COMMENTS AND RESPONSE TO COMMENTS ON ANNEX XV SVHC: PROPOSAL AND JUSTIFICATION
Disclaimer
The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a
Substance of Very High Concern. The comments were received during the public consultation of the Annex XV dossier. The table has been used as a
meeting document of the Member State Committee. The table does not contain any confidential information provided. Furthermore it has not been
revised taking into account the discussions and conclusions of the Member State Committee.
Substance name: Cyclododecane
CAS number: 294-62-2
EC number: 206-33-9
Reason of the submission of the Annex XV: PBT/vPvB
General comments
Date
Submitted by
20080804
Organisation/MSCA
Company
Comment
All my general comments are on
References
(p.14)
(1) A significant part of the information
presented in the Dossier is without
reference. Some of the references that
can already be found in the Dossier are
missing in the reference list. Some of
the existing entries give too little detail
to allow finding the cited information
in the corresponding publications.
Please
revise.
Response
(1) This comment is too unspecific to
be addressed. It is not clear to which
reference it is referred.
(2) This modification has been taken
(2) Please correct the title of the journal into account in the Draft Support
for Atkinson (1987): Int. J. Chem. Document.
Kinet.
-1-
Date
Submitted by
Organisation/MSCA
Comment
Response
(3) The year for both Hangleiter GmbH (3) This modification can be done.
and Kremer Pigmente GmbH & Co. However the reference is not reported
KG should be 2008 (when the websites in the Draft Support Document
were read).
20080811
20080811
Ellen Sweeney
Individual, Canada
UK Competent Authority
I
support
the
nomination
of
cycylododecane to the Candidate List,
and believe it is important, given its
properties, for it to be as strictly
controlled as possible.
We cannot support the proposal for
prioritisation of cyclododecane for
inclusion in Annex XIV at this stage
since it is designated P and T based on
screening data only. The substance has
not been fully evaluated since it was
previously considered that exposures
have been very low. Further
information should be collected on
environmental exposure arising from its
use in archaeology and restoration and
if this is significant, further testing is
required to confirm whether the P and
T
criteria
are
met.
No answer is required.
We can agree with UK that
cyclododecane has been considered by
the
TC
NES
subgroup
on
identification of PBT and vPvB
substances to be a PBT and vPvB
substance based on the screening
criteria. PBT LIST NO. 40
Since the B criteria is largely fulfilled,
and that the P criteria and T criteria
only meet the screening criteria, it may
be appropriate to consider this
substance as a substance of equivalent
concern rather than as a PBT
substance. (Art. 57 f REACH
Regulation (EC) No 1907/2006)
The absence of ready biodegradation Exposure would need to be quantified
can only be an indication of possible in order to confirm the significance of
persistence, and given also the very low this exposure.
water solubility, should only be used
-2-
Date
Submitted by
20080818
MSCA
Organisation/MSCA
Comment
Response
within a testing strategy for persistence.
Equally, the identification of the
substance as T is based solely on
QSAR predictions even though there
are some data (which have not been
reviewed) that indicate that the
substance is not acutely toxic at the
limit of water solubility. We do not
agree with this approach.
Federal Institute for Concerning environmental issues we
Occupational Safety and support the proposal to include
Health (German CA)
Cyclododecane in Annex XIV.
The Annex XV Dossier outlines the
major findings of the TC NES subgroup on PBT/vPvB Substances and
shows that Cyclododecane is regarded
as a PBT/vPvB substance. We
appreciate that the Annex XV Dossier
continues the work of the PBT
Working
Group.
However with respect to Human Health
the following facts should be taken into
consideration:
Cyclododecane
is
bioaccumulative.
Other
intrinsic
hazards seem not to be confirmed.
Substitutes indicated for uses in
archeology are terpenes with a low
boiling Point (e.g. campheme 40 *C),
which are classified as irritant
(R36/37/38) or are labelled with
-3-
Thank you for this information on
substitutes. However the section on
Alternative substances is not reported
in the Draft Support Document.
Date
Submitted by
Organisation/MSCA
Comment
R50/51.
Response
There is no exposure information that We agree that the PBT assessment
suggests that the intrinsic hazards of aims to protect most of the living
cyclododecane result in a real risk. A organisms, including human.
first glance at the hazard for human
health suggests that cyclododecane
might bear fewer risks for workers than
the
substitutes.
Is it, with respect to this initial To be discussed in an appropriate
information, proportional to put committee (MSC?)
cyclododecane on a candidate list for
candidates for authorisation? Is it
proportional to require producers of
cyclododecane to bear the costs of
authorisation? It is quite probable that
producers of cyclododecane might not
identify the use in archeology as an
identified use. This might result in
enhanced risks in the workplace
because questionable substitutes would
be
put
on
the
market.
The case raises some fundamental
questions:
The candidates for the list according to
Art. 58 are available to public
discussion. Is it really sufficient to put
substances on this list, just because of
-4-
Date
Submitted by
Organisation/MSCA
Comment
Response
intrinsic hazard? Should not there be at
least some plausible information on
exposure and risk? Is it wise to
completely disregard hazards to human
health in the SVHC Dossier? Is it
appropriate to give so little interest to
substitutes, without giving the reason
for
this?
