Appendix 1

Basic Manual for Calculation of the Estimated Human
Exposure Used in the Risk Assessment of Consumer
Products

Table of Contents
I Purpose of This Document ........................................................................................................1
II Basic Exposure Scenario and Algorithm ................................................................................3
II-1 Inhalation Route..................................................................................................................3
II-2 Dermal Route .................................................................................................................... 11
II-3 Oral Exposure ...................................................................................................................15
Reference: Exposure Factors ................................................................................................19
III Specific Exposure Scenarios by the Application Category of the Products and Exposure
Assessment Examples...............................................................................................................21
III-1 Household Adhesive .......................................................................................................22
III-1-1 Scope of This Category ............................................................................................22
III-1-2 Characteristics of This Category .............................................................................22
III-1-3 Exposure Scenario and Algorithm...........................................................................22
III-1-4 Example of Assessment ...........................................................................................24
III-2 Household Coating Material and Wax ............................................................................27
III-2-1 Scope of this Category .............................................................................................27
III-2-2 Characteristics of this Category ..............................................................................27
III-2-3 Exposure Scenario and Algorithm...........................................................................27
III-2-4 Example of Assessment ...........................................................................................29
III-3 Household Detergent.......................................................................................................35
III-3-1 Scope of this Category .............................................................................................35
III-3-2 Characteristics of this Category ..............................................................................35
III-3-3 Exposure Scenario and Algorithm...........................................................................35
III-3-4 Example of Assessment ...........................................................................................37
III-4 Deodorant/Air Freshener and Repellents for Nuisance Insects ..................................43
III-4-1 Scope of this Category .............................................................................................43
III-4-2 Characteristics of this Category ..............................................................................43
III-4-3 Exposure Scenario and Algorithm...........................................................................43
III-4-4 Example of Assessment ...........................................................................................45
III-5 Auto Products ..................................................................................................................52
III-5-1 Scope of this Category .............................................................................................52
III-5-2 Characteristics of this Category ..............................................................................52
III-5-3 Exposure Scenario and Algorithm...........................................................................52
III-5-4 Example of Assessment ...........................................................................................54

I Purpose of This Document
This Appendix describes the algorithms (calculations) needed to estimate the amount of human
exposure for each possible route of exposure (inhalation, dermal, or oral) shown in Figure 1fn foruse in the risk assessment of consumer products.
The amount of general exposure may represent “Intake amount” of chemical substances frommediums such as the air, or “Uptake amount” of it into a human body. In exposure assessments, it
is important to clarify whether the target amount is either the aforementioned “Intake” or “Uptake”.
“Intake” is generally estimated using measured or estimated values of the concentration in themedium, frequency and duration of application. With respect to an estimate of transition from the“Intake” amount to the “Uptake” amount, there is little necessary information with a few exceptions.
Therefore, in this Appendix, firstly the “Intake” amount should be calculated using the algorithms
corresponding to the scenario set for each exposure route, and then the “Uptake” amount shouldbe estimated by multiplying the value obtained by the uptake fraction (a). The “Uptake” value
obtained is the Estimated Human Exposure (EHE). Without the case that the uptake fraction of thehumans or animals used in the hazard assessment of chemical substances, has been identified, a= 1 (100 %) for the uptake fraction (a) should always be used as the uptake fraction, in every
exposure route.

IntakeUptakePotential
Dose

Applied
Dose

Internal
Dose

BiologicallyEffective
Dose

Inhalation Exposure
IntakeExposure

UptakePotential
Dose

Applied
Dose

Internal
Dose

BiologicallyEffective
Dose

ChemicalSubstance
Mouth/ Nostrils

Alveolar walls

Dermal Exposure
ExposureInternal
Dose

Applied
Dose

Organ

Effects

Organ

Effects

BiologicallyEffective
Dose

Chemical SubstanceSkin

Effects

Metabolism

UptakePotential
Dose

Organ

Metabolism

Oral Exposure
UptakeIntakePotential
Dose

Exposure

Applied
Dose

Internal
Dose

BiologicallyEffective
Dose

ChemicalSubstance
Mouth

Gastrointestinal tract

Metabolism

Figure I Schematic of Dose and Exposure1

Although this Appendix describes algorithms considered to be appropriate for calculating EHE,
they are not always applicable to the wide variety of consumer products available. Therefore, after
carefully considering the characteristic of the consumer product and the chemical substances
contained in the product, usage pattern of the product and other such factors, it may be necessary
to establish individual algorithms for the EHE calculations, by actual measurements of parameters
through experimental or other methods, and scientifically reliable reference documents or sources.
In addition, beside the algorithms introduced in this Appendix, there might be other similar or
improved/reinforced algorithms available. Moreover, occasionally some or all of the factors
required for the algorithms might be available by experiments. If the evaluator has ascertained
scientifically reliable algorithms or actual measured values available, they may use them inassessments.

2

II Basic Exposure Scenario and Algorithm
In this section some exposure scenarios are provided for each of the exposure routes of
inhalation, dermal, or oral as basic consumer product exposure scenarios. Note that this Appendix
does not provide scenarios that take exposure via general environment or other consumer
products into account. The initial concentrations have not been set (the initial concentration = 0),
as the contribution from another products and the general environment are not considered here.

II-1 Inhalation RouteThe following is a basic algorithm 1for estimating Human Exposure through the inhalation route.
That is, it estimates the respiratory intake of target substances in the air from breathing air.

EHE (inha ) =Cat × Q × t × n × a (inha )BW(II-1-1)

EHE (inha)：Uptake of Inhalation Exposure (mg/kg/day)
Cat: Average Air Concentration of Exposure Duration (mg/m3)
Q: Inhalation rate of the exposed person (m3/h)
t: Duration of Exposure per Event (h/event)n: Mean number of events per day (events/day)a (inha): Uptake Fraction (inhalation) (dimensionless)*Unless the body absorbance by humans and animals used in the hazard assessment of
the chemical substance has been identified, a (inha) = 1 (100 %) should be used,regardless of exposure route.

BW: Body Weight (kg)With inhalation exposure, as the inhalation rate of the exposed person is assumed to be aconstant, estimation of the concentration of the compound in the air is important. Depending on
the emission characteristics of the chemical substance in the consumer product used one of thefollowing 4 modes should be selected and used to calculate the Cat (Average Air Concentration of
Exposure Duration).
1) Simple Estimation Mode
2) Instantaneous Evaporation Modea. Monotonically Decreasingb. Consider the Time in Use3) Steady Emission Mode4) Saturated Vapor Pressure Mode

1

Similar to the formula (2) described in the APPENDIX II 3.1.1 “Inhalation exposure” of the “European Union Technical GuidanceDocument (EU TGD) 2ed Edition Part1” (European Commission 2003).

31) Simple Estimation Mode[Characteristics]
This model is the simplest estimation method utilizing the weight fraction of the compound in the
Product, and the volume of space that the product is used in (rooms, virtual space etc). Assume
that when the product is used, the chemical substance immediately diffuses uniformly into thespace and that the concentration remains constant without regard to ventilation or inhalation.

Figure II-1 shows the relationship between concentration and time.

No VentilationConc.

No Change in Concentration

Time
Figure II-1 Relationship between Concentration and Time with the Simple
Estimation Mode
Average Air Concentration of Exposure Duration (Cat) should be calculated using Productamount (Ap), Weight Fraction of the compound in the Product (Wr), and Volume of Space (V).
Depend on the characteristics of the product, the volume of virtual space around the body can beused instead of the volume of the whole room.
[Algorithm]

Cat =Ap × Wr
V(II-1-2)

Cat: Average Air Concentration of Exposure Duration (mg/m3)
Ap: Product Amount (mg)
Wr: Weight Fraction of the compound in the Product (dimensionless)
V: Volume of Space (m3)

Assign this Cat to the formula II-1-1 to calculate the amount of inhalation exposure.
Use of the Simple Estimation Mode is most effective when the duration of use is short and4ventilation rate2 (air exchange rate) is low.

2) Instantaneous Evaporation Mode
Replacement of the air (ventilation) occurs in real room spaces. However, with the Simple
Estimation Mode, this ventilation is not taken into consideration and therefore sometimes
overestimation may occur. If it seems to have been overestimated, a change in concentration suchas decrease of chemical substance caused by ventilation, should be considered.
The Instantaneous Evaporation Mode is based on an algorithm 3 that takes changes inconcentration into account.

a. Instantaneous Evaporation Mode: Monotonically Decreasing[Characteristics]
This mode assumes that all the chemical substances immediately diffuse into the space after
the product is used, and hence similar to the Simple Estimation Mode, the concentration of thechemical substance is calculated with the Weight of Chemical Substance (Ap x Wr) used andVolume of Space (V). However, the upper limit of vapor pressure is the saturated vapor pressure.
In addition, it is assumed that emission of the chemical substance is instantaneous and notcontinuous. The concentration in the room gradually decreases from the initial concentration, justafter application has completed, caused by ventilation. This mode is applied to products whosetime of use is extremely short in relation to the entire exposure time and that not emit after use.
Figure II-2 shows the relationship between concentration and time.

2

Ventilation rate (air exchange rate) indicates how many times the air volume in the space (room volume) changes per hour. A
ventilation rate of 0.5/h denotes that a volume of air equivalent to half the total volume is replaced with air from outside every
hour while a ventilation frequency of 1/h denotes that a volume of air equivalent to the total volume is replaced with air fromoutside every hour.
3
Based on the algorithm used in E-FAST version 2.0, the risk assessment adopted by the TSCA of the U.S. EPA. For moredetails regarding the algorithm refer to the “Exposure and Fate Assessment Screening Tool (E-FAST) version 2.0
Documentation Manual” (U.S. EPA, 2007). In addition, see also the “EU TGD 1st Edition Part 1, APPENDIX IV, Attachment A”(European Commission, 1996). The following is what the algorithm was based on.

Ca = Ca0 × exp(− N × t ) +G× [1 − exp(− N × t )]
N ×V
3

3

-1

Ca: Concentration of Air (mg/m ), Ca0: Initial Concentration of Substance in Air (mg/m ), N: Ventilation Rate (h ), V: Room
3
Volume (m ), G: Emission Rate (mg/h), t: Time (h)5Conc.

With Ventilation

Monotonically Decreasing

Time
Figure II-2 Relationship between Concentration and Time during Instantaneous
Evaporation Mode (Monotonically Decreasing)[Algorithm]
The concentrations in Figure II-2 at Time (t) can be represented with the following algorithm.

Ca =Ap × Wr× exp(− N × t )V(II-1-3)

Ca: Concentration of Compound in the room air (mg/m3)
Ap: Product Amount (mg)
Wr: Weight fraction of the compound in the total product(dimensionless)
V: Volume of Space (m3)
N: Ventilation Rate of the space (number of air exchanges/h)t: Time (h)The formula II-1-3 calculates the concentration at Time (t). Average Air Concentration of
Exposure Duration (Cat) can be calculated using the following algorithm.

⎛⎜ Ap × Wr ⎞⎟V⎠⎝× [1 − exp(− N × t )]
N
Cat =
t

(II-1-4)

Cat: Average Air Concentration of Exposure Duration (mg/m3)
Ap: Product Amount (mg)
Wr: Weight fraction of the compound in the total product(dimensionless)
V: Volume of Space (m3)6

N: Ventilation Rate of the space (number of air changes/h)t: Exposure Duration (h)Assign this Cat value to the formula II-1-1 to calculate the amount of inhalation exposure over
exposure duration (t).

b. Instantaneous Evaporation Mode: Consider the Time in Use[Characteristics]
Figure II-3 represents the relationship between concentration and time in this mode, which issuitable for products such as paint or adhesive. The air concentration of the compound increases
during use of the product, and then gradually decreases from the initial concentration by
ventilation.

After UseWith Ventilation

Conc.

DuringUse

Time
Figure II-3 Relationship between Concentration and Time during Instantaneous
Evaporation Mode (Consider the Time in Use)In this case, the total amount of inhalation should be obtained by adding the exposure amountduring use and after use. They are estimated separately.

[Algorithm]i) Calculation of Exposure During Use
To estimate the concentration of the compound during use, increase in concentration due to
product use, and decrease in concentration due to ventilation must be considered. The
concentration can be represented using the following algorithm.

