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Calcium dihydroxide

Addendum to the CSR:

Occupational, Consumer, and Environmental

Exposure scenarios for calcium dihydroxide

20 August 2010

EBRC Consulting GmbH

Raffaelstr. 4

30177 HannoverGermany

ARCHE

Stapelplein 70, box 104

9000 Gent

Belgium


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Exposure scenarios 20 August 2010

Table of contents

9 Exposure Assessment....................................................................................................... 5

9.0 Introduction .....................................................................................................................59.0.1 Methodology used for environmental exposure assessment............................................5

9.0.1.1 Environmental exposure from industrial use of lime ...................................................................5

9.0.2 Methodology used for occupational exposure assessment............................................14

9.0.2.1 Measured data ..........................................................................................................................15

9.0.2.2 Modelled exposure ....................................................................................................................16

9.0.3 Methodology used for consumer exposure assessment ................................................17

9.0.3.1 Inhalation exposure ..................................................................................................................17

9.0.3.2 Dermal exposure .......................................................................................................................18

9.0.3.3 Oral exposure ...........................................................................................................................19

9.0.3.4 Exposure of the eyes ................................................................................................................19

9.0.4 Exposure assessment: overview of the exposure scenarios ..........................................20

9.1 Manufacture and industrial uses of aqueous solutions of lime substances ..................25

9.2 Manufacture and industrial uses of low dusty solids/powders of lime substances ...... .31

9.3 Manufacture and industrial uses of medium dusty solids/powders of lime substances 37

9.4 Manufacture and industrial uses of high dusty solids/powders of lime substances ......44

9.5 Manufacture and industrial uses of massive objects containing lime substances ........50

9.6 Professional uses of aqueous solutions of lime substances .........................................55

9.7 Professional uses of low dusty solids/powders of lime substances ..............................62

9.8 Professional uses of medium dusty solids/powders of lime substances ......................699.9 Professional uses of high dusty solids/powders of lime substances ............................76

9.10 Professional use of lime substances in soil treatment................................................83

9.11 Professional uses of articles/containers containing lime substances .........................89

9.12 Consumer use of building and construction material (DIY do it yourself) ................92

9.13 Consumer use of CO2 absorbent in breathing apparatuses ......................................95

9.14 Consumer use of garden lime/fertilizer .......................................................................99

9.15 Consumer use of lime substances as water treatment chemicals ............................102

9.16 Consumer use of cosmetics containing lime substances .........................................106

9.17 Regional assessment...............................................................................................107

10 Risk Characterisation ..................................................................................................109

10.1 Industrial uses of lime substances ............................................................................10910.0.1 Occupational exposure ...............................................................................................109

10.0.2 Environmental emissions: Aquatic compartment (including sediment and secondary

poisoning) ..............................................................................................................................109

10.2 Professional uses of lime substances ......................................................................110

10.0.3 Occupational exposure ...............................................................................................11010.0.4 Environmental emissions from agricultural soil protection ..........................................110

10.0.4.1 Aquatic pelagic compartment................................................................................................110

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10.0.4.2 Soil and groundwater compartment......................................................................................110

10.0.5 Environmental emissions from soil treatment in civil engineering ...............................111

10.0.5.1 Soil and groundwater compartment......................................................................................111

10.3 Professional uses of articles containing lime substances .........................................11110.0.6 Occupational exposure ...............................................................................................111

10.0.7 Environmental exposure .............................................................................................111

10.4 Consumer uses of lime containing preparations .......................................................11110.0.8 Consumer exposure ...................................................................................................111

10.0.9 Environmental exposure .............................................................................................112

11 References ..................................................................................................................114

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Executive summary

The current document includes all relevant occupational and environmental exposure scenarios

(ES) for the production and use of calcium dihydroxide as required under the REACH Regulation

(Regulation (EC) No 1907/2006). For the development of the ES the Regulation and the relevant

REACH Guidance have been considered. For the description of the covered uses and processes,

the R.12 Use descriptor system guidance (Version: 2, March 2010, ECHA-2010-G-05-EN), for

the description and implementation of risk management measures (RMM) the R.13 Risk

management measures guidance (Version: 1.1, May 2008), for the occupational exposure

estimation the R.14 Occupational exposure estimation guidance (Version: 2, May 2010, ECHA-

2010-G-09-EN) and for the actual environmental exposure assessment the R.16 Environmental

Exposure Assessment (Version: 2, May 2010, ECHA-10-G-06-EN) was used.

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9 Exposure Assessment

9.0 Introduction

9.0.1 Methodology used for environmental exposure assessment

General strategy

Only the local scale is being addressed, including municipal sewage treatment plants (STPs) or

industrial waste water treatment plants (WWTPs) when applicable, both for production and

industrial uses as any effects that might occur would be expected to take place on a local scale.

The regional assessment provides a summary of pH-ranges observed in Europe.

The strategy deployed for the local exposure and risk assessment of calcium dihydroxide for the

environment is presented below for the industrial uses and the wide dispersive uses.

Industrial uses (local scale)The exposure and risk assessment of calcium dihydroxide is only relevant for the aquatic

environment, when applicable including STPs/WWTPs, as emissions of calcium dihydroxide in the

industrial stages mainly apply to (waste) water. The aquatic effect and risk assessment only deal

with the effect on organisms/ecosystems due to possible pH changes related to OH - discharges,

since the toxicity of Ca2+ is expected to be negligible compared to the (potential) pH effect.

The high water solubility and very low vapour pressure indicate that calcium dihydroxide will be

found predominantly in water. Significant emissions or exposure to air are not expected due to the

low vapour pressure of calcium dihydroxide. Similarly, significant emissions or exposure to the

terrestrial environment are not expected for the industrial uses.

The exposure assessment for the aquatic environment will therefore only deal with the possible pHchanges in STP effluent and surface water related to the OH - discharges at the local scale. The

exposure assessment is approached by assessing the resulting pH impact: the surface water pH

should not increase above 9. This approach is in line with the EU RAR on NaOH published in 2007

(ECB, 2007), and accepted by the EU Member States.

Wide dispersive uses (local scale)

The exposure and risk assessment of calcium dihydroxide is only relevant for the aquatic and

terrestrial environment. Again, the aquatic effect and risk assessment is determined by the pH

effect. Nevertheless, the classical PEC/PNEC approach was adopted because the responsible EU

Member State1 required a PEC calculation in the biocidal registration dossier for the use of lime as

disinfection product of sewage sludge or manure to be applied on agricultural soil.

9.0.1.1 Environmental exposure from industrial use of lime

Since the environmental safety assessment is focused on pH effect and pH control, a survey was

conducted to collect information on pH measurements and pH control. About 4 European calcium

dihydroxide producers voluntarily collected detailed information on the lime production in their

industrial sites; additionally, about 125 downstream users have submitted relevant information on

environmental emissions of lime from their industrial sites.

1 The UK-HSE (Health and Safety Executive) is rapporteur for the registration submission of lime substances,

according to the Biocidal Products Directive 98/8/EC, as amended by Directive 2009/107/EC.

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Environmental risk management measure: pH control

Risk management measures related to the environment aim to avoid discharging lime solutions

into municipal wastewater or to surface water, in case such discharges are expected to cause

significant pH changes. Regular control of the pH value during introduction into open waters is

required. In general discharges should be carried out such that pH changes in receiving surface

waters are minimised. In general, most aquatic organisms can tolerate pH values in the range of 6-9. This is also reflected in the description of standard OECD tests with aquatic organisms.

The results on waste water and effluent treatment from the producers and the downstream users

survey are provided in Table 1. As clearly identified by the collected data, neutralisation of lime

containing waste waters and effluent is widespread (often it is also required by national legislation).

With respect to the production sites specifically and taking into account European and national

legislations, it is noted that effluent neutralisation is common practice (68% of the sites that

provided information neutralise the effluent if present).

Table 1: Information collected from European lime producers and downstream users on waste

water and effluentWASTE WATER EFFLUENT DATA

Is waste

water

treated?

Is waste water

neutralised before

discharging?

Is the effluent

pH mainly

caused by

Lime?

Is it obligatory to

neutralise the effluent

before discharging?

Total 130 130 130 130

yes(%) 68% 55% 22% 54%

yes 87 72 29 70

no 23 31 73 33

not available 20 27 25 27

Environmental releases (pH measurements) and aquatic fate

The production of calcium dihydroxide can potentially result in an aquatic emission and locally

increase the calcium dihydroxide concentration and affect the pH in the aquatic environment.

When the pH is not neutralised, the discharge of effluent from calcium dihydroxide production sites

may impact the pH in the receiving water. The pH of effluents is normally measured frequently and

can be neutralised easily as often required by national laws. The results from the questionnaires

are reported in Table 2 and provide an overview of information collected on the effluent and the

receiving water. Twenty-four percent of the respondents indicated the final effluent did not contain

lime (based on the 177 completed questionnaires).