20080818
MSCA (NL CA)
RIVM
The Netherlands CA is submitting their
comments in separate files for each
substance that follows the headings of
this webpage. We do this for internal
QA purposes and for ease of
submission. Each heading is numbered
chronologically according to the
headings on this page. We assume this
is acceptable.
Please use the form to submit your
comments in order to make this task
easier for all of us and to avoid
mistakes in moving through several
documents. Traceability and quality
could be improved.
In the summary it is only briefly
indicated that the substance is a Information on the framework and on
PBT/vPvB substance. We advise to the EC (2007) PBT fact sheet has been
include in this section a summary of the added.
key-parameters/ study results on
PBT/vPvB properties, on which this
conclusion is based. In addition, we
would like to suggest making reference
to the framework in which this
conclusion is derived (TC-NES PBT
working group) and the date or meeting
at which this decision became final.
-5-
Date
Submitted by
Organisation/MSCA
Comment
Response
According to the guidance for the The Annex XV report will be checked
preparation of Annex XV SVHC for editorial modifications.
dossiers it is indicated that information
on exposure can be of use for priority
setting for inclusion in Annex XIV. It
would therefore be recommendable to
include an overview of the available
exposure data for the relevant
protection targets (e.g. worker,
consumer, man indirectly exposed via
the environment and environment) for
all relevant life cycle stages (e.g.
production, formulation, industrial use,
private use, service life and waste
treatment), presented in a transparent
and orderly manner. In addition, also
available information on alternatives
should be included.
We agree that it would be nice to
have a full risk assessment available
however these expectations might be
too high considering the level of
information on uses currently available.
There are a number of typing and
spelling mistakes in the report. A good
editorial review of the report would be
helpful.
-6-
Date
Submitted by
Organisation/MSCA
Comment
20080818
De Leon, F
Canadian Environmental The Canadian Environmental Law
Law Association (NGO) Association (CELA) (www.cela.ca) is a
Canadian based non-profit, public
interest organization, established in
1970 to use existing laws to protect the
environment
and
to
advocate
environmental law reforms. It is also a
free legal advisory clinic for the public,
and will act at hearings and in courts on
behalf of citizens or citizens’ groups
who are otherwise unable to afford
legal assistance. CELA is funded by
Legal Aid Ontario (LAO). It is one of
80 community legal clinics located
across Ontario, 18 of which offer
services in specialized areas of the law.
CELA also undertakes educational and
law and policy reform projects that are
funded by LAO as well as government
and private foundations. CELA’s public
policy reform programs focus on four
issue areas: pollution and health, water
sustainability, land use planning and
access
to
justice.
CELA has a long, rich history
advocating for effective chemicals
management policy in Canada as well
as on the global level through the
Stockholm Convention on Persistent
Organic Pollutants. CELA participated
-7-
Response
Date
Submitted by
Organisation/MSCA
Comment
Response
and responded to the government of
Canada’s proposals in categorizing the
23, 000 substances under the Domestic
Substances List as part of its legal
obligations under the Canadian
Environmental
Protection
Act,
Canada’s main environmental statute
addressing toxic substances. CELA’s
interest in the implementation of the
REACH policy and the process to
establish a list of substances for
authorization are seen as significant in
the efforts to protect human health and
environment from exposure to toxic
substances. Furthermore, Canadians
see the results of REACH as important
initiatives that are relevant and essential
to the efforts being undertaken in
Canada
under
its
Chemicals
Management Plan (CMP). The results
of REACH will inform priorities for
action to be taken in Canada under
CMP, confirm if there are other
substances that should be focused for
action and most importantly inform
appropriate measures of phase out for
PBT substances and non-threshold
substances
in
following
the
precautionary principle. Under section
75 (3) of the Canadian Environmental
Protection Act, our government is
-8-
Date
Submitted by
Organisation/MSCA
Comment
Response
obligated to review the “…a decision to
specifically prohibit or substantially
restrict any substance by or under the
legislation of another jurisdiction for
environmental or health reasons,…”
CELA supports the initial list of
substances
(Anthracene;
4,4'Diaminodiphenylmethane;
Dibutyl
phthalate; Cyclododecane; Cobalt
dichloride;
Diarsenic
pentaoxide;
Diarsenic trioxide; Sodium dichromate,
dehydrate; 5-tert-butyl-2,4,6-trinitro-mxylene (musk xylene); Bis (2ethyl(hexyl)phthalate)
(DEHP);
Hexabromocyclododecane (HBCDD);
Alkanes, C10-13, chloro (Short Chain
Chlorinated
Paraffins);
Bis(tributyltin)oxide; Lead hydrogen
arsenate; Triethyl arsenate; Benzyl
butyl phthalate) for inclusion to the
candidate list for authorization. We Thank you for the information.
are please to see the initial list of
substances nominated for authorization.
