Opinion on the results of the Risk Assessment of: O-ANISIDINE - CAS No.: 90-04-0 - EINECS No.: 201-963-1. Report version : draft of April 2000 carried out in the framework of Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances1. Opinion expressed at the 21st CSTEE plenary meeting, Brussels, 30 January 2001.
Terms of reference
In the context of
Regulation 793/93 (Existing
Substances Regulation), and on
the basis of the examination of
the Risk Assessment Report the
CSTEE is invited to examine the
following issues:
1. Does the CSTEE agree
with the conclusions of the
Risk Assessment Report
2. If the CSTEE
disagrees with such
conclusions, the CSTEE is
invited to elaborate on the
reasons for this divergence of
opinion.
Introduction
o-Anisidine is used as
an intermediate for a number of
azo and naphtol pigments and
dyes which are used for
printing (90%) and for paper
(3%) and textile (7%) dyeing.
At present, the production
volume in the EU is below
1000t/y.
GENERAL COMMENTS
It is to be noted that,
during its 7th plenary meeting
(January 18th 1999) the CSTEE
has expressed an opinion on
"the risk of cancer caused by
textiles and leather goods
coloured with azo-dyes".
The document follows the
recommendations of the TGD and
is, in general, comprehensive
and properly written with the
exception of some minor points
i.e. the table of contents is
not completed as well as the
reference list in p.109. The
issue of products imported from
non-EU countries should be
better assessed. The rationale
for this is that, on the one
hand e.g. textiles and
garments, possibly contain more
azo-dyes than those
manufactured in EU countries
and, as said in the Report,
there is already concern for
babies who use to suckle
clothes even if they contain a
low level of dyes and, on the
other hand, o-anisidine, along
with azo-dyes, may be released
during the recycling process of
printed papers and textiles. In
this regard, the human exposure
may have been underevaluated in
the report.
The CSTEE agrees with
the overall conclusion of the
risk assessment. However, even
acknowledging the ongoing risk
reduction strategy, because
exposure of young children are
a cause for concern, the CSTEE
would recommend further testing
regarding reproductive and
developmental toxicity
(conclusion: i).
SPECIFIC COMMENTS
The list of synonyms is
far from thorough and, once
again, the CSTEE regrets the
logistic difficulties which
make many reports that are
quoted in the reference list
impossible to get.
Environment
Emissions
It is difficult to
properly assess the
contribution of emission into
surface water from the use
(washing) of products
(garments) which are printed or
coloured with o-anisidine based
pigments and dyes, especially
those coming from non EU
countries. The same is true
during the recycling processes
of dyed textiles and papers.
Exposure assessment
The report proposes
readily biodegradation on the
assumption that adaptation
occurs in Sewage Treatment
Works (STW). This is likely to
be the case for industrial
plants, and given that the
substance is used almost
exclusively as an intermediate,
most of the releases to STW are
likely to be through industrial
systems. Hence, the CSTEE
believes that « readily
biodegradation » is a
reasonable conclusion.
Both low log Kow and BCF
indicate a low potential for
o-anisidine to enter the food
chain, however, the report by
Wearne et al. (1996)
establishing a prioritisation
scheme to identify manufactured
organic chemicals, including
o-anisidine, as contaminants of
food should have been quoted.
Effects assessment
For the aquatic
compartment short-term studies
are available for each trophic
level and they have been
conducted in compliance with
international guidelines. Only
two long-term toxicity tests
are available; one for algae
and one for the most sensitive
species (Daphnia magna). Under
these conditions, using the
lowest NOEC from long-term
studies with an assessment
factor of 10 to derive the PNEC
is not strictly in keeping with
the TGD recommendations.
However, it is to be noted that
the same value for PNEC is
obtained when applying an
assessment factor of 1000 to
the lowest NOEC from short-term
toxicity tests.