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Exposure scenarios

Table 2: Effluent and receiving water data for lime producers and industrial users in the EU (survey conducna = not available)

EFFLUENT DATA No. Is waste

water

treated?

Is waste water

neutralized

before

discharging?

Is the

effluent pH

mainly

caused by

lime?

Is it obligatory to

neutralize the

effluent before

discharging?

pH

(average)

Lowest

pH

Highest

pH

Ty

rec

w

1 no no no no 7.2 6.8 7.5 o2 no no no no - - - 3 no no no no 8.0 6.6 9.0 4 yes yes no yes 7 6 8 5 yes no no no 7.3 6.9 7.8 r6 yes no no no 10.4 9.2 11 7 nr nr nr nr - - - 8 yes yes no yes 8.4 5.5 9.5 s9 yes yes no yes 7 6.5 9.5 10 no no no no - - - 11 no nr nr nr - - - 12 yes yes yes yes 9 4 11 r13 yes yes yes yes 9 4 11 r14 no no nr nr - - - 15 no nr nr nr - - - 16 nr nr nr nr - - - 17 yes yes no yes 9 7 10 o18 no no yes no 12 7 12.5 19 no no no no - - 20 no no yes no 12 7 12.5

21 no no no no - - - 22 yes no no no 7 6 8 r23 yes no no no 7 6 8 r24 nr nr nr nr - - - 25 no no no no 5 2.6 8.4 o26 yes yes yes yes 10 3 12 r27 yes yes yes yes 7 6 9 r

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Exposure scenarios


water

treated?

Is waste water

neutralized

before

discharging?

Is the

effluent pH

mainly

caused by

lime?

Is it obligatory to

neutralize the

effluent before

discharging?

pH

(average)

Lowest

pH

Highest

pH

Ty

rec

w

28 nr nr nr nr - - - 29 yes yes yes yes - 2 12 o30 yes yes no yes 8 6 9 o31 yes yes yes yes 6.8 5.3 9 o32 yes yes yes yes - - - 33 yes yes no yes 7 6 12 o34 yes yes yes yes 7.2 6 9.5 o35 yes yes yes yes - - - o36 yes yes yes yes 7.3 6.48 9.69 o37 yes yes yes yes 7.5 4.4 11.2 r38 yes no no no 9.7 9 10.2 r

39 no yes yes no 9.7 9 10.2 r40 yes yes no yes 8 6.5 9 o41 yes no no no - - - 42 yes yes yes yes 7 6.5 9 r43 yes no no yes - - - 44 nr nr nr no - - - 45 yes no no no 10.7 7.42 11.78 r46 yes no no no 10.7 7.42 11.78 r47 no nr nr nr - - - 48 no nr nr nr - - - 49 no nr nr nr - - - 50 nr nr nr nr - - - 51 yes yes yes yes 8.52 7.5 9.5 s52 nr nr nr nr - - - 53 yes yes no yes - - - 54 no no no no - - - 55 yes yes no yes 7.8 6.5 8.5 s56 no no no no - - - o57 yes yes yes yes 8 6.5 9 r

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Exposure scenarios


water

treated?

Is waste water

neutralized

before

discharging?

Is the

effluent pH

mainly

caused by

lime?

Is it obligatory to

neutralize the

effluent before

discharging?

pH

(average)

Lowest

pH

Highest

pH

Ty

rec

w

58 yes yes no yes - - - 59 yes yes no yes - - - 60 yes yes no yes - - - 61 nr nr nr nr - - - 62 yes yes no yes - - - 63 yes yes no yes - - - 64 yes yes no yes - - - 65 yes yes no yes - - - 66 nr nr nr nr - - - 67 nr nr nr nr - - - 68 nr nr nr nr - - -

69 nr nr nr nr - - - 70 nr nr nr nr - - - 71 nr nr nr nr - - - 72 nr nr nr nr - - - 73 yes yes no yes 7.9 6 - s74 yes yes yes yes 6.8 - 9.2 75 yes yes no yes 7.5 5.5 9.5 76 yes yes yes yes - - - 77 yes no no no - - - 78 nr nr nr nr - - - 79 nr nr nr nr - - - 80 yes yes no yes - - - 81 nr nr nr nr - - - 82 nr nr nr nr - - - 83 yes yes no yes 7.25 6.41 9.07 84 yes yes yes no 7.5 6.5 9 o85 no no no no - - - 86 nr nr nr nr - - - 87 yes yes no no 7.3 6.8 7.7 o

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Exposure scenarios


water

treated?

Is waste water

neutralized

before

discharging?

Is the

effluent pH

mainly

caused by

lime?

Is it obligatory to

neutralize the

effluent before

discharging?

pH

(average)

Lowest

pH

Highest

pH

Ty

rec

w

88 nr nr nr nr - - - 89 no nr nr nr - - - 90 yes yes no yes 7.7 7 8 91 no no no no 8.11 7.91 8.41 r92 no nr nr nr - - - 93 no nr nr nr - - - 94 no nr nr nr - - - 95 no no no no - - - 96 yes yes no yes 7.5 6 9 s97 no no no no - - - 98 yes yes no yes 7.7 7 8

99 nr nr nr nr - - - 100 nr nr nr nr - - - 101 nr nr nr nr - - - 102 nr nr nr nr - - - 103 nr nr nr nr - - - 104 nr nr nr nr - - - 105 nr nr nr nr - - - 106 yes yes yes no - - 12 o107 yes yes no yes 8 6 9 s108 yes yes no yes 8 6 9 r109 yes yes yes yes 7.7 7.2 9 r110 yes yes no yes 7 5.5 8.2 r111 yes yes no yes 7.2 6.6 9 s112 yes yes no yes 7.2 6.6 8.6 s113 yes yes no yes 8.55 7.61 8.6 r114 yes no no no 6.8 6.5 9 es115 yes yes yes yes 8.2 7.4 7 r116 nr nr nr nr - - 8.7 rive117 yes yes no yes 7.3 6.7 -

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Exposure scenarios


water

treated?

Is waste water

neutralized

before

discharging?

Is the

effluent pH

mainly

caused by

lime?

Is it obligatory to

neutralize the

effluent before

discharging?

pH

(average)

Lowest

pH

Highest

pH

Ty

rec

w

118 yes yes no yes 8.3 8 8 s119 yes yes no no 8.5 8.3 9.1 s120 yes yes no yes 8 6 8.8 s121 yes yes no yes 8.1 7.8 10 es121 yes yes no yes 8.1 7.8 8.3 es123 yes yes yes yes - - 8.3 o124 nr nr nr nr - - - 125 yes yes no no 8.14 7.02 9.16 r126 yes no no no - - - r127 yes no no no - - - 128 yes no no no - - -

129 nr nr nr nr - - - 130 nr nr nr nr - - - 131 yes yes no yes 8.3 7.8 8.7 132 yes yes yes yes 7.7 7.2 8.2 r133 yes yes yes yes - - - o134 yes yes no yes 8.01 7.5 8.3 r135 yes yes no yes 8.01 7.5 8.3 r136 yes yes yes yes 7.5 5.5 9.5 r137 nr nr nr nr - - - 138 yes yes yes yes 8.2 6.5 9 s139 yes yes yes yes 7.43 6.57 8.97 r140 yes no no no 8.5 na na o141 nr nr nr nr - - -

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When lime is emitted to surface water, sorption to particulate matter and sediment will be

negligible. The pH may increase, depending on the buffer capacity of the water. The higher the

buffer capacity of the water, the lower the effect on pH will be. In general the buffer capacity

preventing shifts in acidity or alkalinity in natural waters is regulated by the equilibrium between

carbon dioxide (CO2), the bicarbonate ion (HCO3-) and the carbonate ion (CO3

2-):

CO2 + H2O HCO3- + H+ (pKa1 = 6.35)

HCO3- CO3

2- + H+ (pKa2 = 10.33)

If the pH is < 6, un-ionised CO2 is the predominant species and the first equilibrium reaction is

most important for the buffer capacity.

At pH values of 6-10 the bicarbonate ion (HCO3-) is the predominant species and at pH values > 10

it is the carbonate ion (CO32-) that is the predominant species. In the majority of natural waters the

pH values are between 6 and 10, thus the lime concentration and the second equilibrium reaction

are most important for the buffer capacity (Rand, 1995; De Groot and Van Dijk, 2002). Table 2 alsosummarizes the reported pH values in the receiving water compartment. The average pH is in all

cases below 9. The maximum reported pH is in some cases above 9. This can be attributed to the

impact of other alkaline substances. Only in two cases, the maximum reported pH is above 9 and

there is no treatment. For these, neutralization treatment techniques should be applied.

