Process-based

•May be highly over-predictive or may be under-predictive

•Need very careful interpretation (context)

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How to assess it – Empirical models

• Tier 2• Generic

• Often linked to original data sources

• Better defined inputs and outputs

• Data specifically collected to address specific scenarios

• Multiple individual targeted models (inhalation, dermal)

• More refined for aerosols and dermal exposures

• Expertise needed to select correct models and defaults

• Can select appropriate values from the distributions of exposure (50%, 75% 90%, 95% values) to inform acute, short, medium, long term exposure scenarios

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What models do we have?

• Inhalation• ECETOC TRA

• Stoffenmanager

• ART (Tier 2)

• BEAT (Tier 2)

• EMKG

• MEASE

• SprayExpo

• Dermal• ECETOC TRA

• Riskofderm

• BEAT (biocides)

• POEM/BROWSE (plant protection products)

• Ingestion• ?

ECETOC - TRA workers v2

• ECHA guidance R14 – “the preferred model”

• Standalone and simple to use

• Developed from EASE – based on UK HSE exposure data from range of industrial workplaces

• Amended on the basis of industry professional judgement

• Developed to align with and influence structure of exposure assessment under REACH

• Not scientifically validated (Eteam project) but decent documentation

• Introduces exposure reduction factors as RMMs and operational conditions

• Introduced concept of Process Categories (PROCs)

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ECETOC - TRA worker v2 user defined variables

• Fugacity (dustiness or volatility: 3 bands for each)

• Molecular weight, physical state

• Volatility (Pa) for liquids

• Process Category (30+)

• Industrial or public domain use (professional)

• Indoors/outdoors

• Local exhaust ventilation (yes/no) • PROCs define effectiveness

• Duration of activity (4 bands)

• RPE used? (0%, 90%, 95% reduction in exposure)

• Preparation (yes/no)

• Concentration range (<1%, 1-5%, 5-25%, >25%)

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ECETOC - TRA Boundaries of applicability

Aerosols/mists X

Fibrous materials X

Inhalable v respirable X

Process fumes X

Solids in liquids X

Gases X

CMRs and Sensitisers - use caution ?

Mixtures - take care ?

UVCBs – developed for mono-constituents ?

Elevated temperatures ?

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ECETOC – TRA worker v2 issues

• Generally ok to accept point of departure of inhalation exposures but high exposure reduction through LEV is questionable

• Very wide volatility bands (same answer for all substances in band)

• Address long term and not short term inhalation exposure

• All estimates deemed to be 90th percentile values

• Personal protective equipment for dermal exposure is not included

• The dermal exposure for some situations (with local exhaust ventilation) is underestimated compared to measured data

• Artificially uses hands, forearms and face as target exposed area –can lead to spurious conclusions on RMMs

• Model has limited scientific foundation for dermal exposure

• LEV modifier automatically applied for dermal if used for inhalation

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ECETOC TRA worker v3

• Similar to version 2 but with some new modifiers related to gloves, general ventilation and use of mixtures for dermal exposure, peak exposures.

• New “very low volatility” category for liquids

• Model default decouples LEV from dermal exposure

• Some changes to LEV effectiveness for some PROCs

• Changes to LEV effectiveness for dermal challenge

• Standalone version not user friendly and all TRA tools bundled together

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ECETOC TRA worker v3 (input)

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comments:

Molecular weight 120 g.mol -1-> HH and env

Vapour pressure (Pa OR hPa) 2.20E+01 Pa conversion 2.20E+01 VP [Pa] at °C 20 -> HH and env

Water solubility 40000 mg.L-1 at °C 20 -> Env

Partition coefficient octanol-water ( - OR Log(Kow)) 1.10E+00 logKow conversion 1.26E+01 Kow [-] -> Env

Biodegradability test result readily biodegradable -> Env

Chemical class for Koc-QSAR -> Env

Koc (L.kg-1) OR Log(Koc)) Koc Koc L.kg-1-> Env

Partition coefficient ksoil/water L.kg-1optional - can be estimated by QSAR -> Env

Partition coefficient ksediment/water L.kg-1optional - can be estimated by QSAR -> Env

Partition coefficient to suspended solids L.kg-1optional -> Env

Additional physico-chemical parameter input for refined environmental assessment (TIER 2) Input of additional PC data: go to row 165 of datasheets

No. Scenario name

Process Category

(PROC)

Type of setting

(PROC 7 and 22 always

industrial, PROC 11 and 20

always professional) Is substance a solid? (yes/no)

Dustiness of solids OR

VP of volatiles (Pa) at

process temperature

(clear entries if you

change column F to

"No")

Duration of activity

[hours/day]

Use of ventilation ?

