Opinion on The report by WS Atkins International Ltd (vol. A) "Assessment of the Risks to Health and to the Environment of Tin Organic Compounds in Antifouling Paint and of the Effects of Further Restrictions on their Marketing and Use", opinion expressed at the 6th CSTEE plenary meeting, Brussels, 27 November 1998.
Title of Opinion
On the WS Atkins Final
Report Volume A, April 1998:
"Assessment of the risks to
health and to the environment
of Tin Organic Compounds in
Antifouling Paint and of the
effects of further restrictions
on their marketing and use"
Abbreviated Summary
Opinion of the
Scientific Committee for
Toxicity, Ecotoxicity and
Environment (CSTEE)
The CSTEE has been asked
to express its opinion on the
adequacy of the report named
above:
(1) With regard to tin,
is the reported degree of risk
to the aquatic environment and
to man via the environment
sufficiently justified by the
study?
(2) Are studies of a
good quality taking account of
the constraints on the
consultants in terms of budget
and timing?
Opinion:
(1) The degree of risk
for both the aquatic
environment and human health
reported in the study of WS
Atkins is sufficiently
justified although it should be
noted that no reference is made
to the possible activity of TBT
as an endocrine disrupting
chemical. Nonetheless, a lower
ADI (0.25 m g/Kg/day) is
recommended instead of the 1.6
m g/Kg/day, based on
immunotoxicity findings in a
chronic study with rats.
(2) The CSTEE declines
to comment on the budget and
timing constraints placed on WS
Atkins in preparing the report,
although it should be deemed as
appropriate for decision
making.
Executive Summary
Question: Whether the
assessment of the degree of
risk to the environment and
man, as assessed by the Atkins
Final Report Volume A, April
1998, "Assessment of the risk
to health and to the
environment of Tin Organic
Compounds in antifouling Paint
and of effects of further
restrictions on their marketing
and use", is sufficiently
justified and to provide a
comment on the general quality
of Report.
Answer: The present
report has some serious
deficiencies. In particular no
reference is made to the
possible endocrine disrupting
activity of TBT. Although there
is a scarcity of available data
about the budget and timing
constraints placed on WS Atkins
in preparing the report, it may
be deemed as generally
appropriate for decision
making.
- The Main Element of
the scientific justification of
the answer has been based on a
range of information from
published literature, trade
association, regulatory
authorities and WHO.
- No reference was made
to the endocrine disrupting
effects of organic tin
products.
Assessment
The European Commission
has previously addressed this
question on at least three
different occasions:
(i) A report prepared
for the former Scientific
Advisory Committee for the
Examination of Toxicity and
Ecotoxicity of Chemical
Compounds (CSTE) by P.L.
Chambers and
(ii) a MESDPA research
contract of D.G. XI besides
sponsoring of International
Organotin Symposia.
(iii) Atkins Report
Summary
Tributyltin (TBT) is the
only tin organic compound used
in antifouling paint. TBT is
amongst the most toxic
molecules ever introduced
deliberately into the marine
environment.
Fouling of ship hulls
has an important effect on fuel
consumption. Without the use of
antifouling substances fuel
consumption can be more than
50% higher.
The ecological and
economical impact of TBT did
not become evident until
deformation and reproductive
failure were observed in
commercial stocks of oysters.
The most sensitive organisms to
TBT are molluscs, namely larvae
and juveniles' groups, with
threshold concentrations in
order of the ng/l. The EU Water
Quality Objective for TBTO in
marine waters is 1 ng/l. This
was submitted by the CSTE for
adoption in June 1992.