Environmental exposure from wide dispersive/professional use of lime

The wide dispersive/professional use of calcium dihydroxide on a local scale, which is discussed

below applies to application of calcium dihydroxide to agricultural or urban/industrial soil. The

environmental exposure was assessed based on data and a modelling tool. The FOCUS/ Exposit

tool was used to assess terrestrial and aquatic exposure according to the ECHA guidance (R16).All parameters needed to run the tool are provided in the ESs. The model description can be found

below.

Model description

The PEC calculation for soil and surface water is based on the recommendation from the relevant

guidance document of the FOCUS soil group (FOCUS, 1996) and on the draft guidance on the

calculation of predicted environmental concentration values (PEC) of plant protection products for

soil, ground water, surface water and sediment (Kloskowksi et al., 1999).

The FOCUS/EXPOSIT modelling tool is preferred to EUSES as it is more appropriate for

agricultural applications where parameters such as the drift need to be accounted for in the

modelling. FOCUS is a model typically developed for biocidal applications and was further

elaborated on the basis of the German EXPOSIT 1.0 model, where parameters such as drifts can

be improved according to collected data: once applied on the soil, calcium dihydroxide can indeed

migrate then towards surface waters, via drift.

Exposure concentration in soil and groundwater

As experimentally shown (pH measurements in soil treated with hydrated lime), the increase in pH

of moist soil after addition of lime is a very rapid and transient process. After the initial increase in

pH, carbonatisation takes place due to the presence of CO 2 in the soil. Calcium carbonate is

formed within hours, resulting in a rapid decline of the pH of the soil. DT50 values were

experimentally determined to be 1.36-2.34 hours. DT90 values were experimentally determined to

be 4.52 and 7.79 hours. Since the experimentally determined DT50 values were based onmeasurements in two different soil types only, a DT50 value of 4 hours was assumed, which is

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higher than the experimentally determined DT50 of 1.36-2.34 hours and thus represents a worst

case.

In addition to the initial PEC in soil, which represents the predicted environmental concentrations

immediately after application, actual (PECact) and time weighted average (PECtwa) concentrations

were calculated as short-term (24 hours, 2 days, and 4 days after application) and as long-term (7,

14, 21, 28, 50 and 100 days) values.The initial, actual and time-weighted PEC at various time points were calculated using the

degradation formulas given in the FOCUS report on soil persistence model and EU registration

(FOCUS, 1996). The respective formulas are:

PECini:

bdd

fAPECini

**100

)1(* int=

PECact:

)502ln(

DTt

iniact PECPEC

=

PECtwa:

)1(2ln

50 )50

2ln(

DTt

initwa et

DTPECPEC

=

where A = application rate [g/ha]

fint= fraction intercepted by plant cover

d = depth of the soil layer [cm]

bd = bulk density [g/cm]

DT50 = half-life for dissipation

t = time period concerned.

Exposure concentration in aquatic pelagic compartment

After application to soil, lime may enter an adjacent surface water via run-off or spray drift. The

PECini in surface water can be calculated using the model EXPOSIT 2.0c (Winkler, 2005 developed

by the German UBA and BBA on the basis of the following assumptions:

The model Exposit 2.0c assumes that a storm event causing run-off takes place three daysafter application. During the period between application and storm event, lime is transformed tothe respective carbonates with a DT50(soil) of 4 hours (1st order degradation kinetics).

Exposit 2.0c assumes that 0.5 % of the applied amount, which is calculated to be stillpresent in the soil on day 3 after application, reaches the surface water. A field of 100 mx 100 m and an adjacent surface water basin of 30 cm depth, 100 m length and 1 m width isassumed, resulting in a water volume of 30000 L. The simple scenario implies 20 mmprecipitation and 50 % run-off (10 mm), which results in 100000 L run-off water. According toExposit, 50 % reduction of the run-off water reaching the surface water is obtained by a bufferzone of 5 m width, while a reduction of 90 % can be obtained by a 10 m buffer zone. The initialPECsw can then be calculated for buffer zones of 0 m, 5 m and 10 m. Movement of the waterbody can be further assumed resulting in a dilution by 1:2.

Initial PECsw values can be calculated, which represent the predicted environmentalconcentrations immediately after lime enters the surface water.

As a worst-case approach, degradation or transformation (carbonatisation) processes duringrun-off are not considered, although based on the available experimental resultscarbonatisation in soil and water) it can be concluded that the carbonatisation processcontinues during run-off.

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9.0.2 Methodology used for occupational exposure assessment

According to the REACH Guidance R.14 (Occupational exposure estimation, Version: 2, May

2010, ECHA-2010-G-09-EN) different methodologies may be used for occupational exposure

assessment. Preference should be given to monitoring data measured under the same operational

conditions (OC) and with the same risk management measure (RMM) in place as set in the

exposure scenario. If such data are not available, analogous data can be used given that OCs and

RMMs are similar to an extent which justifies such read-across. If no monitoring data are available

at all, occupational exposure can be assessed by the aid of exposure assessment tools.

By definition an ES has to describe under which OC and RMMs the substances can be handled

safely. This is demonstrated if the estimated exposure level is below the respective derived no-

effect level (DNEL), which is expressed in the risk characterisation ratio (RCR). For workers, the

repeated dose DNEL for inhalation as well as the acute DNEL for inhalation are based on the

respective recommendations of the scientific committee on occupational exposure limits (SCOEL)

being 1 mg/m and 4 mg/m, respectively. Since the SCOEL recommendation refers to respirable

dust while the exposure estimates in MEASE reflect the inhalable fraction, an additional safetymargin is inherently included in the exposure scenarios below when MEASE has been used to

derive exposure estimates.

For a quantitative approximation of this safety margin, dustiness tests for calcium dihydroxide

representing typical specifications that are placed on the market were conducted. Based on the

obtained particle size data, the MMAD of the airborne fraction, and subsequently particle

deposition rates in different regions of the respiratory tract were estimated (Grewe, 2010). The

main conclusion drawn can be summarised as follows:

(i) The tested lime substances have a limited deposition potential in the human respiratory tract:Less than 67 % of airborne material is estimated to deposit. The rest of the airborne material isnot inhaled due to physical phenomena related to air streams and turbulences close to themouth or is simply exhaled (i.e. not deposited).

(ii) Only about 4 % or less of the inhaled material are predicted to deposit in the pulmonary region(PU), thus representing the respirable fraction, whereas the material deposited in thetracheobronchial (TB) and the extrathoracic region (Head) may be assumed to be cleared to thegastro intestinal tract (i.e., by mucociliary escalation and subsequent swallowing).

Thus, for inhalation exposure estimates the safety factor can be assumed to be in the range of 25.

However, since not only mechanical agitation is assumed to lead to inhalation exposure but also

hot processes producing fumes and other processes potentially modifying the particle size

distribution of the handled lime material, this additional safety factor is neither applied to the

exposure estimates nor to the corresponding risk characterisation ratios.

In Chapter R.14 of the technical guidance documents (TGD) for REACH, it is stated that acuteexposure estimates (commonly understood as peak exposure levels reflective of an exposure

duration of 15 minutes) can be extrapolated from adequate full-shift exposure estimates. If 90th

percentiles of the exposure distribution have been used to estimate the full-shift exposure level, it

is proposed in the TGD to use an extrapolation factor of two. In consideration of the ratio acute

DNEL/long-term DNEL of four, it is assumed that the RCR for long-term exposure covers acute

exposures as well.

When comparing full-shift exposure estimates with long-term DNELs, a reduction of the exposure

estimate by reflecting the actual exposure duration is common practice. This is normally indicated

by the use of time weighted averages (TWA) for the respective exposure estimates. For acute

effects, this is generally not assumed to be appropriate as peak exposures possibly causing acuteeffects would be averaged out. Since the remaining safety margin of two considering an

extrapolation from full-shift to short-term exposure levels (see above), a reduction of the exposure

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estimate by a factor of two would still appropriately address acute effects. Thus, a reduction of the

exposure duration in the ES below was only considered during exposure estimation to a level

above half-shift (240 minutes). For MEASE exposure estimates, this would lead to an exposure

reduction of 40 % inherently maintaining an additional safety margin.

9.0.2.1 Measured dataMeasured data have been provided for the professional use of lime substances for soil treatment.

In this application the substance is spread by professionals with the aid of special spreading

vehicles or by means of tractor-drawn spreading trailers. In both cases, the worker is sitting in a

cabin with filtered air supply during application of calcium dihydroxide to the soil. A monitoring

survey was conducted to obtain levels of personal inhalation exposure during this task since such

data were previously not available. The data fulfil strict quality criteria as given below.

