Document ID: EPA-HQ-OPPT-2002-0054-0268
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-11-22T05:00Z

OCDE
OECD
ORGANISATION
DE
COOPÉRATION
ET
ORGANISATION
FOR
ECONOMIC
DE
DÉVELOPPEMENT
ÉCONOMIQUES
CO­
OPERATION
AND
DEVELOPMENT
DIRECTION
DE
L'ENVIRONNEMENT
ENVIRONMENT
DIRECTORATE
Division
de
l'Hygiène
et
de
la
Sécurité
de
l'Environment
Environmental
Health
and
Safety
Division
2,
rue
André
Pascal
75775
PARIS
CEDEX
16
Tél.
:
45
24
82
00
To:
SIDS
Contact
Points
cc:
Members
of
the
Steering
Group
on
Existing
Chemicals
(
letter
and
Chapter
1
of
the
Manual
only)
Members
of
the
Risk
Assessment
Advisory
Body
(
RAAB)
(
letter
only)
National
Delegations
(
letter
only)

ENV/
EHS/
DT/
th/
97.41
Paris,
30
July
1997
Re:
SIDS
Manual
(
Third
Revision)

Dear
Madam/
Sir,

Please
find
enclosed
the
updated
SIDS
Manual
(
third
revision)
which
reflects
the
state­
of­
the­
art
of
the
OECD
SIDS
Programme.
As
only
certain
chapters
have
been
updated,
only
copies
of
those
chapters
(
i.
e.
Cover
pages,
Chapters
1­
3
and
Annexes
4­
6)
are
enclosed.
The
other
chapters
in
the
May
1996
version
are
still
valid.
In
addition,
a
diskette
is
enclosed,
including
all
the
chapters
of
the
latest
SIDS
Manual
(
i.
e.
updated
and
unchanged
chapters)
in
Word
6.0
files.
SIDS
Contact
Points
are
expected
to
make
this
manual
available
to
people
who
are
involved
in
the
SIDS
work.

The
following
revisions
have
been
made
in
the
current
version,
dated
July
1997:

1.
Chapter
1
(
Description
of
OECD
Work
on
Investigation
of
High
Production
Volume
Chemicals)
has
been
updated
to
reflect
the
current
situation
regarding
the
definition
of
OECD
HPV
List,
SIDS
Review
process,
procedures
for
gathering
and
transmitting
exposure
information,
etc.

2..
Section
2.5
(
Guidance
for
collection
and
transmission
of
exposure
information
for
SIDS
Initial
Assessment)
has
been
added
based
on
the
agreed
procedures.
Section
2.1
and
2.2
have
also
been
modified
and
Annex
5
has
been
simplified.

3.
A
part
of
Chapter
3
(
Data
Evaluation,
Preparation
of
SIDS
Dossiers
and
Testing
Plans)
has
been
revised
based
on
the
agreed
new
SIDS
Review
process.

4.
Information
in
Annex
4
and
6
has
been
updated.

In
order
to
ensure
publication
of
SIDS
Initial
Assessment
Reports
and
SIDS
Dossiers
of
high
quality
in
a
more
harmonised
way,
it
is
strongly
recommended
that
the
reports
and
the
dossiers
be
prepared
according
to
the
guidance
set
out
in
this
Manual.
SIDS
Contact
Points
are
encouraged
to
use
the
Manual
to
the
greatest
extent
possible
in
carrying
out
SIDS
work
in
their
countries/
organisations.

If
you
have
any
questions
or
comments,
please
send
them
to
Kazu
Chikazawa
(
Tel:
33­
1­
45.24.76.98,
Fax:
33­
1­
45.24.16.75,
E­
mail:
kazuhiko.
chikazawa@
oecd.
org).
Kazu
will
take
over
the
work
on
the
SIDS
Manual
which
was
done
by
Terry
Hayamizu
to
date,
after
he
leaves
OECD
at
the
end
of
August
1997.
Additional
copies
or
diskettes
are
available
from
Eimear
Cantwell
(
Tel:
33­
1­
45.24.16.74,
Fax:
33­
1­
45.24.16.75,
E­
mail:
eimear.
cantwell@
oecd.
org).

Yours
sincerely,
2
Dian
Turnheim
Environmental
Health
and
Safety
Division
Encl.:
a
set
of
paper
copies
(
7
documents)
and
a
diskette
EXCH\
MANUAL\
97COVER.
DOC/
July
1997
SIDS
MANUAL
(
Third
Revision)

SCREENING
INFORMATION
DATA
SET
MANUAL
OF
THE
OECD
PROGRAMME
ON
THE
CO­
OPERATIVE
INVESTIGATION
OF
HIGH
PRODUCTION
VOLUME
CHEMICALS
July
1997
OECD
SECRETARIAT
EXCH\
MANUAL\
97COVER.
DOC/
July
1997
TABLE
OF
CONTENTS
Foreword
1.
Description
of
OECD
Work
on
Investigation
of
High
Production
Volume
Chemicals
2.
SIDS
and
Data
Collection
2.1
Introduction
2.2
Content
of
the
Screening
Information
Data
Set
(
SIDS)
2.3
Outline
of
the
Harmonized
Electronic
Data
SET
(
HEDSET)
2.4
Guidance
for
the
Responder
to
the
OECD
Request
for
Available
Data
on
High
Production
Volume
(
HPV)
Chemicals:
"
Revised
OECD
HPV
Form
1"
2.5
Guidance
for
collection
and
transmission
of
exposure
information
for
SIDS
Initial
Assessment
3.
Data
Evaluation,
Preparation
of
SIDS
Dossiers
and
Testing
Plans
3.1
Introduction
3.2
Quality
of
and
Access
to
Data
Used
to
Prepare
SIDS
Dossiers
3.3
Considerations
for
Developing
SIDS
Testing
Plans
3.4
Guidance
for
Meeting
the
SIDS
Requirements
(
The
SIDS
Guide)
3.5
Considerations
Concerning
the
Adequacy
of
Data
in
the
SIDS
3.6
SIDS
Testing
of
Chemicals
with
Limited
Exposure
Potential
4.
Preparation
of
the
SIDS
Initial
Assessment
Report
4.1
Introduction
4.2
Provisional
Guidance
for
the
Outline
of
the
SIDS
Initial
Assessment
Report
4.3
Provisional
Guidance
for
the
Initial
Assessment
of
Environmental
Exposure
4.4
Provisional
Guidance
for
the
Initial
Assessment
of
Occupational
and
Consumer
Exposure
4.5
Provisional
Guidance
for
the
Initial
Assessment
of
Aquatic
Effects
4.6
Provisional
Guidance
for
the
Initial
Assessment
of
Health
Effects
5.
Overview
of
the
Post
SIDS
Work
Annex
1
OECD
Decision­
Recommendation
of
the
Council
on
the
Co­
operative
Investigation
and
Risk
Reduction
of
Existing
Chemicals
[
C(
90)
163(
Final)]

Annex
2
Model
SIDS
Dossier
Annex
3
Synopsis
of
OECD
Test
Guidelines
for
Studies
Included
in
the
SIDS
Annex
4
OECD's
Guidelines
for
the
Testing
of
Chemicals
­
Currently
Available
Guidelines,
Draft
Guidelines,
and
Guidance
and
Review
Documents
Annex
5
An
Example
of
the
Format
for
Gathering
Detailed
Exposure
Information
Annex
6
List
of
SIDS
Contact
Points
EXCH\
MANUAL\
97COVER.
DOC/
July
1997
FOREWORD
At
the
20th
Joint
Meeting
of
the
Chemicals
Group
and
Management
Committee
of
the
Special
Programme
on
the
Control
of
Chemicals
in
May
1993,
it
was
agreed
that
a
SIDS
Manual
would
be
prepared
in
order
to
disseminate
information
on
the
OECD
activity
on
the
Co­
operative
Investigation
of
High
Production
Volume
(
HPV)
Chemicals
and
to
facilitate
the
process
of
gathering
information
on
the
Screening
Information
Data
Set
(
SIDS)
elements
as
well
as
that
of
testing
and
assessing
HPV
chemicals.

This
manual,
prepared
by
the
OECD
Secretariat,
presents
guidance
documents
to
be
used
for
data
evaluation
and
initial
assessment
as
well
as
agreements
reached
in
the
OECD
Existing
Chemicals
Programme.
A
Model
SIDS
Dossier
is
also
included
in
an
Annex.
This
manual
is
to
be
distributed
in
Member
countries
through
SIDS
Contact
Points,
who
should
make
it
available
to
their
industry
and
scientific
community
in
order
to
encourage
their
co­
operation
in
SIDS
work.
It
is
strongly
recommended
that
SIDS
Dossiers
and
SIDS
Initial
Assessments
Reports
be
prepared
according
to
the
guidance
set
out
in
this
manual.

The
manual
has
been
and
will
continue
to
be
updated
and
new
documents
will
be
added
as
appropriate
in
order
to
reflect
the
state­
of­
the­
art
of
the
SIDS
Programme,
as
this
programme
is
essentially
carried
out
on
the
principle
of
"
learning
by
doing".
In
the
same
context,
the
programme
will
continue
to
be
closely
co­
ordinated
with
developments
in
other
national,
regional
and
international
programmes
on
existing
chemicals.

In
order
to
keep
the
manual
compact,
some
of
the
rather
extensive
documents
referred
to
in
the
manual,
such
as
"
Manuals
of
the
Exposure
Models",
are
not
included.
These
documents
can
be
obtained
from
the
SIDS
Contact
Points
or
from
the
OECD
Secretariat.

In
the
third
revision,
made
available
in
July
1997,
the
following
revisions
have
been
made.

1.
Chapter
1
(
Description
of
OECD
Work
on
Investigation
of
High
Production
Volume
Chemicals)
has
been
updated
to
reflect
the
current
situation
regarding
the
definition
of
OECD
HPV
List,
SIDS
Review
process,
procedures
for
gathering
and
transmitting
exposure
information,
etc.

2..
Section
2.5
(
Guidance
for
collection
and
transmission
of
exposure
information
for
SIDS
Initial
Assessment)
has
been
added
based
on
the
agreed
procedures.
Section
2.1
and
2.2
have
also
been
modified
and
Annex
5
has
been
simplified.

3.
A
part
of
Chapter
3
(
Data
Evaluation,
Preparation
of
SIDS
Dossiers
and
Testing
Plans)
has
been
revised
based
on
the
agreed
new
SIDS
Review
process.

4.
Information
in
Annex
4
and
6
has
been
updated.

The
other
chapters
remain
unchanged.
A
diskette
which
includes
all
the
latest
updated
files
is
available
from
SIDS
Contact
Points
and
from
the
Secretariat.
This
Manual
will
be
made
available
through
the
OECD
Internet
Homepage
(
http://
www.
oecd.
org/
ehs/)
in
near
future.
EXCH\
MANUAL\
97­
1.
DOC/
July
1997
1
1.
DESCRIPTION
OF
OECD
WORK
ON
INVESTIGATION
OF
HIGH
PRODUCTION
VOLUME
CHEMICALS*

Summary
Through
a
1990
OECD
Council
Decision
[
C(
90)
163(
Final)]
(
see
Annex
1
to
this
Manual)
Member
countries
have
decided
to
undertake
the
investigation
of
high
production
volume
(
HPV)
chemicals
in
a
co­
operative
way.
These
HPV
chemicals
include
all
chemicals
reported
to
be
produced
or
imported
at
levels
greater
than
1,000
tonnes
per
year
in
at
least
one
Member
country.
The
Decision
means
that
Member
countries
will
co­
operatively:

·
select
the
chemicals
to
be
investigated;
·
collect
effects
and
exposure
information
from
government
and
public
sources
and
encourage
industry
to
provide
information
from
their
files;
·
complete
the
agreed
dossier
for
the
Screening
Information
Data
Set
(
SIDS)
by
testing;
and
·
make
an
initial
assessment
of
the
potential
hazard
of
each
chemical
investigated.

When
a
full
SIDS
dossier
on
a
chemical
is
available,
an
initial
assessment
of
the
information
is
undertaken
and
conclusions
are
drawn
according
to
the
potential
risks
posed
by
the
chemical
and
recommendations
are
made
on
the
need
for
further
work.
The
conclusion
might
be,
for
example,
that
the
chemical
is
of
low
potential
risk
and
therefore
currently
of
low
priority
for
further
work.
If
a
potential
risk
to
man
and/
or
the
environment
is
identified,
various
conclusions
might
be
possible:
limited
exposure
or
current
risk
management
measures
in
Member
countries
could
make
further
action
to
manage
the
risk
unnecessary
at
this
time;
it
could
be
recommended
that
IPCS
(
International
Programme
on
Chemical
Safety)
consider
the
chemical
a
candidate
for
an
Environmental
Health
Criteria
or
similar
document;
and/
or
it
could
be
recommended
that
risk
management
actions
be
considered
at
the
national
or,
as
appropriate,
international
level.
In
addition,
the
conclusion
might
be
that
further
information
is
required
to
assess
concerns
identified
in
the
SIDS
process,
and
that
post­
SIDS
testing
is
recommended
on
such
chemicals.

In
the
policy
bodies
of
OECD,
Member
countries
discuss
and
agree
on
any
follow­
up
actions
on
chemicals
posing
a
potential
risk,
and
indeed,
discuss
and
confirm
all
conclusions
and
recommendations
made
on
all
chemicals
which
have
been
assessed
in
the
SIDS
programme.

When
full
SIDS
dossiers
and
initial
assessment
reports
are
finalised,
the
results
are
made
available
world­
wide
through
UN
bodies
such
as
IRPTC
(
UNEP's
International
Register
of
Potentially
Toxic
Chemicals)
and
IPCS,
with
whom
close
co­
operation
is
maintained
to
this
effect.

The
chemical
industry
fully
supports
the
OECD
activities
on
HPV
chemicals
because
this
work
avoids
duplication
of
efforts
among
chemical
companies
to
test
chemicals
to
fulfil
various
national
and
regional
requirements.
This
OECD
activity
is
undertaken
in
close
co­
ordination
with
other
national,
regional
and
international
existing
chemicals
programmes.

*
This
document
was
prepared
by
the
OECD
Secretariat
based
on
the
agreements
reached
in
the
OECD
Existing
Chemicals
Programme
up
to
June
1997
EXCH\
MANUAL\
97­
1.
DOC/
July
1997
2
Background
and
Rationale
The
investigation
of
the
safety
of
the
nearly
100,000
chemicals
currently
in
commerce
is
a
daunting
global
challenge
that
can
only
be
met
if
approached
in
a
systematic
way.
This
enormous
task
has
been
undertaken
by
the
OECD
and
is
based
on
compilation,
review
and
assessment
of
environmental
health
and
safety
data
and
exposure
information
on
selected
existing
chemicals.

Many
existing
chemicals
are
international
commodities.
Various
national
governments
and
chemical
companies
have
independently
initiated
activities
to
evaluate
their
safety,
often
using
the
guidance
developed
by
the
OECD.
Such
activities,
however,
are
time
and
resource
intensive
and
have
led
to
the
duplication
of
efforts
on
(
groups
of)
chemicals.
In
order
to
tackle
this
problem,
Member
countries
decided
through
a
Council
Decision­
Recommendation
in
1987
[
C(
87)
90(
Final)]
to
undertake
a
Systematic
Investigation
of
Existing
Chemicals.
They
agreed
to
establish
or
strengthen
national
programmes
to
investigate
existing
chemicals,
in
order
to
identify
those
which
pose
risks
that
need
to
be
managed
and/
or
controlled.
In
1990,
it
was
recommended
in
a
further
Council
Decision
(
on
the
Co­
operative
Investigation
and
Risk
Reduction
of
Existing
Chemicals)
that
Member
countries
work
together
and
"
share
the
burden"
of
investigating
the
potential
risks
from
priority
chemicals
of
mutual
concern.
By
sharing
the
burden
in
this
manner,
and
by
working
towards
internationally
agreed
objectives,
governments
could
avoid
wasting
resources
by
duplicative
efforts.
Industry
also
benefits
by
avoiding
duplication
of
information
gathering
or
testing
to
fulfil
various
national
and
regional
requirements
and
international
commitments.

In
order
to
share
the
burden
of
investigation,
each
Member
country
carries
out
a
specific
part
of
the
total
work
and
makes
the
information
it
has
collected
or
generated
available
to
other
Member
countries.
Chemical
industries
in
Member
countries
play
a
significant
role
in
the
conduct
of
this
co­
operative
work.
The
Business
and
Industry
Advisory
Committee
to
OECD
(
BIAC)
and
national
chemical
industry
associations
promote
the
collection
of
information
and
help
ensure
that
tests
which
need
to
be
conducted
are
undertaken
in
a
timely
manner.
The
work
is
carried
out
in
collaboration
with
the
International
Programme
on
Chemical
Safety
(
IPCS)
and
the
International
Register
of
Potentially
Toxic
Chemicals
(
IRPTC,
now
called
UNEP
Chemicals).

This
co­
operative
OECD
work
leads
to
considerable
benefits
for
many
parties:

·
Environmental
protection
and
human
health
will
be
improved
as
existing
chemicals
are
investigated
more
effectively.
·
The
financial
costs
of
testing
will
be
substantially
reduced
as
a
result
of
increased
co­
operation
and
sharing
the
burden
in
testing.
·
The
mutual
understanding
of
national
procedures
for
initial
assessment
of
chemicals
will
be
increased,
leading
to
eventual
harmonization
of
these
procedures.
·
The
use
of
animals
in
testing
will
be
reduced,
as
much
duplicative
testing
will
be
avoided.

Objectives
Since
1988,
OECD
existing
chemicals
activities
have
centred
primarily
on
the
investigation
high
production
volume
(
HPV)
chemicals,
based
on
the
assumption
that
production
volume
is
an
indicator
of
potential
occupational,
consumer
and
environmental
exposure.

·
The
first
objective
of
this
co­
operative
work
is
to
ensure
that
the
basic
information
necessary
to
undertake
a
first
evaluation
of
potential
hazards
associated
with
HPV
chemicals
is
either
available
or
generated.
·
A
second
objective
is
to
undertake
an
initial
assessment
of
this
information
and
to
draw
conclusions
on
the
potential
risk
of
the
chemicals
and
make
recommendations
related
to
the
need
for
further
work.
·
Finally,
when
complete
data
sets
and
risk
assessments
are
available,
Member
countries
may
decide
to
develop
common,
consistent
or
harmonized
risk
management
actions
for
those
HPV
chemicals
which
have
been
found
to
be
of
concern
to
man
or
the
environment.

The
OECD
List
of
High
Production
Volume
Chemicals
EXCH\
MANUAL\
97­
1.
DOC/
July
1997
3
The
OECD
List
of
HPV
Chemicals
is
compiled
on
the
basis
of
submissions
by
Member
countries
to
the
OECD
Secretariat.
These
submissions
contain
industrial
chemicals
for
which
a
Chemical
Abstracts
Service
(
CAS)
Registry
Number
had
been
assigned.
For
the
first
OECD
List
in
1990,
eighteen
Member
countries
(
including
all
major
chemical
producing
countries)
provided
national
inventories
of
HPV
chemicals
produced
in
or
imported
into
their
countries.
These
inventories
were
merged
into
the
OECD
List,
which
included
all
chemicals
reported
to
be
produced
or
imported
in
excess
of
10,000
tonnes
per
year
in
any
one
Member
country
or
in
excess
of
1,000
tonnes
per
year
in
two
or
more
countries.

The
List
has
been
modified
a
couple
of
times.
The
1997
OECD
HPV
List
is
currently
being
compiled
by
combining
the
European
Union's
HPV
list
(
i.
e.
Annex
I
to
EC
Regulation
793/
93)
and
the
updated
national
HPV
submissions
from
non­
EU
OECD
Member
countries.
It
was
agreed
at
the
26th
Joint
Meeting
(
i.
e.
the
Joint
Meeting
of
the
Chemicals
Group
and
Management
Committee
of
the
Special
Programme
on
the
Control
of
Chemicals)
that
the
definition
of
the
HPV
chemicals
be
modified
to
"
all
chemicals
reported
to
be
produced
or
imported
at
levels
greater
than
1,000
tonnes
per
year
in
at
least
one
Member
country
as
of
the
1997
List.
It
is
expected
to
contain
about
4,000
entries.

Any
chemical
on
the
1997
OECD
List
of
HPV
Chemicals
can
be
sponsored
by
Member
countries
as
their
share
of
the
co­
operative
work
on
HPV
chemicals.
Member
countries
can
select
either
chemicals
for
which
limited
data
are
available
and
for
which
development
of
SIDS
data
is
needed
(
i.
e.
"
data
poor'
chemicals),
or
chemicals
for
which
full
SIDS
information
is
available
and
for
which
an
initial
assessment
can
be
carried
out
without
delay
(
i.
e.
"
data
rich"
chemicals).
In
this
way
the
work
undertaken
in
the
EU
Member
States
in
compliance
with
the
EC
Regulation
forms
their
contribution
to
the
OECD
programme.

Priority
Setting
The
priority
setting
procedure
has
evolved
since
the
OECD
programme
began.
At
the
beginning,
Member
countries
surveyed
the
1990
List
and
by
consulting
national
and/
or
international
databases
gathered
data
that
were
readily
available
for
the
individual
chemicals.
The
annotated
List
was
then
reviewed
at
meetings
of
experts
from
Member
countries,
other
international
organisations
and
industry,
where
it
was
decided
that
those
substances
for
which
little
or
no
information
was
available
should
have
highest
priority
for
further
work
in
the
phases
of
the
SIDS
project.
As
a
result
of
these
deliberations,
a
"
working
list"
of
648
chemicals
was
developed
in
1992,
from
which
Member
countries
selected
chemicals
for
sponsorship.

As
of
1993,
selection
was
no
longer
limited
to
the
"
working
list".
This
change
was
made
in
order
to
allow
those
Member
countries
with
small
chemical
industries
to
participate
and
to
follow
the
evolution
of
national
and
regional
existing
chemicals
programmes
­
some
of
which
are
currently
aimed
less
at
filling
data
gaps
and
more
at
assessing
chemicals
of
concern
for
which
a
great
deal
of
data
are
available,
in
order
to
recommend
further
action
as
appropriate.
The
OECD
List
of
HPV
Chemicals
serves
as
the
overall
priority
list
from
which
chemicals
are
selected
for
SIDS
testing
and/
or
assessment.
This
gives
Member
countries
greater
flexibility
in
the
programme
and
facilitates
the
participation
of
industry.
Chemicals
for
which
SIDS
data
gap
are
probable
will
be
identified
by
searching
main
databases
and
these
will
be
marked
in
the
1997
OECD
List
of
HPV
Chemicals
for
the
information
of
Member
countries
wishing
to
sponsor
"
data
poor"
chemicals.

Selection
of
Chemicals
In
order
to
share
the
burden,
chemicals
are
selected
by
Member
countries
in
batches
of
approximately
50
for
every
"
phase"
of
the
programme.
In
consultation
with
their
chemical
industries,
they
identify
chemicals
for
which,
on
a
voluntary
basis,
they
will
act
as
a
Sponsor
country
in
the
HPV
programme.
The
overall
number
of
chemicals
which
any
Member
country
or
group
of
Member
countries
(
through,
for
example,
the
EU
programme)
sponsors
should,
as
a
minimum,
be
proportional
to
its
financial
contribution
to
the
OECD
Chemicals
Programme,
which
in
turn
is
proportional
to
its
(
combined)
Gross
National
Product.

The
Screening
Information
Data
Set
(
SIDS)

The
objective
of
this
OECD
activity
is
to
undertake
an
initial
screening
of
the
potential
risks
of
HPV
chemicals
to
man
and/
or
the
environment.
A
prerequisite
for
this
generic
approach
was
the
identification
of
the
necessary
elements,
or
data
set,
on
which
to
base
an
informed
judgement
as
to
the
potential
hazards
of
the
chemicals.
The
data
elements
needed
for
"
screening"
HPV
chemicals
were
brought
together
as
the
Screening
Information
Data
Set,
or
SIDS,
which
comprises
EXCH\
MANUAL\
97­
1.
DOC/
July
1997
4
characterisation
and
effects
data
similar
to
the
Minimum
Pre­
marketing
set
of
Data
(
MPD)
for
new
chemicals
(
the
OECD
Council
Decision
in
1982
[
C(
82)
196(
Final)]),
as
well
as
elements
of
exposure
information
(
see
Section
2.2).
The
SIDS
is
regarded
as
the
minimum
information
needed
to
assess
an
HPV
chemical
to
determine
whether
any
further
work
should
be
carried
out
or
not.
However,
all
available
data
are
used
to
make
the
assessment.
In
practice,
and
especially
following
the
change
in
scope
of
the
chemicals
covered,
the
available
data
often
goes
far
beyond
SIDS.

Responsibilities
of
a
Sponsor
Country
Each
Sponsor
country
nominates
a
SIDS
Contact
Point
who
organises
the
actual
work
and
is
available
for
communication
(
see
Annex
6
to
this
Manual).
The
responsibilities
of
a
Sponsor
country,
again
in
collaboration
with
its
industry,
include:

·
preparing
and
managing
the
collection
of
effects
and
exposure
data
(
if
necessary,
undertaking
a
further
literature
search);
·
identifying
a
lead
organisation,
usually
a
chemical
company,
for
each
chemical;
·
reviewing
the
data
received,
assessing
their
quality,
preparing
a
SIDS
Dossier
and
developing,
as
appropriate,
a
SIDS
Testing
Plan
for
generating
further
information
by
testing;
·
providing
the
information
on
SIDS
testing/
no
testing
for
the
Secretariat;
·
organising
and
supervising
any
agreed
SIDS
testing;
·
assisting
other
national
SIDS
Contact
Points
by
forwarding
exposure
information
or
other
requested
data
on
their
chemicals;
·
making
an
evaluation
of
the
full
SIDS
Dossier
and
preparing
a
SIDS
Initial
Assessment
Report
(
SIAR),
including
proposals
for
conclusions
and
recommendations
on
any
follow­
up
actions
to
be
undertaken
on
the
chemical;
·
circulating
the
SIAR
to
other
Member
countries
and
presenting
it
at
a
SIDS
Initial
Assessment
Meeting
(
SIAM);
and
·
finalising
the
SIAR
for
publication,
taking
into
account
the
comments
provided
and
discussions
at
a
SIAM.

Each
Member
country
is
responsible
for
generating
and
making
available
SIDS
data
for
those
priority
HPV
chemicals
for
which
it
is
the
Sponsor
country.
In
return,
it
will
benefit
from
receiving
similar
data
on
the
other
priority
HPV
chemicals
from
other
Member
countries
and
from
the
fact
that
the
need
for
duplicate
testing
will
be
eliminated.

Data
Collection,
SIDS
Dossiers
and
Testing
Plans
After
selection
of
chemicals
by
Sponsor
countries,
the
first
activity
involves
collection
of
information
on
the
chemicals.
In
addition
to
readily
available
data,
industry
is
also
requested
to
provide
Sponsor
countries
with
data
and
full
copies
of
studies
which
are
in
their
files
and
have
not
so
far
been
published
in
the
open
literature.

To
assist
Sponsor
countries
in
the
collection
of
data
in
a
standardised
manner,
the
OECD
in
co­
operation
with
the
European
Commission
has
developed
a
computer
format,
which
can
be
used
by
responders
when
providing
information.
Not
only
all
information
required
by
the
SIDS,
but
also
further
information
on
existing
chemicals
required
within
the
framework
of
the
EU
programme,
can
be
accommodated
in
the
system.
Diskettes
on
which
the
data
elements
for
the
Harmonized
Electronic
Data
Set
(
HEDSET)
may
be
entered,
together
with
explanatory
documents
on
recording
information,
are
available
from
the
Secretariat,
the
European
Commission
and
SIDS
Contact
Points
(
see
Section
2.3).

As
additional
information,
beyond
SIDS
elements,
could
be
helpful
to
the
Sponsor
country
in
formulating
its
plan
for
SIDS
testing,
HEDSET
includes
a
wider
range
of
data
elements
than
those
required
in
the
SIDS.
Information
holders
are
therefore
encouraged
to
provide
information
for
as
many
of
the
data
elements
on
the
diskette
as
possible.

Although
use
of
the
HEDSET
diskette
is
strongly
encouraged,
either
the
paper
form,
the
"
Revised
OECD
HPV
Form
1"
(
see
Section
2.4),
in
Word
6.0
or
its
diskette
equivalent,
are
acceptable
alternatives.
The
empty
form
is
available
from
SIDS
Contact
Points
or
the
OECD
Secretariat.
EXCH\
MANUAL\
97­
1.
DOC/
July
1997
5
At
this
stage,
information
on
exposure
of
the
chemical
should
also
be
collected.
Sponsor
countries
of
the
chemicals
collect
detailed
information,
whereas
other
countries
also
collect
easily­
available
information
and
transmit
it
to
relevant
Sponsor
countries
(
see
Section
2.2
and
2.5).

When
no
information
is
available
for
a
given
data
element,
calculation
or
estimates
derived
from
Quantitative
Structure
Activity
Relationships
(
QSARs)
can
sometimes
be
provided
(
e.
g.
for
physical­
chemical
properties
or
aquatic
toxicity),
but
an
indication
of
the
quality
of
the
methods
used
should
be
given.

For
any
SIDS
element
on
effects
or
characterisation
for
which
no
data
are
available
or
the
data
are
not
considered
adequate,
testing
will
in
principle
be
carried
out.

Any
testing
to
complete
the
SIDS
should
be
conducted
according
to
the
OECD
Test
Guidelines
and
the
Principles
of
Good
Laboratory
Practice
(
GLP),
in
order
to
ensure
that
generated
data
are
mutually
acceptable
among
Member
countries
and
that
tests
carried
out
in
accordance
with
the
OECD
Council
Decision
on
the
Mutual
Acceptance
of
Data
[
C(
81)
30(
Final)]
need
not
be
repeated.

The
quality
of
the
collected
data
is
of
great
importance.
In
order
to
harmonize
its
evaluation
and
to
assist
Sponsor
countries
in
preparing
the
SIDS
Dossiers
and
SIDS
Testing
Plans
for
their
chosen
chemicals,
the
OECD
has
prepared
guidance
for
evaluating
and
documenting
the
quality
of
data
including
a
SIDS
Guide
which
addresses
details
for
each
SIDS
element
(
see
Chapter
3).
A
Model
Dossier
has
also
been
prepared
to
indicate
what
kind
of
data
should
be
included,
how
the
data
should
be
expressed,
etc.
(
see
Annex
2
to
this
manual).

SIDS
Review
Up
to
1993,
the
SIDS
Dossiers
and
SIDS
Testing
Plans
had
been
forwarded
by
the
Sponsor
country
to
all
SIDS
Contact
Points,
so
that
the
experts
from
each
OECD
country
and
those
from
non­
Member
countries
nominated
by
IPCS
could
study
the
proposals
made
by
the
Sponsor
country.
The
proposals
were
then
scrutinised
at
a
meeting
of
experts
of
Member
countries
(
SIDS
Review
Meeting)
in
order
to
confirm
the
adequacy
of
information
and
reach
agreement
on
the
SIDS
Testing
Plan.

Beginning
with
phase
4,
this
SIDS
Review
was
undertaken
via
a
written
procedure
by
sending
the
SIDS
Dossiers
and
SIDS
Testing
Plans
to
all
SIDS
Contact
Points.
However,
it
was
agreed
in
November
1996
to
simplify
the
procedures
by
circulating
a
statement
regarding
testing
needs
with
relevant
information.
This
is
aimed
at
reducing
work
for
countries
but
still
informing
the
Secretariat
and
all
Member
countries
of
progress
and
decisions
regarding
data
quality
and
testing
needs
taken
by
Sponsor
countries
(
see
Section
3.1
for
details).

The
Secretariat
collates
the
information
provided
by
Sponsor
countries
and
circulates
it
to
all
SIDS
Contact
Points.
Any
comments
are
provided
to
Sponsor
countries
through
SIDS
Contact
Points
within
2
months.
If
opposing
views
exist,
they
will
be
discussed
bilaterally
between
the
individual
Member
country
providing
comments
and
the
Sponsor
country.
Where
no
consensus
can
still
be
reached,
discussion
and
resolution
should,
in
principle,
be
handled
by
the
Steering
Group
on
Existing
Chemicals,
a
sub­
group
of
the
Joint
Meeting.
Sponsor
countries
can
request
preliminary
discussion
of
SIDS
Dossiers
and
Testing
Plans
at
a
SIDS
Initial
Assessment
Meeting
(
SIAM).

Following
these
SIDS
Review
procedures,
the
outcome
concerning
the
data
needs
for
SIDS
end­
points
is
one
of
the
following:

·
existing
data
are
adequate;
no
testing
is
needed;
·
existing
data
are
not
adequate;
agreed
testing
will
be
carried
out;
or
·
existing
data
are
not
adequate,
but
there
is
agreed
(
written)
scientific
justification
for
not
requiring
testing.

Initial
Assessment
of
Full
SIDS
Chemicals
When
the
Sponsor
country
has
obtained
all
the
data
elements
of
the
SIDS
for
the
sponsored
chemical
(
a
Full
SIDS
Chemical),
it
will
prepare
the
SIDS
Initial
Assessment
Report
(
SIAR)
to
accompany
the
full
SIDS
Dossier
on
the
chemical
and
make
an
evaluation
including
conclusions
on
the
potential
risk
and
recommendations
for
further
action,
if
appropriate.
EXCH\
MANUAL\
97­
1.
DOC/
July
1997
6
Five
provisional
guidance
documents
for
Sponsor
countries
to
use
in
carrying
out
initial
assessments
and
preparing
their
recommendations
have
been
developed
and
reviewed
by
Member
countries,
taking
into
account
experience
obtained
at
SIAMs.
These
documents
are
included
in
Chapter
4:

­­
Provisional
Guidance
for
the
Outline
of
the
SIDS
Initial
Assessment
Report
­­
Provisional
Guidance
for
the
Initial
Assessment
of
Environmental
Exposure
­­
Provisional
Guidance
for
the
Initial
Assessment
of
Occupational
and
Consumer
Exposure
­­
Provisional
Guidance
for
the
Initial
Assessment
of
Aquatic
Effects
­­
Provisional
Guidance
for
the
Initial
Assessment
of
Health
Effects
Models
used
for
exposure
estimation
have
been
developed
based
on
the
results
of
various
OECD
workshops
and
have
been
distributed
to
SIDS
Contact
Points
(
see
Sections
4.3
and
4.4).

Peer
Review
The
SIDS
Dossiers
and
Testing
Plans
as
well
as
the
SIDS
Initial
Assessment
Reports
(
SIARs)
are
subject
to
extensive
peer
review
in
two
stages.
As
discussed
above,
in
the
first
stage,
a
statement
of
SIDS­
testing/
no
testing
together
with
relevant
information
is
circulated
to
SIDS
Contact
Points
who
review
and
comment
on
the
adequacy
of
the
Sponsor
country's
decision.
A
two­
month
period
is
allowed
for
this
review.
Sponsor
countries
receive
comments
via
SIDS
Contact
Points
and
complement
their
data
and/
or
adjust
their
Testing
Plans
as
appropriate.

In
the
second
stage,
the
SIARs,
which
include
evaluations,
conclusions
and
recommendations,
are
circulated,
together
with
the
updated
SIDS
Dossier,
to
SIDS
Contact
Points
in
a
timely
manner
prior
to
the
SIDS
Initial
Assessment
Meeting
(
SIAM).
Once
again,
experts
in
countries
are
consulted
and
comments
prepared
for
discussion
at
the
SIAM.
In
some
cases,
initial
comments
are
relayed
to
the
Sponsor
country
prior
to
the
SIAM,
so
a
revised
SIAR
can
be
prepared
and
circulated,
if
appropriate.
Three
months
are
allowed
for
this
process.
At
the
SIAM
itself,
the
SIARs
are
discussed
and
consensus
reached
on
the
initial
assessment
and
the
conclusions
and
recommendations
for
each
chemical,
resulting
in
an
internationally
agreed
assessment.

Participants
in
the
SIAM
include:

·
representatives
of
the
Sponsor
countries;
·
representatives
from
other
Member
countries
and
the
European
Commission;
·
experts
from
non­
Member
countries
nominated
by
IPCS;
·
secretariat
staff
from
OECD,
IPCS
and
IRPTC;
·
experts
nominated
by
OECD's
Business
and
Industry
Advisory
Committee
(
BIAC)
and
Trade
Union
Advisory
Committee
(
TUAC);
and
·
representatives
of
companies
which
produce
the
chemical
(
for
that
part
of
the
discussions
which
concerns
their
chemical).

Outcome
and
public
availability
For
each
chemical,
the
end
product
of
the
work,
in
the
framework
of
the
OECD
Existing
Chemicals
activities,
should
be
that
all
data
elements
of
the
SIDS
(
Full
SIDS)
are
available,
their
adequacy
has
been
peer
reviewed
and
an
initial
assessment
report
prepared.
This
information
will
have
been
evaluated,
and
conclusions
on
the
potential
risk
posed
by
the
chemical
and
recommendations
for
further
actions,
if
any,
agreed
among
Member
countries.

The
conclusions
and
recommendations
might
state,
for
example,
that
the
chemical
is
of
low
potential
risk
and
therefore
currently
of
low
priority
for
further
work.
If
a
potential
risk
to
man
and/
or
the
environment
is
identified,
various
conclusions
might
be
possible:
limited
exposure
or
current
risk
management
measures
in
Member
countries
could
make
further
action
to
manage
the
risk
unnecessary
at
this
time;
it
could
be
recommended
that
IPCS
consider
the
chemical
a
candidate
for
a
Health
and
Safety
Guide
or
an
Environmental
Health
Criteria
document;
and/
or
it
could
be
recommended
that
risk
management
actions
be
considered
at
the
national
or,
as
appropriate,
international
level.
In
addition,
the
conclusion
EXCH\
MANUAL\
97­
1.
DOC/
July
1997
7
might
be
that
further
information
is
required
assess
concerns
identified
in
the
SIDS
process,
and
that
post­
SIDS
testing
is
recommended
on
such
chemicals.

The
conclusions
and
recommendations
on
the
chemicals
agreed
at
a
SIAM
are
reported
to
the
Steering
Group
on
Existing
Chemicals
and
confirmed.
They
are
subsequently
transmitted
to
the
Joint
Meeting
to
be
endorsed.

Sponsor
countries
finalise
the
SIAR
taking
into
account
the
comments
provided
by
other
countries
and
the
discussion
at
a
SIAM,
and
submit
it
to
the
OECD
Secretariat
together
with
the
SIDS
Initial
Assessment
Profile
and
the
Full
SIDS
Dossier
or
the
finalised
data
in
the
HEDSET.
In
addition,
Sponsor
countries
are
expected
to
make
test
reports
supporting
these
data
publicly
available,
wherever
possible.

The
Secretariat
transfers
the
submitted
SIAR
and
other
information
to
IRPTC
for
inclusion
in
their
database
and
publication
as
a
contribution
to
the
International
Programme
on
the
Sound
Management
of
Chemicals
(
IOMC).
These
are
also
made
available
on
Internet.
In
this
way,
all
information
resulting
from
the
OECD
SIDS
Programme
will
be
available
world­
wide.

Post­
SIDS
Activities
Where
a
chemical
has
been
reviewed
at
the
SIAM
and
it
has
been
recommended
that
further
information
is
required
to
assess
identified
concerns,
any
follow­
up
testing
or
information
gathering
is
regarded
as
post­
SIDS
work.
The
SIAM
will
give
an
indication
of
what
data
need
to
be
collected,
generated
and/
or
analysed,
and
the
priority
relative
to
other
chemicals
for
which
post­
SIDS
work
is
envisaged.

Although
a
Member
country
will
monitor
progress
and
oversee
development
of
this
additional
work,
the
overall
responsibility
for
initiating
and
undertaking
any
work
rests
with
industry.
Industry
has
the
most
knowledge
about
their
chemicals,
and
is
in
the
best
position
to
negotiate
ways
and
means
of
sharing
the
burden
of
the
administrative
and
operational
costs
involved.

The
Member
country,
in
collaboration
with
industry,
supervises
the
work
in
order
to
promote
the
establishment
by
producer
and
user
industries
of
"
consortia"
to
undertake
the
work,
to
monitor
that
any
necessary
testing
is
conducted
appropriately
under
the
suggested
schedule,
and
to
circulate
the
final
report
of
the
work
to
SIDS
Contact
Points.
Non­
Member
countries
are
encouraged
to
participate
in
the
programme
and
share
the
burden.

When
all
the
additional
information
has
been
collected
or
generated
and
analysed,
the
chemical
will
be
discussed
at
a
Post­
SIDS
Assessment
Meeting,
which
will
have
a
similar
format
and
participation
as
the
SIAM.
The
results
of
post­
SIDS
work
and/
or
a
revised
SIAR
will
be
provided
to
IRPTC
and
IPCS
and
be
publicly
available.

Some
chemicals
for
which
SIAM
draws
the
conclusion
that
the
initial
assessment
has
shown
them
to
pose
a
potential
risk
to
man
and/
or
the
environment
may
not
require
any
further
work
in
the
SIDS
context
and
might
be
considered
candidates
for
follow­
up
in
IPCS,
in
order
to
build
on
the
information
provided
in
the
SIAR
and
to
make
it
more
useful
in
a
global
context.

Some
chemicals
of
concern
may
be
considered
by
SIAM
to
have
a
limited
potential
for
exposure
and/
or
to
be
adequately
managed
in
OECD
countries.
Recommendations
might
be
made
to
the
effect
that
BIAC
will
continue
to
monitor
risk
management
activities
by
industry
for
these
chemicals.

Certain
chemicals
of
concern
might
be
considered
by
SIAM
to
require
risk
management
action,
either
nationally
or
internationally.
Further
consideration
of
proposed
risk
management
actions
will
be
discussed
at
the
Advisory
Group
on
Risk
Management,
another
sub­
group
of
the
Joint
Meeting.

Overview
of
the
SIDS
process
including
Post­
SIDS
work
A
synopsis
of
the
stages
involved
in
the
OECD
work
on
SIDS
is
presented
below
(
also
see
the
flowchart
in
Annex
to
this
Chapter):

1)
development
and
maintenance
of
an
OECD
List
of
HPV
chemicals;
EXCH\
MANUAL\
97­
1.
DOC/
July
1997
8
2)
selection
of
chemicals
from
the
List
by
Sponsor
countries;
3)
collection
of
data;
4)
review
of
the
quality
of
data,
preparation
of
SIDS
Dossiers
and
SIDS
Testing
Plans;
5)
circulation
of
the
information
on
SIDS­
testing/
no
testing
to
all
SIDS
Contact
Points;
6)
agreement
on
SIDS
Testing
Plans
through
the
SIDS
Review
(
by
written
procedure);
7)
SIDS
Testing
and/
or
collection
of
information,
as
appropriate;
8)
preparation
of
a
SIDS
Initial
Assessment
Report
by
the
Sponsor
country
with
conclusions
on
potential
risk
and
recommendations
on
further
work
to
be
undertaken;
9)
co­
operative
initial
assessment
and
agreement
on
conclusions
and
recommendations
at
the
SIAM
and
confirmation
at
the
Steering
Group
on
Existing
Chemicals
and
the
Joint
Meeting;
10)
if
necessary,
further
testing
and/
or
data
analysis
(
post­
SIDS
work)
and
post­
SIDS
assessment;
recommendation
as
candidate
for
development
of
an
IPCS
document;
or
recommendation
as
a
candidate
for
national
or
international
risk
management
activities.

Co­
operation
with
International
Organisations
In
the
SIDS
programme,
it
has
been
demonstrated
that
Member
countries
can
successfully
co­
operate
in
gathering
data,
testing
and
assessing
existing
chemicals.
It
should
be
noted
that
in
January
1991,
after
consideration
by
Environment
Ministers
of
the
results
from
the
first
phase
of
SIDS
work,
Member
countries
made
a
formal
commitment,
in
the
form
of
the
OECD
Council
Act
on
Co­
operative
Investigation
and
Risk
Reduction
of
Existing
Chemicals
[
C(
90)
163(
Final)],
that
they
would
co­
operate
in
the
systematic
investigation
and
assessment
of
existing
chemicals.
In
this
Council
Act,
particular
attention
is
paid
to
co­
operation
with
international
organisations.

In
the
Council
Act,
it
was
decided
that
Member
countries
shall
make
information
obtained
from
the
co­
operative
investigation
of
existing
chemicals
publicly
available
via
IRPTC,
while
respecting
legitimate
claims
for
protection
of
confidential
data.
IRPTC
has
agreed
that
it
will
not
only
work
as
an
archive
for
the
data
collected
or
generated
in
the
SIDS
project,
but
also
disseminate
data
through
its
databases.
Therefore,
SIDS
Initial
Assessment
Reports
and
all
information
summarised
in
the
SIDS
dossiers
or
in
the
HEDSET
are
transmitted
to
IRPTC
and
entered
in
the
IRPTC
database.
Responding
to
the
request
made
by
UNCED
in
Agenda
21
to
expand
and
accelerate
the
international
assessment
of
chemical
risks,
IRPTC
is
now
issuing
a
new
series
of
documents
including
the
OECD
initial
assessments
of
HPV
chemicals,
both
is
paper
form
and
on
Internet.
It
is
anticipated
that
in
the
near
future
the
data
collected
on
HEDSET
and
the
assessment
report
itself
will
be
able
to
be
transferred
directly
through
electronic
means
to
IRPTC,
and
from
IRPTC
to
users
throughout
the
world.

IPCS
was
invited,
through
the
Council
Act,
to
use
the
results
of
the
investigations
of
existing
chemicals
by
OECD
Member
countries
in
preparing
its
assessments
of
the
health
and
environmental
impacts
of
existing
chemicals.
Information
collected
will
be
used
in
the
preparation
of
Environmental
Health
Criteria
or
other
documents
by
the
IPCS
on
specific
chemicals
of
concern.
(
not
modified)

References
·
OECD
Council
Decision
on
the
Mutual
Acceptance
of
Data
in
the
Assessment
of
Chemicals
[
C(
81)
30(
Final)],
May
1981.

·
OECD
Council
Decision
on
the
Systematic
Investigation
of
Existing
Chemicals
[
C(
87)
90(
Final)],
July
1987.

·
OECD
Council
Decision­
Recommendation
on
the
Co­
operative
Investigation
and
Risk
Reduction
of
Existing
Chemicals
[
C(
90)
163(
Final)],
January
1991
(
see
Annex
1
to
this
manual).

·
Council
Regulation
(
EEC)
No.
793/
93
on
the
Evaluation
and
Control
of
the
Risks
of
Existing
Substances,
European
Communities,
23
March
1993
The
following
articles
will
be
of
interest:
EXCH\
MANUAL\
97­
1.
DOC/
July
1997
9
·
Brydon,
James
E.,
Morgenroth
III,
Victor
H.,
Smith,
Alan
M.
and
Visser,
Rob
(
1990);
OECD's
Work
on
Investigation
of
High
Production
Volume
Chemicals,
International
Environment
Reporter,
June
1990,
263­
270.

·
Smith,
Alan
M.,
Arai,
Shin­
ichi,
Tanaka,
Katsutoshi
and
Visser,
Rob
(
1993);
Review
of
the
SIDS
Project
of
the
OECD
Existing
Chemicals
Programme,
International
Environment
Reporter,
November
3,
1993.

·
Turnheim,
Dian
(
1994);
Evaluating
Chemical
Risks,
OECD
Observer,
189,
August/
September
1994,
12­
15.
Sponsor
Country
OECD
Testing
Plan
not
agreed
Testing
Plan
agreed
No
testing
Conclusions
and
Recommendations,
(
for
example)
­
requiring
further
information
to
assess
identified
concerns
­
low
potential
risk;
low
priority
for
further
work
Joint
Meeting
­
potential
risk
identified,
but
adequately
controlled;
low
priority
for
further
action
IRPTC
IPCS
(
data
storage
(
Preparation
of
­
potential
risk
identified;
priority
for
further
action,
publication)
EHC,
as
appropriate
ICSC,
etc.
as
appropriate)
IOMC
SIDS
Work
Post
SIDS
Work
Conclusions
and
Recommendations
Joint
Meeting
IRPTC
IPCS
IOMC
Selection
of
chemicals
for
sponsorship
from
HPV
chemicals
list
Collection
of
data
Review
of
the
quality
of
data,
preparation
of
SIDS
Dossiers
and
SIDS
Testing
Plans
SIDS
Testing
and/
or
collection
of
information
Preparation
of
SIDS
Initial
Assessment
Report
with
Conclusions
and
Recommendations
(
Full
SIDS
Chemical)
SIDS
Review
SIDS
initial
assessment
and
agreement
on
conclusions
and
recommendations
for
Full
SIDS
Chemical
at
SIDS
Initial
Assessment
Meeting
(
SIAM)

Identification
of
Post
SIDS
Work
by
SIAM
Further
Testing,
Data
Analysis
Assessment
at
Post
SIDS
Assessment
Meeting
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
1
2.
SIDS
AND
DATA
COLLECTION*

2.1
Introduction
This
chapter
describes
the
Screening
Information
Data
Set
(
SIDS),
including
characterisation
and
effects
data,
as
well
as
exposure
information,
to
be
collected
and
collated
into
a
SIDS
Dossier
by
a
Sponsor
country.
It
describes
the
various
means
which
have
been
developed
to
assure
harmonized
presentation
of
the
SIDS
for
use
in
OECD
Existing
Chemicals
activities.

For
a
Sponsor
country,
collection
of
SIDS
data
from
industry
and
other
Member
countries
is
a
very
important
procedure
for
drawing
up
both
a
SIDS
Dossier
and
a
SIDS
Testing
Plan
for
an
assigned
chemical.
Input
of
the
data
collected
for
SIDS
(
see
Section
2.2)
can
be
done
using
the
HEDSET
diskette,
a
hard
copy
of
"
Revised
OECD
HPV
Form
1"
or
a
diskette
equivalent
in
Word
6.0,
all
of
which
can
be
obtained
through
SIDS
Contact
Points
or
the
OECD
Secretariat.
Although
the
choice
depends
upon
the
preference
of
the
data
submitter,
use
of
the
HEDSET
diskette
is
strongly
encouraged.

The
Harmonized
Electronic
Data
SET
(
HEDSET),
which
has
been
developed
in
co­
operation
with
the
European
Commission,
has
become
available,
together
with
its
manual
and
an
explanatory
note,
as
a
device
for
data
collection
in
the
OECD
SIDS
procedure.
By
using
IUCLID
software
developed
by
the
European
Commission,
data
in
a
HEDSET
diskette
can
be
transferred
to
a
database
easily.
In
addition,
data
will
be
able
to
be
transferred
to
IRPTC
without
manual
inputting
by
means
of
a
conversion
program.
The
HEDSET
diskette
and
requirements
for
its
use
are
described
in
Section
2.3.

To
date,
a
paper
form
called
"
OECD
HPV
Form
1",
which
was
agreed
and
distributed
in
1990,
has
been
used
widely
by
Member
countries.
This
form
was
slightly
modified
in
1993,
taking
into
account
the
format
of
HEDSET.
The
revised
form,
presented
in
Section
2.4,
can
be
used
instead
of
HEDSET
if
necessary.
However,
it
should
be
noted
that
it
is
quite
time­
consuming
to
draw
up
a
report
from
information
obtained
from
various
sources
using
the
paper
form.
Furthermore,
inputting
the
data
on
the
form
to
computer
files
will
be
necessary
in
the
end
in
order
to
make
the
data
available
to
the
public
through
IRPTC.
Although
it
might
be
slightly
easier
to
edit
data
by
using
a
PC
file
of
Revised
OECD
HPV
Form
1,
it
is
recommended
to
collect
information
using
HEDSET
if
possible.

In
Section
2.5,
guidance
for
collection
and
transmission
of
exposure
information
is
described.

*
The
documents
in
this
chapter
were
prepared
by
the
OECD
Secretariat
based
on
the
agreements
reached
in
the
OECD
Existing
Chemicals
Programme
up
to
June
1997.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
2
2.2
Content
of
the
Screening
Information
Data
Set
(
SIDS)
**

The
following
lists
the
content
of
the
Screening
Information
Data
Set
(
SIDS).
In
preparing
the
SIDS,
the
"
Guidance
for
Meeting
the
SIDS
Requirements"
(
see
Section
3.4)
and
a
Model
SIDS
Dossier
(
see
Annex
5
to
this
manual)
will
help
data
submitters
and
SIDS
Contact
Points
understand
what
kind
of
data
are
required
and
how
the
data
are
to
be
described
in
HEDSET
or
the
Revised
OECD
HPV
Form
1.

Basic
Information
The
following
data
elements
on
characterisation,
exposure
and
effects
are
basically
required
for
preparing
the
SIDS
Dossier.
The
items
marked
with
a
dagger
(*)
are
specifically
required
for
inorganic
chemicals.
Oxidation­
reduction
potential
should
also
be
required
for
organic
chemicals
when
deemed
necessary.

1.
General
Information
·
Substance
Information
·
CAS
Number
·
Name
(
OECD
name)
·
CAS
Descriptor
*
·
Structural
Formula
·
Quantity
(
production
ranges
expressed
as
tonnes
per
year)
·
Use
Pattern
(
categories
and
types
of
use,
see
also
next
page)
·
Sources
of
Exposure
(
exposure
information,
see
also
next
page)

2.
Physical­
chemical
Data
·
Melting
Point
·
Boiling
Point
·
Relative
Density
*
·
Vapour
Pressure
·
Partition
Co­
efficient:
n­
Octanol/
Water
·
Water
Solubility
·
Dissociation
Constant
·
Oxidation­
reduction
Potential
*

3.
Environmental
Fate
and
Pathways
·
Photodegradation
(
by
estimation)
·
Stability
in
Water
(
by
estimation)
·
Monitoring
Data
(
environmental)
·
Transport
and
Distribution
between
Environmental
Compartments
including
Estimated
Environmental
Concentrations
and
Distribution
Pathways
[
by
estimation,
including
Henry's
Law
constant
as
calculated
from
data
under
heading
2,
aerosolisation,
volatilisation,
soil
adsorption
and
desorption
calculated
using
Structure
Activity
Relationships
(
SARs)]
·
Aerobic
Biodegradability
**
The
content
of
the
SIDS
was
agreed
at
the
13th
Joint
Meeting
of
the
Chemicals
Group
and
Management
Committee
of
the
Special
Programme
on
the
Control
of
Chemicals
(
November
1989).
The
procedures
for
collecting
and
transmitting
exposure
information
were
agreed
at
the
Meeting
of
the
Steering
Group
on
Existing
Chemicals
and
confirmed
at
the
25th
Joint
Meeting
(
November
1996).
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
3
4.
Ecotoxicity
·
Acute
Toxicity
to
Fish
·
Acute
Toxicity
to
Daphnia
(
If
there
is
concern
for
possible
long­
term
effects,
prolonged/
chronic
toxicity
testing
should
be
considered
in
addition
to
acute
tests.)
·
Toxicity
to
Algae
·
If
significant
exposure
is
expected
in
the
terrestrial
environmental
compartment,
efforts
should
be
made
to
perform
appropriate
terrestrial
toxicity
tests.
In
addition,
when
aquatic
toxicity
testing
is
not
possible
(
e.
g.
insolubility
of
the
test
chemicals),
efforts
should
also
be
made
to
perform
terrestrial
toxicity
tests.

5.
Toxicological
Data
·
Acute
Toxicity
·
Repeated
Dose
Toxicity
·
Genetic
Toxicity
(
two
end
points,
generally
point
mutation
and
chromosomal
aberrations)
·
Reproduction
Toxicity
(
including
fertility
and
developmental
toxicity)
·
Experience
with
Human
Exposure
(
if
available)

It
has
also
been
agreed
that
some
data
in
SIDS
are
not
required
for
chemicals
with
limited
exposure,
such
as
intermediates
(
see
Section
3.6).

Exposure
Information
It
was
agreed
in
May
1993
that
certain
elements
of
exposure
information
be
part
of
the
SIDS.
Such
elements
included
those
which
were
essential
to
allow
effective
application
of
even
simple
models
and
methods.
However,
despite
the
decision
to
encourage
collection
of
exposure
information,
difficulties
arose
in
actual
data
collection.
Therefore,
a
Task
Force
under
the
Steering
Group
on
Existing
Chemicals
met
in
June
1995
and
made
recommendations
for
effective
and
efficient
procedures
for
collection
and
transmission
of
exposure
information,
as
well
as
on
exposure
data
elements
to
be
gathered
for
the
SIDS
Initial
Assessment.

Taking
into
account
the
experiences
gained
in
a
pilot
study
based
on
the
recommendations,
another
approach
was
proposed
and
discussed
at
the
4th
SIDS
Initial
Assessment
Meeting
held
in
Tokyo
in
May
1996.
Finally,
the
Steering
Group
agreed
at
its
meeting
in
November
1996
on
the
following
procedures
for
collecting
and
transmitting
exposure
information,
which
were
subsequently
confirmed
at
the
25th
Joint
Meeting
in
November
1996:

First
Step
(
Beginning
with
Phase
5
chemicals)

(
a)
The
Secretariat
informs
Member
countries
which
chemicals
are
being
sponsored
and
requests
them
to
collect
exposure
information
on
these
chemicals,
i.
e.
at
the
information
gathering
stage.
(
Beginning
with
Phase
6,
information
giving
the
rationale
for
the
selection
of
each
chemical
is
provided
for
Member
countries
to
easily
focus
on
specific
exposure
situations.)

(
b)
Member
countries
gather
easily­
available
exposure
information
on
the
elements
in
the
following
list
on
all
the
chemicals
at
this
stage
and
forward
it
to
the
relevant
Sponsor
countries
within
6
months.

·
Produced,
imported
or
used?
·
Quantity
(
production,
import
and/
or
export
volume)
·
General
information
on
use
pattern
·
MAK
or
equivalent
occupational
standards
·
Information
on
classification
and
labelling
·
National
regulatory
standards
or
other
measures
for
management
of
exposure
·
Other
information
(
e.
g.
results
of
workplace
monitoring,
other
information
on
occupational
exposure,
information
on
release
to
the
environment,
results
of
environmental
monitoring,
information
on
consumer
exposure,
safe
handling
procedures,
etc.)

(
c)
Sponsor
countries
gather
more
detailed
national
exposure
information
on
their
own
sponsored
chemicals.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
4
Second
step
(
Beginning
with
specific
chemicals
identified
at
SIAM4)

·
More
detailed
information
will
be
gathered
later
by
Member
countries
for
specific
chemicals,
especially
those
for
which
a
potential
hazard
has
been
identified
at
a
SIAM.

Guidance
for
collection
and
transmission
of
exposure
information
is
given
in
Section
2.5.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
5
2.3
Outline
of
the
Harmonized
Electronic
Data
SET
(
HEDSET)

HEDSET
(
Harmonized
Electronic
Data
SET)

HEDSET
is
a
data
entry
system
compiled
on
diskette
with
supporting
programmes.
It
has
been
developed
in
order
to
accommodate
data
on
a
chemical
and
allow
their
transfer
to
a
data
export
file
on
diskette,
which
can
then
be
circulated
as
necessary.
It
is
written
in
CLIPPER
software
and
can
be
run
on
any
type
of
IBM
compatible
PC
with
a
minimum
of
640
KB
memory
and
MS­
DOS
version
3.3
or
higher.
It
is
used
after
installing
on
a
hard
disk
(
with
minimum
of
10
MB
free
disk
space).
Further
details
are
given
in
a
manual.
It
should
be
noted
that
HEDSET
does
not
itself
have
database
or
word
processor
functions.
These
functions
are
available
through
IUCLID
software.

The
HEDSET
comprises
the
following
data
items,
which
were
identified
and
agreed
to
be
necessary
for
the
initial
assessment
of
a
chemical:

·
general
information
on
a
chemical;
·
information
on
producer,
importer,
etc.;
·
physical­
chemical
properties;
·
information
on
environmental
fate
and
exposure;
·
ecotoxicological
properties;
and
·
toxicological
properties.

The
data
elements
in
HEDSET
are
essentially
the
same
as
those
in
the
Revised
OECD
HPV
Form
1,
but
with
some
differences
in
the
numbering
system.

For
the
purpose
of
promoting
user
friendliness,
HEDSET
has
many
functions
for
inputting
data
by
means
of
a
glossary,
multi­
entry
facilities,
free
text
data
fields,
and
CAS
and
EINECS
number
checking
programmes.
Although
HEDSET
will
be
available
in
nine
EU
official
languages,
only
the
English
version
should
be
used
for
the
OECD
work
on
HPV
chemicals.

Print
files,
made
by
using
the
printing
function,
are
ASCII
files.
They
can
be
printed
out
directly
or
can
be
edited
using
any
word
processing
software.

Although
data
inputted
on
the
hard
disk
of
a
PC
will
automatically
be
converted
to
CLIPPER
format,
the
data
export
programme
makes
ASCII
files
for
transfer
to
diskette.
These
export
files
can
be
read
and
incorporated
into
another
PC
using
the
import
programme.

Because
HEDSET
does
not
have
database
functions,
users
cannot
electronically
compare
the
data
(
on
two
or
more
chemicals).
They
may
wish
to
obtain
the
IUCLID
software
for
this
purpose.

It
should
be
noted
that,
for
copyright
reasons,
modification
of
the
HEDSET
diskette
is
prohibited
without
the
prior
permission
of
the
European
Commission.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
6
Data
Collection
Process
It
is
recommended
that
the
following
be
used
to
collect
information
on
HPV
chemicals
for
Phase
4
onwards,
in
place
of
the
Revised
OECD
HPV
Form
1:

·
a
PC
with
HEDSET
installed;
·
the
explanatory
note
for
HEDSET;
·
the
manual
for
HEDSET;
and
·
an
export
file
on
diskette
for
circulation
(
only
one
chemical
per
diskette).

The
diskette
and
supporting
documents
will
be
distributed
to
data
submitters,
(
i.
e.
manufacturers
or
importers
of
chemicals)
through
the
National
SIDS
Contact
Points.
Data
submitters
will
input
the
data
and
send
export
files
on
diskettes
to
the
National
SIDS
Contact
Points
for
onward
circulation
to
Member
countries
and
the
OECD
Secretariat.

The
information
in
these
files
will
be
used
nationally
for
review
and/
or
the
initial
assessment
of
the
sponsored
HPV
chemicals,
and
also
at
SIDS
review
procedure
and
SIDS
initial
assessment
meetings.
In
addition,
the
data
collected
will
be
made
available
to
IRPTC
for
wider
dissemination.
Work
is
under
way
on
a
conversion
programme
to
allow
automatic
input
of
HEDSET
export
file
data
into
the
IRPTC
database.

IUCLID
(
International
Unified
ChemicaL
Information
Database)

IUCLID
is
a
database
software
which
has
been
developed
by
the
European
Commission
in
order
to
deal
specifically
with
data
collected
using
the
HEDSET
system.

IUCLID
is
capable
to
run
on
different
hardware
platforms
and
operating
systems.
The
following
operating
systems
are
supported:
IBM­
AIX
(
Unix),
SCO­
UNIX,
VMS,
DEC­
UNIX,
SUN
SOLARIS
and
MS­
DOS.
A
corresponding
version
of
the
ORACLE
database
management
software
is
required.
To
operate
IUCLID
on
a
PC
with
MS­
DOS
a
disk
space
of
100
Mbytes
and
a
main
memory
of
16
Mbytes
is
required.
A
PC
with
a
PENTIUM
processor
is
recommended.

IUCLID
can
import
and
compile
data
from
export
files
made
under
HEDSET.
Database
functions
such
as
data
search,
data
sorting,
etc.,
as
well
as
printing
functions,
are
included.
ASCII
files
for
exporting
data
can
also
be
prepared,
which
could
be
used
for
circulation
instead
of
HEDSET
diskette.

The
IUCLID
database
software
and
an
explanatory
manual
is
available
from
the
European
Commission.
Recently,
a
CD­
ROM
for
Windows
which
includes
non­
confidential
data
concerning
HPV
chemicals
in
the
EU
(
i.
e.
chemicals
in
Annex
I
of
Regulation
(
EEC)
793/
93)
has
been
made
available
as
a
low­
cost
version
of
the
IUCLID
database.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
7
2.4
Guidance
for
the
Responder
to
the
OECD
Request
for
Available
Data
on
High
Production
Volume
(
HPV)
Chemicals:
"
Revised
OECD
HPV
Form
1"

1.
The
attached
blank
form,
Revised
OECD
HPV
Form
1,
is
for
the
provision
of
available
information
on
HPV
chemicals:
i.
e.
a
Screening
Information
Data
Set
(
SIDS)
in
the
form
of
a
"
SIDS
Dossier".
This
original
HPV
Form
1
was
agreed
and
distributed
in
1990,
then
revised
in
order
to
achieve
full
compatibility
with
HEDSET
in
1993.
This
"
Revised
OECD
HPV
Form
1",
now
fully
compatible
with
HEDSET,
is
available
both
in
paper
form
and
on
a
diskette
written
in
Word
6.0
from
the
National
SIDS
Contact
Points
or
the
OECD
Secretariat.