The effects of TBT on
aquatic animals include
reproduction anomalies in
gastropods (imposex),
oystershell thickening, reduced
growth rates for mussels and
impaired oogenesis and egg
production. The LOEC in marine
organisms was found in the
gastropod Nucella lapillus for
the imposex phenomenon (1
ng/l). The acceptable NOEC can
be obtained by dividing the
LOEC by two thus giving a NOEC
of 0.5 ng/l for Nucella
lapillus. An assessment factor
of 1 for this species which
seems to be the most sensitive
marine organism, is considered
appropriate, producing a PNEC
value of 0.5 ng/l
TBT is metabolised by
typical phase I and phase II
reactions, the former via
cytochromes P450 (CYP) and the
latter involving conjugation
reactions. Phase I and Phase II
enzyme systems facilitate the
elimination of TBT. Oysters and
other bivalves have very low
CYP activity which correlates
with their slow rate of
toxicant oxidation. This low
CYP-depedent detoxifying
activity generally found in
molluscs may partially explain
this group susceptibility to
TBT (Lee, 1991).
Although the hormonal
systems of invertebrates are
poorly understood as compared
with those of vertebrates, it
is known that molluscan
steroidogenesis is similar to
that of vertebrates. Imposex
(as well as intersex) are forms
of endocrine disruption
possibly mediated by inhibition
of cytochrome P450 aromatase
(CYP19A1) resulting in high
levels of testosterone that
masculinize exposed females due
to a built up of testosterone
in TB-exposed females. In the
case of TBT, it would seem that
the effect is due to
competitive inhibition of the
cytochrome P450 aromatase
(CYP19A1).
TBT has a Kow>3 and a
bioconcentration factor between
1000-7000 depending on the
organism tested. It has a
persistence of ca.2 weeks in
column water and ca.2 months in
biota and between 0.5-20 years
in sediments depending on the
oxygen concentration. The
dumping of contaminated
sediments can have significant
effects on the water quality of
the area.
Release from
manufacture, application and
use of TBT in antifouling
paints takes place into the
aquatic environment.
Directive 89/677/EEC
limited the use of TBT based
paints to ships with hulls
greater than 25 m in length.
Besides the application of TBT
based paints in dockyards those
boats additionally contribute
to a continuous release of TBT
to the aquatic environment.
Health risks to man are
likely to exist in two
instances:
(i) When at the
workplace, during manufacture
and application of TBT based
paints, no adequate protection
equipment is used;
(ii) by ingestion of TBT
contaminated fish and seafood.
In situation (i)
adequate respiratory protective
equipment must be provided.
This should eliminate the risk
to health or at least the risks
should then become negligible.
In situation (ii) a
health risk (impairment of
immune system probably through
reduction of proliferative
activity of thymocytes) exists
if the water concentration of
TBT attains values in the order
of 130 ng/l assuming a daily
intake of 115g of fish and/or
seafood using an ADI of 112m g
(1.6m g/kg/day) and a
concentration factor of 7000
(worst case assumptions). These
high TBT concentrations in
water can only be attained near
repair dockyards.
The ADI of 1.6m g/kg/day
is the one used in the WS
Atkins report and also the one
adopted by the Japanese
authorities. Perhaps a more
cautionary level of 0.25m
g/kg/day should be used as the
ADI. Such an ADI is recommended
by the work of Vos. et al.
(1990) on the immune system in
the rat. The WHO (1990)
considers that this endpoint is
still controversial for human
risk assessment. The US EPA in
IRIS currently gives a Bench
Mark Dose (BMD10) of 0.03
mg/Kg/day based on the work of
Vos et al. (1990) based on the
immunotoxic response in rats;
taking a safety factor of 100
this leads to an ADI of 0.30m
g/Kg/day.
IRIS goes on to state
that no information was located
regarding toxicity of TBTO in
humans following oral exposure.
Human data summarised by Boyer
(1989) suggest that tributyltin
oxide is a potent
non-allergenic dermal irritant.
Indeed the effects of
TBT in humans are not well
documented, except for
induction of apoptosis in
granulocytes and human
thymocytes.
A value for an accurate
ADI of TBT for man has not yet
been universally agreed. The
current acceptable values range
from 5.0 - 0.25 m g/Kg/day,
(WHO, De Mora and Pelletier,
1997).