Cai =

G
× [1 − exp(− N × ti )]N ×V(II-1-5)

G：Emission Rate During Use (mg/h)
Cai: Concentration of Compound in the air in Time of Use ti (mg/m3)
7

N: Ventilation rate of the room (Numbers /h)
V: Volume of Space (m3)ti: Time During Use (h)The concentration at Time (ti) can be calculated by the formula II-1-5. Average Air Concentrationof Exposure Duration (Cati) can be calculated using the following algorithm.

G1⎧⎫
× ⎨ti − × [1 − exp(− N × ti )]⎬N ×V ⎩N⎭
Cati =
ti(II-1-6)

Cat: Average Air Concentration During Product Use (mg/m3)
N: Ventilation rate of the room (Numbers /h)
V: Volume of Space (m3)
G: Emission Rate (mg/h)ti: Exposure Duration (During Use) (h)Assign this Cati value to the formula II-1-1 to calculate the amount of inhalation exposure over
exposure duration (ti).
Emission Rate (G) during Use may also be calculated using the following formula.

G=

Ap × Wrti(II-1-7)

G: Emission Rate (During Use) (mg/h)
Ap: Product Amount (mg)
Wr: Weight fraction of the compound in the total product(dimensionless)ti: Time During Use (h)ii) Calculation of Exposure Amount After Use
Concentration reaches a maximum by product use, and then monotonically decreases when
use of the product has ended. It can be represented using the following algorithm.

Caii = Ca1 × exp (− N × tii )(II-1-8)

Caii: Concentration of Compound in the air at Staying Time tii (mg/m3)
Ca1: Concentration of Compound in the air when use of the product8

ended (mg/m3)
tii: Time During Stay (h)Here the Air Concentration when use of the product ended (Ca1) should be calculated bysubstituting the total time of use for ti in the formula II-1-5.
Formula II-1-8 shows the concentration at time (tii). Average Air Concentration During Stay (Catii)
can be calculated using the following algorithm.

Ca1
× [1 − exp(− N × tii )]Catii = Ntii

(II-1-9)Catii: Average Air Concentration During Stay (mg/m3)
Ca1: Concentration of Compound in the air in Time of Use (mg/m3)
N: Ventilation rate of the room (Numbers/h)tii: Exposure Duration (During Stay) (h)Assign this Catii to the formula II-1-1 to calculate the amount of inhalation exposure at Exposure
Duration (tii).
The total amount of inhalation exposure during and after product use, should be calculated byadding amount of each inhalation exposure.

Spray products can be considered the same as in Instantaneous Evaporation Mode. However,as use of spray products is localized in many cases, they can be classified into 2 types as follows.
1.

Sprayed around a person: If the product is sprayed around a person take the “small virtual
space” around the person into consideration.

2.

Sprayed throughout the room: If the product is sprayed throughout the room, consider thewhole room space, not the virtual space.

As the spray is forced to disperse, it is not necessary to set an upper limit for the saturated vapor
pressure; however inhaling the mist (aerosol) in inhalation exposure must be considered. The
particle size of the mist varies, and large size particle of mist is not inhaled. However, it is very
difficult to predict what proportion of the mist is actually inhaled. Therefore, unless scientificallyreliable value has been available, all the mist should be assumed to be of a size that is inhaled.

3) Steady Emission Mode[Characteristics]
When usage time of the product is long and the product has a constant emission rate, use
9emission rate to estimate the amount of exposure. The Air Concentration (Ca) does not changeover time, and shown in Figure II-1. The Air Concentration (Ca) here is constant due to theequilibrium between increasing concentration by emission of the chemical substance, anddecreasing concentration by inflow of the air to the space and outflow from the space. As there is
no change in the Air Concentration, Average Air Concentration of Exposure Duration (Cat) is thesame as Ca. And therefore the amount of inhalation exposure should be calculated using Average
Air Concentration of Exposure Duration (Cat), the inhalation rate of the exposed person (Q), andExposure Duration (t). However, if the time of use of the product is short and use of the productended before it reaches a certain concentration. Results using the Steady Emission Mode can beoverestimate. If the measured value of the emission rate, considering the conditions of use of the
product including any possible misuse, is available, it should be used.
The algorithm in figure II-4 can be obtained as it takes the mass balance of steady emission into
account.

Volume of Space: V (m3)Concentration of Chemical Substance: Ca (mg/m3)
Ventilation Rate: N (1/h)

N＝v/V

Inflow of Fresh
Air v (m3/h)

→

v＝N×V

Outflow of
Air v (m3/h)

Emission Source
Emission Rate: G (mg/h)

Mass Balance of Chemical Substance
Emission Rate in Space： G
Outflow Rate to Outside the Space: v×Ca
Mass Balance between Emission into the Space and Outflow
to Outside the Space: G＝v×Ca
Therefore: Ca＝G/v＝G/(N×V)

Figure II-4 Algorithm of Air Concentration in Steady Emission Mode
[Algorithm]

Cat =

G
N ×V

(II-1-10)

Cat: Average Air Concentration of Exposure Duration (mg/m3)
N: Ventilation Rate of the room (Numbers s/h)
V: Volume of Space (m3)
G: Emission Rate (mg/h)
10Assign this Cat to the formula II-1-1 to calculate the amount of inhalation exposure.
4) Saturated Vapor Pressure Mode[Characteristics]
For products with a fast emission rate that quickly reach saturated vapor pressure, the Air
Concentration (Ca) of the chemical substance should be calculated assuming that air
concentration is always at the saturated vapor pressure of the substance. In other words,
regardless of ventilation rate, the concentration always reaches the saturated vapor pressure. Air
Concentration does not change over time. It is similar to Figure II-1 for the Simple Estimation
Mode. As there is no change in air concentration, the Average Air Concentration of Exposure
Duration (Cat) is the same as the Ca. And therefore the amount of inhalation exposure should be
calculated using Average Air Concentration (Cat), the inhalation rate of the exposed person (Q),and Exposure Duration (t). The following is the algorithm where the Saturated Vapor Pressure wasobtained in units of Pa.
[Algorithm]

Cat = 0.4037 × M × P(II-1-11)

Cat: Average Air Concentration of Exposure Duration (mg/m3)
0.4037: Unit Conversion Constant (mg-mol/g/Pa/m3)
M: Molecular Weight (g/mol)
P: Saturated Vapor Pressure (Pa)4Assign this Cat to the formula II-1-1 to calculate the amount of inhalation exposure.
II-2 Dermal Route
Differing from exposure via general environment, dermal exposure is a very important exposure
route when considering direct exposure from consumer products. In the assessment of Inhalation
exposure and oral exposure, external boundaries (Intake: nose, mouth) are clearly distinguishedfrom internal boundaries (Uptake: lung, gastrointestinal tract) (Figure 1). However, in the case ofdermal exposure, the skin is an external boundary as well as an internal boundary. This can makeit difficult to estimate the amount of exposure when compared to exposure estimations of
inhalation and oral routes.
The following two types of basic dermal exposure5 will be considered in this Appendix.
4(Ref.) Unit of pressure: 1 atm = 101325 Pa, 1 bar= 100000 Pa, 1 psi = 6894.757 Pa, 1 Torr (mmHg) = 133.322 Pa, 1 at =98066.5 Pa.

111) Dermal exposure through contact with liquid solutions (or solids) containing thesubstance
a．Virtual Volume Mode that assumes a contact volume (amount)b． Dermal Absorption Rate Mode which uses the Absorption Rate of the contact
substance2) Dermal Exposure that assumes some or all of the chemical substance used adhere to
the skin1) Dermal exposure through contact with liquid solutions (or solids) containing thesubstance
a. Virtual Volume Mode that assumes a certain contact volume[Characteristics]
To estimate the amount of dermal exposure, it is necessary to know the amount that adheres(contacts) to the skin. It is possible to consider simply that the entire product amount used isinvolved in exposure; however, it could result in overestimations. Therefore, assume that the
product (or concentration of the product) of the Skin Contact Layer within a certain distance of theskin should be involved in exposure. To calculate the volume of that contact layer set the assumed
thickness to be the section that will adhere to the skin (hereinafter referred to as the Thickness ofSkin Contact Layer (Ls)). And then multiply the area adhering to the skin by the Thickness of Skin
Contact Layer (Ls) to calculate the volume of the product involved in exposure.
If the assessment target product is a liquid, it can be assumed that the entire volume of thevirtual volume will be involved in exposure unless scientifically reliable data is available to thecontrary. That is, assume that the entire volume of the target chemical substance in the virtual
volume will be exposed.
On the other hand, if the assessment target product is solid, overestimations may occur if theentire volume of the target chemical substance in the virtual volume is involved in exposure, andtherefore the Transition Rate from the product to the skin should be considered. If information
regarding the Transition Rate is unavailable, assume that the entire volume of the chemical
substance in the virtual volume will be exposed. In addition, if the Thickness of Skin Contact Layer
can not be assumed, then refer to “2) Dermal Exposure through Adherence from Some Parts used
to the Skin (Constant Ratio Adherence)” that a certain part of the solid object is assumed to adhere,
or use a combination of the formulas of “Virtual Volume Mode” and “Constant Ratio Adherence”.

5

The algorithm for dermal exposure in this document references the algorithm described in “ConsExpo4.0 Consumer Exposureand Uptake Models Program Manual” (RIVM 2005) and was edited according to the concept of this Appendix. The algorithm
itself is basically the same as that used in ConsExpo4.0.

12

[Algorithm]

EHE(derm) =Cl (or Cs ) × Ls × Sp × n × a(derm)BW(II-2-1)

EHE (derm)：Uptake of Dermal Exposure (mg/kg/day)
Cl: Concentration of Substance in Liquid Solution (mg/cm3) or
Cs：Concentration of Substance in Solid (mg/cm3)
Ls: Thickness of Skin Contact Layer (cm)6
Sp: Skin Surface Area available for Contact (cm2)
n: Mean number of events per day (events/day)* If the target product is a solid and information is available regarding the Transition Rate,then multiply with the Transition Rate.

a (derm): Uptake Fraction (derm) (dimensionless)*Unless the bodily absorbance by the humans and animals used in the hazard assessment
for the chemical substance has been identified, a (derm) = 1 (100 %) should be used,regardless of exposure route.

BW: Body Weight (kg)b. Dermal Absorption Rate Mode Which Uses the Rate of Absorption of the Contact Material[Characteristics]
About some substances, the Dermal Absorption Rate (Ml) mg/cm2/h, absorption rate from theskin into the body, may have already been measured or capable of being estimated. In this casethe amount of exposure should be calculated using the Dermal Absorption Rate, Skin Surface
Area (available for contact) (Sp) cm2, which is the area the substances adhere to, Exposure
Duration (t) h/event, and mean number of events per day (n) events/day. When Dermal Absorption
Rate (Ml) mg/cm2/h is available, the Uptake Fraction a (derm) can be excluded from thecalculation. This is because the Uptake Fraction a (derm), which denotes the absorption ratio fromthe skin to the body, has already been considered as for the Dermal Absorption Rate. However,the Dermal Absorption Rate must also be correspondingly taken into the hazard assessment,[Algorithm]

EHE (derm ) =Sp × Ml × t × nBW(II-2-2)

EHE (derm): Uptake of Dermal Exposure (mg/kg/day)

6-3

The Thickness of Skin Contact Layer Ls is represented as 2.14~10 cm in the “European Union Risk Assessment Report for
TRICHLOROETHYLENE” (EU 2004) and 0.01cm in the “European Union Risk Assessment Report for PHENOL” (EU 2006).
Use these as references in determining the appropriate Thickness of Skin Contact Layer.

13Sp: Skin Surface Area available for Contact (cm2)
Ml: Dermal Absorption Rate (mg/cm2/h)
32* Occasionally “cm/h (= cm /cm /h)” is used as the unit of dermal absorption rate; however a3

2

concentration of target substance (mg/cm ) is similar to mg/cm /h/t: Exposure Duration (h/event)n: Mean number of events per day (events/day)
BW: Body Weight (kg)Even when the substance adheres to objects then adheres to the skin (indirect adherence), it
should be considered to be dermal exposure, through contact with objects containing thesubstance. For example, when laundry is washed using washing detergent, although it may only
be a small amount, some of the detergent component will adhere to the laundry. And if the laundry
is processed using softening agent, then the softening component will adhere to the laundry.
Wearing the laundry, in particularly underwear, detergent component may transfer to the skin.
Basically it can be calculated using the formula II-2-1; but the important points are the ways toestimate adheres to laundry, and the transfer ratio from laundry to the skin.