2.
Revised
OECD
HPV
Form
1,
used
for
preparing
the
SIDS
Dossier,
includes
the
SIDS
Profile
and
SIDS
Summary.
These
should
be
filled
in
after
data
entry.

3.
The
information
presented
should
be
sufficiently
reported
and
referenced
with
respect
to
the
substance
tested,
methods
used,
endpoints
examined
and
results
obtained
so
as
to
allow
reviewers
to
make
an
informed
judgement
of
the
quality
and
suitability
of
the
data.

4.
In
general,
the
support
data
and
reports
will
not
be
kept
confidential.
[
See
also
OECD
Council
Act
C(
83)
98(
Final)
and
its
OECD
List
of
Non­
Confidential
Data
on
Chemicals.]
In
exceptional
cases,
where
data
are
indicated
to
be
confidential,
they
will
be
made
available
for
review
on
a
confidential
basis
by
specific
experts
in
each
Member
country
that
receives
the
data.
That
is,
in
these
cases
the
OECD
Council
Act
concerning
Exchange
of
Confidential
Data
on
Chemicals
[
C(
83)
97(
Final)]
applies.

5.
When
a
standard
test
method
(
e.
g.
OECD,
ISO,
DIN,
EPA)
has
been
used,
it
should
be
identified
but
it
is
not
necessary
to
repeat
details
in
the
text.
When
a
non­
standard
method
has
been
used,
details
of
the
method,
equivalent
to
those
in
an
OECD
Test
Guideline,
should
be
provided
when
possible.

6.
When
the
test
method
allows
the
use
of
alternatives
for
certain
test
parameters
(
e.
g.
species),
the
alternatives
chosen
should
be
indicated.
In
the
case
of
aquatic
toxicity
tests,
it
is
important
to
indicate
whether
nominal
or
measured
concentrations
were
used.

7.
If
more
than
one
set
of
data
is
available
for
a
given
item,
each
set
should
be
submitted.
The
preferred
results
should
be
identified
as
"
preferred
results"
and
should
come
first
in
the
set
of
data
of
the
item
after
the
data
evaluation
is
over.

8.
Under
the
entry
for
"
Test
substance",
where
possible
the
purity,
percentages
of
known
impurities,
and
details
of
any
vehicle
used
should
be
given.

9.
When
submitting
the
test
results
for
any
individual
data
element,
the
format
should,
where
possible,
be
based
on
the
corresponding
Test
Report
section
described
in
the
relevant
OECD
Test
Guideline.

10.
Calculated
values
must
be
identified
and
the
calculation
method
should
be
cited.

11.
Under
the
section
"
References",
the
source
of
information
used
to
respond
to
the
request
should
be
identified.
In
general,
information
should
be
taken
from
primary
sources
and
quoting
from
secondary
references
such
as
a
book
or
a
review
article
should
be
avoided.
Indicate
the
title
of
the
article;
journal
where
study
appears;
volume;
page
numbers;
and
date
of
report
or
publication.
Where
appropriate,
indicate
"
unpublished
report",
its
authors
and
their
affiliation.
Lesser
details
can
be
cross­
referenced
within
the
appropriate
individual
data
element.

12.
Where
data
for
the
sponsored
chemical
are
not
available,
the
responders
are
encouraged
to
submit
existing
data
on
related
compounds
such
as:

·
isomers
which
have
similar
structure
activity
profiles;
·
closely
related
homologues;
·
relevant
precursors
and
breakdown
products,
along
with
information
on
metabolism
and
degradation.

13.
Data
elements
marked
with
an
asterisk
(*)
correspond
to
those
in
the
Screening
Information
Data
Set
(
SIDS),
and
those
marked
with
a
dagger
(*)
are
specifically
requested
for
inorganic
chemicals.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
8
14.
In
order
to
facilitate
filling
in
this
form
in
an
appropriate
fashion,
a
Model
Dossier
has
been
prepared
and
is
set
out
in
Annex
2
to
this
Manual.
Explanations
related
to
data
requested
in
this
form
can
also
be
found
in
the
HEDSET
Explanatory
Note
available
from
the
European
Commission.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
9
REVISED
OECD
HPV
FORM
1
SIDS
DOSSIER
ON
THE
HPV
PHASE
.
.
.
.
.
.
CHEMICAL
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.

CAS
No.
.
.
.
.
­
.
.
­
.

Sponsor
Country
:
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.

DATE:
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
10
CONTENTS
Page
SIDS
PROFILE
SIDS
SUMMARY
1.
GENERAL
INFORMATION
1.01
SUBSTANCE
INFORMATION
*
A.
CAS­
NUMBER
B.
NAME
(
IUPAC­
NAME)
*
C.
NAME
(
OECD
NAME)
*
D.
CAS
DESCRIPTOR
E.
EINECS­
NUMBER
F.
MOLECULAR
FORMULA
*
G.
STRUCTURAL
FORMULA
H.
SUBSTANCE
GROUP
I.
SUBSTANCE
REMARK
J.
MOLECULAR
WEIGHT
1.02
OECD
INFORMATION
A.
SPONSOR
COUNTRY
B.
LEAD
ORGANISATION
C.
NAME
OF
RESPONDER
(
COMPANY)
1.1
GENERAL
SUBSTANCE
INFORMATION
A.
TYPE
OF
SUBSTANCE
B.
PHYSICAL
STATE
C.
PURITY
1.2
SYNONYMS
1.3
IMPURITIES
1.4
ADDITIVES
1.5
*
QUANTITY
1.6
LABELLING
AND
CLASSIFICATION
(
USE
AND/
OR
TRANSPORTATION)
1.7
*
USE
PATTERN
A.
GENERAL
USE
PATTERN
B.
USES
IN
CONSUMER
PRODUCTS
1.8
OCCUPATIONAL
EXPOSURE
LIMIT
VALUE
1.9
*
SOURCES
OF
EXPOSURE
1.10
ADDITIONAL
REMARKS
A.
OPTIONS
OF
DISPOSAL
B.
OTHER
REMARKS.

2.
PHYSICAL­
CHEMICAL
DATA
2.1
*
MELTING
POINT
2.2
*
BOILING
POINT
2.3
*
DENSITY
(
RELATIVE
DENSITY)
2.4
*
VAPOUR
PRESSURE
2.5
*
PARTITION
COEFFICIENT
n­
OCTANOL/
WATER
2.6
*
WATER
SOLUBILITY
A.
SOLUBILITY
B.
pH
VALUE,
pKa
VALUE
2.7
FLASH
POINT
(
LIQUIDS)
2.8
AUTO
FLAMMABILITY
(
SOLID/
GASES)
2.9
FLAMMABILITY
2.10
EXPLOSIVE
PROPERTIES
2.11
OXIDISING
PROPERTIES
2.12
*
OXIDATION:
REDUCTION
POTENTIAL
2.13
ADDITIONAL
REMARKS
A.
PARTITION
CO­
EFFICIENT
BETWEEN
SOIL/
SEDIMENT
AND
WATER
(
Kd)
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
11
B.
OTHER
REMARKS
3.
ENVIRONMENTAL
FATE
AND
PATHWAYS
3.1
STABILITY
3.1.1
*
PHOTODEGRADATION
3.1.2
*
STABILITY
IN
WATER
3.1.3
STABILITY
IN
SOIL
3.2
*
MONITORING
DATA
(
ENVIRONMENT)
3.3
*
TRANSPORT
AND
DISTRIBUTION
BETWEEN
ENVIRONMENTAL
COMPARTMENTS
INCLUDING
ESTIMATED
ENVIRONMENTAL
CONCENTRATIONS
AND
DISTRIBUTION
PATHWAYS
3.3.1
TRANSPORT
3.3.2
THEORETICAL
DISTRIBUTION
(
FUGACITY
CALCULATION)
3.4
MODE
OF
DEGRADATION
IN
ACTUAL
USE
3.5
*
BIODEGRADATION
3.6
BOD­
5,
COD
OR
RATIO
BOD­
5/
COD
3.7
BIOACCUMULATION
3.8
ADDITIONAL
REMARKS
A.
SEWAGE
TREATMENT
B.
OTHER
4.
ECOTOXICITY
4.1
*
ACUTE/
PROLONGED
TOXICITY
TO
FISH
4.2
ACUTE
TOXICITY
TO
AQUATIC
INVERTEBRATES
*
A.
DAPHNIA
B.
OTHER
AQUATIC
ORGANISMS
4.3
*
TOXICITY
TO
AQUATIC
PLANTS
e.
g.,
ALGAE
4.4
TOXICITY
TO
BACTERIA
4.5
CHRONIC
TOXICITY
TO
AQUATIC
ORGANISMS
4.5.1
CHRONIC
TOXICITY
TO
FISH
4.5.2
(*)
CHRONIC
TOXICITY
TO
AQUATIC
INVERTEBRATES
(
e.
g.,
DAPHNIA
REPRODUCTION)
4.6
TOXICITY
TO
TERRESTRIAL
ORGANISMS
4.6.1
TOXICITY
TO
SOIL
DWELLING
ORGANISMS
4.6.2
TOXICITY
TO
TERRESTRIAL
PLANTS
4.6.3
TOXICITY
TO
OTHER
NON­
MAMMALIAN
TERRESTRIAL
SPECIES
(
INCLUDING
BIRDS)
4.7
BIOLOGICAL
EFFECTS
MONITORING
(
INCLUDING
BIOMAGNIFICATION)
4.8
BIOTRANSFORMATION
AND
KINETICS
4.9
ADDITIONAL
REMARKS
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
12
5.
TOXICITY
5.1
*
ACUTE
TOXICITY
5.1.1
ACUTE
ORAL
TOXICITY
5.1.2
ACUTE
INHALATION
TOXICITY
5.1.3
ACUTE
DERMAL
TOXICITY
5.1.4
ACUTE
TOXICITY
BY
OTHER
ROUTES
OF
ADMINISTRATION
5.2
CORROSIVENESS/
IRRITATION
5.2.1
SKIN
IRRITATION/
CORROSION
5.2.2
EYE
IRRITATION/
CORROSION
5.3
SKIN
SENSITISATION
5.4
*
REPEATED
DOSE
TOXICITY
5.5
*
GENETIC
TOXICITY
IN
VITRO
A.
BACTERIAL
TEST
B.
NON­
BACTERIAL
IN
VITRO
TEST
5.6
*
GENETIC
TOXICITY
IN
VIVO
5.7
CARCINOGENICITY
5.8
*
TOXICITY
TO
REPRODUCTION
5.9
*
DEVELOPMENTAL
TOXICITY
/
TERATOGENICITY
5.10
OTHER
RELEVANT
INFORMATION
A.
SPECIFIC
TOXICITIES
(
NEUROTOXICITY,
IMMUNOTOXICITY
etc.)
B.
TOXICODYNAMICS,
TOXICOKINETICS
5.11
*
EXPERIENCE
WITH
HUMAN
EXPOSURE
6.
REFERENCES
Note:
*;
Data
elements
in
the
SIDS
*;
Data
elements
specially
required
for
inorganic
chemicals
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
13
S
I
D
S
P
R
O
F
I
L
E
DATE:

1.01
A.
CAS
No.

1.01
C.
CHEMICAL
NAME
(
OECD
Name)

1.01
D.
CAS
DESCRIPTOR
1.01
G.
STRUCTURAL
FORMULA
OTHER
CHEMICAL
IDENTITY
INFORMATION
1.5
QUANTITY
1.7
USE
PATTERN
1.9
SOURCES
AND
LEVELS
OF
EXPOSURE
ISSUES
FOR
DISCUSSION
(
IDENTIFY,
IF
ANY)
SIDS
testing
required:
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
14
S
I
D
S
S
U
M
M
A
R
Y
DATE:

CAS
NO:
..................

STUDY
Y/
N
Y/
N
Y/
N
Y/
N
Y/
N
Y/
N
Y/
N
PHYSICAL­
CHEMICAL
DATA
2.1
2.2
2.3
2.4
2.5
2.6
2.12
Melting
Point
Boiling
Point
Density
Vapour
Pressure
Partition
Coefficient
Water
Solubility
pH
and
pKa
values
Oxidation:
Reduction
potential
OTHER
P/
C
STUDIES
RECEIVED
ENVIRONMENTAL
FATE
and
PATHWAY
3.1.1
3.1.2
3.2
3.3
3.5
Photodegradation
Stability
in
water
Monitoring
data
Transport
and
Distribution
Biodegradation
OTHER
ENV
FATE
STUDIES
RECEIVED
ECOTOXICITY
4.1
4.2
4.3
4.5.2
4.6.1
4.6.2
4.6.3
Acute
toxicity
to
Fish
Acute
toxicity
to
Daphnia
Toxicity
to
Algae
Chronic
toxicity
to
Daphnia
Toxicity
to
Soil
dwelling
organisms
Toxicity
to
Terrestrial
plants
Toxicity
to
Birds
OTHER
ECOTOXICITY
STUDIES
RECEIVED
TOXICITY
5.1.1
5.1.2
5.1.3
5.4
5.5
5.6
5.8
5.9
5.11
Acute
Oral
Acute
Inhalation
Acute
Dermal
Repeated
Dose
Genetic
Toxicity
in
vitro
.
Gene
mutation
.
Chromosomal
aberration
Genetic
Toxicity
in
vivo
Reproduction
Toxicity
Development
/
Teratogenicity
Human
experience
OTHER
TOXICITY
STUDIES
RECEIVED
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
15
1.
GENERAL
INFORMATION
1.01
SUBSTANCE
INFORMATION
*
A.
Cast
number
.
.
.
.
.
.
.
.
.
.
.
­
.
.
.
.
.
.
.
.
.
­
.
.
.
.
.
.
.
.

B.
Name
(
IUPAC
name)
.......................................................................................................................................

*
C.
Name
(
OECD
name)
.......................................................................................................................................

*
D.
CAS
Descriptor
(
where
applicable
for
complex
chemicals)

.......................................................................................................................................

E.
EINECS­
Number
.
.
.
.
.
.
.
.
.
.
.
.
­
.
.
.
.
.
.
.
.
.
­
.
.
.
.
.
.
.
.

F.
Molecular
Formula
.......................................................................................................................................

*
G.
Structural
Formula
(
indicate
the
structural
formula
in
smiles
code,
if
available)

.......................................................................................................................................

H.
Substance
Group
(
if
possible,
only
for
petroleum
products,
see
HEDSET
explanatory
note)

.......................................................................................................................................

I.
Substance
Remark
(
Indicate
the
substance
remark
as
prescribed
in
the
EINECS
Inventory,
if
possible)

.......................................................................................................................................

J.
Molecular
Weight
.......................................................................................................................................

1.02
OECD
INFORMATION
A.
Sponsor
Country:
.......................................................................................................................................

B.
Lead
Organisation:

Name
of
Lead
Organisation:
.....................................................................................................................................
Contact
person:..........................................................................................................................................................
Address:
Street:
..........................................................................................................................................................
Postal
code:
.................................................................................................................................................
Town:..........................................................................................................................................................
Country:.......................................................................................................................................................
Tel:..............................................................................................................................................................
Fax:
.............................................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
16
C.
Name
of
responder
(
Information
on
a
responder
should
be
provided
when
companies
respond
to
Lead
Organisation
or
SIDS
Contact
Points.)

Name:........................................................................................................................................................................
Address:
....................................................................................................................................................................
Street:
..........................................................................................................................................................
Postal
code:
................................................................................................................................................
Town:..........................................................................................................................................................
Country:.......................................................................................................................................................
Tel:..............................................................................................................................................................
Fax:
.............................................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
17
1.1
GENERAL
SUBSTANCE
INFORMATION
A.
Type
of
Substance
element
[
];
inorganic
[
];
natural
substance
[
];
organic
[
];
organometallic
[
];
petroleum
product
[
]

B.
Physical
State
(
at
20
°
C
and
1.013
hPa)

gaseous
[
];
liquid
[
];
solid
[
]

C.
Purity
(
indicate
the
percentage
by
weight/
weight)....................................................................................................

1.2
SYNONYMS
......................................................................................................................................................
......................................................................................................................................................
......................................................................................................................................................
......................................................................................................................................................
......................................................................................................................................................

1.3
IMPURITIES
[
Indicate
CAS
No.,
chemical
name
(
IUPAC
name
is
preferable),
percentage,
if
possible
EINECS
number.]

CAS
No:
.
.
.
.
.
.
.
.
.
.
.
­
.
.
.
.
.
.
.
.
.
­
.
.
.
.
.
.
.
.
EINECS
No:
.......................................................................................................................................
Name:
.......................................................................................................................................
Value:
.......................................................................................................................................
Remarks:
.......................................................................................................................................

1.4
ADDITIVES
(
e.
g.
stabilising
agents,
inhibitors
etc.
Indicate
CAS
No.,
chemical
name
(
IUPAC
name
is
preferable),
percentage,
if
possible
EINECS
number),
the
component
of
the
UVCB
(
substance
with
no
defined
composition)
should
be
indicated
here.)

CAS
No:
.
.
.
.
.
.
.
.
.
.
.
­
.
.
.
.
.
.
.
.
.
­
.
.
.
.
.
.
.
.
EINECS
No:
.
.
.
.
.
.
.
.
.
.
.
­
.
.
.
.
.
.
.
.
.
­
.
.
.
.
.
.
.
.
Name:
.......................................................................................................................................
Value:
.......................................................................................................................................
Remarks:
.......................................................................................................................................

*
1.5
QUANTITY
[
Information
on
production
or
import
levels
should
be
provided
in
figures
or
ranges
(
e.
g.
1,000­
5,000,
5,000­
10,000
tonnes,
etc.)
per
responder
or
country
and
the
date
for
which
those
ranges
apply
should
be
given.
For
EU
Member
states,
only
indicate
the
EU
import
figure.
Give
an
estimation
of
the
global
production
quantity
in
the
remarks
field.
Information
on
the
number
of
producers
in
the
country
and
the
source
of
information
should
also
be
given
in
the
remarks
field.)

Remarks:
(
If
possible,
indicate
if
the
substance
was
produced
and/
or
imported
during
the
12
months
following
adoption
of
the
EU
regulation
on
existing
chemicals.)
.....................
.......................................................................................................................................
.......................................................................................................................................
Reference:
.......................................................................................................................................
1.6
LABELLING
AND
CLASSIFICATION
[
If
possible,
enter
information
on
labelling
and
classification,
such
as
labelling
and
classification
system,
existence
of
specific
limit,
symbols,
nota,
R­
Phrases
and
S­
Phrases
of
EC
Directive
67/
548/
EEC.
See
HEDSET
Explanatory
Note.]

Labelling
Type:
.......................................................................................................................................
Specific
limits:
.......................................................................................................................................
Symbols:
.......................................................................................................................................
Nota:
.......................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
18
R­
phrases:
.......................................................................................................................................
S­
phrases:
.......................................................................................................................................
Text
of
S­
phrases:
.......................................................................................................................................
Remarks:
.......................................................................................................................................

Classification
Type:
.......................................................................................................................................
Category
of
danger:
.......................................................................................................................................
R­
phrases:
.......................................................................................................................................
Remarks:
.......................................................................................................................................

*
1.7
USE
PATTERN
A.
General
[
Data
on
use
pattern
have
to
be
given
by
assigning
main
types
according
to
their
exposure
relevance
(
i.
e.
non­
dispersive
use,
use
in
closed
systems,
use
resulting
in
inclusion
into
or
onto
matrix
and
wide
dispersive
use),
industrial
categories
(
e.
g.
basic
chemical
industry,
chemical
industry,
agricultural
industry,
personal
and
domestic
use)
and
use
categories
such
as
colouring
agents,
intermediates,
solvents,
adhesives,
cleaning/
washing
agents,
fertilisers,
impregnation
agents,
surface­
active,
etc.
If
available,
give
an
estimation
of
different
uses
in
percentage
terms.]

Type
of
Use:
Category:

(
a)
main
............................................................................................
industrial
............................................................................................
use
............................................................................................

(
b)
main
............................................................................................
industrial
............................................................................................
use
............................................................................................

Remarks:
(
a)
.......................................................................................................................................
.......................................................................................................................................

(
b)
.......................................................................................................................................
.......................................................................................................................................

Reference:
.......................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
19
B.
Uses
in
Consumer
Products
[
If
the
chemical
is
present
in
consumer
products
as
marketed,
give
details
of
products'
function
(
e.
g.
detergent,
etc.),
and
percentage
in
product
and
physical
state
of
product
as
marketed
(
e.
g.
aerosol,
powder
or
liquid)]

Function
Amount
present
Physical
state
...............................
........................................
.....................................

Remarks:
.
.....................................................................................................................................................
Reference:
.
.....................................................................................................................................................

1.8
OCCUPATIONAL
EXPOSURE
LIMIT
VALUE
(
Indicate
the
type
of
occupational
exposure
limit
value
including
short­
term
exposure
limit
value.
If
a
value
does
not
exist,
give
the
hygiene
standard
of
the
producer
company
if
available.
See
also
5.11.)

Exposure
limit
value
Type:
......................................................................................................................................................
Value:
......................................................................................................................................................

Short
term
exposure
limit
value
Value:
......................................................................................................................................................
Length
of
exposure
period:........................................................................................................................................
Frequency:
......................................................................................................................................................
Remarks:
......................................................................................................................................................
Reference:
......................................................................................................................................................

*
1.9
SOURCES
OF
EXPOSURE
Describe
sources
of
potential
human
[
other
than
concentration
of
chemicals
in
the
workplace
and
indoor
environment
(
see
5.11)],
or
environmental
exposure,
including
emission
data
(
e.
g.
quantities
per
media
with
information
such
as
time
dimensions
of
release,
indication
of
type
of
release
(
e.
g.
point
source
or
diffuse),
type
of
estimating
(
e.
g.
average
or
worst
case),
uncertainties
in
estimation),
for
all
phases
of
the
life
cycle
of
the
chemical,
if
available,
including
manufacturing
and
user
areas.

For
environmental
exposure,
indicate
the
production
process
briefly,
number
of
sites
of
manufacture
and,
the
basis
for
concluding
that
the
process
is
"
closed"
if
applicable.

Also
an
indication
of
measured
exposure
levels
(
expressed
in
an
appropriate
form,
e.
g.
geometric
mean
and
standard
deviation)
can
be
mentioned
here.
Any
information
that
will
help
to
focus
the
assessment
of
exposure
(
either
quantitative
or
quantitative
in
nature)
can
be
mentioned,
if
available.)

Source:
Media
of
release:...........................................................................................................................
Quantities
per
media:....................................................................................................................
Remarks:
......................................................................................................................................................
Reference:
......................................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
20
1.10
ADDITIONAL
REMARKS
A.
Options
for
disposal
[
Mode
of
disposal
(
e.
g.
incineration,
release
to
sewage
system,
etc.)
for
each
category
and
type
of
use,
if
appropriate;
recycling
possibility]

Remarks:
......................................................................................................................................................
Reference:
......................................................................................................................................................

B.
Other
remarks
Remarks:
......................................................................................................................................................
Reference:
......................................................................................................................................................

2.
PHYSICAL­
CHEMICAL
DATA
*
2.1
MELTING
POINT
(
If
more
than
one,
identify
the
recommended
value.)

Value:
.
.
.
.
.
.
.
.
.
.
.
°
C
Decomposition:
Yes
[
]
No
[
]
Ambiguous
[
]
Sublimation:
Yes
[
]
No
[
]
Ambiguous
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used)]
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
2.2
BOILING
POINT
(
If
more
than
one,
identify
the
recommended
value.)

Value:
.
.
.
.
.
.
.
.
.
.
.
°
C
Pressure:
at
.
.
.
.
.
.
.
.
.
.
hPa
Decomposition:
Yes
[
]
No
[
]
Ambiguous
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
2.3
DENSITY
(
relative
density)
(
Where
applicable,
indicate
the
relative
density
of
the
substance.)

Type:
Bulk
density
[
];
Density
[
];
Relative
Density
[
]
Value:
.......................................................................................................................................
Temperature:
.
.
.
.
.
.
.
.
.
.
.
°
C
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
2.4
VAPOUR
PRESSURE
(
if
more
than
one,
identify
the
recommended
value)

Value:
.
.
.
.
.
.
.
.
.
.
.
hPa
Temperature:
.
.
.
.
.
.
.
.
.
.
.
°
C
Method:
calculated
[
];
measured
[
]
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used)].
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
21
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
2.5
PARTITION
COEFFICIENT
log10Pow
(
if
more
than
one,
identify
the
recommended
value)

Log
Pow:
.
.
.
.
.
.
.
.
.
.
.
Temperature:
.
.
.
.
.
.
.
.
.
.
.
°
C
Method:
calculated
[
];
measured
[
]
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
.....................
method
used)].
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
2.6
WATER
SOLUBILITY
(
if
more
than
one,
identify
the
recommended
value)

A.
Solubility
Value:
.
.
.
.
.
.
.
.
.
.
.
Temperature:
.
.
.
.
.
.
.
.
.
.
.
°
C
Description:
Miscible
[
];
Of
very
high
solubility
[
];
Of
high
solubility
[
];
Soluble
[
];
Slightly
soluble
[
];
Of
low
solubility
[
];
Of
very
low
solubility
[
];
Not
soluble
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

B.
pH
Value,
pKa
Value
pH
Value:
.
.
.
.
.
.
.
.
.
.
.
Concentration:
.
.
.
.
.
.
.
.
.
.
.
Temperature:
.
.
.
.
.
.
.
.
.
.
.
°
C
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used).
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
(
Where
applicable,
enter
values
for
the
dissociation
constant(
s)
and
the
conditions
under
which
they
were
measured.)
pKa
value
.
.
.
.
.
.
.
.
.
.
.
at
25
°
C
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................
2.7
FLASH
POINT
(
liquids)

Value:
.
.
.
.
.
.
.
.
.
.
.
°
C
Type
of
test:
Closed
cup
[
];
Open
cup
[
];
Other
[
]
Method:
(
with
the
year
of
publication
or
updating
of
the
method
used).
.....................................
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

2.8
AUTO
FLAMMABILITY
(
solid/
gases)

Value:
.
.
.
.
.
.
.
.
.
.
.
°
C
Pressure:
.
.
.
.
.
.
.
.
.
.
.
hPa
Method:
(
with
the
year
of
publication
or
updating
of
the
method
used).
.....................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
22
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

2.9
FLAMMABILITY
Results:
Extremely
flammable
[
];
Extremely
flammable
­
liquified
gas
[
];
Highly
Flammable
[
];
Flammable
[
];
Non
flammable
[
];
Spontaneously
flammable
in
air
[
];
Contact
with
water
liberates
highly
flammable
gases
[
];
Other
[
]
Method:
(
with
the
year
of
publication
or
updating
of
the
method
used).
.....................................
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

2.10
EXPLOSIVE
PROPERTIES
Results:
Explosive
under
influence
of
a
flame[
];
More
sensitive
to
friction
than
m­
dinitrobenzene
[
];
More
sensitive
to
shock
than
m­
dinitrobenzene
[
];
Not
explosive
[
];
Other
[
]
Method:
(
with
the
year
of
publication
or
updating
of
the
method
used).
.....................................
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
23
2.11
OXIDISING
PROPERTIES
Results:
Maximum
burning
rate
equal
or
higher
than
reference
mixture
[
];
Vigorous
reaction
in
preliminary
test
[
];
No
oxidising
properties
[
];
Other
[
]

Method:
(
with
the
year
of
publication
or
updating
of
the
method
used).
.....................................
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
2.12
OXIDATION:
REDUCTION
POTENTIAL
(
Where
applicable,
indicate
the
redox
potential
and
the
conditions
under
which
it
was
measured.)

Value:
.
.
.
.
.
.
.
.
.
.
.
mV
Method:
(
with
the
year
of
publication
or
updating
of
the
method
used)
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

2.13
ADDITIONAL
DATA
A.
Partition
co­
efficient
between
soil/
sediment
and
water
(
Kd)

Value:
.
.
.
.
.
.
.
.
.
.
.
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

B.
Other
data
(
e.
g.
Henry's
Law
constant,
fat
solubility,
surface
tension
(
of
aqueous
solution),
adsorption/
desorption
on
soil,
particle
size
distribution,
etc.)

Results:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
24
3.
ENVIRONMENTAL
FATE
AND
PATHWAYS
[
Reporting
of
studies
should
give
the
test
method,
test
conditions
(
laboratory
versus
field
studies),
test
results
(
e.
g.
%
degradation
in
specified
time
period)
and
reference.
Information
on
breakdown
products
(
transient
and
stable)
should
be
provided
when
available.]

3.1
STABILITY
*
3.1.1
PHOTODEGRADATION
Type:
Air
[
];
Water
[
];
Soil
[
];
Other
[
]
Light
source:
Sunlight
[
];
Xenon
lamp
[
];
Other
[
]
Light
spectrum:
.
.
.
.
.
.
.
.
.
.
.
nm
Relative
intensity:
.
.
.
.
.
.
.
.
.
.
.
(
based
on
intensity
of
sunlight)
Spectrum
of
substance:
[
e.
g.
lambda
(
max.)(>
295nm)
and
epsilon
(
max)
or
epsilon
(
295nm)]
.
.
.
.
.
.
.
.
.
.
.
nm
Concentration
of
Substance:
.
.
.
.
.
.
.
.
.
.
.
Temperature:
.
.
.
.
.
.
.
.
.
.
.
°
C
Direct
photolysis:
Half
life:
.
.
.
.
.
.
.
.
.
.
.
Degradation:
.
.
.
.
.
.
.
.
.
.
.
%
(
weight/
weight)
after
.
.
.
.
.
.
.
.
.
.
.
(
exposure
time)
Quantum
yield:
.
.
.
.
.
.
.
.
.
.
.
Indirect
Photolysis:
Type
of
sensitizer:
.
.
.
.
.
.
.
.
.
.
.
Concentration
of
sensitizer:
.
.
.
.
.
.
.
.
.
.
.
Rate
constant
(
radical):
.
.
.
.
.
.
.
.
.
.
.
cm
3/
molecule*
sec
Degradation:
.
.
.
.
.
.
.
.
.
.
.
Method:
calculated
[
];
measured
[
]
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)]
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
3.1.2
STABILITY
IN
WATER
Type:
Abiotic
(
hydrolysis)
[
];
biotic
(
sediment)[
]
Half
life:
.
.
.
.
.
.
.
.
.
.
.
at
pH
.
.
.
.
.
.
.
.
.
.
.
at
.
.
.
.
.
.
.
.
.
.
.
°
C
Degradation:
.
.
.
.
.
.
.
.
.
.
.
at
pH
.
.
.
.
.
.
.
.
.
.
.
at
.
.
.
.
.
.
.
.
.
.
.
°
C
after
.
.
.
.
.
.
.
.
.
.
.
(
exposure
time)
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)]
......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
(
e.
g.
CAS
number,
name
and
percentage
of
degradation
products)
.......................................................................................................................................
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
25
3.1.3
STABILITY
IN
SOIL
Type
:
Field
trial
[
];
Laboratory
[
];
Other
[
]
Radiolabel:
Yes
[
]
No
[
]
?
[
]
Concentration:
.
.
.
.
.
.
.
.
.
.
.
Soil
temperature:
.
.
.
.
.
.
.
.
.
.
.
°
C
Soil
humidity:
.
.
.
.
.
.
.
.
.
.
.
Soil
classification:
DIN19863
[
];
NF
X31­
107
[
];
USDA
[
];
Other
[
]
year
.
.
.
.
.
.
.
.
Content
of
clay
etc.:
Clay
.
.
.
.
.
.
%,
Silt
.
.
.
.
.
.
.
%,
Sand
.
.
.
.
.
.
%
Organic
Carbon:
.
.
.
.
.
.
.
.
.
.
.
Soil
pH:
.
.
.
.
.
.
.
.
.
.
.
Cation
exchange
capacity:
.
.
.
.
.
.
.
.
.
.
.
Microbial
biomass:
.
.
.
.
.
.
.
.
.
.
.
Dissipation
time:
DT
50
:
.
.
.
.
.
.
.
.
.
.
.
DT
90
:
.
.
.
.
.
.
.
.
.
.
.
Dissipation
:
.
.
.
.
.
.
.
.
.
.
.
%
after
.
.
.
.
.
.
.
.
.
.
(
time)
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)]
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
3.2
MONITORING
DATA
(
ENVIRONMENTAL)

Note
that
data
on
biological
effects
monitoring,
including
biomagnification,
and
biotransformation
and
kinetics
in
environmental
species
are
to
be
reported
in
section
4.7
and
4.8,
respectively.
Nonetheless,
concentration
in
various
biota
should
be
reported
here.
Data
on
concentration
in
the
workplace
or
indoor
environment
should
be
reported
under
item
5.11.

Type
of
Measurement:
Background
[
];
At
contaminated
site
[
];
Other
[
]
Media:
.......................................................................................................................................
Results:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

3.3
TRANSPORT
AND
DISTRIBUTION
BETWEEN
ENVIRONMENTAL
COMPARTMENTS
INCLUDING
ESTIMATED
ENVIRONMENTAL
CONCENTRATIONS
AND
DISTRIBUTION
PATHWAYS
(
e.
g.
during
the
chemical
life­
cycle.
The
information
should
indicate
whether
the
calculation
is
on
a
global
basis
or
is
site­
specific,
and
whether
it
is
based
on
laboratory
measurements
or
field
observations.)
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
26
*
3.3.1
TRANSPORT
Type:
Adsorption
[
];
Desorption
[
];
Volatility
[
];
Other
[
]
Media:
.......................................................................................................................................
Method:
.......................................................................................................................................
Results:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
3.3.2
THEORETICAL
DISTRIBUTION
(
FUGACITY
CALCULATION)

Media:
Air­
biota
[
];
Air­
biota­
sediment­
soil­
water
[
];
Soil­
biota
[
];
Water­
air
[
];
Water­
biota
[
];
Water­
soil
[
];
Other
[
]
Method:
Fugacity
level
I
[
];
Fugacity
level
II
[
];
Fugacity
level
III
[
];
Fugacity
level
IV
[
];
Other
(
calculation)
[
];
Other
(
measurement)[
]
.......................................................................................................................................
Results:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

3.4
IDENTIFICATION
OF
MAIN
MODE
OF
DEGRADABILITY
IN
ACTUAL
USE
Results:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
3.5
BIODEGRADATION
Type:
aerobic
[
];
anaerobic
[
]
Inoculum:
adapted
[
];
non­
adapted
[
];
......................................................................................
Concentration
of
the
chemical:
.
.
.
.
.
.
.
.
related
to
COD
[
];
DOC
[
];
test
substance
[
]
Medium:
water
[
];
water­
sediment
[
];
soil
[
];
sewage
treatment
[
]
Degradation:
(
percentage
reduction/
exposure
time)
.
.
.
.
.
.
.
.
.
.
%
after
.
.
.
.
.
.
.
.
.
.
.
(
time)
Results:
(
see
OECD
Guidelines)
readily
biodeg.
[
];
inherently
biodeg.
[
];
under
test
condition
no
biodegradation
observed
[
],
other
[
]
Kinetic
(
e.
g.
Zahn­
Wellens­
Test)
.
.
.
.
.
.
.
.
.
.
%
in
.
.
.
.
.
.
.
.
.
.
.
.
(
time)
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
[
In
the
case
of
poorly
soluble
chemicals,
treatment
given
(
nature,
concentration,
CAS
number,
name
and
percentage
of
degradation
products
etc.)]:.
....................................
.......................................................................................................................................
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
27
3.6
BOD5,
COD
OR
RATIO
BOD5/
COD
BOD5
Method:
.
.
.
.
.
.
.
.
.
.
.
Concentration:
.
.
.
.
.
.
.
.
.
.
.
related
to
COD
[
];
DOC
[
];
Test
substance
[
]
Value:
.
.
.
.
.
.
.
.
.
.
.
mg
O2/
l
GLP:
Yes
[
]
No
[
]
?
[
]

COD
Method:
.
.
.
.
.
.
.
.
.
.
.
Value:
.
.
.
.
.
.
.
.
.
.
.
mg
O2/
g
GLP:
Yes
[
]
No
[
]
?
[
]

Ratio
BOD5/
COD:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

3.7
BIOACCUMULATION
Species:
.......................................................................................................................................
Exposure
period:
.......................................................................................................................................
Temperature:
.
.
.
.
.
.
.
.
.
.
.
°
C
Concentration:
.
.
.
.
.
.
.
.
.
.
.
BCF:
.
.
.
.
.
.
.
.
.
.
.
Elimination:
Yes
[
]
No
[
]
?
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].
.......................................................................................................................................
Type
of
test:
calculated
[
];
measured
[
]
static
[
];
semi­
static
[
];
flow­
through
[
];
other
(
e.
g.
field
test)
[
]
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

3.8
ADDITIONAL
REMARKS
A.
Sewage
treatment
(
information
on
treatability
of
the
substance)

Results:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

B.
Other
information
[
information
that
will
help
to
focus
the
exposure
assessment
(
either
qualitative
or
quantitative)]

Results:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
28
4.
ECOTOXICITY
*
4.1
ACUTE/
PROLONGED
TOXICITY
TO
FISH
Type
of
test:
static
[
];
semi­
static
[
];
flow­
through
[
];
other
(
e.
g.
field
test)
[
]
open­
system
[
];
closed­
system
[
]
Species:
.......................................................................................................................................
Exposure
period:
.......................................................................................................................................
Results:
LC50
(
24h)
=
.
.
.
.
.
.
.
mg/
l
LC50
(
48h)
=
.
.
.
.
.
.
.
mg/
l
LC50
(
72h)
=
.
.
.
.
.
.
.
mg/
l
LC50
(
96h)
=
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
.
.
mg/
l
Analytical
monitoring:
Yes
[
]
No
[
]
?
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

4.2
ACUTE
TOXICITY
TO
AQUATIC
INVERTEBRATES
*
A.
Daphnia
Type
of
test:
static
[
];
semi­
static
[
];
flow­
through
[
];
other
(
e.
g.
field
test)
[
];
open­
system
[
];
closed­
system
[
]
Species:
.......................................................................................................................................
Exposure
period:
.......................................................................................................................................
Results:
EC50
(
24h)
=
.
.
.
.
.
.
.
.
mg/
l
EC50
(
48h)
=
.
.
.
.
.
.
.
.
mg/
l
ECxx
(..
h)
=
.
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
.
.
.
.
mg/
l
Analytical
monitoring:
Yes
[
]
No
[
]
?
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

B.
Other
aquatic
organisms
Type
of
test:
static
[
];
semi­
static
[
];
flow­
through
[
];
other
(
e.
g.
field
test)
[
];
open­
system
[
];
closed­
system
[
]
Species:
.......................................................................................................................................
Exposure
period:
.......................................................................................................................................
Results:
EC50
(
24h)
=
.
.
.
.
.
.
.
.
mg/
l
EC50
(
48h)
=
.
.
.
.
.
.
.
.
mg/
l
ECxx
(..
h)
=
.
.
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
.
.
.
mg/
l
Analytical
monitoring:
Yes
[
]
No
[
]
?
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
29
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
4.3
TOXICITY
TO
AQUATIC
PLANTS,
e.
g.
algae
Species:
.......................................................................................................................................
Endpoint:
Biomass
[
];
Growth
rate
[
];
Other
[
]
Exposure
period:
.......................................................................................................................................
Results:
.
.
.
.
.
.
.
.
.
.
.
.
EC50
(.
.
.
.
.
.
.
h)
=
.
.
.
.
.
.
.
mg/
l
(
Endpoint)
ECxx
(.
.
.
.
.
.
.
h)
=
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
mg/
l
Analytical
monitoring:
Yes
[
]
No
[
]
?
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
open­
system
[
];
closed­
system
[
]
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

4.4
TOXICITY
TO
BACTERIA
(
Single
species
tests
and
tests
on
overall
processes
such
as
nitrification
or
soil
respiration
are
included
in
this
item.)

Type:
Aquatic
[
];
Field
[
];
Soil
[
];
Other
[
]
Species:
.......................................................................................................................................
Exposure
Period:
.......................................................................................................................................
Results:
EC50
(.
.
.
h)
=
.
.
.
.
.
.
.
mg/
l
ECxx
(.
.
.
h)
=
.
.
.
.
.
.
.
mg/
l
Analytical
monitoring:
Yes
[
]
No
[
]
?
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

4.5
CHRONIC
TOXICITY
TO
AQUATIC
ORGANISMS
4.5.1
CHRONIC
TOXICITY
TO
FISH
(
effects
on
reproduction,
embryo/
larva,
etc.)

Type
of
test:
static
[
];
semi­
static
[
];
flow­
through
[
];
other
(
e.
g.
field
test)
[
];
open­
system
[
];
closed­
system
[
]
Species:
.......................................................................................................................................
Endpoint:
Length
of
fish
[
];
Weight
of
fish
[
];
Reproduction
rate
[
];
Other
[
]
Exposure
period:
.......................................................................................................................................
Results:
.
.
.
.
.
.
.
.
.
.
EC50
(..
d)
=
.
.
.
.
.
.
.
mg/
l
(
Endpoint)
ECxx
(..
d)
=
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
.
mg/
l
Analytical
monitoring:
Yes
[
]
No
[
]
?
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
30
Reference:
.......................................................................................................................................

(*)
4.5.2
CHRONIC
TOXICITY
TO
AQUATIC
INVERTEBRATES
(
e.
g.
daphnia
reproduction.
The
need
to
conduct
tests
for
this
endpoint
will
depend
inter
alia
upon
possible
concern
for
long
term
effects.)

Type
of
test:
static
[
];
semi­
static
[
];
flow­
through
[
];
other
(
e.
g.
field
test)
[
];
open­
system
[
];
closed­
system
[
]
Species:
.......................................................................................................................................
Endpoint:
Mortality
[
];
Reproduction
rate
[
];
Other
[
]
Exposure
period:
.
.
.
.
.
.
.
.
.
.
.
.
Results:
.
.
.
.
.
.
.
.
.
.
.
EC50
(.
.
.
.
.
h)
=
.
.
.
.
.
.
.
mg/
l
(
Endpoint)
ECxx
(.
.
.
.
.
.
d)
=
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
.
mg/
l
Analytical
monitoring:
Yes
[
]
No
[
]
?
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
31
4.6
TOXICITY
TO
TERRESTRIAL
ORGANISMS
4.6.1
TOXICITY
TO
SOIL
DWELLING
ORGANISMS
Type
:
Artificial
soil
[
];
Filter
paper
[
];
Other
[
]
Species:
.......................................................................................................................................
Endpoint:
Mortality
[
];
Weight
[
];
Other
[
]
Exposure
period:
.......................................................................................................................................
Results:
.
.
.
.
.
.
.
.
.
.
EC50
(.
.
.
.
.
d)
=
.
.
.
.
.
.
.
mg/
kg
(
Endpoint)
EC50
(.
.
.
.
.
d)
=
.
.
.
.
.
.
.
mg/
kg
ECxx
(.
.
.
.
.
d)
=
.
.
.
.
.
.
.
mg/
kg
NOEC
=
.
.
.
.
.
.
.
.
.
.
.
mg/
kg
LOEC
=
.
.
.
.
.
.
.
.
.
.
.
mg/
kg
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

4.6.2
TOXICITY
TO
TERRESTRIAL
PLANTS
(
a)
Species:
.......................................................................................................................................
Endpoint:
Emergence
[
];
Growth
[
];
Other
[
]
Exposure
period:
.......................................................................................................................................
Results:
EC50
and/
or
LC50
(
7d)
=
.
.
.
.
.
.
.
.
mg/
l
EC50
and/
or
LC50(
14d)
=
.
.
.
.
.
.
.
.
mg/
l
ECxx
and/
or
LCxx
(
xxd)
=
.
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
mg/
l
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

(
b)
Species:
.......................................................................................................................................
Endpoint:
Emergence
[
];
Growth
[
];
Other
[
]
Exposure
period:
.......................................................................................................................................
Results:
EC50
and/
or
LC50
(
7d)
=
.
.
.
.
.
.
.
mg/
l
EC50
and/
or
LC50(
14d)
=
.
.
.
.
.
.
.
.
mg/
l
ECxx
and/
or
LCxx
(
xxd)
=
.
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
mg/
l
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

(
c)
Species:
......................................................................................................................................
.
Endpoint:
Emergence
[
];
Growth
[
];
Other
[
]
Exposure
period:
.......................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
32
Results:
EC50
and/
or
LC50
(
7d)
=
.
.
.
.
.
.
.
mg/
l
EC50
and/
or
LC50(
14d)
=
.
.
.
.
.
.
.
.
mg/
l
ECxx
and/
or
LCxx
(
xxd)
=
.
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
mg/
l
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

4.6.3
TOXICITY
TO
OTHER
NON
MAMMALIAN
TERRESTRIAL
SPECIES
(
INCLUDING
AVIAN)

Species:
.......................................................................................................................................
Endpoint:
Mortality
[
];
Reproduction
rate
[
];
Weight
[
];
Other
[
]
Exposure
period:
.......................................................................................................................................
Results:
LDxx
or
LCxx
(
xxd)
=
.
.
.
.
.
.
.
mg/
kg
NOEC
=
.
.
.
.
.
.
.
mg/
kg
LOEC
=
.
.
.
.
.
.
.
mg/
kg
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)]

GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
..........,
purity:
..........
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

4.7
BIOLOGICAL
EFFECTS
MONITORING
(
INCLUDING
BIOMAGNIFICATION)
(
Studies
on
variation
of
predominant
species
in
certain
ecosystems
(
e.
g.
mesocosm)
and
monitoring
of
biological
effects
are
included.)

Results:
Substance:......................................................................................................................
Species
or
ecosystem
studied:........................................................................................
Effects
monitored:
.........................................................................................................
Results:..........................................................................................................................
Chemical
analysis:.........................................................................................................
Remarks:
(
Information
on
environmental
conditions
(
e.
g.
water
characteristics:
suspended
matter,
pH,
temperature,
hardness;
soil/
sediment
characteristics:
%
organic
matter,
clay
content)
.......................................................................................................................................
Reference:
.......................................................................................................................................

4.8
BIOTRANSFORMATION
AND
KINETICS
(
Under
this
item,
studies
on
absorption,
distribution,
metabolism
and
excretion
etc.
should
be
given.)

Type:
Animal
[
];
Aquatic
[
];
Plant
[
];
Terrestrial
[
];
Other
[
]
Results:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

4.9
ADDITIONAL
REMARKS
Results:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
33
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
34
5.
TOXICITY
(
Where
observations
on
humans
are
available,
these
should
be
entered
in
the
appropriate
"
Comments"
section
or
under
section
5.11.)

*
5.1
ACUTE
TOXICITY
5.1.1
ACUTE
ORAL
TOXICITY
Type:
LD0
[
];
LD100
[
];
LD
50
[
];
LDL0
[
];
Other
[
]
Species/
strain:
.......................................................................................................................................
Value:
.
.
.
.
.
.
.
.
.
mg/
kg
b.
w.:
Discriminating
dose:
.....................................................................................................
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

5.1.2
ACUTE
INHALATION
TOXICITY
Type:
LC0
[
];
LC100
[
];
LC50
[
];
LCL0
[
];
Other
[
]
Species/
strain:
.......................................................................................................................................
Exposure
time:
.......................................................................................................................................
Value:
.......................................................................................................................................
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

5.1.3
ACUTE
DERMAL
TOXICITY
Type:
LD0
[
];
LD100
[
];
LD
50
[
];
LDL0
[
];
Other
[
]
Species/
strain:
.......................................................................................................................................
Value:
.
.
.
.
.
.
.
.
.
.
.
.
.
.
mg/
kg
b.
w.
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
35
5.1.4
ACUTE
TOXICITY,
OTHER
ROUTES
OF
ADMINISTRATION
(
e.
g.
subcutaneous,
intravenous,
etc.)

Type:
LC0
[
];
LC100
[
];
LC50
[
];
LCL0
[
];
Other
[
]
LD0
[
];
LD100
[
];
LD50
[
];
LDL0
[
];
Other
[
]
Species/
strain:
.......................................................................................................................................
Route
of
Administration:
i.
m.
[
];
i.
p.
[
];
i.
v.
[
];
infusion
[
];
s.
c.
[
];
other
[
]
Exposure
time:
.......................................................................................................................................
Value:
.......................................................................................................................................
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

5.2
CORROSIVENESS/
IRRITATION
5.2.1
SKIN
IRRITATION/
CORROSION
Species/
strain:
.......................................................................................................................................
Results:
Highly
corrosive
[
];
Corrosive
[
];
Highly
irritating
[
];
Irritating
[
];
Moderate
irritating
[
];
Slightly
irritating
[
];
Not
irritating
[
]
Classification:
(
If
possible,
according
to
EC
Directive
67/
548/
EEC)
Highly
corrosive
(
causes
severe
burns)
[
];
Corrosive
(
causes
burns)
[
];
Irritating
[
];
Not
irritating
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

5.2.2
EYE
IRRITATION/
CORROSION
Species/
strain:
.......................................................................................................................................
Results:
Highly
corrosive
[
];
Corrosive
[
];
Highly
irritating
[
];
Irritating
[
];
Moderate
irritating
[
];
Slightly
irritating
[
];
Not
irritating
[
]
Classification:
(
if
possible,
according
to
EC
Directive
67/
548/
EEC)
Irritating
[
];
Not
irritating
[
];
Risk
of
serious
damage
to
eyes
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................
5.3
SKIN
SENSITISATION
Type:
.......................................................................................................................................
Species/
strain:
.......................................................................................................................................
Results:
Sensitizing
[
];
Not
sensitizing
[
];
Ambiguous
[
]
Classification:
(
if
possible,
according
to
EC
Directive
67/
548/
EEC)
Sensitizing
[
];
Not
sensitizing
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)]
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
36
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
5.4
REPEATED
DOSE
TOXICITY
Species/
strain:
.......................................................................................................................................
Sex:
Female
[
];
Male
[
];
Male/
Female
[
];
No
data
[
]
Route
of
Administration:
...................................................................................................................................
Exposure
period:
.......................................................................................................................................
Frequency
of
treatment:
...............................................................................................................................
Post
exposure
observation
period:
.
.......................................................................................................
Dose:
.......................................................................................................................................
Control
group:
Yes
[
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
];
Concurrent
vehicle
[
];
Historical
[
]
NOEL:
.......................................................................................................................................
LOEL:
.......................................................................................................................................
Results:
.......................................................................................................................................
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Reference:
.......................................................................................................................................

*
5.5
GENETIC
TOXICITY
IN
VITRO
A.
BACTERIAL
TEST
Type:
(
e.
g.
Bacterial
reverse
mutation
assay,
Bacterial
gene
mutation
study,
Cytogenetic
Assay
etc.)......................................................................................................................
.......................................................................................................................................
System
of
testing:
.......................................................................................................................................
Concentration:
.......................................................................................................................................
Metabolic
activation:
With
[
];
Without
[
];
With
and
Without
[
];
No
data
[
]
Results:
Cytotoxicity
conc:
With
metabolic
activation:.............................................................................................
Without
metabolic
activation:........................................................................................
Precipitation
conc:
.......................................................................................................................................
Genotoxic
effects:
+
?
­
With
metabolic
activation:
[
]
[
]
[
]
Without
metabolic
activation:
[
]
[
]
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)]
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
..........,
purity:
..........
Remarks:
..........
Reference:
..........

B.
NON­
BACTERIAL
IN
VITRO
TEST
Type:
(
e.
g.
mammalian
cell
gene
mutation
assay,
cytogenetic
assay,
etc.)
.......................................................................................................................................
System
of
testing:
.......................................................................................................................................
Concentration:
.......................................................................................................................................
Metabolic
activation:
With
[
];
Without
[
];
With
and
Without
[
];
No
data
[
]
Results:
Cytotoxicity
conc:
With
metabolic
activation:.............................................................................................
Without
metabolic
activation:........................................................................................
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
37
Precipitation
conc:
.......................................................................................................................................
Genotoxic
effects:
+
?
­
With
metabolic
activation:
[
]
[
]
[
]
Without
metabolic
activation:
[
]
[
]
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
5.6
GENETIC
TOXICITY
IN
VIVO
Type:
(
e.
g.
micronucleus
assay,
etc.)
.......................................................................................................................................
Species/
strain:
.......................................................................................................................................
Sex:
Female
[
];
Male
[
];
Male/
Female
[
];
No
data
[
]
Route
of
Administration:
...............................................................................................................................
Exposure
period:
.......................................................................................................................................
Doses:
.......................................................................................................................................
Results:
Effect
on
mitotic
index
or
P/
N
ratio:
...............................................................................................................................
Genotoxic
effects:
+
?
­
[
]
[
]
[
]
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)]
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

5.7
CARCINOGENICITY
Species/
strain:
.......................................................................................................................................
Sex:
Female
[
];
Male
[
];
Male/
Female
[
];
No
data
[
]
Route
of
Administration:
...............................................................................................................................
Exposure
period:
.......................................................................................................................................
Frequency
of
treatment:
...............................................................................................................................
Postexposure
observation
period:..............................................................................................................................
Doses:
.......................................................................................................................................
Control
group:
Yes
[
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
];
Concurrent
vehicle
[
];
Historical
[
]
Results:
.......................................................................................................................................
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)]
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
5.8
TOXICITY
TO
REPRODUCTION
Type:
Fertility
[
];
One­
generation
study
[
];
Two­
generation
study
[
];
Other
[
]
Species/
strain:
.......................................................................................................................................
Sex:
Female
[
];
Male
[
];
Male/
Female
[
];
No
data
[
]
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
38
Route
of
Administration:...........................................................................................................................................
Exposure
period:
.......................................................................................................................................
Frequency
of
treatment:.............................................................................................................................................
Post
exposure
observation
period:.............................................................................................................................
Premating
exposure
period:
male:
.
.
.
.
.
.
.
.
.
.
.
.
.
.
,
female:
....................................................................
Duration
of
the
test:
.......................................................................................................................................
Doses:
.......................................................................................................................................
Control
group:
Yes
[
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
];
Concurrent
vehicle
[
];
Historical
[
]
NOEL
Parental:
.......................................................................................................................................
NOEL
F1
Offspring:
.......................................................................................................................................
NOEL
F2
Offspring:
.......................................................................................................................................
Results:
.......................................................................................................................................
General
parental
toxicity:...............................................................................................
Toxicity
to
offspring:
(
weights
of
litter,
postnatal
growth,
viability,
etc.)
.......................................................................................................................................
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
5.9
DEVELOPMENTAL
TOXICITY/
TERATOGENICITY
Species/
strain:
.......................................................................................................................................
Sex:
Female
[
];
Male
[
];
Male/
Female
[
];
No
data
[
]
Route
of
Administration:
..............................................................................................................................
.
Duration
of
the
test:
.......................................................................................................................................
Exposure
period:
.......................................................................................................................................
Frequency
of
treatment:
...............................................................................................................................
Doses:
.......................................................................................................................................
Control
group:
Yes
[
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
];
Concurrent
vehicle
[
];
Historical
[
]
NOEL
Maternal
Toxicity:
...............................................................................................................................
NOEL
teratogenicity
:
.......................................................................................................................................
Results:
.......................................................................................................................................
Maternal
general
toxicity:..............................................................................................
Pregnancy/
litter
data:
.....................................................................................................
Foetal
data:
....................................................................................................................
Method:
[
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updating
of
the
method
used)].......
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
,
purity:
.
.
.
.
.
.
.
.
.
.
.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

5.10
OTHER
RELEVANT
INFORMATION
A.
Specific
toxicities
Type:
(
e.
g.
neurotoxicity,
immunotoxicity,
etc.)
.......................................................................................................................................
Results:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

B.
Toxicodynamics,
toxicokinetics
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
39
Type:
(
e.
g.
toxicodynamics,
toxicokinetics)
.......................................................................................................................................
Results:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
References:
.......................................................................................................................................

*
5.11
EXPERIENCE
WITH
HUMAN
EXPOSURE
(
Describe
information
on
workplace
exposure
such
as
concentration
of
chemicals
in
the
workplace
or
indoor
environment
(
manufacturing,
maintenance
and
professional
use),
number
of
workers
(
in
ranges
for
each
situation),
frequency
and
duration
of
exposure,
if
available.
In
addition,
enter
details
of
effects
of
accidental
or
occupational
exposure,
epidemiological
and
clinical
studies,
case
reports,
etc.)

Results:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

6.
REFERENCES
(
Indicate
the
name
of
the
book,
journal,
etc.
where
the
study
appears;
volume;
page
numbers;
and
date
of
report
or
publication.
In
general,
information
should
be
taken
from
primary
sources
and
quoting
from
secondary
references
such
as
a
review
article
should
be
avoided.
Where
appropriate,
indicate
"
unpublished
report",
its
authors
and
their
affiliation.)
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
40
2.5
Guidance
for
collection
and
transmission
of
exposure
information
for
SIDS
Initial
Assessment
Introduction
1.
Countries
participating
in
the
OECD
Existing
Chemicals
Programme
(
i.
e.
SIDS
Programme)
are
requested
to
collect
a
set
of
exposure
data
on
High
Production
Volume
(
HPV)
chemicals
for
their
initial
assessment.
These
data
will
be
used
to
assess
potential
exposures
to
the
chemical.

2.
In
order
to
collect
exposure
information
in
an
effective
and
efficient
way,
the
Steering
Group
on
Existing
Chemicals
agreed
at
its
meeting
in
November
1996
on
a
two­
step
approach
for
collection
of
exposure
information.
The
OECD
Secretariat
has
developed
a
format
to
be
used
for
gathering
exposure
information
based
on
the
recommendations
of
the
Steering
Group.
Guidance
for
collection
and
transmission
of
exposure
information
is
summarised
below.
The
discussions
at
the
Task
Force
Meeting
held
in
Dortmund,
Germany,
in
June
1995,
and
the
experiences
gained
later
on
are
also
taken
into
account.

First
Step
3.
Beginning
with
Phase
5
chemicals,
the
Secretariat
informs
Member
countries
which
chemicals
are
being
sponsored
and
requests
them
to
collect
exposure
information
on
these
chemicals,
i.
e.
at
the
information
gathering
stage.
Beginning
with
Phase
6,
information
giving
the
rationale
for
the
selection
of
each
chemical
has
been
provided
for
Member
countries
to
easily
focus
on
specific
exposure
situations.
The
list
of
producing
countries
could
also
be
attached.

4.
Member
countries
gather
easily­
available
exposure
information
on
the
elements
in
the
following
list
on
all
the
chemicals
at
this
stage
and
forward
it
to
the
relevant
Sponsor
countries
within
6
months.
Items
to
be
gathered
can
be
selected
by
each
Member
country
depending
on
the
situation,
but
reasonable
efforts
should
be
made
to
collect
the
information.

·
Produced,
imported
or
used?
·
Quantity
(
production,
import
and/
or
export
volume)
·
General
information
on
use
pattern
·
MAK
or
equivalent
occupational
standards
·
Information
on
classification
and
labelling
·
National
regulatory
standards
or
other
measures
for
management
of
exposure
·
Other
information
(
e.
g.
results
of
workplace
monitoring,
other
information
on
occupational
exposure,
information
on
release
to
the
environment,
results
of
environmental
monitoring,
information
on
consumer
exposure,
safe
handling
procedures,
etc.)

5.
A
form
to
be
used
for
this
purpose
has
been
developed
(
see
Annex
1
to
this
Section).
This
is
also
available
on
diskette.
Member
countries
can
modify
it
as
appropriate.
Member
countries
are
expected
to
forward
the
collected
information
to
the
relevant
Sponsor
countries,
with
a
copy
to
the
Secretariat.

6.
Sponsor
countries
gather
more
detailed
national
exposure
information
on
their
own
sponsored
chemicals.
Examples
of
the
items
to
be
collected
are
shown
in
Annexes
2
and
3
to
this
Section,
which
were
included
in
the
recommendations
by
the
Task
Force
Meeting.
An
example
of
a
form
to
be
used
for
collecting
such
information
is
shown
in
Annex
4
to
this
Section.
Member
countries
can
use
it
when
they
collect
information
from
industry,
modifying
it
as
appropriate.
They
can
also
use
it
when
they
summarise
data
to
forward
to
the
appropriate
Sponsor
countries.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
41
Second
step
7.
The
second
step
of
information
gathering
focuses
on
specific
chemicals,
especially
those
for
which
a
potential
hazard
has
been
identified,
normally
at
a
SIDS
Initial
Assessment
Meeting
(
SIAM).

8.
Once
it
has
been
agreed
at
a
SIAM
that
more
detailed
information
on
general
or
specific
exposure
information
(
e.
g.
occupational
exposure,
environmental
release)
be
collected
for
certain
chemicals,
all
Member
countries
are
requested
to
collect
such
information.
This
procedure
started
with
the
chemicals
identified
at
SIAM4
held
in
May
1996.

9.
The
form
shown
in
Annex
4
to
this
Manual
can
be
used,
modified
as
appropriate.

10.
If
Sponsor
countries
feel
that
specific
international
exposure
information
is
needed
for
the
initial
assessment
of
their
sponsored
chemicals,
they
can
request
other
countries
to
collect
it
before
developing
an
assessment
report.
In
this
case,
the
rationale
for
the
request
should
be
clarified.

General
instructions
on
data
collection
11.
At
the
first
step,
non­
Sponsor
countries
are
expected
to
collect
easily­
available
information.
This
can
be
done
by
using
governmental
databases
(
e.
g.
Product
Register,
Release
Inventory),
literature
and/
or
a
simple
request
to
industry.
Sponsor
countries,
on
the
other
hand,
are
expected
to
collect
more
detailed
information
in
co­
operation
with
industry.
At
the
second
step,
every
Member
country
needs
to
work
with
industry
as
well.

12.
It
is
recommended
that
Sponsor
countries
use
the
EXICHEM
database
as
a
starting
place
to
find
out
which
other
Member
countries
or
international
organisations
are
collecting
or
analysing
exposure
information
on
the
sponsored
chemicals.

13.
Industry's
co­
operation
on
collection
of
exposure
information
is
voluntary
in
the
OECD
Existing
Chemicals
Programme,
and
should
be
based
on
readily
available
data
and
responsible
estimates.
However,
it
is
recommended
that
the
industry
which
produces
a
chemical
make
reasonable
efforts
to
provide
exposure
and
release
information
relating
to
manufacture
and
uses
of
that
chemical.
Co­
operation
and
good
communication
between
government
and
industry
is
very
important
when
gathering
exposure
information.

14.
An
example
of
procedure
for
gathering
and
documenting
use­
related
exposure
information
is
given
in
Annex
5
to
this
Section.
As
shown
there,
it
is
important
to
record
the
efforts
taken
including
negative
results
in
order
to
avoid
duplication
of
efforts.

15.
As
these
data
will
be
used
for
the
initial
assessment,
ranges
for
numerical
values
are
acceptable,
especially
in
the
first
step
(
see
the
example
of
production
volume
in
Annex
6
to
this
Section).

16.
If
any
data
are
confidential,
ranges
or
generic
descriptions
should
be
used
to
provide
as
much
non­
confidential
data
as
possible.
Any
confidential
data
can
be
attached
as
an
Annex.
They
will
be
made
available
for
review
only
on
a
confidential
basis,
i.
e.
the
conditions
set
out
in
the
OECD
Council
Act
concerning
Exchange
of
Confidential
Data
on
Chemicals
[
C(
83)
97(
Final)]
apply
to
the
experts
in
each
country
that
receives
the
data.

17.
It
is
recommended
that
all
information
be
provided
in
English
to
the
relevant
Sponsor
countries.

18.
As
the
formats
for
collection
and
transmission
of
exposure
information
are
provided
in
a
diskette
as
a
part
of
this
SIDS
Manual
(
Word
6.0
for
Windows),
space
and
style
can
be
modified
as
appropriate.

19.
A
brief
overview
of
the
exposure
situation
across
the
OECD
should
be
prepared
by
the
Sponsor
country
in
a
SIDS
Initial
Assessment
Report
(
SIAR).
The
SIDS
Dossier
and
SIAR
for
a
given
chemical
should
be
made
available
to
those
interested
parties
who
submitted
data.

Specific
instructions
for
the
collection
of
detailed
data
20.
In
order
to
evaluate
the
quality
of
data,
it
is
important
to
distinguish
"
on­
site"
data
mainly
related
to
production
and
"
off­
site"
data
mainly
related
to
downstream
uses.
The
latter
is
also
important
in
order
to
analyse
the
complete
life
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
42
cycle
of
the
chemical;
however,
it
should
be
noted
that
such
data
concerning
downstream
use
is
usually
derived
based
on
estimation.

21.
Release
in
a
reasonable
worst­
case
should
be
described.

22.
With
respect
to
occupational
exposure,
it
is
also
important
to
distinguish
exposure
during
manufacturing
from
that
during
occupational/
professional
use.

23.
With
respect
to
industry
categories
and
use
categories,
it
is
recommended
to
use
the
categories
in
HEDSET
(
see
Annex
6
to
this
Section).