We recognize that importance of this
first list and milestone in the
implementation of the REACH policy.
However, based on our experience with
the Canadian categorization process,
we strongly urge the EU to ensure that
an explicit timeframe for adding new
nominations to the candidate list and
-9-
Date
Submitted by
Organisation/MSCA
Comment
Response
the release of full list of nominated
substances for authorization be
provided to ensure that the momentum
established with the passing of the
REACH policy does not decline over
time. In our experience with Canadian
categorization process, the release of
the complete list of substances meeting
the criteria outlined under the Canadian
Environmental Protection Act required
a significant response by the Canadian
government. We trust that it would be
similar for the EU context and the
authorization
list.
Although Cyclododecane is not
currently registered under the Canadian
Domestic Substances List (Canadian
Environmental Protection Act) this
substances has been detected in all of
the five Great Lakes in North America
– not on DSL, on nDSL – found in all 5
of the Great Lakes as well as being
detected in sediments collected from
Tobin Lake (near the ManitobaSaskatchewan border, Canada. (refer
to:
http://books.google.ca/books?id=7pt2K
ooggdsC&pg=PA101&lpg=PA101&dq
=Cyclododecane+canada+saskatchewa
n&source=web&ots=23cSJZfg0c&sig=
- 10 -
Date
20080818
Submitted by
Organisation/MSCA
Comment
6RPaRdFBJ7G1imcSVh-SdVzYDQ&hl=en&sa=X&oi=book_result
&resnum=2&ct=result#PPA103,M1)
company
Our main objection is that the Annex
XV dossier for CDD contains
insufficient
evidence
for
the
qualification of CDD as a PBT or vPvB
and therefore does not comply with
Regulation EC/1907/2006 and the
related guidance documents. The
following two examples illustrate this
point.
1. The dossier for CDD according to
Annex XV of EC/1907/2006 does not
contain any quantitative information on
emissions and exposure of the aquatic
environment. The emission to the
aquatic environment due to the uses of
CDD as an intermediate and as a
conservation agent for historic and
archaeological objects is not given.
2. The toxicity to the aquatic
environment is solely based on
theoretical estimates and not on test
information. The dossier refers to test
information that was unreliable and
rejected or in the possession of the
industry and not available to the
authorities for further analysis.
- 11 -
Response
1. We would be pleased to received
quantitative information from IND
2. Would cyclododecane not be an
immediate candidate for Annex XIV,
then we would welcome IND proposal
to provide the relevant information in
order to improve the PBT assessment.
Date
Submitted by
Organisation/MSCA
Comment
Response
One might expect that the author of a
dossier makes a reasonable effort to
search for available information.
Consulting the known producers and
importers is within the scope of what
can be expected from a governmental
organization. The guidance document
for the authorities issued by the ECHA
- “Guidance for the preparation of an
Annex XV dossier on the identification
of substances of very high concern” which in several instances emphasizes
to consult the industry was not
followed
in
this
respect.
The CDD dossier does not contain
information about emissions and
exposures and cannot support the
assessment and control of the risk to the
aquatic environment of the use
categories, which is an important goal
of Annex XIV and REACH.
Comparison of the CDD dossier with
the ones for Anthracene (a PBT and
vPvB candidate substance) and
hexabromocyclododecane
(PBT
candidate substance) demonstrates that
the dossiers for Anthracene and
HBCDD are more substantiated and
that the industry has contributed
emission and exposure information.
- 12 -
Date
Submitted by
Organisation/MSCA
20080818
Reineke, N
WWF
20080818
Van Vliet, L
Comment
Response
The substance, cyclododecane, has not
yet been registered because the timeline
for registration of this phase-in
substance has not yet been reached.
While we understand the Rapporteur’s
interest in examining this substance as
a potential PBT or vPvB substance, it is
our firm belief that it is premature for
the Member State Committee to include
this substance on the Annex XIV list
based on insufficient information.
WWF agrees with the evaluation and No answer required.
supports inclusion in the candidate list.
Health & Environment Page 12: We support this substance to No answer required.
Alliance (NGO)
be included in the Candidate list on the
basis of the criteria summarized on
page 12 of the submitted Annex XV
dossier, section 8.2 Conclusion of PBT
and vPvB or equivalent level of
concern assessment: “Cyclododecane is
considered to be a PBT and vPvB
substance based on the screening
criteria. The substance fulfils the vB
criterion. The P/vP criterion and the T
screening criterion are also met.”
Identity of the substance and physico-chemical properties
Date
Submitted by
Organisation/MSCA
20080804
Company
Comment
Response
p. 5 Table 1 Physical state: “liquid” is This correction has been taken into
- 13 -
not correct and should be deleted account in Table 1 of the Draft
(Melting point 61 °C, next entry) Support Document.
Boiling point: The reference should be This correction has been taken into
“Meyer and Hotz (1976)”.
account in Table 1 of the Draft
Support Document.