Conclusion to question
(1):
The degree of risk for
the aquatic environment
reported in the study of WS
Atkins is sufficiently
justified. For human risk
assessment a lower ADI (0.25 m
g/Kg/day) is recommended.
Conclusion to question
(2):
The CSTEE declines to
comment on the budget and
timing constraints placed on WS
Atkins in preparing the report.
They have used a reasonable
approach for risk assessment,
however there are concerns as
identified above.
Titles:
Boyer, I.J. Toxicology.
55: 253-298, 1989.
Lee, R.F. Marine
Environm. Res. 32: 29-35, 1991.
Matthiesen, P. and
Gibbs, P.E. Environm. Toxicol.
Chem. 17: 37-43, 1998.
De Mora, S.J.;
Pelletier, E. Environm.
Technol. 18: 1169-1177, 1997
Vos, J.G.; De Klerk, A.;
Krajnc, E.I.; Van Loveren, H.
and Rozing, I. Toxicol. Appl.
Pharmacol. 105: 144-155, 1990.
WHO.Environmental Health
Criteria 116. Tributyltin
Compounds. Geneva, 1990.
List of documents made
available to the Scientific
Committee on Toxicity,
Ecotoxicity and the Environment
via its Secretariat to help it
reach the opinion requested by
the services of the Commission
on the subject of : "Assessment
of the Risks to Health and to
the Environment of Tin Organic
Compounds in Antifouling Paint
and of the Effects of Further
Restrictions on their Marketing
and Use"
CSTEE/98/5
Assessment of the Risks
to Health and to the
Environment of Tin Organic
Compounds and of Arsenic in
Certain Biocidal Products and
of the Effects of Further
Restrictions on their Marketing
and Use
Draft Final Report
Volume A :
Assessment of the Risks
to Health and to the
Environment of Tin Organic
Compounds in Antifouling Paint
and of the Effects of Further
Restrictions on their Marketing
and Use
February 1998 - WS
Atkins International Ltd
CSTEE/98/5 - Rev. 1
Assessment of the Risks
to Health and to the
Environment of Tin Organic
Compounds and of Arsenic in
Certain Biocidal Products and
of the Effects of Further
Restrictions on their Marketing
and Use
Final Report
Volume A :
Assessment of the Risks
to Health and to the
Environment of Tin Organic
Compounds in Antifouling Paint
and of the Effects of Further
Restrictions on their Marketing
and Use
April 1998 - WS Atkins
International Ltd
CSTEE/98/5 - Add. 1
CSTEE/98/6 - Add. 1
Annex II to contract
with WS Atkins International
(Tin, Arsenic)
Technical Annex
description.
CSTEE/98/5 - Add. 2
(Doc. III/3505/98)
Review of Directive
89/677 on tin organic
compounds.
CSTEE/98/5 - Add. 3
CSTEE/98/6 - Add. 3
Council Directive of 21
December 1989 amending for the
8th time Directive 76/769/EEC
on the approximation of the
laws, regulations and
administrative provisions of
the Member States relating to
restrictions on the marketing
and use of certain dangerous
substances and preparations
(89/677/EEC) - OJEC No. L
398/19 of 30.12.89.
CSTEE/98/5 - Add. 4
Assessment of the risks
to health and the environment
of tin organic compounds -
Preliminary report - Dr. J.
Rueff.
CSTEE/98/5 - Add. 4 -
Rev.1
Assessment of the risks
to health and the environment
of tin organic compounds -
Preliminary report - Dr. J.
Rueff.
CSTEE/98/5 - Add. 4 -
Rev.2
Assessment of the risks
to health and the environment
of tin organic compounds -
Preliminary report - Dr. J.
Rueff.
CSTEE/98/5 - Add. 5
The toxicity of
bis(tri-n-butyltin)oxide (TBTO)
and di-n-butyltindichloride
(DBTC) in the small fish
species Oryzias latipes
(medaka) and Poecilia
reticulata (guppy) - Report
made by P.W. Wester, J.H.
Canton, A.A.J. Van Iersel, E.I.