24.
Monitoring
data
are
preferable
for
exposure
assessment;
however,
representativeness
should
be
reviewed.
For
validation
of
monitoring
data,
it
is
important
to
give
some
indication
of
the
sampling
and
analytical
methods.
As
space
in
the
format
is
limited,
detailed
results
can
be
attached
to
the
format,
as
appropriate.

25
With
respect
to
off­
site
release
to
the
environment,
it
should
be
noted
that
small
scale
industry,
consumer
end­
use
of
the
chemicals
or
waste
disposal
where
a
chemical
is
likely
to
be
available
for
environmental
and
human
exposure
should
be
considered.
Examples
of
end­
use
categories
are:

·
cosmetics
and
toiletries
·
soaps
and
detergents
·
polishes
and
sanitation
goods
·
paints
and
coatings
·
adhesives
and
sealants
·
automotive
care
products
·
pesticides
and
lawn/
garden
products
26
Detailed
instructions
are
also
given
in
italics
in
the
format.

Other
27.
If
relevant
data
are
not
available,
default
values
will
be
used
in
preparation
of
the
SIARs.

28.
If
the
initial
assessment
identifies
any
concern
for
the
environment
and/
or
human
health,
more
detailed
information
may
be
collected
later,
as
appropriate,
such
as
that
collected
in
the
EPA/
CMA/
SOCMA
Project
(
see
Annex
5
to
this
Manual).
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
43
Annex
1
Form
for
Gathering
Easily­
Available
Exposure
Information
in
Non­
Sponsor
Countries
on
the
Chemicals
at
the
Information
Gathering
Stage
(
Phase
xx
Chemicals)

·
Please
collect
easily­
available
information.
Items
to
be
gathered
can
be
selected
by
each
Member
country.
·
This
form
can
be
used
for
data
collection
and
transmission,
modified
as
appropriate.
This
form
is
also
available
on
diskette.
·
Please
send
the
collected
information
on
each
chemical
to
the
relevant
Sponsor
countries
within
6
months,
with
a
copy
to
the
Secretariat.

CAS
Number:
Responding
Country:

Sponsor
Country:
Chemical
Name:

1.
Produced,
imported
or
used?
·
Production/
Import:
¨
Yes
¨
No
¨
Unknown
·
Use:
¨
Yes
¨
No
¨
Unknown
2.
Quantity
(
tonnes/
year,
ranges
are
acceptable)
·
Production
(
a)
·
Import
(
b)
(
Year:
)
·
Export
(
c)
·
Total
(
a
+
b
­
c)
3.
General
Information
on
use
pattern
(
Please
describe
them.)

·
Is
this
chemical
only
used
in
closed
systems?
¨
Yes
¨
No
¨
Unknown
·
Is
there
any
consumer
use?
¨
Yes
¨
No
¨
Unknown
4.
MAK
or
equivalent
occupational
standard
(
mg/
m
3
with
time
period)

5.
Information
on
classification
and
labelling
(
Please
describe
them.)

6.
National
regulatory
standards
(
purpose
and
value)
or
other
measures
for
management
of
exposure
References
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
44
CAS
Number:
Responding
Country:

7.
Other
information
(
If
some
of
the
following
information
is
available,
please
tick
(
ü
)
the
items
and
describe
data
below
or
attach
an
additional
paper,
as
appropriate.)
¨
Results
of
workplace
monitoring
¨
Other
information
on
occupational
exposure
¨
Information
on
release
to
the
environment
¨
Results
of
environmental
monitoring
¨
Information
on
consumer
exposure
¨
Safe
handling
procedure
¨
Other
information
(
Please
describe
below.)

References
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
45
Annex
2
Proposed
Data
Set
on
Environmental
Exposure
for
the
SIDS
Initial
Assessment***

Information
included
in
the
original
SIDS
elements
1.
production
volume
(
in
each
country
and
approximate
OECD
total,
if
possible)
2.
use
pattern
including
the
approximate
percentage
of
production
volume
in
each
use,
if
possible.
[
identify
use
categories
(
use
a
footnote
or
a
table
to
indicate
countries
reporting
the
use)]

Basic
information
concerning
release
to
the
environment
from
point
sources
3.
national
regulatory
standards
(
e.
g.
effluent
guidelines,
water
quality
criteria)
4.
release
data
to
each
environmental
compartment
(
i.
e.
surface
water,
air,
soil)
5.
industry
sectors
(
e.
g.
industrial
categories
in
the
HEDSET)
in
which
the
chemical
is
processed
or
used.
6.
approximate
number
of
sites
per
industry
sector
and
total
number
of
sites
where
chemical
is
manufactured,
processed
or
used.
7.
industrial
processes
associated
with
uses
of
the
chemical
which
contain
water
as
a
reactant,
solvent
or
by­
product
and
hence
have
a
likelihood
of
generating
a
surface
water
release.

Basic
information
concerning
other
releases
to
the
environment
(
mainly
to
surface
water)

8.
consumer
end­
uses
of
the
chemical
or
small
scale
industry
where
the
chemical
is
likely
to
be
available
for
ecological
exposure.
Examples
of
the
end­
use
categories
could
be:

·
cosmetics
and
toiletries
·
soaps
and
detergents
·
polishes
and
sanitation
goods
·
paints
and
coatings
·
adhesives
and
sealants
·
automotive
care
products
·
pesticides
and
lawn/
garden
products
The
weight
percent
of
the
chemical
in
each
consumer
end­
use
product
should
preferably
be
identified.

Others
9.
Monitoring
data
of
emissions
of
the
chemical
10.
Monitoring
data
of
the
chemical
in
the
environment
***
The
data
set
shown
in
this
Annex
was
proposed
by
the
Task
Force
Meeting
held
in
Dortmund,
Germany,
in
June
1995
as
an
appropriate
one
for
the
SIDS
Initial
Assessment.
After
a
pilot
study,
the
Steering
Group
on
Existing
Chemicals
thought
that
it
might
be
difficult
to
ask
all
the
Member
countries
to
collect
such
information,
but
that
the
Sponsor
countries
should
collect
detailed
information
on
their
Sponsored
chemicals.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
46
Annex
3
Proposed
Data
Set
on
Human
Exposure
for
the
SIDS
Initial
Assessment****

A.
CONSUMER
EXPOSURE
In
this
area
it
is
expected
that
little
measured
data
would
be
available
and
that
the
assessor
would
rely
on
calculated
data.

Basic
Information
1.
use
pattern
(
The
percentage
or
range
of
production
volume
in
each
of
the
use
categories
should
be
identified.)
2.
weight
fraction
in
product
and
dilution
factor
(
before
use)
if
available
3.
form
of
product
as
marketed.

Others
4.
frequency
of
use
5.
duration
of
use
6.
route
and
extent
of
exposure
(
oral,
dermal,
inhalation)
7.
function
of
chemical
in
product
B.
OCCUPATIONAL
EXPOSURE
Basic
Information
1.
details
of
process
or
processes
involved
(
e.
g.
continuous/
batch,
open/
closed)
2.
MAK
or
equivalent
occupational
standard
3.
protective
measures
·
engineering
control
·
personal
protection
4.
use
description
and
approximate
exposure
from
non­
manufacturing
and
professional
use
5.
use
pattern
Others
6.
Workplace
monitoring
data
with
details
of
statistical
analysis
and
description
of
exposure
scenarios
7.
approximate
number
of
sites
per
industry
sector
and
total
number
of
sites
where
chemical
is
manufactured,
processed
or
used.
8.
number
of
workers
per
site
if
available
9.
frequency
and
duration
of
exposure
10.
characteristics
of
exposed
population
****
The
data
set
shown
in
this
Annex
was
proposed
by
the
Task
Force
Meeting
held
in
Dortmund,
Germany,
in
June
1995
as
an
appropriate
one
for
the
SIDS
Initial
Assessment.
After
a
pilot
study,
the
Steering
Group
on
Existing
Chemicals
thought
that
it
might
be
difficult
to
ask
all
the
Member
countries
to
collect
such
information,
but
that
the
Sponsor
countries
should
collect
detailed
information
on
their
Sponsored
chemicals.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
47
Annex
4
Proposed
Format
for
Gathering
More
Detailed
Exposure
Information
for
SIDS
Initial
Assessment
­
COVER
PAGE
­

A.
IDENTITY
OF
RESPONDER
Name:
Company/
Organisation:
Address/
Country:

Tel:
Fax:
Date:

B:
LIST
OF
CHEMICALS
ON
WHICH
EXPOSURE
INFORMATION
HAS
BEEN
GATHERED
(
Please
tick
the
names
of
the
chemicals
for
which
exposure
information
is
attached.)

CAS
No.
Chemical
Name
CAS
No.
Chemical
Name
¨
xxxxx
xxxxxx
¨
xxxxx
xxxxxx
¨
xxxxx
xxxxxx
¨
xxxxx
xxxxxx
Other
chemicals
(
Please
describe
CAS
No.
and
the
name
below.)

General
Instructions
The
attached
format,
developed
by
the
OECD
Secretariat,
is
intended
to
be
used
for
gathering
more
detailed
exposure
information
on
High
Production
Volume
(
HPV)
chemicals
in
the
OECD
Existing
Chemicals
Programme.
It
is
to
be
used
by
industry
when
submitting
data
to
SIDS
Contact
Points.
SIDS
Contact
Points
can
also
use
this
format
when
summarising
data
to
forward
to
the
appropriate
Sponsor
countries,
when
necessary.

Completion
of
this
form
by
each
company
is
voluntary,
and
should
be
based
on
readily
available
data
and
responsible
estimates.
However,
it
is
expected
that
all
reasonable
efforts
will
be
made
in
gathering
the
necessary
information.

As
these
data
will
be
used
for
the
initial
assessment,
ranges
for
numerical
values
are
acceptable.

If
any
data
are
confidential,
please
use
ranges
or
generic
descriptions
to
provide
as
much
non­
confidential
data
as
possible.
Any
confidential
data
could
be
attached
as
an
Annex
to
this
form.
They
will
be
made
available
for
review
only
on
a
confidential
basis,
i.
e.
the
conditions
set
out
in
the
OECD
Council
Act
concerning
Exchange
of
Confidential
Data
on
Chemicals
[
C(
83)
97(
Final)]
apply
to
the
experts
in
each
country
that
receives
the
data.

It
is
recommended
that
this
form
be
completed
in
English.

When
filling
in
the
form,
please
also
read
"
Guidance
for
collection
and
transmission
of
exposure
information
for
SIDS
Initial
Assessment"
(
Section
2.5
of
the
SIDS
Manual)
and
follow
the
instructions
described
in
the
guidance
as
well
as
those
written
in
this
format.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
48
CAS
No:
Country:

EXPOSURE
INFORMATION
FOR
SIDS
INITIAL
ASSESSMENT
1.
IDENTITY
OF
CHEMICAL
1.1
CAS
No.:

1.2
Chemical
name:

2.
GENERAL
INFORMATION
CONCERNING
PRODUCTION
AND
USE
2.1
Quantity
(
tonnes/
year)
(
Most
recent
year's
record.
Plural
years'
records
could
also
be
described.)

Year
Production
(
a)
Import
(
b)
Export
(
c)
Total
(
a+
b­
c)

2.2
Use
pattern
and
approximate
percentage
of
total
volume
in
each
use
category
(
Please
use
glossary
codes
for
HEDSET,
shown
in
the
Annex
to
the
guidance,
as
much
as
possible.
Please
also
distinguish
between
the
on­
site
use
and
the
estimated
off­
site
use
with
*
for
the
latter.)

Main
Category
Industrial
Category
Use
Category
Approximate
%
of
total
2.3
Details
of
process
or
processes
involved
(
e.
g.
continuous/
batch,
open/
closed,
whether
water
is
involved
in
the
process
or
cleaning
the
system.)
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
49
CAS
No:
Country:

3.
OCCUPATIONAL
EXPOSURE
(
If
different
answers
are
expected
for
different
processes,
please
show
them
separately.
Please
also
distinguish
exposure
during
production
from
that
during
occupational/
professional
use.)

3.1
MAK
or
equivalent
occupational
standard
(
mg/
m
3
with
time
period)

3.2
Protective
measures
employed
(
Please
clarify
the
industry
category,
process
and/
or
activity.)

3.2.1
Engineering
control
3.2.2
Personal
protection
(
e.
g.
protective
equipment)

3.3
Other
information
3.3.1
Product
information
Industrial
Category
Use
of
the
product
/
preparation
Form
of
the
product
/
preparation
(
e.
g.
aerosol,
powder,
liquid)
Wt
%
of
the
chemical
in
the
product
/
preparation
Function
of
the
chemical
in
product
/
preparation
3.3.2
Exposure
scenarios
(
Clarify
the
industrial
category.
Please
also
distinguish
exposure
during
production
from
that
during
occupational/
professional
use.)

3.3.2.1
Activities
of
relevance
to
exposure,
and
route
and
extent
of
exposure
3.3.2.2
Frequency
and
duration
of
Use
(
days/
year
and
hrs/
day)

3.3.2.3
Number
of
workers
per
site
3.3.2.4
Characteristics
of
exposed
population
(
e.
g.
gender,
age)
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
50
CAS
No:
Country:

3.3.3
Summary
of
workplace
monitoring
data
[
Please
describe
summary
of
related
activity
and
sampling
and
analytical
methods;
year,
number,
range,
median
and
95%­
percentile
of
data
(
mg/
m
3),
if
possible.]

4.
ENVIRONMENTAL
EXPOSURE
4.1
Release
estimates
from
point
sources
(
Industrial
sectors
in
which
the
chemical
is
manufactured,
processed
or
used
should
be
identified
as
industrial
categories.)

Industrial
Category
Approximate
number
of
sites
Industrial
processes
which
are
likely
to
generate
releases
to
the
environment
(
Distinguish
manufacturing
from
processing
or
use)
Release
estimates
to
each
compartment
(
wt/
year
or
qualitative
distribution)

Surface
water
Air
Soil
Total
4.2
Summary
of
monitoring
data
of
emission
[
Please
clarify
the
source
in
conjunction
with
the
above
table.
Please
describe
media,
summary
of
sampling
and
analytical
methods;
year,
number,
range,
median
and
95%­
percentile
of
data
(
mg/
l,
mg/
g­
dry
or
wet,
mg/
m
3),
if
possible.]
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
51
CAS
No:
Country:

4.3
Release
estimates
from
off­
site
(
Please
try
to
cover
all
the
life
cycle
of
chemicals.)

Release
from:
Approximate
%
of
total
release
Industrial
category
or
Use
category
or
Form
of
waste
Processes
likely
to
generate
releases
to
the
environment
Release
estimates
to
each
compartment
(
wt/
year
or
qualitative
distribution)

Surface
water
Air
Soil
Small
scale
industry
Consumer
use
Waste
disposal
4.4
Summary
of
environmental
monitoring
data
[
Please
see
the
instruction
in
4.2.
Please
also
clarify
whether
the
data
can
be
considered
as
background
level
or
close
to
the
contaminated
site.]

5.
CONSUMER
EXPOSURE
(
Please
fill
in
this
table
in
conjunction
with
2.2.
Protected
measures
could
also
be
described
below
the
table.
If
no
consumer
use
is
expected,
please
skip
this.)

Use
Categories
for
consumer
use
Form
of
product
(
e.
g.
aerosol,
powder,
liquid)
Wt
%
of
chemical
in
product
and
dilution
factor
for
use
Function
of
the
chemical
in
product
Condition
of
use,
route
and
extent
of
exposure
(
e.
g.
oral,
dermal,
inhalation;
outdoors,
indoors)
Frequency
and
duration
of
use
(
days/
year
and
hrs/
day)

(
Any
protective
measures)
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
52
CAS
No:
Country:

6.
REGULATORY
INFORMATION
(
to
be
filled
in
by
SIDS
Contact
Points
only)

6.1
National
regulatory
standards
(
purpose
and
value)

6.2
Classification
and
Labelling
(
Please
describe
them.)

6.3
Other
measures
for
management
of
exposure
7.
OTHER
INFORMATION
WHICH
WILL
HELP
TO
FOCUS
EXPOSURE
ASSESSMENT
(
Any
other
quantitative
or
qualitative
information
could
be
described
here.)

8.
DATA
SOURCES
SEARCHED
(
REFERENCES)
(
Please
enter
full
details
including
negative
results.)

8.1
Data
sources
from
industry
8.2
National
data
sources
8.3
International
data
sources
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
53
Annex
5
An
Example
of
Procedure
for
Gathering
and
Documenting
Use­
related
Information
The
following
list
should
be
regarded
as
a
draft
"
checklist"
describing
individual
steps
in
the
process
of
gathering
and
documenting
use­
related
data.
The
"
checklist"
may
vary
according
to
the
organisations
(
e.
g.
government,
industry)
or
people
involved
in
conducting
the
search.

1.
Searching
substance
identity
data
·
searching
the
CAS­
Registry
file
(
STN)
(
scientific
substance
identity)
·
searching
internal
documentations
(
e.
g.
product
codes)

2.
Gathering
use­
related
information
by
searching
suitable
sources
·
searching
governmental
database
(
e.
g.
EXICHEM,
product
register,
release
inventory)
·
searching
internal
documentations
(
e.
g.
product
catalogues,
customer­
related
documentation)
·
selection
of
suitable
customer
firms
in
order
to
obtain
a
representative
cross­
section
of
use­
related
information
using
an
agreed
proforma.
The
use
of
an
agreed
proforma
is
intended
to
promote
comparability
of
the
information
which
is
obtained
and
may
serve
to
avoid
demotivation
in
the
consulted
firms
due
to
be
confronted
with
different
query
models.
·
searching
printed
literature
·
searching
standard
reference
books
·
searching
bibliographic
references
of
available
original
publications
(
reviews)
·
searching
suitable
electronic
databases
(
e.
g.
on­
line
databases,
CD­
ROM
publications)

3.
Description
of
the
work
done
·
short
description
of
the
search
strategy
(
e.
g.
description
of
the
approach
used
in
accessing
the
various
sources)
·
description
of
the
further
development
of
the
query
formulation
through
the
evaluation
of
the
documents
identified
during
the
search
4.
Documentation
of
search
results
·
short
description
of
the
steps
performed
in
the
search
procedure
·
negative
results:
list,
including
reference
to
the
source
·
positive
results:
present,
including
reference
to
the
source,
and
transfer
to
the
data
transfer
format
·
ensure
anonymity
of
source
information
where
necessary
(
e.
g.
identity
of
customers)
·
brief
assessment
of
search
results
(
e.
g.
out­
dated
literature
data)
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
54
Annex
6
Expressions
for
Quantity
and
Categories
of
Use
Pattern
1.
Quantity
Following
range
of
quantity
produced
or
imported
are
recommended
to
be
used.

10
­
50
tonnes
per
annum
50
­
100
tonnes
per
annum
100
­
500
tonnes
per
annum
500
­
1
000
tonnes
per
annum
1
000
­
5
000
tonnes
per
annum
5
000
­
10
000
tonnes
per
annum
10
000
­
50
000
tonnes
per
annum
50
000
­
100
000
tonnes
per
annum
100
000
­
500
000
tonnes
per
annum
500
000
­
1
000
000
tonnes
per
annum
more
than
1
000
000
tonnes
per
annum
Note:
indicate
the
year
when
these
quantities
were
produced
or
imported.
If
the
annual
figure
is
not
for
a
calendar
year,
specify
it
in
comment
field.

2.
Use
Pattern
Data
on
use
pattern
are
recommended
to
be
given
by
assigning
the
following
glossaries
which
is
also
used
in
HEDSET.
There
are
4
main
groups
according
to
their
exposure
relevance,
15
industrial
categories
and
55
use
categories.

Type
of
Use
­
use
EACH
of
following
terms
·
Main
·
Industrial
·
Use
A.
Main
Categories
­
use
one
of
the
following
glossary
codes
·
Use
in
closed
systems
·
Use
resulting
in
inclusion
into
or
onto
matrix
·
Non
dispersive
use
·
Wide
dispersive
use
Use
in
closed
systems
A
substance
should
be
assigned
only
to
this
category
if
it
remains
within
a
reactor
or
is
transferred
from
vessel
to
vessel
through
closed
pipework
and
therefore
accidental
spillage
is
the
only
likely
cause
for
human
exposure
or
environmental
contamination.
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
55
These
intermediates
are
classified
in
one
of
the
following
3
categories:
·
non­
isolated
intermediates
(
restricted
to
the
reaction
vessel
and
its
dedicated
equipment)
·
isolated
intermediates
stored
on­
site
under
controlled
conditions
·
isolated
intermediates
with
controlled
transport
A
typical
example
is
phosgene
which
will
be
used
only
under
these
conditions.

Substances
that
are
used
in
closed
systems
but
might
be
released
into
the
environment
after
use,
sometimes
in
considerable
quantities,
or
where
significant
discharges
into
the
environment
cannot
be
excluded
during
production
and
use,
should
be
assigned
to
the
"
Non
dispersive
use"
or
even
"
Wide
dispersive
use"
categories.

Typical
examples
in
the
latter
case
are
CFC's
used
as
cooling
agents
or
hydraulic
fluids.

Use
resulting
in
inclusion
into
or
onto
matrix
Use
consisting
of
inclusion
into
or
onto
matrices
means
all
processes
where
chemicals
are
incorporated
into
products
or
articles
from
which
they
would
not
be
released
into
the
environment.
Examples
are
the
inclusion
of
plasticizers
in
plastics,
additives
such
as
pigments
or
dyes
in
plastics
or
fibres
and
catalysts
in
coating
materials.

Non
dispersive
use
Non
dispersive
use
refers
to
chemicals
which
are
used
in
such
a
way
that
only
certain
groups
of
workers,
with
the
knowledge
of
the
processes,
come
into
contact
with
these
chemicals.
Workers
are
normally
aware
of
the
procedures
to
protect
themselves
through
the
use
of
personal
or
technical
protective
measures.
The
employer
should
also
take
the
necessary
steps
to
protect
the
environment
against
exposure.
Thus,
exposure
to
these
chemicals
will
be
limited.

These
chemicals
may
also
be
discharged
into
the
environment
from
point
sources.
Quantities
discharged
will
be
limited
due
to
protective
measures
such
as
waste
water
sewage
treatment
plants
or
air
filters.

Wide
dispersive
use
The
term
"
wide
dispersive
use"
should
be
used
for
a
wide
range
of
activities
particularly
where
end
users
come
into
contact
with
the
products.

Examples
are
detergents,
cosmetics,
disinfectants,
solvents
in
household
paints
B.
Industrial
Categories
­
use
the
following
glossary
codes
·
Agricultural
industry:
e.
g.
Pesticides,
fertilisers
·
Basic
chemical
industry:
basic
chemicals
e.
g.
Solvents,
pH­
regulating
agents
(
acids,
alkalis)
·
Chemical
industry:
chemicals
used
in
synthesis
e.
g.
Intermediates
(
including
monomers),
process
regulators
·
Electrical/
electronic
engineering
industry:
e.
g.
Electrolytes,
semiconductors.
Not:
galvanics,
electroplating
agents
·
Fuel
industry:
e.
g.
Gasoline,
colouring
agents,
fuel
additives,
antiknock
agents
·
Leather
processing
industry:
e.
g.
Dyestuffs,
tanning
auxiliaries
·
Metal
extraction,
refining
and
processing
industry:
e.
g.
Heat
transferring
agents,
electroplating
agents
·
Paints,
lacquers
and
varnishes
industry:
e.
g.
Solvents,
viscosity
adjusters,
dyestuffs
·
Paper,
pulp
and
board
industry:
e.
g.
Dyestuffs,
toners
·
Personal
and
domestic
use:
e.
g.
Consumer
products
such
as
detergents
(
including
additives),
cosmetics,
nonagricultural
pesticides
for
domestic
use
·
Photographic
industry:
e.
g.
Antifogging
agents,
sensitises
·
Polymers
industry:
e.
g.
Stabilisers,
softeners,
antistatic
agents,
dyestuffs
·
Public
domain:
e.
g.
Professional
products
used
in
public
areas
such
as
non­
agricultural
pesticides,
cleaning
agents
·
Textile
processing
industry:
e.
g.
Dyestuffs,
flame
retardants
EXCH\
MANUAL\
97­
2.
DOC/
July
1997
56
·
Other
(
indicate
the
category)

These
15
categories
represent
almost
all
industrial
uses
for
chemicals
and
could
serve
for
setting
up
exposure
scenarios
with
regard
to
the
designated
use
of
a
substance.

C.
Use
Categories
­
use
the
following
glossary
codes
·
Absorbents
and
Adsorbents
·
Adhesive,
binding
agents
·
Aerosol
propellants
·
Anti­
condensation
agents
·
Anti­
freezing
agents
·
Anti­
set­
off
and
anti­
adhesive
agents
·
Anti­
static
agents
·
Bleaching
agents
·
Cleaning/
washing
agents
and
disinfectants
·
Colouring
agents
·
Complexing
agents
·
Conductive
agents
·
Construction
materials
additives
·
Corrosion
inhibitors
·
Cosmetics
·
Dustbinding
agents
·
Electroplating
agents
·
Explosives
·
Fertilisers
·
Fillers
·
Fixing
agents
·
Flame
retardants
and
fire
preventing
agents
·
Flotation
agents
·
Flux
agents
for
casting
·
Foaming
agents
·
Food/
foodstuff
additives
·
Fuel
·
Fuel
additives
·
Heat
transferring
agents
·
Hydraulic
fluids
and
additives
·
Impregnation
agents
·
Insulating
materials
·
Intermediates
(
give
description
in
the
remarks
field)
·
Laboratory
chemicals
·
Lubricants
and
additives
·
Non­
agricultural
pesticides,
·
Odour
agents
·
Oxidising
agents
·
pH­
regulating
agents
·
Pesticides
·
Pharmaceuticals
·
Photochemicals
·
Process
regulators
·
Reducing
agents
·
Reprographic
agents
·
Semiconductors
·
Softeners
·
Solvents
·
Stabilisers
·
Surface­
active
agents
·
Tanning
agents
·
Viscosity
adjusters
·
Vulcanising
agents
·
Welding
and
soldering
agents
·
Others
(
indicate
the
category)
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
1
3.
DATA
EVALUATION,
PREPARATION
OF
SIDS
DOSSIERS
AND
TESTING
PLANS*

3.1
Introduction
1.
This
chapter
includes
documents
relevant
to
both
evaluation
of
data
in
a
SIDS
Dossier
and
developing
SIDS
Testing
Plans.

2.
In
the
past,
the
SIDS
Dossiers
and
the
SIDS
Testing
Plans
prepared
by
the
National
SIDS
Contact
Points
used
to
be
circulated
to
all
SIDS
Contact
Points
and
discussed
at
a
SIDS
Review
Meeting
in
order
to
agree
on
testing
plans.

3.
This
SIDS
Review
process
has
great
value
in
helping
to
ascertain
the
quality
of
the
data
existing,
to
maintain
accountability
regarding
data
quality,
and
to
reach
agreement
on
the
need
for
testing
prior
to
assessment.
However,
circulating
every
SIDS
Dossier
on
a
routine
basis
to
SIDS
Contact
Points
at
the
SIDS
Review
stage
may
create
unnecessary
work
for
Sponsor
countries
and
other
SIDS
Contact
Points.
Nevertheless,
it
is
desirable
for
the
Secretariat
and
other
Member
countries
to
be
aware
of
progress
and
decisions
regarding
data
quality
and
testing
needs
taken
by
Sponsor
countries
on
various
SIDS
chemicals.
Therefore,
the
Steering
Group
on
Existing
Chemicals
agreed
in
November
1996
on
the
following
revised
SIDS
Review
procedure
which
relies
primarily
on
the
judgement
of
the
Sponsor
country
about
the
adequacy
of
the
data.

(
1)
Where
the
Sponsor
country
has
ascertained
that
no
adequate
data
for
a
SIDS
end­
point
are
available,
but
that
testing
is
still
considered
unnecessary,
the
Sponsor
country
forwards
a
statement
to
the
Secretariat
on
this
point,
together
with
full
justification
and
relevant
supporting
data.
The
statement
should
provide
a
freestanding
and
detailed
argument
explaining
why
testing
is
not
needed.
Arguments
for
not
testing
are
expected
to
be
well­
developed
and
convincing.

(
2)
Where
testing
is
required
for
a
SIDS
end­
point,
the
Sponsor
country
forwards
the
information
to
the
Secretariat
regarding
which
tests
are
to
be
conducted
together
with
any
relevant
information.

(
3)
Where
testing
is
not
required
for
any
SIDS
end­
point,
the
Sponsor
country
informs
the
Secretariat
that
the
SIAR
is
being
prepared.

4.
It
has
also
been
agreed
that
the
summary
table
(
i.
e.
SIDS
Profile
and
SIDS
Summary)
showing
SIDS
data
needs
and
whether
testing
is
needed
be
included
in
the
material
which
is
forwarded
by
Sponsor
country
to
the
Secretariat.

5.
After
having
been
informed
on
the
above
by
Sponsor
countries,
the
Secretariat
collates
the
information
and
circulates
it
to
all
SIDS
Contact
Points,
accompanied
by
a
request
for
comments
under
the
written
procedure
with
a
given
2­
month
period.
Any
comments
are
sent
by
SIDS
Contact
Points
to
the
Sponsor
country
and
the
Secretariat.
It
is
assumed
that
Member
countries
not
responding
within
this
time­
frame
are
in
full
agreement
with
the
views
of
the
Sponsor
country.
Attempts
to
resolve
opposing
views
are
discussed
bilaterally
between
the
individual
Member
country
and
the
Sponsor
country.
This
overall
procedure
constitutes
the
SIDS
Review.

6.
To
facilitate
orderly
review,
it
is
important
that
the
format
for
the
SIDS
Dossiers
be
harmonized
and
that,
as
far
as
possible,
similar
approaches
be
used
in
the
assessment
of
the
acceptability
and
quality
of
the
information
received.

7.
Adequacy
of
data
in
the
SIDS
Dossiers
should
be
reviewed
based
on
the
"
Quality
of
and
Access
to
Data
Used
to
Prepare
SIDS
Dossiers"
(
Section
3.2).

8.
"
Considerations
for
Developing
SIDS
Testing
Plans"
(
Section
3.3)
should
be
taken
into
account
when
National
SIDS
Contact
Points
develop
the
testing
plan.
"
Guidance
for
Meeting
the
SIDS
Requirements
(
The
SIDS
Guide)"
(
Section
3.4)
should
also
be
considered.

9.
"
Considerations
Concerning
Adequacy
of
Data
in
the
SIDS"
(
Section
3.5)
should
be
used
for
deciding
if
information
in
the
SIDS
Dossier
is
satisfactory
for
the
use
in
initial
assessment
of
a
chemical
by
National
SIDS
Contact
Points.

*
The
documents
in
this
chapter
were
prepared
by
the
OECD
Secretariat
based
on
agreements
reached
in
the
OECD
Existing
Chemicals
Programme
up
to
June
1997.
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
2
10.
The
OECD
Guidelines
for
the
Testing
of
Chemicals
(
overview
of
currently
available
guidelines
are
shown
in
Annex
4
to
this
Manual)
and
the
Provisional
Data
Interpretation
Guides
for
Initial
Hazard
Assessment
(
DIGS)
(
OECD,
1984)
also
provide
useful
information
regarding
experimental
design,
methods
and
reporting
requirements.
The
"
Revised
Synopsis
of
OECD
Test
Guidelines
for
Studies
Included
in
the
Screening
Information
Data
Set
(
SIDS)"
(
Annex
3
to
this
Manual)
might
be
used
as
a
condensed
reference
to
study
elements,
methods
and
reporting
details
when
results
of
the
test
are
reported.

11.
In
cases
of
intermediates
and
other
chemicals
with
limited
exposure,
"
SIDS
Testing
of
Chemicals
with
Limited
Exposure
Potential"
(
Section
3.6)
should
be
used
in
addition
to
the
documents
cited
above.

12.
In
the
review
of
available
information,
some
studies/
data
may
be
considered
particularly
controversial
or
may
elicit
different
responses
from
SIDS
Contact
Points
as
to
whether
SIDS
Testing
should
be
required.
In
these
cases,
the
SIDS
Contact
Point
of
the
Sponsor
country
may
wish
to
provide
additional
information
beyond
that
requested
in
HEDSET
or
the
Revised
OECD
HPV
Form
1,
and
to
raise
the
issue
for
further
discussion.
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
3
3.2
Quality
of
and
Access
to
Data
Used
to
Prepare
SIDS
Dossiers
The
following
principles
should
be
followed
in
reviewing
and
documenting
the
quality
of
the
data
in
the
SIDS
Dossier:

·
Each
National
SIDS
Contact
Point
must
have
the
opportunity
to
evaluate
the
quality
of
important
supporting
data
for
chemicals
for
which
they
are
responsible
as
a
Sponsor
country.
In
principle,
their
evaluation
of
the
quality,
if
sufficiently
documented,
will
be
relied
upon
by
all
OECD
Member
countries.

·
Data
in
the
SIDS
Dossiers
should
be
appropriately
summarised
and
reported
and
sufficiently
referenced
in
order
to
allow
reviewers
enough
information
on
the
substance
tested,
methods,
endpoints
and
results
to
make
an
informed
judgement
of
the
quality
of
the
data.
The
Model
Dossier
(
see
Annex
2
to
this
manual)
provides
an
example
on
the
amount
of
information
which
should
be
reported.

·
Sponsor
countries
should
have
full
copies
of
studies
cited
in
SIDS
Dossier
so
that
reviewers
from
other
countries
are
able
to
actually
examine
the
studies
and
to
independently
validate
the
results
and
conclusions
reported
in
the
SIDS
Dossiers
if
necessary.
It
should
be
made
clear
in
describing
any
endpoints
where
full
studies
are
not
available.

·
In
general
the
support
data
and
reports
will
not
be
kept
confidential
[
see
also
OECD
Council
Act
C(
83)
98(
Final)
and
its
OECD
List
of
Non­
Confidential
Data
on
Chemicals].

·
In
the
exceptional
cases
where
data
are
indicated
to
be
confidential,
they
will
be
made
available
for
review
on
a
confidential
basis,
i.
e.
the
conditions
set
out
in
the
OECD
Council
Act
concerning
Exchange
of
Confidential
Data
on
Chemicals
[
C(
83)
97(
Final)]
apply
to
specific
experts
in
each
country
that
receives
the
data.

·
In
the
event
that
problems
still
remain
with
providing
support
data
to
SIDS
Contact
Points
other
than
the
Sponsor
country's
own
Contact
Point,
all
efforts
should
be
made
to
come
to
a
specific
solution
which
will
allow
progress
to
be
made
through
the
SIDS
Review
process
(
e.
g.
having
a
report
available
on
request
of
the
other
SIDS
Contact
Points
for
review).

·
If
the
majority
of
the
National
SIDS
Contact
Points
are
not
convinced
that
a
well­
informed
judgement
on
the
quality
of
the
data
can
be
made,
then,
unless
requested
additional
information
is
made
available
by
the
Sponsor
country
within
a
specified
time,
the
relevant
SIDS
Test
to
be
undertaken
and/
or
exposure
information
to
be
collected,
should
be
included
in
the
SIDS
Testing
Plan.

The
specific
"
Considerations
for
Developing
SIDS
Testing
Plans"
(
Section
3.3),
"
Guidance
for
Meeting
the
SIDS
Requirements
(
The
SIDS
Guide)"
(
Section
3.4)
and
"
Considerations
Concerning
the
Adequacy
of
Data
in
the
SIDS"
(
Section
3.5)
should
be
carefully
taken
into
account
in
preparing
the
SIDS
Testing
Plan.
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
4
3.3
Considerations
for
Developing
SIDS
Testing
Plans**

General
1.
The
requirement
to
complete
any
individual
data
element
of
the
SIDS
by
further
testing
will
depend
upon
the
quality
and
quantity
of
data
supplied
by
the
responder
to
the
OECD
request
for
available
data
on
High
Production
Volume
(
HPV)
chemicals
(
i.
e.
contained
in
the
Revised
OECD
HPV
Form
1,
or
preferably,
on
the
HEDSET
diskette).
As
such,
it
is
impossible
to
give
specific
guidance
which
covers
every
situation.
However,
it
is
essential
that
all
data
received
by
the
Sponsor
country
are
assessed
by
suitably
qualified
personnel
and
that
they,
in
collaboration
with
the
responder,
give
the
justification
for
not
completing
any
or
all
of
the
SIDS
data
elements.

2.
In
deciding
which
tests
should
be
undertaken,
the
statement
on
animal
welfare
adopted
by
the
Second
High
Level
Meeting
of
the
Chemicals
Group
[
ENV/
CHEM/
HLM/
M/
82.1,
para.
95]
should
be
taken
into
account.
Appropriate
information
derived
from
(
Quantitative)
Structure
Activity
Relationships
can
be
of
assistance
in
developing
the
SIDS
Testing
Plan.

3.
Any
additional
testing
that
is
required
should
be
performed
according
to
internationally
acceptable
guidelines
(
e.
g.
OECD
Test
Guidelines)
and
in
accordance
with
the
OECD
Principles
of
GLP.
Test
reports
should
contain
suitable,
signed
GLP
and
quality
assurance
statements.
Every
attempt
should
also
be
made
to
follow
the
procedures
specified
under
GLP
Principles.

4.
Expressing
results
by
phrases
such
as
"
insoluble
in
water"
is
discouraged.
A
limit
test
should
be
performed
under
such
circumstances
so
that
a
positive
expression,
such
as
"<
0.1
mg/
l
(
analytical
limit)",
can
be
entered.

Chemicals
for
Testing
5.
When
a
group
of
related
chemicals
is
being
considered,
testing
may
be
conducted
on
the
most
appropriate
analogue,
e.
g.
the
one
with
the
most
severe
potential
effects,
and
the
results
extrapolated
to
the
others.

6.
Practical
reasons
for
completing
less
than
the
SIDS
for
an
individual
chemical
include
the
availability
of
information
concerning:

°
isomers
which
have
a
similar
structure­
activity
profile;
°
closely
related
homologues;
°
relevant
precursors
and
breakdown
products
along
with
information
on
metabolism
and
degradation.

As
a
general
approach,
for
each
particular
endpoint,
the
use
of
range­
finding
tests
may
be
an
appropriate
first
step
to
establish
relative
levels
of
toxicity
between
isomers.

7.
To
avoid
interference
from
additives
and
impurities,
it
is
recommended
that
tests
for
physical­
chemical
properties
be
conducted
on
the
purified
substance
because
they
are
basic
information
on
a
specific
chemical.
The
other
tests,
however,
should
generally
be
carried
out
on
the
substance
with
any
essential
additives
(
e.
g.
stabilisers)
and
impurities
it
normally
contains
in
order
to
know
the
effects
of
the
marketed
product.
Ideally,
the
same
batch
of
substance
should
be
used.
However,
gross
amounts
of
water,
mineral
oil
or
other
solvents
that
are
sometimes
present
in
the
marketed
product
should
be
excluded.

8.
Highly
reactive
chemicals
may
not
be
stable
enough
for
experiments
to
be
conducted,
hence
testing
may
not
be
practical.
In
these
cases,
it
may
be
useful
to
examine
breakdown
products
for
possible
adverse
effects
and,
where
a
compound
is
of
limited
stability,
it
may
be
desirable
to
design
individual
ways
for
testing
the
potential
effect
for
particular
endpoints.
For
example,
in
the
case
of
a
compound
whose
breakdown
properties
have
severely
irritant
properties,
it
may
be
possible
to
test
the
parent
compound
at
doses
below
the
level
at
which
the
irritating
effect
of
the
breakdown
product
occurs.
It
may
also
be
useful
to
determine
the
lowest
dose
which
is
tolerated,
via
a
limited
range
finding
test
using
a
few
animals,
and
to
use
these
results
to
determine
what
toxic
effects
may
be
expected
to
occur
as
a
result
of
repeated
doses.

**
The
content
of
this
section
is
based
on
a
document
discussed
at
the
20th
Joint
Meeting
of
the
Chemicals
Group
and
Management
Committee
of
the
Special
Programme
on
the
Control
of
Chemicals
(
May
1993).
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
5
9.
For
intermediates,
a
limited
data
set
rather
than
a
full
SIDS
might
be
required.
Details
are
provided
in
"
SIDS
Testing
of
Chemicals
with
Limited
Exposure
Potential"
(
Section
3.6).

Ecotoxicity
and
Toxicity
Tests
10.
For
aquatic
effect
testing,
prolonged/
chronic
toxicity
testing
in
Daphnia
should
be
considered
in
addition
to
acute
tests
if
there
is
concern
for
long­
term
effects.

11.
In
determining
whether
significant
exposure
may
be
expected
in
the
terrestrial
environment,
it
should
be
considered
whether:

·
the
chemical
has
a
potential
for
reaching
the
terrestrial
environment
based
on
use
and
transport
patterns
and
disposal
practices,
taking
into
account
all
phases
of
the
life
cycle;

·
physical­
chemical
properties
indicate
that
the
compound
may
be
persistent,
has
a
potential
to
bioaccumulate,
or
that
a
major
portion
may
partition
to
the
soil;
and/
or
·
monitoring
data
indicate
residues
in
soil,
sewage
sludge
or
groundwater.

12.
In
considering
which
terrestrial
testing
should
be
undertaken,
the
studies
selected
should
be
appropriate
to
the
receiving
environmental
compartment
(
e.
g.
in
the
case
of
sewage
sludge,
toxicity
to
earthworms
and
plants).
In
addition,
attention
should
be
given
to
cross­
media
considerations.

13.
For
the
reproduction
toxicity
endpoint:

·
when
a
90­
day
repeated
dose
study
is
available
and
is
sufficiently
documented
with
respect
to
studying
effects
on
reproductive
organs,
and
a
developmental
study
is
available,
the
requirements
for
the
reproduction
toxicity
endpoint
are
satisfied;

·
when
either
a
90­
day
or
a
28­
day
repeated
dose
study
is
the
only
repeated
dose
study
available,
it
is
recommended
that
a
reproduction/
developmental
toxicity
screening
test
(
e.
g.
OECD
Test
Guideline
421)
be
carried
out
in
order
to
satisfy
the
requirements
for
the
reproduction
toxicity
endpoint.

·
when
a
90­
day
repeated
dose
study
is
available
and
demonstrates
no
effects
on
reproductive
organs,
in
particular
the
testes,
then
a
developmental
study
(
e.
g.
OECD
Test
Guideline
414)
can
be
considered
as
an
adequate
test
for
information
on
reproduction/
developmental
effect.
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
6
3.4
Guidance
for
Meeting
the
SIDS
Requirements
(
The
SIDS
Guide)

In
order
to
assure
harmonized
responses
from
Member
countries
and
to
ensure
consistency
on
requests
for
further
testing,
this
guidance
document
(
SIDS
guide)
has
been
developed.
This
documents
show
data
requirements
and
Test
guidelines
to
be
used
on
each
data
element.

Note:
Figures
in
[
]
correspond
to
the
data
elements
in
the
HEDSET
and
in
the
Revised
OECD
HPV
Form
1.

1.
GENERAL
INFORMATION
[
1.01
A.]
CAS­
number
·
Should
always
be
stated.

[
1.01
C.]
Name
of
the
Substance
·
Should
always
be
stated.
·
Use
the
name
supplied
by
the
OECD.

[
1.01
D.]
CAS­
descriptor
·
Should
be
stated
where
applicable
for
complex
chemicals.

[
1.01
G.]
Structural
Formula
·
Should
be
given
where
possible.

[
1.5]
Quantity
·
Should
be
given
where
possible.
·
Information
on
production
and/
or
import
levels
should
be
provided
as
tonnes
per
annum
(
or
ranges,
e.
g.,
100­
500
tonnes,
see
Annex
6
to
Section
2.5)
per
country
and
the
date
for
which
those
figures
or
ranges
apply
should
be
given.

[
1.7]
Use
Pattern
·
Should
be
given
where
possible.
·
Data
on
use
pattern
should
be
given
by
assigning
main
types
according
to
their
exposure
relevance,
industrial
categories
and
use
categories.
Detailed
explanation
on
categories
is
given
in
Annex
to
Section
2.6
and
the
HEDSET
explanatory
note.
·
If
the
chemical
is
present
in
consumer
products
as
marketed,
details
should
be
mentioned
on;
­
function
of
the
products
(
e.
g.
detergent
etc.),
­
weight
fraction
of
the
chemical
in
products
and
­
physical
state
of
products
as
marketed
(
e.
g.
aerosol,
powder
or
liquid))
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
7
[
1.9]
Sources
of
Exposure
·
Should
be
given
where
possible.
·
Describe
sources
of
potential
human
or
environmental
exposure
including
emission
data
if
available
for
all
phases
of
the
life
cycle
of
the
chemical
including
manufacturing
and
user
areas.
·
For
environmental
exposure,
indicate
the
production
process
briefly,
number
of
sites
of
manufacture
and
the
basis
for
concluding
that
the
process
is
"
closed"
if
applicable.
·
Indication
of
measured
exposure
levels
can
be
mentioned
here.
Any
information
that
will
help
to
focus
the
assessment
of
exposure
can
be
mentioned,
if
available
2.
PHYSICAL­
CHEMICAL
DATA
[
2.1]
Melting
Point
·
Should
always
be
stated
for
substances
other
than
gases
(
and
liquids
whose
melting
point
is
lower
than
approximately
0
°
C.)
Temperature
of
decomposition
is
acceptable.
·
OECD
Test
Guideline
102
[
2.2]
Boiling
Point
·
Should
always
be
stated
for
substances
other
than
gases
or
solids
and
liquids
which
either
boil
above
300
°
C
or
decompose
before
boiling
(
in
which
cases
estimates
based
on
vapour
pressure
or
the
boiling
point
under
reduced
pressure
are
necessary).
Temperature
of
decomposition
is
acceptable.
·
OECD
Test
Guideline
103
[
2.3]
Density
(
Relative
Density)

·
Where
applicable,
indicate
the
relative
density
of
the
substance.
This
property
is
generally
more
important
for
inorganic
chemicals.
·
OECD
Test
Guideline
109
[
2.4]
Vapour
Pressure
·
Should
always
be
stated.
·
Calculations
which
indicate
that
the
value
is
probably
less
than
10­
5
kPa
at
25
°
C,
could
preclude
the
need
for
testing.
·
If
a
boiling
point
cannot
be
quoted
due
to
decomposition
or
the
melting
point
is
above
360
°
C,
it
may
not
be
necessary
to
conduct
this
test.
If
a
melting
point
is
<
360
°
C
but
>
200
°
C,
a
limit
value
based
on
measurement
or
a
recognised
calculation
method
is
acceptable.
·
This
test
is
not
essential
for
chemicals
with
a
boiling
point
of
<
30
°
C.
·
OECD
Test
Guideline
104
[
2.5]
Partition
Coefficient
(
n­
Octanol/
water)

·
Should
always
be
stated.
·
Even
for
those
substances
which
are
extremely
soluble/
insoluble
in
either
phase,
an
attempt
should
be
made
to
provide
a
limit
value
(
if
necessary
based
on
the
individual
solubilities
in
n­
Octanol
and
water).
It
is
recognised
that
for
surface
active
substances,
the
measured
result
may
only
be
approximate.
·
The
MedChem
database
is
a
good
source
of
data.
·
If
the
test
cannot
be
performed,
a
calculated
value
for
Log
Pow
should
be
provided.
However
it
should
be
noted
that
calculated
values
which
are
higher
than
6
are,
in
general,
not
reliable.
·
For
calculation
of
Pow,
see
e.
g.:
­
C.
Hansch,
A.
J.
Leo
in
Substituent
Constants
for
Correlation
Analysis
in
Chemistry
and
Biology,
John
Wiley,
New
York,
1979.
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
8
­
W.
J.
Lyman,
W.
J.
Reehl,
D.
H.
Rosenblatt
(
ed.),
Handbook
of
Chemical
Property
Estimation
Methods,
McGraw­
Hill,
New
York,
1983.
­
Annex
to
OECD
Test
Guideline
117.
­
Application
of
Structure
Activity
Relationships
to
the
Estimation
of
Properties
Important
in
Exposure
Assessment,
OECD
Environment
Monograph
No.
67,
1993.
·
OECD
Test
Guidelines
107,
117
[
2.6.
A.]
Water
Solubility
·
Should
always
be
stated,
including
gases
if
necessary,
excluding
volatile
substances
and
substances
unstable
in
water.
·
Determinations
should
be
made
at
or
near
20
°
C.
If
solubility/
temperature
dependence
is
>
3%
per
°
C,
further
measurements
should
be
made
at
10
°
C
above
and
below
the
initially
chosen
temperature.
If
the
substance
is
"
insoluble"
in
water,
the
detection
limit
of
the
analytical
method
should
be
indicated.
·
OECD
Test
Guideline
105
[
2.6.
B.]
pH
Value
and
pKa
Value
·
Where
applicable,
enter
values
for
the
dissociation
constant(
s)
and
the
conditions
under
which
they
were
measured.
·
Dissociation
constants
are
particularly
important
for
acids,
bases
and
inorganic
chemicals
(
and
are
normally
known
calculated
or
measured).
·
OECD
Test
Guideline
112
[
2.12]
Oxidation­
Reduction
Potential
·
Where
applicable,
indicate
the
redox
potential
and
the
conditions
under
which
it
was
measured.
This
property
is
generally
more
important
for
inorganic
chemicals.

[
2.13
A.]
Adsorption/
Desorption
to
Soil
·
Where
applicable,
indicate
the
adsorption/
desorption
to
soil
and
conditions
under
which
it
was
measured.
·
This
property
is
particularly
important
for
inorganic
chemicals
in
cases
where
Log
Pow
is
not
useful
in
view
of
the
expected
properties
of
the
chemicals.
·
OECD
Test
Guideline
106
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
9
3.
ENVIRONMENTAL
FATE
AND
PATHWAYS
[
3.1.1]
Photodegradation
·
For
photodegradation,
an
estimation
is
generally
sufficient.
·
Estimation
of
photodegradability
(
and
hydrolysis)
can
be
based
on
reference
documents,
e.
g.,
"
An
Assessment
of
Test
Methods
for
Photodegradation
of
Chemicals
in
the
Environment"
(
ECETOC
Technical
Report
No.
3)
and
"
Handbook
of
Chemical
Property
Estimation
Methods"
(
W.
J.
Lyman,
W.
J.
Reehl,
D.
H.
Rosenblatt
(
ed.),
Handbook
of
Chemical
Property
Estimation
Methods,
McGraw­
Hill,
New
York,
1983.)
·
OECD
Test
Guideline
113
[
3.1.2]
Stability
in
Water
(
Hydrolysis)

·
Testing
is
generally
required
for
hydrolysis
unless
adequate
data
is
already
available.
But
consideration
should
be
given
to
the
possibility
of
using
estimation
methods.
·
Additional
testing
may
be
required
for
hydrolysis
even
if
data
have
been
supplied,
given
consideration
to:
­
choice
of
test
protocol;
­
quality
of
data.
·
When
possible,
the
products
of
hydrolysis
should
be
identified.
·
OECD
Test
Guideline
111
[
3.2]
Monitoring
Data
(
Environment)

·
Where
available,
indicate
an
overview
of
monitoring
data
in
the
environment
with
specifications
of
conditions.

[
3.3]
Transport
and
Distribution
between
Environmental
Compartments
including
Estimated
Environmental
Concentrations
and
Distribution
Pathways
·
Environmental
concentration
and
important
fate
and
between
pathways
based
on
simple
models,
e.
g.,
those
in
the
"
Guidance
for
Initial
Assessment
of
Environmental
Exposure"
and
"
Compendium
of
Environmental
Exposure
Assessment
Methods
for
Chemicals"
(
OECD
Environment
Monograph
No.
27)
etc.
should
be
described.
·
In
particular
calculation
of
distribution
of
a
chemical
between
environmental
compartments
by
a
Fugacity
Level
I
model
should
be
provided.
(
The
diskettes
which
accommodate
global
reference
model
(
FUGMOD)
and
other
national
models
which
have
been
distributed
by
the
Secretariat
can
be
used
for
this
purpose.)

[
3.5]
Biodegradation
·
Testing
is
generally
required,
other
than
for
gases,
unless
adequate
data
is
already
available.
·
Additional
testing
may
be
required
even
if
data
have
been
supplied,
given
consideration
to:
­
choice
of
test
protocol;
­
quality
of
data.
·
OECD
Test
Guideline
301A­
301F
·
The
feasibility
of
each
OECD
Test
Guideline
(
301A­
301F)
may
be
dependent
on
the
physical­
chemical
properties
(
e.
g.,
stability
in
water),
and
the
structure
of
the
test
substance.

4.
ECOTOXICITY
·
Where
aquatic
tests
are
carried
out
on
poorly
soluble
substances
at
nominal
concentration
above
the
solubility
limit
in
the
test
medium,
and
no
mortalities
or
effects
are
observed,
then
the
LC50,
EC50
and
NOEC
should
be
indicated
as
being
above
the
stated
solubility
limit
in
the
test
medium.
·
For
poorly
soluble
substances,
it
should
also
be
clearly
stated
whether
solvents
were
used
to
enhance
the
solubility.
Testing
at
the
solubility
limit,
without
solvent,
is
preferred.
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
10
(*)
For
substances
which
decompose
in
water,
LC50,
EC50
and
NOEC
should
be
expressed
in
terms
of
the
nominal
concentration
of
the
tested
substance.

[
4.1]
Acute/
Prolonged
Toxicity
to
Fish
·
Testing
is
generally
required
if
no
adequate
data
is
already
available.
·
Additional
testing
may
be
required
even
if
data
have
been
supplied,
given
consideration
to:
­
results
from
testing
and
calculations;
­
quality
of
data.
·
OECD
Test
Guideline
203
(*)

[
4.2.
A]
Acute
Toxicity
to
Aquatic
Invertebrates
(
Daphnia)

·
Acute
testing
is
generally
required
if
no
adequate
data
is
already
available.
·
Additional
testing
may
be
required
even
if
data
have
been
supplied,
given
consideration
to
quality
of
data.
·
OECD
Test
Guideline
202,
Part
1
(*)

[
4.3]
Toxicity
to
Aquatic
plants
e.
g.
Algae
·
Testing
is
generally
required
if
no
adequate
data
is
already
available.
·
Additional
testing
may
be
required
even
if
data
have
been
supplied,
given
consideration
to
quality
of
data.
·
OECD
Test
Guideline
201
(*)

[
4.5.2]
Chronic
Toxicity
to
Aquatic
Invertebrates
(
Daphnia)

·
Chronic
testing
will
be
required
if
there
is
concern
about
possible
long­
term
effects
in
the
aquatic
environment.
·
OECD
Test
Guideline
202,
Part
2
(*)

[
4.6]
Toxicity
to
Terrestrial
Organisms
·
If
significant
exposure
is
expected
in
the
terrestrial
environment
compartment,
appropriate
terrestrial
toxicity
tests
should
be
performed.
·
In
determining
whether
significant
exposure
may
be
expected
in
the
terrestrial
environment,
the
following
should
be
considered:
­
the
chemical
has
a
potential
for
reaching
the
terrestrial
environment
based
on
use
and
transport
patterns
and
disposal
practices
taking
into
account
all
phases
of
the
life
cycle
combined
with;
­
physical­
chemical
properties
indicate
the
compound
may
be
persistent,
has
a
potential
to
bioaccumulate
or
a
major
portion
may
partition
to
the
soil;
or
­
measured
data
indicate
residues
in
soil,
waste
water
sludge
or
groundwater.
·
In
considering
which
terrestrial
testing
should
be
undertaken,
it
should
be
taken
into
account
that
studies
should
be
appropriate
to
the
receiving
environmental
compartment
(
e.
g.,
in
the
case
of
sewage
sludge,
toxicity
to
earthworms
and
plants).
In
addition,
attention
should
be
given
to
cross
media
considerations.
·
Initially,
a
test
should
be
performed
on
terrestrial
invertebrates
and/
or
plants.
The
results
of
other
tests
may
indicate
the
need
for
avian
toxicity
tests.
·
OECD
Test
Guideline
205­
208
(*)
­
205:
Avian
Dietary
Toxicity
Test
­
206:
Avian
Reproduction
Test
­
207:
Earthworms
Acute
Toxicity
Test
·
The
artificial
soil
test
is
preferred
because
the
paper
contact
test
is
not
truly
representative
of
the
natural
habitat.
­
208:
Terrestrial
Plants,
Growth
Test
5.
TOXICITY
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
11
[
5.1]
Acute
Toxicity
·
Testing
is
generally
required
if
no
adequate
data
is
already
available.
Consideration
should
be
given
to
the
possibility
of
using
data
from
analogues
or
repeated
dose
toxicity
studies
on
the
same
substance.
·
Additional
testing
may
be
required
even
if
data
have
been
supplied,
given
consideration
to:
­
test
species;
­
route
of
exposure;
­
quality
of
data.
·
The
rat
is
the
preferred
species
(
oral
and
inhalation).
For
dermal
tests,
the
rat,
rabbit
or
guinea
pig
are
preferred
species.
·
All
substances,
except
gases
and
vapours,
should
be
tested
by
the
oral
route.
Dependent
upon
the
physical­
chemical
properties
of
the
substance
and
the
most
important
route
of
human
exposure,
the
dermal
or
the
inhalation
route
could
also
be
considered.
Gases
should
be
tested
by
the
inhalation
route
alone.
·
OECD
Test
Guideline
401­
403,
420
[
5.4]
Repeated
dose
Toxicity
·
Testing
is
generally
required
if
no
adequate
data
is
already
available.
·
Additional
testing
may
be
required
even
if
data
have
been
supplied,
given
consideration
to:
­
test
species;
­
route
of
exposure;
­
duration
of
exposure;
­
quality
of
data.
·
The
rat
is
the
preferred
species
but
consideration
should
be
given
to
the
species
used
in
the
acute
test.
Oral,
dermal
and
inhalation
routes
should
be
considered.
The
oral
route
is
normally
preferred.
The
appropriate
route
should
be
selected
dependent
on
physical­
chemical
properties
of
the
substance,
the
results
of
the
acute
toxicity
tests
and
the
most
important
route
of
human
exposure.
·
OECD
Test
Guideline
407,
410
and
412
·
The
"
Combined
Repeated
Dose
Toxicity
Study
with
the
Reproduction/
Developmental
Toxicity
Screening
Test"
(
OECD
Test
Guideline
422)
is
also
acceptable.
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
12
[
5.5]
[
5.6]
Genetic
Toxicity
in
vitro
and
in
vivo
·
Testing
is
generally
required
if
no
adequate
data
is
already
available.
·
Additional
testing
may
be
required
even
if
data
have
been
supplied,
given
consideration
to:
­
test
organism,
strain
and/
or
cell
system;
­
if
metabolic
activation
has
been
used;
­
quality
of
data.

·
Two
different
endpoints
should
be
tested:
gene
mutation
and
chromosomal
aberration.
These
endpoints
may
be
evaluated
by
using
the
following
tests:
­
Gene
mutation
in
prokaryotic
cells,
should
be
performed
preferably
in
Salmonella
typhimurium
(
OECD
Test
Guideline
471).
The
chemical
class
of
the
test
substance
may
determine
which
test
organism
and
whether
modified
procedures
may
be
needed.
The
test
should
be
carried
out
with
and
without
metabolic
activation.
­
Chromosomal
aberration
in
mammalian
cells
grown
in
vitro
(
OECD
Test
Guideline
473)
or
in
vivo
methods
such
as
the
micronucleus
test
or
metaphase
analysis
of
bone
marrow
cells
(
OECD
Test
Guidelines
474,
475).
For
chemicals
which
are
in
vitro
mutagens
and
are
handled
and
used
as
if
they
were
in
vivo
mutagens,
then
any
further
in
vivo
tests
may
be
considered
for
post
SIDS
assessment.

[
5.7]
Toxicity
to
Reproduction
·
Testing
is
generally
required
if
no
adequate
data
is
already
available.
·
Additional
testing
may
be
required
even
if
data
have
been
supplied,
given
consideration
to:
­
test
species;
­
duration
of
exposure;
­
quality
of
data.
·
For
the
reproduction
toxicity
endpoint,
­
when
a
90­
day
repeated
dose
study
is
available
and
is
sufficiently
documented
with
respect
to
studying
effects
on
the
reproductive
organs
and
a
developmental
study
is
available,
the
requirements
for
the
reproduction
toxicity
endpoint
are
satisfied;
­
when
either
a
90­
day
or
28­
day
repeated­
dose
study
is
the
only
repeated
dose
study
available,
it
is
recommended
that
the
reproduction/
developmental
toxicity
screening
test
(
e.
g.
OECD
Test
Guideline
421)
be
carried
out
in
order
to
satisfy
the
requirements
for
the
reproduction
toxicity
endpoint;
and
­
when
a
90­
day
repeated
dose
study
is
available
and
demonstrates
no
effect
on
reproductive
organs,
in
particular
the
testes,
then
a
developmental
study
(
e.
g.
OECD
Test
Guidelines
414)
can
be
considered
as
an
adequate
test
to
complete
information
on
reproduction/
developmental
effect.
·
OECD
Test
Guideline
415
­
416.
The
screening
tests
[
OECD
Test
Guideline
422:
Combined
Repeated
Dose
Toxicity
Study
with
the
Reproduction/
Developmental
Toxicity
Screening
Test,
(
for
when
repeated
dose
toxicity
is
not
available)
and
OECD
Test
Guideline
421:
Reproduction/
Developmental
Toxicity
Screening
Test
(
for
when
repeated
dose
toxicity
is
available)]
are
also
acceptable.

[
5.8]
Developmental
Toxicity/
Teratogenicity
·
Endpoint
of
developmental
toxicity
is
generally
required
if
no
adequate
data
is
already
available.
See
Toxicity
to
Reproduction.
·
OECD
Test
Guideline
414
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
13
[
5.11]
Experiences
with
Human
Exposure
(
Work
Place
Exposure)

·
Information
on
work
place
exposure
such
as;
­
concentration
of
chemicals
in
the
workplace
(
manufacturing,
maintenance
and
professional
use)
and
indoor
environment,
­
number
of
workers
(
in
range
or
situations
including
manufacture,
maintenance
and
use),
­
frequency,
duration
and
level
of
exposure
should
be
mentioned
if
available.
·
Effects
of
accidental
or
occupational
exposure,
epidemiological
and
clinical
studies,
case
reports,
etc.
can
be
described.
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
14
3.5
Considerations
Concerning
the
Adequacy
of
Data
in
the
SIDS***

General
1.
Each
National
SIDS
Contact
Point
must
have
the
opportunity
to
evaluate
the
quality
of
data
in
the
SIDS
for
chemicals
with
complete
studies
available
for
which
they
are
responsible
as
a
Sponsor
country.

2.
OECD
Test
Guidelines
and
GLP
Principles
are
generally
used
to
produce
studies
of
acceptable
quality.
However,
data
may
be
considered
adequate
for
the
purposes
of
screening
even
if
not
totally
acceptable
by
international
standards
(
e.
g.
OECD
Test
Guidelines,
GLP
Principles).
This
is
best
determined
by
expert
judgement
on
a
case­
by­
case
basis.

3.
It
may
not
be
necessary
to
conduct
certain
studies
in
cases
when:

·
other
studies,
for
example
on
analogues,
are
available
and
the
results
are
consistent
­
e.
g.,
acute
toxicity
studies,
biodegradation
studies;

·
there
are
other
relevant
studies
or
calculations
available,
and
the
results
are
consistent,
which
diminishes
the
need
for
retesting;
and/
or
·
an
approximate
value
is
adequate
for
screening
purposes,
e.
g.
acute
toxicity
studies.

4.
If
studies
have
been
carried
out
according
to
guidelines
other
than
those
of
the
OECD,
these
test
methods
should
be
clearly
described.
Also
if
calculated
data
are
reported,
the
method
of
calculation
and
its
justification
should
be
described.

5.
In
the
same
way,
if
studies
have
not
been
carried
out
under
the
OECD
GLP
Principles,
an
explanation
for
not
doing
so
must
be
provided.

6.
If
some
SIDS
data
are
inadequate
or
missing,
there
will
be
a
bias
for
testing
unless
a
rationale
for
not
testing
is
provided
and
is
accepted
in
the
international
context.
Again,
bearing
in
mind
animal
welfare
considerations,
internationally
acceptable
methods
of
in
vitro
testing
should
be
considered
as
a
first
line
of
approach.

7.
Studies
should
be
referenced
as
clearly
as
possible
so
that,
when
data
are
prepared
for
transfer
to
IRPTC
and
IPCS,
they
can
be
properly
identified
and
coded.

Physical­
chemical
Data
8.
Physical­
chemical
data
for
boiling
point
and
melting
point
when
taken
from
reliable
references
(
i.
e.
from
handbooks)
rather
than
taken
from
actual
test
reports
can
generally
be
accepted
because
there
is
good
confidence
in
these
data
based
on
experience.
Information
on
related
compounds
may
be
useful
in
affirming
physical­
chemical
parameters.