9.0.2.1.1 Inhalation exposure data

A detailed description of the quality criteria applied to the measured inhalation exposure data can

be found in several risk assessment reports as conducted under 793/93/EEC. Additionalinformation can be found in the technical guidance on occupational exposure assessment (R.14).

For the sake of brevity, only the most relevant qualifiers are listed below:

In general, only personal measurements of inhalation exposure are to be used. However, in the

ES below, measured data have only been used for spreading of lime for soil treatment. For this

individual task, it is assumed that static measurements do accurately reflect personal exposure

for the following reasoning. During this spreading activates, the worker is sitting in a ventilated

vehicle cabin. Due to the resulting air change and the small cabin volume it is assumed that

static measurements taken inside the cabin accurately reflect personal exposure.

Depending on the exposure duration, these values are either full-shift-representative (at

minimum of 120 minutes measurement duration) or were obtained during the entire taskduration. In the latter case and if it could be shown in addition that exposure is negligible for the

remaining shift, values have been weighted accordingly to obtain time weighted averages

(TWA). If applicable, the corresponding task durations can be found under Section 2.1,

Frequency and duration of use/exposure.

The measured fraction must be respirable according to EN 481 in compliance with

corresponding DNEL for inhalation given as respirable dust.

All measurements were assigned to a specific workplace, process or task.

The measurement date has to be reported.

Additionally, information about sampling equipment and about the method of analysis has to be

provided for each individual data set.

9.0.2.1.2 Dermal exposure data

Dermal exposure data are not available.

9.0.2.1.3 Assessment of data quality and percentiles to be used

Measured data are used in the ES (Section 9.10) below have been checked for their quality by

applying the quality criteria as outlined above. According to R.14 (Version 2, May 2010) of the

REACH Guidance, the percentile to reflect the exposure level for workers has to be determined

according to the specificity of the data to the ES of interest and the variability of the data (Table 14-

2) as reflected by the geometric standard deviation (GSD). Additionally, the guidance requires aminimum number of measurements based on the GSD. The table below summarises this

information for all data which can be found in the ES and shown subsequently in this document.

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Measurements were performed when using calcium oxide, which is used as a surrogate substance

for calcium hydroxide. This is in agreement with the common OEL for CaO and Ca(OH)2.

Table 3: Quality assessment of measured data

Exposurescenario

Exposureroute

Type ofmeasurement

Counts

Specificity of dataGSD

Chosenpercentile

Monitoring data for the professional use soil treatment [mg calcium oxide/m air, except for counts]

9.10 Application tosoil(spreading)

Inhalation personal 9*high

(data originate from theworkplace under scrutiny)

3.027

90th

*Data set contains values below the limit of quantification.

9.0.2.1.4 Analysis of air monitoring data

An analysis of the data is provided in the table below:

Table 4: Analysis of personal air monitoring measurements [mg calcium oxide/m air]

Exposure scenario Counts GSD Minimum Median75th

percentile90th

percentileMaximum

9.10 Application tosoil (spreading)

9* 3.027 0.040 0.420 0.600 0.880 0.920

Shaded cells indicate the selected percentile.*Data set contains values below the limit of quantification.

It is noted that the analysed data above represent personal exposure levels outside any respiratory

protective equipment (RPE). If applicable, such equipment was taken into account by dividing the

calculated exposure level by the so-called assigned protection factor (APF) as reported in the

exposure scenarios below. These APFs have been set according to BS EN 529:2005 and can alsobe consulted in the glossary of MEASE.

Exposure estimates for milling and loading for soil treatment are only considered as supportive

information, as the number of data-points does not meet the requirements as described in R.14.

For the spreading activity, 9 values are assessed to fulfil these requirements: these data were

obtained for a highly specialised workplace under defined exposure conditions (see R.14, page 10,

last paragraph). In addition, these data were obtained by also taking into account high dusty lime

substances used for stabilisation although dustiness-reduced materials (wetted) are available for

this use.

9.0.2.2 Modelled exposure

In cases where neither measured data nor analogous data were available, occupational exposure

was assessed with the aid of a modelling tool. At the first tier screening level, the MEASE tool

(http://www.ebrc.de/mease.html) was used to assess inhalation exposure according to the ECHA

guidance (R.14). All parameters needed to run the tool are provided in the ESs below. As can be

seen in section 4 of each of the scenarios below, any downstream user who wants to deviate

slightly from a specific scenario can modify these parameters accordingly and run MEASE for

demonstrating safe handling conditions. The required parameter physical form of the substance

can be determined as defined in the glossary of MEASE under Physical form. A safe use is

demonstrated if the exposure is below the respective derived no-effect level (DNEL), which is

expressed in the RCR.

ES 9.1 - 9.9 are predominantly based on the emission potential corresponding to the physical form

of the produced/used materials. For hot processes (PROC 22, 23, 25, 27a) the emission potential

is however driven by the ratio of process temperature/melting point. Because of the generic nature

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of the ES and in order to reflect worst case situations, a high emission potential was assumed for

exposure estimation for these PROCs. The same strategy was followed for tasks (PROC 24) for

which the emission potential is mainly driven by abrasion, so that the emission potential was also

assumed to be high.

9.0.3 Methodology used for consumer exposure assessment

According to the REACH-guidance (REF R.15) different methodologies may be used for consumer

exposure assessment. In general, measured data are preferred over modelled data provided they

are reliable and representative for the situation that needs to be assessed. However, for most

consumer exposure scenarios, measurements of the actual exposure of consumers will not be

available. Therefore, exposure needs to be assessed with the aid of modelling tools or by read-

across from another description of a comparable task.

By definition an ES has to describe under which conditions the substances, preparation or articles

can be handled safely. For the inhalation exposure to lime substances this can be demonstrated ifthe estimated exposure level is below the respective derived no-effect level (DNEL), which is

expressed in the risk characterisation ratio (RCR). For dermal exposure and exposure to the eye a

qualitative approach has been followed, as no DNEL could be derived for this route due to the

irritating properties of lime. Oral exposure was not assessed as this is not a foreseeable route of

exposure regarding the uses addressed.

9.0.3.1 Inhalation exposure

Inhalation exposure via gaseous releases can be disregarded as the vapour pressure of lime

substances in water is low and generation of mists or aerosols does not take place in the identifiedconsumer uses.

Therefore, inhalation exposure to lime will be to the lime powder itself, released to air during mixing

and loading processes. Powders can disperse into the air during such activities and can

subsequently be inhaled. The inhalation exposure to powders during mixing and loading can in

general be described with the spray model provided in ConsExpo. Instead of aerosols, solid

particles are considered to describe the exposure to a dispersed powder. Parameters such as the

particle size distribution, airborne fraction and mass generation rate are needed to calculate the

inhalation exposure to powders. However, if not all parameters are available, the below-mentioned

data, derived from van Hemmen (1992), can be used to calculate the inhalation exposure.

According to the RIVM report 320104007 Do it yourself products fact sheet read-across from the

inhalation exposure to pesticides resulting from mixing and loading of solid pesticides (wettable

powders) has been proposed. The inventory performed by van Hemmen (1992) for the inhalation

exposure to pesticides for professional use results in an indicative value for mixing and loading of

solid pesticides (wettable powders). The indicative 90th percentile of the inhalation exposure is 15

mg formulation per hour, which is considered applicable for about 25 kg active substance applied

per day.

The indicative value for professional application of pesticides is extrapolated to the consumer

application of pesticides in the Pest Control Products Fact Sheet (RIVM report 320005002/2006).

Although powders may differ significantly between consumer products, it is assumed that the

indicative value found for a pesticide is also appropriate for do-it-yourself (DIY) products.

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Therefore, it is assumed that for consumers the quantity of active substance applied per day is

1000 times lower than for professionals; thus, the amount applied per day is ca. 25 g of active

substance.

The above-mentioned indicative value for professional application is extrapolated to the consumer

application. The inhalation exposure for consumers is estimated at 15 g/hr or 0.25 g/min. Forlarger tasks the inhalation exposure is expected to be higher. A factor of 10 is suggested when the

product amount exceeds 2.5 kg, resulting in the inhalation exposure of 150 g/hr.

To convert these values in mg/m a default value of 1.25 m/hr for the breathing volume under light

working conditions will be assumed (van Hemmen, 1992) giving 12 g/m for small tasks and 120

g/m for larger tasks. However, a low quality factor is assigned for this approach.

When the preparation or substance is applied in granular form or as tablets, reduced exposure to

dust can be assumed. To take this into account if data about particle size distribution and attrition

of the granule are lacking, the model for powder formulations is used, assuming a reduction in dust

formation by 10 % according to Becks and Falks (2006).