(addresses outdoor use, LEV and general

ventilation)

Use of respiratory

protection and, if so,

minimum efficiency ?

Substance in preparation? (applies

to inhalation and dermal for

volatiles and solids) Dermal PPE / Gloves

Consider LEV for dermal

exposure?

(conservative default is

"No")

1

Batch mixing PROC 5 industrial No >4 hours (default)Indoors with LEV and good general

ventilationNo 5-25% Gloves APF 5 No

2

Spaying PROC 7 industrial No >4 hours (default)Indoors with LEV and good general


3

Brushing PROC 10 industrial No >4 hours (default)Indoors with LEV and good general


4

Dipping PROC 13 industrial No >4 hours (default)Indoors with LEV and good general


Human Health Assessment - Workers

mandatory if QSAR estimation of ksoil/water and Ksediment/water is required

Physical-chemical properties - minimum input for Human Health and Environmental Assessment

ECETOC TRA worker v3 (output)

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Long-term Inhalative

Exposure Estimate

(ppm for volatiles) /

(mg/m3 for solids)

Long-term

Inhalative

Exposure

Estimate (mg/m3)

Long-term Dermal

Exposure Estimate

(mg/kg/day)

Short-term Inhalative

Exposure Estimate

(mg/m3)

Local Dermal

Exposure Estimate

(µg/cm2)

Notes/comments on

exposure estimates:

2.10E-01 1.05E+00 1.65E+00 4.20E+00 2.40E+02

LEV efficiency inhalation

[%]: 90, LEV efficiency

demal [%]: 0,

2.10E+00 1.05E+01 2.57E+00 4.20E+01 1.20E+02



demal [%]: 0, Note that

the TRA predicts vapour

phase exposure;

exposure by aerosols is

not taken into account; if

aerosol formation is

relevant, refer to other

information or models.

4.20E-01 2.10E+00 1.65E+00 8.40E+00 1.20E+02



demal [%]: 0,

4.20E-01 2.10E+00 8.23E-01 8.40E+00 1.20E+02



demal [%]: 0,

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Riskofderm

• Attempt to gather dermal exposure data specifically for REACH purposes

• Independent check of earlier work

• Extending dermal exposure into industrial chemicals

• Simple model


ART

• Web-based expert tool

• Assessment of volatile components and aerosols for low volatility substances

• Multiple input fields

• Many variables and easily configured

• Provides outputs at a range of %ile values from distribution

• Requires experienced user to define scenarios


ECETOC TRA v ART (inhalation)

Roller styrene resin: Directly in breathing zone (8 hour twa)

PROC 10 roller application

ECETOC TRA estimate

No LEV (ppm)

ART estimate

No LEV (ppm)

ECETOC TRA estimate

LEV (ppm)

ART estimate

LEV (ppm)

Room size: 300 m3

(ART)30 30 3 15

1000 m3(ART) 30 20 3 10

Styrene (SVP 0.67 kPa @20oC) – major component 10-50%

Boiling Point 145oC ART 90% value

Process temperature 30oC

Typical worker 8-hour exposures to styrene from laminating 30-70 ppm

Short term exposures 100 -150 ppm

ECETOC fugacity range

SVP: 0.5 – 10 kPa

Exposure estimation - Consumers

Principles

• Set in R15 guidance

• Scope very broad (e.g. mixtures, articles, construction material)

• Covers reasonable worst case situation (combined exposure, phases of activities)

• Routes are inhalation, dermal and oral

• Targets can be adults and/or children

• Tools

• Tier I (ECETOC TRA v2, v3.0, v3.1)

• Tier II - Consexpo 4.1

• Other tools (RIVM emission tool, EGRET, REACT)

10/27/2014INTERNAL 25


Tier I models – ECETOC TRA v.2

• Very rigid

• Conservative (i.e. air exposure estimation = event exposure)