9.
For
vapour
pressure,
octanol/
water
partition
coefficients
(
Pow)
and
water
solubility
studies,
more
scrutiny
may
be
required
as
such
data
are
more
critical
to
the
initial
assessment
of
potential
hazards,
e.
g.
bioaccumulation.
In
particular,
calculated
values
of
log
Pow
are
not
reliable
if
greater
than
6.
The
American
MedChem
database
could
be
used
as
a
good
source
of
data
for
these
endpoints.

10.
Key
information
which
affects
the
value
of
physical­
chemical
properties
such
as
temperature
and
methods
used
must
be
provided.

Environmental
Fate
Data
***
The
content
of
this
section
is
based
on
a
document
discussed
at
the
20th
Joint
Meeting
of
the
Chemicals
Group
and
Management
Committee
of
the
Special
Programme
on
the
Control
of
Chemicals
(
May
1993).
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
15
11.
As
for
biodegradation
data
on
a
chemical,
the
most
important
issue
at
the
level
of
the
SIDS
is
whether
a
compound
is
readily
biodegradable
or
not.
Therefore,
in
any
ready
biodegradability
test,
the
following
figures
should
be
provided:

·
the
number
of
micro­
organisms
present;
·
the
time
window
for
10
per
cent
degradation;
and
·
the
test
results
at
the
end
of
the
test.

It
is
necessary
to
present
these
data
for
tests
which
are
comparable
with
ready
biodegradation
tests.
Other
biodegradation
data
that
are
available,
especially
data
obtained
using
natural
media
such
as
soil
or
river
water,
should
also
be
included
in
the
SIDS
dossier.

12.
Distribution
of
a
chemical
between
environmental
compartments
can
be
calculated
by
the
Fugacity
Level
I
Model
in
the
FUGMOD
computer
program,
which
has
been
distributed
by
the
OECD
Secretariat
and
can
be
obtained
from
SIDS
Contact
Points.
Primarily
partition
coefficients
such
as
soil/
water
Koc,
Henry's
constant
and
BCF's
are
required
for
inputting
into
the
fugacity
model
when
it
is
used.

Ecotoxicity
and
Toxicity
Data
13.
If
any
of
the
required
ecotoxicity
or
toxicity
studies
are
lacking,
consideration
may
be
given
to
waiving
some
testing
endpoints
where
there
are
adequate
data
for
closely
related
analogues.
This
should
be
closely
scrutinised
on
a
case­
by­
case
basis.

14.
For
a
proper
evaluation
of
ecotoxicity
and
toxicity
studies,
detailed
information
should
be
reported
in
addition
to
those
explicitly
required
in
the
Revised
OECD
HPV
Form
1
or
the
HEDSET.
Lack
of
detail
in
reporting
toxicity
or
ecotoxicity
data
does
not
automatically
lead
to
the
need
to
re­
test,
but
this
will
delay
a
decision
on
the
acceptability
and
adequacy
of
toxicity
and
ecotoxicity
studies
mentioned
in
the
SIDS
Dossiers.
Availability
of
detailed
information
for
all
tests
make
the
review
by
other
countries
much
easier
and
more
efficient.
Examples
of
details
on
the
information
on
the
aquatic
toxicity
tests
which
could
be
reported,
if
available,
recommended
by
the
Netherlands
and
the
US
respectively,
are
attached
as
an
Annex
to
this
section.

15.
If
the
data
presented
from
studies
not
fully
in
compliance
with
GLP
Principles
and/
or
not
conducted
according
to
internationally
acceptable
test
guidelines
suggest
a
very
low
concern
for
the
desired
endpoints,
i.
e.
a
high
and
acceptable
NOEL,
then
the
test
may
be
considered
adequate
for
screening
purposes.
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
16
Annex
Information
to
be
Used
in
the
Evaluation
of
Aquatic
Toxicity
Test
Results,
if
available
1.
Items
and
Contents
Recommended
by
the
Netherlands
A.
Organism
B.
Method
C.
Test­
system:
static;
semi­
static;
continuous
flow
D.
Test
result:
­­
fish:
24
+
48
+
72
+
96
hour
­­
daphnia/
acute:
24
+
48
hour
­­
algae:
24­
72
hr:
EC50
+
NOEC
+
parameters
used;
biomass
or
growth
rate
­­
daphnia/
chronic:
NOEC,
LC50(
21d),
EC50(
21d)
(
in
cases
where
chronic
data
are
needed)

E.
Purity
of
test
compound
F.
Whether
analysis
has
been
carried
out
and
if
so:
­­
Is
the
result
based
on
the
nominal
or
measured
concentration?
­­
If
the
result
is
based
on
the
measured
concentration,
an
indication
of
the
discrepancies
should
be
given.

G.
Additional
information
for
special
compounds:
(
This
information
also
is
required
for
biodegradation
tests.)
­­
volatile
substance:
was
an
open
or
closed
system
used?
­­
insoluble
substance:
if
a
solvent
is
used,
how
much
has
been
added
and
has
a
solvent
control
been
carried
out?

2.
Items
and
Contents
Recommended
by
the
US
A.
Organism:
Age,
mean
length
and
mean
weight,
as
appropriate;
loading.

B.
Test
System:
For
semi­
static,
time
period
between
renewal;
for
continuous
flow,
number
of
replacements
per
day.

C.
Fish
Test
Result:
24,
48,
72
and
96
hr
results;
discriminate
between
intrinsic
(
chemical)
toxicity
and
physical
toxicity;
sublethal
effects
observed.

D.
Daphnia
Test
Result
(
acute):
24
and
48
hr
result;
discriminate
between
intrinsic
(
chemical)
toxicity
and
physical
toxicity;
sub­
lethal
effects
observed.

E.
Algae
Test
Result:
24­
72
hr
(
96
hr
EC50,
if
available);
NOEC
and
LOEC;
parameter
used
(
biomass
or
growth
rate).
F.
Analytical
Method:
Detection
limit,
mean
per
cent
recovery,
table
of
nominal
concentrations
and
measured
concentrations
with
time
interval(
s)
indicated,
mean
measured
concentrations,
statement
as
to
how
concentrations
below
the
detection
limit
were
handled
in
the
calculation
of
mean
measured
concentrations;
concentration
values
should
be
reported
as
"
100%
active
ingredient."

G.
Dilution
Water:
Source,
hardness,
pH,
total
organic
carbon
(
TOC),
total
suspended
solids
(
TSS).

H.
Algae
Growth
Medium:
Composition;
final
concentrations
of
nutrients
in
medium;
TOC;
hardness.
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
17
I.
pH
of
Test
Solution:
pH
of
test
solution
at
t=
0
hr
and
48
hr
or
96
hr
as
appropriate.

J.
Purity:
Impurities;
physical
state.

K.
Aeration:
Was
aeration
used
during
test;
if
yes,
how
much
and
by
what
method?

L.
Volatile:
For
closed
systems,
presence
of
head
space;
size
of
any
head
space;
modifications
of
closed
test
system
relative
to
open
test
system,
e.
g.
adjustments
in
algal
growth
medium
of
bicarbonate
concentration.

M.
Stock
Solution
Preparation:

(
1)
If
a
stock
solution
was
prepared,
this
procedure
must
be
carefully
evaluated
using
considerations
such
as
the
following:
check
all
calculations
from
test
material
to
stock
solution;
concentration
to
treatment
concentrations;
indicate
clearly
if
stock
solution
concentration
was
based
on
test
material
"
as
is"
or
on
100
percent
active
ingredients;
solvents
or
carriers
used
and
their
possible
effects;
concentration
of
solvents
or
carriers
used;
pH
of
stock
solution;
pH
adjustment,
if
any;
time
between
stock
solution
preparation
and
addition
of
organisms
to
exposure
vessels;
observations
of
physical
appearance
of
stock
solution:
clear,
milky
dispersions
as
observed
for
detergents
and
charged
polymers,
dispersed
solids,
precipitate,
oily
slick
or
phase
separation,
etc.;
if
precipitates
are
present,
how
were
they
handled:
mixed
and
distributed
to
exposure
vessels
of
filtered
out;
if
filtered
out,
what
type
of
filter,
were
all
solids
filtered
or
only
part
of
solids;
was
only
the
water
soluble
fraction
(
WSF)
removed
from
the
stock
solution;
methods
used
to
dissolve
test
material:
sonication
(
how
long),
mixing
time
heating,
etc.

(
2)
If
no
stock
solution
was
prepared,
the
direct
dilution
of
test
material
was
employed.
What
was
the
time
between
direct
dilution
of
the
test
material
to
the
exposure
vessel
and
the
addition
of
organisms?

[
Note:
Not
all
of
these
points
are
of
equal
relevance
to
the
evaluation
of
tests,
depending
on
the
nature
of
the
specific
chemical.
Guidance
could
be
developed
as
to
when
certain
information
is
critical
to
interpreting
study
results
on
a
given
class
of
chemicals
in
later
phases
of
the
HPV
programme.]
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
18
3.6
SIDS
Testing
of
Chemicals
with
Limited
Exposure
Potential****

1.
This
document
is
intended
to
give
exposure
criteria
in
relation
to
SIDS
Testing,
with
regard
to
both
intermediates
and
chemicals
for
which
other
claims
for
limited
exposure
can
be
made.

Definition
of
Intermediates
2.
With
respect
to
intermediates,
any
chemical
which
is
intended
to
undergo
a
further
deliberate
reaction
to
produce
another
industrial
substance
is
considered
an
intermediate.

3.
In
the
context
of
the
SIDS
work,
the
following
types
of
intermediates
which
are
contained
in
closed
systems
and
therefore
have
a
limited
potential
for
exposure
can
be
identified:

a)
non­
isolated
intermediates,
i.
e.
those
chemicals
whose
life­
cycle
is
restricted
to
the
reaction
vessel
and
its
specific
equipment;

b)
isolated
intermediates
which
are
stored
in
controlled
on­
site
facilities;

c)
isolated
intermediates
with
controlled
transport,
i.
e.
to
a
limited
number
of
locations
within
the
same
company
or
second
parties
which
use
the
chemical
in
a
controlled
way
as
an
intermediate
with
a
well­
known
technology.

Reduced
SIDS
4.
For
these
intermediates
of
categories
3a),
b)
and
c),
a
reduced
SIDS
package
reflecting
the
information
needed
to
evaluate
the
hazards
in
case
of
an
accident
could
be
used.
This
consists
of
the
Screening
Information
Data
Set
(
SIDS)
minus
the
tests
for
repeated
dose
toxicity
and
reproduction
toxicity.

5.
For
intermediates
in
categories
3b)
and
3c),
mentioned
above,
inclusion
of
tests
for
reproduction/
developmental
toxicity
included
in
the
reduced
SIDS
package
should
be
considered
on
a
case­
by­
case
basis.

6.
In
view
of
their
limited
exposure
potential,
intermediates
currently
have
a
lower
priority
in
the
context
of
the
SIDS
work
and,
consequently,
the
choice
of
these
chemicals
by
Sponsor
countries
is
discouraged.

7.
It
was
agreed
that
if,
in
spite
of
the
above­
mentioned
discouragement,
an
intermediate
in
categories
3b)
or
3c)
was
chosen
in
one
of
the
early
phases
of
the
SIDS
work,
then
the
Sponsor
country
must
be
prepared
to
undertake
a
developmental
toxicity
study.

8.
The
contribution
to
the
overall
sharing
of
the
burden
and
fulfilling
of
the
SIDS
testing
commitments
by
Sponsor
countries
is
only
partially
satisfied
when
a
reduced
SIDS
is
performed.
In
order
to
conduct
the
initial
phases
in
a
practical
and
equitable
manner,
it
was
agreed
that
when
reduced
SIDS
are
conducted
for
intermediates,
(
an)
additional
chemical(
s)
should
be
taken
up
by
the
Sponsor
country
concerned.
For
example,
when
SIDS
testing
for
a
non­
isolated
intermediate
is
undertaken,
SIDS
testing
for
a
second
non­
isolated
intermediate
would
be
appropriate
to
make
up
a
full
commitment.

Other
Chemicals
for
which
Limited
Potential
for
Exposure
can
be
Claimed
9.
For
chemicals
other
than
intermediates,
the
possibility
of
reduced
SIDS
testing
exists
based
on
considerations
of
limited
potential
for
exposure.
It
was
felt
that
adequate
experience
was
not
yet
available
to
develop
suitable
criteria
to
define
such
considerations
in
sufficient
detail.

10.
Consequently,
it
was
agreed
that,
except
for
the
first
phase,
a
Sponsor
country
would
not
choose
a
chemical
for
which
a
claim
for
limited
potential
for
exposure
could
be
made.

****
The
content
of
this
Section
is
based
on
a
document
discussed
at
an
Expert
Meeting
on
Exposure
Criteria
and
SIDS
Testing,
held
in
Paris
in
March
1991.
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
19
International
Aspects
11.
Whenever
a
Sponsor
country
claims
reduced
SIDS
testing
requirements
for
any
of
its
chemicals
such
chemicals
should
be
considered
carefully
by
other
Member
countries.
If
they
have
substantiated
evidence
of
existing
or
potential
exposure
in
their
country,
they
should
forward
this
information
to
the
Secretariat
and
the
Sponsor
country
so
that
it
can
be
used
in
a
possible
revision
of
the
proposed
SIDS
Testing
Plan
for
the
chemical
concerned.
A
non­
response
or
null
return
by
any
Member
country
will
be
assumed
to
signify
no
exposure
in
that
country.
By
following
this
procedure
the
Sponsor
country,
which
will
undertake
the
necessary
testing,
can
ensure
that
the
international
dimensions
which
are
inherent
in
the
SIDS
work
are
encompassed.
Those
chemicals
for
which
reduced
SIDS
Testing
has
been
internationally
agreed
will
be
periodically
re­
assessed
for
any
changes
in
the
exposure
parameters.

12.
The
international
character
of
the
SIDS
work
suggests
that
exposure
should
not
be
viewed
solely
from
a
national
standpoint.
Hence,
it
has
been
agreed
that
when
a
Sponsor
country
claims
reduced
SIDS
testing
based
on
considerations
of
limited
potential
for
exposure,
and
receives
substantiated
evidence
for
existing
or
potential
exposure
from
another
Member
country,
then
the
Sponsor
country
should
undertake
the
full
SIDS
Testing,
and
an
extensive
fate
and
pathway
assessment
should
be
conducted.

13.
For
chemicals
considered
to
have
limited
potential
for
exposure,
it
is
recommended
that
a
procedure
and
timetable
be
defined
for
collecting
use
information
from
other
Member
countries,
when
a
chemical
moves
into
an
initial
assessment
phase.

Quality
of
Data
14.
The
principles
concerning
the
quality
of
and
access
to
data
in
the
SIDS
Dossier,
which
are
mentioned
in
the
documents
such
as
"
Considerations
Concerning
Adequacy
of
Data
in
the
SIDS"
(
Section
3.5),
etc.,
should
obviously
also
apply
to
the
information
concerning
exposure,
in
the
case
of
claims
for
exemptions
based
on
limited
exposure
as
well
as
in
the
case
of
substantiated
evidence
to
indicate
existing
or
potential
exposure.

15.
It
was
agreed
that,
when
a
claim
for
reduced
SIDS
testing
is
made
based
on
considerations
of
limited
potential
for
exposure,
in
addition
to
completing
the
HEDSET
and/
or
the
Revised
OECD
HPV
Form
1,
further
information
will
need
to
be
provided
to
support
that
claim.
Details
of
the
type
of
such
information
have
been
agreed.
They
include
number
of
sites,
process,
monitoring,
presence
in
products,
and
transport
(
see
Annex
to
this
Section).
EXCH\
MANUAL\
97­
3.
DOC/
July
1997
20
Annex
Information
Requirements
Supporting
Exemption
Claims
for
Reduced
SIDS
Testing
Based
on
Exposure
Considerations
I.
Information
on
sites
A.
Number
of
sites
B.
Basis
for
"
closed
process"
conclusion
at
each
site:

1)
process
description
in
enough
detail
to
clarify
the
basis
for
claiming
that
the
process
is
closed;
2)
if
available,
monitoring
data
showing
no
detection
in
any
media,
including
the
limits
of
detection;
3)
if
monitoring
data
are
not
available,
statement
that
no
monitoring
has
taken
place
and
basis
for
believing,
in
the
absence
of
data,
that
the
chemical
has
not
been
released
and
that
exposure
does
not
occur.

[
Note:
Distinguishing
between
no
data
and
no
detection
is
important.]

C.
Data
on
"
presence
in
distributed
product"
or,
in
the
absence
of
data,
the
basis
for
believing
it
is
not
present.

II.
Information
on
transport
If
transport
also
occurs,
then
in
addition
to
the
above,
the
following
should
be
provided:

·
Mode
of
transport
(
e.
g.
water,
truck,
rail,
pipeline)
·
Volume
(
annual)
·
Types
of
consignments
(
e.
g.
bulk
or
drums)
·
Controls
during
transport
and
transfer
at
despatching
and
receiving
sites
(
placards,
labels,
etc.)

III.
Supporting
evidence
from
a
data
search
showing
that
the
chemical
is
not
present
in
other
end­
products
EXCH\
MANUAL\
96­
4­
1.
DOC/
May
1996
1
4.
PREPARATION
OF
THE
SIDS
INITIAL
ASSESSMENT
REPORT
4.1
Introduction
The
OECD
Secretariat,
supported
by
many
experts
from
Member
counties
and
from
IPCS,
has
developed
five
provisional
guidance
documents
for
use
in
the
initial
assessment
of
SIDS
chemicals.
National
SIDS
Contact
Points
could
use
them
instead
of,
and/
or
in
addition
to,
their
own
methods
in
making
their
Initial
Assessment
Reports.
It
should
be
noted
that
these
guidance
documents
should
be
used
in
the
spirit
of
"
learning
by
doing".
They
will
be
regularly
reviewed
in
order
to
evaluate
their
usefulness,
to
identify
commonalities
in
approaches,
and
to
make
suggestions
for
their
further
improvement.

These
guidance
documents
have
been
revised
taking
into
account
the
EU
"
Technical
Guidance
Documents
on
Risk
Assessment
for
New
and
Existing
Substances"
for
human
and
environmental
effects
and
exposure,
for
the
formatting
of
assessment
reports,
etc.,
which
have
currently
been
developed.
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
1
4.2
Provisional
Guidance
for
the
Outline
of
the
SIDS
Initial
Assessment
Report
*

4.2.1
General
aspects
1.
The
purpose
of
this
document
is
to
provide
guidance
on
the
nature,
structure
and
format
of
the
SIDS
Initial
Assessment
Reports
(
SIARs).
Such
reports
are
to
be
prepared
by
the
Sponsor
countries
and
circulated
to
the
SIDS
Contact
Points
in
a
prompt
manner
to
ensure
their
readiness
for
discussion
at
the
SIDS
Initial
Assessment
Meeting
(
SIAM).

2.
The
structure
of
the
SIDS
Initial
Assessment
Report
should
be
such
that
it
can
be
readily
discussed
at
the
SIDS
Initial
Assessment
Meeting,
and
can
provide
assistance
in
drawing
conclusions
related
to
the
potential
risk
of
the
chemical
and
priority
for
further
work
or
action.
With
this
in
mind,
it
would
be
convenient
if
all
such
reports
followed
the
same
format
and
structure
thus
allowing
quick
and
efficient
references
to
be
made.
It
would
also
enable
the
same
types
of
information
to
be
found
in
the
same
place
in
each
report.

3.
At
the
same
time,
harmonisation
of
assessment
methods
and
contents
of
assessment
reports
is
recommended
in
order
that
the
same
conclusions
are
made
when
similar
data
sets
are
reviewed
and
to
make
reports
more
comprehensible
and
usable
to
all
Member
countries.
This
document
provides
a
model
for
harmonization
of
the
structure
and
content
of
assessment
reports.

4.
Where
an
assessment
report
on
a
chemical
has
already
been
produced
for
a
national
or
regional
programme,
it
should
be
used
to
the
extent
possible,
despite
differences
in
structure
to
that
proposed
here,
in
order
to
avoid
duplication
of
work.
From
this
point
of
view,
flexibility
on
minor
issues,
e.
g.
headings,
is
acceptable
if
the
overall
structure
and
content
of
the
assessment
report
follow
the
guidance
set
out
below.

4.2.2
Documents
to
be
prepared
5.
Documents
to
be
submitted
to
the
SIDS
Initial
Assessment
Meeting,
i.
e.
previously
circulated
to
the
SIDS
Contact
Points
and
the
Secretariat,
consist
of
the
following:

°
Cover
page;
°
SIDS
Initial
Assessment
Profile;
°
Full
SIDS
Summary;
and
°
SIDS
Initial
Assessment
Report
with
Full
SIDS
Dossier
6.
The
cover
page
(
the
format
is
shown
in
Annex
2
to
this
guidance)
reviews
the
decisions
taken
in
the
SIDS
Review
process
regarding
SIDS
testing
to
be
undertaken
and
briefly
describes
the
history
of
the
chemical
in
the
programme
to
date.

7.
The
SIDS
Initial
Assessment
Profile
which
follows
the
cover
page
(
the
format
is
shown
in
Annex
3
to
this
guidance)
summarises
the
conclusions
of
the
initial
assessment
and
recommendations
based
on
them
by
the
Sponsor
country.
Conclusions
include
the
summary
of
properties
and
effects
of
the
chemical
and
the
result
of
the
assessment
on
potential
risk
to
man
and
the
environment.
Recommendations
relate
to
the
need
for
further
work
or
action
on
the
chemical.
The
reasons
which
support
the
recommendations,
including
those
related
to
risk
reduction
measures
or
safe
handling
procedures
in
Member
countries,
should
be
given.
Proposals
for
Post­
SIDS
work
or
in­
depth
risk
assessment,
or
further
action
in
the
area
of
risk
management,
as
appropriate,
should
also
be
described.
This
profile
is
similar
to
Chapter
5
of
the
assessment
report
shown
in
Annex
1
to
this
guidance.

8.
The
full
SIDS
Summary
(
the
format
is
shown
in
Annex
4
to
this
guidance)
will
help
readers
understand
the
properties
and
effects
of
the
chemical.
Although
it
may
repeat
information
later
contained
in
the
assessment
report
and
the
Full
SIDS
Dossier,
this
table
is
meant
to
allow
a
quick
review
of
the
data
(
e.
g.
properties,
exposure
and
effects).
Data
beyond
SIDS
requirements
can
be
added
if
the
items
are
relevant
to
the
assessment
of
the
chemical,
e.
g.
corrosiveness/
irritation,
carcinogenicity.

*
This
document
was
prepared
by
the
OECD
Secretariat
based
on
the
agreements
reached
in
the
OECD
Existing
Chemicals
Programme
up
to
May
1996.
This
guidance
should
be
applied
to
the
assessment
reports
prepared
for
the
4th
SIAM
and
thereafter.
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
2
4.2.3
Full
SIDS
Dossier
9.
The
Full
SIDS
Dossier,
including
information
additional
to
the
SIDS
requirements,
if
available,
should
be
annexed
to
the
SIDS
Initial
Assessment
Report.

10.
In
order
to
avoid
duplicative
work,
it
is
assumed
that
the
original
SIDS
Dossier
prepared
by
the
Sponsor
country
and
reviewed
in
the
SIDS
Review
Process
will
form
the
basis
for
the
SIDS
Initial
Assessment
Report.
This
original
SIDS
Dossier
may
have
to
be
updated
by
the
Sponsor
country
to
become
a
Full
SIDS
Dossier,
i.
e.
inclusion
of
the
results
of
the
SIDS
tests
which
have
been
carried
out
and
any
new
information
obtained,
particularly
with
regard
to
exposure
and
use.
Full
reports
of
the
SIDS
testing
do
not
need
to
be
attached,
but
they
should
be
available
on
request.

11.
The
data
elements
in
the
original
SIDS
Dossier
for
which
no
SIDS
tests
had
been
requested
are
normally
considered
to
be
of
adequate
quality,
and
can
be
used
as
a
basis
for
making
an
initial
assessment.
In
some
cases,
the
content
of
the
data
elements
in
the
original
SIDS
Dossier
might
be
reviewed,
taking
into
account
the
"
Quality
of
and
Access
to
Data
Used
to
Prepare
SIDS
Dossiers"
(
see
Section
3.2)
and
the
comments
by
Member
countries
through
the
SIDS
Review
process.
The
validated
data
should
clearly
be
identified
in
the
SIDS
Dossier
as
"
preferred
results"
(
see
also
Section
2.4,
and
Annex
2
to
this
Manual;
Model
SIDS
Dossier).

12.
The
Full
SIDS
Dossier,
as
well
as
the
original
SIDS
Dossier,
should,
if
possible,
be
submitted
with
data
on
a
HEDSET
diskette,
an
export
file
from
the
IUCLID,
or
their
print
file.

4.2.4
SIDS
Initial
Assessment
Report
13.
The
SIDS
Initial
Assessment
Report
should
include:

°
chemical
identification,
physical/
chemical
properties
and
information
on
classification
and
safe
handling
procedures
(
if
appropriate);
°
assessments
of
environmental
exposure
and
ecotoxicity
data;
°
assessments
of
human
exposure
and
toxicity
data;
°
comparison
of
the
results
of
the
exposure
and
effects
assessments
for
the
environment
and
human
health
respectively;
and
°
conclusions,
and
recommendations
related
to
the
potential
risk
and
follow­
up
work
or
action
if
any
are
considered
necessary.

14.
The
SIDS
Initial
Assessment
Report
should
be
a
"
stand
alone"
document.
Therefore,
the
Report
should
also
include,
in
each
relevant
section,
a
short
self­
explanatory
summary
of
the
data;
for
specific
details,
cross­
reference
should
be
made
to
the
Full
SIDS
Dossier
which
is
annexed.
The
data
used
for
developing
an
assessment
report
should
be
examined
carefully,
especially
for
those
chemicals
which
have
a
great
deal
of
data.
The
key
elements
for
the
data
evaluation
are
shown
in
"
Considerations
Concerning
the
Adequacy
of
Data
in
the
SIDS",
Section
3.5
of
this
Manual.
Finally,
only
the
validated
data,
i.
e.
preferred
results,
should
be
introduced
in
the
assessment
report
and
used
for
the
assessment.

15.
It
is
also
very
important
to
clearly
identify
which
models,
factors,
assumptions,
etc.
have
been
used
in
making
the
initial
assessments,
in
order
to
allow
others
to
understand
the
reasons
(
and
the
uncertainties
associated
with
them)
behind
the
conclusions
and
recommendations.

16.
An
outline
of
the
proposed
structure
and
content
of
the
SIDS
Initial
Assessment
Report
is
set
out
in
Annex
1
to
this
document.
The
structure
has
been
modified
from
that
used
for
reports
up
to
and
including
the
3rd
SIAM.
This
is
because
experience
in
the
SIDS
Programme
has
shown
that
it
may
be
more
appropriate
to
discuss
exposure
and
effects
for
the
environment
and
for
human
health
separately,
rather
than
to
deal
with
all
exposure
situations
and
types
of
effects,
respectively.

17.
The
length
of
the
assessment
report
will
depend
upon
the
chemical
being
considered.
A
great
deal
of
data
related
to
different
endpoints
may
be
available
for
some
chemicals,
while
only
limited
data
on
basic
endpoints
may
be
available
for
others.
In
both
cases,
however,
the
reports
should
generally
be
less
than
about
15
pages,
in
order
to
focus
the
discussion
in
the
assessment
meeting.
Detailed
information
on
the
process
and
the
results
of
assessment,
e.
g.
on
the
estimation
of
environmental
concentrations,
can
be
added
as
an
annex,
where
required.
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
3
18.
At
the
3rd
SIAM
held
in
Williamsburg,
Virginia,
in
February
1995,
participants
agreed
that
the
SIARs
on
Triethanolamine
and
Diethanolamine
developed
by
UK
were
good
models
for
the
preparation
of
SIARs,
though
they
were
written
according
to
the
former
structure.

19.
The
SIDS
Initial
Assessment
Profile
and
Initial
Assessment
Report
along
with
the
Full
SIDS
Dossier
will
be
published
and
made
available
world­
wide
through
IRPTC.

4.2.5
Use
of
Guidance
Materials
20.
The
following
provisional
guidance
documents
(
also
included
in
this
manual)
are
available
from
the
SIDS
Contact
Points:

°
Initial
Assessment
of
Environmental
Exposure
(
Section
4.3);
°
Initial
Assessment
of
Occupational
and
Consumer
Exposure
(
Section
4.4);
°
Initial
Assessment
of
Aquatic
Effects
(
Section
4.5);
and
°
Initial
Assessment
of
Health
Effects
(
Section
4.6).

21.
These
guidance
documents
have
been
developed
based
on
discussions
among
many
experts
from
Member
countries,
the
European
Commission,
IPCS
and
other
bodies,
at
the
OECD
workshops
on
assessment,
in
the
Hazard
Assessment
Advisory
Body
and
in
the
Steering
Group
on
Existing
Chemicals.
The
intention
of
these
guidance
documents
is
to
ensure
that
Sponsor
countries
have
a
common
approach
in
developing
their
SIDS
Initial
Assessment
Reports.

22.
These
guidance
documents
provide
the
"
state­
of­
the­
art"
in
each
area,
i.
e.
several
methods,
models,
factors,
assumptions,
etc,
which
are
used
in
some
Member
countries
are
introduced.
They
are
intended
to
be
used
in
the
spirit
of
"
learning
by
doing".
Therefore,
it
would
be
very
helpful
if
the
Sponsor
countries
could
indicate
in
their
reports
where
they
used
methods
other
than
those
suggested
in
the
provisional
guidance
and,
in
such
cases,
why.

23.
These
guidance
documents
will
be
reviewed
regularly
in
order
to
evaluate
their
usefulness,
to
identify
commonalities
in
approaches,
and
to
make
suggestions
for
further
improvements
and
harmonization.
In
the
long
term,
harmonisation
of
assessment
methods
is
the
goal.

4.2.6
Discussion
at
the
SIDS
Initial
Assessment
Meeting
24.
Each
SIDS
Initial
Assessment
Report
is
circulated
by
the
Sponsor
countries
to
all
SIDS
Contact
Points
and
the
OECD
Secretariat
and
is
then
discussed
at
the
SIDS
Initial
Assessment
Meeting.
The
purpose
of
the
SIDS
Initial
Assessment
Meeting
is
to
reach
consensus
on
the
initial
assessments
and
the
conclusions
and
recommendations.

25.
Based
on
an
initial
assessment
of
the
effects
and
exposure
data
provided
in
the
SIDS
Dossier,
each
chemical
can
be
described
in
light
of
the
potential
it
presents
for
risk
to
man
and/
or
the
environment
(
including
the
extent
of
exposure
and
current
risk
reduction
measures)
and
of
the
need
for
further
work
or
action
(
e.
g.
post­
SIDS
testing,
exposure
analysis,
indepth
risk
assessment,
further
risk
management
action).
Given
the
various
possible
combinations,
conclusions
and
recommendations
could
be
written,
for
example,
as
follows:

°
The
chemical
can
be
considered
to
present
a
low
potential
for
risk
to
man
and
the
environment.
Thus,
there
is
no
current
priority
for
undertaking
post­
SIDS
testing
and/
or
exposure
analysis
or
an
in­
depth
assessment;

°
The
chemical
may
present
a
potential
for
risk
to
man
and/
or
the
environment.
Thus,
there
is
a
priority
for
undertaking
post­
SIDS
testing
and/
or
exposure
analysis
and/
or
an
in­
depth
assessment
to
clarify
the
nature
or
extent
of
the
potential
risk;

°
The
chemical
presents
a
potential
for
risk
to
man
and/
or
the
environment.
However,
risk
reduction
measures
currently
in
place
in
Member
countries
are
considered
adequate
to
control
the
risk.
Thus,
there
is
no
current
priority
for
further
risk
management
action;

°
The
chemical
presents
a
potential
for
risk
to
man
and/
or
the
environment.
Due
to
the
exposure
and/
or
lack
of
current
risk
reduction
measures,
risk
management
actions
might
be
necessary.
These
could
range,
as
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
4
appropriate,
from
responsible
care
activities
by
the
chemical
industry
to
national
or
international
risk
reduction
activities;

°
Etc.

26.
The
hazard(
s)
should
be
identified
in
the
conclusions
and
specific
further
work
or
action
to
be
undertaken
should
be
proposed
in
the
recommendations
by
the
Sponsor
country.
Information
on
risk
reduction
measures
in
Member
countries
(
e.
g.
classification,
safe
handling
procedures,
etc.)
should
also
be
included
in
the
report,
if
relevant.
These
issues
would
be
discussed
and
clarified
at
the
SIAM
and
reviewed
by
the
Steering
Group
and,
subsequently,
by
the
Joint
Meeting.

27.
It
is
conceivable
that
a
chemical
could
be
considered
to
present
a
potential
risk
based
on
a
specific
hazard
and
that
there
could
also
be
a
priority
for
further
activities
to
clarify
other
potential
effects
(
e.
g.
a
chemical
which
is
clearly
genotoxic
but
on
which
further
testing
is
required
to
clarify
aquatic
effects).

28.
For
those
chemicals
for
which
post­
SIDS
work
and/
or
the
in­
depth
risk
assessment
is
recommended,
the
SIAM
has
to
discuss
the
following
issues:

°
the
rationale
for
and
nature
of
further
work
needed
to
be
done;
°
the
relative
priority
of
this
work;
°
the
provisional
time
schedule;
and
°
a
country
to
oversee
the
work
done
by
industry,
etc.
(
see
Chapter
5
of
this
Manual)

29.
For
those
chemicals
which
present
a
potential
for
risk
and
for
which
further
risk
management
actions
are
considered
necessary,
more
discussion
on
the
rationale
for
further
risk
management
actions
etc.
based
on
information
on
current
risk
management
of
the
chemical
will
be
had
in
the
Steering
Group
and,
if
needed,
also
at
another
forum
in
the
OECD.
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
5
Annex
1
PROPOSED
STRUCTURE
AND
CONTENT
OF
THE
SIDS
INITIAL
ASSESSMENT
REPORT
0.
COVER
PAGE
SIDS
INITIAL
ASSESSMENT
PROFILE
FULL
SIDS
SUMMARY
See
Annex
2,
3
and
4
to
this
guidance.

1.
IDENTITY
This
chapter
should
include
the
following
basic
information
on
the
chemical:

°
identification
of
the
chemical
(
e.
g.
CAS
Number,
name,
molecular
formula,
etc.)
°
composition
(
e.
g.
degree
of
purity,
impurities
or
additives,
difference
of
purities
among
products)
°
basic
elements
of
physical­
chemical
properties
(
e.
g.
water
solubility,
Pow,
vapour
pressure,
etc.)
°
classification
used
in
Member
countries,
if
appropriate
It
may
also
suggest
similar
or
analogous
chemicals
for
which
data
is
readily
available
and
with
which
the
SIDS
chemical
under
consideration
could
be
compared.

2.
GENERAL
INFORMATION
ON
EXPOSURE
General
information
on
exposure
should
be
summarised
for
the
clear
understanding
of
the
exposure
scenario
described
in
Chapter
3,
e.
g.:

°
production
volume
°
uses
and
functions
°
form
of
marketed
product(
s)
°
source(
s)
of
release
to
the
environment
°
information
on
safe
handling
procedures
(
e.
g.
MSDS),
if
appropriate
Exposure
situations
in
the
Sponsor
country
and
in
other
countries
should
be
described.

3.
ENVIRONMENT
3.1
Environmental
Exposure
3.1.1
General
Discussion
Based
on
the
information
on
exposure,
use
pattern
and
physical­
chemical
properties,
environmental
fate
and
pathways
are
qualitatively
discussed.
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
6
The
description
here
also
includes
discussion
on:

°
fate
in
waste
water
treatment
plants
(
WWTP),
if
relevant;
°
distribution
in
air,
water,
soil
etc.;
°
abiotic
and
biotic
degradation
in
air,
water,
soil;
°
bioaccumulation
in
different
environmental
compartments;
and
°
possibility
to
form
degradation
products
and
their
environmental
fate
and
pathways.

Environmental
compartments
to
be
discussed
in
the
exposure
assessment
should
be
identified
following
an
analysis
of
release
and
accumulation.

3.1.2
Predicted
Environmental
Concentration
If
quantitative
analysis
is
possible,
Predicted
Environmental
Concentrations
(
PECs)
should
be
derived
based
on
monitoring
data
and/
or
calculation
by
using
exposure
models.
Estimation
includes
two
approaches
depending
on
the
reliability
of
data;

°
based
on
monitoring
data
and
supported
by
calculation
using
models
(
to
be
preferred);
or
°
based
on
calculation
using
models
and
supported,
if
possible,
by
monitoring
data.

When
an
exposure
model
is
used,
the
frame
and
key
parameters
should
be
summarised
here
or
attached
as
an
annex.

At
a
minimum,
PECregional
(
global)
and
PEClocal
in
the
aquatic
compartment
should
both
be
derived.
Monitoring
data
should
be
allocated
to
either
regional
(
global)
or
local
levels.
PECs
in
other
compartments
(
i.
e.
sediment,
soil,
air)
may
be
derived
and
discussed
depending
on
the
exposure
scenario.

If
a
quantitative
analysis
is
not
possible,
a
qualitative
evaluation
using
use
pattern
and
other
information
on
physical­
chemical
properties
and
exposure
may
be
given.

3.2
Effects
on
the
Environment
3.2.1
Aquatic
effects
Results
of
ecotoxicity
tests
are
introduced
and
discussed,
i.
e.:

°
acute
(
short­
term)
toxicity
to
fish,
Daphnia
and
algae;
°
available
subchronic/
chronic
(
prolonged/
long­
term)
toxicity
data
on
fish,
Daphnia
and
algae;
and
°
other
ecotoxicity
data
available.

Qualitative
considerations
are
also
to
be
mentioned
concerning:

°
the
toxic
mode
of
action
of
the
chemical;
and
°
possibility
to
cause
chronic
effects
based
on
physical­
chemical
properties,
stability,
relationship
between
acute
toxicity
and
time,
release
pattern,
degradation
products,
etc.

Finally,
the
Predicted
No
Effect
Concentration
(
PNEC)
value
for
the
aquatic
environment
is
derived
by
applying
relevant
assessment
factors.
The
reasons
for
choosing
these
factors
should
be
stated.

3.2.2
Terrestrial
effects
If
significant
exposure
to
the
terrestrial
environment
is
expected,
effects
assessment
for
the
terrestrial
environment
should
be
considered.

3.2.3
Other
effects
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
7
Other
ecotoxicological
information
that
is
available
should
also
be
taken
into
account
and
discussed
depending
on
the
exposure
scenario
and
the
reliability
of
the
methods
for
effect
assessments
(
e.
g.
"
secondary
poisoning",
effects
on
sediment­
dwelling
organisms,
effects
on
micro­
organisms
in
WWTP,
effects
on
the
atmosphere).
If
there
is
a
bioaccumulation
potential,
the
discussion
on
the
possibility
of
adverse
effects
due
to
"
secondary
poisoning"
is
recommended
to
be
included.

If
a
quantitative
analysis
is
not
possible
(
e.
g.
chemicals
difficult
to
test
or
unstable),
a
qualitative
evaluation
based
on
physical­
chemical
properties
and
estimation
from
analogues
can
be
given.

3.3
Initial
Assessment
for
the
Environment
This
includes
a
comparison
of
exposure
assessments
and
effects
assessment.
The
discussion
on
each
environmental
compartment
should
be
described
in
separate
subsections
(
i.
e.
3.3.1
Aquatic
compartment,
3.3.2
Terrestrial
compartment,
etc.).

If
a
quantitative
analysis
is
possible,
the
PEC/
PNEC
ratio
is
calculated
for
each
relevant
environmental
compartment.

°
If
PEC/
PNEC
³
1,
a
specific
hazard
is
or
may
be
posed
and
Post
SIDS
work
or
other
further
activities
should
be
considered.
°
If
PEC/
PNEC
<
1,
a
hazard
cannot
be
identified
and
the
chemical
can
be
considered
to
present
a
low
potential
for
risk
to
the
environment.
(
If
PEC/
PNEC
<
1
but
near
1,
the
uncertainty
of
exposure
assessment
and
effect
assessment
should
carefully
be
examined.
If
there
is
a
great
degree
of
uncertainty,
refinement
of
the
initial
assessment
is
recommended
as
further
work.)

If
a
quantitative
analysis
is
not
possible,
a
qualitative
evaluation
by
estimation
based
on
exposure
and
effects
information
can
be
given.

4.
HUMAN
HEALTH
4.1
Human
Exposure
Based
on
the
information
on
exposure,
use
pattern
and
physical­
chemical
properties,
the
human
populations
on
which
the
exposure
assessment
should
be
focused
are
identified.
The
exposure
level
for
each
population
is
then
discussed.

4.1.1
Occupational
exposure
Occupational
exposure
situations
are
discussed
and,
if
appropriate,
the
Estimated
Human
Exposure
(
EHE)
value
is
derived
taking
into
account
any
measured
data
available
and/
or
estimation
by
using
models.
Workplace
exposure
limit
values
(
e.
g.
TLV,
MAK)
already
determined
should
be
introduced
here.

4.1.2
Consumer
exposure
Possibilities
for
consumer
exposure
are
discussed
and,
if
appropriate,
the
EHE
is
calculated
by
using
exposure
models.

4.1.3
Indirect
exposure
via
the
environment
Based
on
the
discussion
about
the
environmental
exposure
assessment,
the
possibility
of
indirect
human
exposure
(
via
food,
water
and
air)
is
discussed
and,
if
appropriate,
the
EHE
is
calculated
taking
into
account
the
monitoring
data
on
fish
and
mammals
or
estimation
by
using
models.

4.2
Effects
on
Human
Health
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
8
Results
of
toxicity
tests
and
other
information
are
introduced
and
discussed,
i.
e.:

a)
mode
of
action
of
the
chemical,
toxicokinetics
and
metabolism
b)
acute
toxicity;
c)
repeated
dose
toxicity;
d)
reproduction/
developmental
toxicity;
e)
genetic
toxicity;
and
f)
any
other
human
health
related
information
that
is
available.

If
human
data
are
also
available,
they
should
be
described
separately
from
non­
human
data.
Toxicological
significance
of
breakdown
products
or
metabolites
should
be
discussed
where
necessary.

From
the
test
results
on
repeated
dose
toxicity
and
reproduction/
developmental
toxicity,
NOAELs
are
derived.
Other
toxicity
data
including
test
conditions
should
be
carefully
examined
and
discussed.

4.3
Initial
Assessment
for
Human
Health
This
includes
a
comparison
of
exposure
assessments
and
effects
assessments.
The
routes
of
exposure
resulting
in
toxicity
and
critical
effects
and
target
organs
should
be
identified
in
order
to
clarify
the
use
of
selected
NOAELs.

Finally
hazards
for
different
human
population
should
be
identified
and
described
in
separate
subsections
(
i.
e.
4.3.1
Workers,
4.3.2
Consumers
and
4.3.3
Those
exposed
via
the
environment).

For
repeated
dose
toxicity
and
reproduction/
developmental
toxicity,
risk
for
human
health
is
examined
by
comparing
the
EHE
with
the
NOAEL
form
animal
data
or,
if
available,
with
actual
human
data.

·
If
the
estimated
exposure
level
for
a
specific
human
population
is
larger
than
the
estimated
effect
level
of
concern,
i.
e.
the
EHE
is
larger
than
or
equal
to
the
NOAEL,
a
specific
hazard
may
exist
and
post­
SIDS
work
or
other
further
activities
should
be
considered.
·
If
the
estimated
exposure
level
is
much
smaller
than
the
estimated
effect
level
of
concern,
i.
e.
the
EHE
is
much
smaller
than
the
NOAEL,
a
hazard
cannot
be
identified
and
the
chemical
can
be
considered
to
present
a
low
potential
for
risk
to
man.
·
If
the
estimated
exposure
level
is
less
than
but
close
to
the
estimated
effect
level
of
concern,
i.
e.
the
"
margin
of
safety"
is
not
very
large,
the
uncertainty
of
exposure
assessment
and
effect
assessment
should
carefully
be
examined.
If
there
is
a
great
degree
of
uncertainty,
refinement
of
the
initial
assessment
is
recommended
as
further
work.

For
other
toxicological
endpoints,
a
qualitative
evaluation
can
be
given.

5.
CONCLUSIONS
AND
RECOMMENDATIONS
5.1
Conclusions
Properties
and
effects
of
the
chemical
and
the
result
of
the
initial
assessment
for
the
environment
and
human
health
on
the
potential
risk
are
summarised
in
this
section
as
the
overall
conclusions.
If
significant
data
gaps
exist
(
e.
g.
lack
of
information
on
exposure),
these
should
be
identified.

5.2
Recommendations
The
recommendations
by
the
Sponsor
country
are
related
to
the
need
for
further
work
or
action
(
e.
g.
post­
SIDS
testing,
exposure
analysis,
in­
depth
risk
assessment,
further
risk
management
action)
based
on
the
conclusions.
The
reasons
which
support
the
recommendations,
including
a
summary
of
risk
reduction
measures
or
safe
handling
procedures
in
Member
countries,
are
given.
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
9
If
post­
SIDS
work,
or
other
further
work
or
action
is
recommended,
specific
proposals
should
also
be
given.

6.
REFERENCES
References
not
included
in
the
Full
SIDS
Dossier
should
be
described.
References
on
key
information
could
also
be
introduced
here
even
if
they
are
duplicated
with
those
shown
in
the
Full
SIDS
Dossier.

ANNEX
:
Full
SIDS
Dossier
See
Chapter
2
and
Annex
2
of
this
Manual.
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
10
Annex
2
Cover
Page
to
be
used
for
the
Circulation
of
the
SIDS
Initial
Assessment
Reports
COVER
PAGE
SIDS
Initial
Assessment
Report
for
_
th
SIAM
(
Place,
date)

Chemical
Name:

CAS
No:

Sponsor
Country:

National
SIDS
Contact
Point
in
Sponsor
Country:

HISTORY:

SIDS
Dossier
and
Testing
Plan
were
reviewed
at
the
SIDS
Review
Meeting
or
in
SIDS
Review
Process
on
(
date),
where
the
following
SIDS
Testing
Plan
was
agreed:

no
testing
(
)
testing
(
)

(
If
"
testing"
is
marked,
the
test(
s)
should
be
identified.)

(
If
the
SIAR
was
discussed
at
a
previous
SIAM,
this
should
be
mentioned
and
the
reason
given
for
it
being
discussed
again.)

COMMENTS:

(
Other
remarks
should
be
written
here.)

Deadline
for
circulation:

Date
of
Circulation:
(
To
all
National
SIDS
Contact
Points
and
the
OECD
Secretariat)
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
11
Annex
3
SIDS
INITIAL
ASSESSMENT
PROFILE
CAS
No.

CHEMICAL
NAME
STRUCTURAL
FORMULA
CONCLUSIONS
AND
RECOMMENDATIONS
[
The
summary
of
properties
and
effects
of
the
chemical
and
the
result
of
the
assessment
on
potential
risk,
and
recommendations
related
to
further
work
or
action,
as
appropriate,
together
with
the
reasons
which
support
it]
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
12
Annex
4
FULL
SIDS
SUMMARY
CAS
NO:
SPECIES
PROTOCOL
RESULTS
PHYSICAL­
CHEMICAL
2.1
Melting
Point
°
C
2.2
Boiling
Point
°
C
(
at
kPa)

2.3
Density
kg/
m3
2.4
Vapour
Pressure
kPa
at
°
C
2.5
Partition
Coefficient
(
Log
Pow)

2.6
A.
Water
Solubility
mg/
l
at
°
C
B.
pH
at
°
C
pKa
2.12
Oxidation:
Reduction
Potential
mV
ENVIRONMENTAL
FATE
AND
PATHWAY
3.1.1
Photodegradation
In
air
T1/
2
=
hour
3.1.2
Stability
in
Water
T1/
2
=
min
3.2
Monitoring
Data
In
air
=
mg/
m3
In
surface
water=
mg/
l
In
soil/
sediment=
mg/
g
In
biota
=
mg/
g
3.3
Transport
and
Distribution
Calculated
(
Fugacity
Level
1
type)

(
local
exposure)
In
Air
%
In
Water
%
In
Sediment
%
In
Soil
%
In
Biota
%

3.5
Biodegradation
ECOTOXICOLOGY
4.1
Acute/
Prolonged
Toxicity
to
Fish
LC50
(
24
hr)
=
mg/
l,
LC50
(
48
hr)
=
mg/
l,
LC50
(
72
hr)
=
mg/
l,
LC50
(
96
hr)
=
mg/
l
4.2
Acute
Toxicity
to
Aquatic
Invertebrates
Daphnia
EC50
(
24
hr)
=
mg/
l,
EC50
(
48
hr)
=
mg/
l,

4.3
Toxicity
to
Aquatic
Plants
e.
g.
Algae
EC50
(
hr)
=
mg/
l
NOEC
(
hr)
=
mg/
l
4.5.2
Chronic
Toxicity
to
Aquatic
Invertebrates
(
Daphnia)
EC50s
(
d)
=
mg/
l
(
Reproduction)
EC50s
(
d)
=
mg/
l
(
Growth)
LC50s
(
d)
=
mg/
l
NOECs
(
d)
=
mg/
l
4.6.1
Toxicity
to
Soil
Dwelling
Organisms
LC50
(
d)
=
mg/
Kg
NOEL
(
d)
=
mg/
Kg
4.6.2
Toxicity
to
Terrestrial
Plants
EC50
(
d)
=
mg/
Kg,
LC50
=
mg/
Kg
EC50
(
d)
=
mg/
Kg,
LC50
=
mg/
Kg
EC50
(
d)
=
mg/
Kg,
LC50
=
mg/
Kg
(
4.6.3)
Toxicity
to
Other
Non­
Mammalian
Terrestrial
LD50
(
hr)
=
mg/
Kg
EXCH\
MANUAL\
96­
4­
2.
DOC/
May
1996
13
CAS
NO:
SPECIES
PROTOCOL
RESULTS
Species
(
Including
Birds)

TOXICOLOGY
5.1.1
Acute
Oral
Toxicity
LD50
=
mg/
Kg
5.1.2
Acute
Inhalation
Toxicity
LC50
=
mg/
m3
5.1.3
Acute
Dermal
Toxicity
LD50
=
mg/
Kg
5.4
Repeated
Dose
Toxicity
NOEL
=
mg/
Kg
5.5
Genetic
Toxicity
In
Vitro
A.
Bacterial
Test
(
Gene
mutation)
+
or
­
(
With
metabolic
activation)
+
or
­
(
Without
metabolic
activation)

B.
Non­
Bacterial
In
Vitro
Test
(
Chromosomal
aberrations)
+
or
­
(
With
metabolic
activation)
+
or
­
(
Without
metabolic
activation)

5.6
Genetic
Toxicity
In
Vivo
+
or
­

5.8
Toxicity
to
Reproduction
NOEL
=
mg/
Kg
(
General
toxicity)
NOEL
=
mg/
Kg
(
Repro.
Tox.
parental)
NOEL
=
mg/
Kg
(
Repro.
Tox.
F1
generation)

5.9
Developmental
Toxicity/
Teratogenicity
NOEL
=
mg/
Kg
(
General
toxicity)
NOEL
=
mg/
Kg
(
Pregnancy/
litter)
NOEL
=
mg/
Kg
(
Foetal
data)

5.11
Experience
with
Human
Exposure
[
Note]
Data
beyond
SIDS
requirements
can
be
added
if
the
items
are
relevant
to
the
assessment
of
the
chemical,
e.
g.
corrosiveness/
irritation,
carcinogenicity.
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
1
4.3
Provisional
Guidance
for
the
Initial
Assessment
of
Environmental
Exposure*

4.3.1
Introduction
1.
This
document
provides
guidance
for
the
application
of
simple
models
for
the
initial
assessment
of
environmental
exposure
of
High
Production
Volume
(
HPV)
chemicals
for
which
a
full
SIDS
is
available,
based
mainly
on
the
conclusions
and
recommendations
of
the
OECD
Workshop
on
the
Application
of
Simple
Models
for
Environmental
Exposure
Assessment
(
Berlin,
11­
13
December
1991).

2.
The
objective
of
the
Workshop
was
to
identify
simple
models
which
can
be
used
for
initial
environmental
exposure
assessment
of
new
and
existing
chemicals
with
limited
data
including
indirect
exposure
to
man
via
food
and
drinking
water,
in
particular
those
models
which
can
be
used
in
the
context
of
the
OECD
work
on
HPV
chemicals.
This
means
that
the
models
should
be
applicable
using
data
which
are
available
in
the
SIDS.
One
further
objective
was
to
develop
guidance
for
Member
countries
in
using
these
models
when
they
develop
their
recommendation
related
to
the
initial
assessment
of
SIDS
chemicals.

3.
An
exposure
assessment
consists
of
a
source
assessment
and
a
fate
and
pathway
assessment
(
Ref.
38
and
16).
In
a
source
assessment,
identification
of
emission
source(
s)
and
an
estimation
of
release(
s)
from
the
source(
s)
are
made
by
means
of
information
on
use
categories
of
a
chemical
and
emission
factors
generally.
Exposure
through
the
environment
(
environmental
exposure)
is
considered
in
a
fate
and
pathway
assessment.
Then
indirect
exposure
through
food
and
drinking
water
is
calculated
based
on
these
results.
This
document
focuses
on
three
issues
in
this
procedure:
emission
factors
and
use
categories,
simple
models
for
environmental
exposure,
and
models
for
indirect
exposure.

4.
It
should
be
noticed
that
the
overall
environmental
exposure
assessment
should
strive
to
conduct
an
assessment
at
the
global
level.
Even
though
the
exposure
situation
to
a
chemical
might
be
different
depending
on
local
or
national
conditions,
all
calculations
at
these
levels
should
be
integrated
in
the
global
assessment.

5.
Also
it
is
important
to
consider
a
variety
of
emission
sources
and
to
include
several
sources
in
the
assessment.
To
date,
environmental
exposure
assessments
dealt
with
by
the
SIDS
Initial
Assessment
Meeting
(
SIAM)
almost
always
considered
emission
data
from
a
single
point
source,
e.
g.
one
production
site,
though
various
sources
such
as
other
producers,
subsequent
processing
independent
of
the
producer,
and
produced
product
are
considered
to
exist.
When
several
sources
cannot
be
considered
qualitatively
in
the
assessment,
a
more
simple
qualitative
approach
such
as
a
scoring
system
might
be
considered.

6.
Following
the
recommendations
of
the
Berlin
Workshop,
diskettes
with
national
models
that
were
thought
to
be
appropriate
for
initial
assessment
of
HPV
chemicals
with
full
SIDS
at
the
Workshop
have
been
prepared
and
distributed
separately
with
an
explanatory
note
which
includes
manuals
of
each
model
(
Ref.
35,
details
in
Ref.
F).
Also
local
and
global
reference
models,
which
could
be
used
in
addition
to
and/
or
in
place
of
national
models,
have
been
developed
based
on
the
recommendations
of
the
Workshop
and
have
been
distributed
by
means
of
a
diskette
(
Ref.
36
and
37,
details
in
Ref.
F).

7.
In
addition,
Discussion
Documents
(
Ref.
14,
16,
18,
19)
and
Background
Documents
(
Ref.
20­
22)
prepared
for
the
Workshop
could
be
referred
to
whenever
detailed
information
relating
to
the
assessment
procedure
presented
in
this
document
is
required.
These
documents
were
prepared
on
the
basis
of
information
on
the
procedures
and
the
results
of
the
application
of
ten
Member
countries'
approaches
on
ten
SIDS
chemicals
(
Ref.
1­
13)
and
are
included
in
Environment
Monograph
No.
67
(
Ref.
38).

8.
Structure­
Activity
Relationships
(
SARs)
for
physical­
chemical
properties
important
for
exposure
assessment
were
also
addressed
at
the
Workshop
(
Ref.
17)
and
the
report
has
been
distributed
separately
as
an
Environment
Monograph
(
Ref.
39).

4.3.2
Emission
Factors
and
Use
Categories
of
Chemicals
*
This
document
was
prepared
by
the
OECD
Secretariat
in
1992
based
on
the
OECD
Workshop
on
the
Application
of
Simple
Models
for
Environmental
Exposure
Assessment,
held
in
Berlin
in
December
1991.
It
has
been
updated
to
reflect
comments
by
Member
countries
and
agreements
reached
in
the
context
of
the
OECD
Existing
Chemicals
Programme
up
to
mid­
1994.
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
2
9.
Release
of
chemicals
into
the
various
environmental
compartments
and
the
quantities
concerned
are
strongly
dependent
on
the
use
of
the
chemical.
Therefore,
in
an
exposure
assessment,
the
use
pattern
of
a
substance
should
be
considered
as
a
starting
point
when
using
any
kind
of
exposure
scenario.
When
high
quality
information
and
data
are
lacking,
screening
quality
release
assessments
can
be
made
by
using
a
typical
or
average
release
scenario
based
on
emission
factors
presenting
a
boundary
estimate
of
release
of
chemicals.
It
should
be
noticed
that
the
results
of
the
source
assessment
are
used
as
input
data
for
models
for
environmental
and
indirect
exposure
assessment.

10.
"
Emission
Factors
and
Use
Categories"
(
Ref.
14
and
38)
present
various
approaches
used
in
Member
countries,
and
detailed
information
is
provided
in
Ref
20.
The
tools
mentioned
in
the
documents
will
assist
Member
countries
in
developing
release
assessments,
as
well
as
allow
them
to
understand
the
assessments
of
other
Member
countries.
The
summary
report
of
the
Working
Group
on
this
issue
of
the
Workshop
is
attached
to
this
document
as
Annex
1.

Necessary
Information
for
Source
Assessments
11.
Initial
exposure
assessments
can
often
be
based
on
the
SIDS
Dossier.
However,
in
order
to
improve
the
quality
of
the
assessment,
further
information
on
exposure
and
use
are
considered
to
be
necessary
and
elements
of
exposure
information
have
been
agreed
and
are
included
in
the
SIDS
(
see
Section
2.2).

12.
In
order
to
collect
the
necessary
information,
release
reporting
requirements
such
as
a
product
register
system
would
be
a
good
source
of
information.
In
addition,
manufacturers
could
provide
more
detailed
information
on
chemical
use
and
releases,
and
monitoring
data
could
be
collected
intensively.
Data
from
monitoring
should
be
used
as
much
as
possible,
in
order
to
compare
them
with
the
results
obtained
from
other
methods
such
as
emission
scenario
approaches.

Assessment
Methods
for
Release
of
Chemicals
13.
Approaches
of
Member
countries
for
estimating
releases
of
SIDS
chemicals
into
water,
which
were
discussed
at
the
Workshop,
are
often
conceptually
similar.
However,
differences
in
values
chosen
for
variables
contained
in
release
calculations
frequently
lead
to
widely
varying
release
concentrations.
This
situation
probably
exists
for
other
release
scenarios
that
may
be
evaluated
in
the
future.
There
is
a
clear
need
for
Member
countries
to
work
more
closely
together
to
develop
mutually
compatible
release
estimation
methods.

14.
Releases
should
be
assessed
for
the
entire
life­
cycle
of
SIDS
chemicals.
The
life­
cycle
of
a
chemical
includes:
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
3
­­
manufacture
or
production;
­­
processing
or
formulation;
­­
industrial
use;
­­
private
or
consumer
use;
­­
recycling;
and
­­
disposal
and
treatment.

15.
For
commonly
encountered
release
scenarios,
estimates
of
releases
can
be
presented
in
the
form
of
the
matrix
shown
in
the
Appendix
to
Annex
1
to
this
document,
which
shows
releases
as
a
fraction
of
production
or
use
volume.

16.
All
SIDS
release
assessments
should
be
extremely
clear
with
regard
to
how
they
were
developed
and
should,
when
possible,
include:

­­
rationales,
assumptions
and
data
used
to
generate
release
estimates;
­­
types
of
releases
(
point
source
or
diffuse);
­­
release
quantities;
­­
media
for
release;
­­
time
dimensions
of
releases;
­­
kinds
of
release
estimates
(
average
or
worst
case);
and
­­
uncertainties
associated
with
the
estimates.

17.
Release
assessments
address
releases
up
through
waste
water
treatment.
Water
releases
of
SIDS
chemicals
are
estimated
before
and
after
waste
water
treatment.

18.
The
SIDS
assessment
efforts
should
be
structured
to
avoid
false
negatives
­
incorrectly
excluding
chemicals
of
potential
concern
from
further
consideration,
for
example,
by
considering
a
worst
case
scenario.

19.
An
iterative
approach
to
improving
initial
assessments
may
be
needed
on
occasion.

4.3.3
Local
Models
and
Global
Models
20.
The
environmental
exposure
assessments
are
generally
carried
out
by
means
of
models
and
are
based
on
information
obtained
by
a
source
assessment,
as
well
as
on
information
on
the
properties
of
the
chemical
and
on
the
environment
for
which
estimations
will
be
made.
Application
of
local
and
global
models
for
a
chemical
is
considered
depending
upon
production
and
use
of
the
chemical,
in
order
to
discriminate
local
exposure
and
general
exposure.
In
this
document
local
models
are
those
which
are
concerned
with
the
environment
close
to
the
release
site,
and
with
a
short
time
scale
after
the
release.
They
can
use
environmental
data
which
are
generic,
or
they
can
use
data
from
a
real
situation
if
such
data
are
available.
On
the
other
hand,
global
models
are
those
which
are
concerned
with
the
longer
term,
steady­
state
behaviour
of
a
chemical
and
are
multi­
media.
The
estimated
concentrations
of
a
chemical
in
the
environmental
media
are
used
for
comparison
with
"
a
low
risk
level
of
a
chemical"
derived
from
an
effects
assessment.
An
elaborated
exposure
assessment
based
on
more
precise
and
detailed
information
and/
or
a
refined
effects
assessment
would
be
required
in
cases
where
estimated
concentrations
exceed
the
"
low
risk
level
of
the
chemical".

21.
Diskettes
which
compile
national
and
reference
models
could
be
used
for
the
actual
estimation
of
the
concentration
of
a
chemical
(
see
Ref.
F).

22.
"
Local
and
Global
Models"
(
Ref.
16
and
38)
introduces
a
procedure
for
SIDS
initial
assessment
and
the
issues
to
be
considered
in
an
environmental
exposure
assessment.
Reference
models
which
would
be
used
for
the
initial
environmental
exposure
assessment
are
presented
in
the
document,
"
Reference
models
which
would
be
used
for
the
Initial
Environmental
Exposure
Assessment"
(
Ref.
19
and
38).
Outlines
of
national
models
and
results
of
their
application
for
ten
SIDS
chemicals
are
summarized
in
"
Local
and
Global
Models
in
Member
countries"
(
Ref.
21
and
38).
"
Potential
Approaches
for
Developing
Screening­
Level
Environmental
and
Human
Exposure
Assessment
for
SIDS
Chemicals"
(
Ref.
22
and
38),
which
can
be
applied
when
sufficient
information
on
the
source
and
the
environment
are
available,
presents
an
approach
taken
by
the
US.
The
summary
report
of
the
Working
Group
is
attached
to
this
document
as
Annex
2.

Necessary
Information
for
Models
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
4
23.
The
physical­
chemical
data
available
in
the
SIDS
are
generally
sufficient
for
using
local
and
global
models
used
for
the
initial
assessment.
Information
on
degradation
rates
is
generally
missing
in
the
SIDS
although
they
are
included
implicitly.
This
might
be
a
problem
for
global
models.
Also
the
release
estimates
in
the
previous
section
should
be
able
to
be
used
in
the
models.

Models
Used
in
Initial
Environmental
Exposure
Assessment
24.
Three
local
models
on
a
national
scale
for
estimation
of
the
concentration
of
a
chemical
in
air
phase,
six
for
water
phase
(
including
a
simple
dilution
model
which
does
not
require
PCs
for
calculation),
and
two
for
soil
phase
were
submitted
for
distribution
by
Member
countries.
Eight
of
them,
which
are
thought
to
be
simple
but
appropriate
for
use
for
an
initial
assessment
of
HPV
chemicals
with
full
SIDS,
are
included
in
diskettes.
Also
four
fugacity
type
global
national
models
are
available
through
diskettes.

25.
As
various
modelling
approaches
are
taken
by
Member
countries,
a
set
of
four
so­
called
"
reference
models",
namely
the
Screening
Assessment
Model
System
(
SAMS)
which
consists
of
three
local
models
(
Water,
Air
and
Soil)
and
one
global
model
(
Fugacity
Model,
FUGMOD),
have
been
developed.
The
basis
and
mechanisms
considered
have
been
agreed
at
the
Workshop.
They
serve
as
a
minimum
assessment
procedure,
but
Member
countries
could
use
them
in
addition
to
or
in
place
of
their
own
approaches.
The
choice
of
which
of
the
three
local
models
to
use
will
be
made
on
the
basis
of
the
compartments
identified
as
receiving
the
release
of
the
chemical.
Detailed
information
on
reference
models
is
presented
in
Annex
2
to
this
document,
and
reference
models
developed
are
available
through
a
diskette.

