this document has been prepared according to the provisions of article 136(3)

349 Pages·2008·6.31 MB·English

THIS DOCUMENT HAS BEEN PREPARED ACCORDING TO THE
PROVISIONS OF ARTICLE 136(3) “TRANSITIONAL MEASURES
REGARDING EXISTING SUBSTANCES” OF REACH
(REGULATION (EC) 1907/2006). IT IS NOT A PROPOSAL FOR A
RESTRICTION ALTHOUGH THE FORMAT IS THE SAME
ANNEX XV TRANSITIONAL DOSSIER

SUBMITTED BY: The Netherlands
DATE: November 2008

SUBSTANCE NAME: Coal Tar Pitch, High Temperature
IUPAC NAME: Coal Tar Pitch, High Temperature
EC NUMBER: 266-028-2
CAS NUMBER: 65996-93-2
ANNEX XV TRANSITIONAL DOSSIER - CTPHT CAS 65996-93-2

PREFACE
Coal tar pitch, high temperature (CTPHT) was a priority substance on the 3rd priority list in the
framework of Council Regulation (EEC) 793/93 (EC, 1993). The work on this substance was not
completed within this regulation, therefore in accordance with Article 136(3) of the REACH
regulation (EC, 2006b) a transitional dossier has been made by the Netherlands. The Annex XV
restriction proposal format has been used on request of the ECHA. It is decided to include all
information from the previous dangerous substances regulation for completeness and transparency
reasons.
The knowledge and data regarding the potential risk(s) of CTPHT to the environment and human
health that are reported in this transitional dossier (see Section B) are copied from the human health
and environment risk assessment reports (The Netherlands, 2008ab), which were both endorsed
under Regulation 793/93. In addition, the risk reduction strategy document with respect to workers
(The Netherlands, 2008c) is included (see Section H.1). This risk reduction strategy document was
endorsed at the 15th RRSM in April 2008. The risk assessment for the environment was not finished
until May 2008, which prevented the preparation of the risk reduction strategy for the environment
in time to finalize the work on CTPHT in the framework of Council Regulation (EEC) 793/93.
Conform Article 136(3c) of the REACH regulation (EC, 2006b) this dossier considers how
environmental risks should be addressed. This risk reduction strategy is a new part in this dossier
(incorporated in Sections B.11 - E)
Considerations about the risk assessment of CTPHT
In the human health and environment risk assessment reports (The Netherlands, 2008ab) exposure
to Polycyclic Aromatic Hydrocarbons (PAHs) is often used as an indicator of exposure to CTPHT,
based on the following argumentation, which is copied from these risk assessment reports.
Coal tar pitch, high temperature (CTPHT) possibly contains thousands of substances, and because
of this complexity and variability of CTPHT, great difficulties have been encountered in assessing
exposure in the epidemiological studies. Generally, the presence of coal tars and derived products is
detected by the presence of their specific constituents, especially coal tar pitch volatiles (CTPV) and
Polycyclic Aromatic Hydrocarbons (PAHs), in the air (IARC, 1985). Since PAHs are among the
major components of CTPHT, and some individual PAHs are proven animal carcinogens, PAH
levels are considered as a suitable indicator of exposure to CTPHT (WATCH, 2000). Existing
exposure information suggests that the airborne concentration of benzo(a)pyrene correlates well
with the concentration of total PAHs for most workplaces. Based on these findings and the
availability of exposure data, the Working group on Assessment of Toxic Chemicals (WATCH)
from the Health and Safety Executive (HSE, UK) has pinpointed benzo(a)pyrene as the most
suitable marker for assessing exposure to PAHs1 for coal tar pitch volatile (CTPV) industries
(WATCH, 2000). As such, in conducting this exposure assessment to CTPHT, exposure to
benzo(a)pyrene has been adopted as the primary indicator in the way described in Section B.9.