Classification and labelling
Date
Submitted by
20080818
MSCA
20080818
MSCA (NL CA)
Environmental fate properties
Date
Submitted by
20080707
Kitcher, JP
Organisation/MSCA
Federal Institute for
Occupational Safety and
Health (German CA)
Comment
P6 the conclusion on classification: The
substance is not classified in Annex I of
Directive 67/548/EEC concerning
dangerous substances. There are no
data presented that the substance fulfils
the toxicity criterion according to
Annex XIII (1.3).
RIVM
p. 6 – section 3.1: It might be more Agreed. The text has been modified.
appropriate to state that the substance is
‘not listed’ in the Annex I instead of
‘not classified’ as is now stated given
the fact that the substance is being
considered as a PBT/vPvB substance (a
PBT substance fulfills the criteria for
classification with N; R50/53).
Organisation/MSCA
Individual
Comment
Response
p.7
4.1.2
Biodegradation Degradation observed in particular
That is has been comparatively easy to conditions where cyclododecane was
- 14 -
Response
Agreed. There is no current
classification for cyclododecane. “not
classified” has been replaced by “not
listed in Annex I to Directive
67/548/EC”. The lack of degradation
would at least trigger for the risk
phrase R53.
Date
20080804
Submitted by
Organisation/MSCA
Company
Comment
isolate bacteria from sludge and
sediment that are able to readily
metabolise cyclohexane invalidates your
conclusion
"Very slow or no biodegradation"
p. 6, Chapter 4 The Koc of 65000 is
different from that in 4.2.1 and 4.2.2,
which is 6500. Please check and adjust.
Response
given as sole source of carbon to
adapted inoculums or isolated strain
does not invalidate the general
conclusion.
The correct value is 6500. This
correction has been taken into account
on pages 5 and 6 of the Draft Support
Document.
p. 7 4.2.1 For the reference Sabljic Noted. Correct reference to be
(1987) see other comment (on uses). reported to the Draft Support
Document is: Sabljic, A. (1987). On
the prediction of soil sorption
coefficients of organic pollutants from
molecular structure: application of
molecular topology model. Environ.
Sci. Technol., 21, 358-366
p. 8, 4.2.2 “expected to exist almost
entirely in vapour phase in the ambient
atmosphere” is a statement on This information has been repeated in
distribution modelling and should be section 3.2.3
moved
to
4.2.3.
20080811
UK Competent Authority
p. 8, 4.2.3 The monitoring data in the
second paragraph are not “distribution The statement “no distribution
modelling” information. Real modelling modelling (e.g. Mackay level I) was
data (e.g. Mackay Level I) are missing
performed” has been added in section
3.2.3. of the Draft Support Document
p.7 Section 4.1.3 We agree with the Noted.
statement that ‘Insufficient data are
- 15 -
Date
Submitted by
20080818
MSCA
20080818
Organisation/MSCA
Comment
available to predict the rates of
importance of degradation processes
and further testing are needed.’ We
support further testing before a decision
can be made as to whether the P
criterion is met.
Federal Institute for p.8: Although the substance is highly
Occupational Safety and volatile, it is expected to accumulate
Health (German CA)
mainly in sediment and soil, as
described in the European Commission
(2000)
IUCLID
Dataset
for
cyclododecane. Therefore the rather
short half-life in air does not overrule
the classification as persistent.
Company
Environmental
Fate
Thank you for your comment. This
precision could not be added in 3.3.2
as the distribution data were probably
re-evaluated (Degussa AG (2002)
IUCLID Dataset). Distribution to air
is estimated to be 81%.
Properties:
We agree with the Rapporteur that the
substance is not expected to meet the
screening level criteria of being readily
biodegradable. However, in the Annex
XIII criteria guidance, as well as in Part
C of the REACH guidance on
information requirements for the
chemical safety report, further testing is
expected if a potential concern is raised
via the screening information. At this
point in time, it is premature to assume
that cyclododecane does not degrade in
some way in the environment. In fact, as
is stated in the Annex XV dossier, the
- 16 -
Response
It is acknowledged that cyclododecane
has been considered by the TC NES
subgroup on identification of PBT and
vPvB substances to be a PBT and
vPvB substance based on the
screening criteria. PBT LIST NO. 40
Degradation observed in particular
conditions where cyclododecane was
given as sole source of carbon to
adapted inoculums or isolated strain is
an indication of degradation but is not
sufficient to demonstrate that the P
criteria is not fulfilled.
Date
Submitted by
Organisation/MSCA
Comment
Response
substance has been observed to be
degraded by adapted marine sediment
micro-organisms and by specific
microbial strains.
As such, the
substance may not ultimately persist.
While cyclododecane may have the
potential to bioconcentrate based on the
screening level BCF study, other factors
need to be considered for determining
its ultimate bioaccumulation potential..