2) Dermal exposure through adherence from some parts used to the skin (Constant Ratio
Adherence)[Characteristics]
When adhesive or paint is used the dermal exposure from the skin, due to adherence of someparts of the product must be considered. Assume the ratio that adheres to the skin as the Skin
Adhesion Ratio (Md), and calculate the adhesive amount by multiplying the Weight of Chemical
Substance in the Used Product (Ap x Wr) and Skin Adhesion Rate (Md). Uptake of the Dermal
Exposure (EHE (derm)) are then evaluated as follows.
[Algorithm]

EHE (derm ) =Ap × Wr × Md × n × a (derm )BW(II-2-3)

EHE (derm): Uptake of Dermal Exposure (mg/kg/day)
Ap: Product Amount (mg)
Wr: Weight fraction of the compound in the total product(dimensionless)
Md: Skin Adhesion Ratio (dimensionless)n: Mean number of events per day (events/day)a (derm): Uptake Fraction (derm) (dimensionless)*Unless the bodily absorbance by humans and animals used in the hazard assessment of
the chemical substance has been identified, a (derm) = 1 (100 %) should be used,14

regardless of exposure route.

BW: Body Weight (kg)II-3 Oral Exposure
In assessment of oral exposure via environment, an exposure assessment of the substance,
which are emitted from the consumer product into the environment (general air, water, and soil)
and taken through food or water ingestion, should be considered. However, as it is not included inrisk assessments of consumer product in GHS, assessments via environment are not consideredin this Appendix. Second exposures, for example, touching mouth by hands that the substanceattached, or inhaling house dust that the substance is absorbed, are also not considered here.
Hence the following two basic oral exposure7 algorithms will be presented as examples in thisAppendix.
1)

Unintentional oral exposure from products with possibility to be put in mouth

2)

Oral exposure of substance transferred to food via routes other than environment1) Unintentional oral exposure of products with possibility to be put in mouth[Characteristics]
There are some products that is not assumed to be put in the mouth, but that might be occur
due to common practices such as envelopes (seal), postal stamps and so on. The amount of oral
exposure should be calculated by assuming a residual ratio that remains in the mouth per event(Unintentional Intake Ratio (Mo)).
[Algorithm]

EHE (oral ) =Ap ×Wr × Mo × n × a (oral )BW(II-3-1)

EHE (oral): Uptake of Oral Exposure (mg/kg/day)
Ap: Product Amount (mg)
Wr: Weight fraction of the compound in the total product(dimensionless)
Mo: Unintentional Intake Ratio (dimensionless/event)n: Mean number of events per day (events /day)A (oral): Uptake Fraction (oral) (dimensionless)*Unless the bodily absorbance by humans and animals used in the hazard assessment forthe chemical substance has been identified, a (oral) = 1 (100 %) should be used, regardless

7

The algorithm for oral exposure in this document references the algorithm described in the “ConsExpo4.0 Consumer Exposureand Uptake Models Program Manual” (RIVM 2005) and was edited according to the concept of this Appendix. The algorithm
itself is basically the same as the one used in ConsExpo4.0.

15

of exposure route.

BW: Body Weight (kg)2) Intake of substances transferred to food[Characteristics]
Oral exposure can occur when a product containing the substance contacts food and that foodis eaten. For example, it is applicable if the substance in kitchen cleaner remains on dishes andthen adheres to food or when washing vegetables or fruit are washed by dishwashing detergent
and is then eaten. Estimates should be done using the amount of the adhered substance tokitchenware (or containers) and the Transfer Rate to food.
[Algorithm]<Estimation from the concentration of substance in food>This is applicable when food such as vegetables or fruit are washed using the dishwashingdetergent.

EHE (oral ) =Cf ×Wf × a (oral )BW(II-3-2)

EHE (oral): Uptake of Oral Exposure (mg/kg/day)
Cf: Concentration of Substance in Food (mg/g)
Wf: Amount of Food Consumed (mg/day)a (oral): Uptake Fraction (oral) (dimensionless)*Unless the bodily absorbance by humans and animals used in the hazard assessment forchemical substance has been identified, a (oral) = 1 (100 %) should be used, regardless of
exposure route.

BW: Body Weight (kg)

Although the estimation of a Concentration of Substance in Food (Cf) can be individuallyconducted using a variety of methods, occasionally it might be possible to estimate it by applying
the algorithms or other ways as described in II-2-2 dermal exposure.

<Estimation from Transfer Rate>
When the substance adhering to a container is transferred to food and the food is consumed,
the amount of Oral Exposure is calculated by multiplying the amount of the substance adhering to
the container by Transfer Rate (Mfd) (formula II-3-3).

16

EHE (oral ) =Cd × Mfd × a (oral )BW(II-3-3)

EHE (oral): Uptake of Oral Exposure (mg/kg/day)
Cd: Weight of Adhered Substance on Food Container Used per Day(mg/day)
Mfd: Transfer Rate from Container to Food (dimensionless)a (oral): Uptake Fraction (oral)(dimensionless)*Unless the bodily absorbance by humans and animals used in the hazard assessment forthe chemical substance has been identified, a (oral) = 1 (100 %) should be used, regardlessof exposure route.

BW: Body Weight (kg)

Estimation of the Weight of Adhered Substance on Container is not described here, as it can be
conducted individually using a variety of methods.

<Estimation using Transfer Rate and Contact Time>
If the amount of exposure is estimated by calculating the adhered amount to food from theTransfer Speed Mfp (the ratio at which the substance is migrated to food) and contact time tc, theformula will be the following (Formula II-3-4).

EHE (oral ) =Sf × Mfp × t c × a (oral )BW(II-3-4)

Sf: Area of Food Container (Adhered Section Only) Used per Day(cm2/day)Mfp: Transfer Rate from Container to Food (dimensionless)
tc：Contact Time (h)a (oral): Uptake Fraction (oral) (dimensionless)*Unless the bodily absorbance by humans and animals used in the hazard assessment forthe chemical substance has been identified, a (oral) = 1 (100 %) should be used, regardlessof exposure route.

BW: Body Weight (kg)17

Table II-1 Overview of Exposure Route Scenarios
Expo
sure
Rout
e
Inhal
ation

Exposure
Scenario

Calculation Condition

Overview of scenario

Inhalation
Exposure

Estimation formula for basic
exposureCalculated using Average Air Concentration of
Exposure Duration, Inhalation Rate, Exposure Time,
Use Counts, Body Weight and Absorption Rate.
The Average Air Concentration of Exposure Duration
should be calculated after considering thecharacteristics of the product and various aspects ofthe substance and the appropriate mode thenselected.
Assume that the assessment chemical substance inthe product diffuses throughout the entire space, andthen calculate the Average Air Concentration.
Assume that the assessment chemical substance inproduct diffuses throughout the entire space, and thencalculate the Average Air Concentration during theexposure duration where the concentration decreases
due to ventilation.
i) Average Air Concentration During Use
The concentration of the product during use must take
into consideration both the increase in concentration
due to product use and decrease in concentration due
to ventilation in calculating the Average Air
Concentration During Use.
ii) Average Air Concentration After Use
Same as Monotonically Decreasing, when calculating
the Average Air Concentration During Stay thedecrease in concentration in the air after use of the
product has ended due to ventilation should beconsidered.
Calculate the Average Air Concentration where theemission of the chemical substance and inflow of
external air and outflow of air in the room from outside
are in equilibrium. The concentration is constantbecause it is in equilibrium.
Assume that the chemical substance is always at asaturated vapor pressure level when calculating theconcentration. It should be calculated using the vapor
pressure and molecular weight.
Assume a virtual volume on the skin surface that theninvolves exposure in calculating the amount of
exposure.
If the rate of absorbance of the chemical substancefrom the skin to the body is already known, then use
the Dermal Absorption Rate Mode to calculate theamount of exposure.
Assume a ratio of adherence to the skin in calculating
the amount of exposure.

SimpleMode

Estimation

Instantaneous
Evaporation Mode
Monotonically
Decreasing
Calculation of Average Air Concentration

Instantaneous
Evaporation Mode
Consider the Time in
Use

Steady Emission Mode

Saturated
Pressure Mode

Derm
al

Contact
targetsubstance

with

Virtual Volume Mode

Dermal
Mode

Oral

Vapor

Absorption

Rate

Contactwithtargetsubstance
Unintentional
Intake Ratio

Constant Ratio Adherence

Transition
Food

Calculatefrom
Concentration in Food

to

the

Consider the Transfer Rate

Consider the Transfer Rate
and Contact Time

Where the possibility of being transferred to themouth exists, assume a residual ratio in the mouth incalculating the amount of exposure.
This should be used when the chemical substance is
attached to food due to product use and its
concentration is known. Calculate the amount of
exposure from the attached concentration and intake
volume of food it is attached to.
If the chemical substance is transferred to food due to
product use, then calculate the amount of exposure
from its transition rate and intake volume of food.
If the chemical substance is transferred to food due to
product use, then calculate the amount of exposure
from its transition speed and intake volume of food.

18

Formulanumber

II-1-1II-1-2II-1-4II-1-6II-1-9II-1-10II-1-11II-2-1II-2-2II-2-3II-3-1II-3-2II-3-3II-3-4Reference: Exposure Factors
Various factors come into play when estimating the amount of exposure using each algorithm
introduced in this Appendix. Some of the factors commonly used in various substances include
Weight, Inhalation Rate, and Skin Surface Area and are used as “Exposure Factors” in exposure
assessments.
In maintaining consistency and ensuring transparency, the common “Exposure Factor” values
are desirable. However, sufficient information is not available to determine common exposure
factors for estimating the amount of exposure of consumer products.
In the Exposure Assessment Examples given in Chapter III of this Appendix (Appendix 1) and
Examples of Risk Assessment in Appendix 2, “Exposure Factors” were set for assessment byreferencing the following domestic and foreign reference documents. Table II-2 lists the exposure
factors used in our assessment. However, these values are only reference values and appropriate
exposure factors should be used in assessments on the individual responsibility of evaluators. In
addition, variable values (contents, product amount, contact time etc.) must be applied properly on
the individual responsibility of evaluators, in consideration of foreseeable misuse such as
excessive use.