• Principles following R15 guidance

• Difficult to ensure safe use

• Documentation: Addendum to ECETOC Targeted Risk

Assessment Report No. 93 Technical Report No. 107 –Appendix E (http://www.ecetoc.org/tra)

http://www.ecetoc.org/tra


Tier I models – ECETOC TRA v3.0

• More flexible but still conservative•E.g. air concentration = event concentration

•Not possible to average dose/concentration over the year for infrequent uses

• What’s new:•Saturated vapour concentration

•Dilution in air due to standard room ventilation

•Dermal/oral transfer factor (default = 1)

•Possible to set a new subcategory with new input parameters


Tier I models – ECETOC TRA v3.0

• Shortcomings•How to justify Dermal/oral transfer factor lower than 1

•New subcategory parameter can be set by single registrant

• Documentation•ECETOC TRA version 3: Background and Rationale for the Improvements Technical Report No. 114 (http://www.ecetoc.org/tra) Chapter 3, Appendix F-I.



A: Vapour pressure >= 10 Pa DISCLAIMER

Default Vapour Pressure Band (non-spray)Default fraction

released to air

A: Vapour pressure >= 10 Pa 1 A

B: Vapour pressure between 1 and 10 Pa 0.1

C: Vapour pressure between 0.1 and 1 Pa 0.01

D: Vapour pressure < 0.1 Pa 0.001

2.20E+01

Reference Value (Inhalation) 2.50E+01 mg/m3

Reference Value (Inhalation) mg/kg/day

Reference Value

(Dermal)8.00E+00 mg/kg/day

Reference Value

(Oral)8.00E+00 mg/kg/day

Molecular weight 108 g/mol OPTIONAL (default values will be used if none entered)

Saturated vapour concentration

(SVC)9.59E+02 mg/m3

Use "x" only ADULT CHILD ADULT CHILD

PC1:Adhesives, sealants Glues, hobby use x 0.01

Glues DIY-use (carpet glue, tile glue, wood parquet

glue)0.01

Glue from spray x x 0.01

Sealants 0.01

Select Use by

Product

Subcategory

ECETOC is making this tool available for users to aid them in the risk assessment of

their materials. ECETOC offers no warranty either to the reliability of the tool and of

the provided information or to the conclusions or assumptions made by any user on

the basis of the use of this tool or the use of such information. All usage is at the

discretion of the user and ECETOC is not liable for any consequences resulting from

such use.

Contact Area

(cm2)

Contact Area

(cm2)

Skin Contact

Area (cm2)

Product

Ingredient

Fraction by

Weight

INHALATIONORAL

DEFAULT VP

(non-spray)

CLASSES

A

B

Dermal

Transfer

Factor

1 COLOR CODES

Automatically selected

Optional entries

Mandatory entries

PRODUCT

SUBCATEGORY

Please note that this tool is provided for your personal use only. It should not be

copied or forwarded to third parties.The tool has been subjected to thorough testing.

Despite this, ECETOC does not guarantee that the ECETOC TRA tool works error-

free.

Skin Contact

Area (cm2)

Product is

a spray

DERMAL

Default values of 1 (or 100%)

are used unless noted

otherwise

C

D

Use "x" only

Vapour Pressure (Pa)

Product Subcategory

Amount Product

used per

Application

(g/event)

Descriptor

Select Use

by Sentinel

Product

Oral

Transfer

Factor

Parameter: Product

Ingredient

(g/g)

Contact Area

(cm2)

Transfer Factor

(unitless)

FreQuency of

use

(events / day)

Thickness of

Layer

(cm)

Density

(g/cm3)

Conversion

Factor

(mg/g)

Body Weight

(kg)Exposure

(mg/kg/day)

Algorithm: (PI x CA x TF x FQ x TL x D x 1000) / BW

Descriptor Product Subcategory

PC1:Adhesives, sealants Glues, hobby use 0.01 35.7 1 1 0.01 1 1000 60 5.95E-02

Glues DIY-use (carpet glue, tile glue, wood parquet

glue)

Glue from spray 0.01 35.7 1 1 0.01 1 1000 60 5.95E-02


Beyond Tier I? – ECETOC TRA v3.1

• What’s new:• Inhalation transfer factor included (by default 1)

•Reduction of long term exposure/dose by frequency over the year• Bands of frequency are used to reduce dose/exposure: occasional uses

(less than once/week), infrequent uses (less than once/month), very infrequent uses (less than once/6 months)

• Developed for SCEDs

• Now available on ECETOC website (http://www.ecetoc.org/tra)