Furthermore, it should be noted that for consumers, the repeated dose DNEL for inhalation as well

as the acute DNEL for inhalation are based on the respective recommendations of the Scientific

Committee on Occupational Exposure Limits (SCOEL), being 1 mg/m and 4 mg/m, respectively.

Since the SCOEL recommendation refers to respirable dust while the exposure estimates in

ConsExpo or by the model from van Hemmen reflect the inhalable fraction, an additional safety

margin is inherently included in the exposure scenarios below, i.e. the exposure estimates are very

conservative.

For a quantitative approximation of this safety margin dustiness tests were conducted for lime

substances in typical specifications as being placed on the market. Based on the obtained particle

size distributions the MMADs of the lime substances were estimated and the potential for

deposition in the respiratory tract evaluated using the MPPD model (Grewe, 2010). The main

conclusion drawn can be summarised as follows:

(i) The tested lime substances have a limited deposition potential in the human respiratory

tract: Less than 67 % of the airborne material is predicted to deposit. The rest of the

airborne material is not inhaled due to physical phenomena related to air streams and

turbulences close to the mouth, or simply exhaled (i.e. not deposited).

(ii) Only about 4 % or less of the inhaled material are predicted to deposit in the pulmonary

region (PU), thus representing the respirable fraction, whereas the material deposited in the

tracheobronchial (TB) and the extrathoracic region (Head) may be assumed to be cleared

to the gastrointestinal tract (i.e., by mucociliary escalation and subsequent swallowing).

Thus, for inhalation exposure estimates the safety factor can be assumed to amount to

approximately 25. However, since processes potentially modifying the particle size distribution

might be applied before being available to consumers this additional safety factor is neither applied

to the exposure estimates nor to the corresponding risk characterisation ratios.

9.0.3.2 Dermal exposure

Due to the irritant effects to the skin adoption of appropriate safety measures (PPE) is highly

recommended also for consumers (DIYers). Since adherence to consumer instructions and use of

PPE cannot be expected to be highly effective, dermal exposure has been addressed on aqualitative or quantitative basis not taking into account PPE.

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Dermal exposure to powders

Dermal exposure to powders can be taken into consideration for mixing the powder with water. The

model best suited is the constant rate model. It is assumed that half of both hands (0.5 860 cm)

will be exposed. The time needed to prepare the mixture is dependent on the amount used.

According to the RIVM report 320104007 Do it yourself products fact sheet read-across from thedermal exposure of pesticides resulting from mixing and loading of solid pesticides (wettable

powders) has been proposed, as information about dermal exposure during mixing and loading of

powders is lacking for DIY products.

For dermal exposure of professionals, the inventory performed by van Hemmen (1992) gives an

indicative value during mixing and loading of solid pesticides. The indicative 90th percentile value

for dermal exposure is 2000 mg formulation per hour, which is considered applicable for about 25

kg active substance applied per day. It is assumed that for consumers the quantity of active

substance applied per day is 1000 times lower than for professionals; thus, the amount applied per

day is circa 25 g of active substance.

The above-mentioned indicative value for professional application is extrapolated to the consumer

application. The dermal exposure for consumers is estimated at 2 mg/h, i.e. 0.033 mg/min. Larger

tasks with consequently larger product amounts will result in higher exposures. A factor of 10 is

suggested for tasks with product amounts exceeding 2.5 kg resulting in a dermal exposure of 0.33

mg/min.

The release duration of dust falling on skin is considered the same as the spray duration of 1.33

min (see section 2.4.2 Mixing and loading: powders, Inhalation exposure in RIVM report

320104007). However, a low quality factor is assigned for this approach.

9.0.3.3 Oral exposure

According to the Technical report No 107: Addendum to ECETOC TRA report No. 93, Appendix E-

2, the oral route is not of relevance for the consumer exposure assessment of the identified uses

(expert judgement reflecting discussions within an ECHA consumer expert group comprised of

representatives of ECHA, ECETOC, RIVM, BfR, INERIS and the Danish EPA).

Therefore, poisoning of the general public, including oral uptake by children, is not relevant for

consumers, as misuse is not covered by this assessment.

9.0.3.4 Exposure of the eyes

Due to the irritant effects to the eyes adoption of appropriate safety measures (PPE) is highly

recommended also for consumers (DIYers). Since adherence to consumer instructions and use of

PPE cannot be expected to be highly effective, dermal exposure has been addressed on a

qualitative basis not taking PPE into account.

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9.0.4 Exposure assessment: overview of the exposure scenarios

The exposure assessment of calcium dihydroxide professional and industrial and consumer uses is

performed and organized based on several scenarios. An overview of the scenarios and the

coverage of substance life cycle is presented in Table 5.

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Exposure scenarios

Table 5: Overview on exposure scenarios and coverage of substance life cycle

ES numberExposurescenario title

Manufacture

Identifieduses

Resulting lifecyclestage

LinkedtoIdentifiedUse

Sector of usecategory (SU)

Chemical ProductCategory (PC)

Prca(P

Formulation

Enduse

Consumer

use S

ervicelife

(forarticles)

9.1

Manufacture andindustrial uses ofaqueoussolutions of limesubstances

X X X X 13; 1, 2a, 2b, 4, 5, 6a, 6b, 7, 8,9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19, 20, 23, 24

1, 2, 3, 7, 8, 9a, 9b, 11, 12, 13,14, 15, 16, 17, 18, 19, 20, 21, 23,24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34, 35, 36, 37, 38, 39, 40

1, 28b,15,

9.2

Manufacture andindustrial uses oflow dustysolids/powders oflime substances

X X X X 23; 1, 2a, 2b, 4, 5, 6a, 6b, 7, 8,9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19, 20, 23, 24

1, 2, 3, 7, 8, 9a, 9b, 11, 12, 13,14, 15, 16, 17, 18, 19, 20, 21, 23,24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34, 35, 36, 37, 38, 39, 40

1, 28b,16,22,27a

9.3

Manufacture andindustrial uses ofmedium dustysolids/powders oflime substances

X X X X 33; 1, 2a, 2b, 4, 5, 6a, 6b, 7, 8,9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19, 20, 23, 24

1, 2, 3, 7, 8, 9a, 9b, 11, 12, 13,14, 15, 16, 17, 18, 19, 20, 21, 23,24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34, 35, 36, 37, 38, 39, 40

1, 28b,16,23,27

9.4

Manufacture andindustrial uses of

high dustysolids/powders oflime substances

X X X X 4

3; 1, 2a, 2b, 4, 5, 6a, 6b, 7, 8,

9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19, 20, 23, 24

1, 2, 3, 7, 8, 9a, 9b, 11, 12, 13,

14, 15, 16, 17, 18, 19, 20, 21, 23,24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34, 35, 36, 37, 38, 39, 40

1, 28b,

16,23,27

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Exposure scenarios


Manufacture

Identifieduses





Prca

(P

Formulat

ion

Enduse

Consum

er

use S

ervicelife

(forarticles)

9.5

Manufacture andindustrial uses ofmassive objectscontaining limesubstances

X X X X 53; 1, 2a, 2b, 4, 5, 6a, 6b, 7, 8,9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19, 20, 23, 24

1, 2, 3, 7, 8, 9a, 9b, 11, 12, 13,14, 15, 16, 17, 18, 19, 20, 21, 23,24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34, 35, 36, 37, 38, 39, 40

6, 125

9.6

Professional usesof aqueous

solutions of limesubstances

X X X 6

22; 1, 5, 6a, 6b, 7, 10, 11, 12,

13, 16, 17, 18, 19, 20, 23, 24

1, 2, 3, 7, 8, 9a, 9b, 11, 12, 13,14, 15, 16, 17, 18, 19, 20, 21, 23,

24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34, 35, 36, 37, 38, 39, 40

2, 310,17,

9.7

Professional usesof low dustysolids/powders oflime substances

X X X 722; 1, 5, 6a, 6b, 7, 10, 11, 12,13, 16, 17, 18, 19, 20, 23, 24

1, 2, 3, 7, 8, 9a, 9b, 11, 12, 13,14, 15, 16, 17, 18, 19, 20, 21, 23,24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34, 35, 36, 37, 38, 39, 40

2, 310,18,

9.8

Professional usesof medium dustysolids/powders oflime substances

X X X 822; 1, 5, 6a, 6b, 7, 10, 11, 12,13, 16, 17, 18, 19, 20, 23, 24

1, 2, 3, 7, 8, 9a, 9b, 11, 12, 13,14, 15, 16, 17, 18, 19, 20, 21, 23,24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34, 35, 36, 37, 38, 39, 40