<Reference Materials>
・ National Institute of Advanced Industrial Science and Technology (AIST), Research Centerfor Chemical Risk Management (CRM): Japanese Exposure Factors Handbook (2007)8・ United States Environmental Protection Agency (U.S. EPA): Exposure Factors Handbook(1997)9・ European Exposure Factors: The European Exposure Factors (ExpoFacts) Sourcebook10
・ European Centre for Ecotoxicology & Toxicology of Chemicals (ECETOC)11: Targeted Risk
Assessment (TRA) Technical Report No.93 (2004)
・ Human and Environmental Risk Assessment on ingredients of household cleaning products(HERA): Guidance Document Methodology (2005)128

http://unit.aist.go.jp/riss/crm/exposurefactors/
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=20563
http://expofacts.jrc.ec.europa.eu/
11
http://www.ecetoc.org/
12
http://www.heraproject.com/files/HERA%20TGD%20February%202005.pdf
9

10

19

Table II-2 Exposure Factors Used in this Appendix (Reference Values)
Item
Human
Body

In-room

OthersType
Body Weight

Value
50 kg

Inhalation Rate

0.833 m /h
3
(20 m /day)

1 tatami mat

1.62 mRoom Height for Living Rooms (BuildingStandard Act “Minimum Value”)
Standard living room (6 tatami matsfloor)
Volume of Lavatory

2.1 m

3

20 m

3

20 m

3

2

3

Ambient volume of product (such as
sprays)2m

Ventilation Rate (standard living room)

0.2 h

-1

Ventilation Rate (toilet)

0.5 h

-1

Skin Adhesion Ratio due to theadherence of paint or adhesive whileworking

0.5 %20

SourceInitial Risk Assessment for Chemical Substances Ver.
2.0 Preparation Manual(NITE, CERI 2007)
Initial Risk Assessment for Chemical Substances Ver.
2.0 Preparation Manual(NITE, CERI 2007)
Enforcement Regulations for Fair Competition
Regarding Real Estate Descriptions
Chapter 5 Section 1 Article 16 No. 16
Building Standard Act Cabinet Order Article 21(Japanese law)2
3
6 tatami mats x 1.62 m /tatami x 2.1 m = 20m
Average volume of apartment/studio lavatory unit type0811, 0812, 0815
3
0811 type: 0.8 m x 1.1 m x 2.0 m = 1.76 m
30812 type: 0.8 m x 1.2m x 2.0 m = 1.92 m
30815 type: 0.8 m x 1.5m x 2.0 m = 2.40 m“Guidelines for Initial Risk Assessment” Japan
Chemical Industry Association (Revised version,
March 1997)
Mihara et al. (2004), Journal of RIEMAM, 52,
166-169.
This ventilation rate averaged the minimum value of a
result obtained by various measurement methods.
The ventilation Rate stated in the Building Standards
Act with the consideration that a local ventilation
system or window is installed
European Union Risk Assessment Report TOLUENE(European Commission 2003)

III Specific Exposure Scenarios by the Application Category of the Products andExposure Assessment Examples
This section describes examples of exposure scenarios and exposure assessment with respect
to 5 categories of product application included in the scope of this Appendix (1 Household
Adhesive, 2 Household Coating Material and wax, 3 Household Detergent, 4 Deodorant andFragrance Substances, and Repellents for Nuisance Insects, and 5 Auto Products).
The summary of the following items is described for each of the 5 categories.
1. Scope of product included in the categories
2. Characteristics of the categories
3. Exposure scenario and algorithm
4. Example of assessment
One or some representative examples of exposure assessment are given.
For consumer products not included in the categories described above, and those not fit for theidea of exposure assessment in the categories, the suppliers may use an exposure assessment
by setting their own exposure scenarios and algorithms based on the exposure assessment
method and assessment examples in this Appendix, as well as those in scientifically reliable dataetc.

The assessment examples given in this Appendix are only “examples” for use inunderstanding the concept of an exposure scenario and, including the estimation method for thequantity of exposure, should not be taken as the only correct method. The chemical substances
selected for the assessment examples are provisional ones used to present assessment
examples more specifically, and are not chosen as they are determined to pose chronic healthhazards subject to the risk assessment.
Similarly, the factors used in the assessments or the adequacy of assessment results are notguaranteed.
When conducting practical exposure assessments, the characteristics of the target product,
properties of the target chemical substance, foreseeable misuse etc must be carefully
considered, and the most appropriate exposure scenario should be set.

21

III-1 Household Adhesive
III-1-1 Scope of This Category
This category includes adhesives used in the home or room by general consumers. It does notinclude adhesives contained in, for example, flooring or furniture, or adhesives used in a room
when remodeling has taken place.

III-1-2 Characteristics of This Category
Various chemical substances are used in adhesives according their function. However,generally there are very few chances of exposure (contact) because adhesives is covered with
objects. The exposure occurs mainly when the adhesive is being used (being applied, or when can
is open) and while the adhesive is being cured.
Therefore, main exposure route of adhesives is limited to the following.
1. Inhalation exposure during use and after use when staying in the inhaled air
2. Dermal exposure due to unintended adherence of droplets, or adherence to the hands
during use

III-1-3 Exposure Scenario and Algorithm
Assume the exposure scenario that should be considered, then select the algorithm to estimate
the amount of exposure.
With household adhesives, inhalation exposure during to product use is the most important. In
addition, exposure to the hands by product application and unintended adherence of droplets tothe skin during use should also be considered.
<Exposure Scenario 1> Inhalation exposure to volatile adhesive components
During the application of the product, concentration increase (due to increased amount used)and concentration decrease (due to room ventilation) can both occur. After the application ofadhesive, emission of chemical substances generally completes. However, emission from thegeneration source may continue for some time.
Secondary exposure such as the oral intake of detached pieces of solidified adhesive does notneed to be considered.
Algorithm
If emission completes at the same time application of the product ends, use the formulaII-1-6 and II-1-9 to calculate the Average Air Concentration of Exposure Duration. Thenassign the value to the formula II-1-1 to calculate the amount of inhalation exposure.
If emission continues for a while after application of the product, use the formula II-1-10 to
calculate the room concentration of steady emission, and then assign the value to the formulaII-1-1 to calculate the amount of exposure.

<Exposure Scenario 2> Dermal exposure due to the application of the products
Select the algorithm to be used according to the amount of adhesive used or information (such22as Dermal Absorption Rate) of the dermal exposure of the target component.
Algorithm
If a constant amount of the adhesive used is assumed to contact the skin, use the formulaII-2-3 to calculate the amount of dermal exposure. Use the formula II-2-1 to calculate theamount of exposure, when assuming a Skin Contact Layer. If the Dermal Absorption Rate of
the assessment component is available, use the formula II-2-2 to calculate the amount of
exposure.

23

III-1-4 Example of Assessment
ExampleGeneral-use adhesive (plastic model adhesive)

Chemical substance: acetone<Acetone>・ CAS No.: 67-64-1
・ Molecular Weight: 58.08 g/mol
・ Vapor Pressure: 230 mmHg (25 degrees C)<Exposure Scenario>
・ General-use adhesive (plastic model adhesive) contains 35% acetone.
・ Assess exposure to acetone in the adhesive when assembling plastic models.
・ Assume 5g of the adhesive is used in the standard living room (20 m3, ventilation rate: 0.2
times/h) and a plastic model is assembled once a month.
・ Assume that no long term emission occurs after product use ends, and the emission ofacetone stops at the same time use of the product does.
・ Assume that the working time (the time the product is used for) is 0.5 hour and remains in
the room for 3 hours after that.
・ Skin Adhesion Ratio due to unintended adherence of adhesive during work is 0.5% of theamount used.
<Algorithm>
・ Inhalation Exposure: Instantaneous Evaporation (Consider the Time in Use)・ Dermal Exposure: Constant Ratio Adherence・ Oral Exposure: Not Assumed<Various Data>・ Amount of Product Used (Ap): 5 g・

3・ Inhalation Rate (Q): 0.833 m /h3

Weight Fraction of Acetone in Product (Wr):35 %・ Volume of Room (V): 20 m・

Body Weight (BW): 50 kg

・ Time During Use (ti): 0.5 h・Ventilation Rate (N): 0.2 times/h・ Skin Adhesion Ratio (Md): 0.5 %・Time spent After Use (tii): 3.0 h

・ Frequency of Use (n): Once a month・Uptake Fraction (a): 100 %<Calculation>(1) Inhalation Exposure
Calculate the amount of inhalation exposure using the <Instantaneous Evaporation
Mode: Consider Time in Use>.
[Amount of Inhalation Exposure During Use]
Average Air Concentration During Use should be calculated using the formula II-1-6.

24

Ap × Wr1⎧⎫
× ⎨t i − × [1 − exp(− N × t i )]⎬
N
⎩
⎭
ti

ti
Cati =N ×V

5 g × 0.35

0.5h × ⎧0.5h − 1 × [1 − exp(− 0.2 / h × 0.5h )]⎫⎨⎬0.2 / h × 20m 3 ⎩0.2 / h⎭Cati =
0.5h= 42.33mg / m 3
Assign this to the formula II-1-1 to calculate the amount of inhalation exposure during use.

EHE (inha ) =EHE (inha ) =Ca t × Q × t × a (inha ) × n
BW42.33mg / m 3 × 0.833m 3 / h × 0.5h × 1 × 12

365day50kg= 0.012mg / kg / day[Amount of Inhalation Exposure After Use]
Average Air Concentration During Stay (After Use) should be calculated using the formulaII-1-9.

Ca1
× [1 − exp(− N × tii )]Catii = NtiiHere, Ca1 represents the concentration in the air immediately after use, and therefore the airconcentration immediately after use should be calculated using the formula II-1-5.

Ap × Wr
ti

Ca1 =

N ×V

× [1 − exp( − N × t i ) ]5 g × 0.35
Ca1 =0.5h × [1 − exp(− 0.2 / h × 0.5h )]0.2 / h × 20m3

= 83.267mg / m 3
ThereforeCa1
× [1 − exp(− N × tii )]Catii = Ntii83.267mg / m3
× [1 − exp(− 0.2 / h × 3h )]
0
.
2
/
h
Catii =
3h25

= 62.62mg / m 3
Assign this to the formula II-1-1 to calculate the amount of inhalation exposure during stay(after use).

Cat × Q × t × a (inha ) × n
BW

EHE (inha ) =EHE (inha ) =62.62mg / m 3 × 0.833m 3 / h × 3.0h × 1× 12

365day50kg= 0.103mg / kg / day[Total Amount of Inhalation Exposure]
The amount of exposures during use and after use are added to calculate the total amount of
inhalation exposure:

EHE ( inha ) = 0.012mg / kg / day + 0.103mg / kg / day = 0.115mg / kg / day(2) Dermal Exposure
Calculate the amount of exposure using <Constant Ratio Adherence>.
Calculate the amount of dermal exposure using the formula II-2-3 assuming a constant ratio of
the product has adhered to the skin.

EHE (derm) =EHE(derm) =Ap × Wr × Md × n × a(derm)BW

5mg × 0.35 × 0.005 ×12

365day×1

50kg= 0.006mg / kg / day(3) Estimated Human Exposure (EHE)The Estimated Human Exposure (EHE) should be calculated using the Amount of Inhalation
Exposure (EHE (inha)) and Amount of Dermal Exposure (EHE (derm)).
Since the EHE (inha)：0.115 mg/kg/day, EHE (derm): 0.006mg/kg/day, then the EHE will be as
follows.

EHE = 0.115 mg / kg / day + 0.006 mg / kg / day = 0.121 mg / kg / day<Results>
Amount of Inhalation Exposure: 0.115 mg/kg/day
Amount of Dermal Exposure: 0.006 mg/kg/day
Estimated Human Exposure: 0.121 mg/kg/day

26

III-2 Household Coating Material and Wax
III-2-1 Scope of this Category
Household coating wax and paint are included in this category as they have the same exposure
route. Hence this category covers paint and wax used indoors as well as paint used outdoors suchas in the garden. However, it does not include paint or wax that has already been absorbed into
flooring or furniture.

III-2-2 Characteristics of this Category
Like adhesives, various chemical substances are used in paint for their function. Afterapplication was over, and a dry period passed, paint makes solid surface, and serious inhalation
exposure or dermal exposure to chemical materials is not thought to be occurred.
Hence main exposure route of paints is limited to the following.
1. Inhalation exposure during application and after application when staying in the inhaled air.
2. Dermal exposure due to unintended adherence of droplets or adherence to the hands
during application

III-2-3 Exposure Scenario and Algorithm
Assume the exposure scenarios that should be considered, then select the algorithm toestimate the amount of exposure.
With household paints, inhalation exposure due to product application is the most important. In
addition, exposure to the hands by product application, and unintended adherence of droplets tothe skin during use, should also be considered.
Secondary exposure such as oral intake due to the detachment of solidified paint after emission
is not need to be considered.
<Exposure Scenario 1> Inhalation exposure to volatile components of paintDuring application of the product, similar to adhesive products, concentration increase due to
product application and decrease due to room ventilation occur simultaneously. After theapplication of paint, emission of chemical substances generally completes. However, emission
from the generation source may continue for some time. In the first case, the concentration
decreases due to ventilation, but in the latter case, the concentration becomes constant.
Algorithm
If emission completes at the same time application of the product ends, use the formulaII-1-6 and II-1-9 to calculate the Average Air Concentration of Exposure Duration. Thenassign the value to the formula II-1-1 to calculate the amount of inhalation exposure.
If emission continues for a while after application of the product, use the formula II-1-10 to
calculate the room concentration of steady emission, and then assign the value to the formulaII-1-1 to calculate the amount of exposure.

27

<Exposure Scenario 2> Dermal Exposure due to application of the products
Select the algorithm to be used according to the amount of paint applied or information (such as
Dermal Absorption Rate) of the dermal exposure of the assessment component.