SCEDs

• SCEDs (Specific Consumers Exposure Determinants) define specific new subcategories with related input parameters (to feed TRA v 3.1) with justification/source of info

• Developed by sector organizations (DUCC)

•AISE (PC 35, 31, 3), CEPE (PC 9), CONCAWE (PC 13, 24), FEICA (PC1)

•Available at: http://www.ducc.eu/Activities.aspx

• Boundaries

•Long term exposure only, no post application

http://www.ducc.eu/Activities.aspx


SCEDs

• Areas which needs careful evaluation• Justifications related to dermal/oral/inhalation transfer factors; not clear yet what are convincing reasons to justify a reduction of exposure (measured data for inhalation, viscosity for dermal, etc.)

• Justification to skip exposure routes (unless evident)

•Applicability domain of the SCED (e.g. only for non volatile substance)

•Possibility to average exposure/dose over the year subject to R15 Guidance update.


Tier II tools – Consexpo 4.1

• Complex tool which includes several models•4 for air exposure estimation (1 spray model)

•5 for dermal and 4 for oral

• Boundaries / limitations•Evaporation model not suitable for article (designed for mixture)

•Limited validation (evaporation and spray model only)

•Some boundary not expressed (spray model suited to non volatile substances only)



• Outputs:•Event, daily and yearly averaged concentration/dose

•Sensitivity analysis

•Montecarlo analysis

• Standard scenarios based on RIVM fact sheet•Very useful, input parameter based on well established RIVM fact sheet

•Only few parameters to be entered by the user

•Covering PC 35, PC 31, some PC 9 and PC 1 sub products



• Standard scenarios useful but …•High granularity of sub products: how to ensure representativeness in a reasonable limited number of scenarios (for PC 35 more then 30 RIVM factsheets covering different sub products)

•Pre application, application and post application considered for the same product (e.g. dishwashing). How to reflect it in the ES.

•Some input parameter not easy to understand

• Documentation/tool• http://www.rivm.nl/en/Documents_and_publications/Scientific/Models/D

ownload_page_for_ConsExpo_software

• http://www.rivm.nl/en/Topics/C/ConsExpo/Fact_sheets

http://www.rivm.nl/en/Documents_and_publications/Scientific/Models/Download_page_for_ConsExpo_software

http://www.rivm.nl/en/Topics/C/ConsExpo/Fact_sheets

Exposure estimation - Environment


Principles

• Principles set in R16 Guidance

• Different scale of the assessment• Local scale

• Regional scale

• Environmental exposure assessment encompasses:• Release estimation (release models)

• Exposure estimation for different targets (fate and transport model)

• Exposure estimation and risk characterization for different compartments• Water (fresh/marine water, sediment/pelagic, food chain)

• STP

• Air

• Soil (agricultural soil, food chain)

• Man via environment (oral intake, inhalation)


Scale of the assessment

• At local scale, meaning in the vicinity of point sources of release to the environment:• industrial facilities

• STP (standard town of 10,000 inhabitants)

• As a consequence of the short time between release and exposure, concentration at local scale is controlled by initial mixing and adsorption. Degradation mechanism are not (less) relevant at this level

• The output is the calculation of the Local Concentration

• At regional scale, for a larger area which includes all point sources and wide dispersive sources in that area:• 200 x 200 km with 20 million inhabitants

• More time available for transport and degradation mechanism

• Regional concentration (PEC regional) serves as background for the localPredicted Environmental Concentration (PEC Local)

• PEC Local = Local Concentration + PEC regional


General scheme of the assessmentSubstance

properties

“Stage” described with

at minimum:

- ERC

-Tonnage for that stage:

► daily use at site

► annual use at site

► daily wide dispersive

use

Release estimates

for

-Water

-Air

-Soil

Conditions of use:

OC/RMM

↕

Exposure estimates for

all protection target:

-Water

► fresh and marine :

pelagic, sediment

► STP

► food chain

-Air

-Soil

► soil

► food chain

Release model

E

U

S

E

S

Municipal STP

Dilution in receiving

water

Fate and

transport model


Releases vs transport/fate – Local scenario


Release estimation – “Basic” use conditions

• Amount related determinants• Tonnage per use (used for regional assessment)

• Daily/annual use at a site (used for local assessment)

• Percentage of tonnage used at regional scale (used for regional assessment)

• Municipal sewage treatment plant (STP) related determinants:• Availability of the STP (yes by default)

• Discharge rate of STP: 2000 m3/day by default as in EUSES

• Application of the STP sludge on agricultural soil (yes by default leading to soil exposure)

• Dilution related determinant • Receiving surface water flow rate: set by default to 18 000 m3/day as in

EUSES


Release estimation - Methods

• ERC methods (default)• release factor is given by ERC selection (conservative)

• Release factor• release factor is provided by the registrant, generally derived

from literature (e.g. OECD ESD).