2, 310,18,

9.9

Professional uses

of high dustysolids/powders oflime substances

X X X 9 22; 1, 5, 6a, 6b, 7, 10, 11, 12,13, 16, 17, 18, 19, 20, 23, 24

1, 2, 3, 7, 8, 9a, 9b, 11, 12, 13,

14, 15, 16, 17, 18, 19, 20, 21, 23,24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34, 35, 36, 37, 38, 39, 40

2, 3

10,18,

9.10

Professional useof limesubstances in soiltreatment

X X 10 22 9b 5, 8

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Exposure scenarios


Manufacture

Identifieduses





Prca

(P

Formulat

ion

Enduse

Consum

er

use S

ervicelife

(forarticles)

9.11

Professional usesofarticles/containers containing limesubstances

X X 1122; 1, 5, 6a, 6b, 7, 10, 11, 12,13, 16, 17, 18, 19, 20, 23, 24

0, 2

9.12

Consumer use ofbuilding and

constructionmaterial (DIY)

X 1221 9b, 9a

9.13

Consumer use ofCO2 absorbent inbreathingapparatuses

X 13 21 2

9.14Consumer use ofgardenlime/fertilizer

X 14 21 20, 12

9.15

Consumer use oflime substances

as watertreatmentchemicals inaquaria

X 15 21 20, 37

9.16

Consumer use ofcosmeticscontaining limesubstances

X 16 21 39

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Exposure scenarios

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9.1 Manufacture and industrial uses of aqueous solutions of lime

substances

Exposure Scenario Format (1) addressing uses carried out by workers

1. Title

Free short title Manufacture and industrial uses of aqueous solutions of lime substances

Systematic title basedon use descriptor

SU3, SU1, SU2a, SU2b, SU4, SU5, SU6a, SU6b, SU7, SU8, SU9, SU10, SU11, SU12, SU13, SU14, SU15,SU16, SU17, SU18, SU19, SU20, SU23, SU24

PC1, PC2, PC3, PC7, PC8, PC9a, PC9b, PC11, PC12, PC13, PC14, PC15, PC16, PC17, PC18, PC19,PC20, PC21, PC23, PC24, PC25, PC26, PC27, PC28, PC29, PC30, PC31, PC32, PC33, PC34, PC35,

PC36, PC37, PC38, PC39, PC40AC1, AC2, AC3, AC4, AC5, AC6, AC7, AC8, AC10, AC11, AC13

(appropriate PROCs and ERCs are given in Section 2 below)

Processes, tasksand/or activitiescovered

Processes, tasks and/or activities covered are described in Section 2 below.

Assessment Method The assessment of inhalation exposure is based on the exposure estimation tool MEASE.

2. Operational conditions and risk management measures

PROC/ERC REACH definition Involved tasks

PROC 1 Use in closed process, no likelihood of exposure

Further information is provided in the ECHAGuidance on information requirements and chemical

safety assessment, Chapter R.12: Use descriptorsystem (ECHA-2010-G-05-EN).

PROC 2Use in closed, continuous process with occasional

controlled exposure

PROC 3Use in closed batch process (synthesis or

formulation)

PROC 4Use in batch and other process (synthesis) where

opportunity for exposure arises

PROC 5Mixing or blending in batch processes for formulation

of preparations and articles (multistage and/orsignificant contact)

PROC 7 Industrial spraying

PROC 8aTransfer of substance or preparation

(charging/discharging) from/to vessels/large

containers at non-dedicated facilities

PROC 8bTransfer of substance or preparation (charging/discharging) from/to vessels/large containers at

dedicated facilities

PROC 9Transfer of substance or preparation into small

containers (dedicated filling line, including weighing)

PROC 10 Roller application or brushing

PROC 12 Use of blowing agents in manufacture of foam

PROC 13 Treatment of articles by dipping and pouring

PROC 14Production of preparations or articles by tabletting,

compression, extrusion, pelletisation

PROC 15 Use as laboratory reagent

PROC 16Using material as fuel sources, limited exposure to

unburned product to be expected

PROC 17Lubrication at high energy conditions and in partly

open process

PROC 18 Greasing at high energy conditions

PROC 19Hand-mixing with intimate contact and only PPE

available

ERC 1-7, 12Manufacture, formulation and all types of industrial

uses

ERC 10, 11Wide-dispersive outdoor and indoor use of long-life

articles and materials

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2.1 Control of workers exposure

Product characteristic

According to the MEASE approach, the substance-intrinsic emission potential is one of the main exposure determinants. This isreflected by an assignment of a so-called fugacity class in the MEASE tool. For operations conducted with solid substances at ambienttemperature the fugacity is based on the dustiness of that substance. Whereas in hot metal operations, fugacity is temperature based,taking into account the process temperature and the melting point of the substance. As a third group, high abrasive tasks are based onthe level of abrasion instead of the substance intrinsic emission potential. The spraying of aqueous solutions (PROC7 and 11) isassumed to be involved with a medium emission.

PROC Use in preparation Content in preparation Physical form Emission potential

PROC 7 not restricted aqueous solution medium

All other applicablePROCs

not restricted aqueous solution very low

Amounts used

The actual tonnage handled per shift is not considered to influence the exposure as such for this scenario. Instead, the combination ofthe scale of operation (industrial vs. professional) and level of containment/automation (as reflected in the PROC) is the maindeterminant of the process intrinsic emission potential.

Frequency and duration of use/exposure

PROC Duration of exposure

PROC 7 240 minutes

All other applicablePROCs 480 minutes (not restricted)

Human factors not influenced by risk management

The shift breathing volume during all process steps reflected in the PROCs is assumed to be 10 m/shift (8 hours).

Other given operational conditions affecting workers exposure

Since aqueous solutions are not used in hot-metallurgical processes, operational conditions (e.g. process temperature and processpressure) are not considered relevant for occupational exposure assessment of the conducted processes.

Technical conditions and measures at process level (source) to prevent release

Risk management measures at the process level (e.g. containment or segregation of the emission source) are generally not required inthe processes.

Technical conditions and measures to control dispersion from source towards the worker

PROC Level of separation Localised controls (LC)Efficiency of LC

(according to MEASE)Further information

PROC 7

Any potentially requiredseparation of workers

from the emission sourceis indicated above underFrequency and durationof exposure. A reductionof exposure duration can

be achieved, forexample, by the

installation of ventilated(positive pressure)control rooms or by

removing the worker fromworkplaces involved with

relevant exposure.

local exhaust ventilation 78 % -

PROC 19 not applicable na -


not required na -

Organisational measures to prevent /limit releases, dispersion and exposure

Avoid inhalation or ingestion. General occupational hygiene measures are required to ensure a safe handling of the substance. Thesemeasures involve good personal and housekeeping practices (i.e. regular cleaning with suitable cleaning devices), no eating andsmoking at the workplace, the wearing of standard working clothes and shoes unless otherwise stated below. Shower and changeclothes at end of work shift. Do not wear contaminated clothing at home. Do not blow dust off with compressed air.

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Conditions and measures related to personal protection, hygiene and health evaluation

PROCSpecification of

respiratory protectiveequipment (RPE)

RPE efficiency(assigned protection

factor, APF)Specification of gloves

Further personalprotective equipment

(PPE)

PROC 7 FFP1 mask APF=4Since calcium

dihydroxide is classifiedas irritating to skin, theuse of protective gloves

is mandatory for allprocess steps.

Eye protection equipment(e.g. goggles or visors)must be worn, unless

potential contact with the

eye can be excluded bythe nature and type ofapplication (i.e. closedprocess). Additionally,

face protection, protectiveclothing and safety shoesare required to be worn

as appropriate.


not required na

Any RPE as defined above shall only be worn if the following principles are implemented in parallel: The duration of work (compare withduration of exposure above) should reflect the additional physiological stress for the worker due to the breathing resistance and massof the RPE itself, due to the increased thermal stress by enclosing the head. In addition, it shall be considered that the workerscapability of using tools and of communicating are reduced during the wearing of RPE.For reasons as given above, the worker should therefore be (i) healthy (especially in view of medical problems that may affect the use ofRPE), (ii) have suitable facial characteristics reducing leakages between face and mask (in view of scars and facial hair). Therecommended devices above which rely on a tight face seal will not provide the required protection unless they fit the contours of theface properly and securely.The employer and self-employed persons have legal responsibilities for the maintenance and issue of respiratory protective devices andthe management of their correct use in the workplace. Therefore, they should define and document a suitable policy for a respiratoryprotective device programme including training of the workers.An overview of the APFs of different RPE (according to BS EN 529:2005) can be found in the glossary of MEASE.

2.2 Control of environmental exposure

Amounts used

The daily and annual amount per site (for point sources) is not considered to be the main determinant for environmental exposure.