Algorithm
If a constant amount of paint applied is assumed to contact to the skin, use the formulaII-2-3 to calculate the amount of dermal exposure. Use the formula II-2-1 to calculate theamount of exposure, when assuming a Skin Contact Layer. If the Dermal Absorption Rate of
the assessment component is available, use the formula II-2-2 to calculate the amount of
exposure.

28

III-2-4 Example of Assessment
Example 1) Household synthetic resin emulsion paintChemical substance: Isopropyl Alcohol (IPA)<Isopropyl Alcohol (IPA)>
・ CAS No.: 67-63-0
・ Molecular Weight: 60.10 g/mol
・ Vapor Pressure: 33 mmHg (20 degrees C)<Exposure Scenario>
・ Applied to walls in a room (20 m3).
・ Household synthetic resin emulsion paint (1 L, weight of product: 1200g) contains 2% IPA.
・ Basically, two coats are assumed with half the product (600g) being applied for each coat.
・ Assume that a coat takes 2 hours, and that a user will leave the room after the first coat until
emission has complete (until completely dry), give the second coat, and leave the room
again.
・ Assume that ventilation was inadequate during work, and set the ventilation rate as 0.2
times/h, which is the same for a standard living room.
・ Assume that the frequency of the work is once a year.
・ Assume that Skin Adhesion Ratio due to unintended adherence of paint during work is 0.5%of the amount applied.
<Algorithm>
・ Inhalation Exposure: Instantaneous Evaporation (Consider the Time in Use)・ Dermal Exposure: Constant Ratio Adherence・ Oral Exposure: Not Assumed<Various Data>・ Amount of Product Used (Ap): 600 g
3・ Inhalation Rate (Q): 0.833 m /h3

・ Weight Fraction of IPA (Wr): 2 %・ Body Weight (BW): 50 kg

・ Volume of Room (V): 20 m

・ Ventilation Rate (N): 0.2 times/h・ Time During Application (one time) (ti):・ Time spent After Use (tii): 0.0 h

2.0 h・ Skin Adhesion Ratio (Md): 0.5 %・ Uptake Fraction (a): 100 %・ Frequency of Application (n): Once per Year・ Description of Work: Twice<Calculation>(1) Inhalation Exposure
Calculate the amount of inhalation exposure using the <Instantaneous Evaporation
Mode: Consider the Time in Use>.
Average Air Concentration During Application should be calculated using the formula II-1-6.

29

Ap × Wrti
Cati =

N ×V

1⎧⎫
× ⎨ti − × [1 − exp(− N × ti )]⎬
N
⎩
⎭
ti

600 g × 0.02

2h × ⎧2h − 1 × [1 − exp (− 0.2 / h × 2h )]⎫⎬⎨0.2 / h × 20 m 3 ⎩0 .2 / h⎭Cati =
2h= 263 .7 mg / m 3
Assign this to the formula II-1-1 to calculate the amount of exposure during use (exposure
period during application).

EHE (inha ) =Cat × Q × t × a(inha ) × n
BW

EHE (inha ) =263.7mg / m 3 × 0.833m 3 / h × 2.0h × 1 × 1

365day50kg= 0.024mg / kg / day
As this value is the amount of inhalation exposure from a single coat, the calculation for theamount of inhalation exposure with two coats will be as follows:

EHE (inha ) = 0.024mg / kg / day × 2 = 0.048mg / kg / day(2) Dermal Exposure
Calculate the amount of dermal exposure using the <Constant Ratio Adherence>.
Calculate the amount of dermal exposure using the formula II-2-3 assuming a constant ratioof the product has adhered to the skin.

EHE(derm) =EHE (derm ) =Ap × Wr × Md × n × a(derm)BW

600 g × 0.02 × 0.005 × 1

365day×1

50kg= 3.29 × 10 −3 mg / kg / day
As this value is the amount of dermal exposure from a single coat, the calculation for theamount of inhalation exposure with two coats will be as follows:

EHE (derm) = 3.29 ×10 −3 mg / kg / day × 2 = 0.007mg / kg / day(3) Estimated Human Exposure (EHE)The Estimated Human Exposure (EHE) should be calculated using the Amount of Inhalation

30

Exposure (EHE (inha)) and Amount of Dermal Exposure (EHE (derm)).
Since the EHE (inha)：0.048 mg/kg/day, EHE (derm): 0.007 mg/kg/day then the EHE will be
as follows.

EHE = 0.048mg / kg / day + 0.007mg / kg / day = 0.055mg / kg / day<Results>
Amount of Inhalation Exposure: 0.048 mg/kg/day
Amount of Dermal Exposure: 0.007 mg/kg/day
Estimated Human Exposure: 0.055 mg/kg/day

31

Example 2) Indoor Floor Wax
Chemical Substance: Diethylene glycol monoethyl ether<Diethylene glycol monoethyl ether (DEGEE)>・ CAS No.: 111-90-0
・ Molecular Weight: 134.2 g/mol
・ Vapor Pressure: 19 Pa<Exposure Scenario>
・ Wax applied on indoor flooring.
・ The wax contains 7.75% DEGEE.
・ Assume that 200g of the wax will be applied with a general living room (6 tatami mats floor =20 m3).
・ Normally a mop is used when waxing. However, in this case assume that the wax is appliedwith bare hands with inadequate ventilation and set the ventilation rate as 0.2 times/h,
which is the same for the general living room.
・ Assume that no long term emission occurs after product use, and the emission of DEGEE
stops at the time application has completed.
・ Assume that the working period is one hour and the user stays in the room for one hour
after that.
・ Assume that Skin Adhesion Ratio due to unintended adherence of wax during work is 0.5%of the amount applied.
・ Assume that the frequency of the work is twice a year.
<Algorithm>
・ Inhalation Exposure: Instantaneous Evaporation (Consider the Time in Use)・ Dermal Exposure: Constant Ratio Adherence・ Oral Exposure: Not Assumed<Various Data>・ Amount of Product Used (Ap): 200g

・ Weight Fraction of DEGEE in Product3

・ Inhalation Rate (Q): 0.833 m /h(Wr): 7.75%

・ Volume of Room (V): 20 m3

・ Body Weight (BW): 50 kg

・ Working Hours (ti): 1.0 h

・ Ventilation Rate (N): 0.2 times/h・ Time spent After Use (tii): 1.0 h

・ Frequency of Use (n): Twice per Year・ Skin Adhesion Ratio (Md): 0.5 %・ Uptake Fraction (a): 100 %<Calculation>(1) Inhalation Exposure
Calculate the amount of inhalation exposure using <Instantaneous Evaporation Mode:
Consider the Time in Use>.
[Amount of Inhalation Exposure During Application]
Average Air Concentration During Application should be calculated using the formula II-1-6.
32

Ap × Wrti
N ×V

Cati =

1⎧⎫× ⎨t i − × [1 − exp(− N × t i )]⎬
N
⎩
⎭
ti

200 g × 0.0775

1.0h × ⎧1h − 1 × [1 − exp(− 0.2 / h × 1.0h )]⎫⎨⎬0.2 / h0.2 / h × 20m 3⎩⎭
1hCati == 362.9mg / m 3
Assign the value to the formula II-1-1 to calculate the amount of inhalation exposure during
application (exposure period during application).

EHE (inha ) =Ca t × Q × t × a (inha ) × n
BW

EHE (inha ) =362.9mg / m 3 × 0.833m 3 / h × 1.0h × 1 × 2

365day50kg= 0.033mg / kg / day[Amount of Inhalation Exposure After Application Period]
Average Air Concentration During Stay (After Application) should be calculated using theformula II-1-9.

Ca1
× [1 − exp(− N × tii )]Catii = Ntii
Here Ca1 represents the concentration in the air immediately after use Ca1 should be
calculated using the formula II-1-5.

Ap × Wr
Ca1 =

ti
N ×V

× [1 − exp(− N × t i )]200 g × 0.0775
1.0h × [1 − exp(− 0.2 / h × 1.0h )]Ca1 =
0.2 / h × 20m3
= 702.4mg / m 3
ThereforeCa1
× [1 − exp(− N × tii )]Catii = Ntii33

702.4mg / m 3
× [1 − exp(− 0.2 / h × 1.0h )]
0
.
2
/
h
Catii =
1.0h
= 636.6mg / m 3
Assign the value to the formula II-1-1 to calculate the Amount of Inhalation Exposure During
Stay (After Application).

EHE (inha ) =Ca t × Q × t × a (inha ) × n
BW

EHE (inha ) =636.6mg / m 3 × 0.833m 3 / h × 1.0h × 1 × 2

365day50kg= 0.058mg / kg / day[Total Amount of Inhalation Exposure]
The amounts of exposure during application and after application are added to calculate thetotal amount of inhalation exposure:

EHE (inha ) = 0.033mg / kg + 0.058mg / kg = 0.091mg / kg(2) Dermal Exposure
Calculate the amount of dermal exposure using the <Constant Ratio Adherence>.
Calculate the amount of dermal exposure using the formula II-2-3 and assuming a constantratio of the product has adhered to the skin.

EHE (derm ) =EHE (derm) =Ap × Wr × Md × n × a(derm)BW
200 g × 0.0775 × 0.005 × 2

365day×1

50kg= 0.008mg / kg / day(3) Estimated Human Exposure (EHE)The Estimated Human Exposure (EHE) should be calculated using the Amount of Inhalation
Exposure (EHE (inha)) and Amount of Dermal Exposure (EHE (derm)).
Since the EHE (inha)：0.091mg/kg/day, EHE (derm): 0.008mg/kg/day then the EHE will be as
follows.

EHE = 0.091mg / kg / day + 0.008mg / kg / day = 0.099mg / kg / day<Results>
Amount of Inhalation Exposure: 0.091 mg/kg/day
Amount of Dermal Exposure: 0.008 mg/kg/day
Estimated Human Exposure: 0.099 mg/kg/day

34

III-3 Household Detergent
III-3-1 Scope of this Category
This category of household detergent includes laundry detergents, hand dishwashingdetergents, and home cleaners for cleaning furniture and home appliances. In addition, although
not detergent, fabric softener, starch, and bleach for laundry are also included in this category..

III-3-2 Characteristics of this Category
Detailed research on risk assessment methods for household detergents has taken place as
voluntary efforts made by the SDA (The Soap and Detergent Association)13 and HERA (Humanand Environmental Risk Assessment on Ingredients of Household Cleaning Products: CEFIC
European Chemical Industry Council and A.I.S.E. Soap and Detergent Association ofEurope)14and the content has already been published15.
Referring to these existing risk assessment methods and considering how household
detergents are used in Japan, the following exposures are considered important.
1. Dermal exposure to the hands from detergent (laundry, dishes)
2. Dermal exposure to compounds remaining on laundry after use of products
3. Inhalation exposure to spray products
4. Oral exposure to compounds remaining on dishes (Oral Intake of substances transferred tofood)III-3-3 Exposure Scenario and Algorithm
Assume the exposure scenario that should be considered, then select the algorithm to estimate
the amount of exposure.
1. Dermal exposure to detergent (laundry, dishes)
When washing the laundry16 or dishes using synthetic detergents dermal exposure is the mainroute of exposure.
(Exposure scenario) Dermal exposure from the use of detergent (laundry, dishes) when used withbare hands without rubber gloves
Algorithm
Use the formula II-2-1 which assumes a Skin Contact Layer to calculate the amount of
exposure. Or if the Dermal Absorption Rate of the assessment compound is available, use
the formula II-2-2 to calculate the amount of exposure.

2. Dermal exposure to the compound remaining on laundry after use of the product
When laundry is washed using detergent, although it may only be a small amount, some of the13

http://cleaning101.com/files/Exposure_and_Risk_Screening_Methods_for_Consumer_Product_Ingredients.pdf
http://www.heraproject.com/Library.cfm
The Japan Soap and Detergent Association are also cooperating in these projects.
16
In Japan most users use the laundry machines, however, depending on the type or form of the laundry hand washing may
occur.
1415

35

detergent will remain on the laundry. In addition, if the laundry is processed using a fabric softener,
then the softening agent will also remain on the laundry. Therefore wearing the laundry, inparticular underwear, which directly touch the skin, can result in the remnant components beingtransferred to the skin. The important point is how the residual amount in the laundry and theamount transferred from the laundry to the skin should be estimated.
(Exposure Scenario) Dermal exposure to the compound remaining on laundry after use of the
product
Algorithm
Use the formula II-2-1 which assumes a Skin Contact Layer to calculate the amount of
exposure. Or if the Dermal Absorption Rate of the assessment target component is available,
use the formula II-2-2 to calculate the amount of exposure.