The database on possible health hazards induced by CTPHT is rather limited, and it is, therefore,
hardly possible to perform a full risk assessment for all the required endpoints. There is, though,
quite some information from epidemiological studies on workers in specific industrial processes
where CTPHT is produced and/or used, that indicate that carcinogenicity is a striking hazard
associated with CTPHT. This is attributed to the presence of the PAHs in CTPHT, as indicated
above. Given the uncertainties with respect to the effects of other chemical constituents of CTPHT
(and related substances), it is not completely sure that carcinogenicity is the only relevant effect of
CTPHT. However, as it is also noted that the carcinogenic potencies of these PAHs are quite high,
limitation of the risks for cancer will automatically reduce the risk for any other possible effect,

1 These are 11 PAHs identified by HSE as having the greatest carcinogenic potential of the PAH family of compounds.
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ANNEX XV TRANSITIONAL DOSSIER - CTPHT CAS 65996-93-2 PREFACE
quite possibly even to zero. Therefore, in view of the limited database, it is decided that this
transitional dossier will focus on the carcinogenic and mutagenic properties, using the best-studied
PAH benzo(a)pyrene as a guidance substance (see for further information Sections B.5, B.5.8, and
B.10.1.1).
For the environmental risk assessment the use of one single marker substance has little meaning. It
is well realised that each of the many substances that constitute coal tar pitch may be relevant for
the receiving environment. It is however the Rapporteur's opinion that the assessment should be
focused on the risk of the emission of polycyclic aromatic hydrocarbons (PAHs) only, since this
was the main reason to put CTPHT on the 3rd priority list (EC, 1993). Moreover, based on the
available information, it is only for the EPA 16 homocyclic PAHs that sufficient effect and
exposure data are available. It is for this reason that the risk assessment of CTPHT for the
environment is restricted to this group of PAHs and regards them as representative for the total
emission of PAH, accepting that the potential risk of CTPHT might be underestimated.
Since so many unintentional sources contribute to the total emission of PAHs into the environment
(see Section B.8.2.2), which by extension are not related to production and use of CTPHT, the risk
assessment will only be focussed on the PAHs that is emitted by producers and the downstream
users of CTPHT on a local scale. To put this emission into perspective, the calculated local
concentrations will be related to the background levels measured in urban and rural areas.

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TABLE OF CONTENTS
A. Proposal...........................................................................................................................................1
A.1 Proposed restriction(s)...........................................................................................................1
A.1.1 The identity of the substance(s).................................................................................1
A.1.2 Conditions of restriction(s)........................................................................................1
A.2 Summary of the justification..................................................................................................1
A.2.1 Identified hazard and risk...........................................................................................1
A.2.2 Justification that action is required at Community-wide basis..................................2
A.2.3 Justification that the proposed restriction is the most appropriate measure..............2
B. Information on hazard and risk.......................................................................................................3
B.1 Identity of the substance(s) and physical and chemical properties........................................3
B.1.1 Name and other identifiers of the substance(s)..........................................................3
B.1.2 Composition of the substance(s)................................................................................4
B.1.2.1 Purity/Impurities, Additives......................................................................4
B.1.3 Physico-chemical properties......................................................................................6
B.1.3.1 Water solubility.........................................................................................6
B.1.3.2 Multiple elution.........................................................................................8
B.1.4 Justification for grouping...........................................................................................9
B.2 Manufacture and uses..........................................................................................................11
B.2.1 Manufacture and import of a substance...................................................................11
B.2.2 Uses..........................................................................................................................13
B.2.2.1 Introduction.............................................................................................13
B.2.2.2 Use as binding agent in the production of electrodes..............................13
B.2.2.3 Use as binding agent in the production of other products.......................14
B.2.2.3.1 Other carbon and graphite products.....................................14
B.2.2.3.2 Refractory brick...................................................................14
B.2.2.3.3 Production of active carbon.................................................14
B.2.2.3.4 Binder for road construction and roofing............................15
B.2.2.3.5 Clay pigeons........................................................................15
B.2.2.3.6 Coal briquetting...................................................................15
B.2.2.3.7 Heavy duty corrosion protection.........................................16
B.2.2.4 Application of carbon and graphite electrodes........................................17
B.2.2.4.1 Aluminium production.........................................................17
B.2.2.4.2 Ferro-alloys and non-ferro metals (alloys)..........................18
B.2.3 Uses advised against by the registrants....................................................................20
B.2.4 Description of targeting...........................................................................................20
B.3 Classification and labelling..................................................................................................22
B.3.1 Classification in Annex I of Directive 67/548/EEC.................................................22
B.3.2 Self classification(s) and labelling...........................................................................22
B.4 Environmental fate properties..............................................................................................24
B.4.1 Degradation..............................................................................................................25
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B.4.1.1 Atmospheric degradation (or fate in the atmosphere).............................25