Frequency and duration of use

Intermittent (< 12 time per year) or continuous use/release

Environment factors not influenced by risk management

Flow rate of receiving surface water: 18000 m/day

Other given operational conditions affecting environmental exposure

Effluent discharge rate: 2000 m/day

Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil

Risk management measures related to the environment aim to avoid discharging lime solutions into municipal wastewater or to surfacewater, in case such discharges are expected to cause significant pH changes. Regular control of the pH value during introduction intoopen waters is required. In general discharges should be carried out such that pH changes in receiving surface waters are minimised(e.g. through neutralisation). In general most aquatic organisms can tolerate pH values in the range of 6-9. This is also reflected in thedescription of standard OECD tests with aquatic organisms. The justification for this risk management measure can be found in theintroduction section.

Conditions and measures related to waste

Solid industrial waste of lime should be reused or discharged to the industrial wastewater and further neutralized if needed.

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3. Exposure estimation and reference to its source

Occupational exposure

The exposure estimation tool MEASE was used for the assessment of inhalation exposure. The risk characterisation ratio (RCR) is thequotient of the refined exposure estimate and the respective DNEL (derived no-effect level) and has to be below 1 to demonstrate a safeuse. For inhalation exposure, the RCR is based on the DNEL for calcium dihydroxide of 1 mg/m (as respirable dust) and the respectiveinhalation exposure estimate derived using MEASE (as inhalable dust). Thus, the RCR includes an additional safety margin since therespirable fraction being a sub-fraction of the inhalable fraction according to EN 481.

PROCMethod used for

inhalation exposureassessment

Inhalation exposureestimate (RCR)

Method used for dermalexposure assessment

Dermal exposureestimate (RCR)

PROC 1 MEASE 0.001 mg/m (0.001)

Since calcium dihydroxide are classified as irritating

to skin, dermal exposure has to be minimised as faras technically feasible. A DNEL for dermal effects

has not been derived. Thus, dermal exposure is notassessed in this exposure scenario.

PROC 2 MEASE 0.001 mg/m (0.001)

PROC 3 MEASE 0.01 mg/m (0.01)




PROC 8a MEASE 0.05 mg/m (0.5)

PROC 8b MEASE 0.01 mg/m (0.01)



PROC 12 MEASE < 0.001 mg/m (< 0.001)








Environmental exposure

The environmental exposure assessment is only relevant for the aquatic environment, when applicable including STPs/WWTPs, asemissions of lime substance in the different life-cycle stages (production and use) mainly apply to (waste) water. The aquatic effect andrisk assessment only deal with the effect on organisms/ecosystems due to possible pH changes related to OH- discharges, being thetoxicity of Ca2+ is expected to be negligible compared to the (potential) pH effect. Only the local scale is being addressed, includingmunicipal sewage treatment plants (STPs) or industrial waste water treatment plants (WWTPs) when applicable, both for production andindustrial use as any effects that might occur would be expected to take place on a local scale. The high water solubility and very lowvapour pressure indicate that lime substance will be found predominantly in water. Significant emissions or exposure to air are notexpected due to the low vapour pressure of lime substance. Significant emissions or exposure to the terrestrial environment are notexpected either for this exposure scenario. The exposure assessment for the aquatic environment will therefore only deal with thepossible pH changes in STP effluent and surface water related to the OH- discharges at the local scale. The exposure assessment isapproached by assessing the resulting pH impact: the surface water pH should not increase above 9.

Environmentalemissions

The production of lime substance can potentially result in an aquatic emission and locally increase the limesubstance concentration and affect the pH in the aquatic environment. When the pH is not neutralised, the

discharge of effluent from lime substance production sites may impact the pH in the receiving water. The pHof effluents is normally measured very frequently and can be neutralised easily as often required by nationallaws.

Exposureconcentration in wastewater treatment plant(WWTP)

Waste water from lime substance production is an inorganic wastewater stream and therefore there is nobiological treatment. Therefore, wastewater streams from lime substance production sites will normally notbe treated in biological waste water treatment plants (WWTPs), but can be used for pH control of acidwastewater streams that are treated in biological WWTPs.

Exposureconcentration inaquatic pelagiccompartment

When lime substance is emitted to surface water, sorption to particulate matter and sediment will benegligible. When lime is rejected to surface water, the pH may increase, depending on the buffer capacity ofthe water. The higher the buffer capacity of the water, the lower the effect on pH will be. In general the buffercapacity preventing shifts in acidity or alkalinity in natural waters is regulated by the equilibrium betweencarbon dioxide (CO2), the bicarbonate ion (HCO3-) and the carbonate ion (CO32-).

Exposure

concentration insediments

The sediment compartment is not included in this ES, because it is not considered relevant for lime

substance: when lime substance is emitted to the aquatic compartment, sorption of to sediment particles isnegligible.Exposureconcentrations in soiland groundwater

The terrestrial compartment is not included in this exposure scenario, because it is not considered to berelevant.

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Exposureconcentration inatmosphericcompartment

The air compartment is not included in this CSA because it is considered not relevant for lime substance:when emitted to air as an aerosol in water, lime substance is neutralised as a result of its reaction with CO2(or other acids), into HCO3- and Ca2+. Subsequently, the salts (e.g. calcium(bi)carbonate) are washed outfrom the air and thus the atmospheric emissions of neutralised lime substance largely end up in soil andwater.

Exposureconcentration relevantfor the food chain(secondary poisoning)

Bioaccumulation in organisms is not relevant for lime substance: a risk assessment for secondary poisoningis therefore not required.

4. Guidance to DU to evaluate whether he works inside the boundaries set by the ESOccupational exposure

The DU works inside the boundaries set by the ES if either the proposed risk management measures as described above are met or thedownstream user can demonstrate on his own that his operational conditions and implemented risk management measures areadequate. This has to be done by showing that they limit the inhalation and dermal exposure to a level below the respective DNEL(given that the processes and activities in question are covered by the PROCs listed above) as given below. If measured data are notavailable, the DU may make use of an appropriate scaling tool such as MEASE (www.ebrc.de/mease.html) to estimate the associatedexposure. The dustiness of the substance used can be determined according to the MEASE glossary. For example, substances with adustiness less than 2.5 % according to the Rotating Drum Method (RDM) are defined as low dusty, substances with a dustiness lessthan 10 % (RDM) are defined as medium dusty and substances with a dustiness 10 % are defined as high dusty.

DNELinhalation: 1 mg/m (as respirable dust)

Important note: The DU has to be aware of the fact that apart from the long-term DNEL given above, a DNEL for acute effects exists at alevel of 4 mg/m. By demonstrating a safe use when comparing exposure estimates with the long-term DNEL, the acute DNEL istherefore also covered (according to R.14 guidance, acute exposure levels can be derived by multiplying long-term exposure estimates

by a factor of 2). When using MEASE for the derivation of exposure estimates, it is noted that the exposure duration should only bereduced to half-shift as a risk management measure (leading to an exposure reduction of 40 %).

Environmental exposure

If a site does not comply with the conditions stipulated in the safe use ES, it is recommended to apply a tiered approach to perform amore site-specific assessment. For that assessment, the following stepwise approach is recommended.

Tier 1: retrieve information on effluent pH and the contribution of the lime substance on the resulting pH. Should the pH be above 9 andbe predominantly attributable to lime, then further actions are required to demonstrate safe use.

Tier 2a: retrieve information on receiving water pH after the discharge point. The pH of the receiving water shall not exceed the value of9. If the measures are not available, the pH in the river can be calculated as follows:

pHriver= Log Qeffluent*10

pHeffluent+

Qriverupstream*10

pHupstream

Qriverupstream+Qeffluent

(Eq 1)

Where:

Q effluent refers to the effluent flow (in m/day)

Q river upstream refers to the upstream river flow (in m/day)

pH effluent refers to the pH of the effluent

pH upstream river refers to the pH of the river upstream of the discharge point

Please note that initially, default values can be used:

Q river upstream flows: use the 10th of existing measurements distribution or use default value of 18000

m/day

Q effluent: use default value of 2000 m/day

The upstream pH is preferably a measured value. If not available, one can assume a neutral pH of 7 ifthis can be justified.

Such equation has to be seen as a worst case scenario, where water conditions are standard and not case specific.

Tier 2b: Equation 1 can be used to identify which effluent pH causes an acceptable pH level in the receiving body. In order to do so, pHof the river is set at value 9 and pH of the effluent is calculated accordingly (using default values as reported previously, if necessary).As temperature influences lime solubility, pH effluent might require to be adjusted on a case-by-case basis. Once the maximumadmissible pH value in the effluent is established, it is assumed that the OH- concentrations are all dependent on lime discharge andthat there is no buffer capacity conditions to consider (this is a unrealistic worst case scenario, which can be modified where informationis available). Maximum load of lime that can be annually rejected without negatively affecting the pH of the receiving water is calculatedassuming chemical equilibrium. OH- expressed as moles/litre are multiplied by average flow of the effluent and then divided by the molarmass of the lime substance.