3. Inhalation exposure to spray products
Assume that exposure occurs in a limited space over a limited period of time. Inhalation of mist
(aerosol) from the spray should be considered. Although the particle size of the mist varies andlarge size particles of mist will not be inhaled, it is very difficult to predict what proportion of themist will be inhaled. Therefore, unless scientifically reliable value has been available, all the mist
should be assumed to be of a size that can be inhaled.
(Exposure Scenario) Inhalation exposure to spray products (Instantaneous Evaporation)
Algorithm
Depending on the form of the product, select from the formula II-1-2 through to the formulaII-1-9 and calculate the concentration for a virtual space or room (real space), which can be
subject to the Exposure by spray, then use the formula II-1-1 to calculate the Amount of
Inhalation Exposure.

4. Oral exposure to the compound remaining on dishes
When dishes are washed using hand dishwashing detergent, although it may only be a small
amount, some of the detergent components will adhere to the dishes, and then transfer to foodfrom the dishes, which can result in oral exposure. The adhered amount and concentration ofdetergent will drastically decrease after being rinsed with water. Although all of detergent
components will not be transferred to food, 100 % of it is assumed to transferred in this case. In
addition, washing vegetables or fruit using a detergent may cause detergent components toadhere to them. In this case, use the algorithm for dermal exposure to calculate the weight ofcomponents on the vegetables, and then calculate the amount of exposure from the Intake
Amount of Food per day.
<Exposure Scenario> Oral exposure to the compound remaining on dishes
Algorithm
Select one of the formula II-3-2, II-3-3, or II-3-4 to calculate the amount of oral exposure.

36

III-3-4 Example of Assessment
Example 1) Hand Dishwashing Detergent
Chemical Substance: Ethanol<Ethanol>・ CAS No.: 64-17-5
・ Molecular Weight: 46.1
・ Vapor Pressure: 5.8 kPa (at 20 degrees C)<Exposure Scenario>
・ Hand Dishwashing detergent contains 5% ethanol.
・ Assume dermal exposure occurs from handwashing dishes using hand dishwashingdetergent and oral exposure through dishes/food.
・ Assume the frequency of hand dishwashing to be 3 times a day (45 minutes/event).
・ Assume the concentration of hand dishwashing detergent during handwashing dishes to be
100 mg/cm3.
・ Assume that the surface area of the hands and arms exposed during handwashing dishes tobe 1980 cm2.
・ Assume the Dermal Absorption Rate of Ethanol during dishwashing to be 0.8×10-3 cm/h.
・ Oral exposure to dishes is caused by the transfer of washing liquid remaining on the dishes
to food and then from eating that food. However, assume the Trancfer Rate from Dishes toFood to be 100 %.
・ Assume that oral exposure through food occurs from washing vegetables and fruit with hand
dishwashing detergent and then in taking the remaining liquid on the vegetable and fruit.
--------------------------*1 This exposure assessment references the exposure scenarios and factors described in the “Guidance Document
Methodology” from “HERA (Human and Environmental Risk Assessment on Ingredients of Household Cleaning Products)”(2005)*2 and “SDA (The Soap and Detergent Association) Exposure and Risk Screening Methods for Consumer Product
Ingredients” (2005) *3.
*2 “Guidance Document Methodology” (HERA, 2005) can be obtained from the following
URL: http://www.heraproject.com/files/HERA%20TGD%20February%202005.pdf*3 “Exposure and Risk Screening Methods for Consumer Product Ingredients” (SDA, 2005 ) can be obtained from the following
URL: http://cleaning101.com/files/Exposure_and_Risk_Screening_Methods_for_Consumer_Product_Ingredients.pdf*4 “About the amine oxide blended cleaning agent” from “Health Science 1989, Research regarding the safety of food cleaning
agents (No. 1)” About amine oxide blended cleaning agent” (Japan Food Cleaners and Hygienic Association, 1991) was
referred to in the Concentration of Substances in Vegetables and Fruit.

<Algorithm>
・ Inhalation Exposure: Not Assumed
・ Dermal Exposure: Dermal Absorption Rate Mode・ Oral Exposure: The estimated Transfer Rate and estimated concentration of the substance37

in food<Various Data>・ Body Weight (BW): 50 kg

・・ Weight Fraction of Ethanol (Wr): 5%

Concentration

of

Hand

Detergent:: 100 mg/cm

Dishwashing3・ Working Hours per Count: 0.75 h/count・Exposure Surface Area (Sp): 1,980 cm2

・ Dermal Absorption Rate (Ml): 0.8×10-3

・

Frequency of Work per day (n): 3 times/day

・Concentration

cm/h
3

2

Surface: 5.5×10 cm /cm

・・ Concentration of Substance in Vegetable(Cf1): 1.4×10 mg/g
・ Concentration of Substance in Fruit (Cf2):

Contact Area of Food and Dish: 5,400
cm2/day・-3

Product

Remaining on Dishes: 0.8 mg/cm

・ Transition Rate from Dish to Food (Mfd):
100 %Residual
3・ Amount of Residual liquid on the Dish-5

of

Intake Amount of Vegetables (Wf1): 263
g/day

・

Intake Amount of Fruits (Wf1): 256 g/day

・Uptake Fraction (a): 100 %-4

2.4×10 mg/g
<Calculation>(1) Dermal Exposure
Calculate the amount of dermal exposure using the <Dermal Absorption Rate Mode>.
The Dermal Absorption Rate can be determined using the formula II-2-2. As the unit used in
Dermal Absorption Rate above is in “cm/h”, and hence needs to be converted into “mg/cm2/h” toconsider the concentration of Ethanol in hand dishwashing detergent. The concentration of
ethanol in detergent should be calculated with the following formula:
As the Concentration of Ethanol (mg/cm3) = Concentration of the Hand Dishwashing Detergent x
Weight Fraction of Ethanol in product,
Concentration of Ethanol (mg/cm3) = 100 mg/cm3x 0.05 = 5 mg/cm3.
Therefore, Dermal Absorption Rate Ml (mg/cm2/h) is as follow:
Dermal Absorption Rate Ml (mg/cm2/h) = Concentration of Ethanol (mg/cm3) x Dermal
Absorption Rate (cm/h),
Dermal Absorption Rate Ml (mg/cm2/h) = 5mg/cm3 x 0.8×10-3 m/h = 4.0×10-3 mg/cm2/h.
Assign it to the formula II-2-2:

EHE (derm) =Sp × Ml × t × n
BW1,980cm 2 × 4.0 × 10 −3 mg / cm 2 / h × 0.75h × 3 / day
50kg= 0.356mg / kg / day

EHE (derm ) =(2) Oral Exposure[Amount of Oral Exposure from Dishes]38

Calculate the amount of oral exposure using the <Estimation from Transition Rate>.
The Amount of Oral Exposure to Ethanol in cleaning solution remaining on dishes should be
calculated using the formula II-3-3.
Here, Cd (mg/day) the Weight of Adhered Substance on Dishes per Day should be calculatedusing the following formula:
Cd (mg/day) = Concentration of Residual Product Remained on Dishes x Weight Fraction of
Ethanol in Product (Wr) x Residual Fluid Amount on Dish Surface x Contact Area between Foodand Dish:
Cd (mg/day) = 0.8 mg/cm3 x 0.05×5.5×10-5 cm3/cm2 x 5,400 cm3/day = 1.188×10-2 mg/day
Assign this to the formula II-3-3,

Cd × Mfd × a (oral )BW
1.188 × 10 −2 mg / day × 1 × 1
EHE (oral ) == 2.38 × 10 −4 mg / kg / day
50kg

EHE (oral ) =[Amount of Oral Exposure from Vegetables]
Calculate the amount of oral exposure using the <Estimation from the Concentration of
Substance in Food>.
The Amount of Oral Exposure to Ethanol in the cleaning solution remaining on the vegetables
should be calculated using the formula II-3-2.

Cf ×Wf × a (oral )BW
0.0014mg / g × 263g / day × 1
EHE (oral ) == 7.36 × 10 −3 mg / kg / day
50kg
EHE (oral ) =[Amount of Oral Exposure from Fruit]Calculate the amount of oral exposure using the <Estimation from the Concentration of
Substance in Food>.
The Amount of Oral Exposure from Ethanol in the cleaning substance remaining on the fruit
should be calculated using the formula II-3-2.

Cf ×Wf × a (oral )BW
0.00024mg / g × 256g / day × 1
EHE (oral ) == 1.23 × 10 −3 mg / kg / day
50kg
EHE (oral ) =[Total Amount of Oral Exposure]
Add each amount of each type of exposure to calculate the amount of oral exposure:39

EHE (oral ) =2.38 × 10 −4 mg / kg / day + 7.36 × 10 −3 mg / kg / day + 1.23 × 10 −3 mg / kg / day= 0.009mg / kg / day(3) Estimated Human Exposure (EHE)The Estimated Human Exposure (EHE) should be calculated using the Amount of Dermal
Exposure (EHE (derm)) and Amount of oral Exposure (EHE (oral)). Since the EHE (derm): 0.356
mg/kg/day, EHE (oral): 0.009 mg/kg/day, the EHE will be as follows:

EHE = 0.356mg / kg / day + 0.009mg / kg / day = 0.365mg / kg / day<Results>
Amount of Dermal Exposure: 0.356 mg/kg/day
Amount of Oral Exposure: 0.009 mg/kg/day
Estimated Human Exposure: 0.365 mg/kg/day

40

Example 2) Residual laundry detergent substances on laundry
Chemical substance: Linear Alkylbenzene Sulfonete (LAS)<Linear Alkylbenzene Sulfonete (LAS)>・ CAS No.: 25155-30-0 (for C18H29SO3Na) and others
・ Molecular Weight: 348.48 (for C18H29SO3Na)・ Vapor pressure: <Exposure Scenario>
・ Assume that 0.025 mg of LAS per 1cm2 of laundry remains.
・ Assume that the bodily surface area contacting the laundry is 17,600 cm2 and the Transfer
Ratio from Laundry to Skin is 0.01 %・ Assume the frequency of wearing the laundry with remaining detergent on it to be once aday.
----------------------------*1 This exposure assessment references the exposure scenarios and factors described in the “Guidance Document
Methodology (2005)*2” and “Linear Alkylbenzene Sulphonate Human Health Risk Assessment (2007)” (HERA (Humanand Environmental Risk Assessment on Ingredients of Household Cleaning Products)) and was partially edited according
to the concept of this Appendix.
*2 “Guidance Document Methodology” (HERA, 2005) can be obtained from the following
URL: http://www.heraproject.com/files/HERA%20TGD%20February%202005.pdf*3 “Linear Alkylbenzene Sulphonate Human Health Risk Assessment” (HERA, 2003) can be obtained from the following
URL: http://www.heraproject.com/files/4-F-HERA_LASFinalReport2007revision10_07.pdf<Algorithm>
・ Inhalation Exposure: Not Assumed
・ Dermal Exposure: Virtual Volume Mode, Partially Modified
・ Oral Exposure: Not Assumed<Various Data>・ Body Weight (BW): 50 kg

・Contact Area to Laundry (Sp): 17,600 cm2・ Residual Amount of LAS on Laundry:・Transfer Ratio from Laundry to Skin:

0.025 mg/cm

2・ Frequency of Use (n): Once/day

0.01 %
・

Uptake Fraction (a): 100 %<Calculation>
 Dermal Exposure
Calculate the amount of dermal exposure using the <Virtual Volume Mode>.
With the Virtual Volume Mode (the formula II-2-1), the Weight of Chemical Substance in thevirtual volume is calculated using Thickness of Skin Contact Layer (Ls) and Contact Area (Sp)and Concentration (Cs) as shown below. The Amount of Exposure is then calculated bydetermining how many times that weight is absorbed per day.