26.
By
using
local
models,
Member
countries
should
be
able
to
have
opportunities
to
adapt
the
input
data
to
their
own
particular
situation.
The
possibility
of
developing
a
reference
scenario
which
represents
generic
local
conditions
should
also
be
investigated.
A
conservative
approach
to
the
choice
of
generic
parameters
should
be
taken.

27.
Even
for
a
chemical
used
in
closed
systems,**
estimation
of
the
amount
of
the
chemical
that
can
be
expected
to
reach
the
environment
can
be
carried
out.
An
approach
presented
in
the
MNSEM
model
based
on
the
physical­
chemical
properties
can
be
considered
as
one
of
the
methods
that
can
be
applied.

28.
FUGMOD,
which
is
the
latest
version
of
the
Fugacity
Level
III
model,
is
to
be
used
as
the
basis
of
the
global
models.
The
default
environmental
parameters
for
this
version
also
could
be
used
in
the
assessment
in
addition
to,
or
in
place
of,
parameters
for
the
environment
of
each
country.
This
global
reference
model
is
available
on
a
diskette.

29.
Currently
there
are
various
models
which
can
be
identified
for
use
in
environmental
exposure
assessment.
However,
to
date
there
is
a
lack
of
standardisation
of
selection
of
distribution
models
employed
for
the
initial
assessments.
Harmonization
in
this
field
would
be
desirable.

30.
Methods
used,
including
any
assumptions
made,
extra
data
required,
and
QSAR
estimation
adopted,
should
be
transparent
to
others
in
order
to
undertake
the
assessment
of
HPV
chemicals
in
a
co­
operative
way.

31.
It
is
the
responsibility
of
the
user
of
the
models
to
assess
the
effect
of
uncertainties
in
the
data
when
estimation
is
carried
out
by
the
models.

4.3.4
Models
for
Indirect
Exposure
by
Food
and
Drinking
Water
32.
Exposure
of
human
beings
is
generally
expressed
as
an
average
daily
intake
of
a
chemical
per
unit
of
body
weight.
In
the
initial
indirect
exposure
assessment
this
average
daily
intake
of
a
chemical
is
compared
with
the
"
low
risk
level
of
average
intake",
which
is
derived
from
the
results
of
toxicity
testing
and
other
information.
Models
for
indirect
exposure
by
food
and
drinking
water
are
used
for
estimation
of
the
average
daily
intake
using
default
values,
the
data
for
intake
volume
of
food,
drinking
water
and
air,
and
concentrations
of
chemicals
in
the
media.
Therefore
there
is
a
close
relation
with
environmental
exposure
models
and
indirect
exposure
models.
Some
models
consist
of
both
a
model
for
**
A
chemical
used
in
closed
system:
a
substance
should
only
be
considered
to
be
used
in
closed
systems
if
it
remains
within
a
reactor
or
is
transferred
from
vessel
to
vessel
through
closed
pipework
and
therefore
accidental
spillage
is
the
only
likely
cause
for
human
exposure
or
environmental
contamination.
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
5
environmental
exposure
and
a
model
for
indirect
exposure
in
order
to
conduct
an
assessment
in
an
integrated
way.
An
elaborated
exposure
assessment
would
be
required
in
cases
where
estimated
intake
exceeds
the
"
safe
level
of
average
intake."

33.
"
Indirect
Exposure
of
Human
Beings
to
Organic
Chemicals"
(
Ref.
18
and
38)
summarises
the
approaches
of
Member
countries.
Four
national
models
which
are
compiled
on
the
diskette
could
be
used
for
estimation.
Also
estimation
of
indirect
exposure
could
be
done
partly
by
reference
models.

Necessary
Information
34.
Physical­
chemical
data
in
the
SIDS
are
thought
to
be
sufficient
for
the
models
submitted
by
Member
countries,
but
further
data
on
the
estimation
of
emission
beyond
data
included
in
the
SIDS
are
considered
to
be
necessary.

Models
35.
Four
models
(
CHEMCAN,
CHEMFRANCE,
MNSEM,
and
RISK)
are
adaptable
to
individual
country
needs
and
are
available
for
those
Member
countries
who
wish
to
use
them
in
their
initial
indirect
exposure
assessment
of
HPV
chemicals
to
humans.
All
of
them
are
available
through
diskettes.
In
addition,
reference
models
could
be
used
for
partial
estimation
of
indirect
exposure.

36.
Both
local
and
global
approaches
should
be
used
when
circumstances
indicate
that
this
type
of
insight
would
be
useful
to
the
assessment.

37.
The
indirect
exposure
assessment
should
cover
critical
target
groups
such
as
children
and
elderly
people.

38.
Calculations
for
extreme
dietary
compositions
such
as
high
and
low
consumption
of
fish
should
be
carried
out
if
available
information
suggests
this
is
important.
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
6
Annex
1
Emission
Factors
and
Use
Categories
of
Chemicals
(
Summary
Report
of
Working
Group
I
of
the
OECD
Workshop
held
in
Berlin
in
December
1991)

Objectives
and
Purpose
of
the
Working
Group
1.
Environmental
release
estimation
is
the
first
step
within
the
exposure
assessment.
Release
estimates
involve
the
identification
of
the
sources
and
the
receiving
environmental
media
for
each
stage
of
the
chemical's
life
cycle.
Specific
quantities
released
during
these
stages
can
be
expressed
as
emission
rates
or
emission
factors.
The
objective
of
release
assessments
is
to
develop
information
that
provides
a
starting
point
for
estimating
chemical
concentrations
in
media
of
concern.
Working
Group
I
considered
issues
related
to
releases
before
and
after
waste
water
treatment.
It
was
agreed
that
water
releases
of
SIDS
chemicals
will
be
estimated
before
and
after
waste
water
treatment.

Information
and
Data
Sources
for
Developing
Release
Assessments
2.
The
Discussion
documents
(
Ref.
14
and
15)
and
the
Background
documents
(
Ref.
20,
24
and
29)
developed
for
the
Workshop
were
presented.
The
documents
detail:

°
databases
containing
chemical
release
information;
°
sources
for
obtaining
emission
factors
for
chemicals;
°
approaches
for
estimating
releases
used
in
the
EC
and
US
new
chemicals
programmes.

3.
In
addition,
nine
Member
countries
provided
estimates
of
releases
and
exposures
for
nine
selected
SIDS
chemicals.
These
submissions
also
provide
insight
into
methods
that
numerous
Member
countries
use
to
estimate
chemical
releases.

4.
Most
participants
agreed
that
initial
exposure
assessments
should
be
based
on
the
SIDS
dossier
with
the
understanding
that
it
may
be
necessary
to
get
additional
exposure
information
on
chemicals
of
concern
after
the
initial
assessment.
Participants
from
one
Member
country
were
concerned
that
initial
assessment
of
SIDS
chemicals
may
be
impossible
given
the
information
in
the
SIDS
dossier.
Participants
from
a
number
of
Member
countries
indicated
they
would
assure
that
their
assessments
would
be
based
on
information
beyond
what
is
available
in
the
SIDS
Dossier.
Participants
from
other
Member
countries
expressed
their
anxiety
that
they
may
not
have
the
resources
to
obtain
additional
information,
though
they
have
extensive
dialogue
with
industry
for
each
SIDS
chemical.
Therefore,
they
may
prefer
a
screening
assessment
which
uses
only
SIDS
Dossier
data
or
accepted
worst
case
assumptions
in
order
to
complete
the
SIDS
screening
on
a
timely
basis.

5.
The
Working
Group
recommended
that
Member
countries
take
advantage
of
mandatory
release
reporting
requirements
or
other
data
sources
of
several
Member
countries.
Product
registries
are
an
example
of
this
kind
of
relevant
data.
It
was
recommended
that
Member
countries
strive
to
use
as
much
as
possible
monitoring
data,
such
as
that
available
in
the
literature
and
databases,
whenever
appropriate
in
their
release
and
exposure
assessments.
Assessments
based
on
monitoring
data
should
be
compared
to
estimates
using
other
approaches.
The
Working
Group
recommended
that
release
assessors
should
involve
waste
management
officials
in
the
development
of
their
assessments.
In
addition,
chemical
manufacturers
may
be
able
to
provide
more
detailed
information
on
chemical
use
and
releases.
The
Working
Group
was
aware
that
the
further
downstream
a
release
scenario
was
from
manufacturing,
the
poorer
the
use
information
may
be
supplied
by
the
manufacturer.

Life­
cycle
Assessment
and
Relevant
Emission
Scenarios
6.
There
was
agreement
that
releases
should
be
assessed
for
the
entire
life­
cycle
of
SIDS
chemicals.
The
life­
cycle
of
a
chemical
includes:

­­
manufacture
or
production;
­­
processing
or
formulation;
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
7
­­
industrial
use;
­­
private
or
consumer
use;
­­
recycling;
­­
disposal
and
waste
treatment.

7.
For
commonly
encountered
release
scenarios,
estimates
of
releases
may
be
based
on
working
models
and
might
take
the
form
of
the
matrix
shown
in
the
Appendix
to
this
Annex
which
shows
releases
as
a
fraction
of
production
or
use
volume.

8.
It
was
agreed
that
an
iterative
approach
to
improving
initial
assessments
may
be
needed
on
occasion.

9.
There
was
concern
in
the
Working
Group
that
many
release
estimating
models
are
based
on
estimates
of
production
or
use
volumes
which
are
not
necessarily
of
high
quality.

Scope
of
SIDS
Release
Assessments
10.
There
was
general
agreement
that
all
SIDS
release
assessments
should
be
extremely
clear
with
regard
to
how
they
were
developed
and
should,
when
possible,
include:

­­
rationales,
assumptions
and
data
used
to
generate
release
estimates;
­­
types
of
releases
(
point
source
or
diffuse);
­­
release
quantities;
­­
media
for
release;
­­
time
dimensions
of
releases;
­­
kinds
of
release
estimates
(
average
or
worst
case);
­­
uncertainties
associated
with
the
estimates.

Results
of
Comparison
of
Release
Estimating
Methods
for
Selected
SIDS
Chemicals
11.
The
Working
Group
considered
release
and
exposure
estimates
for
the
selected
chemicals
as
submitted
by
nine
Member
countries.
Member
country
approaches
to
estimating
water
releases
of
chemicals
were
often
conceptually
similar.
However,
differences
in
values
chosen
for
variables
contained
in
release
calculations
frequently
lead
to
widely
varying
release
concentrations.
This
situation
probably
exists
for
other
release
scenarios
that
may
be
evaluated
in
the
future.
There
is
a
clear
need
for
the
Member
countries
to
work
more
closely
together
to
develop
mutually
compatible
release
estimating
methods.

12.
It
was
generally
agreed
that
the
SIDS
assessment
efforts
should
be
structured
to
avoid
false
negatives
­
incorrectly
excluding
chemicals
of
potential
concern
from
further
consideration.
False
positives
should
be
identified
during
the
exposure
assessment
process.

Applicability
of
New
Chemical
Assessment
Methods
to
the
SIDS
Programme
13.
Patterns
of
the
intended
use
are
usually
well
known
for
new
chemicals.
For
HPV
chemicals,
use
patterns
may
not
be
easily
identifiable.
For
some
Member
countries
this
means
that
assumptions,
such
as
default
values,
may
be
more
commonly
relied
on
for
HPV
chemical
assessment
than
for
new
chemical
assessment.

Summary
of
Conclusions
and
Recommendations
14.
Even
though
it
was
not
possible
for
the
Working
Group
to
develop
consensus
decisions
regarding
the
details
on
how
to
estimate
releases
for
selected
scenarios,
there
were
many
useful
results.
The
most
significant
were:

14.
a
Many
relevant
release
assessment
tools
were
distributed
to
the
participants
through
the
Discussion
documents
and
the
Background
Document.
These
tools
will
assist
Member
countries
in
developing
release
assessments
as
well
as
allow
them
to
understand
the
assessments
of
other
Member
countries.
Additional
assessment
methods,
use
category
documents,
and
other
materials
not
yet
submitted
from
other
Member
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
8
countries
should
be
exchanged
through
the
OECD.
The
OECD
should
endeavour
to
expand
the
Working
Group
Background
Document
to
include
additional
assessment
tools
available
in
other
Member
countries
and
make
it
available.

14.
b
There
was
agreement
that
releases
should
be
assessed
for
the
entire
life­
cycle
of
SIDS
chemicals.
The
lifecycle
of
a
chemical
includes:

­­
manufacture
or
production;
­­
processing
or
formulation;
­­
industrial
use;
­­
private
or
consumer
use;
­­
recycling;
­­
disposal
and
treatment.

14.
c
There
was
agreement
that
all
SIDS
release
assessments
should
be
extremely
clear
with
regard
to
how
they
were
developed
and
should,
when
possible,
include:

­­
rationales,
assumptions
and
data
used
to
generate
release
estimates;
­­
types
of
releases
(
point
source
or
diffuse);
­­
release
quantities;
­­
media
for
release;
­­
time
dimensions
of
releases;
­­
kinds
of
release
estimates
(
average
or
worst
case);
­­
uncertainties
associated
with
the
estimates.

14.
d
Member
country
approaches
to
estimating
SIDS
chemical
intermediate
water
releases,
were
often
conceptually
similar.
However,
differences
in
values
chosen
for
variables
contained
in
release
calculations
frequently
lead
to
widely
varying
release
concentrations.
This
situation
probably
exists
for
other
release
scenarios
that
may
be
evaluated
in
the
future.
There
is
a
clear
need
for
the
Member
countries
to
work
more
closely
together
to
develop
mutually
compatible
release
estimating
methods.

14.
e
Release
assessments
will
address
releases
up
through
waste
water
treatment.
Water
releases
of
SIDS
chemicals
will
be
estimated
before
and
after
waste
water
treatment.

14.
f
For
many
use
categories
there
are
no
adequate
emission
scenarios.
Member
countries
should
develop
and
share
use
category
information
and
other
assessment
tools.

APPENDIX
TO
ANNEX
1
Industrial
Category
Use
category
/
Function
Release
Estimates
Applicable
Steps
of
Life
Cycle
Water
Air
Soil
Waste
1.
Agricultural
chemicals
Fertilisers
Pesticides
Production
Compounding
Processing
Use
(
private)
Recovery
Pharmaceutical
(
vet.)
Production
Compounding
Processing
Use
(
private)
Recovery
2....
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
9
..

15....

­
Diffuse
­
Local:
point
source
(
fraction,
time
periods,...)
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
10
Annex
2
Local
and
Global
Models
(
Summary
Report
of
Working
Group
II
of
the
OECD
Workshop
held
in
Berlin
in
December
1991)

Objectives
1.
The
objectives
of
the
Working
Group
were
to
identify
and
recommend
suitable
environmental
models
for
use
in
initial
screening
assessment.
Appropriate
models
would
provide
estimates
of
concentrations
in
environmental
compartments
of
concern
(
Predicted
Environmental
Concentration,
PEC).
Additional
information
on
mass
balances,
mass
fluxes
or
residence
times
from
the
models
would
be
valuable
for
a
better
understanding
and
evaluation
of
the
fate
and
pathways
of
the
chemicals.
The
models
should
be
able
to
use
release
estimates
from
Working
Group
I
and
the
data
available
in
the
SIDS.

Scope
of
the
Models
2.
A
range
of
modelling
approaches
was
used
by
Member
countries
in
the
estimates
carried
out
in
preparation
for
the
workshop.
These
are
summarized
in
Background
Documents
(
Ref.
21
and
22).
It
was
obvious
from
the
discussions
in
the
Working
Group
that
different
Member
countries
had
different
methods
which
they
would
like
to
use.
The
approach
agreed
therefore
was
to
find
a
set
of
models
which
would
act
as
a
minimum
assessment
procedure,
but
which
Member
countries
could
use
in
addition
to,
or
in
place
of,
their
own
approaches.

3.
It
was
agreed
that
the
Working
Group
should
aim
to
recommend
models
which
covered
the
range
of
spatial
and
temporal
scales
over
which
assessments
are
carried
out.
After
discussion
a
set
of
four
models
was
decided
upon
­
three
local
models,
each
concerned
with
a
single
environmental
phase
(
Air,
Water,
Soil),
and
one
global
model.
For
the
purposes
of
this
document,
local
models
are
those
which
are
concerned
with
the
environment
close
to
the
release
site,
and
with
a
short
time
scale
after
the
release.
They
can
use
environmental
data
which
is
generic
or
they
can
use
data
from
a
real
situation
if
such
information
is
available.
The
choice
of
which
of
the
three
local
models
to
use
would
be
made
on
the
basis
of
the
compartments
identified
as
receiving
the
release
of
the
chemical.
Global
models
are
those
which
are
concerned
with
the
longer
term,
steady
state
behaviour
of
a
chemical,
and
are
multi
media.
The
scale
of
those
models
favoured
by
the
group
was
national
or
regional.

Description
of
Models
4.
It
was
agreed
at
the
beginning
of
the
discussions
that
the
aim
would
be
to
identify
the
key
processes
involved
and
the
data
requirements
(
both
for
the
chemical
and
the
environment).
As
far
as
possible
the
chemical
data
should
be
available
from
the
SIDS
or
through
the
SAR
methods
discussed
in
the
Special
Session
on
SAR.
It
was
decided
that
only
the
basis
of
the
models
would
be
recommended
and
not
actual
models
for
use.
The
discussion
was
based
on
the
Discussion
Document
(
Ref.
16
and
19).
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
11
Local
Models
a.
Water
model
i.
Major
processes:
dilution.

ii.
Optional
processes:
volatilization,
degradation,
adsorption.

iii.
Chemical
data:
release
rate
(
mass/
time,
mass/
site/
time),
release
concentrations
and
discharge
flows,
Henry's
Law
Constant,
Bioconcentration
Factor
(
BCF),
Organic
Carbon
Sorption
Constant
(
Koc).

iv.
Environmental
data:
flow
rates
(
generic
or
site
specific).

v.
Remarks:
Calculation
of
dilution
is
the
minimum
necessary.
Member
countries
may
then
use
the
concentration
obtained
in
order
to
calculate
concentrations
in
sediment,
biota
etc.
through
the
appropriate
physical­
chemical
data.
They
may
also
use
the
available
data
to
indicate
whether
reductions
in
this
concentration
through
degradation,
volatilization
are
likely.

[
Note:

i.
Major
processes:
the
processes
which
should
be
considered
in
the
Models.
ii.
Optional
processes:
the
processes
which
can
be
considered
optionally
in
the
Models.
iii.
Chemical
data:
the
physical­
chemical
data
of
a
chemical
which
are
necessary
for
calculation
by
the
Models
as
input
data.
iv.
Environmental
data:
the
data
on
the
environment
for
which
the
calculation
is
carried
out.]

b.
Air
model
i.
Major
processes:
dispersion,
dilution.

ii.
Optional
processes:
degradation,
deposition.

iii.
Chemical
data:
release
rate
(
mass/
time).
No
other
data
required
for
basic
assessment;
degradation
and
physical­
chemical
data
may
be
used
to
modify
the
assessment.

iv.
Environmental
data:
source
height,
mixing
layer
height,
meteorological
parameters;
for
all
these,
generic
or
site
specific
information
could
be
used.

v.
Remarks:
The
calculation
of
dilution
is
the
minimum
necessary.
The
approach
for
calculation
of
concentrations
is
dependent
on
the
type
of
release.
For
a
point
source,
a
local
plume
model
should
be
used.
A
modification
of
this
could
be
used
to
describe
a
larger
area
source,
for
example
a
city.
For
other
types
of
source
a
box
model
may
be
more
appropriate.
Member
countries
should
use
their
judgement
in
choosing
which
method
to
apply.
The
results
required
are
the
concentration
in
the
plume
where
it
first
interacts
with
the
ground
or
with
a
receptor
of
interest,
or
the
distributed
concentration
in
the
box
model.
Degradation
and
physical­
chemical
data
may
be
used
to
indicate
whether
changes
in
the
calculated
levels
are
likely.
They
could
also
be
used
to
estimate
deposition
rates
for
use
as
input
into
the
soil
model.
c.
Soil
model
i.
Major
processes:
partitioning
between
water
and
soil;
removal
by
degradation,
leaching.

ii.
Optional
processes:
volatilization,
root
uptake.

iii.
Chemical
information:
Henry's
Law
Constant,
Koc,
degradation
rate(
s),
deposition
rate,
concentration
in
sewage
sludge.

iv.
Environmental
data:
soil
properties
(
porosity,
water
content,
organic
carbon
content,
depth
of
root
zone
and
surface
layer
(
see
remarks));
meteorological
properties
(
rainfall,
evaporation,
or
a
water
balance).
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
12
v.
Remarks:
This
situation
is
more
complicated
than
the
previous
two
models.
Two
possible
release
routes
were
considered:
deposition
from
air,
or
application
of
sewage
sludge
containing
the
chemical.
Member
countries
may
consider
other
release
routes
if
they
so
wish.
It
was
agreed
that
concentrations
were
desired
to
assess
effects
on
soil
organisms
and
on
possible
levels
in
groundwater.
Accordingly
there
are
actually
two
versions
of
the
same
model
that
may
be
used
here.
For
assessing
effects
on
soil
organisms,
a
model
of
only
the
shallow
surface
layer
might
be
considered.
For
levels
in
groundwater,
calculations
would
be
carried
out
for
soil
to
the
depth
of
the
root
zone
or
below;
the
concentration
in
the
leaching
water
would
be
then
available
for
use
in
assessing
groundwater
concentrations.
Different
values
for
organic
carbon
content
etc.
could
be
used
for
the
two
cases.
Values
for
the
depths
of
the
two
layers,
and
the
soil
properties
should
be
chosen
by
the
Member
countries
(
generic
or
site
specific).
The
possibility
of
volatilization
affecting
the
estimated
concentrations
was
considered,
but
it
was
felt
that
the
routes
of
release
had
already
taken
this
into
account.

General
Comments
on
the
Local
Models
5.
Throughout
these
models
there
are
opportunities
for
Member
countries
to
adapt
them
to
their
own
particular
situations.
Whilst
it
was
agreed
that
this
should
be
done
where
the
data
was
available,
it
was
felt
by
several
of
the
participants
that
the
application
of
a
set
of
generic
local
conditions
as
a
reference
scenario
would
also
be
useful.
It
is
recommended
that
the
possibility
of
developing
such
scenarios
be
investigated.
It
is
also
recommended
that
Member
countries
take
a
conservative
approach
to
the
choice
of
generic
parameters.

Global
Model
6.
Rather
than
derive
a
multi
media
model
from
basic
processes,
the
group
decided
after
discussion
that
the
Mackay
level
III
model
should
be
used
as
the
basis
of
the
global
model.
However,
this
did
not
rule
out
the
use
of
other
models
considering
long
term
fate
if
a
Member
country
had
such
models
available.

7.
As
a
number
of
versions
of
this
model
have
been
available
over
the
years,
it
was
agreed
that
it
was
important
that
all
Member
countries
had
the
same
basic
model
with
which
to
work,
if
they
wished
to
use
this
approach.
The
version
chosen
was
that
presented
by
Frank
Wania
(
University
of
Toronto)
at
the
Workshop,
and
described
in
"
Generic
Models
for
Evaluating
the
Regional
Fate
of
Chemicals"
by
D.
Mackay
et
al.
(
Chemosphere,
in
press
1992)
(
Ref.
34).
This
should
be
adapted
to
model
the
environment
of
the
Member
country
if
this
was
possible,
for
example
by
using
appropriate
sizes
for
the
compartments.
If
this
was
not
possible,
the
default
compartment
sizes
as
presented
in
the
article
should
be
used.
In
line
with
the
comment
above
on
the
local
models,
it
was
felt
by
many
of
the
participants
that
it
would
be
useful
for
each
country
to
use
these
default
values
in
addition
to
their
own
values
if
possible.
In
order
to
allow
Member
countries
to
modify
the
environmental
parameters,
development
of
a
modified
version
of
the
computer
program
was
necessary.

i.
Chemical
data
required:
physical­
chemical
data
from
the
SIDS
data
set;
degradation
rate
data,
release
rate
appropriate
to
the
model
used.

ii.
Environmental
parameters:
compartment
volumes,
areas,
densities,
organic
carbon
content
where
appropriate.
These
are
the
parameters
which
users
can
input
in
the
modified
version.

iii.
Remarks:
Where
parameters
such
as
Koc,
BCF
are
estimated
from
other
data
it
is
important
that
the
method
used
is
indicated.
This
is
also
the
case
for
estimates
of
degradation
rate.
For
the
generic
model,
an
appropriate
input
rate
should
be
used,
for
example
1%
of
the
total
release
in
the
OECD
Member
countries.

General
Remarks
8.
It
is
important
when
using
the
approaches
indicated
above
that
any
assumptions
made
or
extra
data
used
are
made
clear,
for
example
the
reasons
for
choosing
flow
rates
in
the
water
model
should
be
given.
If
SAR
methods
are
used
to
estimate
other
data,
the
method
used
should
be
given.
It
is
essential
that
the
methods
used
are
transparent
to
other
Member
countries.

9.
The
physical­
chemical
data
available
in
the
SIDS
are
generally
sufficient
for
these
models.
For
some
data
it
is
necessary
to
use
SAR
methods.
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
13
10.
There
is
a
general
lack
of
information
on
degradation
rates
in
the
SIDS
data
set.
This
may
not
be
important
for
the
local
models
in
the
first
instance,
but
it
is
an
obvious
problem
for
global
models.
Therefore
the
Working
Group
recommends
that
efforts
be
made
to
improve
the
provision
of
such
data,
whether
through
measurement
or
estimation.

11.
Where
there
are
uncertainties
in
the
data
used,
the
user
should
assess
the
effect
these
have
on
the
concentration
estimates.
In
addition
it
should
be
noted
that
there
are
some
chemicals
for
which
these
methods
are
not
suitable.

12.
It
is
recommended
that
models
based
on
the
methods
in
this
report
should
be
developed
and
distributed
to
Member
countries
by
the
OECD
Secretariat
in
time
to
perform
the
next
round
of
assessment
of
HPV
phase
1
chemicals.
Member
countries
are
invited
to
submit
their
own
models
to
be
distributed
at
the
same
time.
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
14
Annex
3
Models
for
Indirect
Exposure
by
Food
and
Drinking
Water
(
Summary
Report
of
Working
Group
III
of
the
OECD
Workshop
held
in
Berlin
in
December
1991)

1.
The
objectives
of
the
Working
Group
were
to
identify
and
recommend
suitable
models
for
indirect
human
exposure
assessment.
It
was
generally
agreed
that
such
models
cannot
be
considered
separate
from
models
used
for
estimating
environmental
concentrations.
Therefore,
discussions
touched
parts
of
the
discussion
in
Working
Groups
I
and
II,
especially
concerning
the
scale
on
which
indirect
exposure
of
human
beings
is
considered.

2.
The
main
discussion
point
concerned
the
connection
between
environmental
models
and
indirect
exposure
models.
The
exact
process
descriptions
were
seen
as
of
minor
importance,
as
they
are
more
or
less
the
same
in
most
models.

Models
presented
3.
There
were
six
models
presented
by
the
members
of
the
Working
Group.

3.
a
CHEMCAN
2
(
Canada,
Ref.
1)

i.
This
is
a
global
model
based
on
Mackay
Level
III
dividing
Canada
into
24
regions
considering
four
primary
(
air,
water,
soil,
sediment)
and
four
secondary
compartments
(
groundwater,
coastal
water,
terrestrial
plants
and
terrestrial
animals).

ii.
Indirect
exposure
of
humans
can
be
calculated
from
the
concentrations
in
food
but
up
to
now
it
is
not
included
in
the
model.
Fine
tuning
of
some
pathways
(
e.
g.
soil­
plant)
has
to
be
carried
out.

3.
b
CHEMFRANCE
(
France,
Ref.
3)

This
model
is
similar
to
CHEMCAN
2
dividing
France
in
12
regions.

3.
c
MNSEM
(
Japan,
Ref.
5
and
6)

This
model
is
also
similar
to
CHEMCAN
2,
that
means
it
is
also
based
on
Mackay
Level
III
and
it
is
specific
for
Japan.
It
calculates
concentrations
for
all
relevant
compartments
as
well
as
the
total
daily
intake
for
adults.
Elimination
according
to
first
order
kinetics
can
also
be
calculated.

3.
d
RISK
(
Netherlands,
Ref.
7)

RISK
is
a
local
model
for
a
generic
standard
environment
and
is
specific
for
average
conditions
in
the
Netherlands.
It
is
a
worst
case
approach
for
indirect
exposure
of
humans,
but
can
be
modified
to
a
realistic
worst
case.
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
15
3.
e
US
Approach
(
Ref.
11
and
22)

It
is
a
local
model,
generic
or
site
specific,
and
refers
to
the
situation
in
the
US.
EPA
databases
on
emission
patterns
and
stream
flows
are
used.
Certain
pathways,
e.
g.
exposure
via
cattle
or
crops,
are
not
included
and
there
is
no
automated
version
available,
e.
g.
for
a
PC.

3.
f
HESP
(
SHELL,
ECETOC)

HESP
is
a
site
specific
model
for
Hazard
Assessment
when
there
is
soil
pollution.
For
the
exposure
of
humans
(
adults
as
well
as
children)
detailed
information
is
given
on
the
various
routes
(
inhalation,
ingestion
and
dermal
absorptions).

Evaluation
of
the
Models
4.
The
following
table
shows
the
evaluation
of
each
model.

Table:
Evaluation
of
the
Models
NAME
Scale
Input
data
Data
covered
by
SIDS
CHEM­
FRANCE
global,
specific
for
France
physical­
chemical
emission
estimates
+­

CHEMCAN
2
global,
specific
for
Canada
physical­
chemical
emission
estimates
+­

MNSEM
global,
specific
for
Japan
physical­
chemical
emission
estimates
+­

RISK
local,
generic
physical­
chemical
emission
estimates
+­

US
Approach
local,
generic
or
specific
physical­
chemical
emission
estimates
+­

HESP
site
specific
physical­
chemical
soil
concentration
+­

5.
For
all
models
emission
estimates
or
soil
concentrations
are
necessary
but
not
available
from
SIDS.

6.
The
structure
of
indirect
exposure
models
as
proposed
in
Figure
1
of
the
Discussion
document
(
Ref.
18)
was
agreed.
One
amendment
is
proposed
by
adding
SEDIMENT
as
a
pathway
to
FISH.

1
2
7
6
7
AIR
SURFACE
WATER
SEDIMENT
SOIL
HUMAN
BEINGS
Groundwater
Grass
Fish
Drinking
Water
Crops
Cattle
Meat
Milk
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
16
6
8
3
7
3
4
7
5
7
1
inhalation
2
bioconcentration
water­
fish
3
bioconcentration
soil­
plant
4
biotransfer
to
meat
5
biotransfer
to
milk
6
purification
of
drinking
water
7
consumption
8
ingestion
of
soil
Figure
1
­
Schematic
Representation
of
the
Indirect
Exposure
to
Human
Beings
Conclusions
7.
It
was
stressed
that
because
certain
target
groups
like
children
or
elderly
people
behave
differently
from
the
average
adult,
it
is
important
that
such
critical
target
groups
be
included
in
indirect
exposure
assessments.
There
may
be
also
large
differences
between
the
exposure
of
communities
which
live
near
the
source
compared
to
the
population
as
a
whole.

8.
All
models
except
HESP
are
in
fact
environmental
models
which
include
modules/
methods
for
estimating
human
intake.
This
emphasizes
the
strong
relationship
with
the
local
and
global
models
as
discussed
in
Working
Group
II.
HESP
is
the
only
true
human
exposure
model,
developed
for
specific
application.
Four
models
namely
CHEMCAN,
CHEMFRANCE,
MNSEM
and
RISK
have
been
developed
for
specific
regions.
They
are
adaptable
and,
therefore,
are
available
to
those
Member
countries
who
wish
to
use
them
in
their
initial
indirect
exposure
assessment
of
HPV
chemicals
to
humans.

9.
Both
local
and
global
approaches
were
thought
to
be
important
in
order
to
obtain
insight
into
the
exposure
of
local
and
average
populations.
Both
types
of
models
are
strongly
recommended
to
be
used,
when
circumstances
indicate
that
this
type
of
insight
will
be
useful
to
the
assessment.
Similarly,
to
the
extent
warranted
by
other
factors
or
information,
it
is
recommended
to
carry
out
calculations
for
extreme
dietary
compositions,
e.
g.
high
and
low
consumption
of
fish,
meat
or
vegetable.

10.
It
was
considered
that
the
US
approach
is
not
so
easily
adaptable
and,
therefore,
is
of
limited
use
to
other
Member
countries.
HESP
can
be
used
only
for
specific
purposes
(
soil
contamination)
and
is
therefore
out
of
scope
for
the
initial
exposure
assessment
of
HPV
chemicals
of
the
OECD
Existing
Chemicals
Programme.
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
17
Annex
4
References
A.
Member
Countries'
Responses
to
the
Questionnaire
1.
Application
of
a
Fugacity­
Based
Model
to
the
Estimation
of
the
Environmental
Fate
of
10
Chemicals
on
the
OECD
SIDS
List,
J.
Sitwell
and
D.
M.
Kane,
National
Health
and
Welfare
(
Canada)

2.
Environmental
Exposure
Assessment,
Product
Register
Data
on
Ten
Selected
Substances,
P.
Andersen,
National
Institute
of
Occupational
Health
(
Denmark)

3.
Environmental
Behavior
of
Ten
Organic
Compounds,
J.
Devillers
and
D.
Domine
CTIS
(
France)

4.
Response
from
Germany,
P.
Greiner,
Umweltbundesamt
(
Germany)

5.
Application
of
Simple
Model
for
Environmental
Exposure
Assessment,
K.
Yoshida,
Mitsubishi­
kasei
Institute
of
Toxicological
and
Environmental
Sciences
(
Japan)

6.
Multi­
Phase
Non­
Steady
State
Equilibrium
Model
(
MNSEM)
Version
1.4.5
Model
Information,
K.
Yoshida,
Mitsubishi­
kasei
Institute
of
Toxicological
and
Environmental
Sciences
(
Japan)

7.
Assessment
of
Environmental
Concentrations
and
Risk
Quotients
for
the
Netherlands:
Application
of
Simple
Models,
C.
Toet,
D.
van
de
Meent,
Th.
E.
M.
ten
Hulscher,
K.
D.
van
den
Hout,
National
Institute
of
Public
Health
and
Environmental
Protection
etc.
(
the
Netherlands)

8.
Environmental
Exposure
Assessment,
E.
Hoygaard,
State
Pollution
Control
Authority
(
Norway)

9.
Initial
Exposure
Assessment
of
10
HPV/
P1
Chemicals,
Applying
a
Swedish
Exposure
Model
(
Revised
version),
S.
Fischer,
National
Chemicals
Inspectorate
(
Sweden)

10.
Response
from
United
Kingdom,
P.
J.
Corcoran,
Department
of
the
Environment
(
United
Kingdom)

11.
Engineering
and
Environmental
Exposure
Report
for
Ten
High
Production
Volume
SIDS
Chemicals,
(
US
Environmental
Protection
Agency)

B.
Request
and
Data
on
the
Ten
SIDS
Chemicals
12.
Data
on
ten
selected
SIDS
Chemicals
from
HPV
Form
1
(
OECD
Secretariat)

13.
Estimates
of
Ecotoxicity
(
Aquatic
Effects)
and
Bioaccumulation,
Data
of
the
Ten
SIDS
Chemicals
(
the
Netherlands)

C.
Discussion
Documents
for
the
OECD
Workshop
held
in
Berlin
in
December
1991
14.
Emission
Factors
and
Use
Categories
of
Chemicals
(
for
W.
G.
I)
(
W.
Penberthy,
P.
Greiner)

15.
Memorandum:
OECD
Scheme
for
Estimating
Rates
of
Removal
in
Waste
Water
Treatment
(
for
W.
G.
I
­
comments
on
Ref.
14
by
the
US)
(
R.
Boethling)

16.
Local
and
Global
Models
(
for
W.
G.
II)
(
OECD
Secretariat)

17.
Application
of
SARs
to
the
Estimation
of
Properties
Important
in
Exposure
Assessment,
Fraunhofer
­
Institute
(
for
the
Special
Session)
(
P.
Degner,
H.
Jackel,
M.
Muller,
N.
Nendza,
B.
von
Oepen,
W.
Klein)

18.
Indirect
Exposure
of
Human
Beings
to
Organic
Compounds
(
C.
Toet,
S.
Arai)
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
18
19.
Reference
Models
which
would
be
used
for
the
Initial
Environmental
Exposure
Assessment
(
for
W.
G.
II)
(
M.
Matthies)

D.
Background
Documents
for
the
OECD
Workshop
held
in
Berlin
in
December
1991
20.
Emission
factors
and
Use
Categories
of
Chemicals
(
for
W.
G.
I)
(
W.
Penberthy,
P.
Greiner)

21.
Local
and
Global
Models
(
for
W.
G.
II)
(
OECD
Secretariat)

22.
Potential
Approaches
for
Developing
Screening­
Level
Environmental
and
Human
Exposure
Assessments
for
SIDS
Chemicals
(
for
W.
G.
II)
(
E.
Bryan)

E.
Additional
References
23.
OECD's
Work
on
Investigation
of
High
Production
Volume
Chemicals,
OECD,
1991
24.
Environmental
Releases
of
Chemicals
in
Household
Products,
US
EPA,
Dec.
1991
25.
Site­
Specific
Surface
Water
Flows
and
REACH
Number,
US
EPA,
Dec.
1991
26.
Stream
Dilution
Factor
Programme
Outputs
for
40
Industrial
Categories,
US
EPA,
Dec.
1991
27.
User's
Guide
to
Probabalistic
Dilution
Model
3
(
PDM
3),
US
EPA,
Dec.
1991
28.
Probabalistic
Dilution
Model
3
(
PDM3),
US
EPA,
Dec.
1991
29.
A
Model
of
Organic
Chemical
Fate
in
a
Biological
Wastewater
Treatment
Plant,
B.
Clark
et
al.
University
of
Toronto,
Oct.
1989
30.
Comparison
of
different
models
for
Environmental
Hazard
Classification
of
Chemicals,
KEMI
Report
No.
9/
89
31.
Systems
for
Testing
and
Hazard
Evaluation
of
Chemicals
in
the
Aquatic
Environment,
A
Manual
for
an
Initial
Assessment
­
ESTER,
KEMI
Report
No.
4/
88
32.
Substances
and
Preparations
Dangerous
for
the
Environment,
A
System
for
Classification,
Labelling
and
Safety
Data
Sheets,
Final
Report
from
a
Nordic
Working
Group,
Nordic
Council
of
Ministers,
1990
33.
Fugacity
Models,
D.
Mackay
et
al.,
Practical
Application
of
QSAR
in
Environmental
Chemistry
and
Technology
,
June
1990,
Klamer
Academic
Publication,
pp.
433­
461
34.
Generic
Models
for
Evaluating
the
Regional
Fate
of
Chemicals,
D.
Mackay
et
al.
(
Chemosphere,
in
press
1992)

35.
The
Explanatory
Note
for
Diskettes
Comprising
National
Models,
OECD
Secretariat,
July
1992
36.
Screening
Assessment
Model
Systems
("
SAMS",
The
Explanatory
Note
for
Diskette
of
the
Local
Reference
Models,
Version
1.1),
OECD
Secretariat,
December
1992
37.
The
Explanatory
Note
for
Diskette
of
the
Global
Reference
Model,
OECD
Secretariat,
July
1992
38.
Report
of
the
OECD
Workshop
on
the
Application
of
Simple
Models
for
Environmental
Exposure
Assessment,
Environment
Monographs
No.
69,
1993
39.
Application
of
Structure­
Activity
Relationships
to
the
Estimation
of
Properties
important
in
Exposure
Assessment,
Environment
Monographs
No.
67,
1993
F.
List
of
Diskettes
and
Documents
Distributed
to
the
SIDS
Contact
Points
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
19
a.
Reference
Models
and
National
Models
(
ENV/
EHS/
SA/
fcl/
92.40,
11th
August
1992,
and
ENV/
EHS/
SA/
fcl/
93.1,
11th
January
1993)

·
Diskettes
of
Reference
Models
("
Screening
Assessment
Model
System
(
SAMS)"
Version
1.1
and
"
Fugacity
Model
(
FUGMOD)")
·
Two
diskettes
of
National
Environmental
Exposure
Models
(
i.
e.
The
Netherlands,
UK,
Canada,
France
and
Japan)
·
Explanatory
Note
of
a
Diskette
of
the
Global
Reference
Model
(
FUGMOD)
·
Explanatory
Note
of
a
Diskette
of
the
Local
Reference
Models
(
SAMS
Version
1.1)
·
Explanatory
Note
of
Diskettes
Comprising
National
Models
b.
Documents
and
Diskettes
of
the
U.
S.
models
(
ENV/
EHS/
SA/
fcl/
92.41,
11th
August
1992)

·
A
letter
from
Ms.
E.
Bryan
to
Rob
Visser
dated
23rd
March
1992
·
Models
1.
STP
(
Sewage
Treatment
Plant
model
or
"
Toronto
model")
­
The
diskette
of
"
Water"
includes
STP
2.
Water
(
the
following
sub
models)

A.
Exposure
from
Airborne
Release
a.
Turner
model
­
Enclosure
I
of
the
letter:
Document
for
Generic
Turner
Method
for
Estimated
Exposure
from
Near­
Ground
Releases
to
Air
b.
ISCLT
model
(
Industrial
Source
Complex
Long
Term
model)
­
Enclosure
II
of
the
letter:
Documentation
for
Generic
ISCLT
Method
for
Estimating
Exposure
form
Elevated
Release
to
Air
B.
Site­
specific
Surface
Water
Release
Calculation
C.
Industrial
SIC­
Code
Based
Water
Surface
Water
Calculation
D.
Drinking
Water
Exposure
from
Landfilled
Chemicals
­
Enclosure
III
of
the
letter:
Draft
Guidelines
for
Groundwater
Assessments
for
PMN
Chemicals
E.
Chemical
Removal
from
Adsorption
Diskette
­
Water
(
including
above
mentioned
six
models)
­
STP
(
Toronto
Model)
­
PMNPLUME
Model
3.
PMNPLUME
­
PMNPLUME
Exposure
Model
Description
and
Use's
Manual
­
The
diskette
of
"
Water"
includes
PMNPLUME
4.
Probabilistic
Dilution
Model
3
(
PDM3)
­
Draft
Report,
Probabilistic
Dilution
Model
3
(
PDM3),
Volume
1
and
2
­
Final
report,
User's
Guide
to
PDM3
­
Diskettes
"
PDM3"
(
6
diskettes
for
a
set)
1.
Option
1
Estimated
flows
2.
Option
1
Measured
flows,
disk
1
of
3
3.
do
,
disk
2
of
3
4.
do
,
disk
3
of
3
5.
PDM.
EXE
6.
Option
2
SIC
code
data
5.
ReachScan
EXCH\
MANUAL\
96­
4­
3.
DOC/
May
1996
20
­
ReachScan
User's
Manual
­
a
diskette
of
ReachScan
with
Region
3
Stream
Data
6.
PCGEMS
­
PCGEMS
User's
Guide
Release
1.0
­
Diskettes
for
PCGEMS
(
21
diskettes
for
a
set)
EXCH\
MANUAL\
96­
4­
4.
DOC/
May
1996
1
4.4
Provisional
Guidance
for
the
Initial
Assessment
of
Occupational
and
Consumer
Exposure*

4.4.1
Introduction
1.
This
document
provides
guidance
for
the
initial
assessment
of
the
occupational
and
consumer
exposure
of
High
Production
Volume
(
HPV)
chemicals
for
which
a
full
SIDS
is
available,
based
mainly
on
the
results
of
the
OECD/
US
EPA
Workshop
held
in
Orlando,
Florida
in
February
1992.
The
results
of
the
Workshop
are
published
by
the
OECD
as
OECD
Environment
Monograph
No.
70,
Occupational
and
Consumer
Exposure
Assessments
(
from
now
on
referred
to
as
"
Monograph
No.
70").

2.
The
objective
of
any
occupational
and
consumer
exposure
assessment
is
to
calculate
a
"
realistic"
Estimated
Human
Exposure
(
EHE)
level,
expressed
in
terms
of
dose
per
unit
weight,
e.
g.
mg/
kg,
based
on
data
contained
within
the
full
SIDS
Dossier
for
the
"
sponsored"
chemical.
This
level
can
then
be
compared
with
the
results
obtained
from
conducting
the
Initial
Assessment
of
Health
Effects
and
a
judgement
made
as
to
whether
the
chemical
presents
a
cause
for
concern
and
the
possibility
of
further
action.
For
consistency
within
assessments,
when
calculating
the
human
exposure
level,
in
the
absence
of
evidence
to
the
contrary,
there
may
be
a
need
to
standardise
some
of
the
appropriate
physiological
parameters.
In
this
respect
it
is
suggested
to
assume
that:

(
a)
an
adult
weighs
70
kg;
(
b)
the
respiratory
volume
is
10
m
3
(
i.
e.
10,000
litres)
per
working
day
(
8
hours);
(
c)
the
consumer
respiratory
volume
is
15
litres
per
minute.

3.
Other
factors,
which
should
be
obtained
before
assessing
exposure,
relate
to
the
physical
state
of
the
chemical
and
its
weight
fraction
in
any
product
or
formulation
that
is
professionally
used.
If
the
chemical
is
also
present
in
consumer
products,
an
appropriate
adjustment
should
be
made
to
the
EHE.

4.4.2
Occupational
Exposure
4.
For
exposure
via
the
inhalation
route,
some
chemicals
may
have
been
assigned
a
national
or
company­
based
occupational
exposure
limit
(
e.
g.
TLV,
MAK,
MAC,
OES,
etc.),
perhaps
even
further
refined
to
encompass
short­
term
limits
or
ceiling
values.
Whenever
possible
these
levels,
preferably
expressed
as
mg/
m
3
rather
than
p.
p.
m.,
should
be
used
as
the
basis
for
calculating
the
EHE.
It
is
important
to
compare
these
occupational
exposure
limits
as
the
values
may
differ
between
Member
countries.
The
toxicity
and
exposure
data
used
and
the
date
the
limits
were
set
should
also
be
considered
in
the
comparison.

5.
In
other
cases
actual
monitoring
data,
both
personal
and
background,
may
be
available
and
can,
after
suitable
statistical
treatment
(
e.
g.
geometric
mean
and
standard
deviation),
be
used
in
a
similar
manner.
The
overall
procedure
should
be
repeated
for
all
the
various
production
processes
and
uses
made
of
the
chosen
chemical
and,
from
a
knowledge
of
frequency
and
duration
of
exposure,
the
results
of
the
"
worst
case"
highlighted.
Again
knowledge
that
technical
or
personal
protective
equipment
is
required
may
assist
in
formulating
views.
6.
However,
for
the
majority
of
SIDS
chemicals
it
is
anticipated
that
"
real"
data
will
not
be
available
and
hence
"
estimation"
methods
will
need
to
be
used.
Three
such
methods,
as
proposed
by
Germany,
the
UK
and
the
USA,
with
varying
levels
of
detail
and
from
which
the
National
SIDS
Contact
Points
are
free
to
choose,
have
been
identified.
These
are
attached
to
Monograph
No.
70
as
Annexes
I­
III.
They
rely
on
a
knowledge
of
similar
production
processes
and
use
patterns
and/
or
on
the
physical­
chemical
properties
of
the
"
sponsored"
or
surrogate
chemical.
Thus
where
"
real"
data
are
missing
for
the
chosen
chemical
it
may
be
possible
to
substitute
data
from
another
chemical
meeting
the
criteria
mentioned
above.
In
all
these
methods
the
amount
of
detail
and
level
of
sophistication
required
for
a
"
quantitative"
estimation
depends
to
some
extent
on
the
toxicity
of
the
chemical.
Therefore,
the
occupational
exposure
(
and
consumer
exposure)
assessment
should
not
be
conducted
in
isolation.
For
example,
a
chemical
showing
low
toxicity
may
require
only
qualitative,
or
at
most
semiquantitative
exposure
estimation.
In
those
cases
where
a
chemical
is
also
incorporated
into
a
consumer
product,
the
occupational
or
professional
exposure
should
be
supplemented
by
the
appropriate
component
of
the
consumer
exposure
assessment
in
calculating
the
overall
EHE.
The
situation
is
not
so
clear­
cut
regarding
dermal
exposure
and
only
the
model
*
This
document
was
prepared
by
the
OECD
Secretariat
in
1992
based
on
the
results
of
the
OECD/
US
EPA
Workshop
held
in
Orlando,
Florida,
in
February
1992.
It
has
been
updated
to
reflect
comments
by
Member
countries
and
agreements
reached
in
the
context
of
the
OECD
Existing
Chemicals
Programme
up
to
mid­
1994.
EXCH\
MANUAL\
96­
4­
4.
DOC/
May
1996
2
used
by
the
US
EPA
addresses
this
point.
Indeed
one
of
the
conclusions
of
the
Orlando
workshop
was
that
more
work
was
needed
in
this
area
and
that
Member
countries
should
share
their
experiences.
Such
information
will
be
invaluable
in
updating
this
provisional
guidance,
for
both
occupational
and
consumer
exposure.

Overview
of
Models
for
Estimating
Occupational
Exposure
7.
The
US
EPA
submission
provides
a
number
of
model
approaches
whose
applicability
relies
on
some
knowledge
of
production
and
use
scenarios
in
the
US
(
e.
g.
the
NIOSH
National
Occupational
Exposure
Survey).
The
identification
of
critical
unit
operations
during
manufacture
and
use
leading
to
significant
exposure
scenarios
allows
a
degree
of
specificity
in
the
assessment.
However,
some
reservations
as
to
the
applicability
of
the
models,
in
circumstances
of
more
modest
resources
or
expertise,
could
restrict
their
use.
(
See
Annex
I
to
Monograph
No.
70.)

8.
The
UK
HSE
submission
illustrates
a
possible
approach
based
on
a
structured
logic
tree
using
analogous
exposure
data.
Its
recent
development
into
a
simple,
validated
"
expert
system"
for
screening
purposes
is
attractive,
particularly
as
the
ultimate
choice
of
exposure
databases
could
be
adapted
to
national
needs.
In
the
first
instance
the
use
of
the
UK
National
Exposure
Database
(
NEDB)
could
be
a
relevant
tool
in
the
development
of
this
approach.
The
classifications
based
on
physical
and
(
apparent)
toxicological
properties
and
containment
levels
will
need
careful
definition
for
more
general
future
use.
(
See
Annex
II
to
Monograph
No.
70.)

9.
The
German
BAU
submission
offers
a
generally
qualitative
screening
approach
based
on
common
knowledge
of
the
exposure
situations
in
different
areas
of
use
and
on
an
example
of
"
mass
balance"
calculations.
This
could
be
a
particularly
relevant
screening
tool
when
there
was
an
early
indication
that
a
high
degree
of
sophistication
was
unlikely
to
be
warranted.
(
See
Annex
III
to
Monograph
No.
70.)

4.4.3
Consumer
Exposure
10.
Much
of
the
foregoing
can
also
be
applied
to
the
assessment
of
consumer
exposure
in
that
the
objective,
when
combined
with
any
possible
occupational
exposure,
is
to
calculate
an
EHE,
that
"
real"
data
is
to
be
preferred,
and
that
the
toxicity
of
the
chemical
should
be
brought
to
bear
on
the
level
of
detail
required.
Again
for
most
SIDS
chemicals,
it
is
expected
that
"
estimation"
methods
will
be
required
and
two
have
been
identified.
One
of
these,
as
used
by
the
US
EPA,
is
available
on
computer
diskette.
Although
a
synopsis
is
attached
to
Monograph
No.
70
as
Annex
IV,
further
details
of
its
use
are
best
obtained
from
the
incorporated
files,
most
of
which
are
"
menu­
driven".
The
other
one,
a
discussion
paper
from
the
Netherlands,
is
also
attached
to
Monograph
No.
70
as
Annex
V.
Unlike
the
occupational
setting
where,
to
a
greater
or
lesser
extent,
some
exposure
is
bound
to
occur,
there
will
of
course
be
no
requirement
to
undertake
an
exposure
assessment
if
the
chemical
is
not
present
in
a
consumer
product.
Product
registers
and
inventories,
etc.
will
need
to
be
consulted,
perhaps
with
assistance
from
other
Member
countries,
to
check
if
this
is
indeed
the
case.
There
may,
however,
be
the
need
to
incorporate
other
factors,
such
as
presence
in
drinking
water,
in
obtaining
an
overall
EHE.

Overview
Models
for
Estimating
Consumer
Exposure
11.
Details
of
the
method
proposed
by
the
US
EPA
are
obtained
from
the
diskette
which
contains
the
SCIES,
AMEM,
FLUSH
and
DERMAL
procedures
and
explanatory
documents.
Both
have
been
distributed
to
the
SIDS
Contact
Points
(
see
the
list
in
Reference
as
well
as
details
in
Annex
IV
to
Monograph
No.
70.)

·
SCIES
is
a
Screening­
level
Consumer
Inhalation
Exposure
Software
program
for
the
passive
and
active
annual
average
inhalation
exposure
to
components
of
consumer
products.

·
AMEM
is
an
estimation
model
for
assessing
migration
of
a
chemical
from
a
polymer
and
the
inhalation
exposure.

·
FLUSH
is
a
program
for
estimating
concentrations
of
chemicals
in
surface
waters
that
may
result
from
disposal
of
consumer
products
containing
these
chemicals
into
household
wastewater
and
also
provides
estimates
of
human
exposure
from
ingestion
of
drinking
water
and
fish
that
may
become
contaminated
by
these
household
wastewater
releases.
EXCH\
MANUAL\
96­
4­
4.
DOC/
May
1996
3
·
DERMAL
is
a
program
which
allows
estimation
of
dermal
exposure,
in
terms
of
potential
dose
rate,
for
contact
with
(
1)
a
film
of
liquid
deposited
on
the
skin,
(
2)
dusts
and
powders,
and
(
3)
chemicals
contained
in
or
adhering
to
solid
matrices.

A
computer
expert
may
need
to
be
consulted
on
the
AMEM
program
as
a
"
maths
co­
processor"
is
required.

12.
The
proposed
model
from
the
Netherlands
in
Annex
V
to
Monograph
No.
70
is
self­
explanatory
and
allows
one
to
input
selected
values
or,
in
certain
circumstances,
to
choose
the
"
default"
value.

4.4.4
Reporting
13.
General
guidance
for
preparing
the
report
is
given
in
the
document
entitled
"
Provisional
Guidance
for
the
Outline
of
the
SIDS
Initial
Assessment
Report"
(
see
Section
4.2),
but
it
is
worth
re­
emphasizing
that
the
approach
used
in
obtaining
any
estimation
of
the
EHE,
including
the
underlying
assumptions
and
uncertainties,
should
be
sufficiently
well
explained
to
enable
other
interested
parties
to
confirm
the
conclusions
and
respond
effectively.
Also
as
a
reminder,
it
is
requested
that
the
use,
or
otherwise,
made
of
this
"
provisional"
guidance
be
highlighted
so
that
future
versions
can
be
modified.
Views
of
the
users
on
the
suitability
of
various
"
default"
or
other
"
standardised"
values
will
also
be
welcome.
EXCH\
MANUAL\
96­
4­
4.
DOC/
May
1996
4
Reference
List
of
Diskettes
and
Documents
for
Consumer
Exposure
Assessment
Distributed
to
the
SIDS
Contact
Points
(
ENV/
EHS/
AS/
fcl/
92.4,
11th
August
1992)

·
A
diskette
of
"
Models
for
Consumer
Exposure
Assessment"

·
An
explanatory
note
for
the
diskette
·
Screening­
level
Consumer
Inhalation
Exposure
Software
(
SCIES):
Description
and
User's
Manual,
Version
3.0
(
Draft),
USEPA
·
FLUSH
User's
Manual
(
Final
Draft
Report),
USEPA
·
Dermal
Exposure
Model
Description
and
User's
Manual
(
Draft),
USEPA
·
Methods
for
Assessing
Exposure
to
Chemical
Substances
Volume
11,
Methodology
for
Estimating
the
Migration
of
Additives
and
Impurities
from
Polymeric
Materials,
USEPA
Annexes
(
not
reprinted
here:
to
be
found
in
OECD
Environment
Monograph
No.
70,
Occupational
and
Consumer
Exposure
Assessments,
OECD,
1993)

Annex
I
Approaches
for
Developing
Screening
Quality
Estimates
of
Occupational
Exposure
used
by
the
US
EPA's
Office
of
Toxic
Substances
and
their
Applicability
to
the
OECD
SIDS
Programme,
US
EPA,
December
1992
Annex
II
The
estimation
of
Occupational
Exposure
to
Chemicals,
HSE,
UK
Annex
III
Occupational
Exposure
Assessment
for
Selected
SIDS
Chemicals,
BAU,
Germany
Annex
IV
Screening
Level
Consumer
Exposure
Assessment,
US
EPA
Annex
V
Estimation
of
Consumer
Exposures
to
Chemicals:
Application
of
Simple
Models,
RIVM,
the
Netherlands
EXCH\
MANUAL\
96­
4­
5.
DOC/
May
1996
1
4.5
Provisional
Guidance
for
the
Initial
Assessment
of
Aquatic
Effects*

4.5.1
Introduction
1.
This
document
provides
guidance
for
the
initial
assessment
of
aquatic
effects
of
High
Production
Volume
(
HPV)
chemicals
with
a
full
SIDS.
It
is
based
mainly
on
the
"
Guidance
Document
for
Aquatic
Effects
Assessment"
(
Ref.
1),
which
was
drafted
initially
by
the
Netherlands
in
the
framework
of
the
OECD
Hazard
Assessment
Programme
and
is
now
published
as
OECD
Environment
Monograph
No.
92.
This
Monograph
is
based
on
the
reports
of
the
following
three
Workshops:

­­
Application
of
Quantitative
Structure
Activity
Relationships
(
QSARs)
to
estimate
ecotoxicity
data
(
Utrecht,
12­
14
September
1990)
(
Ref.
2);
­­
Extrapolation
of
ecotoxicity
data
to
the
real
environment
(
Arlington,
Virginia,
10­
12
December
1990)
(
Ref.
3);
­­
Effects
assessment
of
chemicals
in
sediment
(
Copenhagen,
13­
15
May
1991)
(
Ref.
4)

2.
These
documents
(
Ref.
1,
2,
3
and
4)
can
be
referred
to
whenever
detailed
information
relating
to
the
assessment
procedure
presented
in
this
document
is
required.
In
particular,
examples
of
effects
assessments
in
Ref.
1
are
useful
for
understanding
the
procedure.

3.
This
guidance
can
be
applied
to
soluble
compounds;
however,
it
may
not
be
suitable
for
elements
in
the
metallic
state
and
for
insoluble
substances.

4.
Recently,
the
European
Commission
has
developed
the
Technical
Guidance
Document
for
risk
assessment
of
new
and
existing
chemicals
(
Ref.
5),
that
includes
detailed
guidance
for
aquatic
effects
assessment.

4.5.2
Background
to
Aquatic
Hazard
Assessment
5.
Environmental
hazard
assessment
is
defined
as
the
assessment
of
the
potential
of
a
chemical
to
cause
adverse
effects
on
the
environment
and/
or
man.
Effects
assessment
can
be
defined
as
the
identification
and
quantification
of
the
potential
adverse
effects
of
chemicals
on
individuals,
population
or
ecosystems
by
means
of
laboratory
testing
or
field
observations.
In
an
assessment
procedure,
a
comparison
is
made
of
the
calculated
"
low
risk"
concentration
where
no
unacceptable
adverse
effects
on
the
ecosystem
are
expected
(
i.
e.
Predicted
No
Effect
Concentration,
PNEC)**
and
the
concentrations
that
are
present
in
the
environment,
either
measured
or
calculated
(
i.
e.
Predicted
Environmental
Concentration,
PEC).***
This
comparison
gives
some
insights
into
the
risks
that
the
chemical
under
study
poses
to
human
beings
or
to
specific
species
in
any
environmental
compartment.

6.
Aquatic
effects
assessment
of
chemicals
is
a
sequential
process
that
may
comprise
three
stages:
initial,
refined
and
comprehensive,
where
each
stage
depends
on
the
type
and
quantity
of
information
that
is
available.

7.
In
the
initial
aquatic
effects
assessment
on
which
this
document
focuses,
the
impact
of
the
chemical
is
generally
assessed
against
only
one
or
two
representatives
from
each
of
three
trophic
levels
by
means
of
short­
term
toxicity
tests;
i.
e.
using
primary
producers
(
algae),
primary
consumers
(
Daphnia)
and
predators
(
fish).
Refined
effects
assessments
are
based
on
chronic
or
sub­
chronic
tests,
whereas
(
semi­)
field
studies
provide
the
basis
for
comprehensive
effects
assessments.
Hence,
the
process
of
effects
assessment
goes
through
stages
of
imprecise
to
precise
estimations
of
the
concentration
that
will
have
no
adverse
effect
on
the
ecosystem
under
consideration.

*
This
Provisional
Guidance
was
first
prepared
by
the
OECD
Secretariat
in
1992
based
on
the
results
of
three
OECD
Workshops
(
see
para
1).
It
has
been
updated
to
reflect
comments
by
Member
countries
and
agreements
reached
in
the
context
of
the
OECD
Existing
Chemicals
Programme
up
to
April
1996.

**
Maximum
Tolerable
Concentration
(
MTC)
is
also
used
synonymously.

***
The
methods
which
can
be
used
to
calculate
environmental
concentrations
are
addressed
in
"
Provisional
Guidance
of
Initial
Assessment
of
Environmental
Exposure"
(
see
Section
4.3).
Diskettes
comprising
environmental
exposure
models
for
calculation
of
PECs
are
also
available.
It
should
be
noted
that
all
important
emission
sources
should
be
clearly
identified
in
determining
PECs.
EXCH\
MANUAL\
96­
4­
5.
DOC/
May
1996
2
8.
Figure
1
presents
an
example
of
a
scheme
for
an
aquatic
effects
assessment.
It
includes
not
only
the
initial
assessment
procedure,
but
also
refined
and
comprehensive
assessment
procedures
which
can
be
performed
when
information
beyond
that
in
SIDS
is
available.

9.
Information
available
through
databases
and
publications
as
well
as
from
industry
should
be
collected
intensively.
The
data
should
then
be
evaluated
by
appropriate
assessors,
for
example
experts
in
the
field
of
environmental
chemistry
and
toxicology,
before
they
are
used
for
an
environmental
effects
assessment.
It
is
necessary
to
review
the
original
publication
to
assess
the
data
collected
through
databases.
In
the
SIDS
work,
the
data
should
be
generated
according
to
guidelines
such
as
the
OECD
Test
Guidelines
using
Good
Laboratory
Practice
(
GLP)
Principles.
(
Criteria
which
could
be
used
for
evaluation
of
data
is
given
in
Section
3
of
Ref.
1.
Its
summary,
with
some
amendments,
is
attached
as
Annex
1
to
this
document.)

10.
In
an
initial
assessment
based
on
the
information
obtained
in
the
SIDS
work,
a
set
of
assessment
factors
would
be
applied
(
see
Section
6
of
Ref.
1).
Also
a
QSAR
approach
using
physical­
chemical
properties
is
applicable
for
estimating
the
toxicity
of
chemicals
on
a
case­
by­
case
basis
when
no
data
or
only
data
for
one
test
species
are
available
or
when
the
measured
data
for
a
species
is
deemed
to
be
unacceptable.
This
approach
may
also
be
used
for
estimating
a
PNEC
value
by
the
application
with
assessment
factors
(
see
Section
7
of
Ref.
1).
For
chemicals
where
additional
information
beyond
the
SIDS
are
available,
the
possibility
of
carrying
out
higher
stages
of
assessments
could
be
considered
[
e.
g.
those
based
on
field
testing
(
see
Section
4
of
Ref.
1),
those
by
the
extrapolation
method
(
see
Section
5
of
Ref.
1)].

11.
In
addition,
indirect
effects
on
birds
and
mammals
(
see
Section
8
of
Ref.
1)
and
effects
on
benthic
organisms
(
see
Section
9
of
Ref.
1)
of
a
chemical
could
be
considered
depending
on
the
use
and
properties
of
the
chemical.