In the absence of valid
experimental data, and
considering the
physical-chemical properties
and the toxicological profile
of this compound, it is
acceptable to apply the
equilibrium partitioning method
for the effects assessment on
the terrestrial compartment and
sediment.
Risk characterisation
Due to the low PEC/PNEC
ratio, the CSTEE agrees with
the conclusion that there is no
need to further information and
for risk reduction measures
beyond those that are being
applied already.
Human Health
Exposure assessment
As mentioned in the
report, a complete risk
assessment is not possible due
to the lack of information
regarding the amount of
imported textiles dyed with
o-anisidine based colorant.
This should be an important
source of exposure because, on
the one hand, significant
amounts of textiles dyed with
colorants on the basis of
o-anisidine are imported from
non EU countries such as India
and China, and, on the other
hand, o-anisidine production in
China has been evaluated as
about 7 000 t/y, that is 7
times the EU production. Taking
also into consideration that
other products such as
household textiles, carpets and
leather watch straps may
contain o-anisidine (see RIVM
report of February 2000), it is
likely that the human exposure
has been somehow underevaluated
in this report.
Effects assessment
It is difficult to
understand why the report,
although issued in April 2000,
always refers to the 1982 IARC
evaluation on o-anisidine
whereas a new one had been
published in 1999. This is
rather unfortunate because
there is a discrepancy as
regard the genotoxic effect,
which is recognised in the
present RAR and not in the 1999
IARC evaluation. The CSTEE
would rather agree with the
conclusion of the RAR taking
also into account a publication
by Brennan and Schiestl (1999)
not referenced in the report,
which shows that o-anisidine is
able to induce deletions, due
to intrachromosomal
recombination, in Saccharomyces
cerevisae.
Although no human data
are indeed available on the
sensitising effects of
o-anisidine, a report by Traupe
et al . (1997) has described a
higher frequency of atopic
dermatitis in children exposed
to a mixture of chemicals,
among which was o-anisidine, in
a chemical accident in
Frankfurt. This should
obviously be assessed.
Risk characterisation
As mentioned in the
report, the documented need for
tests to evaluate the
sensitising properties and the
developmental toxicity of
o-anisidine should be revisited
in the light of the risk
reduction strategy for
o-anisidine currently ongoing
in the EU.
However, given that
exposure of young children is a
cause for concern, and because
reproductive and developmental
toxicity would be crucial
end-points to be considered
later on, the CSTEE would
encourage further testing for
these points.
References
Brennen, R.J. and
Schiestl, R.H.
The aromatic amine
carcinogens o-toluidine and
o-anisidine induce free
radicals and intrachromosomal
recombination in Saccharomyces
cerevisae.
Mutat. Res. 430 : 37-45
; 1999.
IARC monographs on the
evaluation of carcinogenic risk
of chemicals to humans.
73 : 49-58 ; 1999.
Traupe, H. ; Menge, G. ;
Kandt, I. and Karmaus, W.
Higher frequency of
atopic dermatitis and decrease
viral warts among children
exposed to chemicals liberated
in a chemical accident in
Frankfurt, Germany.
Dermatology ; 195 :
112-118 ; 1997.
Wearne, S.J. et al.
Contaminants of food :
Prioritisation scheme to
identify manufactured organic
chemicals as potential
contaminants of food.
Environ. Sci. Poll. Res.
Int. 3 : 83-88. 1996.
Zeilmaker, M.J. ; van
Kranen, H.J. ; van Veen, M.P.
and Janus, J.A.
Cancer risk assessment
of azo dyes and aromatic amines
from tattoo bands, folders of
paper, toys bedclothes
watchstraps and ink.
RIVM report 601503019 ;
February 2000.
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1 Regulation 793/93
provides a systematic framework
for the evaluation of the risks
to human health and the
environment of those substances
if they are produced or
imported into the Community in
volumes above 10 tonnes per
year. The methods for carrying
out an in-depth Risk Assessment
at Community level are laid
down in Commission Regulation
(EC) 1488/94, which is
supported by a technical
guidance document.