41

EHE(derm) =Cs × Ls × Sp × n × a(derm)BW

Here the weight of chemical substance on the skin surface is calculated using Residual
Amount of LAS on Laundry (mg/cm2), Contact Area of Laundry and the Transfer Rate fromlaundry to the skin surface.
Therefore Cs (mg/cm3) x Ls (cm) x Sp (cm2) = Residual Amount of LAS on Laundry (mg/cm2)
x Transfer Rate from Laundry to the Skin Surface x Sp (cm2), then the amount of dermal
exposure should be:

EHE (derm ) =0.025mg / cm 2 × 0.0001 × 17,600cm 2 × 1 / day × 1
50kg= 8.80 × 10 −4 mg / kg / day<Results>
Amount of Dermal Exposure: 8.80×10-4 mg/kg/day
Estimated Human Exposure: 8.80×10-4 mg/kg/day

42III-4 Deodorant/Air Freshener and Repellents for Nuisance Insects
III-4-1 Scope of this Category
The scope of this category includes deodorant/air freshener and repellents for nuisance insects
used in living rooms or lavatory.

III-4-2 Characteristics of this Category
There are different types of deodorant/air freshener and repellents for Insects: those sprayed on
the object, those forced to volatilize by heat or burn , and those set in a room for emission.
Therefore, exposure through the following need to be considered:
1. Inhalation exposure to spray products
2. Inhalation exposure from products forced to volatilize by heat or burn
3. Inhalation exposure to emission/sublimation productsIII-4-3 Exposure Scenario and Algorithm
Assume the exposure scenario that should be considered, then select the algorithm to estimate
the amount of exposure.

1. Inhalation exposure to spray products
Sprayed on objects, nuisance insects, or in a space several times over a short period of time.
Determine the total weight of the product using spray period, spray volume and frequency of spray,
and then calculate the weight of the compound sprayed using the content of the compound in the
product. If spray period is short, and a spray object is near a user, set virtual space around theuser, assume that the sprayed compound homogeneously distributed in the space, and calculate
the concentration of the compound in the virtual space.
On the other hand, if the compound to be sprayed diffuses throughout the whole room, chosethe compound concentration of the whole room rather than that of the virtual space. The amount of
exposure should be calculated using the concentration of the compound and frequency of use perday. As the particle of the mist ranges in size, and large mist particles will not be inhaled, it is very
difficult to predict the proportion of the mist particles that will be inhaled. Therefore, all the mist
should be assumed to be of a size that will be inhaled, unless scientifically reliable value has been
available.
(Exposure Scenario) Inhalation exposure to components of the spray being used against theobjectAlgorithm
Depending on the type of product, use the formula II-1-2 for the Simple Estimation Mode or
the formula II-1-4 for the Instantaneous Evaporation Mode (Monotonically Decreasing) to
calculate the average exposure concentration in the virtual space or actual space.

43

2 Forced volatilization products
Forced volatilization product contains fragrance components or components with repellent effect,that vaporize through burning or heating. The rate of volatilization should be calculated using theusable life time per product and content ratio of the compound.

If the rate of volatilization isrelatively small compared with the space (Room volume), the component is thought to volatilize
from the product by a constant rate (Emission Rate). If the rate of volatilization is large, the room
concentration is thought to increase gradually, in spite of decrease due to ventilation. In bothcases the concentration in rooms will gradually decrease after volatilization ends. Based on theassumption above, the amount of inhalation exposure is calculated using the room concentrationand staying time, during and after volatilization.
<Exposure Scenario> Inhalation exposure from the use of forced volatilization products
Algorithm
Depending on the form of the product use, the formula II-1-10 (Steady Emission Mode) or
II-1-6 (Instantaneous Evaporation Mode: Consider the Time in Use) is used to calculate theconcentration during volatilization. After volatilization has ended, use the formula II-1-9 in bothcases to calculate the concentration. From the concentration and staying time during andafter volatilization, the amount of inhalation exposure will be calculated using the formulaII-1-1. However, if the formula II-1-10 (Steady Emission) is used, depending on the situation,
the time to reach steady status may become too long, and result in overestimation. Therefore,
the characteristics of the product and usage pattern should be carefully considered. If it
seems to have been overestimated, then compare it with a value calculated with
Instantaneous Evaporation Mode (Consider the Time in Use), and then review if the exposure
scenario has fitted the characteristics and usage pattern of the product, and the chemical
substances.

3. Release/volatilization products
Release/volatilization products emit compounds into the space with a constant Emission Rate.
Therefore, calculate the concentration of the compound emitted into the air using the Emission
Rate. However, if the status of the compound reaches saturated vapor pressure, calculate theconcentration in the air using the Saturated Vapor Pressure.
<Exposure Scenario> Inhalation exposure to slow-released products in rooms
Algorithm
The concentration in the space is calculated using the formula II-1-10 (Steady EmissionMode) or II-1-5 (Saturated Vapor Pressure Mode), depending on the form of the product. Use
the concentration in the space and the staying time, the amount of inhalation exposure is
calculated by the formula II-1-1.

44

III-4-4 Example of Assessment
Example 1) Aerosol type deodorant for lavatory
Chemical substance n-butane＜n-butane＞
・ CAS No.: 106-97-8
・ Molecular Weight: 58.12 g/mol
・ Vapor Pressure: 1,830mmHg (25 degrees C)<Exposure Scenario>
・ Household aerosol type toilet deodorant (200g) for lavatory is used in lavatory.
・ Contains 59.4% n-butane.
・ Assume that each spray is 1 second (1g/sec)*1.
・ Assume that the ventilating rate is 0.5 time/hour considering that a local ventilation system orwindow is in the lavatory.
・ Assume that the frequency of using the lavatory is 6 times/day*2 and that deodorant forlavatory is used 3 of the 6 times.
・ Assume that user stays in the lavatory for 2 minutes (0.0333 h) after the spray is used.
・ Assume a virtual space as the effective range of the spray. And in this case assume that thevirtual space is the same as the volume of the lavatory (2 m3), and use the real lavatory
volume in evaluations.
・ Assume the concentration soon after entering in the lavatory is 0, as a lot of air is moved
around when entering.
・ All the spray components are assumed to be of a mist size that can be inhaled.
----------------------------*1 The injection amount of spray was abstracted from the “How does it get cold? Cold spray” in Fukushima Prefecture
Consumer Advice Centre (http://www.pref.fukushima.jp/syouhi/test/H15spray.htm).
*2 The staying time and frequency of using toilets was abstracted from ”Everyone’s Lavatory: How to build a public lavatory”
on the Kochi Prefecture Civil Engineering Department Building Division Home page(http://www.pref.kochi.jp/~kenchiku/kenchiku/toile_onepoint.html).

<Algorithm>
・ Inhalation Exposure: Simple Estimation Mode or Instantaneous Evaporation Mode
(Monotonically Decreasing)・ Dermal Exposure:・ Oral Exposure:

Not Assumed

Not Assumed* There are two types of calculation methods: one ignores ventilation while the other takes it into consideration. In this section,[Simple Estimation Mode] and [Instantaneous Evaporation Mode (Monotonically Decreasing)] are shown respectively.

<Various Data>

45

・ Used Amount (/count) (Ap): 1 g

・ Weight Fraction of n-butane (Wr): 59.4 %3・ Volume of Lavatory (V): 2 m

・ Staying Time After Spray (t): 0.0333

・ Ventilation Rate (N): 0.5 times/hh/count

・ Inhalation Rate (Q): 0.833 m3/h

・ Body Weight (BW): 50 kg

・ Uptake Fraction (a): 100 %・ Frequency of Spray per Day (n): 3
times/day<Calculation>
 Inhalation Exposure
For the [Simple Estimation Mode]:
Calculate the amount of inhalation exposure using the <Simple Estimation Mode>.
As the staying time after using splay is short (2 minutes), the Simple Estimation Mode is usedhere to calculate the amount of inhalation exposure during the stay. The air concentration is
calculated using the formula II-1-2:

Cat =Ap × Wr 1000mg × 0.594== 297 mg / m 3
3
V
2mAssign this to the formula II-1-1 to calculate the amount of exposure during the stay in thelavatory.

EHE (inha ) =Ca t × Q × t × a (inha ) × n
BW297mg / m × 0.833m / h × 0.0333h × 1 × 3 / day
EHE (inha ) == 0.494mg / kg / day
3

3

50kg

------------------------------------------------------------------------------------------------------------------------For the [Instantaneous Evaporation Mode: Monotonically Decreasing]
Calculate the amount of exposure using the <Instantaneous Evaporation Mode:
Monotonically Decreasing>.
Using the formula II-1-4 calculate the average concentration in the lavatory when the spray is
injected throughout the lavatory and the user then remain in the room for 2 minutes.

Ap × WrCat =N

V × [1 − exp(− N × t )]t1g × 0.594
Cat =

0.5 / h2m3 × [1 − exp(− 0.5 / h × 0.0333h )]0.0333h= 294.8mg / m3

Assign this to II-1-1 to calculate the amount of inhalation exposure during stay in lavatory.

46

SinceEHE (inha ) =EHE (inha ) =Ca t × Q × t × a (inha ) × n
BW294.8mg / m 3 × 0.833m 3 / h × 0.0333h × 1× 3 / day= 0.491mg / kg / day
50kg* As the exposure period per single count is only 2 minutes, there will be little difference in the
results. If the ventilation frequency is large or the staying time is long, that difference will belarger. Therefore, carefully consider the characteristics and usage pattern of the product andany other factors, and then select the appropriate exposure scenario.
<Results>
Amount of Inhalation Exposure:0.494 mg/kg/day [Simple Estimation Mode]
0.491 mg/kg/day [Instantaneous Evaporation Mode (Monotonically Decreasing)]
Estimated Human Exposure:0.494 mg/kg/day [Simple Estimation Mode]
0.491 mg/kg/day [Instantaneous Evaporation Mode (Monotonically Decreasing)]

47

Example 2) Electric vaporizer type repellent
Chemical substance: Metofluthrin<Metofluthrin>
・ CAS No.: 240494-70-6
・ Molecular Weight: 360.35 g/mol
・ Vapor Pressure: 1.47×10-5 mmHg (25 degrees C)<Exposure Scenario>
・ Use of an electric vaporizer type repellent in 6 tatami mats floor (20 m3).
・ Amount of the product used is 1.2 mg (Assume the Weight Fraction of Metofluthrin to be100%).
・ The amount of volatilization product is 0.2 mg/h, a value that considerably exceeds the
maximum value of commercial items.
・ Assume the used period of electric vaporizer type repellent is 6 hours and the user stays in
the room during use.
・ Assume that the user stay 2 hours when use of the product has completed.
・ Assume that the repellent agent is used everyday.
<Algorithm>
・ Inhalation Exposure: Instantaneous Evaporation Mode (Consider the Time in Use) or SteadyEmission Mode and Instantaneous Evaporation Mode (Monotonically Decreasing)・ Dermal Exposure: Not Assumed
・ Oral Exposure: Not Assumed* Two types of exposure are assumed: one where the concentration increases with use of the product (Instantaneous
Evaporation considering the time in use) similar to paint and adhesives, and the other, Steady Emission during use andMonotonically Decreasing after use. In this section the [Instantaneous Evaporation Mode (Consider the Time in Use)] or[Steady Emission Mode and Instantaneous Evaporation Mode (Monotonically Decreasing)] are respectively documented.

<Various Data>
・ Used Amount (Ap): 1.2 mg
・ Volume of Room・ Weight Fraction of Metofluthrin (Wr): 100%
3・ Emission Rate (G): 0.2 mg/h(V): 20 m

・ Staying Time During Use (ti): 6.0 h

・ Staying Time After Use (tii): 2.0 h

3・ Inhalation Rate (Q): 0.833 m /h・ Ventilation Rate (N): 0.2 times/h・ Uptake Fraction (a): 100 %・ Body Weight (BW): 50 kg

・ Frequency of Use (n): Once/day<Calculation>
 Inhalation Exposure
For [Instantaneous Evaporation Mode: Consider the Time in Use]
Calculate the amount of inhalation exposure using the <Instantaneous Evaporation
Mode: Consider the Time in Use>.
[Amount of Inhalation Exposure During Use]48

Average Air Concentration During Use should be calculated by using the formula II-1-6.