12.
When
considering
refinement
of
effect
assessments
or
further
testing,
refinement
of
exposure
assessment
should
also
be
considered.
EXCH\
MANUAL\
96­
4­
5.
DOC/
May
1996
3
Figure
1
­
An
Example
of
an
Aquatic
Effects
Assessment
Flow
Scheme
1.
Calculation
of
PNEC
Data
Collection
and
Evaluation
(
Section
3)

Effects
Assessment
on
Aquatic
Organisms
yes
yes
Beyond
SIDS
Field
Data
Use
of
Field
Data
PNEC
for
Selection
Criteria
Comprehensive
no
no
(
Section
4)
Assessment
no
yes
Data
on
Chronic
e.
g.
Extrapolation
PNEC
for
Tox.
on
Multiple
Method
Refined
Species
(
e.
g.
five
(
Section
5)
Assessment
or
more
different
species)

Toxicity
Data
Assessment
PNEC
for
on
1
or
more
yes
Factors
Initial
Species
(
Section
6)
Assessment
no
yes
QSAR
QSAR
Approach
no
(
Section
7)

Testing
Note:
Section
numbers
in
brackets
(
e.
g.
Section
3)
refer
to
the
appropriate
Sections
in
Ref.
1.

2.
Comparison
of
PNEC
with
PEC
·
PEC/
PNEC
<
1
­
Chemicals
of
low
current
priority
for
further
work
·
PEC/
PNEC
³
1
­
Consideration
of
further
work
or
actions
(
post
SIDS
testing,
detailed
exposure
analysis,
indepth
risk
assessment
or
further
risk
management
actions)
EXCH\
MANUAL\
96­
4­
5.
DOC/
May
1996
4
4.5.3
Outline
of
Various
Approaches
to
Aquatic
Effects
Assessment
Assessment
Factors
13.
When
only
a
limited
data
set
is
available
for
an
initial
assessment
of
a
chemical,
such
as
is
the
case
for
most
SIDS
chemicals,
assessment
factors
can
be
used
to
adjust
the
effect
concentration
and
to
estimate
a
PNEC.
However,
assessment
factors
should
be
applied
with
care
to
acute
data
for
substances
which
are
suspected
of
having
a
specific
mode
of
action,
or
which
have
a
high
log
Pow
or
which
significantly
bioaccumulate.

14.
Assessment
factors
may
be
used
to
extrapolate:
­
from
the
lowest
chronic
NOEC
to
the
field
situation;
­
from
concentrations
with
acute
effects
to
NOECs;
and
­
to
take
account
of
inter­
species
differences
in
sensitivity.

15.
Several
sets
of
assessment
factors
have
been
proposed
to
date.
Table
1
summarises
proposals
from
the
OECD
Arlington
Workshop
(
Ref.
1
and
3),
the
European
Commission
(
Ref.
5)
and
ECETOC
(
Ref.
6).
These
factors
can
be
modified
under
certain
conditions
(
e.
g.
an
assessment
factor
of
1000
in
the
EU
Technical
Guidance
Document
can
be
lowered
to
100
with
certain
evidence);
however,
such
modifications
of
the
factors
are
not
explained
here
(
please
see
the
references).

Table
1.
Proposed
Assessment
Factors
for
Application
to
Aquatic
Toxicity
Data
for
Estimating
a
PNEC
Available
information
applied
Assessment
factor
applied
to
the
lowest
value
(
modifications
not
included)

(
a)
OECD
Workshop
(
b)
EU
Technical
Guidance
Document
(
c)
ECETOC
proposal
One
acute
L(
E)
C50
for
acute
toxicity
from
one
trophic
level
1000
­
­

At
least
one
acute****
L(
E)
C50
from
each
of
three
trophic
levels
of
the
base­
set
(
fish,
Daphnia
and
algae)
100
1000
200
One
chronic
NOEC
(
either
fish
or
Daphnia)
­
100
­

Two
chronic
NOECs
from
species
representing
two
trophic
levels
(
fish
and/
or
Daphnia
and/
or
algae)
­
50
5
Chronic
NOECs
from
at
least
three
species
(
normally
fish,
Daphnia
and
algae)
representing
three
trophic
levels
10
10
Field
data
or
model
ecosystems
­
case­
by­
case
1
****
In
the
EU
Technical
Guidance
Document,
"
short­
term
toxicity"
and
"
long­
term
toxicity"
are
used
instead
of
"
acute
toxicity"
and
"
chronic
toxicity".
EXCH\
MANUAL\
96­
4­
5.
DOC/
May
1996
5
16.
With
respect
to
the
OECD
Arlington
Workshop
proposals,
a
factor
of
10
is
suggested
for
each
extrapolation
step
described
in
para
14.
This
approach
is
a
modification
of
a
method
proposed
by
US
EPA
(
Ref.
7).

17.
Assessment
factors
proposed
in
the
EU
technical
Guidance
Document
depend
on
the
properties
of
the
chemical
and
the
conditions
of
testing
(
such
as
use
of
the
most
sensitive
species).
In
a
recent
study
(
Ref.
8),
a
factor
of
100
between
the
E(
L)
C50
of
acute
toxicity
and
NOEC
of
chronic
toxicity
has
been
shown
by
measured
data
to
be
generally
justifiable.

18.
ECETOC's
proposals
are
based
on
comparisons
of
toxicity
data.
An
acute:
chronic
ratio
of
40,
a
chronic:
ecosystem
ratio
of
5,
and
an
ecosystem:
field
ratio
of
1
are
suggested.

QSAR
Approach
19.
When
experimental
data
are
limited,
QSARs
are
useful
for
estimating
toxicities
of
chemicals.
QSARs
based
on
chemical
classes
are
used
widely
(
for
example
Ref.
9).
Proper
selection
and
use
of
a
model
for
a
given
chemical
can
be
carried
out
on
a
case­
by­
case
basis
by
using
computerised
systems
such
as
US
EPA
ASTER
(
Ref.
10)
and
ECOSAR
(
Ref.
11).
QSARs
can
also
be
applied
to
chemicals
with
a
common
mode
of
toxic
action,
such
as
narcosis
where
the
mechanism
is
dependent
on
a
chemical's
hydrophobicity
(
e.
g.
log
Pow).
It
should
be
noted
that
QSARs
are
valid
only
for
liquids
at
room
temperature
and
for
solids
on
which
data
on
water
solubility
are
available.

20.
QSARs
for
chemicals
with
a
common
mode
of
toxic
action
were
discussed
in
the
OECD
Utrecht
Workshop
for
two
classes,
Class
I
(
inert
chemicals,
baseline
toxicity)
and
Class
II
(
less
inert
chemicals)
shown
in
Table
2.
For
a
Class
I
chemical,
QSARs
may
be
used
to
establish
whether
the
experimental
toxicity
of
a
chemical
agrees
with
baseline
toxicity.
If
so,
then
QSAR
equations
may
be
used
to
extend
the
data
on
fish,
Daphnia
and
algae.
For
a
Class
II
chemical,
estimation
by
QSAR
can
be
done
for
acute
toxicity
to
fish
although
QSARs
should
not
be
used
when
reliable
experimental
data
are
available
(
Ref.
2).

Table
2.
Categorisation
of
Chemicals
for
QSARs
for
Approach
by
Common
Mode
of
Action
Class
Structure
Available
QSARs
Reliability
Class
I
aliphatic
alcohols,
aliphatic
ketones,
aliphatic
ethers,
alkoxyethers,
aliphatic
halogenated
hydrocarbons,
saturated
alkanes
and
halogenated
benzenes
(
only
C,
H,
N,
O,
F,
Cl,
Br
could
be
included)
acute
and
chronic
tox.
to
fish
and
to
Daphnia
magna,
chronic
tox.
to
algae
(
for
only
nonpolar
narcotics)
concentration
can
be
predicted
Class
II
non­
or
weakly
acidic
phenols,
aromatic
amines
and
anilines,
aliphatic
primary
amines,
weakly
basic
pyridines
acute
tox.
to
fish
(
phenol
and
primary
aromatic
amines)
a
range
can
be
predicted
21.
A
recent
evaluation
by
the
US
and
EC
of
QSARs
used
by
the
US
EPA
OPPT
has
demonstrated
good
agreement
between
predicted
and
measured
toxicity
for
Daphnia
and
fish
(
Ref.
12).

22.
A
PNEC
may
be
derived
from
QSAR
estimates
in
combination
with
or
without
experimental
data
by
the
application
of
assessment
factors,
using
values
similar
to
those
proposed
for
experimental
data.

23.
QSAR
can
also
be
used
to
validate
laboratory
tests
or
to
decide
which
further
data
are
necessary.

Extrapolation
Methods
EXCH\
MANUAL\
96­
4­
5.
DOC/
May
1996
6
24.
Extrapolation
methods,
which
allow
for
different
sensitivities
of
other,
non­
tested,
species
within
ecosystems,
can
be
used
to
estimate
a
PNEC
when
chronic
toxicity
data
are
available.
Three
extrapolation
methods,
which
require
at
least
laboratory
data
on
the
chronic
toxicity
of
a
chemical
to
five
or
more
different
aquatic
species,
are
available
through
a
computer
program
(
Ref.
3).

(
Semi­)
Field
Test
25.
If
the
results
from
testing
using
complex
systems
such
as
multi­
species
laboratory
systems,
microcosms,
experimental
ponds
and
field
trials
are
available,
a
comprehensive
assessment
should
be
considered.
Although
there
are
no
internationally
agreed
protocols
for
ecosystem
tests
up
to
now,
multi­
species
tests
have
been
developed
by
US
EPA
(
Ref.
13
and
14)
and
guidance
for
multi­
species
studies
has
been
developed
by
SETAC
(
Ref.
15
and
16).
Criteria
for
judging
the
applicability
of
these
results
for
estimation
of
a
PNEC
in
the
comprehensive
assessment
are
recommended
in
Ref.
1.

4.5.4
Aquatic
Effects
Assessments
Procedure
for
SIDS
Chemicals
A.
Evaluation
of
data
used
for
the
assessment
26.
Before
conducting
an
effects
assessment,
data
should
be
evaluated
for
their
adequacy.
For
example,
it
should
be
affirmed
that
the
test
and
effect
concentrations
did
not
exceed
the
solubility
limit.
Test
results
using
solvents
should
carefully
be
examined.
Other
criteria
are
mentioned
in
Section
3
of
Ref.
1
or
Annex
1
to
this
document.

B.
Assessment
possible
when
only
SIDS
data
are
available
Assessment
Factors
27.
The
experimental
data
on
aquatic
effects
available
from
SIDS
testing
will
include:
­­
the
fish
acute
test;
­­
the
Daphnia
acute
test;
­­
the
algal
test
(
usually
acute
data);
and,
possibly
­­
the
Daphnia
chronic
test
(
in
cases
where
there
is
concern
about
long­
term
effects
in
the
aquatic
environment)

28.
The
recommended
approach
for
estimating
a
PNEC
with
such
a
limited
data
set
is
to
use
assessment
factors
(
see
paragraphs
13­
18).
Table
3
shows
data
which
would
be
obtained
from
the
SIDS
Dossiers
and
the
assessment
factors
which
could
be
applied.
The
approach
to
the
selection
of
an
assessment
factor
is
described
below,
taking
current
discussions
into
consideration.
EXCH\
MANUAL\
96­
4­
5.
DOC/
May
1996
7
Table
3.
Data
in
the
SIDS
Dossiers
and
Assessment
Factors
for
Estimating
an
PNEC
Case
Data
available
Range
of
Assessment
factor
(
a)
EC50
algae
(
72hr)

EC50
Daphnia
(
24­
48hr
acute
test)

LC50
fish
(
96hr)
100
­
1000
(
b)
NOEC
Daphnia
(
14­
21d
chronic
toxicity
test)

NOEC
algae
(
72hr)

[
NOEC
fish
(
chronic
toxicity
test)]
10
­
100
[
Note]
1.
In
case
(
a),
all
three
acute
data
are
included
in
the
SIDS.
2.
In
case
(
b),
NOECalgae
is
a
SIDS
element
and
NOECDaphnia
may
also
be
included
in
the
SIDS
for
certain
chemicals.
NOECfish
is
available
rarely.

29.
When
only
acute
toxicity
data
in
the
SIDS
are
available,
an
assessment
factor
of
between
1000
and
100
is
applied
to
the
lowest
L(
E)
C50
[
i.
e.
case
(
a)].
A
factor
of
1000
is
a
conservative
and
protective
factor
and
applied
when
only
limited
data
are
available,
i.
e.
this
value
may
be
reduced
to
100
if
evidence
is
available
to
suggest
that
this
may
be
a
more
appropriate
factor.
Such
evidence
would
include:

(
1)
availability
of
data
from
a
wide
variety
of
species
including
those
which
are
considered
to
represent
the
most
sensitive
species;

(
2)
information,
from
structurally
similar
compounds
or
QSAR,
to
suggest
that
the
acute
to
chronic
ratio
is
likely
to
be
lower
than
that
for
many
other
compounds;

(
3)
information
to
suggest
that
the
chemical
acts
in
a
non­
specific
or
narcotic
manner,
with
little
inter­
species
variation
in
toxicity;
and
(
4)
information
to
suggest
that
the
chemical's
release
would
be
short­
term
or
intermittent,
and
the
chemical
would
not
be
persistent
in
the
environment;

30.
When
chronic
toxicity
data
are
available
in
addition
to
acute
data,
an
assessment
factor
of
between
100
and
10
is
applied
to
the
lowest
NOEC
[
i.
e.
case
(
b)],
taking
the
following
situation
into
account:

(
1)
If
chronic
NOEC
is
available
from
one
or
two
species
representing
one
or
two
trophic
levels
(
i.
e.
fish,
Daphnia
or
algae),
a
factor
of
100
or
50
is
applied
to
the
lowest
NOEC.
In
this
case,
a
PNEC
value
derived
from
chronic
data
should
be
compared
to
that
derived
from
the
lowest
acute
data.
It
is
then
the
lowest
value
that
is
compared
to
the
PEC.

(
2)
If
chronic
NOECs
are
available
from
three
species
representing
three
trophic
levels
(
i.
e.
fish,
Daphnia
and
algae),
a
factor
of
10
is
applied
to
the
lowest
NOEC.
If
there
is
convincing
evidence
that
the
most
sensitive
species
has
been
tested,
a
factor
of
10
may
also
be
applied
to
the
lowest
NOEC
from
two
species
representing
two
trophic
levels
(
i.
e.
fish
and/
or
Daphnia
and/
or
algae).

31.
Variation
in
the
assessment
factors
applied
should
be
clearly
justified
in
the
assessment
report.
EXCH\
MANUAL\
96­
4­
5.
DOC/
May
1996
8
QSAR
Approach
32.
In
the
SIDS
Programme
there
is
a
preference
for
using
measured
data
in
effects
assessment
and
in
estimation
of
PNECs.
However,
if
appropriate
QSARs
are
available,
they
could
be
used
and
PNECs
estimated
by
application
of
suitable
assessment
factors.
A
factor
similar
to
that
shown
in
Table
3
could
be
used.
In
this
case
the
QSAR
used
and
its
reliability
should
clearly
be
indicated.

C.
Assessment
Possible
When
Data
Beyond
SIDS
are
Available
Extrapolation
Methods
33.
It
is
considered
that
extrapolation
methods
for
the
estimation
of
a
PNEC
in
a
refined
assessment
will
not
be
an
option
for
most
HPV
chemicals
because
chronic
NOEC
values
for
at
least
five
different
species
are
required.

(
Semi­)
Field
Test
34.
The
results
of
(
semi­)
field
studies
including
short­
term
multi­
species
trials
and
long­
term
mesocosm
trials
are
not
thought
to
be
available
for
many
HPV
chemicals.
Where
they
are
available
and
are
considered
appropriate,
they
provide
the
basis
for
a
comprehensive
effects
assessment
in
combination
with
chronic
toxicity
data.
The
assessment
factor
to
be
used
will
need
to
be
reviewed
on
a
case­
by­
case
basis.

D.
Consideration
of
Indirect
Effects
Assessment
and
Assessment
on
Benthic
Organisms
35.
In
addition
to
the
effects
assessments
using
pelagic
aquatic
organisms,
assessments
of
indirect
effects
on
birds
and
mammals
and
effects
on
benthic
organisms
(
Ref.
4)
could
be
done
if
information
on
the
chemical
suggests
possible
hazard.
However,
these
are
thought
to
be
beyond
the
scope
of
the
initial
assessment
of
HPV
chemicals
with
SIDS.
Some
methods
mentioned
in
Ref.
1
and
Ref.
7,
namely
an
approach
using
BCF
for
indirect
effects
and
the
equilibrium
partitioning
method
for
benthic
organisms,
could
be
considered.
However,
assessments
carried
out
using
only
data
available
in
SIDS
may
be
very
uncertain.

4.5.5
Outcome
of
the
Initial
Assessment
36.
It
should
be
stressed
that
all
initial
assessments
in
SIDS
work
should
be
extremely
clear
with
regard
to
how
they
were
developed,
including
approaches
taken,
any
data
used,
and
any
assumptions
made.
Also
data
and
estimations
of
exposure
of
a
chemical
which
were
used
should
be
mentioned
clearly.
Examples
in
Ref.
1
are
considered
quite
useful
not
only
for
understanding
the
assessment
procedure
but
also
for
a
model
form
of
the
report
of
the
aquatic
effects
assessment.

37.
If
the
conclusions
of
the
initial
assessment
of
a
chemical
suggest
a
possible
risk
to
aquatic
organisms,
a
more
precise
assessment
by
further
testing,
as
well
as
elaborating
exposure
assessment,
could
be
considered
and
proposed.
For
example,
in
cases
where
an
estimated
PNEC
was
derived
from
the
results
of
acute
toxicity
tests
and
assessment
factors,
doing
chronic
tests
with
appropriate
species
(
e.
g.
most
sensitive
species
in
acute
tests)
would
be
considered
as
one
of
the
possible
further
activities.
Also
if
there
is
a
possibility
of
indirect
effects
on
birds
and
mammals
or
a
possible
hazard
to
benthic
organisms,
assessments
on
these
could
be
considered
and
proposed
for
the
next
phase.
EXCH\
MANUAL\
96­
4­
5.
DOC/
May
1996
9
Annex
1
Criteria
for
Evaluation
of
Data
A.
Octanol­
water
Partition
Coefficient
1.
The
octanol­
water
partition
coefficient
(
Pow)
should
be
examined
carefully
because
it
is
very
critical
to
the
initial
assessment
of
potential
hazard.
For
example,
determination
of
Pow
by
the
shake
flask
method
is
not
suitable
for
highly
hydrophobic
chemicals
(
log
Pow
>
5).
For
those
chemicals,
the
slow
stirring
method
or
generator
column
method
can
be
used.
It
should
also
be
noted
that
log
Pow
may
not
work
for
surfactants,
polymers,
inorganics,
and
organometalics.

B.
Bioaccumulation
2.
Data
on
bioaccumulation
are
principally
used
only
for
evaluating
indirect
effects
of
a
chemical.
They
could
be
obtained
through
a
QSAR
equation
by
using
Pow
as
well
as
by
experiment.
It
should
be
noted
that
simple
bioaccumulation
QSARs
often
cannot
predict
the
concentrations
of
extremely
hydrophobic
chemicals
under
field
conditions.
If
more
than
one
bioconcentration
factor
(
BCF)
is
available
for
the
same
species,
the
geometric
mean
for
the
species
could
be
used;
however,
the
test
concentration
should
be
taken
into
account.
If
BCFs
are
available
for
two
or
more
species,
the
highest
factor
for
a
trophic
level
should
be
used.
BCFs
for
algae,
daphnids
and
fish
should
not
be
mixed
and
should
be
kept
separate
for
each
trophic
level.

C.
Aquatic
Toxicity
3.
Results
of
chronic
toxicity
tests
are
preferred
for
chemicals
that
have
been
shown
to
bioconcentrate/
bioaccumulate
or
are
potentially
bioaccumulative.
For
some
of
these
chemicals,
a
96­
hour
exposure
in
acute
tests
may
not
be
sufficiently
long.
In
any
case,
the
water
solubility
of
the
test
substance
must
be
measured
or
predicted
and
the
solubility
limit
must
be
compared
to
effect
concentrations
(
e.
g.
96h­
LC50).

4.
Interpretation
of
the
data
is
important.
For
example,
the
key
aspects
of
the
study
methods
which
affect
study
quality,
such
as
measured
or
nominal
concentration,
control
response,
use
of
"
insensitive"
species,
and
water
quality
values,
should
be
considered.
Endpoints
which
have
direct
ecological
relevance
(
e.
g.
survival,
growth,
reproduction)
should
be
given
more
weight
than
other
endpoints
(
e.
g.
biochemical
parameters).
Consideration
of
test
species
is
also
important;
for
example,
in
those
cases
where
chronic
studies
have
not
been
done
with
the
most
sensitive
species
in
the
acute
tests.

5.
If
several
toxicity
data
are
available
for
one
test
species,
the
following
rules
may
be
applied:

­­
If
these
data
are
based
on
the
same
effect
parameter
(
endpoint)
and
the
same
time
period,
the
geometric
mean
value
should
be
used.
­­
If
different
effect
parameters
or
different
exposure
times
within
the
same
species
are
used,
only
the
lowest
value
from
the
longest
test
time
should
be
used
taking
into
account
the
importance
of
the
endpoints
and
the
exposure
periods
in
the
various
tests.
­­
Data
used
for
the
extrapolation
methods
as
described
in
Section
5
of
Ref.
1
are
restricted
to
NOEC
values
or
geometric
mean
MATC
values
[
MATC
=
(
NOEC
x
LOEC)
1/
2].
Results
of
chronic
tests
reporting
only
the
lowest
test
concentration
(
LOEC)
might
be
included
if
they
are
converted
to
estimated
NOEC
values
appropriately.
For
example,
the
equation:
NOEC=
LOEC/
2
could
be
used
in
several
cases.
Regression
methods
also
can
be
used
for
estimation.
EXCH\
MANUAL\
96­
4­
5.
DOC/
May
1996
10
Annex
2
References
1.
OECD
Environment
Monograph
N0.
92,
Guidance
Document
for
Aquatic
Effects
Assessment,
1995
2.
OECD
Environment
Monograph
No.
58,
Report
of
the
OECD
Workshop
on
Quantitative
Structure
Activity
Relationships
(
QSARs)
in
Aquatic
Effects
Assessment,
1992
3.
OECD
Environment
Monograph
No.
59,
Report
on
the
OECD
Workshop
on
the
Extrapolation
of
Laboratory
Aquatic
Toxicity
Data
to
the
Real
Environment,
1992
4.
OECD
Environment
Monograph
No.
60,
Report
on
the
OECD
Workshop
on
the
Effects
Assessment
of
Chemicals
in
Sediment,
1992
5.
Technical
Guidance
Documents
in
Support
of
the
Commission
Directive
93/
67/
EEC
on
Risk
Assessment
for
New
Substances
and
the
Commission
Regulation
(
EC)
N
o
1488/
94
on
Risk
Assessment
for
Existing
Substances
(
in
print)

6.
Technical
Report
No.
51,
Environmental
Hazard
Assessment
of
Substances,
European
Centre
for
Ecotoxicology
and
Toxicology
of
Chemicals
(
ECETOC),
January
1993
7.
Estimation
of
"
concern
levels"
for
concentrations
of
chemical
substances
in
the
environment,
US
EPA,
OTS,
Health
and
Environmental
Review
Division,
Environmental
Effects
Branch,
1984
8.
Heger,
W.,
S.
M.
Jung,
S.
Martin,
H.
Peter;
Acute
and
Prolonged
Toxicity
to
Aquatic
Organisms
of
New
and
Existing
Chemicals
and
Pesticides.
Chemosphere
Vol.
31,
No.
2,
2707­
2726,
1995
9.
Estimating
Toxicity
of
Industrial
Chemicals
to
Aquatic
Organisms
using
Structure
Activity
Relationships,
OTS,
US
EPA,
1988
10.
ASTER
(
Assessment
Tools
for
the
Evaluation
of
Risk),
Scientific
Outreach
Program,
US
EPA,
Environmental
Research
Laboratory­
Duluth,
1991
11.
ECOSAR
(
A
Computer
Program
for
Estimating
the
Ecotoxicity
of
Industrial
Chemicals
Based
on
Structure
Activity
Relationships.),
OPPT,
US
EPA,
1994
12.
OECD
Environmental
Monograph
No.
88,
US
EPA/
EC
Joint
Project
on
the
Evaluation
of
(
Quantitative)
Structure
Activity
Relationships,
1994
13.
Federal
Register
Vol.
52,
No.
187,
Sept.
28,
1987,
pp
36334
to
36371.

14.
Methods
for
Ecological
Toxicology:
A
Critical
Review
of
Laboratory
Multispecies
Tests.
A.
S.
Hammons,
Ed.
Ann
Arbor
Science
Publications,
Inc./
The
Butterworth
Group,
1981.

15.
Guidance
Document
on
Testing
Procedures
for
Pesticides
in
Freshwater
Mesocosms,
Society
of
Environmental
Toxicology
and
Chemistry
(
SETAC)
­
Europe,
1991
16.
Workshop
Report
(
Workshop
on
Aquatic
Microcosms
for
Ecological
assessment
of
Pesticides,
Wintergreen,
Virginia,
6
­
12
October
1991),
SETAC,
February
17,
1992
EXCH\
MANUAL\
96­
4­
6.
DOC/
May
1996
1
4.6
Provisional
Guidance
for
the
Initial
Assessment
of
Health
Effects*

4.6.1
Introduction
1.
This
document
provides
guidance
for
the
initial
assessment
of
health
effects
of
chemicals
with
a
full
SIDS,
including
suggestions
for
making
decisions
on
any
follow­
up
testing
if
this
is
considered
to
be
necessary.
This
document
was
first
drafted
based
on
relevant
sections
of
the
monographs
of
the
International
Programme
on
Chemical
Safety
(
IPCS).
These
monographs
are
listed
in
Annex
2
to
this
document
and
can
be
consulted
for
information
about
making
fuller
assessments
of
chemical
substances.

2.
Although
the
SIDS
is
the
minimum
requirement
for
making
an
initial
assessment
of
High
Production
Volume
(
HPV)
chemicals
in
the
OECD
Existing
Chemicals
Programme,
for
many
chemicals
currently
under
consideration
there
will
be
data
already
available
in
excess
of
SIDS;
these
should,
of
course,
be
assessed
and
taken
into
consideration
when
developing
conclusions
and
recommendations.
However,
in
making
the
initial
assessment
of
health
effects,
the
elements
in
the
SIDS
which
are
relevant
in
this
respect
are:

·
Acute
Toxicity;
·
Repeated
Dose
Toxicity;
·
Genetic
Toxicity;
and
·
Reproduction/
Developmental
Toxicity.

3.
In
the
traditional
assessment
of
repeated
dose
toxicity
and
reproduction/
developmental
toxicity,
Uncertainty
Factors
(
UF's)
are
used
and
the
Estimated
Level
of
Low
Concern
(
EDLC)
is
calculated
from
the
No­
Observed­
Adverse­
Effect
level
(
NOAEL)
or,
when
not
available,
the
Lowest
Observed­
Adverse­
Effect
level
(
LOAEL)
derived
from
animal
test
results;
however,
since
UF's
are
always
chosen
arbitrarily,
it
is
often
difficult
for
readers
of
assessment
reports
to
understand
the
relevance
of
the
factors
used.
Although
this
approach
has
been
used
for
many
years,
there
is
no
strong
scientific
evidence
supporting
its
use.
Therefore,
at
the
4th
SIDS
Initial
Assessment
Meeting
in
May
1996,
participants
agreed
that
UF's
should
not
be
included
in
assessment
reports
which
are
to
be
discussed
and
published
in
the
OECD
context.

4.
Instead
of
using
UF's
and
EDLC,
N(
L)
OAEL
or,
if
available,
actual
human
data
can
be
compared
directly
to
the
Estimated
Human
Exposure
(
EHE)
level.
This
approach,
the
so­
called
"
margin
of
safety"
approach,
is
adopted
in
the
EU
Technical
Guidance
Documents
for
the
implementation
of
the
EC
Regulation
793/
93
and
is
described
in
this
Provisional
Guidance.
Tentative
general
guidance
for
using
UF's
is
attached
as
Annex
1
for
possible
use
by
Member
countries
in
risk
assessment
at
a
national
level.
Both
approaches
have
a
similar
end
result.
Whichever
is
used,
it
is
important
to
consider
both
the
effects
and
(
potential)
exposure
of
each
chemical
in
a
case­
by­
case
manner
and
to
apply
professional
judgement
by,
for
example,
toxicologists
and
occupational
hygienists
when
evaluating
the
adequacy
of
any
tests
and
the
interpretation
of
results.

*
This
document
was
first
prepared
by
the
OECD
Secretariat
based
on
the
monographs
of
the
IPCS.
It
has
been
updated
to
reflect
comments
by
Member
countries
and
agreements
reached
in
the
context
of
the
OECD
Existing
Chemicals
Programme
up
to
May
1996.
EXCH\
MANUAL\
96­
4­
6.
DOC/
May
1996
2
4.6.2
Acute
Toxicity
5.
In
the
assessment
of
the
toxicity
of
a
chemical,
the
determination
of
the
acute
toxicity
is
often
the
first
step.
It
provides
information
on
the
health
effects
likely
to
arise
from
short­
term
exposure
at
a
relatively
high
dose.
Substances
are
classified
either
on
the
basis
of
the
approximate
LD50
(
or
LC50)
value
or
a
discriminating
dose.
Other
information
obtained
from
the
acute
toxicity
test,
such
as
types
of
effects
observed,
their
time
of
onset,
duration
and
severity,
and
shape
of
the
dose­
response
curve
(
steep
or
shallow)
are
also
useful
in
the
hazard
assessment
(
and
in
the
design
of
further
studies).

6.
When
only
acute
oral
data
are
available,
the
need
to
obtain
data
from
tests
by
other
routes
should
be
considered
in
the
light
of
the
physical­
chemical
properties
of
the
chemical,
the
nature
and
magnitude
of
the
results
from
the
oral
route
study,
the
actual
or
potential
routes
of
exposure,
and
the
measured
or
estimated
exposure
level.

7.
In
the
initial
assessment
of
SIDS
chemicals,
data
on
acute
toxicity
will
usually
not
lead
to
recommending
action
for
follow­
up
testing,
although
exceptional
findings
(
high
lethality,
neurotoxicity
seen
at
low
doses,
etc.)
may
warrant
such
action.

8.
When
data
on
acute
toxicity
indicate
that
a
chemical
is
(
very)
toxic
or
harmful,
this
could
lead
to
risk
management
activities,
such
as
labelling
or
reduction
of
occupational
exposure.
In
many
cases,
however,
recommendations
for
such
activities
would
not
be
needed
for
SIDS
chemicals
because
where
acute
toxicity
data
were
known,
appropriate
action
would
have
already
been
taken.

4.6.3
Repeated
Dose
Toxicity
9.
One
of
the
main
objectives
of
any
repeated
dose
study
with
a
duration
of
administration
of
normally
at
least
28­
days
is
to
obtain
a
value
for
the
No­
Observed­
Adverse­
Effect
level
(
NOAEL),
or
the
Lowest
Observed­
Adverse­
Effect
level
(
LOAEL),
based
on
which
the
estimated
effect
level
of
concern
for
humans
will
be
considered.
The
NOAEL
could
also
be
used
in
identifying
chemicals
which
could
be
candidates
for
further
testing.
The
NOAEL
is
considered
to
be
the
highest
daily
dose
or
concentration
of
a
substance
at
which
there
is
no
adverse
alteration
observed
in
the
morphology,
functional
capacity,
growth,
development,
etc.
of
the
target.
The
LOAEL,
on
the
other
hand,
is
considered
to
be
the
lowest
daily
dose
or
concentration
of
a
substance
at
which
any
of
these
adverse
alterations
is
actually
observed.
In
general,
greater
confidence
for
establishing
an
estimated
effect
level
of
concern
is
placed
in
a
NOAEL
than
in
a
LOAEL;
in
a
NOAEL
obtained
from
a
sub­
chronic
study
rather
than
one
from
a
sub­
acute
study;
in
a
test
which
demonstrates
a
clear
dose­
response
relationship;
and
in
a
test
in
which
the
manifestations
of
toxicity
are
well­
defined.
In
principle,
a
NOAEL
should
be
obtained
in
each
repeated
dose
study
and
can
be
used
as
a
marker
for
human
effects.
However,
when
a
reliable
dose­
response
relationship
is
obtained,
and
a
NOAEL
cannot
be
estimated,
a
LOAEL
could
be
used
for
this
purpose.

10.
As
an
alternative
to
this
"
classical"
NOAEL
approach,
where
feasible
the
so­
called
"
bench­
mark
dose"
approach
could
also
be
adopted.
However,
as
this
latter
system
uses
the
lower
confidence
limit
of
the
dose
corresponding
to
the
lowest
increase
judged
to
be
toxicologically
significant
in
the
incidence
of
an
effect,
and
calculated
on
the
basis
of
at
least
two
dose
levels
showing
an
effect,
it
is
anticipated
that
the
number
of
repeated
dose
studies
where
adequate
quantal
or
continuous
information
is
available
will
be
limited.

11.
For
the
initial
assessment
of
repeated
dose
toxicity,
it
might
be
useful
to
consider
each
route
of
potential
human
exposure
(
oral,
inhalation,
dermal)
separately
assuming
equal
absorption
rates
when
no
specific
data
on
actual
absorption
are
available.
If
it
is
expected
that
exposure
via
several
routes
will
occur,
the
total
dose
from
all
these
routes
should
preferably
be
considered.
EXCH\
MANUAL\
96­
4­
6.
DOC/
May
1996
3
12.
What
is
considered
to
be
an
adverse
effect
is
dependent
on
expert
judgement.
In
those
cases
where
an
adverse
effect
is
observed
in,
for
example,
a
parameter
which
monitors
an
organ
system,
such
as
a
clinical
biochemical
change
in
a
measurement
of
liver
function,
more
weight
can
be
attributed
to
its
significance
if
other
observations
for
that
organ
system,
such
as
necropsy
findings
and
to
a
lesser
extent
organ
weight
difference,
also
indicate
an
adverse
effect.
In
addition,
the
dose
response
of
an
adverse
effect,
i.
e.
the
progression
of
a
change
in
an
organ
system
with
the
dose,
is
a
factor
which
adds
weight
to
the
significance
of
the
effect.
Further
aspects
which
are
usually
considered
include:
reversibility
of
the
toxicity,
severity
of
the
effect,
latency
of
the
onset
of
the
effect
and
the
shape
of
the
dose­
response
curve.

13.
For
the
screening
of
chemicals,
the
initial
assessment
can
be
conducted
using
an
Estimated
Human
Exposure
(
EHE)
level
and
the
N(
L)
OAEL.
The
EHE
can
be
obtained
by
using
the
approaches
described
in
the
Provisional
Guidance
for
the
Initial
Assessment
of
Environmental
Exposure
and
of
Occupational
and
Consumer
Exposure
(
see
Section
4.3
and
4.4).
If
the
EHE
is
larger
than
or
equal
to
the
N(
L)
OAEL,
a
hazard
may
exist
and
further
testing
or
other
activities
should
be
considered.
If
the
EHE
is
smaller
than
the
N(
L)
OAEL,
the
magnitude
of
the
N(
L)
OAEL/
EHE
ratio,
called
"
margin
of
safety",
needs
to
be
considered
taking
account
of
the
following
parameters:

·
Difference
in
exposure
(
route,
duration,
frequency
and
pattern)
·
The
nature
and
severity
of
the
effect
·
The
dose
(
concentration)­
response
(
effect)
relationship
observed
·
The
inter­
and
intraspecies
variability
·
The
overall
confidence
in
the
database
Expert
judgement
is
required
to
weigh
these
individual
parameters
on
a
case­
by­
case
basis.

14.
As
mentioned
above,
Uncertainty
Factors
(
UF's)
have
traditionally
been
used
for
initial
assessment
of
repeateddose
toxicity
(
see
Annex
1).
To
a
large
extent,
both
approaches
can
be
considered
equivalent
in
that
they
reflect
the
confidence
of
the
assessor
in
the
quality
and
relevance
of
the
database
for
a
particular
endpoint.
The
approach
used
should
be
transparent
and
a
justification
should
be
provided
by
the
assessor
for
the
conclusion
reached.

4.6.4
Genetic
Toxicity
15.
Testing
for
genetic
toxicity
is
conducted
so
that
chemicals
may
be
assessed
for
their
potential
to
cause
transmissible
damage
to
the
genetic
material
of
somatic
cells
(
with
potential
carcinogenic
consequences)
and
germ
cells
(
which
may
result
in
heritable
damage
to
the
offspring).
Unlike
most
other
toxicological
effects,
genotoxic
effects
in
vivo
are
generally
assumed
to
have
no
exposure
threshold.
Thus
an
important
factor
to
be
taken
into
account
when
thinking
about
further
testing
and/
or
risk
reduction
is
whether
or
not
human
exposure
occurs
or
may
occur
and,
if
so,
which
and
how
many
humans
are
(
potentially)
exposed
and
the
circumstances
of
any
such
exposures
rather
than
the
levels.

16.
It
is
also
essential
to
differentiate
between
the
in
vitro
tests
which
are
primarily
used
to
investigate
intrinsic
potential
of
chemicals
to
cause
genetic
damage
and
the
in
vivo
tests
which
are
often
used
to
investigate
if
these
intrinsic
properties
are
expressed
in
whole
animals,
to
confirm
negative
in
vitro
results
and
to
study
effects
of
metabolites.
Where
an
in
vivo
study
is
not
available
it
should
be
considered
whether
the
activation
system
used
in
in
vitro
is
adequate.

17.
For
the
initial
assessment,
results
of
at
least
two
tests
for
genetic
toxicity
will
generally
be
provided
in
the
SIDS.
These
are
expected
to
include
results
of
a
point
mutation
test
[
e.
g.
an
in
vitro
Salmonella
typhimurium,
Reverse
Mutation
Assay,
OECD
Test
Guideline
(
TG
471)]
and
a
chromosomal
aberration
test
[
e.
g.
an
in
vitro
Mammalian
Cytogenetic
Test
(
TG
473)
or
an
in
vivo
Micronucleus
Test
(
TG
474)].

18.
Various
different
approaches
are
available
to
assist
with
the
initial
assessment
of
genetic
toxicity
(
see
Tables
1,
2
and
3
for
guidance
proposed
by
the
OECD,
Japan
and
the
EU
respectively).
The
OECD
approach
(
Table
1)
is
the
only
one
to
consider
the
scenario
where
one
of
the
two
initial
assessment
tests
is
an
in
vivo
study
for
clastogenicity.
A
somewhat
more
simplified
approach,
recommended
by
Japan,
is
summarised
in
Table
2.
In
some
cases,
the
results
of
more
than
the
two
initial
tests,
even
standardised
in
vitro
or
in
vivo
germ
cell
tests,
may
be
available.
The
general
approach,
as
recommended
by
the
European
Commission
to
be
used
for
initial
assessment
based
on
the
various
patterns
of
results,
is
summarised
in
Table
3.

4.6.5
Reproduction/
Developmental
Toxicity
EXCH\
MANUAL\
96­
4­
6.
DOC/
May
1996
4
19.
Reproduction
toxicity
represents
any
effect
on
fertility
and
reproduction
that
can
adversely
affect
the
continuation
of
the
species.
Developmental
toxicity
is
any
adverse
effect
induced
during
the
developmental
period,
i.
e.
from
conception
through
puberty.
The
major
manifestations
of
developmental
toxicity
include
death
of
the
developing
organism,
structural
abnormalities,
altered
growth
and
functional
deficiencies.
Developmental
toxicity
can
be
considered
a
component
of
reproductive
toxicity,
and
often
it
is
difficult
to
distinguish
between
effects
mediated
through
the
parents
versus
direct
interaction
with
developmental
processes.

20.
Because
of
the
nature
of
the
observations
and
variety
of
classes
of
reproduction/
developmental
toxicity,
the
following
paragraphs
describe
in
slightly
more
detail
suggestions
for
the
initial
assessment
of
these
studies.
The
organisation
of
the
information
for
an
assessment
of
reproduction
and
developmental
toxicity
is
described
in
a
number
of
OECD
Test
Guidelines
related
to
these
endpoints
(
TG
414,
415,
416)
and
the
guidelines
for
the
Combined
Repeated
Dose
Toxicity
Study
with
the
Reproduction/
Developmental
Toxicity
Screening
Test
(
TG
422)
and
the
Reproduction/
Developmental
Toxicity
Screening
Test
(
TG
421).
For
example,
toxic
response
data
should
be
considered
by
sex
and
dose
and,
when
possible,
be
sub­
divided
into
reproductive
and
developmental
effects.
Reproduction
effects
would
include,
inter
alia,
altered
fertility
indices
for
males
and
females,
effects
on
mating
performance
or
other
factors
affecting
reproductive
function
and,
when
related
to
the
nursing
capacity
of
the
females,
postnatal
viability
indices
for
the
offspring
or
other
postnatal
signs
of
toxicity.
Developmental
effects,
either
as
a
consequence
of
maternal
toxicity
or
as
a
direct
effect
on
the
developing
organism,
would
include,
inter
alia,
decreased
numbers
and
percentages
of
live
offspring
per
litter,
and
increased
numbers
and
percentage
of
affected
offspring
(
male,
female
or
combined)
per
litter.
Data
on
maternal
toxicity
and
on
certain
metabolic
or
kinetic
observations
need
to
be
considered
when
determining
the
nature,
severity
and
relevance
of
developmental
toxicity.

21.
Reproductive
and
developmental
effects
exhibit
dose­
response
relationships,
and
where
these
effects
are
not
genotoxic
(
e.
g.
heritable)
thresholds
are
generally
assumed
to
exist.
It
is
thus
possible
to
estimate
exposure
levels
unlikely
to
produce
effects
in
humans
on
the
basis
of
a
NOAEL
obtained
in
an
animal
experiment,
in
a
similar
manner
to
that
for
repeated
dose
toxicity.

22.
The
occurrence
of
a
dose
level
producing
well
defined
toxicity
is
considered
of
crucial
importance
in
reproductive
toxicity
studies.
This
is
called
for
in
the
OECD
Test
Guidelines
for
both
screening
tests,
421
and
422.
Tests
in
which
toxicity
is
not
observed
should,
therefore,
not
be
considered
as
adequate
tests
unless
the
limit
concentration
of
1000
mg/
kg
has
been
included.

23.
In
addition,
useful
information
can
be
derived
from
the
repeated
dose
toxicity
study,
e.
g.
pathology
in
the
reproductive
organs,
if
specific
histological
examination
has
been
carried
out
and
a
comparison
of
dose­
response
curves
for
such
an
effect
between
males
and
females
could
be
made
both
in
the
repeated
dose
toxicity
and
the
reproduction
toxicity
study.

24.
For
the
reproduction
toxicity
endpoint:

·
when
a
90­
day
repeated
dose
study
is
available
and
is
sufficiently
documented
with
respect
to
studying
effects
in
the
reproductive
organs
and
a
developmental
study
is
available,
the
requirements
for
the
reproduction
toxicity
endpoint
would
be
satisfied;

·
when
either
a
90­
day
or
28­
day
repeated
dose
study
is
the
only
repeated
dose
study
available,
it
is
recommended
that
the
reproduction/
developmental
toxicity
screening
test
(
e.
g.
TG
421)
be
carried
out
in
order
to
satisfy
the
requirements
for
the
reproduction
toxicity
endpoint;
and
·
when
a
90­
day
repeated
dose
study
is
available
and
demonstrates
no
effects
on
the
reproductive
organs,
in
particular
the
testes,
then
a
developmental
study
(
e.
g.
TG
414)
can
be
considered
as
an
adequate
test
to
complete
information
on
reproduction/
developmental
effect.

25.
In
the
similar
way
to
repeated
dose
toxicity,
the
"
margin
of
safety"
approach
could
be
used
for
the
initial
assessment
instead
of
using
Uncertainty
Factors
(
UF's).
Guidance
for
the
use
of
UF's
is
described
in
Annex
1
to
this
document.

26.
When
considering
the
"
margin
of
safety"
for
reproduction/
developmental
toxicity,
its
magnitude
can
be
compared
to
that
of
repeated
dose
toxicity.
A
relatively
high
"
margin
of
safety"
may
be
acceptable
when
severe
or
EXCH\
MANUAL\
96­
4­
6.
DOC/
May
1996
5
irreversible
developmental
effects
occur
at
exposure
levels
below
those
that
induce
well­
defined
parental
toxicity;
in
other
words
when
the
test
substance
produces
severe
developmental
effects
that
are
not
secondary
to
general
toxicity.
The
same
level
of
"
margin
of
safety"
may
be
acceptable
when
developmental
toxicity
is
only
observed
at
exposure
levels
that
are
also
toxic
to
the
parent
animals.
The
same
considerations
for
the
repeated
dose
study
should
be
addressed
when
considering
"
margin
of
safety"
for
reproductive/
developmental
toxicity.
An
assessment
of
whether
the
effects
seen
in
reproduction
toxicity
studies
are
secondary
to
general
toxicity,
or
are
specific
reproductive
effects,
is
important
and
expert
judgement
is
necessary.

27.
This
concept
of
considering
higher
"
margin
of
safety"
for
developmental
effects
when
they
occur
in
the
absence
of
maternal
toxicity
than
when
observed
at
levels
that
are
also
toxic
to
the
parent
animals
is
generally
accepted.
However,
individual
Member
countries
may
consider
developmental
toxicity
in
the
presence
of
maternal
toxicity
of
as
great
a
concern
as
developmental
toxicity
seen
in
its
absence.

4.6.6
Suggestions
for
Follow­
up
Testing
Repeated
Dose
Toxicity
28.
If
the
estimated
exposure
level
(
EHE)
for
a
specific
human
population
is
larger
than
or
close
to
the
estimated
effect
level
of
concern
calculated
from
a
28­
day
repeated
dose
study,
a
90­
day
subchronic
toxicity
test
(
TG
408,
411
or
413)
could
be
conducted,
depending
on
reliability
of
the
exposure
estimation.
Information
on
exposure
should
be
considered
in
detail
before
deciding
if
this
is
needed.
In
the
subchronic
toxicity
test,
a
more
detailed
examination
of
effects
observed
in
a
28­
day
study
would
be
important.
If
the
effects
found
in
a
28­
day
repeated
dose
toxicity
test
are
reason
for
concern,
and
substantial
long­
term
exposure
is
expected
to
occur,
it
might
be
more
effective
to
consider
undertaking
a
longer
toxicity
test
with
an
exposure
duration
of
at
least
six
months.
If
there
is
sufficient
justification
for
a
study
for
"
conventional"
(
i.
e.
noncarcinogenic
toxic
effects
of
longer
duration
than
90
days,
then
it
should
be
combined
with
a
carcinogenicity
bioassay.
EXCH\
MANUAL\
96­
4­
6.
DOC/
May
1996
6
Reproduction/
Developmental
Toxicity
29.
If
EHE
is
larger
than
or
close
to
the
estimated
effect
level
of
concern
derived
from
reproduction/
developmental
toxicity
studies
at
a
screening
level,
a
One­
or
Two­
Generation
Reproduction
Toxicity
test
(
TG
415
or
416),
which
could
include
peri­
and
postnatal
administration
and/
or
a
Developmental
Toxicity
test
(
TG
414),
could
be
considered
depending
on
the
reliability
of
the
dose­
response
curve
and
the
type
of
toxic
effects
seen.
Follow­
up
studies
which
are
tailored
to
address
a
specific
concern
might
also
be
appropriate.
For
example,
foetal
or
birth
weight
reduction
is
often
the
only
indicator
of
possible
developmental
toxicity
and
could
be
followed
up
in
cases
of
concern
by
studies
to
evaluate
postnatal
viability,
growth
and
survival
through
weaning.
Studies
in
a
second
species
might
also
be
useful.

30.
When
deciding
to
conduct
a
follow­
up
reproduction/
developmental
toxicity
study,
information
on
exposure
has
to
be
taken
into
consideration.
For
example,
for
substances
which
have
only
been
tested
in
a
reproductive
screening
test
(
e.
g.
TG
421
or
422)
and
substantial,
widespread
and/
or
prolonged
exposure
is
anticipated,
serious
consideration
should
be
given
to
conducting
definitive
reproduction
toxicity
tests
(
i.
e.
TG
415/
416
and
414).
Also
SARs
may
be
taken
into
account
when
considering
further
testing.

31.
For
both
repeated
dose
and
reproduction/
developmental
toxicity,
when
more
than
one
route
is
of
concern,
the
route
giving
the
greatest
reason
for
concern
could
be
chosen
for
a
follow­
up
test.
Similarly,
if
the
concern
is
for
more
than
one
observed
effect,
then
any
follow­
up
test
could
be
tailored
to
study
that
effect
having
the
greatest
concern.
EXCH\
MANUAL\
96­
4­
6.
DOC/
May
1996
7
Table
1
OECD
Proposals
for
the
Initial
Assessment
for
Genetic
Toxicity
Point
mutation
test
in
vitro
Chromosomal
aberration
test
in
vivo
Chromosomal
aberration
test
Second
in
vivo
test
Action
A
Negative
Negative
No
need
for
further
testing
B
Negative
Positive
Positive
Negative
Positive
Negative
Candidate
for
in­
depth
review
Candidate
for
in­
depth
review
No
need
for
further
testing
C
Positive
Positive
Candidate
for
in­
depth
review
D
Positive
Negative
Positive
Negative
Positive
Negative
Candidate
for
in­
depth
review
Candidate
for
in­
depth
review
No
need
for
further
testing
E
Negative
Negative
No
need
for
further
testing
F
Negative
Positive
Candidate
for
in­
depth
review
G
Positive
Positive
Candidate
for
in­
depth
review
H
Positive
Negative
Positive
Negative
Candidate
for
in­
depth
review
No
need
for
further
testing
Note:
This
table
assumes
that
the
results
from
a
point
mutation
(
e.
g.
Ames
type)
test,
and
an
in
vitro
(
A
to
D)
or
an
in
vivo
(
E
to
H)
chromosomal
aberration
test,
are
available.
The
arrows
indicate
the
proposed
sequence
of
actions
following
these
results.
EXCH\
MANUAL\
96­
4­
6.
DOC/
May
1996
8
Table
2
Proposal
by
Japan
for
Initial
Assessment
of
Genetic
Toxicity
Point
mutation
test
in
vitro
chromosomal
aberration
test
in
vivo
cytogenetic
test
Second*
in
vivo
test
Action
­
ve
­
ve
No
need
for
follow­
up
test
+
ve
+
ve
­
ve
+
ve
­
ve
+
ve
+
ve
­
ve
+
ve
­
ve
Candidate
for
risk
reduction
Candidate
for
risk
reduction
Candidate
for
risk
reduction
No
need
for
follow­
up
test
*
In
vivo
liver
UDS
test,
mouse
spot
test,
or
gene
mutation
test
with
transgenic
animals.

Note:
Negative
in
both
point
mutation
test
and
in
vitro
chromosomal
aberration
test
does
not
need
for
followup
test.
While,
chemicals
that
give
positive
results
in
both
in
vitro
tests
are
candidates
for
risk
reduction.
Essentially
any
in
vivo
positive
indicates
the
need
for
risk
reduction
activity.
In
order
to
negate
positive
in
vitro
data
in
vivo
negative
information
from
at
least
two
different
tissues
will
be
needed.

Any
positive
in
vivo
(
also
both
in
vitro
positive)
data
might
be
negated
by
the
negative
data
of
in
vivo
germ
cell
test
(
e.
g.
dominant
lethal
test
or
germ
cell
cytogenetic
test)
and
also
the
negative
data
of
long­
term
carcinogenicity
test.
EXCH\
MANUAL\
96­
4­
6.
DOC/
May
1996
9
Table
3
Proposal
by
the
European
Commission
for
Initial
Assessment
of
Genetic
Toxicity
·
in
vivo
germ
cell
positive:

No
further
testing.
Control
measures
necessary.
Further
information
on
exposure
may
be
required
to
assess
possibility
of
risk
by
reducing
exposure.

·
in
vivo
somatic
cell
positive:

Control
measures
as
above.
Consider
testing
for
germ
cell
effects
if
not
already
done
to
an
adequate
standard.

·
in
vitro
positive:

One
somatic
cell
test
in
vivo
conducted
and
negative:

Consider
control
measures.
A
second
test
should
be
conducted
in
vivo
using
a
different
somatic
target
tissue
from
the
first.

·
in
vitro
positive
but
no
testing
yet
in
vivo:

Consider
control
measures.
Test
in
vivo
in
somatic
cells,
usually
bone
marrow.

·
in
vitro
negative
(
two
adequate
tests):

Consider
further
testing
in
relation
to
potential
for
human
exposure,
e.
g.
where
there
may
be
widespread
consumer
exposure
to
significant
amounts
of
a
substance,
a
third
test,
preferably,
in
vitro,
may
be
considered
necessary
for
added
assurance.
Structure
Activity
Relationships
(
SAR)
may
be
of
use.

Note
1:
The
suggested
approach
is
based
on
the
assumption
that
any
positive
in
vitro
result
should
be
tested
in
vivo.
Also
that
when
a
chemical
gives
a
positive
result
in
somatic
cells
in
vivo,
there
is
no
need
for
further
testing
for
somatic
cell
effects
in
vivo,
but
testing
for
potential
germ
cell
effects
should
be
considered,
and
the
chemical
should
be
regarded
as
a
potential
human
carcinogen.

Note
2:
In
order
to
"
negate"
positive
in
vitro
data,
in
vivo
data
from
at
least
two
different
tissues
will
be
needed.
A
negative
result
in
the
first
tissue
(
invariably
the
bone
marrow)
will
not
(
under
any
circumstance
that
we
can
envisage)
be
adequate.
EXCH\
MANUAL\
96­
4­
6.
DOC/
May
1996
10
Annex
1
Guidance
for
the
Use
of
Uncertainty
Factors
Introduction
1.
In
the
context
of
initial
assessments,
the
Estimated
Dose
of
Low
Concern
(
EDLC)
on
repeated­
dose
toxicity
and
reproduction/
developmental
toxicity
can
be
derived
by
dividing
a
N(
L)
OAEL
by
an
Uncertainty
Factor
(
UF)
and
compared
to
the
Estimated
Human
Exposure
(
EHE).

2.
Uncertainty
Factors
(
UF's)
mentioned
in
this
Annex
are
used
in
the
context
of
being
equivalent
to
"
safety
factors",
"
assessment
factors",
etc.,
which
are
generally
applied
to
results
from
animal
experiments
to
increase
the
confidence
that
recommended
exposure
concentrations
for
humans,
if
realised,
do
not
lead
to
adverse
effects
in
the
majority
of
people
exposed.
Thus,
in
general,
the
more
relevant
the
available
animal
data
are
to
the
human
situation,
e.
g.
if
the
same
exposure
route
is
anticipated,
the
smaller
the
UF.
These
UF's
are
only
guidance
values
for
use
in
assessing
consumer/
general
public
exposure.
They
are
not
intended
for
occupational
exposure
for
which
lower
values
may
be
appropriate.

3.
UF's
will
not
be
used
in
the
OECD
context;
however,
the
approach
can
be
used
for
any
considerations
at
a
national
level.

Uncertainty
Factors
for
Repeated
Dose
Toxicity
4.
Traditionally,
factors
of,
for
example,
10
x
10
for
inter­
and
intra­
species
variations
have
been
used.
Intraspecies
variation
refers
to
the
differences
in
sensitivity
within
the
same
species
(
e.
g.
differences
due
to
age),
while
interspecies
variation
refers
to
the
differences
in
sensitivity
between
humans
and
animals.
This
has
been
a
workable
approach
to
deal
with
the
uncertainties
inherent
in
the
extrapolation
process,
and
is
often
based
on
the
NOAEL
from
a
study
with
an
exposure
duration
of
at
least
90
days.
However,
the
reliance
on
such
pre­
determined
values
may
be
misleading
in
terms
of
the
confidence
placed
in
the
test
results.
UF's
are
guidance
values
only,
and
consideration
should
be
given
to
increasing
or
decreasing
their
value
on
a
case­
by­
case
basis
depending
on
the
confidence
that
can
be
placed
in
the
value
of
NOAEL.
Factors
affecting
this
confidence
are
the
duration
of
the
study,
the
dose­
response
relationships,
the
nature
of
the
effects
observed,
the
spacing
between
the
doses,
the
quality
of
the
toxicity
data,
and
the
type
and
severity
of
toxic
effects
observed.
In
one
Member
country,
based
on
a
28­
day
test,
in
addition
to
an
UF
of
100,
a
factor
of
10
is
used
to
extrapolate
to
90­
day
studies
and
an
additional
factor
of
10
to
extrapolate
from
such
studies
to
long­
term
studies.

5.
The
following
ranges
UF's
are
suggested
for
guidance
when
applied
to
the:

·
NOAEL:
100­
300/
500
·
LOAEL:
500­
1500/
2500
These
UF's
cover
the
values
generally
used
in
Member
countries,
which
might
also
include
the
value
for
the
consideration
of
the
worst
case.
It
should
be
realised
that
UF's
are
always
arbitrarily
chosen
and
are
not
supported
by
strong
scientific
evidence.
EXCH\
MANUAL\
96­
4­
6.
DOC/
May
1996
11
Uncertainty
Factors
for
Reproduction/
Developmental
Toxicity
6.
UF's
which
are
suggested
to
obtain
an
EDLC
for
reproduction/
developmental
toxicity
may
be
different
from
those
for
repeated
dose
toxicity.
The
use
of
a
relatively
high
UF
is
suggested
when
severe
or
irreversible
developmental
effects
occur
at
exposure
levels
below
those
that
induce
well­
defined
parental
toxicity,
in
other
words
when
the
test
substance
produces
severe
developmental
effects
that
are
not
secondary
to
general
toxicity.
The
same
UF
may
be
applied
when
developmental
toxicity
is
only
observed
at
exposure
levels
that
are
also
toxic
to
the
parent
animals.
The
same
considerations
that
went
into
the
selection
of
the
UF
for
the
repeated
dose
study
should
be
addressed
when
selecting
the
UF
for
allocating
an
EDLC
for
reproductive/
developmental
toxicity.
An
assessment
of
whether
the
effects
seen
in
reproduction
toxicity
studies
are
secondary
to
general
toxicity,
or
are
specific
reproductive
effects,
is
important
and
expert
judgement
is
necessary.

7.
As
in
the
case
of
repeated
dose
toxicity,
an
additional
uncertain
factor
of
5
is
suggested
when
a
NOAEL
cannot
be
obtained
in
the
study
and
a
LOAEL
has
to
be
used.
Depending
on
the
nature
of
the
effects,
the
dose­
response
relationship
and
the
spacing
between
the
doses
in
the
study,
an
even
higher
factor
might
be
used.

8.
UF
ranges
which
are
suggested
as
guidance
for
the
NOAEL
are:

a)
parental
toxicity,
impaired
fertility
and
reproduction
toxicity
100­
300/
500
b)
NOAEL
for
developmental
effects
lower
than
the
NOAEL
for
maternal
toxicity
1000­
3000/
5000
c)
NOAEL
for
developmental
effects
higher
than,
or
equal
to,
the
NOAEL
for
maternal
toxicity
100­
300/
500
9.
Again,
they
cover
the
values
generally
used
in
Member
countries,
which
might
also
include
the
value
for
the
worst
case
analysis.
As
stated
for
the
UF's
for
repeated
dose
toxicity,
it
should
be
realised,
however,
that
UF's
are
always
arbitrarily
chosen
and
although
this
approach
has
been
used
for
many
years
it
is
not
supported
by
strong
scientific
evidence
.

10.
This
concept
of
using
more
stringent
UF's
for
developmental
effects
when
they
occur
in
the
absence
of
maternal
toxicity
than
when
observed
at
levels
that
are
also
toxic
to
the
parent
animals
is
generally
accepted.
However,
individual
Member
countries
may
consider
developmental
toxicity
in
the
presence
of
maternal
toxicity
of
as
great
a
concern
as
developmental
toxicity
seen
in
its
absence.
EXCH\
MANUAL\
96­
4­
6.
DOC/
May
1996
12
Annex
2
References
1.
Relevant
Monographs
of
the
IPCS
·
Environmental
Health
Criteria
document
(
EHC)
No.
6,
Principles
and
Methods
for
Evaluating
the
Toxicity
of
Chemicals,
1978.

·
Environmental
Health
Criteria
document
(
EHC)
No.
70,
Principles
for
the
Safety
Assessment
of
Food
Additives
and
Contaminants
in
Food,
1987.

·
Environmental
Health
Criteria
document
(
EHC)
No.
104,
Principles
for
the
Toxicological
Assessment
of
Pesticide
Residues
in
Food,
1990.

·
Environmental
Health
Criteria
document
(
EHC)
No.
170,
Assessing
Human
Health
Risks
of
Chemicals:
Derivation
of
Guidance
for
Health­
based
Exposure
Limit,
1994
2.
Reference
for
"
margin
of
safety"
approach
·
Technical
Guidance
Documents
in
Support
of
the
Commission
Directive
93/
67/
EEC
on
Risk
Assessment
for
New
Substances
and
the
Commission
Regulation
(
EC)
N
O
1488/
94
on
Risk
Assessment
for
Existing
Substances,
European
Commission
(
in
print)

3.
Reference
for
Uncertainty
Factors
·
V.
J.
Feron,
P.
J.
van
Bladeren
and
R.
J.
J.
Hermus,
A
Viewpoint
on
the
Extrapolation
of
Toxicological
Data
from
Animals
to
Man,
Fd
Chem
Tox,
Vol
28,
No.
11,
783­
789,
1990.
EXCH\
MANUAL\
96­
5.
DOC/
May
1996
1
5.
OVERVIEW
OF
THE
POST
SIDS
WORK*

Initial
Assessment
1.
In
the
various
phases
of
the
SID
programme,
information
collected
on
chemicals
is
collated
into
SIDS
Dossiers
and
reviewed
by
Member
countries
during
the
SIDS
review
process.
As
necessary,
SIDS
testing
and/
or
additional
data
gathering
is
recommended
to
complete
the
SIDS,
thus
enabling
the
chemical
to
have
a
full
SIDS
data
package.
Based
on
a
full
SIDS
data,
the
SIDS
Initial
Assessment
Report
with
any
recommendations
on
future
work
or
action
as
appropriate
is
developed
by
the
Sponsor
country
and
discussed
at
the
SIDS
Initial
Assessment
Meeting
(
SIAM).

2.
Based
on
an
initial
assessment
of
the
effects
and
exposure
data
provided
in
the
SIDS
Dossier,
each
chemical
can
be
described
in
light
of
the
potential
it
presents
for
risk
to
man
and/
or
the
environment
(
including
the
extent
of
exposure
and
current
risk
reduction
measures)
and
of
the
need
for
further
work
or
action
(
e.
g.
post­
SIDS
testing,
exposure
analysis,
indepth
risk
assessment,
further
risk
management
action).
Given
the
various
possible
combinations,
conclusions
and
recommendations
could
be
written,
for
example,
as
follows:

(
a)
The
chemical
can
be
considered
to
present
a
low
potential
for
risk
to
man
and
the
environment.
Thus,
there
is
no
current
priority
for
undertaking
post­
SIDS
testing
and/
or
exposure
analysis
or
an
in­
depth
assessment;

(
b)
The
chemical
may
present
a
potential
for
risk
to
man
and/
or
the
environment.
Thus,
there
is
a
priority
for
undertaking
post­
SIDS
testing
and/
or
exposure
analysis
and/
or
an
in­
depth
assessment
to
clarify
the
nature
or
extent
of
the
potential
risk;

(
c)
The
chemical
presents
a
potential
for
risk
to
man
and/
or
the
environment.
However,
risk
reduction
measures
currently
in
place
in
Member
countries
are
considered
adequate
to
control
the
risk.
Thus,
there
is
no
current
priority
for
further
risk
management
action;

(
d)
The
chemical
presents
a
potential
for
risk
to
man
and/
or
the
environment.
Due
to
the
exposure
and/
or
lack
of
current
risk
reduction
measures,
risk
management
actions
might
be
necessary.
These
could
range,
as
appropriate,
from
responsible
care
activities
by
the
chemical
industry
to
national
or
international
risk
reduction
activities;

(
e)
Etc.

3.
These
conclusions
and
recommendations
agreed
at
the
SIAM
are
confirmed
at
the
Steering
Group
on
Existing
Chemicals,
and
subsequently
by
the
Joint
Meeting.

4.
Any
further
work
mentioned
in
the
example
2(
b)
will
be
considered
as
post­
SIDS
work.
As
in­
depth
risk
assessment
is
normally
undertaken
under
the
auspices
of
IPCS,
the
following
description
will
only
cover
other
work,
e.
g.
post­
SIDS
testing,
detailed
exposure
analysis.

Post­
SIDS
Work
5.
Post­
SIDS
work
is
undertaken
in
the
framework
of
the
OECD
Programme
on
HPV
Chemicals,
on
chemicals
identified
at
a
SIAM.
In
some
chases,
suitable
analogues
may
be
picked
up
at
the
same
time.
This
work
can
encompass:

(
a)
data
collection
or
generation
by
further
testing
with
a
view
to
clarifying
specific
effects­
related
issues.
(
b)
data
collection
or
generation
and
subsequent
analysis
of
more
detailed
exposure
aspects,
e.
g.
exposure
with
respect
to
targets,
levels,
frequency,
duration,
etc.