• Measured releases• Release rate measured at the site is provided by the registrant

(e.g. from manufacturing site)

• SPERC• Release factor together with related condition of use (either at

the process level or as end of pipe RMMs) are provided by sector organization in standard format


CoU driving release factor / rate

• Unless default (conservative) ERC release method is used, the registrant should justify release factors / rate and report related Condition of Use

•At the process level: e.g. water contact (dry/wet process), equipment cleaning, efficient use of chemicals (water reuse), etc.

•RMM reducing releases to air (e.g. air scrubber) or water (e.g. WWTP like physical separator, chemical oxidation, etc.)


SPERCs

• SPERCs are developed by sector organisation (e.g. ESIG, Eurometaux, FEICA, AISE, CEPE, ACEA, etc.)

• SPERCs provide release factors, justifications, related CoU (OC/RMM) for different uses supported by sector organization

• Those elements are collected in standardised format called “SPERC Factsheet”

• Can be used by registrant for release estimation in their dossier

• Ongoing project held by ECHA (via contractor) in collaboration with industries:

• Define SPERC requisites

• Develop good examples of SPERCs

• Same principles above apply to SPERCs

• SPERCs documentation available at CEFIC and sector organisation website.


Fate and transport estimation

• The EUSES fate/transport estimation encompasses different mechanism/model:•Partitioning and degradation behaviour (mainly driven by substance properties).

•Distribution and fate model at local scale

•Distribution and fate model at regional scale

•Modelling STP (% of inflow substance which biodegrades, adsorbs into sludge, volatilizes and will be finally released to surface water)


10 m

air

aerosolrainwater

gas phase

partitioning

wind

wet deposition

partitioning

dry deposition

degradation

1000 m

100 m

Average deposition flux

Accumulation over 10 year

0 m

heat content 0 MW

Cair

Csoil

STP

dilu

tion

pa rti tioningsus pend ed

m atter

vo

latil is

atio

n

degrad ations edimen tatio n/

res us pens ion(regional)

(regional)

Air model: Local scale SW model: Local scale

REGIONAL MODEL:

Overview

Chemical Safety assessment tool


Chesar tool

• Chemical Safety Assessment and Reporting Tool

• IT Tool developed by ECHA

• supports registrants to prepare their CSA

• used to carry out the exposure assessment and risk assessment

• TRA workers and consumers (v 3.0 - 3.1) and EUSES (+release module) are embedded in Chesar

• facilitates the re-use of CSA elements imported from external sources (e.g. SPERC / SCED developed by industry organisations)

• enables automated generation of the Chemical Safety Report (CSR) and the Exposure Scenario (ES) for communication

• greater efficiency, harmonisation & consistency

• Available at: https://chesar.echa.europa.eu/

https://chesar.echa.europa.eu/


Assessment workflow

10/27/201410/27/2014

Fulfil information requirements for the

various endpoints

Derive hazard assessment conclusions (DNELs,

PNECs, CnL)

Describe the uses of the sub-stance; compile information on

the existing conditions of use

Exposure scenario building, exposure estimation, risk

characterisation

Communicate information on substance properties and conditions of safe use via extended SDS

CSR to authorities

Exposure Scenario Conference – Oslo

Scaling

24 October 2014

Stefano Frattini

Risk Management Identification D2

Overview

• Verification of the ES attached to SDS

• What the scaling is

• Option and limitation of scaling

• How to apply scaling

• Outcome of scaling

• Example of scaling

10/27/2014INTERNAL 51

Verification of the ES attached to SDS

• The use and condition of use are covered by the ES

• No action! Only document conclusion of the verification

• It is not clear whether the use and use condition are covered by the ES

• Use might be included in more general use in the ES

• Scaling might be applicable

• The use and condition of use are not covered by the ES

• Actions are needed• Modify use and/or use condition

• Request the supplier to include the use / use condition into a new ES

• Look for another supplier

• Do not use the substance

• Prepare DU CSR

10/27/2014INTERNAL 52

What the scaling is

• It is a mathematical method to show that DU works under use condition described in the ES