As the Rapporteur mentioned, the
substance has low water solubility and a
low potential to migrate to groundwater
due to its affinity for soil and sediment,
indicating that the substance will largely
partition to soil and sediment, rather
than groundwater and surface water. It
is important to note that, when a
substance is bound to soils and
sediments, it can become less
bioavailable and the BCF values that
have been measured in a laboratory can
become less reliable predictors of actual
uptake and accumulation. Compounds
with Koc values above 5000 often bind
to particulate matter. That means that
they may not be “available” for an
organism to take up and use
biologically. With compounds meeting
this type of criteria, it is imperative to
- 17 -
Most of the substances fulfilling the B
criteria share these properties having a
low solubility, high affinity to soil and
sediment etc… The bioavailability
from the water column may be
reduced but for such substances, other
exposure pathway may become
predominant such as food ingestion.
Annex XIII sets trigger values for
BCF obtained e.g. with OECD 305.
This test is relevant to show the
bioaccumulation potential, but in fact,
it does not take into account additional
route of exposure, like ingestion.
Date
Submitted by
Organisation/MSCA
Comment
Response
assess other ways to understand the
possibility of bioaccumulation, not just
bioconcentration in a clean aqueous
system.
We agree with the Rapporteur’s No response required.
characterization that the substance is
volatile, will react with OH-radicals in
the atmosphere, has a relatively short
half-life in the atmosphere, and is not
likely to be subject to long-range
atmospheric
transport.
While we recognize that the ready Noted.
biodegradability test and the BCF test
are important screening-level tests for
setting substance evaluation priorities
and to determine the need for further
testing, we do not believe that these
alone are sufficient to justify inclusion
of cyclododecane on the Annex XIV
list.
It should also be noted that the
substance is predicted to be readily
removed from wastewater streams by
aeration and in the primary sludge,
thereby minimizing any releases
directly to the water compartment.
Taking all distribution and fate
parameters into account, we recognize
- 18 -
This removal would need to be
quantified in order to demonstrate the
lack of significant releases. And this
point of view does not take into
account the environmental becoming
of
primary
sludge,
where
cyclododecane accumulates. Besides,
it should be ascertained that all
Date
Submitted by
Organisation/MSCA
Comment
Response
that there are legitimate concerns being releases would be primarily directed
raised but these concerns do not yet to an STP.
meet a level of scientific reliability to
justify addition to Annex XIV.
We note and agree with the
Rapporteur’s statements indicating that
the results of several studies were not
reviewed by the Rapporteur because the
reports were not available, and we note
and agree with the statements indicating
that further testing is needed. Such
statements support our central position
that it is premature to include this
substance on Annex XIV. Registrants
of this substance, as well as the
Rapporteur, should be given the
opportunity, as part of the registration
process, to obtain the full study reports
so that the data can be properly
reviewed and its reliability determined.
If existing data is found to be
incomplete
or
unreliable,
then
registrants should be given the
opportunity to complete further testing
either as part of the registration process
or
under
substance
evaluation.
Likewise, the Committee should have
the benefit of this type of information
before voting to include the substance
on Annex XIV. Following this logical
- 19 -
Would cyclododecane not be an
immediate candidate for Annex XIV,
then we would welcome IND proposal
to provide the relevant information in
order to improve the PBT assessment.
Date
Submitted by
Organisation/MSCA
Comment
Response
process, as laid out in the regulation, is
critical to ensuring that the regulation is
applied in a scientifically valid and nondiscriminatory manner as intended and
expressed in the legislation in Recitals
#3 and #95.
Otherwise, the
Authorisation process runs the risk of
focusing on the wrong substances and
the credibility of the process will be
jeopardized.
20080818
MSCA(NL)
RIVM
p. 7 – section 4.2.1: Inconsistent Noted
information is given in this section. The
first paragraph states that the Koc is
6500 whereas the second paragraph
states that insufficient information is
available.
Organisation/MSCA
Federal Institute for
Occupational Safety and
Health (German CA)
Comment
P6 the conclusion on classification: The
substance has not been classified in the
context of Directive 67/548/EEC
concerning dangerous substances.
Human health hazard assessment
Date
Submitted by
20080818
MSCA
20080818
Company
Response
There is no current classification for
cyclododecane. “Not classified” has
been replaced by “not listed in Annex
I to Directive 67/548/EC”.
P5 human health hazard assessment, Noted. The available information
section 5: No data presented.
would not have improved the PBT
assessment.
Human Health Hazard Assessment: We It was not the intent to state that the
- 20 -
Date
Submitted by
Organisation/MSCA
Comment
disagree with the Rapporteur’s
statement that the Human Health
Hazard Assessment is not relevant for
the PBT assessment. Substances that
persist in the environment and have
been shown to have a potential to
bioaccumulate may also be metabolized
by higher organisms without adverse
effects. Registrants, as well as the
Rapporteur
or
other
regulatory
authorities, should be given the
opportunity to review any metabolism /
pharmacokinetics information that may
exist for the substance, or structurally
similar substances, so that there is a
complete
understanding
and
consideration of existing information
before
being
considered
for
Authorisation.