B.4.1.2 Aquatic degradation (incl. sediment)......................................................27
B.4.1.2.1 Abiotic.................................................................................27
B.4.1.2.2 Biodegradation.....................................................................28
B.4.1.3 Degradation in soil..................................................................................29
B.4.1.4 Summary of environmental degradation.................................................30
B.4.2 Environmental distribution......................................................................................31
B.4.2.1 Adsorption...............................................................................................31
B.4.2.2 Precipitation.............................................................................................39
B.4.2.3 Volatilisation...........................................................................................40
B.4.2.4 Distribution in wastewater treatment plants............................................40
B.4.3 Bioaccumulation......................................................................................................40
B.4.3.1 Aquatic organisms...................................................................................41
B.4.3.2 Terrestrial organism.................................................................................64
B.4.4 Secondary poisoning................................................................................................64
B.5 Human health hazard assessment........................................................................................65
B.5.1 Toxicokinetics..........................................................................................................66
B.5.1.1 Summary of toxicokinetics......................................................................67
B.5.2 Acute toxicity...........................................................................................................68
B.5.2.1 Studies in animals....................................................................................68
B.5.2.1.1 In vivo studies......................................................................68
B.5.2.2 Studies in humans....................................................................................69
B.5.2.3 Summary of acute toxicity.......................................................................69
B.5.3 Irritation...................................................................................................................69
B.5.3.1 Skin..........................................................................................................69
B.5.3.1.1 Studies in animals................................................................69
B.5.3.1.2 Studies in humans................................................................70
B.5.3.2 Eye...........................................................................................................70
B.5.3.2.1 Studies in animals................................................................70
B.5.3.2.2 Studies in humans................................................................70
B.5.3.3 Respiratory tract......................................................................................71
B.5.3.3.1 Studies in animals................................................................71
B.5.3.3.2 Studies in humans................................................................71
B.5.3.4 Summary of irritation..............................................................................71
B.5.4 Corrosivity...............................................................................................................71
B.5.5 Sensitisation.............................................................................................................71
B.5.5.1 Summary of sensitisation........................................................................72
B.5.6 Repeated dose toxicity.............................................................................................72
B.5.6.1 Studies in animals....................................................................................72
B.5.6.1.1 In vivo studies......................................................................72
B.5.6.1.2 Repeated dose toxicity observed in carcinogenicity
studies..................................................................................72
B.5.6.1.3 Repeated dose toxicity with high-boiling coal liquid..........74
B.5.6.2 Studies in humans....................................................................................75
B.5.6.3 Summary of repeated dose toxicity.........................................................75
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B.5.7 Mutagenicity............................................................................................................75
B.5.7.1 Studies in vitro.........................................................................................76
B.5.7.1.1 In vitro: bacteria, yeast and mammalian cells.....................76
B.5.7.1.2 In vitro: human body fluids.................................................76
B.5.7.2 Studies in vivo..........................................................................................78
B.5.7.2.1 In vivo: animal data.............................................................78
B.5.7.2.2 In vivo: human data.............................................................79
B.5.7.3 Summary of mutagenicity.......................................................................82
B.5.8 Carcinogenicity........................................................................................................83
B.5.8.1 Studies in animals....................................................................................83
B.5.8.2 Studies in humans....................................................................................87
B.5.8.2.1 Introduction..........................................................................87
B.5.8.2.2 Epidemiological data relevant for the different
exposure scenarios...............................................................88
B.5.8.2.3 Meta-analysis on lung and bladder cancer risk after
exposure to PAHs................................................................89
B.5.8.2.4 Summary of carcinogenicity................................................91
B.5.9 Toxicity for reproduction.........................................................................................93
B.5.9.1 Effects on fertility....................................................................................93
B.5.9.1.1 Studies in animals................................................................93
B.5.9.1.2 Studies in humans................................................................94
B.5.9.2 Developmental toxicity...........................................................................94
B.5.9.2.1 Studies in animals................................................................94
B.5.9.2.2 Studies in humans................................................................96
B.5.9.2.3 Summary of toxicity for reproduction.................................96