• It is applicable to quantitative parameter only

• Is applicable if registrant has used an exposure model for the assessment

• Not applicable if the assessment is based on measured data

• Scaling is not a means for DU to justify his condition of use if the received ES is ultra conservative

10/27/2014INTERNAL 53

Options and limitations

• Options for scaling

• Are included in section 4 of ES received by the supplier

• They include• Method, i.e. formula or link to software or model

• Parameters that may be scaled and their limits of variability

• Limitation of scaling

• The RCR obtained by scaling should not be higher than the RCR obtained under the condition of use set in the ES

• Scaling does not impact on other elements of the assessment• Qualitative assessment

• PEC regional for the environment (i.e. increasing release rate to water compensated by higher dilution factor)

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How to apply scaling

• Compare your condition of use to those reported in the ES and identify what parameters do not correspond

• Verify if scaling is foreseen in the ES and if parameters previously identified can be scaled. If not, scaling is not applicable

• Use scalable parameter reflecting CoU at the site as input to a model (or formula) mentioned in section 4 of the ES

• Verify if scaling boundaries are fulfilled (e.g. RCR is not increased)

• Document the outcome of scaling

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Outcome of the scaling

• Scaling shows that the use is covered

• Scaling does not fulfil boundaries (e.g. RCRSC > RCRES

or parameters are not scalable or scaling is not foreseen in section 4)

• The use is not covered

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Example of scaling - Environment

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4. Guidance to DU to evaluate whether he works inside the

boundaries set by the ES

Scaling method – Environment

Exposure estimation tool used: EUSES 2.1.2

Scalable Parameters: Environment

Daily quantity

The effectiveness of the following RMM, if available at DU sites, can be included

in the scaling parameters

On site air emission abatement system

On site waste water treatment

Non scalable parameters

Other parameters (different from those indicated under scalable parameters)

have to be taken (with no change) from the Exposure Scenario provided

Boundaries of Scaling

RCR not to be exceeded are described in Section 3of the ES.

Release Rate not to be exceeded as described in Section 3 of the ES

Scaling instructions

For Scaling instructions and scaling software please go to the following website:

http://companyX-reach/scaling/

Example of scaling - Environment

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Parameter ES DUDaily use of the

substance (kg/d)0.02 0.1

Wastewater

treatment plant flow

(m3/d)

2000 In line with ES

Receiving water

body flow rate

(m3/d)

18000 In line with ES

Onsite Removal

Efficiency -

Wastewater - other

than on-site STP (%)

0% (not

foreseen)90%

Municipal Sewage

Treatment Plant

used?

Yes In line with ES

On-site (industrial)

Sewage treatment

plant used ?

Yes In line with ES

Municipal Sewage

Sludge applied to

soil? (yes/no)

Yes In line with ES

Release rate

Release route ES Scaling Tool (DU conditions)

Conclusion

Water 0.1 kg/day 0.05 Kg/Day OK

RCR

Protection target ES Scaling (DU)

OK

Freshwater 0.378 0.189 OK

Sediment (freshwater)

0.377 0.189 OK

Marine water 0.3780.189

OK

Sediment (marine water) 0.378 0.189 OK

Sewage treatment plant 0.026 0.013 OK

Agricultural soil 0.154 0.078 OK

Man via Environment –Inhalation

< 0.01 < 0.01 OK

Man via Environment – Oral < 0.01 < 0.01 OK

Background slides

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From hazard conclusions to exposure assessment

Route Type of effect Type of risk

characterisation

Hazard conclusion (see section

5.11)

Inhalation

Systemic effect - Long-term Quantitative DNEL = 24.7 mg/m3

Systemic effects -Acute Not required No hazard identified

Local effects - Long-term Qualitative Hazard unknown (no further

information required)

Local effects - Acute Qualitative Hazard unknown (no further

information required))

Dermal

Systemic effect - Long-term Quantitative DNEL = 7 mg/kg bw /day

Systemic effects -Acute - Not required No hazard identified

Local effects - Long-term Qualitative Low hazard

Local effects - Acute Qualitative Low hazard

Eyes Local effects –Acute Qualitative Low hazard


spraying

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