Human health hazard assessment of physico-chemical properties
Date
Submitted by
Organisation/MSCA
Comment
Environmental hazard assessment
Date
Submitted by
20080804
Organisation/MSCA
Company
Comment
p. 9, 7.1.1.1 Hüls AG (1997) used
the 1992 version of the EC guideline,
i.e. Directive 92/69/EEC, C.1. (“Year”
in the IUCLID data set submitted by
- 21 -
Response
human health hazard assessment is not
relevant for the PBT assessment. We
fully agree that for substances having
a potential to bioaccumulate, toxicity
in higher trophic levels including
mammals (and thus humans) is
relevant.
In this specific case however, we
would like to underline that
metabolisation and other process
observed in animals with a high level
of organisation may not be applicable
to simplest organisms that may be at
risk.
Response
Response
Noted. This correction has been taken
into account on page 9 of the Draft
Support Document.
Degussa AG refers to the publication of
the guideline.)
Noted. This correction has been taken
p. 10, 7.1.1.1 Please note that one into account on page 9 of the Draft
Support Document.
control (!) fish died on day 4.
p. 10, 7.1.1.3 The algae test of Hüls
AG (1995) was performed according to Noted. This correction has been taken
the 1992 version of the EC guideline, into account on page 10 of the Draft
Support Document.
i.e. Directive 92/69/EEC, C.3.
20080811
UK Competent Authority
20080818
Company
p. 10 Section 7.1.1 The identification of
the substance as T is based solely on
QSAR predictions. However, there is
toxicity test data available which
suggests that cyclododecane is not
acutely toxic to fish and Daphnia at its
solubility limit. The available test data
should be evaluated and further testing
may be required before a decision can
be made as to whether the T criterion is
met.
Environmental Hazard Assessment: In
the dossier, the Rapporteur mentioned
three fish studies, two of which were
deemed ‘not valid’ due to the
methodology used. The third study was
not rejected; however, the full report
was not evaluated and was not used in
the hazard assessment. Although the
full reports of these studies were not
- 22 -
It is acknowledged that cyclododecane
has been considered by the TC NES
subgroup on identification of PBT and
vPvB substances to be a PBT and
vPvB substance based on the
screening criteria. PBT LIST NO. 40
Would cyclododecane not be an
immediate candidate for Annex XIV,
then we would welcome IND proposal
to provide the relevant information in
order to improve the PBT assessment.
available for an evaluation, the reported
results at least suggest that further work
is necessary before making a final
conclusion on fish toxicity. Similar
uncertainties exist with studies
involving aquatic invertebrates and
plants. We disagree with Rapporteur’s
choice of using Ecosar predicted values
instead, which while may be suitable
for screening purposes, should not be
relied upon solely for Authorisation.
As previously stated, registrants as well
as the Rapporteur and other regulatory
authorities should be given the
opportunity to obtain, review, and
summarize the full study reports that
are available and obtain new data
where necessary during the registration
process so that the Committee has the
benefit of this type of information
before voting to include the substance
on Annex XIV.
20080818
MSCA(NL)
RIVM
In order to use the results provided by a Such a justification should be based
QSAR model, sufficient documentation after an evaluation of the original
about the model and its validity, and study reports with a discussion of the
the validity of the results for the validity of the QSAR used.
intended use needs to be provided.
Neutral organic substances like
cyclododecane
fall
within
the
applicability domain of the Ecosar
model. This and other related
- 23 -
information on the model and the
validity of the results need to be added
to the Annex XV report since at the
moment, no arguments are provided for
the use of QSARs, or the validity of the
method or the results. It needs to be
justified why computer models are
considered better/more valid than the
experimental data when the computer
models are in contradiction with
(unavailable) test data (i.e. the study
data of Hüls).
PBT/vPvB or equivalent level of concern assessment
Date
Submitted by
Organisation/MSCA
20080818
MSCA
Federal Institute for
Occupational Safety and
Health (German CA)
20080818
Company
Comment
p.3, p. 11 and p.12: It is not clearly
stated whether the substance is
considered to fulfil the P/vP criterion or
the P/vP screening criterion.
PBT/vPvB Assessment: We agree with
the Rapporteur that further testing is
unlikely to reveal “fast” degradation.
While fast aquatic biodegradation is
useful at the screening level for
substance evaluation purposes, it
should not be the only measure used to
evaluate the degradation potential of a
compound. Given that only a cursory
review of the data on cyclododecane
has been performed, it is premature to
propose it for Authorisation.
In
- 24 -
Response
Noted. This has been clarified on
pages 3, 11 and 12 that only the
screening criteria are fulfilled.
Would cyclododecane not be an
immediate candidate for Annex XIV,
then we would welcome IND proposal
to provide the relevant information in
order to improve the PBT assessment.
Information from IND on uses of
cyclododecane on EU market is
welcomed.
addition, we agree that the substance is
mainly used as an intermediate and, in
fact, this use may be the only one that
will be registered.