Tier 3: measure the pH in the receiving water after the discharge point. If pH is below 9, safe use is reasonably demonstrated and theES ends here. If pH is found to be above 9, risk management measures have to be implemented: the effluent has to undergoneutralisation, thus ensuring safe use of lime during production or use phase.

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9.2 Manufacture and industrial uses of low dusty solids/powders

of lime substances

Exposure Scenario Format (1) addressing uses carried out by workers

1. Title

Free short title Manufacture and industrial uses of low dusty solids/powders of lime substances

Systematic title basedon use descriptor

SU3, SU1, SU2a, SU2b, SU4, SU5, SU6a, SU6b, SU7, SU8, SU9, SU10, SU11, SU12, SU13, SU14, SU15,SU16, SU17, SU18, SU19, SU20, SU23, SU24

PC1, PC2, PC3, PC7, PC8, PC9a, PC9b, PC11, PC12, PC13, PC14, PC15, PC16, PC17, PC18, PC19,PC20, PC21, PC23, PC24, PC25, PC26, PC27, PC28, PC29, PC30, PC31, PC32, PC33, PC34, PC35,

PC36, PC37, PC38, PC39, PC40AC1, AC2, AC3, AC4, AC5, AC6, AC7, AC8, AC10, AC11, AC13

(appropriate PROCs and ERCs are given in Section 2 below)

Processes, tasksand/or activitiescovered

Processes, tasks and/or activities covered are described in Section 2 below.

Assessment Method The assessment of inhalation exposure is based on the exposure estimation tool MEASE.

2. Operational conditions and risk management measures

PROC/ERC REACH definition Involved tasks

PROC 1 Use in closed process, no likelihood of exposure Further information is provided in the ECHAGuidance on information requirements and chemical

safety assessment, Chapter R.12: Use descriptorsystem (ECHA-2010-G-05-EN).

PROC 2Use in closed, continuous process with occasional

controlled exposure

PROC 3Use in closed batch process (synthesis or

formulation)

PROC 4Use in batch and other process (synthesis) where

opportunity for exposure arises

PROC 5Mixing or blending in batch processes for formulation

of preparations and articles (multistage and/orsignificant contact)

PROC 6 Calendering operations

PROC 7 Industrial spraying

PROC 8aTransfer of substance or preparation

(charging/discharging) from/to vessels/largecontainers at non-dedicated facilities

PROC 8bTransfer of substance or preparation (charging/discharging) from/to vessels/large containers at

dedicated facilities

PROC 9Transfer of substance or preparation into small

containers (dedicated filling line, including weighing)

PROC 10 Roller application or brushing

PROC 13 Treatment of articles by dipping and pouring

PROC 14Production of preparations or articles by tabletting,

compression, extrusion, pelletisation

PROC 15 Use as laboratory reagent

PROC 16Using material as fuel sources, limited exposure to

unburned product to be expected

PROC 17Lubrication at high energy conditions and in partly

open process

PROC 18 Greasing at high energy conditions

PROC 19Hand-mixing with intimate contact and only PPE

available

PROC 21Low energy manipulation of substances bound in

materials and/or articles

PROC 22Potentially closed processing operations with

minerals/metals at elevated temperatureIndustrial setting

PROC 23Open processing and transfer operations with

minerals/metals at elevated temperature

PROC 24High (mechanical) energy work-up of substances

bound in materials and/or articles

PROC 25 Other hot work operations with metals

PROC 26Handling of solid inorganic substances at ambient

temperature

PROC 27a Production of metal powders (hot processes)

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PROC 27b Production of metal powders (wet processes)

ERC 1-7, 12Manufacture, formulation and all types of industrial

uses

ERC 10, 11Wide-dispersive outdoor and indoor use of long-life

articles and materials

2.1 Control of workers exposure

Product characteristic

According to the MEASE approach, the substance-intrinsic emission potential is one of the main exposure determinants. This isreflected by an assignment of a so-called fugacity class in the MEASE tool. For operations conducted with solid substances at ambienttemperature the fugacity is based on the dustiness of that substance. Whereas in hot metal operations, fugacity is temperature based,taking into account the process temperature and the melting point of the substance. As a third group, high abrasive tasks are based onthe level of abrasion instead of the substance intrinsic emission potential.

PROC Use in preparation Content in preparation Physical form Emission potential

PROC 22 not restrictedsolid/powder,

moltenhigh


moltenhigh

PROC 24 not restricted solid/powder high


moltenhigh

PROC 27a not restrictedsolid/powder,

moltenhigh


not restricted solid/powder low

Amounts used

The actual tonnage handled per shift is not considered to influence the exposure as such for this scenario. Instead, the combination ofthe scale of operation (industrial vs. professional) and level of containment/automation (as reflected in the PROC) is the maindeterminant of the process intrinsic emission potential.

Frequency and duration of use/exposure

PROC Duration of exposure

PROC 22 240 minutes


480 minutes (not restricted)

Human factors not influenced by risk management

The shift breathing volume during all process steps reflected in the PROCs is assumed to be 10 m/shift (8 hours).

Other given operational conditions affecting workers exposure

Operational conditions like process temperature and process pressure are not considered relevant for occupational exposureassessment of the conducted processes. In process steps with considerably high temperatures (i.e. PROC 22, 23, 25), the exposureassessment in MEASE is however based on the ratio of process temperature and melting point. As the associated temperatures areexpected to vary within the industry the highest ratio was taken as a worst case assumption for the exposure estimation. Thus allprocess temperatures are automatically covered in this exposure scenario for PROC 22, 23 and PROC 25.

Technical conditions and measures at process level (source) to prevent release

Risk management measures at the process level (e.g. containment or segregation of the emission source) are generally not required inthe processes.

Technical conditions and measures to control dispersion from source towards the worker

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PROC Level of separation Localised controls (LC)Efficiency of LC

(according to MEASE)Further information

PROC 7

Any potentially requiredseparation of workers

from the emission sourceis indicated above underFrequency and durationof exposure. A reductionof exposure duration can

be achieved, forexample, by the

installation of ventilated(positive pressure)control rooms or by

removing the worker fromworkplaces involved with

relevant exposure.

general ventilation 17 % -

PROC 17 general ventilation 17 % -

PROC 18 general ventilation 17 % -

PROC 19 not applicable na -

PROC 22 local exhaust ventilation 78 % -





PROC 27a local exhaust ventilation 78 % -

All other applicable

PROCs not required na -

Organisational measures to prevent /limit releases, dispersion and exposure

Avoid inhalation or ingestion. General occupational hygiene measures are required to ensure a safe handling of the substance. Thesemeasures involve good personal and housekeeping practices (i.e. regular cleaning with suitable cleaning devices), no eating andsmoking at the workplace, the wearing of standard working clothes and shoes unless otherwise stated below. Shower and changeclothes at end of work shift. Do not wear contaminated clothing at home. Do not blow dust off with compressed air.

Conditions and measures related to personal protection, hygiene and health evaluation

PROCSpecification of

respiratory protectiveequipment (RPE)

RPE efficiency(assigned protection

factor, APF)Specification of gloves

Further personalprotective equipment

(PPE)

PROC 22 FFP1 mask APF=4

Since calcium

dihydroxide is classified

as irritating to skin, the

use of protective gloves

is mandatory for all

process steps.

Eye protection equipment(e.g. goggles or visors)must be worn, unless

potential contact with theeye can be excluded bythe nature and type ofapplication (i.e. closedprocess). Additionally,

face protection, protectiveclothing and safety shoesare required to be worn

as appropriate.

PROC 24 FFP1 mask APF=4

PROC 27a FFP1 mask APF=4


not required na

Any RPE as defined above shall only be worn if the following principles are implemented in parallel: The duration of work (compare withduration of exposure above) should reflect the additional physiological stress for the worker due to the breathing resistance and massof the RPE itself, due to the increased thermal stress by enclosing the head. In addition, it shall be considered that the workerscapability of using tools and of communicating are reduced during the wearing of RPE.For reasons as given above, the worker should therefore be (i) healthy (especially in view of medical problems that may affect the use ofRPE), (ii) have suitable facial characteristics reducing leakages between face and mask (in view of scars and facial hair). Therecommended devices above which rely on a tight face seal will not provide the required protection unless they fit the contours of the

face properly and securely.The employer and self-employed persons have legal responsibilities for the maintenance and issue of respiratory protective devices andthe management of their correct use in the workplace. Therefore, they should define and document a suitable policy for a respiratoryprotective device programme including training of the workers.An overview of the A

ca(oh)2 - es-addendum to csr

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