B.5.10 Other effects.............................................................................................................98
B.5.11 Derivation of DNEL(s)/DMEL(s) or other quantitative or qualitative measure
for dose response......................................................................................................98
B.6 Human health hazard assessment of physico-chemical properties......................................98
B.6.1 Explosivity...............................................................................................................98
B.6.2 Flammability............................................................................................................98
B.6.3 Oxidising properties.................................................................................................98
B.7 Environmental hazard assessment.......................................................................................98
B.7.1 Aquatic compartment (including sediment).............................................................99
B.7.1.1 Naphthalene.............................................................................................99
B.7.1.1.1 Fresh water environment.....................................................99
B.7.1.1.2 Marine environment...........................................................100
B.7.1.1.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................100
B.7.1.2 Anthracene.............................................................................................101
B.7.1.2.1 Fresh water environment...................................................101
B.7.1.2.2 Marine environment...........................................................102
B.7.1.2.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................102
B.7.1.3 Phenanthrene.........................................................................................103
B.7.1.3.1 Fresh water environment...................................................103
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B.7.1.3.2 Marine environment...........................................................103
B.7.1.3.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................103
B.7.1.4 Fluoranthene..........................................................................................104
B.7.1.4.1 Fresh water environment...................................................104
B.7.1.4.2 Marine environment...........................................................105
B.7.1.4.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................105
B.7.1.5 Pyrene....................................................................................................106
B.7.1.5.1 Fresh water environment...................................................106
B.7.1.5.2 Marine environment...........................................................106
B.7.1.5.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................107
B.7.1.6 Fluorene.................................................................................................107
B.7.1.6.1 Fresh water environment...................................................107
B.7.1.6.2 Marine environment...........................................................107
B.7.1.6.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................107
B.7.1.7 Acenaphthylene.....................................................................................108
B.7.1.7.1 Fresh water environment...................................................108
B.7.1.7.2 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................108
B.7.1.8 Acenaphthene........................................................................................108
B.7.1.8.1 Fresh water environment...................................................108
B.7.1.8.2 Marine environment...........................................................109
B.7.1.8.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................109
B.7.1.9 Chrysene................................................................................................109
B.7.1.9.1 Fresh water environment...................................................109
B.7.1.9.2 Marine environment...........................................................110
B.7.1.9.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................110
B.7.1.10 Benz(a)anthracene.................................................................................110
B.7.1.10.1 Fresh water environment...................................................110
B.7.1.10.2 Marine environment...........................................................111
B.7.1.10.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................111
B.7.1.11 Benzo(b)fluoranthene............................................................................112
B.7.1.11.1 Fresh water environment...................................................112
B.7.1.11.2 Marine environment...........................................................112
B.7.1.11.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................112
B.7.1.12 Benzo(ghi)perylene...............................................................................112
B.7.1.12.1 Fresh water environment...................................................112
B.7.1.12.2 Marine environment...........................................................112
B.7.1.12.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................113
B.7.1.13 Benzo(k)fluoranthene............................................................................113
B.7.1.13.1 Fresh water environment...................................................113
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B.7.1.13.2 Marine environment...........................................................113
B.7.1.13.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................113
B.7.1.14 Benzo(a)pyrene......................................................................................113
B.7.1.14.1 Fresh water environment...................................................113
B.7.1.14.2 Marine environment...........................................................114
B.7.1.14.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................115
B.7.1.15 Dibenzo(a,h)anthracene.........................................................................116
B.7.1.15.1 Fresh water environment...................................................116
B.7.1.15.2 Marine environment...........................................................116
B.7.1.15.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................116
B.7.1.16 Indeno(123-cd)pyrene...........................................................................117
B.7.1.16.1 Fresh water environment...................................................117
B.7.1.16.2 Marine environment...........................................................117
B.7.1.16.3 Calculation of Predicted No Effect Concentration
(PNEC)..............................................................................117
B.7.1.17 Evaluation of the applied assessment factors........................................117
B.7.1.17.1 Pyrene................................................................................117
B.7.1.17.2 Benz(a)anthracene.............................................................118