- 25 -
INFORMATION ON USE, EXPOSURE, ALTERNATIVE AND RISKS ON ANNEX XV SVHC1
Substance name: Cyclododecane
CAS number: 294-62-2
EC number: 206-33-9
Reason of the submission of the Annex XV: PBT
Information on manufacture and uses
Date
Submitted by
Organisation/MSCA
20080804
Company
Comment
p. 5, 2nd half Delete the first main use.
Cyclododecane is not used as a
precursor for its hexabromo derivative
(C12H18Br6,
HBCDD).
Both
cyclododecane and HBCDD are made
directly of 1,5,9-Cyclododecatriene
(CDDT). The reaction CDDT =>
HBCDD is efficient, while CDDT =>
Cyclododecane
=>
HBCDD
is
completely inefficient.
Second main use: Sabljic (1987)
as cited in the reference list (p. 14) does
not exist. Environ. Sci. Technol. 17,
329-334 is from 1983 (not 1987). It
was written by Samoiloff et al. and
1
Response
Noted. Information extracted from: de
Wit, C.A. An overview of brominated
flame retardants in the environment.
Chemosphere 46, 583-624 (2002)
Checking has been done. However the
references are not reported in the Draft
Support Document.
Correct references are:
1/ Griesbaum K; Ullmann’s Encycl
Industr Chem 5th ed NY: VCH
The information (comments and responses) on use, exposure, alternatives and risks were not considered by the Member State Committee for the identification of substances of
very high concern, but will be taken into account in the later stages of the authorisation process. For clarity, this information is now indicated with shaded background.
- 26 -
does not include information on use. Publishers A13:238 (1989) instead of
Please check and correct. Kuney (1991) Sablijc (1987).
is missing in the reference list and
therefore cannot be verified.
2/ Kuney JH; Chemcyclopedia 1991.
Washington DC: Amer Chem Soc p.
58 (1991)
20080811
Leonie Saltzmann
Company: Hans-Michael
Hangleiter
GmbH,
Germany
20080818
MSCA
Federal Institute for
Occupational Safety and
Health (German CA)
20080818
Company
p. 5, last lines Degussa AG is now
Evonik Degussa GmbH. Hüls AG has
become part of this company. Oxeno
(typing error Oexno) Olefinchemie
GmbH is now Evonik Oxeno GmbH.
Noted.
p. 13, 1. No evidence is presented for
the claims “recent rise in interest” and
“more and more restoration activities”.
Please correct.
p.13. Even though Cyclododecane is
widely used for conservation and
restoration purposes, the amounts used
are rather small. A standard packing
unit is 1 kg.
p. 5-6. manufacture and uses:
Requirements are fulfilled. The
presented data includes information on
uses. No information on manufactured
volumes is given.
Noted.
We would appreciate to have the
quantities dedicated to this use also
expressed as EU tonnage.
Information on volumes currently
manufactured was not available to
RMS.
Manufacture
and
Use: The uses in sealing and restoration of
While we agree with the Rapporteur archeological and old artifacts should
- 27 -
20080818
MSCA(NL)
Exposure information
Date
Submitted by
20080811
Leonie Saltzmann
RIVM
that the most significant use of
cyclododecane is as an intermediate for
producing other chemical substances in
closed systems, we disagree that the
other types of uses in sealing and
restoration of archeological and old
artifacts should be classified as
dispersive. These latter activities are
not expected to disperse the substance
in the environment in large quantities.
be qualified as dispersive.
It may be nevertheless considered that
the actual exposure of the environment
is limited, provided some quantitative
data could support this statement.
p. 13 – section 1: The information
provided in section 1 on p. 13 and in
section 2 on p. 5-6 contradicts the
conclusions on further testing provided
in section 8.1 on p. 11. Section 8.1 on
p. 11 states that the substance is mainly
used as intermediate and is therefore
considered that no further testing is
required at the present (presumably
because emissions are expected to be
low). In contrast, section 1 on p. 13 and
section 2 on p. 5-6 state that the
substance is also used in archeological
excavations
and
transport
of
archeological objects.
Both applications were identified by
RMS. This archeological use should
be qualified as dispersive and justify
the approach.
Organisation/MSCA
Comment
Response
Company: Hans-Michael p.13.
Thank you for this information.
Hangleiter
GmbH, Cyclododedcane is solely produced by
- 28 -
Date
Submitted by
20080811
20080818
MSCA
20080818
MSCA(NL)
Organisation/MSCA
Germany
Comment
Degussa and Invista. Degussa does not
sell raw Cyclododecane at all; Invista
only sells to Hans-Michael Hangleiter
GmbH. The amount used and resold by
Hans-Michael Hangleiter GmbH does
not exceed 1 ton per year.
UK Competent Authority p. 13 Section 1 Further information on
the tonnage and possible level of
emissions arising from the use in
archaeological and restoration activities
should be provided in order to assess
the potential for environmental
exposure.
Federal Institute for P13 information on use, exposure,
Occupational Safety and alternatives and risks, information on
Health (German CA)
exposure: Requirements are fulfilled.
RIVM
Response
Information provided by the IND in
this commenting table can be added.