Ap × Wr1⎧⎫
× ⎨t i − × [1 − exp(− N × t i )]⎬
N
⎩
⎭
ti

ti
N ×V

Cati =

1.2mg × 1

6.0h × ⎧6.0h − 1 × [1 − exp(− 0.2 / h × 6.0h )]⎫⎬⎨0.2 / h0.2 / h × 20m 3 ⎩⎭Cati =
6.0h= 0.02088mg / m 3
Assign this to the formula II-1-1 to calculate the amount of inhalation exposure during use.

Ca ti × Q × t × a (inha ) × n
BW0.02088mg / m 3 × 0.833m 3 / h × 6.0h × 1 × 1 / day
EHE (inha ) =50kg−3= 2.09 × 10 mg / kg / day
EHE (inha ) =[Amount of Inhalation Exposure After Use]
Average Air Concentration During Stay (After Use) should be calculated using the formulaII-1-9.

Ca1
× [1 − exp(− N × t ii )]N
Catii =t ii
Here, Ca1 represents the concentration in the air immediately after use. The air concentration
immediately after use should be calculated using the formula II-1-5.

Ap × Wr
Ca1 =

ti
N ×V

× [1 − exp(− N × t i )]1.2mg × 1

Ca1 =6.0h × [1 − exp(− 0.2 / h × 6.0h )] = 0.03494mg / m 3
0.2 / h × 20m 3

ThereforeCa1
× [1 − exp(− N × t ii )]N
Catii =
t ii
0.03494 mg / m 3
× [1 − exp(− 0.2 / h × 2.0h )]
0
.
2
/
h
Catii =
= 0.02880mg / m 3
2.0h
Assign this value to the formula II-1-1 to calculate the amount of inhalation exposure during

49

stay after use.

Ca ti × Q × t × a (inha ) × n
BW
0.02880mg / m 3 × 0.833m 3 / h × 2.0h × 1 × 1 / day
EHE (inha ) =50kg−4= 9.60 × 10 mg / kg / day
EHE (inha ) =[Total Amount of Inhalation Exposure]
The total amount of inhalation exposure is caluculated by the amount of exposure during use
and after use:

EHE (inha ) = 2.09 × 10 −3 mg / kg / day + 9.60 × 10 −4 mg / kg / day = 3.05 × 10 −3 mg / kg / day------------------------------------------------------------------------------------------------------------------------For the [Steady Emission Mode and Instantaneous Evaporation Mode: Monotonically
Decreasing]
Calculate the amount of inhalation exposure using the <Steady Emission Mode andInstantaneous Evaporation Mode: Monotonically Decreasing>.
[Amount of Inhalation Exposure During Use]
Average Air Concentration During Use should be calculated using the formula II-1-10.

Cat =

G
N ×V

Cat =

0.2mg / h
= 0.05mg / m 3
30.2 / h × 20m

Assign this value to the formula II-1-1 to calculate the amount of inhalation exposure duringuse.

Ca ti × Q × t × a (inha ) × n
BW0.05mg / m 3 × 0.833m 3 / h × 6.0h × 1 × 1 / day
EHE (inha ) =50kg−3= 5.00 × 10 mg / kg / day
EHE (inha ) =[Amount of Inhalation Exposure After Use]
Average Air Concentration During Stay (After Use) should be calculated using the formulaII-1-9.

Ca1
× [1 − exp(− N × t ii )]Catii = Nt iiHere, Ca1 is the air concentration immediately after use, As there is no concentration changes
during use, the Average Air Concentration During Use (0.05 mg/m3) can be used as Ca1 in theformula II-1-9.

50

Therefore

0.05mg / m 3
× [1 − exp(− 0.2 / h × 2.0h )]0 .2 / hCatii =
= 0.04121mg / m 3
2.0h
Assign this value to the formula II-1-1 to calculate the amount of inhalation exposure during
stay after use.

Ca ti × Q × t × a (inha ) × n
BW
0.04121mg / m 3 × 0.833m 3 / h × 2.0h × 1 × 1 / day
EHE (inha ) =50kg−3= 1.37 × 10 mg / kg / day
EHE (inha ) =[Total Amount of Inhalation Exposure]
The total amount of inhalation exposure is calculated by the amount of exposure during use
and after use.

EHE (inha ) = 5.00 × 10 −3 mg / kg / day + 1.37 × 10 −3 mg / kg / day = 6.37 × 10 −3 mg / kg / day<Results>
Amount of Inhalation Exposure:
3.05×10-3 mg/kg/day [Instantaneous Evaporation Mode : Consider the Time in Use)]
6.37×10-3 mg/kg/day [Steady Emission Mode and Instantaneous Evaporation Mode: Monotonically Decreasing]
Estimated Human Exposure:
3.05×10-3 mg/kg/day [Instantaneous Evaporation Mode : Consider the Time in Use)]
6.37×10-3 mg/kg/day [Steady Emission Mode and Instantaneous Evaporation Mode: Monotonically
Decreasing]51III-5 Auto ProductsIII-5-1 Scope of this Category
Similar to living rooms, there are various products for use inside vehicles and many products areavailable on the market as maintenance goods. In this Appendix, those types of vehicle andmaintenance products are all considered as auto products. However, adhesive and paint used in
the interiors/exteriors of vehicles are excluded.

III-5-2 Characteristics of this Category
The time to spend in cars is relatively short compared to living rooms where we spend a lot oftime. Although it varies with each individual, vehicles are commonly used to commute to office orschool and leisure activities. It is important to assess exposure to auto products.
The temperature changes that occur in cars are large when compared to living rooms, and thetemperature sometimes gets very high17 when left the car in the sun. In addition, ventilation isextremely varied depending on the introduction of external air. Therefore, those factors must be
considered when assessing exposure.
Although a wide variety of products are used in cars, exposure through the following should beconsidered:
1. Deodorant/Air Freshener: Inhalation exposure due to emission of chemical substances in
the cars
2. Maintenance goods: Inhalation and dermal exposure due to the use of detergents andwax

III-5-3 Exposure Scenario and Algorithm
Assume the exposure scenario that should be considered, and then select the algorithm toestimate the amount of exposure.

1. Deodorant/Air freshener
Deodorant/air freshener purposefully emit (spray) chemical substances. Depending on the formof the product (spray and setting type deodorants), the appropriate algorithms should be used to
calculate the concentration in cars and estimate the amount of exposure. As times of ventilationvary depending on the usage pattern of the vehicle, ignore times of ventilation or set it refer to theventilation rate for a living room. If the usage patterns are available, set the ventilation rate using
the flow rate of the air conditioning etc.
(Exposure Scenario) Inhalation exposure to air freshener in the air inside cars
Air Freshener used in cars is considered to include spray types, setting type, and types which

17

It is known that the temperature in cars during summer can get very high, and has been reported at to 27 – 51 degrees C(average 41 degrees C) in daytime in summer (Tsuji et. al., Journal of Society of Indoor Environment, Japan, 2006, 9(2),90-91). In addition a report made by National Consumer Affairs Center of Japan stated that the maximum temperature in a carin the hot sun during summer was 60.3 degrees C and the temperature on the dashboard was 86.7 degrees C (“Evaluating
safety in passenger vehicles”, National Consumer Affairs Center of Japan, 2003).

52

air freshener set in front of the air conditioner outlet.
With spray types the inhalation of mist (aerosol) diffused in the car need to be considered.
Although the particle size of the mist varies, and large size particle of mist will not be inhaled, it isvery difficult to predict what proportion of the mist that will be inhaled. Therefore, unlessscientifically reliable value has been available, all the mist should be assumed to be of a size thatwill be inhaled.
With installed types, as it is emitted into the space at a Constant Emission Rate, calculations
should be done using the Emission Rate.
Algorithm
Depending on the form of the product, choose one of the formula II-1-2, II-1-4, II-1-6, orII-1-9 to calculate the average air concentration, and then use the formula II-1-1 to calculate
the amount of inhalation exposure.
Example of the type that air freshener set in front of the air conditioner outlet is shown in“III-5-4 Example of Assessment”, because it is characteristic of automotive chemical products.
As the exposure scenario and algorithms of installed or spray type deodorant/air freshenerare similar to that in “III-4 Deodorant/Air Freshener and Repellents”, the amount of exposure
should be calculated refer to the examples in III-4 using Room Volume and Ventilation Ratefor cars.

2. Maintenance goods
Although maintenance goods are classified as automotive chemical products, the sameassessment method as that for adhesive, paint, and detergents can be used.
Detergents: As they use the same assessment method for household detergents refer to “III-3
Household Detergent” for more details.
Wax: As it uses the same assessment method for Coating Materials and Adhesive refer to “III-1
Household Adhesive” and “III-2 Household Coating Material and Wax” for more details.

53III-5-4 Example of Assessment
ExampleAir Freshener for Vehicle

Chemical substance: d-limonene<d-limonene>
・ CAS No.: 138-86-3
・ Molecular Weight: 136.23 g/mol
・ Vapor Pressure: 1.55 mmHg
<Exposure Scenario>
・ Air freshener for vehicle (10g) of the type set in front of air-conditioning outlets.
・ Assume that the amount of d-limonene contained is 2.9 % (amount of entire fragrance
chemical is 14 % *1).
・ As this is the types which air freshener set in front of the air conditioner outlet, it is assumed
that the air conditioning is always working while in the car.
・ Assume that the intake flow rate of external air to be 9 m3/h *2(the flow rate of the air
conditioning), the volume of the vehicle 3 m3 *3, and ventilation frequency 3 times/h *4.
・ Calculate the emission rate assumed from the product life (6 months at 2 hours use/day)*5.
----------------------------*1 Value used in the “Mapping of chemical substances in air fresheners and other fragrance liberating products”, (Danish
Environmental Protection Agency, 2002) was used for the product composition.
*2 Assumes that the air intake of the air conditioning comes from outside. The appropriate value for the amount was also
assumed to be within the possible range.
*3 Assumes that 60 % of the space in a Standard Light Motor Vehicle (3.4 m long, 1.48 m wide, 2 m high) is within the car
body and half of that is the space inside the car.
3

3

3

*4 The Ventilation Frequency (N) is N = 9 m /h/3 m = 3/h as it is assumed that the external air flow into the car is 3 m at a3

flow rate of 9 m /h.
*5 If calculated using the Emission Rate = Weight of Product x Content Volume of Compound/Use (Possible) time, then the
Emission Rate G (mg/h) is G = 10 g × 0.029/(2 h/day × 180 day) = 0.806 mg/h. However, when the air conditioning is not
used, it is assumed that no emission takes place.

<Algorithm>
・ Inhalation Exposure: Steady Emission Mode・ Dermal Exposure: Not Assumed
・ Oral Exposure: Not Assumed<Various Data>
・ Used Amount: 10 g

・ Weight Fraction of d-limonene (Wr):・ Emission Rate of d-limonene (G): 0.806

2.9 %・ Inhalation Rate (Q): 20 m3/day

mg/h
・ Flow Rate of Air Conditioning: 9 m3/h

・ Volume in Vehicle (V): 3 m3・ Ventilation Rate (N): 3 times/h・ Staying Time in Vehicle (t): 2.0 h/day54

・ Inhalation Rate (Q): 0.833 m3/h

・ Body Weight (BW): 50 kg

・ Uptake Fraction (a): 100 %<Calculation>
 Inhalation Exposure
Calculate the amount of inhalation exposure using the <Steady Emission Mode>.
Average Air Concentration During Staying Time in vehicle should be calculated using theformula II-1-10.

Cat =

G
N ×V

Cat =

0.806mg / h= 0.0896mg / m 3
3
3 / h × 3m

Assign this value to the formula II-1-1 to calculate the amount of inhalation exposure duringriding time.

Ca ti × Q × t × a (inha ) × n
BW0.0896mg / m 3 × 0.833m 3 / h × 2.0h × 1 × 1 / day
EHE (inha ) =50kg= 2.99 × 10 −3 mg / kg / day
EHE (inha ) =<Results>
Amount of Dermal Exposure: 2.99×10-3 mg/kg/day
Estimated Human Exposure: 2.99×10-3 mg/kg/day

55