Krajnc and H.A.M.G. Vaessen and
accepted 17 July 1989.
CSTEE/98/5 - Add. 6
Tributyltin compounds -
Environmental Health Criteria
116 - Report published under
the joint sponsorship of the
United Nations Environment
Programme, the International
Labour Organisation, and the
World Health Organization (1990
- First draft).
CSTEE/98/5 - Add. 7
Immunotoxicity of
Bis(tri-n-butyltin)oxide in the
Rat: Effects on
Thymus-Dependent Immunity and
on Nonspecific Resistance
following Long-Term Exposure in
Yound versus Aged Rats - J.G.
Vos, A. De Klerk, E.I. Krajnc,
H. Van Loveren and J. Rozing -
Report accepted May 3, 1990.
CSTEE/98/5 - Add. 8
Histopathological study
of Poecilia reticulata (guppy)
after long-term exposure to
bis(tri-n-butyltin)oxide (TBTO)
and di-n-butyltindichloride
(DBTC) - P.W. Wester and J.H.
Canton - Report accepted 18
February 1987.
CSTEE/98/5 - Add. 9
Tributyltin oxide (TBTO)
- CASRN 56-35-9 (09/01/97) -
Dr. J. Rueff.
CSTEE/98/5 - Add. 10
Comments on the Draft
Final Report "Assessment of the
Risks to Health and to the
Environment of Tin Organic
Compounds in Antifouling Paint
and of the Effects of Further
Restrictions on their Marketing
and Use".
Federal Environmental
Agency of Germany -
Umweltbundesamt Berlin -
23/4/1998.
CSTEE/98/5 - Add. 11
Swedish comments to the
first interim report by WS
Atkins - October 1997 - on Tin
Organic Compounds in
Antifouling Paint.
21 November 1997 - KEMI.
CSTEE/98/5 - Add. 12
CSTEE/98/6 - Add. 12
Review of Directive
89/677 on Arsenic and Tin
(Inter Alia) "Swedish comments
to First Interim Reports by WS
Atkins on Assessment of the
Risks to Health and to the
Environment of Tin Organic
Compounds and Arsenic in
Certain Biocidal Products,
October 1997".
28 November 1997 - KEMI.
CSTEE/98/5 - Add. 13
Swedish comments to :
Interim Report Part B by WS
Atkins December 1997 on "Tin
organic compounds - Effects of
further Restrictions on the
Marketing and Use".
KEMI - 26 January 1998.
CSTEE/98/5 - Add. 14
Literature survey on
ecotoxicology and environmental
exposure of organotin compounds
with emphasis on use in
antifouling paints - Final
draft.
National Chemicals
Inspectorate - Sylvia Karlsson
- September 1997.
CSTEE/98/5 - Add. 15
The Baltic Sea
environment, and its
sensitivity to pollutants with
emphasis on organic tin
compounds.
KEMI Report PM Nr 3/97 -
March 1997.
CSTEE/98/5 - Add. 16
Consequences of
restricted use of organic tin
compounds for the shipping in
the Baltic Sea and the North
Sea.
KEMI Report PM Nr 7/97 -
Karin Magnusson - Exemption
Substances Project.
CSTEE/98/5 - Add. 17
CSTEE/98/6 - Add. 14
Review of Directive
89/677/EEC on Arsenic and Tin
(Inter Alia).
11 March 1998 - KEMI.
CSTEE/98/5 - Add. 18
Comments on the Final
Report "Assessment of the Risks
to Health and to the
Environment of Tin Organic
Compounds and of Arsenic in
Certain Biocidal Products and
of the Effects of Further
Restrictions on their Marketing
and Use, Volume A: Assessment
of the Risks to Health and to
the Environment of Tin Organic
Compounds in Antifouling Paint
and of the Effects of Further
Restrictions on their Marketing
and Use" prepared by WS Atkins
Consultants.
July 06, 1998 - Witco
GmbH, Elf Atochem Vlissingen
B.V.