B.7.1.17.3 Benzo(b)fluoranthene........................................................118
B.7.1.17.4 Dibenzo(a,h)anthracene.....................................................119
B.7.1.17.5 Indeno(123-cd)pyrene........................................................119
B.7.1.17.6 Comparison between Log K and derived PNEC...........119
OW
B.7.1.18 PNEC summary for fresh and marine water..........................................119
B.7.1.19 Toxicity test results for sediment organisms.........................................120
B.7.1.19.1 Equilibrium partitioning....................................................120
B.7.1.19.2 Naphthalene.......................................................................120
B.7.1.19.3 Anthracene.........................................................................121
B.7.1.19.4 Phenanthrene......................................................................121
B.7.1.19.5 Fluoranthene......................................................................122
B.7.1.19.6 Pyrene................................................................................124
B.7.1.19.7 Fluorene.............................................................................125
B.7.1.19.8 Acenaphthylene.................................................................125
B.7.1.19.9 Acenaphthene....................................................................125
B.7.1.19.10 Chrysene............................................................................125
B.7.1.19.11 Benz(a)anthracene.............................................................125
B.7.1.19.12 Benzo(b)fluoranthene........................................................125
B.7.1.19.13 Benzo(ghi)perylene............................................................125
B.7.1.19.14 Benzo(k)fluoranthene........................................................126
B.7.1.19.15 Benzo(a)pyrene..................................................................126
B.7.1.19.16 Dibenzo(a,h)anthracene.....................................................126
B.7.1.19.17 Indeno(123-cd)pyrene........................................................126
B.7.1.19.18 PNEC summary for marine and fresh water sediments.....126
B.7.2 Terrestrial compartment.........................................................................................126
B.7.2.1 Equilibrium partitioning........................................................................126
B.7.2.2 Naphthalene...........................................................................................127
B.7.2.3 Anthracene.............................................................................................128
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B.7.2.4 Phenanthrene.........................................................................................128
B.7.2.5 Fluoranthene..........................................................................................129
B.7.2.6 Pyrene....................................................................................................129
B.7.2.7 Fluorene.................................................................................................130
B.7.2.8 Acenaphthylene.....................................................................................130
B.7.2.9 Acenaphthene........................................................................................130
B.7.2.10 Chrysene................................................................................................131
B.7.2.11 Benz(a)anthracene.................................................................................131
B.7.2.12 Benzo(b)fluoranthene............................................................................131
B.7.2.13 Benzo(ghi)perylene...............................................................................131
B.7.2.14 Benzo(k)fluoranthene............................................................................131
B.7.2.15 Benzo(a)pyrene......................................................................................132
B.7.2.16 Dibenzo(a,h)anthracene.........................................................................133
B.7.2.17 Indeno(123-cd)pyrene...........................................................................133
B.7.2.18 PNEC summary for the terrestrial compartment...................................133
B.7.3 Atmospheric compartment.....................................................................................133
B.7.4 Microbiological activity in sewage treatment systems..........................................134
B.7.5 Non compartment specific effects relevant for the food chain (secondary
poisoning)...............................................................................................................134
B.8 PBT and vPvB assessment.................................................................................................135
B.8.1 Assessment of PBT/vPvB properties-Comparison with criteria of Annex XIII....135
B.8.2 Emission characterisation......................................................................................136
B.8.2.1 Sources of PAH emission......................................................................136
B.8.2.1.1 Industrial............................................................................136
B.8.2.1.2 Domestic............................................................................137
B.8.2.1.3 Mobile................................................................................137
B.8.2.1.4 Agricultural........................................................................137
B.8.2.2 PAH emissions from the different sources............................................137
B.8.2.2.1 Emissions to air..................................................................137
B.8.2.2.2 Emissions to water.............................................................142
B.8.2.2.3 Summary............................................................................143
B.9 Exposure assessment..........................................................................................................143
B.9.1 General discussion on releases and exposure........................................................143
B.9.1.1 Summary of existing legal requirements...............................................144
B.9.1.2 Summary of effectiveness of the implemented risk management
measures................................................................................................145
B.9.2 Exposure assessment for workers..........................................................................146
B.9.2.1 Introduction...........................................................................................146
B.9.2.2 Occupational Scenario 1: Production of CTPHT in coal tar
distillation plants...................................................................................150
B.9.2.3 Occupational Scenario 2: Use as a binding agent for electrodes...........154
B.9.2.3.1 Sub-scenario (i): Use as a binding agent for electrodes
in the aluminium industry..................................................154
B.9.2.3.2 Sub-scenario (ii):Use as a binding agent in the graphite
electrode production and impregnation of electrodes........163
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