However this section is not reported in
the Draft Support Document
No answer required.
3.2 Exposure information
New information provided by IND
p. 13 : Only very general statements are will be added to the document
made about the use of the substance for
archeological and restoration activities.
If necessary and if the data are
available, this section might be
expanded to provide more detailed
information on these uses. This is
possibly critical for section 3 RiskRelated Information on p. 13 which
states that the use of the substance is
widespread. However, no concrete data
are available to support this statement.
- 29 -
Information on risks related to the substance
Date
Submitted by
Organisation/MSCA
20080818
MSCA
Federal Institute for
Occupational Safety and
Health (German CA)
20080818
Company
Comment
p. 13 information on use, exposure,
alternatives and risks, conclusion on
risk-related information: Requirements
are fulfilled.
Risk Related to the Substance: We
disagree that archeological and
restoration activities are a dispersive
way for the substance to reach the
environment and that the substance
therefore presents a significant risk. In
this type of application, the function of
cyclododecane is to slowly volatilize
into the atmosphere where it will be
quickly degraded due to its short
atmospheric half-life. This use appears
to present a low potential for
distribution in the environment. The
current market for this application is
believed to be relatively small
During the registration process,
potential registrants are given the
opportunity
to
evaluate
and
characterize the risks of the uses they
intend to register and this information
is of critical importance in determining
which substances should be given
priority for nomination to Annex XIV.
This makes the process risk based, not
simply hazard based. At this point, the
- 30 -
Response
No answer required.
The uses in sealing and restoration of
archeological and old artifacts should
be qualified as dispersive.
It may be nevertheless considered that
the actual exposure of the environment
is limited, provided some quantitative
data could support this statement.
20080818
MSCA(NL)
RIVM
potential registrants for this substance
have not yet decided which uses they
intend to include in their registrations.
It is our hope that the Committee will
give the registration process and the
substance evaluation process a chance
to reveal all that there is to know about
this substance and that the Committee
reserves any preemptive action for
substances where unacceptable risk has
already been clearly demonstrated.
p. 13: The report is a bit inconsistent
when discussing possible risks. The
substance has two primary uses: as an
intermediate and in archeological work.
For the use as intermediate, no further
persistency
testing
is
required,
presumably because
of
limited
emissions and exposure (p. 13,
conclusions from the EU PBT WG). In
contrast, for the second primary use (in
archeology), it is stated that significant
risks can be expected because of wide,
dispersive
use
on
numerous
archeological sites. It would strengthen
the report if the two uses were
discussed separately or alternatively, if
the conclusion on further testing is
removed from section 8.1 on p. 11.
This would decrease the confusion that
this inconsistency may create.
- 31 -
There is apparently no need to
separate the uses in different reports as
you correctly summarized the problem
which should be discussed at the
MSC.
Information on alternative substances and techniques
Date
Submitted by
Organisation/MSCA
20080811
Leonie Saltzmann Company: Hans-Michael
Hangleiter
GmbH,
Germany
Comment
p.13.
In 1996 the volatile binding media were
introduced into conservation. The
substances used were Cyclododecane,
Tricyclene-Camphene and Menthol.
After 12 years of experience the
Cyclododecane has proven to be the
safest substance to work with for
human health, archeological objects
and pieces of art. The two alternative
substances belong to the chemical
group of terpenes, they both react with
most organic binding media, this
means, they cannot be used on most
canvas and panel paintings, polychrome
sculpture and modern art. They both
have a very strong smell and are irritant
to eyes and mucous membranes.
Tricyclene-Camphene is a non stable
product with non volatile stabilizing
agents and non volatile degradation
products. These remain in the treated
object, causing stains and an
accelerated decay. It has a higher
vapour pressure and lower boiling point
than Cyclododecane, this leads to a
very high material consumption.
Outdoor use in summer is not practical
due to the high vapour pressure.
Menthol has a melting point of 30°C
- 32 -
Response
Thank you for the information.
However, this section is not reported
in the Draft Support Document.
20080818
MSCA
making it unsuitable for any use in non
climatized areas in summertime. On
site use is not possible due to the
extreme smell and its irritant effect on
moucoses and eyes. Furthermore it is
inappropriate for a church to smell like
chewing gum or toothpaste after
conservation!
Federal Institute for P13 information on use, exposure,
Occupational Safety and alternatives and risks, conclusion on
Health (German CA)
alternative substances: Requirements
are
fulfilled.
Information gap: It was commented
that no information have been available
on alternative techniques.
Information on risks related to alternatives
Date
Submitted by
Organisation/MSCA
20080818
MSCA
Federal Institute for
Occupational Safety and
Health (German CA)
Comment
P13 information on use, exposure,
alternatives and risks: Information gap:
No data presented.
- 33 -
Information provided by IND and UK
can be added on alternative
techniques. However, this section is
not reported in the Draft Support
Document.
Response
Information provided by IND and UK
can be added on alternative
techniques. However, this section is
not reported in the Draft Support
Document.