6.
For
both
the
options
in
paragraph
5,
the
recommendations
from
the
SIAM
will
include:

*
This
document
was
prepared
by
the
OECD
Secretariat
based
on
a
paper
discussed
at
the
18th
Joint
Meeting
of
the
Chemicals
Group
and
Management
Committee
in
November
1992.
It
has
been
revised
to
reflect
agreements
reached
in
the
context
of
the
Existing
Chemicals
Programme
from
then
and
up
to
April
1996.
EXCH\
MANUAL\
96­
5.
DOC/
May
1996
2
(
a)
an
indication
of
what
data
need
to
be
collected,
generated
and/
or
analysed;
(
b)
the
rationale
behind
this
requirement;
(
c)
the
relative
priority
for
this
work
as
compared
with
that
on
other
post­
SIDS
chemicals;
(
d)
the
Member
country(
ies)
to
monitor
progress
and
oversee
developments
in
this
work;
(
e)
a
suggestion
for
a
provisional
time
schedule
for
completion
of
this
work.

The
Steering
Group
will
review
at
the
first
occasion
the
conclusions
reached
at
the
SIAM,
together
with
proposals
on
how
to
follow
up
on
the
recommendations
of
SIAM.

7.
The
overall
responsibility
for
undertaking
any
work
as
outlined
in
paragraph
5.
will
rest
with
industry.
Industry
has
the
most
knowledge
about
their
chemicals
and
is
in
the
best
position
to
negotiate
ways
and
means
of
sharing
the
burden
of
the
administrative
and
operational
costs
involved.

8.
The
Member
country(
ies)
overseeing
the
work
and
monitoring
progress
is
encouraged,
in
collaboration
with
the
chemical
industry,
BIAC
and
other
international
chemical
industry
associations
such
as
ICCA,
to:

(
a)
promote
the
formation
of
consortia
by
(
inter)
national
producer
and
user
industries
to
undertake
the
work
and
share
the
burden
of
the
inherent
costs;
(
b)
discuss
plans
and
progress
with
the
responsible
industry/
association/
institute,
etc.
identified
to
conduct
the
work;
(
c)
ensure
that
any
necessary
testing
under
5(
b)
is
conducted
according
to
OECD
GLP
Principles
and,
where
possible,
using
the
appropriate
OECD
Test
Guideline;
(
d)
monitor
progress
in
meeting
the
time
schedule
suggested
under
6(
e);
(
e)
investigate
the
possibilities
of
participation,
on
a
case­
by­
case
basis,
of
interested
non­
industry
parties;
and
(
f)
circulate
the
final
report
of
the
work
to
the
OECD
Secretariat
and
Member
countries.

9.
The
OECD
Secretariat
will
liaise
with
Member
countries
to
avoid
duplication
of
testing
and
assessments
of
chemicals
in
which
they
have
a
mutual
interest.

10.
As
in
many
SIDS
chemicals
may
be
produced
or
used
in
non­
Member
countries,
they
will
be
encouraged
to
participate
in
the
programme
and
share
the
burden.

11.
When
all
the
additional
post­
SIDS
information
has
been
gathered,
generated
and
collated,
the
chemical
will
be
discussed
at
a
post­
SIDS
Assessment
Meeting,
which
will
have
a
similar
format
and
participation
to
that
of
a
SIDS
Initial
Assessment
Meeting:
i.
e.
SIDS
Contact
Points,
experts
from
non­
Member
countries,
BIAC,
IPCS
and
IRPTC,
as
well
as
companies
which
have
participated
in
the
post­
SIDS
work.
EXCH\
MANUAL\
96­
5.
DOC/
May
1996
3
12.
As
in
SIDS
work,
relevant
reports
arising
from
post­
SIDS
work
would
be
made
publicly
available
through
IRPTC
and
published
as
a
contribution
to
IOMC.

13.
Although
chemicals
for
which
the
recommendations
are
similar
to
that
described
in
paragraph
2(
d)
are
not
candidates
for
post­
SIDS
work,
their
potential
risk
and
any
further
activities
recommended
for
follow­
up
in
OECD
should
be
carefully
identified.
The
Joint
Meeting
will
confirm
the
recommendations
and
discuss
the
modalities
of
further
action
on
these
chemicals,
such
as
responsible
care
activities
by
the
chemical
industry
or
any
risk
reduction
activities.
Such
activities
will,
in
the
first
instance,
be
the
responsibility
of
industry,
which
would
report
to
the
Joint
Meeting,
through
BIAC,
on
progress
made.
EXCH\
MANUAL\
96­
AN1.
DOC/
May
1996
ANNEX
1
OECD
Decision­
Recommendation
of
the
Council
on
the
Co­
operative
Investigation
and
Risk
Reduction
of
Existing
Chemicals
[
C(
90)
163/
FINAL]
EXCH\
MANUAL\
96­
AN1.
DOC/
May
1996
EXCH\
MANUAL\
96­
AN1.
DOC/
May
1996
ORGANISATION
FOR
ECONOMIC
GENERAL
DISTRIBUTION
CO­
OPERATION
AND
DEVELOPMENT
Paris,
drafted:
31­
JAN
1991
OLIS:
31
JAN
1991
dist.:
01
FEB
1991
C(
90)
163/
FINAL
COUNCIL
DECISION­
RECOMMENDATION
OF
THE
COUNCIL
on
the
Co­
operative
Investigation
and
Risk
Reduction
of
Existing
Chemicals
(
adopted
by
the
Council
at
its
750th
Session
on
31st
January
1991)

32132
C(
90)
163/
FINAL
EXCH\
MANUAL\
96­
AN1.
DOC/
May
1996
2
THE
COUNCIL,

Having
regard
to
Articles
5
a)
and
5
b)
of
the
Convention
on
the
Organisation
for
Economic
Co­
operation
and
Development
of
14th
December
1960;

Having
regard
to
the
conclusions
concerning
the
control
of
existing
chemicals
reached
at
the
First,
Second
and
Third
High
Level
Meetings
of
the
Chemicals
Group
of
12th
May
1980,
15th
November
1982
and
17th
March
1987,
respectively;

Having
regard
to
the
conclusion
of
the
Second
High
Level
Meeting
of
the
Chemicals
Group
concerning
the
importance
of
animal
welfare
with
respect
to
the
testing
of
chemicals;

Having
regard
to
the
Resolution
of
the
Council
concerning
a
Procedure
for
Notification
and
Consultation
on
Measures
for
Control
of
Substances
Affecting
Man
and
the
Environment
[(
C(
71)
73(
Final)];

Having
regard
to
the
Recommendation
of
the
Council
of
31st
January
1991
on
Integrated
Pollution
Prevention
and
Control
[
C(
90)
164/
FINAL]
and,
in
particular,
the
Recommendation
that
Member
countries
practice
integrated
pollution
prevention
and
control,
taking
into
account
the
effect
of
activities
and
substances
on
the
environment
as
a
whole
and
the
whole
commercial
and
environmental
life
cycles
of
substances
when
assessing
the
risks
they
pose
and
when
developing
and
implementing
controls
to
limit
their
release;

Having
regard
to
the
Decision­
Recommendation
of
the
Council
of
26th
June
1987
on
the
Systematic
Investigation
of
Existing
Chemicals
[
C(
87)
90(
Final)];

Having
regard
to
the
Recommendation
of
the
Council
of
14th
November
1974
on
the
Assessment
of
the
Potential
Environmental
Effects
of
Chemicals
[
C(
74)
215];

Having
regard
to
point
6
of
the
Declaration
on
"
Environment:
Resource
for
the
Future",
of
20th
June
1985,
adopted
by
the
governments
of
OECD
Member
countries
and
of
Yugoslavia
which
states
that
more
effective
control
of
both
new
and
existing
chemicals
from
their
manufacture
to
ultimate
disposal
will
be
achieved
through
shared
and
co­
ordinated
efforts;

Having
regard
to
the
Recommendations
of
the
World
Commission
on
Environment
and
Development
of
1987
that
major
chemical­
producing
countries
should
reinforce
on­
going
efforts
to
obtain
international
agreement
on
the
selection
of
existing
chemicals
for
priority
testing,
on
criteria
and
procedures
for
their
assessment,
and
on
a
system
for
international
sharing
of
the
tasks
and
the
resources
required;

Having
regard
to
the
Bergen
Ministerial
Declaration
on
Sustainable
Development
in
the
ECE
Region
of
16th
May
1990,
in
particular
to
point
IV,
15c
and
point
V,
16c;

Considering
the
experience
gained
to
date
by
Member
countries
in
the
co­
operative
investigation
of
existing
chemicals
which
has
led
to
the
initiating
of
concerted
data
collection,
testing
and
evaluation
of
the
first
group
of
priority
existing
chemicals;

Considering
that
concerted
identification,
assessment
and
management
of
existing
chemicals
can
produce
more
efficient
utilisation
of
national
and
international
resources
towards
reduction
of
any
risks
to
the
environment
and/
or
to
the
health
of
the
general
public
or
workers
uncovered
in
all
phases
of
the
life
cycle
of
the
chemicals;
C(
90)
163/
FINAL
EXCH\
MANUAL\
96­
AN1.
DOC/
May
1996
3
Considering
that
assessments
of
the
effects
on
health
and
the
environment
for
the
purpose
of
reducing
risks
should
include
evaluation
of
the
risks
and
benefits
of
using
the
substance
and
its
substitutes
and
the
economic
effects
of
any
control
action;

Considering
that
co­
operative
international
efforts
constitute
an
efficient
and
innovative
way
to
apply
economic
and
regulatory
approaches
for
the
systematic
investigation
and
reduction
of
the
risks
of
hazardous
existing
chemicals;

Considering
that
strengthened
national
and
co­
operative
international
efforts
to
investigate
systematically
and
reduce
the
risks
of
hazardous
existing
chemicals
will
substantially
alleviate
threats
of
serious
or
irreversible
damage
to
the
environment
and/
or
the
health
of
the
general
public
or
workers;

Considering
that
the
co­
operative
work
underway
on
selected
chemicals
of
concern
to
Member
countries
to
assess,
to
develop
risk
reduction
strategies
and,
where
appropriate,
to
take
actions
to
reduce
their
risks
will
be
of
value
for
further
efforts
in
this
regard;

On
the
proposal
of
the
15th
Joint
Meeting
of
the
Management
Committee
of
the
Special
Programme
on
the
Control
of
Chemicals
and
the
Chemicals
Group
of
the
Environment
Committee,
as
approved
by
the
4th
Meeting
of
the
Environment
Committee
at
Ministerial
Level:

I.
Co­
operative
Investigation
and
Risk
Reduction
of
Existing
Chemicals
A.
Co­
operative
Investigation
1.
DECIDES
that
Member
countries
shall
co­
operatively
investigate
high
production
volume
(
HPV)
chemicals*
in
order
to
identify
those
which
are
potentially
hazardous
to
the
environment
and/
or
to
the
health
of
the
general
public
or
workers.

2.
DECIDES
that
Member
countries,
in
undertaking
the
task
set
out
in
paragraph
I.
A.
1
shall:

i)
co­
operatively
select
the
HPV
chemicals
for
investigation;

ii)
acquire
an
agreed­
upon
basic
data
set
needed
to
make
an
informed
judgement
concerning
the
potential
hazards
of
each
chemical
through
collection
of
available
data
or
by
ensuring
that
testing
is
undertaken;
and
iii)
co­
operatively
make
an
initial
assessment
of
the
potential
hazards
of
each
chemical
based
on
the
basic
data
set.

3.
RECOMMENDS
that
Member
countries
undertake
additional
co­
operative
activities
including
the
generation
of
further
data
and
the
completion
of
more
in­
depth,
systematic
assessments
of
the
hazards
and
risks
posed
by
those
HPV
chemicals
found
in
the
initial
assessment
to
be
potentially
hazardous.

4.
RECOMMENDS
that
Member
countries
also
co­
operate
in
undertaking
work
on
the
investigation
of
those
non­
HPV
existing
chemicals
for
which
they
share
a
concern.

*
For
purposes
of
this
Decision­
Recommendation
HPV
chemicals
are
those
chemicals
included
in
the
OECD
Representative
List
of
High
Production
Volume
(
HPV)
Chemicals,
as
established
and
updated
regularly.
C(
90)
163/
FINAL
EXCH\
MANUAL\
96­
AN1.
DOC/
May
1996
4
5.
DECIDES
that
Member
countries
shall
make
information
obtained
from
the
co­
operative
investigation
of
existing
chemicals
publicly
available
via
the
United
Nations
Environment
Programme's
­
International
Register
of
Potentially
Toxic
Chemicals
(
UNEP/
IRPTC),
respecting
legitimate
claims
for
protection
of
confidential
data.

6
INVITES
the
International
Programme
on
Chemical
Safety
(
IPCS)
to
use
the
results
of
the
investigations
of
existing
chemicals
by
OECD
Member
countries
in
preparing
its
assessments
of
the
health
and
environmental
impacts
of
existing
chemicals.

B.
Risk
Reduction
1.
DECIDES
that
Member
countries
shall
establish
or
strengthen
national
programmes
aimed
at
the
reduction
of
risks
from
existing
chemicals
to
the
environmental
and/
or
the
health
of
the
general
public
or
workers.

2.
RECOMMENDS
that
Member
countries
collaborate
to
develop
common
criteria
to
determine
which
chemicals,
among
those
which
are
included
in
the
co­
operative
investigations
referred
to
in
Section
I.
A
and/
or
the
procedures
foreseen
in
paragraph
II.
1.
ii,
are
suitable
candidates
for
concerted
risk
reduction
activities.

3.
RECOMMENDS
that,
where
appropriate,
Member
countries
undertake
concerted
activities
to
reduce
the
risks
of
selected
chemicals
taking
into
account
the
entire
life
cycle
of
the
chemicals.
These
activities
could
encompass
both
regulatory
and
non­
regulatory
measures
including:
the
promotion
of
the
use
of
cleaner
products
and
technologies;
emission
inventories;
product
labelling;
use
limitations;
economic
incentives;
and
the
phase­
out
or
banning
of
chemicals.

II.
Implementation
1.
INSTRUCTS
the
Management
Committee
of
the
Special
Programme
on
the
Control
of
Chemicals,
having
regard
to
the
work
of
other
international
organisations:

i)
to
pursue
a
programme
of
work
designed
to
facilitate
the
practical
implementation
of
this
Decision­
Recommendation;
and
ii)
to
establish
procedures
for
the
notification
of,
and
exchange
of
information
on
activities
in
Member
countries,
to
reduce
the
risks
of
existing
chemicals;

iii)
to
the
extent
that
Member
countries
undertake
concerted
risk
reduction
activities
pursuant
to
paragraph
I.
B.
3,
to
propose,
where
appropriate,
agreements
on
reducing
the
risk
of
specific
chemicals
or
groups
of
chemicals.

2.
INVITES
the
Secretary­
General
to
take
the
necessary
steps
to
ensure
that
this
work
is
carried
out
in
cooperation
with
other
international
organisations
and,
in
particular,
in
collaboration
with
the
UNEP/
IRPTC
and
the
IPCS.

3.
INSTRUCTS
the
Management
Committee
of
the
Special
Programme
on
the
Control
of
Chemicals
to
review,
by
the
end
of
1994,
the
actions
taken
by
Member
countries
in
pursuance
of
the
Decision­
Recommendation.
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
ANNEX
2
Model
SIDS
Dossier
This
Model
SIDS
Dossier
is
intended
to
show
how
the
data
will
be
described
in
the
SIDS
Dossier
in
an
appropriate
fashion.
Good
examples
of
data
description
are
presented
in
general
but
in
some
cases
data
which
is
considered
to
be
inappropriate
are
included
for
the
purpose
of
comparison.

The
format
of
the
Model
Dossier
is
following
the
Revised
HPV
Form
1,
which
is
virtually
identical
with
the
HEDSET.
It
should
be
noted
that
the
data
used
are
not
real
ones
although
most
of
them
have
been
taken
from
Dossiers
of
Phase
1
and
2
chemicals
originally.
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
i
MODEL
SIDS
DOSSIER
ON
THE
HPV
PHASE
......
CHEMICAL
....................

CAS
No.
xxxx­
xx­
x
Sponsor
Country:
OECD
DATE:
July
1994
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
ii
CONTENTS
Page
SIDS
PROFILE.......................................................................................................................................................
1
SIDS
SUMMARY..................................................................................................................................................
2
1.
GENERAL
INFORMATION.................................................................................................................................
3
1.01
SUBSTANCE
INFORMATION........................................................................................................................
3
*
A.
CAS­
NUMBER....................................................................................................................................
3
B.
NAME
(
IUPAC­
NAME)......................................................................................................................
3
*
C.
NAME
(
OECD
NAME).......................................................................................................................
3
*
D.
CAS
DESCRIPTOR.............................................................................................................................
3
E.
EINECS­
NUMBER..............................................................................................................................
3
F.
MOLECULAR
FORMULA.................................................................................................................
3
*
G.
STRUCTURAL
FORMULA................................................................................................................
3
H.
SUBSTANCE
GROUP.........................................................................................................................
3
I.
SUBSTANCE
REMARK.....................................................................................................................
3
J.
MOLECULAR
WEIGHT.....................................................................................................................
3
1.02
OECD
INFORMATION....................................................................................................................................
3
A.
SPONSOR
COUNTRY
.......................................................................................................................
3
B.
LEAD
ORGANISATION.....................................................................................................................
3
C.
NAME
OF
RESPONDER
(
COMPANY).............................................................................................
4
1.1
GENERAL
SUBSTANCE
INFORMATION....................................................................................................
5
A.
TYPE
OF
SUBSTANCE......................................................................................................................
5
B.
PHYSICAL
STATE..............................................................................................................................
5
C.
PURITY................................................................................................................................................
5
1.2
SYNONYMS..........................................................................................................................
5
1.3
IMPURITIES..........................................................................................................................
5
1.4
ADDITIVES...........................................................................................................................
5
1.5
*
QUANTITY.......................................................................................................................................................
5
1.6
LABELLING
AND
CLASSIFICATION
(
USE
AND/
OR
TRANSPORTATION)
..........................................
6
1.7
*
USE
PATTERN..................................................................................................................................................
6
A.
GENERAL
USE
PATTERN.................................................................................................................
6
B.
USES
IN
CONSUMER
PRODUCTS..................................................................................................
7
1.8
OCCUPATIONAL
EXPOSURE
LIMIT
VALUE
............................................................................................
7
1.9
*
SOURCES
OF
EXPOSURE
.............................................................................................................................
7
1.10
ADDITIONAL
REMARKS...............................................................................................................................
8
A.
OPTIONS
OF
DISPOSAL....................................................................................................................
8
B.
OTHER
REMARKS.............................................................................................................................
8
2.
PHYSICAL­
CHEMICAL
DATA...........................................................................................................................
9
2.1
*
MELTING
POINT..............................................................................................................................................
9
2.2
*
BOILING
POINT...............................................................................................................................................
9
2.3
*
DENSITY
(
RELATIVE
DENSITY)..................................................................................................................
10
2.4
*
VAPOUR
PRESSURE.......................................................................................................................................
10
2.5
*
PARTITION
COEFFICIENT
n­
OCTANOL/
WATER......................................................................................
10
2.6
*
WATER
SOLUBILITY......................................................................................................................................
10
A.
SOLUBILITY
......................................................................................................................................
10
B.
pH
VALUE,
pKa
VALUE....................................................................................................................
11
2.7
FLASH
POINT
(
LIQUIDS)...............................................................................................................................
11
2.8
AUTO
FLAMMABILITY
(
SOLID/
GASES).....................................................................................................
12
2.9
FLAMMABILITY
.............................................................................................................................................
12
2.10
EXPLOSIVE
PROPERTIES
..................................................................................................
12
2.11
OXIDIZING
PROPERTIES...............................................................................................................................
12
2.12
*
OXIDATION:
REDUCTION
POTENTIAL.......................................................................................................
13
2.13
ADDITIONAL
REMARKS...............................................................................................................................
13
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
iii
A.
PARTITION
CO­
EFFICIENT
BETWEEN
SOIL/
SEDIMENT
AND
WATER
(
Kd)..........................
13
B.
OTHER
REMARKS.............................................................................................................................
13
3.
ENVIRONMENTAL
FATE
AND
PATHWAYS...................................................................................................
14
3.1
STABILITY
.......................................................................................................................................................
14
3.1.1
*
PHOTODEGRADATION..................................................................................................................................
14
3.1.2
*
STABILITY
IN
WATER...................................................................................................................................
15
3.1.3
STABILITY
IN
SOIL.........................................................................................................................................
15
3.2
*
MONITORING
DATA
(
ENVIRONMENT).....................................................................................................
16
3.3
*
TRANSPORT
AND
DISTRIBUTION
BETWEEN
ENVIRONMENTAL
COMPARTMENTS
INCLUDING
ESTIMATED
ENVIRONMENTAL
CONCENTRATIONS
AND
DISTRIBUTION
PATHWAYS................
17
3.3.1
TRANSPORT.....................................................................................................................................................
17
3.3.2
THEORETICAL
DISTRIBUTION
(
FUGACIT
CALCULATION)..................................................................
17
3.4
MODE
OF
DEGRADATION
IN
ACTUAL
USE.............................................................................................
18
3.5
*
BIODEGRADATION........................................................................................................................................
18
3.6
BOD­
5,
COD
OR
RATIO
BOD­
5/
COD............................................................................................................
18
3.7
BIOACCUMULATION
....................................................................................................................................
19
3.8
ADDITIONAL
REMARKS
..............................................................................................................................
20
A.
SEWAGE
TREATMENT.....................................................................................................................
20
B.
OTHER.................................................................................................................................................
20
4.
ECOTOXICITY.................................................................................................................................................
21
4.1
*
ACUTE/
PROLONGED
TOXICITY
TO
FISH........................................................................
21
4.2
ACUTE
TOXICITY
TO
AQUATIC
INVERTEBRATES.................................................................................
21
*
A.
DAPHNIA.............................................................................................................................................
21
B.
OTHER
AQUATIC
ORGANISMS......................................................................................................
22
4.3
*
TOXICITY
TO
AQUATIC
PLANTS
e.
g.,
ALGAE..........................................................................................
22
4.4
TOXICITY
TO
BACTERIA..............................................................................................................................
23
4.5
CHRONIC
TOXICITY
TO
AQUATIC
ORGANISMS.....................................................................................
23
4.5.1
CHRONIC
TOXICITY
TO
FISH......................................................................................................................
23
4.5.2
(*)
CHRONIC
TOXICITY
TO
AQUATIC
INVERTEBRATES3
(
e.
g.,
DAPHNIA
REPRODUCTION).................................................................................................................
24
4.6
TOXICITY
TO
TERRESTRIAL
ORGANISMS...............................................................................................
24
4.6.1
TOXICITY
TO
SOIL
DWELLING
ORGANISMS
..........................................................................................
24
4.6.2
TOXICITY
TO
TERRESTRIAL
PLANTS........................................................................................................
25
4.6.3
TOXICITY
TO
OTHER
NON­
MAMMALIAN
TERRESTRIAL
SPECIES
(
INCLUDING
BIRDS)......................................................................................................................................
26
4.7
BIOLOGICAL
EFFECTS
MONITORING
(
INCLUDING
BIOMAGNIFICATION)......................................
27
4.8
BIOTRANSFORMATION
AND
KINETICS....................................................................................................
27
4.9
ADDITIONAL
REMARKS...............................................................................................................................
27
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
iv
5.
TOXICITY..............................................................................................................................................................
28
5.1
*
ACUTE
TOXICITY...........................................................................................................................................
28
5.1.1
ACUTE
ORAL
TOXICITY...............................................................................................................................
28
5.1.2
ACUTE
INHALATION
TOXICITY.................................................................................................................
28
5.1.3
ACUTE
DERMAL
TOXICITY.........................................................................................................................
29
5.1.4
ACUTE
TOXICITY
BY
OTHER
ROUTES
OF
ADMINISTRATION............................................................
30
5.2
CORROSIVENESS/
IRRITATION....................................................................................................................
30
5.2.1
SKIN
IRRITATION/
CORROSION
..................................................................................................................
30
5.2.2
EYE
IRRITATION/
CORROSION....................................................................................................................
31
5.3
SKIN
SENSITISATION....................................................................................................................................
33
5.4
*
REPEATED
DOSE
TOXICITY.........................................................................................................................
32
5.5
*
GENETIC
TOXICITY
IN
VITRO.....................................................................................................................
36
A.
BACTERIAL
TEST..............................................................................................................................
36
B.
NON­
BACTERIAL
IN
VITRO
TEST..................................................................................................
37
5.6
*
GENETIC
TOXICITY
IN
VIVO.......................................................................................................................
37
5.7
CARCINOGENICITY.......................................................................................................................................
38
5.8
*
TOXICITY
TO
REPRODUCTION...................................................................................................................
38
5.9
*
DEVELOPMENTAL
TOXICITY
/
TERATOGENICITY.................................................................................
40
5.10
OTHER
RELEVANT
INFORMATION............................................................................................................
40
A.
SPECIFIC
TOXICITIES
(
NEUROTOXICITY,
IMMUNOTOXICITY
etc.).......................................
40
B.
TOXICODYNAMICS,
TOXICOKINETICS.......................................................................................
40
5.11
*
EXPERIENCE
WITH
HUMAN
EXPOSURE...................................................................................................
41
6.
REFERENCES........................................................................................................................................................
42
Note:
*;
Data
elements
in
the
SIDS
*;
Data
elements
specially
required
for
inorganic
chemicals
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
1
S
I
D
S
P
R
O
F
I
L
E
DATE:

1.01
A.
CAS
No.
xxxx­
xx­
x
1.01
C.
CHEMICAL
NAME
(
OECD
Name)
Phosphonic
acid,
(
nitrilo
tris(
methylene))
tris
1.01
D.
CAS
DESCRIPTOR
Not
applicable
in
this
case
1.01
G.
STRUCTURAL
FORMULA
N(
CH2PO3H2)
3
OTHER
CHEMICAL
IDENTITY
INFORMATION
1.5
QUANTITY
In
Country
A
approx
1,700
tonnes
in
1989.
Estimated
global
production
was
5,000
tonnes
in
1989.

1.7
USE
PATTERN
(
a)
Non
dispersive
use
in
chemical
industry
as
an
intermediate
in
synthesis
(
85
%
was
used
in
a
factory
in
Town
B
in
1989)

(
b)
Wide
dispersive
use
in
personal
and
domestic
use
as
cosmetics
(
10
%
was
used
as
an
ingredients
of
a
nail
lacquer
in
Country
A
in
1988.)

(
c)
Gloss
agent,
approx.
3%
as
paste
1.9
SOURCES
AND
LEVELS
OF
EXPOSURE
1.
Amount
released
from
production
site
to
water
is
<
0.5
kg/
year
in
Country
A.
All
leaks
and
spills
are
contained
and
cleaned
up
in
an
appropriate
manner,
i.
e.,
water
treatment
or
incineration.

2.
Amount
released
to
air
from
production
site
is
negligible
in
Country
A.

3.
Information
on
consumer
exposure
is
not
available.

ISSUES
FOR
DISCUSSION
(
IDENTIFY,
IF
ANY)
SIDS
testing
required:
NONE
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
2
S
I
D
S
S
U
M
M
A
R
Y
DATE:

CAS
NO:
..................

STUDY
Y/
N
Y/
N
Y/
N
Y/
N
Y/
N
Y/
N
Y/
N
PHYSICAL­
CHEMICAL
DATA
2.1
2.2
2.3
2.4
2.5
2.6
2.12
Melting
Point
Boiling
Point
Density
Vapour
Pressure
Partition
Coefficient
Water
Solubility
pH
and
pKa
values
Oxidation:
Reduction
potential
OTHER
P/
C
STUDIES
RECEIVED
ENVIRONMENTAL
FATE
and
PATHWAY
3.1.1
3.1.2
3.2
3.3
3.5
Photodegradation
Stability
in
water
Monitoring
data
Transport
and
Distribution
Biodegradation
OTHER
ENV
FATE
STUDIES
RECEIVED
ECOTOXICITY
4.1
4.2
4.3
4.5.2
4.6.1
4.6.2
4.6.3
Acute
toxicity
to
Fish
Acute
toxicity
to
Daphnia
Toxicity
to
Algae
Chronic
toxicity
to
Daphnia
Toxicity
to
Soil
dwelling
organisms
Toxicity
to
Terrestrial
plants
Toxicity
to
Birds
OTHER
ECOTOXICITY
STUDIES
RECEIVED
TOXICITY
5.1.1
5.1.2
5.1.3
5.4
5.5
5.6
5.8
5.9
5.11
Acute
Oral
Acute
Inhalation
Acute
Dermal
Repeated
Dose
Genetic
Toxicity
in
vitro
.
Gene
mutation
.
Chromosomal
aberration
Genetic
Toxicity
in
vivo
Reproduction
Toxicity
Development
/
Teratogenicity
Human
experience
OTHER
TOXICITY
STUDIES
RECEIVED
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
3
1.
GENERAL
INFORMATION
1.01
SUBSTANCE
INFORMATION
*
A.
CAS­
Number
xxxx­
xx­
x
B.
Name
(
IUPAC
name)
Phosphonic
acid,
(
nitrilo
tris(
methylene))
tris
*
C.
Name
(
OECD
name)
Phosphonic
acid,
(
nitrilo
tris(
methylene))
tris
*
D.
CAS
Descriptor
(
where
applicable
for
complex
chemicals)
Not
applicable
in
this
case
E.
EINECS­
Number
xxx­
xxx­
x
F.
Molecular
Formula
C3
H12
N
O9
P3
*
G.
Structural
Formula
(
indicate
the
structural
formula
in
smiles
code,
if
available)
N
(
CH2
PO3H2)
3
H.
Substance
Group
(
if
possible,
only
for
petroleum
products,
see
HEDSET
Explanatory
note)
Not
applicable
I.
Substance
Remark
(
indicate
the
substance
remark
as
prescribed
in
the
EINECS
Inventory,
if
possible)

.......................................................................................................................................

J.
Molecular
Weight
299
1.02
OECD
INFORMATION
A.
Sponsor
Country:
OECD
B.
Lead
Organisation:
Name
of
Lead
Organisation:
Environment
Directorate
Contact
person:
Ms
A.
N.
OTHER
Address:
2,
rue
André­
Pascal
75775
Paris
Cedex
16
France
Tel:
33­
1­
45.24.79.07
Fax:
33­
1­
45.24.16.75
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
4
C.
Name
of
responder
(
Information
on
a
responder
should
be
provided
when
companies
respond
to
Lead
Organisation
or
SIDS
Contact
Points)

Name:
I.
M.
Nobody
Address:
XYZ
Company
15
Boulevard
de
L'Amiral­
Bruix
75116
Paris
France
Tel:
...............................................................................................................................
Fax:
..............................................................................................................................
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
5
1.1
GENERAL
SUBSTANCE
INFORMATION
A.
Type
of
Substance
element
[
];
inorganic
[
];
natural
substance
[
];
organic
[
X
];
organometallic
[
];
petroleum
product
[
]

B.
Physical
State
(
at
20
°
C
and
1.013
hPa)
gaseous
[
];
liquid
[
];
solid
[
X
]

C.
Purity
(
indicate
the
percentage
by
weight/
weight)
82%
weight/
weight
Products
are
supplied
as
aqueous
solutions
containing
approx
50%
of
the
substance.

1.2
SYNONYMS
Amino
tris
(
methylene
phosphonic
acid)
ATMP
Dequest
2000
TM
Briquest
301­
500
TM
1.3
IMPURITIES
(
indicate
CAS
No.,
chemical
name
(
IUPAC
name
is
preferable)
,
percentage,
if
possible
EINECS
number)

CAS
No:
123­
45­
7
EINECS
No:
.......................................................................................................................................
Name:
Amino
bis
(
methylene
phosphonic
acid);
Value:
ca.
10%
Remarks:
.......................................................................................................................................

1.4
ADDITIVES
(
e.
g.
stabilizing
agents,
inhibitors
etc.
Indicate
CAS
No.,
chemical
name
(
IUPAC
name
is
preferable)
,
percentage,
if
possible
EINECS
number),
the
component
of
the
UVCB
(
Substance
with
no
defined
composition)
should
be
indicated
here)

CAS
No:
.......................................................................................................................................
EINECS
No:
.......................................................................................................................................
Name:
.......................................................................................................................................
Value:
None
Remarks:
.......................................................................................................................................

*
1.5
QUANTITY
(
Information
on
production
or
import
levels
should
be
provided
in
figures
or
ranges
(
e.
g.,
1,000
­
5,000,
5,000­
10,000
tonnes,
etc.)
per
responder
or
country
and
the
date
for
which
those
ranges
apply
should
be
given.
For
EEC
Member
states
only
indicate
the
Community
import
figure.
Give
an
estimation
of
the
global
production
quantity
in
the
remarks
field.
Information
on
the
number
of
producers
in
the
country
and
the
source
of
information
should
also
be
described
in
the
remarks
field)

Remarks:
(
If
possible,
indicate
if
the
substance
has
been
produced
and/
or
imported
during
the
12
month
after
adoption
of
the
EEC
regulation
on
existing
chemicals)
There
is
only
one
manufacturing
site
in
Country
A.
Estimated
global
production
was
5,000
tonnes
in
1989.
Reference:
Chemical
News,
1990
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
6
1.6
LABELLING
AND
CLASSIFICATION
(
If
possible,
enter
information
on
labelling
and
classification
such
as
labelling
and
classification
system,
existence
of
specific
limit,
symbols,
nota,
R­
Phrases
and
S­
Phrases
of
EC
Directive
67/
548/
EEC,
See
HEDSET
Explanatory
note.)

Labelling
Type:
Directive
67/
548//
EEC
Specific
limits:
no
data
Symbols:
Xi
Nota:
.......................................................................................................................................
R­
phrases:
36/
37/
38­
43
S­
phrases:
24­
26­
37
Text
of
S­
phrases:
Avoid
contact
with
skin,
In
case
of
contact
with
eyes,
rinse
immediately
with
plenty
of
water
and
seek
medical
advice,
Wear
suitable
gloves
Remarks:
.......................................................................................................................................

Classification
Type:
Directive
67/
548/
EEC
Category
of
danger:
irritant
R­
phrases:
36/
37/
38/­
43
Remaks:
Text
of
R­
phrases,
irritating
to
eyes,
irritating
to
respiratory
system,
irritating
to
skin,
may
cause
sensitization
by
skin
contact
*
1.7
USE
PATTERN
A.
General
(
Data
on
use
pattern
have
to
be
given
by
assigning
main
types
according
to
their
exposure
relevance
(
i.
e.
Non
dispersive
use,
Use
in
closed
systems,
Use
resulting
in
inclusion
into
or
onto
matrix
and
Wide
dispersive
use),
industrial
categories
(
e.
g.
Basic
chemical
industry,
Chemical
industry,
Agricultural
industry,
Personal
and
domestic
use)
and
use
categories
such
as
Colouring
agents,
Intermediates,
Solvents,
Adhesives,
Cleaning/
washing
agents,
Fertilizers,
Impregnation
agents,
Surface­
active,
etc.
If
available,
give
an
estimation
of
different
uses
in
percentage
terms.)

Type
of
Use:
Category:

(
a)
main
Non
dispersive
use
industrial
Chemical
Industry:
used
in
synthesis
use
Intermediate
(
b)
main
Wide
dispersive
use
industrial
Personal
and
domestic
use
use
Cosmetics
(
Nail
lacquer)

Remarks:
(
a)
85
%
was
used
in
a
factory
in
Town
B
in
1989
(
b)
10
%
was
used
as
an
ingredients
of
a
nail
lacquer
in
the
Country
C
in
1988
­
Information
on
use
in
other
countries
is
not
available.

Reference:
Kirk­
Othmer,
1991
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
7
B.
Uses
in
Consumer
Products
(
If
the
chemical
is
present
in
consumer
products
as
marketed
give
details
of
form
of
products
function
(
e.
g.
detergent
etc.),
and
percent
in
product
and
physical
state
of
product
as
marketed
(
e.
g.
aerosol,
powder
or
liquid))

Function
Amount
present
Physical
state
Gloss
agent
approx
3%
Paste
Remarks:
Information
on
use
in
other
countries
is
not
available.
Reference:
Danish
Product
Register,
1988
1.8
OCCUPATIONAL
EXPOSURE
LIMIT
VALUE
(
Indicate
the
type
of
the
occupational
exposure
limit
value
including
Short
term
exposure
limit
value.
If
a
value
does
not
exist,
give
the
hygiene
standard
of
the
producer
company
if
available.
See
also
5.11)

Exposure
limit
value
Type:
LV,
MAK(
DE),
MSC(
NL),
MEL(
UK)
Value:
mg/
m3
(
approx.
135
ppm)

Short
term
exposure
limit
value
Value:
.......................................................................................................................................
Length
of
exposure
period:
........................................................................................................................
Frequency:
.......................................................................................................................................
Remarks:
.......................................................................................................................................
Reference:
ACGIH,
Threshold
Limit
Value
1987
*
1.9
SOURCES
OF
EXPOSURE
Describe
sources
of
potential
human,
(
other
than
concentration
of
chemicals
in
the
workplace
and
indoor
environment
(
see
5.11)),
or
environmental
exposure
including
emission
data
(
e.
g.
quantities
per
media
with
information
such
as
time
dimensions
of
release,
indication
of
type
of
release
(
e.
g.
point
source
or
diffuse),
type
of
estimating
(
e.
g.
average
or
worst
case)
uncertainties
in
estimation),
if
available
for
all
phases
of
the
life
cycle
of
the
chemical
including
manufacturing
and
user
areas.

For
environmental
exposure,
indicate
the
production
process
briefly,
number
of
sites
of
manufacture
and
the
basis
for
concluding
that
the
process
is
"
closed"
if
applicable.

Also
an
indication
of
measured
exposure
levels
(
expressed
in
and
appropriate
form
e.
g.,
geometric
mean
and
standard
deviation)
can
be
mentioned
here.
Any
information
that
will
help
to
focus
the
assessment
of
exposure
(
either
quantitative
or
quantitative
in
nature
can
be
mentioned,
if
available)

(
a)
Source:
Media
of
release:
Water
from
a
production
site
Quantities
per
media:
<
0.5
kg/
year
at
the
production
site
in
Country
A.

Remarks:
ABCDE
is
produced
in
batches
of
12
tonnes
in
only
one
factory
in
the
country
A.
From
each
batch
740
litres
of
filter
washing
water
saturated
with
ABCDE
(<
0.5
mg/
l)
is
released
into
a
effluent
treatment
plant
and
subsequently
released
into
a
river
B
(
average
flow
is
500
m
3/
sec).
Assuming
a
production
of
1000
batches
per
annum,
less
than
0.5
kg
per
annum
eventually
reach
the
river
B,
even
removal
by
the
treatment
plant
is
not
taken
into
account.
All
leaks
and
spills
are
contained
and
cleaned
up
in
an
appropriate
manner
(
water
treatment
or
incineration).
Reference:
Unpublished
report
of
XYZ
corporation,
1989
(
b)
Source:
Media
of
release:
Air
from
a
production
site
Quantities
per
media:
Negligible
at
the
production
site
in
Country
A.
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
8
Remarks:
All
process
ventilation
are
treated
by
incineration.
Then
they
will
pass
a
gas­
scrubber
before
release
to
the
air.
Also
incinerator
used
for
disposal
of
production
waste
is
equipped
with
a
scrubber.
References:
Unpublished
report
of
XYZ
corporation.

(
c)
Remarks:
Exposure
information
in
other
countries
is
not
available.

1.10
ADDITIONAL
REMARKS
A.
Options
for
disposal
(
Mode
of
disposal
(
e.
g.,
incineration,
release
to
sewage
system,
etc.)
for
each
category
and
type
of
use,
if
appropriate;
recycling
possibility)

Remarks:
The
substance
can
be
incinerated
at
quite
low
temperatures
(
300
°
C),
but
is
photooxidised
to
phosphoric
acid
and
methyl
amine
in
sunlight.
Reference:

B.
Other
remarks
Remarks:
No
studies
located
Reference:
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
9
2.
PHYSICAL­
CHEMICAL
DATA
*
2.1
MELTING
POINT
(
if
more
than
one,
identify
the
recommended
value)

(
a)
Preferred
result
Value:
=
139
°
C
Decomposition:
Yes
[
]
No
[
X]
Ambiguous
[
]
Sublimation:
Yes
[
]
No
[
X]
Ambiguous
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
usd))
Other
GLP:
Yes
[
]
No
[
]
?
[
X]
Remarks:
Substance
used
for
the
measurement
is
described
in
1.1
C.,
purity
82%.
Result
is
the
mean
of
12
determinations
by
differing
methods
Reference:
University
of
Michigan,
1982
(
b)
Value:
=
137.5
°
C
Decomposition:
Yes
[
]
No
[
X]
Ambiguous
[
]
Sublimation:
Yes
[
]
No
[
X]
Ambiguous
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used)
OECD
TG
102
(
1981)
GLP:
Yes
[
]
No
[
]
?
[
X]
Remarks:
Substance
used
for
the
measurement
is
described
in
1.1
C.,
purity
82%.
Reference:
Monsanto,
1987
*
2.2
BOILING
POINT
(
if
more
than
one,
identify
the
recommended
value)

(
a)
Preferred
result
Value:
=
198
°
C
Pressure:
at
30.6
hPa
Decomposition:
Yes
[
]
No
[
X]
Ambiguous
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used)
)
Other
GLP:
Yes
[
]
No
[
]
?
[
X]
Remarks:
Substance
used
for
the
measurement
is
described
in
1.1
C.,
purity
82%
Reference:
Monsanto,
1987
(
b)
Value:
=
296
°
C
Pressure:
at
.
.
.
.
.
.
.
hPa
(
approx
atmospheric)
Decomposition:
Yes
[
]
No
[
X]
Ambiguous
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
TG
103
(
modified)
(
1981)
GLP:
Yes
[
]
No
[
]
?
[
X]
Remarks:
Substance
used
for
the
measurement
was
"
ABCDE",
purity
was
not
stated,
but
believed
to
be
82%
Extrapolation
from
higher
pressures
Reference:
University
of
Michigan,
1982
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
10
*
2.3
DENSITY
(
Relative
density)
(
Where
applicable,
indicate
the
relative
density
of
the
substance)

Type:
Bulk
density
[
];
Density
[
];
Relative
Density
[
X]
Value:
1.02
kg/
m3
Temperature:
20
°
C
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used)
OECD
TG
109
(
1981)
GLP:
Yes
[
X]
No
[
]
?
[
]
Remarks:
.......................................................................................................................................
Reference:
Monsanto,
1992
*
2.4
VAPOUR
PRESSURE
(
if
more
than
one,
identify
the
recommended
value)

Value:
=
0.004
hPa
Temperature:
60
°
C
Method:
calculated
[
];
measured
[
X]
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used)
OECD
TG
104
(
1981)
GLP:
Yes
[
]
No
[
]
?
[
X]
Remarks:
Purified
substance
(
98%)
used
Reference:
Albright
&
Wilson,
1986
*
2.5
PARTITION
COEFFICIENT
log10Pow
(
if
more
than
one,
identify
the
recommended
value)

Log
Pow:
=
2.49
Temperature:
20
°
C
Method:
calculated
[
X];
measured
[
]
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used)
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
Based
on
calculations
in
MedChem
database,
USA
Reference:
.......................................................................................................................................

*
2.6
WATER
SOLUBILITY
(
if
more
than
one,
identify
the
recommended
value)

A.
Solubility
(
a)
Preferred
result
Value:
234
­
240
mg/
l
Temperature:
25
°
C
Description:
Miscible[
];
Of
very
high
solubility
[
];
Of
high
solubility
[
];
Soluble
[
];
Slightly
soluble
[
];
Of
low
solubility
[
X];
Of
very
low
solubility
[
];
Not
soluble
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used):
OECD
TG
105
(
1981)
GLP:
Yes
[
]
No
[
]
?
[
X]
Remarks:
Solvent
extraction.
Range
of
5
tests
Reference:
Jones,
A.
Z
and
Roberts,
P.
Q,
1991
(
b)
Value:
456.9
mg/
l
Temperature:
50
°
C
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used)
Other
GLP:
Yes
[
]
No
[
X]
?
[
]
Remarks:
HPLC
method
Reference:
DoE
laboratory
report,
1989
B.
pH
Value,
pKa
Value
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
11
(
a)
Preferred
result
pH
Value:
=
5.6,
measured
Concentration:
200
mg/
l
Temperature:
Not
stated
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used)
Other
GLP:
Yes
[
]
No
[
]
?
[
X]
(
Where
applicable,
enter
values
for
the
dissociation
constant(
s)
and
the
conditions
under
which
they
were
measured.)
pKa
value
=
3.9
calculated
at
25
°
C
Remarks:
Measurement
method
of
pH
is
not
stated,
but
assumed
to
be
hydrogen
electrode.
pKa
calculated
from
Henderson
equation;
temp.
=
20
°
C
Reference:
Jones,
A.
Z
and
Roberts
P.
Q,
1991
(
b)
pH
Value:
=
6,
measured
Concentration:
"
saturated"
aqueous
solution
Temperature:
25
°
C
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used):
Other
GLP:
Yes
[
]
No
[
]
?
[
X]
(
Where
applicable,
enter
values
for
the
dissociation
constant(
s)
and
the
conditions
under
which
they
were
measured.)
pKa
value
Not
given
Remarks:
Measurement
method
is
not
stated,
but
assumed
to
be
pH
papers
"
saturated"
assumed
to
be
approx.
250
mg/
l
Reference:
Bozetto,
1981
2.7
FLASH
POINT
(
liquids)

Value:
.
.
.
.
.
.
.
.
.
°
C
Type
of
test:
Closed
cup
[
];
Open
cup
[
];
Other
[
]
Method:
(
with
the
year
of
publication
or
updated
of
the
method
used)
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
Not
tested.
Substance
is
a
solid
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
12
2.8
AUTO
FLAMMABILITY
(
solid/
gases)

Value:
.
.
.
.
.
.
.
.
.
°
C
Pressure:
.
.
.
.
.
.
.
.
.
hPa
Method:
(
with
the
year
of
publication
or
updated
of
the
method
used)
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
No
studies
located
Reference:
.......................................................................................................................................

2.9
FLAMMABILITY
Results:
Extremely
flammable
[
];
Extremely
flammable
­
liquified
gas
[
];
Highly
Flammable
[
];
Flammable
[
];
Non
flammable
[
];
Spontaneously
flammable
in
air
[
];
Contact
with
water
liberates
highly
flammable
gases
[
];
Other
[
]
Method:
(
with
the
year
of
publication
or
updated
of
the
method
used)
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
No
studies
located,
but
not
expected
from
the
structure
to
be
flammable
Reference:
.......................................................................................................................................

2.10
EXPLOSIVE
PROPERTIES
Results:
Explosive
under
influence
of
a
flame[
];
More
sensitive
to
friction
than
m­
dinitrobenzene
[
];
More
sensitive
to
shock
than
m­
dinitrobenzene
[
];
Not
explosive
[
];
Other
[
]
Method:
(
with
the
year
of
publication
or
updated
of
the
method
used)
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
No
studies
located,
but
not
expected
from
structure
to
be
explosive
Reference:
.......................................................................................................................................

2.11
OXIDIZING
PROPERTIES
Results:
Maximum
burning
rate
equal
or
higher
than
reference
mixture
[
];
Vigorous
reaction
in
preliminary
test
[
];
No
oxidizing
properties
[
];
Other
[
]
Method:
(
with
the
year
of
publication
or
updated
of
the
method
used)
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
No
studies
located,
but
not
expected
from
structure
to
have
oxidizing
properties
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
13
*
2.12
OXIDATION:
REDUCTION
POTENTIAL
(
Where
applicable,
indicate
the
redox
potential
and
the
conditions
under
which
it
was
measured.)

Value:
12.75
±
0.04
mV
Method:
(
with
the
year
of
publication
or
updated
of
the
method
used)
Electroanalytical
GLP:
Yes
[
]
No
[
]
?
[
X]
Remarks:
Result
taken
from
international
reference
book
Reference:
Handbook
of
Chemistry
&
Physics,
1985
2.13
ADDITIONAL
DATA
A.
Partition
co­
efficient
between
soil/
sediment
and
water
(
Kd)

Value:
.......................................................................................................................................
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Remarks:
No
studies
located
Reference:
.......................................................................................................................................

B.
Other
data
(
e.
g.,
Henry's
law
constant,
fat
solubility,
surface
tension
(
of
aqueous
solution),
adsorption/
desorption
on
soil,
particle
size
distribution
etc.)

Results:
No
studies
located
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
14
3.
ENVIRONMENTAL
FATE
AND
PATHWAYS
(
Reporting
of
studies
should
give
the
test
method,
test
conditions
(
laboratory
versus
field
studies),
test
results
(
e.
g.,
%
degradation
in
specified
time
period)
and
reference.
Information
on
breakdown
products
(
transient
and
stable)
should
be
provided
when
available.)

3.1
STABILITY
*
3.1.1
PHOTODEGRADATION
(
a)
Type:
Air
[
X
];
Water
[
];
Soil
[
];
Other
[
]
Light
source:
Sun
light
[
];
Xenon
lamp
[
];
Other
[
]
Light
spectrum:
.
.
.
.
.
.
.
.
.
.
nm
Relative
intensity:
.
.
.
.
.
.
.
.
.
.
(
based
on
intensity
of
sunlight0
Spectrum
of
substance:
(
e.
g.
lambda
(
max.)[>
295nm]
and
epsilon[
max]
or
epsilon
[
295nm])
.
.
.
.
.
.
.
.
.
.
nm
Concentration
of
Substance:
........................................................................................................................
Temperature:
.
.
.
.
.
.
.
.
.
.
°
C
Direct
photolysis:
Half
life:
.
.
.
.
.
.
.
.
.
.
Degradation:
.
.
.
.
.
.
.
.
.%
(
weight/
weight)
after
.
.
.
.
.
.
.
.
.
.
(
exposure
time)
Quantum
yield:
.
.
.
.
.
.
.
.
.
.
Indirect
Photolysis:
Type
of
sensitizer:
OH
Concentration
of
sensitizer:
.
.
.
.
.
.
.
.
.
.
Rate
constant
(
radical):
.
.
.
.
.
.
.
.
.
.
cm3/
molecule*
sec
Degradation:
50%
after
7
­
8.8
hour
Method:
calculated
[
X
];
measured
[
]
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
Other
(
calculated,
according
to
Atkinson
1986)
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
Substance
grade,
purity:
not
specified.
Remarks:
Half­
life
(
7
­
8.8
hour)
is
calculated
based
on
measured
values
of
reaction
rate
constants
with
OH­
radicals,
(
55*
10­
12)
molecules­
1
s­
1
(
1),
43.7*
10­
12
molecules­
1
s­
1
(
2).

Reference:
(
1)
Atkinson,
R.,
1986.
(
2)
Witte,
F.
and
Zetsch,
C.,
1988
(
b)
Type:
Air
[
];
Water
[
X
];
Soil
[
];
Other
[
]
Light
source:
Sun
light
[
];
Xenon
lamp
[
];
Other
[
]
Light
spectrum:
.......................................................................................................................................
Relative
intensity:
.......................................................................................................................................
Spectrum
of
substance;
(
e.
g.
lambda
(
max.)[>
295nm]
and
epsilon[
max]
or
epsilon
[
295nm])
.......................................................................................................................................
Concentration
of
Substance:
....................................................................................................................................
Temperature:
.
.
.
.
.
.
.
.
.
.
°
C
Direct
photolysis:
Half
life:
.......................................................................................................................................
Degradation:
.
.
.
.
.
.
.
.
.
.
%
(
weight/
weight)
after
.
.
.
.
.
.
.
.
.
.(
exposure
time)
Quantum
yield:
.......................................................................................................................................
Indirect
Photolysis:
Type
of
sensitizer:
...............................................................................................................................
Concentration
of
sensitizer:
........................................................................................................................
Rate
constant
(
radical):
.
.
.
.
.
.
.
.
.
.
.
.
cm3/
molecule*
sec
Degradation:
.
.
.
.
.
.
.
.
.
.
%
after
.
.
.
.
.
.
.
.
.
.
.
(
exposure
period)
Method:
calculated
[
X
]
measured
[
]
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
Other,
Not
specified.
(
Based
on
Photolysis
in
water
by
using
Hg­
lamp
(
253
nm))
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
15
GLP:
Yes
[
]
No
[
]
?
[
X
]
Test
substance:
as
prescribed
by
1.1­
1.4,
purity:
=
82%
Remarks:
Data
on
Half­
life
is
not
available.
Formation
of
Cl­,
CO2,
CO
and
methylene
chloride
were
observed.
pH
of
the
test
solution
is
not
specified.
Reference:
Baxter,
J.
N.
and
Johnson,
F.
J.,
1968
*
3.1.2
STABILITY
IN
WATER
Type:
Abiotic
(
hydrolysis)
[
X
];
biotic
(
sediment)[
]
Half
life:
2.8
min
at
pH
not
specified
at
40
°
C
Degradation:
.
.
.
.
.
.
.
at
pH
.
.
.
.
.
.
.
at
.
.
.
.
.
.
.
°
C
after
.
.
.
.
.
.
(
exposure
time)
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
Other,
Not
specified
GLP:
Yes
[
]
No
[
]
?
[
X
]
Test
substance:
as
prescribed
by
1.1­
1.4,
purity:
=
82%
Remarks:
(
e.
g.
CAS
number,
name
and
percentage
of
degradation
products)
CH3COOH
and
CH3OH
are
formed
as
a
result
of
hydrolysis.
The
rate
Reference:
The
Condensed
Chemical
Dictionary,
1981.

3.1.3
STABILITY
IN
SOIL
Type:
Field
trial
[
];
Laboratory
[
X];
Other
[
]
Radiolabel:
Yes
[
X
]
No
[
]
?
[
]
Concentration:
0.1
mg/
kg
Soil
temperature:
25
°
C
Soil
humidity:
75%
of
field
capacity
Soil
classification:
DIN19863
[
];
NF
X31­
107
[
];
USDA
[
];
Other
[
X
]
year
.
.
.
.
.
.
.
.
.
Content
of
clay
etc.:
Clay
30%,
Silt
50%,
Sand
20%
Organic
Carbon:
1.0
%
Soil
pH:
6.9
Cation
exchange
capacity:
25
m
mol/
kg
Microbial
biomass:
...............................................................................................................................
Dissipation
time:
DT
50:
3
days
DT
90:
>
50
days
Dissipation:
10
%
after
1
day,
37%
after
2
days,
60%
after
4
days
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
TG
304A
(
1981)
GLP:
Yes
[
]
No
[
]
?
[
X
]
Test
substance:
as
prescribed
by
1.1­
1.4,
purity:
=
82%
Remarks:
...............................................................................................................................
Reference:
XYZ
Corporation,
1988
*
3.2
MONITORING
DATA
(
ENVIRONMENT)

Note
that
Data
on
Biological
Effects
Monitoring
including
Biomagnification,
and
Biotransformation
and
Kinetics
in
Environmental
Species
is
to
be
reported
in
section
4.7
and
4.8
respectively.
Nonetheless
concentration
in
various
biota
should
be
reported
here.
Data
on
concentration
in
the
work
place
or
indoor
environment
should
be
reported
under
item
5.11.

(
a)
Type
of
Measurement:
Background
[
X
];
At
contaminated
site
[
];
Other
[
]
Media:
Air
Results:
ND
(
ND
=
Not
detected,
Detection
limits:
0.5
mg/
m
3,)
in
17
areas
in
Japan
in
1990
Remarks:
.......................................................................................................................................
Reference:
Environment
Agency
of
Japan,
1977
and
1992
(
b)
Type
of
Measurement:
Background
[
X
];
At
contaminated
site
[
];
Other
[
]
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
16
Media:
Surface
water
Results:
ND
­
0.028
(
Detection
limits:
0.01­
0.2
mg/
l)
in
23
areas
in
Japan
in
1976,
ND
­
0.058
(
Detection
limits:
0.02
mg/
l)
in
16
areas
in
Japan
in
1990
Remarks:
.......................................................................................................................................
Reference:
Environment
Agency
of
Japan,
1977
and
1992
(
c)
Type
of
Measurement:
Background
[
X
];
At
contaminated
site
[
];
Other
[
]
Media:
Surface
water
Results:
0.01
­
0.05
mg/
l
in
5
samples
in
1989,
see
4.7
Remarks:
.......................................................................................................................................
Reference:
XYZ
Institute,
1991
(
d)
Type
of
Measurement:
Background
[
X
];
At
contaminated
site
[
];
Other
[
]
Media:
Soil
Results:
ND
­
0.018
(
Detection
limits:
0.0002­
0.0016
mg/
l)
in
23
areas
in
Japan
in
1976
Remarks:
.......................................................................................................................................
Reference:
Environment
Agency
of
Japan,
1977
and
1992
(
e)
Type
of
Measurement:
Background
[
X
];
At
contaminated
site
[
];
Other
[
]
Media:
Sediment
Remarks:
ND
(
Detection
limits:
0.02
mg/
g)
in
19
areas
in
Japan
in
1990
Reference:
Environment
Agency
of
Japan,
1977
and
1992
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
17
(
f)
Type
of
Measurement:
Background
[
X
];
At
contaminated
site
[
];
Other
[
]
Media:
Biota
(
specify
species)
Remarks:
ND
­
0.0046
(
Detection
limits:
0.002
mg/
g)
in
18
areas
in
Japan
in
1990,
mussel
and
bar
were
used
for
the
research.
Reference:
Environment
Agency
of
Japan,
1977
and
1992
(
g)
Type
of
Measurement:
Background
[
];
At
contaminated
site
[
];
Other
[
]
Media:
Surface
water
and
food
Remarks:
No
data
located.
Reference:
.......................................................................................................................................

3.3
TRANSPORT
AND
DISTRIBUTION
BETWEEN
ENVIRONMENTAL
COMPARTMENTS
INCLUDING
ESTIMATED
ENVIRONMENTAL
CONCENTRATIONS
AND
DISTRIBUTION
PATHWAYS
(
e.
g.
during
the
chemical
life­
cycle).
The
information
should
indicate
whether
the
calculation
is
on
a
global
basis
or
is
site­
specific,
and
whether
it
is
based
on
laboratory
measurements
or
field
observations.)

*
3.3.1
TRANSPORT
Type:
Adsorption
[
X
]:
Desorption
[
];
Volatility
[
]:
Other
[
]
Media:
Water­
Soil
Method:
OECD
TG
106
Results:
Adsorption
coefficient
19.0
l/
kg
Remarks:
Compound
ABCDE
in
10
ml
aquaous
solytion
was
suspendid
with
2.5
g
silt
loam
(
1.2
%
o.
m.;
pH
6.7).
Suspensions
shaken
for
24
hr.
Adsorption
coefficients
calcualted
using
Freundlich
equation
(
1/
n:
0.9;
Koe:
1580)
Reference:
XYZ
Corporation,
1992.

*
3.3.2
THEORETICAL
DISTRIBUTION
(
FUGACITY
CALCULATION)

Media:
Air­
biota
[
];
Air­
biota­
sediment­
soil­
water
[
X];
Soil­
biota
[
];
Water­
air
[
];
Water­
biota
[
];
Water­
soil
[
];
Other
[
]
Method:
Fugacity
level
I
[
X];
Fugacity
level
II
[
];
Fugacity
level
III
[
];
Fugacity
level
IV
[
];
Other
(
calculation)
[
];
Other
(
measurement)[
]
Generic
Model
of
OECD
(
FUGMOD,
1992)
Results:
70.7
%
to
Air
28.8
%
to
Water
0.11
%
to
Sediment
0.49
%
to
Soil
0.000028
%
to
Biota
(
Fish)
0.0037
%
to
Suspended
Solid
in
Water
Remarks:
The
Global
Reference
model
of
OECD
Existing
Chemicals
Programme
was
used
for
calculation.
Default
values
for
the
environmental
parameters
were
not
changed.
Water
solubility
230mg/
l,
vapour
pressure
0.004
hPa
and
Pow
2.49
were
used
for
the
calculation.
Reference:
OECD
Secretariat,
1992
a
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
18
3.4
IDENTIFICATION
OF
MAIN
MODE
OF
DEGRADABILITY
IN
ACTUAL
USE
Results:
No
studies
located.
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

*
3.5
BIODEGRADATION
Type:
aerobic
[
X
];
anaerobic
[
]
Inoculum:
adapted
[
];
non­
adapted
[
X
];
activated
sludge,
30
mg/
l
as
suspended
solid
Concentration
of
the
chemical:
100
mg/
l
related
to
COD
[
];
DOC
[
];
Test
substance
[
X
];
Medium:
water
[
X
];
water­
sediment
[
];
soil
[
];
sewage
treatment
[
]
Degradation:
(
percentage
reduction/
exposure
time)
2.5
%
after
7
days
(
based
on
BOD)
2.4
%
after
14
days
(
based
on
BOD)
4
%
after
14
days
(
based
on
DOC)
3
%
after
14
days
(
based
on
HPLC
analysis)
Results:
(
see
OECD
Guidelines)
Readily
biodeg.
[
];
Inherently
biodeg.
[
];
under
test
condition
no
biodegradation
observed
[
X
],
Other
[
]
Kinetic
(
e.
g.
Zahn­
Wellens­
Test)
.
.
.
.
.
.
.
.
.
.
%
in
.
.
.
.
.
.
.
.
.
.
.
(
time)
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
TG
301C
(
1992)
GLP:
Yes
[
X
]
No
[
]
?
[
]
Test
substance:
As
prescribed
by
1.1
­
1.4,
purity:
>
99%
Remarks:
(
In
the
case
of
poorly
soluble
chemicals,
treatment
given
(
nature,
concentration,
CAS
number,
name
and
percentage
of
degradation
products
etc.)):
The
results
indicate
that
the
chemical
is
not
readily
biodegradable.
Concentration
of
activated
sludge
and
that
of
the
chemical
are
30
mg/
l
and
100
mg/
l
respectively
as
shown
in
the
TG.
The
chemical
was
analyzed
by
HPLC.
Reference:
Chemical
Inspection
and
Testing
Institute
of
Japan,
1992
3.6
BOD5,
COD
OR
RATIO
BOD5/
COD
BOD5
Method:
Other
(
1960)
Concentration:
3
mg/
l
related
to
COD
[
];
DOC
[
];
Test
substance
[
X
];
Value:
=
0.66
mg
O2/
l
GLP:
Yes
[
]
No
[
]
?
[
X
]

COD
Method:
Other
(
1960)
Value:
=
2.31
mg
O2/
g
GLP:
Yes
[
]
No
[
]
?
[
X
]
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
19
Ratio
BOD5/
COD:
0.286
Remarks:
Methods
used
followed
those
given
in
the
11th
Edition
of
Standard
Methods
for
the
Examination
of
Water
and
Wastewater,
1960
The
seed
material
used
for
BOD
testing
was
filtered
437
Secondary
Effluent
(
effluent
form
the
Midland
plant
of
the
Michigan
Division
general
wastewater
treatment
system.)

Reference:
XYZ
Corporation
(
1992)

3.7
BIOACCUMULATION
(
a)
Species:
Pimephales
promelas
(
Fathead
minnow)
Exposure
period:
28
days
Temperature:
18
°
C
Concentration:
ca.
1
mg/
l
BCF:
17.7
±
5.2
(
Steady
state)
Elimination:
Yes
[
X
]
No
[
]
?
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
Guideline
305E
(
1981)
Type
of
test:
[
]
calculated;
[
X
]
measured
static
[
];
semi­
static
[
];
flow­
through
[
X
];
other
(
e.
g.
field
test)
[
]
GLP:
Yes
[
]
No
[
]
?
[
X
]
Test
substance:
Synthesised
for
the
test,
purity:>
99%,
radio­
labelled
by
using
14
C
Remarks:
4
weeks
exposure
to
test
material
followed
by
2
weeks
depuration.
The
mean
BCF
increased
slowly
after
1
week
exposure
and
reached
a
plateau
with
an
average
BCF
of
24
after
2­
3
weeks.
Following
incubation
in
pure
dilution
water
a
rapid
decrease
of
BCF
values
based
on
whole
body,
wet
weight.
Half
life
was
ca.
3
days.
BIOFAC
computer
model
is
used
for
calculation
of
BCF.
Reference:
Steber
J.
and
Wierich
P.,
1987
(
b)
Species:
Cyprinus
carpio
(
Carp)
Exposure
period:
8
weeks
Temperature:
25
°
C
Concentration:
20
mg/
l
and
2
mg/
l
BCF:
362­
636
(
20
mg/
l,
Steady
state)
357­
718
(
2
mg/
l,
Steady
state)
Elimination:
Yes
[
]
No
[
]
?
[
X
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
OECD
Guideline
305C
(
1992)
Type
of
test:
[
]
calculated;
[
X
]
measured
static
[
];
semi­
static
[
];
flow­
through
[
X
];
other
(
e.
g.
field
test)
[
]
GLP:
Yes
[
]
No
[
]
?
[
X
]
Test
substance:
Substance
grade,
purity:>
99%,
Remarks:
Stock
solution
of
the
test
substance
was
prepared
by
using
40
times
weight
of
Ethyl
alcohol
of
the
test
substance.
Reference:
Chemical
Inspection
and
Testing
Institute
of
Japan,
1992
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
20
3.8
ADDITIONAL
REMARKS
A.
Sewage
treatment
(
information
on
treatability
of
the
substance)

Results:
Waste
water
containing
ABCDE
can
be
treated
with
NH3,
NH4
+
salts
or
amines
which
split
off
NH3
at
reaction
temperature.
After
these
treatments,
the
suspended
solids
will
be
separated.
Remarks:
.......................................................................................................................................
Reference:
Hazardous
Substance
Data
Base,
1992
B.
Other
information
(
information
that
will
help
to
focus
the
exposure
assessment
(
either
qualitative
or
quantitative)

Results:
No
studies
located
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
21
4.
ECOTOXICOLOGICAL
DATA
*
4.1
ACUTE/
PROLONGED
TOXICITY
TO
FISH
Type
of
test:
static
[
];
semi­
static
[
];
flow­
through
[
X
];
other
(
e.
g.
field
test)
[
]
open­
system
[
X
];
closed­
system
[
]
Species:
Oncorhynchus
mykiss
Walbaum
(
Rainbow
trout)
Exposure
period:
96
hr
Results:
LC50
(
24h)
=
2.3
mg/
l
LC50
(
48h)
=
1.5
mg/
l
LC50
(
96h)
=
1.5
mg/
l
NOEC
=
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
mg/
l
Analytical
monitoring:
Yes
[
X
]
No
[
]
?
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
TG
203
(
1992)
GLP:
Yes
[
X
]
No
[
]
?
[
]
Test
substance:
As
prescribed
by
1.1
­
1.4,
purity:
=
82%
Remarks:
Groups
of
ten
rainbow
trout
were
exposed
to
mean
analyzed
treatment
levels
of
0.20,
0.33,
0.56,
0.94,
1.7
and
3.1
mg/
l
active
ingredient
(
a.
i.),
DMF
(
N,
Ndimethylformamide
controls
and
laboratory
water
controls.
The
LC50
(
96h)
was
determined
to
be
1.5
mg/
l
with
a
95
%
confidence
level
of
0.94
to
3.1
mg/
l.
Reference:
Weinberg,
J.
T.,
et.
al.,
1991
4.2
ACUTE
TOXICITY
TO
AQUATIC
INVERTEBRATES
*
A.
Daphnia
Type
of
test:
static
[
X
];
semi­
static
[
];
flow­
through
[
];
other
(
e.
g.
field
test)
[
];
open­
system
[
];
closed­
system
[
X
]
Species:
Daphnia
Magna
Straus
Exposure
period:
48­
hr
Results:
EC50
(
24h)
=
1.85
mg/
l
EC50
(
48h)
=
2.13
mg/
l
ECxx
(..
h)
=
.
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
mg/
l
Analytical
monitoring:
Yes
[
X
]
No
[
]
?
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
TG
202
(
1984)
GLP:
Yes
[
X
]
No
[
]
?
[
]
Test
substance:
As
prescribed
by
1.1­
1.4,
purity:
=
82%
Remarks:
Thirty
daphnids
(
3
replicates;
10
organisms
per
replicate)
were
exposed
to
analyzed
treatment
level
of
0.87,
1.27,
2.14,
4.25,
8.44
and
15.9
mg/
l.
A
DMF
control
and
daphnid
water
control
were
also
included.
95%
confidence
levels
for
48
hr
EC50
were
1.13
to
4.56
mg/
l
.
Reference:
Milazzo,
D.
P.,
Servinski,
M.
F.
and
Rick,
D.
L.,
1992
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
22
B.
Other
aquatic
organisms
Type
of
test:
static
[
];
semi­
static
[
];
flow­
through
[
];
other
(
e.
g.
field
test)
[
];
open­
system
[
];
closed­
system
[
]
Species:
.......................................................................................................................................
Exposure
period:
.......................................................................................................................................
Results:
EC50
(
24h)
=
.
.
.
.
.
.
mg/
l
EC50
(
48h)
=
.
.
.
.
.
.
mg/
l
ECxx
(..
h)
=
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
.
.
mg/
l
Analytical
monitoring:
Yes
[
]
No
[
]
?
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
.......................................................................................................................................
GLP:
Yes
[
]
No
[
]
?
[
]
Test
substance:
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.,
purity:............................................................................
Remarks:
No
studies
located
Reference:
.......................................................................................................................................

*
4.3
TOXICITY
TO
AQUATIC
PLANTS
e.
g.
Algae
Species:
Selenastrum
capricornutum
Printz
End­
point:
Biomass
[
X
];
Growth
rate
[
X
];
Other
[
]
Exposure
period:
72
hours
Results:
Biomass:
EC50
(
24h)
=
14.3
mg/
l
EC50
(
72h)
=
14.1mg/
l
NOEC
=
3.3
mg/
l
LOEC
=
.
.
.
.
.
.
.
mg/
l
Growth:
EC50
(
24h)
=
11.7
mg/
l
EC50
(
72h)
=
8.8
mg/
l
NOEC
=
not
calculated
LOEC
=
.
.
.
.
.
.
.
mg/
l
Analytical
monitoring:
Yes
[
X
]
No
[
]
?
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
TG
201
(
1984)
open­
system
[
];
closed­
system
[
X
]
GLP:
Yes
[
X
]
No
[
]
?
[
]
Test
substance:
As
prescribed
by
1.1
­
1.4,
purity:
>
99%
Remarks:
Static
test.
The
EC50
values
for
biomass
(
total
cell
count/
ml)
and
for
growth
rate
(%
inhibition)
were
calculated
based
on
nominal
concentrations.
Chemical
analysis
show
that
94%
to
133%
(
mean,
114%)
of
added
ABCDE
remained
in
the
solution
after
72
hours.
Reference:
Milazzo,
D.
P.
and
Servinski,
M.
F.,
1991
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
23
4.4
TOXICITY
TO
BACTERIA
(
Single
species
tests
and
tests
on
overall
processes
such
as
nitrification
or
soil
respiration
are
included
in
this
item.)

Type:
Aquatic
[
X
];
Field
[
];
Soil
[
];
Other
[
]
Species:
Activated
Sludge
Exposure
Period:
.
.
.
.
.
.
.
.
.
.
.
Results:
EC10
(
3
h)
=
490.5
mg/
l
EC50
(
3
h)
=
>
1,000
mg/
l
EC100
(
3
h)
=
>>
1,000
mg/
l
Analytical
monitoring:
Yes
[
X
]
No
[
]
?
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
Directive
88/
302/
EEC,
Part
C,
Respiration
inhibition
Test
(
1986)
GLP:
Yes
[
]
No
[
]
?
[
X
]
Test
substance:
as
prescribed
by
1.1­
1.4,
but
purified;
purity:
>=
99%
Remarks:
ABCDE
was
added
directly
to
diluent
water.
No
toxic
effects
were
observed
for
saturated
solution.
Measured
concentrations
were
83­
106
%
of
nomincal
concentration.
Reference:
XYZ
Corporation,
1987.

4.5
CHRONIC
TOXICITY
TO
AQUATIC
ORGANISMS
4.5.1.
CHRONIC
TOXICITY
TO
FISH
(
effects
on
reproduction,
embryo/
larva
etc.)

Type
of
test:
static
[
];
semi­
static
[
];
flow­
through
[
X
];
other
(
e.
g.
field
test)
[
];
open­
system
[
X
];
closed­
system
[
]
Species:
Pimephales
promelas
(
Fathead
Minnow)
End­
point:
Length
of
fish
[
];
Weight
of
fish
[
];
Reproduction
rate
[
];
Other
[
]
Exposure
period:
274
days
Results:
Mortality:
LC50
(..
d)
=
.
.
.
.
.
.
.
mg/
l
LCxx
(..
d)
=
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
mg/
l
Growth:
EC50
(
274
d)
=
0.50
mg/
l
(
incl.
Reproduction)
ECxx
(...
d)
=
.
.
.
.
.
.
.
mg/
l
NOEC
=
0.15
mg/
l
LOEC
=
0.25
mg/
l
Analytical
monitoring:
Yes
[
X
]
No
[
]
?
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
TG
204
(
1984)
GLP:
Yes
[
X
]
No
[
]
?
[
]
Test
substance:
Substance
grade
,
purity:
>
99%
Remarks:
EC50
(
274
d)
was
calculated
for
weight
of
young
fish
and
reproduction
rate
of
two
generations
(
F0
and
F1).
Analytical
monitoring
of
the
concentrations
of
the
chemical
was
carried
out
during
the
test
period.
ABCDE
(
no
solvent
used)
was
tested
at
5
concentrations
(
0.075
­
1.5
mg/
l)
in
tapwater
(
pH:
7.4,
hardness:
130
mgCaCO3
/
l).
Flow
rate
equivalent
to
5
replacements/
day.
NOEC,
LOEC
(
both
at
p
<
0.05)
and
EC50
values
based
on
nominal
concentrations.
Measured
concentrations
were
86­
97
%
of
nominal
concentrations.
Mean
measured
concentrations
were
used
for
the
determination
of
EC50.
Reference:
Springborn
Laboratories,
U.
S.,
1992
(*)
4.5.2.
CHRONIC
TOXICITY
TO
AQUATIC
INVERTEBRATES
(
e.
g.
daphnia
reproduction.
The
need
to
conduct
tests
for
this
end­
point
will
depend
inter
alia
upon
concern
for
long
term
effects.)

Type
of
test:
static
[
];
semi­
static
[
X
];
flow­
through
[
];
other
(
e.
g.
field
test)
[
];
open­
system
[
X];
closed­
system
[
]
Species:
Daphnia
Magna
Strauss
End­
point:
Mortality
[
X
];
Reproduction
rate
[
X
];
Other
[
X
]
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
24
Exposure
period:
21
day
Results:
Immobility:
EC50
(
48
h)
>
2.67
mg/
l
EC50
(
21
d)
=
2.48
mg/
l
NOEC
=
1.18
mg/
l
LOEC
=
1.78
mg/
l
Mortality:
LC50
(
48
h)
>
2.67
mg/
l
LC50
(
21
d)
=
1.94
mg/
l
NOEC
=
0.31
mg/
l
LOEC
=
0.61
mg/
l
Reproduction:
EC50
(
21
d)
=
1.10
mg/
l
NOEC
=
1.18
mg/
l
LOEC
=
1.78
mg/
l
Growth:
EC50
(
21
d)
>
2.67
mg/
l
NOEC
=
1.78
mg/
l
LOEC
=
2.68
mg/
l
Analytical
monitoring:
Yes
[
X
]
No
[
]
?
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
Test
Guideline
202
(
1984)
GLP:
Yes
[
X
]
No
[
]
?
[
]
Test
substance:
As
prescribed
by
1.1­
1.4;
purity:
=
82%
Remarks:
ABCDE
(
solvent:
acetone
at
<
0.1ml/
l)
was
tested
at
5
concentrations
(
0.25­
2.5
mg/
l)
in
dechlorinated
pond
water
(
pH:
7.9;
hardness:
200
mg
CaCO3/
l).
LC50,
NOEC
and
LOEC
are
based
on
concentration
adjusted
to
100%
active
ingredient.
Renewal
each
day.
NOEC,
LOEC
(
both
at
p
<
0.05)
and
EC50
values
based
on
measured
concentrations.
Mean
maesured
concentrations
were
24­
29
%
below
nominal
ones.
Less
than
10%
mortality
in
control
and
solvent
control.
Reference:
Milazzo,
D.
P.,
Servinski,
M.
F.,
Rick,
D.
L.
and
Martin
M.
D.
(
1992)

4.6
TOXICITY
TO
TERRESTRIAL
ORGANISMS
4.6.1
TOXICITY
TO
SOIL
DWELLING
ORGANISMS
Type:
Artificial
soil
[
];
Filter
paper
[
];
Other
[
X
]
Species:
Eisenia
foetida
(
Worm
(
Annelida))
End­
point:
Mortality
[
X
];
Weight
[
];
Other
[
]
Exposure
period:
14
day
Results:
LC50
(
7d)
=
685
mg/
kg
LC50
(
14d)
=
668
mg/
kg
(
dry
weight
of
substance)
LCxx
(..
d)
=
.
.
.
.
.
.
mg/
kg
NOEC
=
316
mg/
kg
LOEC
=
562
mg/
kg
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
TG
207
(
1984)
GLP:
Yes
[
]
No
[
]
?
[
X
]
Test
substance:
As
prescribed
by
1.1­
1.4,
purity:
=
82%
Remarks:
Nominal
concentrations.
Analytical
monitoring
was
not
carried
out.
Following
soil
was
used
for
the
test;
Soil
type:
Clay
20%,
Silt
50%,
Sand
30%,
Soil
pH:
6.5,
Contents
of
organic
matter
4%,
Cation
exchange
capacity
4
me/
100g,
Microbial
biomass:
not
measured.
Reference:
XYZ
corporation,
1990.

4.6.2
TOXICITY
TO
TERRESTRIAL
PLANTS
(
a)
Species:
Oryza
sativa
(
Rice,
Toyonishiki)
End­
point:
Emergence
[
X
];
Growth
[
X
];
Other
[
]
Exposure
period:
14
day
Results:
EC50
and/
or
LC50
(
7d)
=
>
100
mg/
l
EC50
and/
or
LC50(
14d)
=
>
100
mg/
l
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
25
ECxx
and/
or
LCxx
(
xxd)
=
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
mg/
l
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
Test
Guideline
208
(
1984)
GLP:
Yes
[
]
No
[
X
]
?
[
]
Test
substance:
As
prescribed
by
1.1­
1.4,
purity:
=
82%
Remarks:
EC50
for
Growth
inhibition
and
LC50
for
germination
are
expressed
as
nominal
concentration
adjusted
to
100%
active
ingredient.
The
substance
is
practically
insoluble.
Following
soil
was
used
for
the
test;
Soil
type:
Clay
20%,
Silt
50%,
Sand
30%,
Soil
pH:
6.5,
Contents
of
organic
matter
4%,
Cation
exchange
capacity
4
meq/
100g
dry
soil,
Microbial
biomass:
not
measured.
Reference:
Environment
Agency
of
Japan,
1991
(
b)
Species:
Brassica
rapa
(
Turnip,
Hikari)
End­
point:
Emergence
[
X
];
Growth
[
X
];
Other
[
]
Exposure
period:
14
day
Results:
EC50
and/
or
LC50
(
7d)
=
>
100
mg/
l
EC50
and/
or
LC50(
14d)
=
>
100
mg/
l
ECxx
and/
or
LCxx
(
xxd)
=
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
mg/
l
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
Test
Guideline
208
(
1984)
GLP:
Yes
[
]
No
[
X
]
?
[
]
Test
substance:
As
prescribed
by
1.1­
1.4,
purity:
=
82%
Remarks:
C50
for
Growth
inhibition
and
LC50
for
germination
are
expressed
as
nominal
concentration
adjusted
to
100%
active
ingredient.
The
substance
is
practically
insoluble.
Following
soil
was
used
for
the
test;
Soil
type:
Clay
20%,
Silt
50%,
Sand
30%,
Soil
pH:
6.5,
Contents
of
organic
matter
4%,
Cation
exchange
capacity
4
meq/
100g
dry
soil,
Microbial
biomass:
not
measured.
Reference:
Environment
Agency
of
Japan,
1991
(
c)
Species:
Lactuca
sativa
(
Lettuce,
Top
mark)
End­
point:
Emergence
[
X
];
Growth
[
X
];
Other
[
]
Exposure
period:
14
day
Results:
EC50
and/
or
LC50
(
7d)
=
>
100
mg/
l
EC50
and/
or
LC50(
14d)
=
>
100
mg/
l
ECxx
and/
or
LCxx
(
xxd)
=
.
.
.
.
.
.
.
mg/
l
NOEC
=
.
.
.
.
.
.
.
mg/
l
LOEC
=
.
.
.
.
.
.
.
mg/
l
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
Test
Guideline
208
(
1984)
GLP:
Yes
[
]
No
[
X
]
?
[
]
Test
substance:
As
prescribed
by
1.1­
1.4,
purity:
=
82%
Comments:
EC50
for
Growth
inhibition
and
LC50
for
germination
are
expressed
as
nominal
concentration
adjusted
to
100%
active
ingredient.
The
substance
is
practically
insoluble.
Following
soil
was
used
for
the
test;
Soil
type:
Clay
20%,
Silt
50%,
Sand
30%,
Soil
pH:
6.5,
Contents
of
organic
matter
4%,
Cation
exchange
capacity
4
meq/
100g
dry
soil,
Microbial
biomass:
not
measured.
Reference:
Environment
Agency
of
Japan,
1991
4.6.3
TOXICITY
TO
OTHER
NON
MAMMALIAN
TERRESTRIAL
SPECIES
(
INCLUDING
AVIAN)

Species:
Conturnix
conturnix
End­
point:
Mortality
[
];
Reproduction
rate
[
];
Weight
[
];
Other
[
X
]
Exposure
period:
28
days
Results:
LDxx
or
LCxx
(
xxd)
=
.
.
.
.
.
.
.
mg/
kg
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
26
NOEC
=
5
mg/
kg
food
LOEC
=
.
.
.
.
.
.
.
mg/
kg
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
TG
206
(
1984)
GLP:
Yes
[
X
]
No
[
]
?
[
]
Test
substance:
purity:
>
98%
Remarks:
Quails,
4­
5
weeks
old,
were
tested
at
5
concentrations
(
1.5
to
50
mg/
kg
food).
No
effects
on
survival,
body
weight
and
egg­
laying
rate
were
observed.
Blood
and
brain
cholinesterase
activities
were
significantly
affected
(
p
<
0.05)
at
concentrations
>=
15
mg/
kg
food.
Reference:
Schafer,
E.
W.
et
al.,
(
1985).
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
27
4.7
BIOLOGICAL
EFFECTS
MONITORING
(
INCLUDING
BIOMAGNIFICATION)
(
Studies
on
variation
of
predominant
species
in
certain
ecosystems
(
e.
g.
mesocosm)
and
monitoring
of
biological
effects
are
included.)

Results
Substance:
ABCDE
Species
or
ecosystem
studied:
Mytilus
edulis
(
common
mussel)
in
5
points
in
coastal
region.
Effects
monitored:
Concentration
of
the
substance
in
the
body
and
malformation
of
the
shell.
Results:
The
range
of
concentration
in
the
body
was
0.06
­
0.75
ppm
in
1989
which
is
almost
the
same
as
the
results
in
1987.
Malformation
of
the
shell
was
not
observed.
Chemical
analysis:
ABCDE
was
analyzed
by
using
Atomic
Absorption
Analysis.
Remarks:
(
Information
on
environmental
conditions
(
e.
g.
water
characteristics:
suspended
matter,
pH,
temperature,
hardness.
Soil/
sediment
characteristics:
%
organic
matter,
clay
content.)
Concentration
of
the
chemical
in
surface
water
where
the
organism
were
gathered
is
presented
in
3.2.

Reference
XYZ
Institute,
1991
4.8
BIOTRANSFORMATION
AND
KINETICS
(
Under
this
item,
studies
on
absorption,
distribution,
metabolism
and
excretion
etc.
should
be
given.)

Type:
Animal
[
];
Aquatic
[
];
Plant
[
];
Terrestrial
[
];
Other
[
]
Results:
No
studies
located
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

4.9
ADDITIONAL
REMARKS
Results:
No
studies
located
Remarks:
Reference:
.......................................................................................................................................
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
28
5.
TOXICITY
(
Where
observations
on
humans
are
available
these
should
be
entered
in
the
appropriate
"
Comments"
section
or
under
section
5.11)

*
5.1
ACUTE
TOXICITY
5.1.1
ACUTE
ORAL
TOXICITY
(
a)
Preferred
Result
Type:
LD0
[
];
LD100
[
];
LD
50
[
X
];
LDL0
[
];
Other
[
]
Species/
strain:
Rat
(
Wistar)
Value:
=
500
(
mg/
kg):
Discriminating
dose:
N/
A
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
401.
1981
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
Commercial,
purity:
96.5%
Remarks:
Administered
at
0,
250,
500,
or
750
mg/
kg
in
corn
oil
by
oral
gavage.
Apathy,
reeling,
dyspnoea,
cyanosis,
incoordination,
ataxia,
reduced
mobility,
and
prostration
in
the
500
and
750
mg/
kg
groups.
The
surviving
animals
recovered
within
2
to
3
days
of
administration.
Dissection
revealed
gastro­
intestinal
irritation
and
residues
of
the
substance
in
the
abdominal
cavity
and
a
"
yellowish
brown"
liver.
Reference:
Brutus
el
al.,
1986.

(
b)
Type:
LD0
[
];
LD100
[
];
LD
50
[
X
];
LDL0
[
];
Other
[
]
Species/
strain:
Mouse
(
strain
and
sex
not
given)
Value:
<=
750
mg/
kg
Discriminating
dose:
N/
A
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
Other
GLP:
Yes
[
]
No
[
]
?
[
X]
Test
substance:
Substance
grade
and
purity
not
stated
Remarks:
Mice
were
administered
0,
750,
or
1500
mg/
kg
by
gavage.
Convulsions
and
body
tremors
were
observed
in
both
treatment
groups.
All
mice
died
in
the
high
1500
mg/
kg
group.
Old
study
with
poor
study
design.
Vehicle
and
recovery
period
not
stated.
Reference:
Jacks
et
al.,
1974
5.1.2
ACUTE
INHALATION
TOXICITY
(
a)
Preferred
Result
Type:
LC0
[
];
LC100
[
];
LC50
[
X
];
LCL0
[
];
Other
[
]
Species/
strain:
Rat
(
Wistar)
Exposure
time:
4
hours
Value:
>
750
mg/
m3
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
402
(
1987)
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
Commercial,
purity:
96.5%
Remarks:
Exposed
to
0,
250,
500,
or
750
mg/
m3
There
were
no
deaths.
Signs
of
poisoning
were
reduced
motility,
slight
to
moderate
dyspnoea,
and
moderate
irritation
of
the
eyes,
nose,
pharynx
and
snout.
The
symptoms
had
subsided
1
hour
after
exposure.
On
dissection,
macroscopically
slight
haemorrhages
were
found
in
the
lungs.
Reference:
Ajax
et
al.,
1989.

(
b)
Type:
LC0
[
];
LC100
[
];
LC50
[
X
];
LCL0
[
];
Other
[
]
Species/
strain:
Mouse
(
strain
and
sex
not
given)
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
29
Exposure
time:
.......................................................................................................................................
Value:
Not
stated
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
Other
GLP:
Yes
[
]
No
[
]
?
[
X]
Test
substance:
Grade
and
purity
not
stated.
Remarks:
Exposure
for
8­
hr
to
0,
750,
or
1500
mg/
m3
At
1500
mg/
m3
respiratory
rate
was
decreased
by
over
50%.
No
further
details
are
given.
The
quality
of
this
study
cannot
be
properly
evaluated
as
experimental
details
are
not
documented.
Reference:
Smyth
et
al.,
1976.

5.1.3
ACUTE
DERMAL
TOXICITY
(
a)
Preferred
Result
Type:
LD0
[
];
LD100
[
];
LD
50
[
X
];
LDL0
[
];
Other
[
]
Species/
strain:
Rabbit
(
New
Zealand
white)
Value:
650
(
mg/
kg
b.
w.)
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
403
(
1981)
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
Commercial,
purity:
96.5%
Comments:
None
Remarks:
0,
250,
500,
or
750
mg/
kg
applied
in
corn
oil.
Symptoms
of
systemic
poisoning
and
deaths
occurred
in
the
750
mg/
kg
group.
Moderate
irritant
effects
developed
at
the
application
site
in
the
250
and
500
mg/
g
groups.
Reference:
Moreno,
1987.

(
b)
Type:
LD0
[
];
LD100
[
];
LD
50
[
X
];
LDL0
[
];
Other
[
]
Species/
strain:
Guinea
pig
(
strain
and
sex
not
given)
Value:
Not
reported
(
mg/
kg
b.
w.)
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
Other
GLP:
Yes
[
]
No
[
]
?
[
X]
Test
substance:
Substance
grade
and
purity
not
stated.
Remarks:
Guinea
pigs
(
number
not
stated)
had
0
or
1250
mg/
kg
applied
to
their
skin.
Moderate
skin
irritation
occurred
but
vehicle
used,
application
method
and
washing
are
not
documented.
No
mention
of
any
deaths.
Study
details
are
inadequate
to
properly
evaluate
this
study.
Reference:
Luck
et
al.,
1978.

5.1.4
ACUTE
TOXICITY,
OTHER
ROUTES
OF
ADMINISTRATION
(
e.
g.
subcutaneous,
intravenous
etc.)

Type:
LC0
[
];
LC100
[
];
LC50
[
];
LCL0
[
];
Other
[
]
LD0
[
];
LD100
[
];
LD
50
[
X
];
LDL0
[
];
Other
[
]
Species/
strain:
Rats
(
strain,
sex
and
number
not
given)
Route
of
Administration:
i.
m.
[
];
i.
p.
[
];
i.
v.
[
X
];
infusion
[
];
s.
c.
[
];
other
[
]
Exposure
time:
N.
A.
Value:
<
1500
mg/
kg
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
Other
GLP:
Yes
[
]
No
[
X]
?
[
]
Test
substance:
Substance
grade
not
stated,
purity:
unknown
Remarks:
Rats
were
administered
a
single
dose
of
1500
mg/
kg
i.
v.
All
the
rats
died
within
five
minutes
after
administration
Reference:
Jacksson
et
al.,
1974
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
30
5.2
CORROSIVENESS/
IRRITATION
5.2.1
SKIN
IRRITATION/
CORROSION
(
a)
Preferred
Result
Species/
strain:
Rabbit
(
New
Zealand
White)
Results:
Highly
corrosive
[
];
Corrosive
[
];
Highly
irritating
[
X
];
Irritating
[
];
Moderate
irritating
[
];
Slightly
irritating
[
];
Not
irritating
[
]
Classification:
(
If
possible,
according
to
EC
Directive
67/
548/
EEC)
Highly
corrosive
(
causes
severe
burns)
[
];
Corrosive
(
caused
burns)
[
];
Irritating
[
];
Not
irritating
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
404
(
1992)
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
Commercial,
purity:
96.5%
Remarks:
Single
application
of
500
mg/
kg
in
corn
oil
Severe
irritation
with
reddening,
oedema
and
scar­
formation
(
irritation
index
measured
as
6.75
on
a
scale
of
0
to
8)
Reference:
Clayton
et
al.,
1987
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
31
(
b)
Species/
strain:
Rabbit
(
New
Zealand
White)
Results:
Highly
corrosive
[
];
Corrosive
[
];
Highly
irritating
[
X
];
Irritating
[
];
Moderate
irritating
[
X
];
Slightly
irritating
[
];
Not
irritating
[
]
Classification:
(
If
possible,
according
to
EC
Directive
67/
548/
EEC)
Highly
corrosive
(
causes
severe
burns)
[
];
Corrosive
(
caused
burns)
[
];
Irritating
[
];
Not
irritating
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
Other,
under
occlusion.
GLP:
Yes
[
]
No
[
]
?
[
X]
Test
substance:
Grade
and
purity
not
documented
Remarks:
Single
application
of
2.6
g/
kg
to
intact
or
abraded
skin
for
24
hr
Reference:
Moreno,
1967
5.2.2
EYE
IRRITATION/
CORROSION
(
a)
Preferred
results
Species/
strain:
Rabbit
(
New
Zealand
White)
Results:
Highly
corrosive
[
];
Corrosive
[
];
Highly
irritating
[
X
];
Irritating
[
];
Moderate
irritating
[
X
];
Slightly
irritating
[
];
Not
irritating
[
]
Classification:
(
If
possible,
according
to
EC
Directive
67/
548/
EEC)
Irritating
[
];
Not
irritating
[
];
Risk
of
serious
damage
to
eyes
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
OECD
405
(
1987)
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
Commercial,
purity:
96.5%
Remarks:
500
mg/
l
instilled
in
a
solution
of
50%
corn
oil.
Moderately
severe
symptoms
of
irritation
of
the
cornea,
iris
and
conjunctiva
(
irritation
index
28.59
on
a
scale
of
0
to
110)
Reference:
Carpenter
et
al.,
1988.

(
b)
Species/
strain:
Rat
(
strain
and
sex
not
given)
Results:
Highly
corrosive
[
];
Corrosive
[
];
Highly
irritating
[
X
];
Irritating
[
];
Moderate
irritating
[
X
];
slightly
irritating
[
];
not
irritating
[
]
Classification:
(
If
possible,
according
to
EC
Directive
67/
548/
EEC)
Irritating
[
];
Not
irritating
[
];
Risk
of
serious
damage
to
eyes
[
];
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
Other
GLP:
Yes
[
]
No
[
]
?
[
X]
Test
substance:
Substance
grade
and
purity
not
stated.
Remarks:
Instillation
of
one
drop
of
a
12.5,
25
or
50%
solution
in
oil
(
no
further
details)
or
of
undiluted
substance.
The
25
and
50%
solution
or
undiluted
chemical
produced
reddening
and
swelling
of
the
conjunctiva,
lacrimation
and
mucous
secretion,
but
there
was
no
damage
to
the
cornea.
Recovery
occurred
within
8
to
96
hours,
depending
on
the
concentration.
The
12.5%
solution
caused
no
signs
of
irritation.
Original
study
is
not
available
Reference:
Chemical
Abstracts,
1987.

5.3
SKIN
SENSITISATION
(
a)
Type:
Maximisation
Species/
strain:
Rabbit
(
New
Zealand
White)
Results:
Sensitizing
[
X
];
Not
sensitizing
[
];
ambiguous
[
]
Classification:
(
If
possible,
according
to
EC
Directive
67/
548/
EEC)
Sensitizing
[
];
Not
sensitizing
[
]
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
32
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
Similar
to
OECD
406
GLP:
Yes
[
]
No
[
X]
?
[
]
Test
substance:
Commercial,
purity:
96.5%
Remarks:
No.
of
animals
with
skin
reaction
at
challenge:
Treated:
4/
10
Control
group:
0/
10
The
chemical
is
classified
as
a
moderate
skin
sensitizer
Reference:
Kligman,
1966.

(
b)
Type:
Patch
Test
Species/
strain:
Human
Results:
Sensitizing
[
X
];
Not
sensitizing
[
];
ambiguous
[
]
Classification:
(
If
possible,
according
to
EC
Directive
67/
548/
EEC)
Sensitizing
[
];
Not
sensitizing
[
]
Method:
(
e.
g.
OECD,
other
(
with
the
year
of
publication
or
updated
of
the
method
used))
Other
GLP:
Yes
[
]
No
[
X]
?
[
]
Test
substance:
Commercial,
purity:
96.5%
Remarks:
In
an
attempt
to
induce
sensitization
using
the
maximization
procedure,
29
volunteers
were
given
five
48­
hr
covered
patch
tests
(
over
a
10­
day
period)
with
4%
in
petrolatum.
The
attempt
was
unsuccessful
since
none
of
the
subjects
gave
local
reactions
when
challenged
10­
14
days
after
the
induction
phase
by
a
final
48­
hr
covered
patch
test
with
the
4%
petrolatum
mixtures.
Reference:
Kligman,
1966;
Kligman
&
Epstein,
1975;
Epstein,
1976.
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
33
*
5.4
REPEATED
DOSE
TOXICITY
(
a)
Species/
strain:
Rat
(
Wistar)
Sex:
Female
[
];
Male
[
];
Male/
Female
[
X
];
No
data
[
]
Route
of
Administration:
oral
feed
Exposure
period:
28
days
Frequency
of
treatment:
7
days/
week
Post
exposure
observation
period:
14
days
Dose:
0,
125,
500
or
750
mg/
kg
(
10
animals
/
group)
Control
group:
Yes
[
X
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
X
];
Concurrent
vehicle
[
];
Historical
[
]
NOEL:
125
mg/
kg
LOEL:
.......................................................................................................................................
Results:
On
the
10th
day
a
slight
reddening
and
crusting
of
the
skin
was
evident.
The
body
weights
on
the
9th
and
10th
day,
and
the
relative
and
absolute
thymus
weights
on
the
28th
day,
were
significantly
(
p
£
0.05)
reduced.
There
were
no
effects
on
the
weights
of
the
heart,
liver,
spleen
or
kidneys,
the
levels
of
protein,
albumin,
and
a1­,
ß1­
and
gamma­
globulin
contents
in
the
serum,
or
the
activity
of
alanine
aminotransferase
in
the
serum.
Histologically,
the
following
effects
on
organs
were
observed
in
the
500
and
750
mg/
kg
groups
as
compared
with
controls:
Liver
Histiocytic
and
inflammatory
granulomas,
peripheral
fine­
droplet
fatty
degeneration
Lungs
Interstitial
pneumonia,
bronchiectasis,
severe
round­
cell
bronchitis
Kidneys
Epithelial­
cell
necrosis,
cysts,
basophilic"
balloon
nuclei"
Heart
Inter­
and
intracellular
oedema,
necrobiotic
muscle
fibres,
interstitial
oedema
Testes
Interstitial
oedema,
reduced
spermiatogenesis
Thymus
Increased
"
colloidocytes"
Adrenals
Cortex
very
rich
in
lipids
Histochemical
investigation
of
the
liver
showed
raised
succinate­
dehydrogenase
activity
and
reduced
lactate
dehydrogenase
activity.
Tests
on
acid
phosphatase
and
non­
specific
a­
naphthylacetate
esterase
activity
and
on
fat
coloration
gave
no
indications
of
any
change.
Method:
OECD
412
(
1981)
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
Commercial,
purity:
96.5%
Reference:
Ganning
et
al.,
1987.

(
b)
Species/
strain:
Rat
(
Wistar)
Sex:
Female
[
];
Male
[
];
Male/
Female
[
];
No
data
[
X
]
Route
of
Administration:
oral
feed
Exposure
period:
10
days
Frequency
of
treatment:
...............................................................................................................................
Postexposure
observation
period:
........................................................................................................
Dose:
0,
500
or
1000
mg/
kg
(
5
animals
/
group)
Control
group:
Yes
[
X
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
];
Concurrent
vehicle
[
];
Historical
[
]
NOEL:
.......................................................................................................................................
LOEL:
.......................................................................................................................................
Results:
Significantly
increases
in
absolute
liver
weights,
levels
of
cytoplasmic
and
microsomal
epoxide
hydrolase,
glutathione­
S­
transferase
activity
and
also
cytoplasmic
and
microsomal
protein
content
in
the
liver
were
found,
all
at
a
p­
value
of
<
0.05
Method:
Other
GLP:
Yes
[
]
No
[
X]
?
[
]
Test
substance:
Commercial,
purity:
96.5%
Remarks:
5
rats
per
group
and
sex
received
0,
500
or
1000
mg/
kg
in
the
diet
for
10
days
followed
by
sacrifice.
Clinical
signs
were
recorded
and
at
sacrifice
gross
and
histopathological
examination
and
biochemical
tests
were
performed.
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
34
Reference:
Hammock
et
al.,
1977
(
c)
Species/
strain:
Rat
(
Wistar)
Sex:
Female
[
];
Male
[
];
Male/
Female
[
];
No
data
[
X
]
Route
of
Administration:
oral
feed
Exposure
period:
90
days
Frequency
of
treatment:
...............................................................................................................................
Postexposure
observation
period:
........................................................................................................
Dose:
0,
125,
500
or
750
mg/
kg
(
10
animals
/
group)
Control
group:
Yes
[
X
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
];
Concurrent
vehicle
[
];
Historical
[
]
NOEL:
.......................................................................................................................................
LOEL:
.......................................................................................................................................
Results:
Increased
relative
stomach
weights
occurred
in
males
in
the
500
and
125
mg/
kg/
day
groups.
No
effects
on
relative
and
absolute
testicular
weight
or
microscopic
lesions
were
observed.
Method:
OECD:
411
(
1981)
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
Commercial,
purity:
96.5%
Remarks:
.......................................................................................................................................
Reference:
Rhodes,
1987.

(
d)
Species/
strain:
Rat
(
Wistar)
Sex:
Female
[
];
Male
[
];
Male/
Female
[
X
];
No
data
[
]
Route
of
Administration:
gavage
Exposure
period:
90
days
Frequency
of
treatment:
...............................................................................................................................
Postexposure
observation
period:
........................................................................................................
Dose:
0,
25,
125,
250
or
500
mg/
kg/
day
(
3
animals
/
sex
/
group)
Control
group:
Yes
[
X
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
];
Concurrent
vehicle
[
];
Historical
[
]
NOEL:
125
mg/
kg
LOEL:
.......................................................................................................................................
Results:
Decreased
feeding
and
body
weight
occurred
in
animals
in
the
high
dose
group.
Cyanideinsensitive
palmitoyl­
CoA­
oxidation
was
induced
in
the
livers
of
both
sexes
in
the
250
and
500
mg/
kg/
day
groups.
Testicular
weights
were
normal.
Method:
Other
GLP:
Yes
[
]
No
[
]
?
[
X]
Substance:
Industrial,
purity:
80%
Remarks:
"
Limited
study"
with
three
rats
per
sex
per
group.
It
is
not
clear
whether
the
micropathological
examination
of
the
testes
was
conducted.
Reference:
Ota
et
al.,
1977.

(
e)
Species/
strain:
Rat
(
Wistar)
Sex:
Female
[
];
Male
[
];
Male/
Female
[
];
No
data
[
X
]
Route
of
Administration:
oral
feed
Exposure
period:
24
month
Frequency
of
treatment:
...............................................................................................................................
Postexposure
observation
period:
........................................................................................................
Dose:
0,
75,125
or
500
mg/
kg/
day
(.
.
.
.
.
.
.
animals
/
group)
Control
group:
Yes
[
X
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
];
Concurrent
vehicle
[
];
Historical
[
]
NOEL:
.
.
.
.
.
.
.
.
.
.
.
mg/
kg
LOEL:
.
.
.
.
.
.
.
.
.
.
.
mg/
kg
Results:
The
animals
given
500
mg/
kg
showed
signs
of
liver
and
kidney
damage.
The
absolute
and
relative
liver
weights
were
increased
in
both
sexes.
At
dissection,
the
livers
of
the
female
rats
were
hyperaemic
and/
or
swollen
and
degenerative
changes
were
evident
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
35
in
the
kidneys
of
the
males.
Histological
examination
revealed
slight
and
reversible
changes
to
the
liver
and
kidneys.
The
testes
were
scheduled
for
examination
but
the
results
are
not
documented.
Method:
Other
GLP:
Yes
[]
No
[
]
?
[
X]
Test
substance:
Commercial,
purity:
96,5%
Remarks:
Confirmation
that
no
effects
on
the
testes
occurred
is
being
sought.
See
also
"
Section
5.7"
Reference:
James
et
al.,
1978.

(
f)
Species/
strain:
Rat:
(
Crl:
CD
(
SD)
BR
VAF7
Plus
strain)
Sex:
Female
[
];
Male
[
];
Male/
Female
[
X
];
No
data
[
]
Route
of
Administration:
oral
Exposure
period:
4
and
6
weeks
Frequency
of
treatment:
...............................................................................................................................
Postexposure
observation
period:
..........................................................................................................................
Dose:
0,
500
or
1,000
mg/
kg/
day
(
10
animals
/
sex
/
group)
Control
group:
Yes
[
X
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
];
Concurrent
vehicle
[
];
Historical
[
]
NOEL:
1,000
mg/
kg
for
6
weeks
(
female)
500
mg/
kg
for
2
weeks
(
male)
LOEL:
.
.
.
.
.
.
.
.
.
.
.
mg/
kg
Results:
Signs
of
toxicity
were
not
observed
in
males.
Females
showed
no
signs
of
toxicity
during
premating
(
0­
2
weeks).
During
pregnancy
(
0­
20
days)
bodyweight
decreased
by
6­
9%
in
the
1,000
mg
×
kg­
1
×
day­
1
group.
Method:
OECD
Preliminary
Screening
Test
for
Reproductive
and
Repeated
Dose
Toxicity.
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
Industrial:
96.2%
Remarks:
"
General
toxicity"
or
effects
on
male
reproduction
were
not
observed.
Reference:
Powell,
1992.

*
5.5
GENETIC
TOXICITY
IN
VITRO
A.
BACTERIAL
TEST
(
a)
Type:
(
e.
g.
Bacterial
reverse
mutation
assay,
Bacterial
gene
mutation
study,
Cytogenetic
Assay
etc.)
Bacterial
reverse
mutation
assay
System
of
testing:
Species/
strain:
S.
typhimurium
TA
98,
TA
100,
TA
1535,
TA
1537,
TA
1538
Concentration:
0,
50,
250,
1000
or
5000
mg/
plate
Metabolic
activation:
With
[
];
Without
[
];
With
and
Without
[
X
];
No
data
[
]
Results:
Cytotoxicity
conc:
With
metabolic
activation:
1000
mg/
plate
Without
metabolic
activation:
1000
mg/
plate
Precipitation
conc:
>
5000
mg/
plate
Genotoxic
effects:
+
?
­
With
metabolic
activation:
[
X]
[
]
[
]
Without
metabolic
activation:
[
]
[
]
[
X]
Method:
OECD
471
(
1983)
GLP:
Yes
[
X]
No
[
]
?
[
]
Teat
substance:
Commercial,
purity:
96.5%
Remarks:
Procedure:
Pre­
incubation.
Plates/
test:
1
Activation
system:
Liver
S­
9
fraction
from
Aroclor
1254
pretreated
male
SD
rats
with
NADPH­
generating
system
Media:
Histidine
selective
No.
replicates:
2
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
36
Reference:
Kirby
et
al.,
1988.

(
b)
Type:
(
e.
g.
Bacterial
reverse
mutation
assay,
Bacterial
gene
mutation
study,
etc.)
Bacterial
reverse
mutation
assay
System
of
testing:
Species/
strain:
S.
typhimurium
TA
98,
TA
100,
TA
1535,
TA
1537,
TA
1538
Concentration:
0,
50,
250,
1000
or
5000
mg/
plate
Metabolic
activation:
With
[
];
Without
[
];
With
and
Without
[
X
];
No
data
[
]
Results:
Cytotoxicity
conc:
With
metabolic
activation:
Not
stated
Without
metabolic
activation:
Not
stated
Precipitation
conc:
Not
stated
Genotoxic
effects:
+
?
­
With
metabolic
activation:
[
]
[
X]
[
]
Without
metabolic
activation:
[
]
[
X]
[
]
Method:
Other
GLP:
Yes
[
]
No
[
]
?
[
X]
Test
substance:
Grade
and
purity
not
stated
Remarks:
Procedure:
Not
stated
Plates/
test:
Not
stated
Activation
system:
Liver
S­
9
fraction
from
Aroclor
1254
pretreated
male
SD
rats
with
NADPH­
generating
system
Media:
Histidine
selective
No.
replicates:
Not
stated
Test
of
little
use
in
assessment
Reference:
Carol
et
al.,
1988.

B.
NON­
BACTERIAL
IN
VITRO
TEST
Type:
(
e.
g.
Mammalian
cell
gene
mutation
assay,
Cytogenetic
Assay
etc.)
Cytogenetics
Assay
System
of
testing:
Species/
strain:
Human
lymphocytes
Concentration:
Incubated
with
0,
124,
500,
1000
or
2500
mg/
plate
Metabolic
activation:
With
[
];
Without
[
];
With
and
Without
[
X
];
No
data
[
]
Results:
Cytotoxicity
conc:
With
metabolic
activation:
1000
mg/
plate
Without
metabolic
activation:
500
mg/
plate
Precipitation
conc:
not
stated
Genotoxic
effects:
+
?
­
With
metabolic
activation:
[
X]
[
]
[
]
Without
metabolic
activation:
[
]
[
X]
[
]
Method:
OECD
473
(
1983)
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
Commercial,
purity
96.2%
dissolved
in
physiological
medium
Remarks:
Human
lymphocytes
cultured
in
vitro
were
used.
Fixation
time:
Minimum
of
at
least
2
hr.
Dose
levels:
100­
800
mg
×
ml­
1
Plates/
test:
2
Activation
system:
S­
9
fraction
from
the
liver
of
Aroclor
1254­
induced
male
SD
derived
rats
with
NADPH­
generating
system
Media:
RPMI
1640
medium
plus
10%
foetal
calf
serum
plus
phytohaemagglutinin
No.
replicates:
1
Reference:
Fischer,
1978.

5.6
GENETIC
TOXICITY
IN
VIVO
Type:
Micronucleus
assay
Species/
strain:
Mice;
B6
C3
F1
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
37
Sex:
Female
[
];
Male
[
];
Male/
Female
[
X
];
No
data
[
]
Route
of
Administration:
i.
p.
injection
Exposure
period:
.......................................................................................................................................

Doses:
0,
456
mg/
kg/
day
(
6
animals
/
sex
/
group)
Results:
Effect
on
mitotic
index
or
P/
N
ratio:
50%
increase
Genotoxic
effects:
+
?
­
[
X]
[
]
[
]
Method:
OECD
474
(
1983)
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
Commercial,
purity
96.2%
dissolved
in
medium
Remarks:
Micronucleus
test
(
erythrocytes):
single
i.
p.
injection
of
456
mg/
kg,
or
the
same
dose
twice
with
a
24­
hour
interval.
A
control
group
(
6
animals/
sex)
received
the
solvent
maize
oil,
and
a
positive
control
group
received
triethylene
melamine
(
TEM)
The
substance
has
the
potential
to
cause
mutagenic
events.
Reference:
Kirby
et.
al.,
1988
5.7
CARCINOGENICITY
Species/
strain:
Rat
(
Wistar)
Sex:
Female
[
];
Male
[
];
Male/
Female
[
X
];
No
data
[
]
Route
of
Administration:
oral
feed
Exposure
period:
24
months
Frequency
of
treatment:
...............................................................................................................................
Postexposure
observation
period:
........................................................................................................
Doses:
0,
75,
125
or
500
mg/
kg
(
50
animals
/
group)
Control
group:
Yes
[
X
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
X
];
Concurrent
vehicle
[
];
Historical
[
]
Results:
Carcinogenic
effects
were
not
observed.
The
animals
given
500
mg/
kg
showed
signs
of
liver
and
kidney
damage.
The
absolute
and
relative
liver
weights
were
increased
in
both
sexes.
At
dissection,
the
livers
of
the
female
rats
were
hyperaemic
and/
or
swollen
and
degenerative
changes
were
evident
in
the
kidneys
of
the
males.
Histological
examination
revealed
slight
and
reversible
changes
to
the
liver
and
kidneys.
The
testes
were
scheduled
for
examination
but
the
results
are
not
documented.
Method:
OECD
451
(
1981)
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
Commercial,
purity:
96.5%
Remarks:
Confirmation
that
no
affects
on
the
testes
occurred
is
being
sought.
See
also
"
Section
5.4"
Reference:
James
et
al.,
1978.

*
5.8
TOXICITY
TO
REPRODUCTION
(
a)
Type:
Fertility
[
];
One
generation
study
[
];
Two
generation
study
[
];
Other
[
X
]
Species/
strain: 
Rat
slc:
SD
Sex:
Female
[
];
Male
[
];
Male/
Female
[
X
];
No
data
[
]
Route
of
Administration:
gavage
Exposure
period:
Males
for
42
days;
females
from
14
days
before
mating
to
day
3
of
lactation.
Frequency
of
treatment:
...............................................................................................................................
Postexposure
observation
period:
........................................................................................................
Premating
exposure
period:
male:
.
.
.
.
.
.
.
.
.
.
.
.
.
.,
female:
.....................................................................
Duration
of
the
test:
.......................................................................................................................................
Doses:
0,
100,
300,
or
1000
mg/
kg
(
12
/
animals
/
sex/
group)
Control
group:
Yes
[
X
];
No
[
];
No
data
[
];
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
38
Concurrent
no
treatment
[
X
];
Concurrent
vehicle
[
];
Historical
[
]
NOEL
Parental:
=
100
mg/
kg/
day
NOEL
F1
Offspring:
=
1,000
mg/
kg/
day
NOEL
F2
Offspring:
N/
A
Results:
There
were
no
effects
on
mating,
fertility
and
oestrus
cycle
or
on
dams
during
the
lactation
period.
External
examination
of
pups
revealed
no
increase
in
appearance
of
abnormal
pups.
Body
weight
gain
of
pups
was
normal.
Stillborn,
dead
pups
and
pups
killed
at
day
4
showed
no
abnormal
gross
findings.
General
parental
toxicity:
see
section
5.4.
For
toxicity
to
offspring:
(
weights
of
litter,
postnatal
growth,
viability,
etc.)
.......................................................................................................................................
Method:
Combined
Repeated
Dose
and
Reprotox.
Screening
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
ABCDE
purity
99.15%
Remarks:
.......................................................................................................................................
Reference:
Unpublished
report
from
Biosafety
Research
Center,
(
An­
pyo
Center),
Japan.

(
b)
Type:
Fertility
[
];
One
generation
study
[
X
];
Two
generation
study
[
];
Other
[
]
Species/
strain:
Rat
(
Wistar)
Sex:
Female
[
];
Male
[
];
Male/
Female
[
X
];
No
data
[
]
Route
of
Administration:
oral
feed
Exposure
period:
.......................................................................................................................................
Frequency
of
treatment:
...............................................................................................................................
Postexposure
observation
period:
..........................................................................................................................
Premating
exposure
period:
male:
.
.
.
.
.
.
.
.
.
.,
female:
.............................................................................
Duration
of
the
test:
.......................................................................................................................................
Doses:
0,
250,
500
or
750
mg/
kg
(
24/
animals
/
sex/
group)
Control
group:
Yes
[
X
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
X
];
Concurrent
vehicle
[
];
Historical
[
]
NOEL
Parental:
=
250
mg/
kg/
day
NOEL
F1
Offspring:
<
250
mg/
kg/
day
NOEL
F2
Offspring:
N/
A
Results:
General
parental
toxicity:
9.8%
decreased
bodyweight
gain
for
females
given
750
mg/
kg
during
pregnancy.
This
was
not
associated
with
decreased
food
intake
or
decreased
energy
efficiency
compared
with
controls.
Effects
were
not
observed
in
the
other
dose
groups.
NOEL
=
500
mg/
kg
Repro.
toxicity
(
parental):
A
significant
number
of
resorptions
occurred
in
the
500
and
750
mg/
kg
groups.
Repro.
toxicity
(
offspring)
(
weights
of
litter,
postnatal
growth,
viability,
etc.):
Litter
weight
was
significantly
decreased
for
all
dose
groups
Method:
OECD
415
(
1983)
GLP:
Yes
[
X]
No
[
]
?
[
]
Test
substance:
Industrial:
purity:
82%
Remarks:
None
Reference:
.......................................................................................................................................

*
5.9
DEVELOPMENTAL
TOXICITY/
TERATOGENICITY
Species/
strain:
Rabbit,
strain
not
stated
Sex:
Female
[
X
];
Male
[
];
Male/
Female
[
];
No
data
[
]
Route
of
Administration:
gavage
Duration
of
the
test:
Sacrifice
on
the
20
days
Exposure
period:
12th
day
of
gestion
Frequency
of
treatment:
Single
oral
(
gavage)
administration
of
on
the
12th
day
of
gestation.
Doses:
100
or
550
mg/
kg
(
12
/
animals
/
group)
Control
group:
Yes
[
X
];
No
[
];
No
data
[
];
Concurrent
no
treatment
[
X
];
Concurrent
vehicle
[
];
Historical
[
]
NOEL
Maternal
Toxicity:
=
100
mg/
kg
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
39
NOEL
teratogenicity:
.......................................................................................................................................
Results:
Maternal
general
tox:
Decreased
maternal
feed
intake
in
the
500
mg/
kg
group,
NOEL:
100
mg/
kg
Pregnancy/
litter
data:
Resorptions
in
the
500
mg/
kg
group,
NOEL:
100
mg/
kg
Foetal
data:
All
pups
born
dead
in
the
500
mg/
kg
group
NOEL:
100
mg/
kg
Method:
Other
GLP:
Yes
[
]
No
[
X]
?
[
]
Test
substance:
Not
stated,
but
probably
commercial
grade
92%
Remarks:
The
effects
seen
require
a
good
deal
of
follow­
up
work
Reference:
.......................................................................................................................................

5.10
OTHER
RELEVANT
INFORMATION
A.
Specific
toxicities
Type:
(
neurotoxicity,
immunotoxicity
etc.)
.......................................................................................................................................
Results:
No
studies
located
Remarks:
.......................................................................................................................................
Reference:
.......................................................................................................................................

B.
Toxicodynamics,
toxicokinetics
Type:
(
Toxicodynamics,
toxicokinetics)
.......................................................................................................................................
Results:
No
studies
located
Remarks:
.......................................................................................................................................
References:
.......................................................................................................................................
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
40
*
5.11
EXPERIENCE
WITH
HUMAN
EXPOSURE
(
Describe
information
on
work
place
exposure
such
as
concentration
of
chemicals
in
the
work
place
or
indoor
environment
(
manufacturing,
maintenance
and
professional
use),
number
of
workers
(
in
ranges
for
each
situation),
frequency
and
duration
of
exposure,
if
available.
In
addition,
enter
details
of
effects
of
accidental
or
occupational
exposure,
epidemiological
and
clinical
studies,
case
reports,
etc.)
(
a)
Results:
Source:
Maintenance
Work
Number
of
Workers
exposed:
approx.
20
Frequency
and
duration
of
exposure:
3
times
per
day
for
15
min
each
Emission
estimated:
5
mg/
m3
Year:
1989
Remarks:
.......................................................................................................................................
Reference:
XYZ
Company
data,
1988
(
b)
Results:
No
reproductive
health
effects
on
women
exposed
to
ABCDE
in
their
working
place
is
reported.
Remarks:
Exposure
is
not
estimated
quantitatively.
Reference:
Unpublished
internal
report
of
XYZ
company
(
1990)
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
41
6.
REFERENCES
(
Indicate
the
name
of
the
book,
journal
etc.
where
the
study
appears;
volume;
page
numbers;
and
date
of
report
or
publication.
In
general
information
should
be
taken
from
primary
sources
and
quoting
from
secondary
references
such
as
a
review
article
should
be
avoided.
Where
appropriate
indicate
"
unpublished
report",
its
authors
and
their
affiliation.)

ACGIH,
Threshold
Limit
Values,
1987
Albright
&
Wilson
(
1986),
Report
apw/
43/
1986.

Atkinson,
R.
(
1986),
Tabellietre
Einzelbestimmeungen
organisher
Stoffe
in
der
Umwelt.
Research
Report
.

Baxter,
J.
N.
and
Johnson,
F.
J.,
(
1968),
Radiat.
Res.,
33,
303­
310.

Bozetto
(
1981),
Laboratory
report
23/
81.

Chemical
Inspection
and
Testing
Institute
of
Japan
(
1992),
Unpublished
Report.

Chemical
News,
10,
June
1990,
page
27
Danish
Product
Register,
1988
DoE
laboratory
report
(
1989),
23/
89.

Environment
Agency
of
Japan
(
1977
and
1992),
Chemicals
in
the
Environment:
Report
of
Environmental
Survey
and
Wildlife
Monitoring
of
Chemicals
Environment
Agency
of
Japan
(
1991),
Unpublished
Reports
on
Toxicity
of
ABCDE
to
Plants.

Handbook
of
Chemistry
&
Physics
(
1985),
66th
Ed,
p
479.

Hazardous
Substance
Data
Base
(
1992),
Online
searching
on
ABCDE.

Jones,
A.
Z
and
Roberts
(
1991),
P.
Q
Toxicological
Letters,
29,
110­
112.

Kirk­
Othmer,
1991,
p
76
Milazzo,
D.
P.
and
Servinski,
M.
F.(
1991),
ABCDE:
The
toxicity
to
the
Green
Alga,
Selenastrum
capricornutum
Milazzo,
D.
P.,
Servinski,
M.
F.
and
Rick,
D.
L.(
1992),
ABCDE:
Evaluation
of
the
Acute
Toxicity
to
the
Daphnid,
Daphnia
magna
Straus.
Unpublished
Report
of
XYZ
Corporation.

Milazzo,
D.
P.,
Servinski,
M.
F.,
Rick,
D.
L.
and
Martin,
M.
D.(
1992).
ABCDE:
Evaluation
of
the
Chronic
Toxicity
to
the
Daphnid,
Daphnia
magna
Straus.
Unpublished
Report
of
XYZ
Corporation.

Monsanto
(
1985),
internal
report
bp/
3.

Monsanto
(
1987),
Internal
report
MS/
mp
223.

Monsanto
(
1992),
Material
Safety
Data
Sheet.

OECD
Secretariat
(
1992
a),
The
Explanatory
Note
for
Diskette
of
the
Global
Reference
Model
OECD
Secretariat
(
1992
b),
The
Explanatory
Note
for
Diskette
of
the
Local
Reference
Models
Printz,
A.
1983
Unpublished
Report
of
XYZ
Corporation.
Schafer,
E.
W.
et
al;.(
1985),
Arch.
Environm.
Contam.
Toxicol.
12,
355­
382.
EXCH\
MANUAL\
96­
AN2.
DOC/
May
1996
42
Springborn
Labs.
U.
S.
(
1992),
ABCDE:
Chronic
toxicity
of
the
fathead
minnow
during
full
life­
cycle
exposure,
(
No.
92­
7­
4324)

Steber
J.
and
Wierich
P.
(
1987),
Chemosphere,
16(
6),
1323­
1337
The
Condensed
Chemical
Dictionary,(
1981),
10th
ed.
Gessener
G.
Hawley
editor,
Van
Nostrand
Teinhold
Company,
New
York,
6­
7.

University
of
Michigan
(
1982),
Report
entitled
"
Properties
of
chelating
agents",
page
23.

Weinberg,
J.
T.,
Richardson,
C.
H.,
Rick,
D.
L.
and
Mayes,
M.
A.(
1991),
ABCDE:
Evaluation
of
the
Acute
Toxicity
to
the
Rainbow
Trout,
Oncorhynchus
mykiss
Walbaum.
Unpublished
Report
of
XYZ
Corporation.

Witte,
F.
and
Zetsch,
C.
(
1988),
Messung
der
OH­
Geschwindigkeitskonstaten
der
Reaktionen
von
ausgewahlten
umweltrelevanten
Altstoffen.
Forschungsbericht,
Berlin.

XYZ
Corporation
(
1987),
ABCDE:
Toxicity
to
Bacteria,
Unpublished
report
(
No.
V
87­
514).

XYZ
Corporation
(
1988),
ABCDE:
Stability
in
Soil,
Unpublished
report
(
No.
V
88­
520).

XYZ
Corporation
(
1990),
ABCDE:
Toxicity
to
Soil
Dwelling
Organisms,
Unpublished
report
(
No.
V
90­
567).

XYZ
Corporation
(
1992),
ABCDE:
Calculation
for
Equilibrium
Constant,
Unpublished
report
(
No.
V
92­
150).

XYZ
Institute
(
1991),
The
report
on
Environmental
Survey
and
Wild
life
Monitoring
of
Chemicals
in
1989.
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
1
ANNEX
3
Synopsis
of
OECD
Test
Guidelines
for
Studies
Included
in
the
SIDS*

This
document
provides
a
summary
of
the
information
which
should
be
reported
for
specific
tests
of
the
Screening
Information
Data
Set
(
SIDS)
as
extracted
from
the
appropriate
OECD
Test
Guidelines.
It
is
not
intended
to
be
inclusive
or
exhaustive;
in
cases
of
uncertainty
over
the
interpretation
of
the
acceptability
of
a
study,
evaluators
should
consult
the
relevant
guideline
or
other
guidance
documents
such
as
the
following,
or
flag
the
issue
for
further
discussion
at
the
SIDS
review
process:

·
Quality
of
and
Access
to
Data
Used
to
Prepare
SIDS
Dossiers
(
Section
3.2);
·
Considerations
for
Developing
SIDS
Testing
Plans
(
Section
3.3);
·
Guidance
for
Meeting
the
SIDS
Requirements
(
The
SIDS
Guide)
(
Section
3.4);
and
·
Considerations
Concerning
Adequacy
of
Data
in
the
SIDS
(
Section
3.5).

Figures
in
[
]
correspond
to
the
data
elements
in
the
HEDSET
and
the
Revised
OECD
HPV
Form
1.

*
This
document
was
prepared
by
the
OECD
Secretariat
based
on
the
agreements
reached
in
the
OECD
Test
Guideline
and
the
Existing
Chemicals
Programme
up
to
April
1996.
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
2
1.
GENERAL
INFORMATION
Each
study
should
report
full
identity
and
the
necessary
references.

2.
PHYSICAL­
CHEMICAL
DATA
General
Considerations
Each
study
should
report:

­
full
identification
of
substance
tested
(
state,
structural
formula,
spectra,
purity,
impurities
stabilizers,
etc.
should
be
identified
as
completely
as
possible
including
percentage,
potential
impact
where
known,
indicating
sensitivity
of
tests
in
relation
to
impurities
and
their
potential
impact
on
health
or
the
environment).

Note:
In
SIDS
work,
tests
for
physical­
chemical
properties
should
be
conducted
in
principle
on
the
purified
substance
to
avoid
interference
form
impurities
etc.

­
methods:
apparatus,
procedure
employed,
sensitivity
and
accuracy
of
results,
use
of
reference
standards/
controls,
statistical
analysis,
any
limitations
or
difficulties.

Note:
In
SIDS
work,
when
a
standard
test
method
such
as
OECD
Test
Guideline
has
been
used,
the
method
should
be
identified
and
it
is
not
necessary
to
repeat
details
of
the
test
in
the
HEDSET
or
in
Revised
OECD
HPV
Form
1.

­
results:
all
results
and
all
information
relevant
to
interpretation
of
results.

Specific
Consideratoins
for
Individual
Data
Elements
[
2.1]
MELTING
POINT
Ref.
OECD
TG
102
­
m.
p.
or
melting
range
expressed
as
°
C;
­
mean
of
at
least
2
measurements
±
range
of
accuracy
of
method;
­
if
decomposition
occurs,
the
temperature
of
decomposition
should
be
stated;
for
viscous
liquids,
"
pour
point"
may
be
an
acceptable
alternative.

[
2.2]
BOILING
POINT
Ref.
OECD
TG
103
­
mean
of
at
least
2
measurements
±
b.
p.
or
b.
p.
range
expressed
as
°
C
at
a
given
pressure
(
KPa);
­
measured
values
corrected
to
standard
pressure;
­
if
substance
decomposes
before
boiling,
the
temperature
of
decomposition
should
be
stated.

[
2.3]
DENSITY
Ref.
OECD
TG
109
­
density
expressed
as
kg/
m
3,
preferably
at
20
°
C,
as
mean
of
at
least
2
measurements;
­
temperature
at
which
the
measurement
was
carried
out,
method
of
measurement
in
the
Test
Guideline,
physical
state
of
the
substance
should
be
reported.
[
2.4]
VAPOUR
PRESSURE
Ref.
OECD
TG
104
­
v.
p.
should
be
determined
for
at
least
3
temperatures
in
the
range
0­
50
°
C,
and
a
mean
v.
p.
expressed
as
Pascal
units
(
N/
m
2)
at
20
or
25
°
C.
This
value
should
preferably
be
experimental
but
may
be
interpolated
or
extrapolated
if
necessary;
­
transitions
(
change
of
state,
decomposition)
should
be
reported,
giving
temperature
at
which
the
change
occurs
at
atmospheric
pressure,
and
vapour
pressure
at
10
and
20
°
C
below
and
above
transition.
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
3
[
2.5]
PARTITION
COEFFICIENT
N­
OCTANOL/
WATERRef.
OECD
TG
107
and
117
­
results
expressed
as
log
Pow
at
°
C
(
measured
or
calculated,
Annex
of
TG
117
can
be
used
for
calculation.)
­
for
TG
107,
measurement
concentrations
in
both
phases
for
each
determination
(
suggest
12
concentrations
be
reported
(
duplicate
determinations
of
concentrations
in
n­
octanol
and
in
water
under
3
different
conditions)
­
for
TG
117,
average
retention
data
as
mean
of
at
least
2
measurements
be
reported
in
addition
to
details
on
fitted
regression
line,
calibration
methods,
deadtime
etc.
­
any
special
considerations
(
e.
g.
if
compound
is
surface
active,
dissociative,
insoluble
in
water,
metal
organic)

[
2.6.
A.]
WATER
SOLUBILITY
Ref.
OECD
TG
105
­
results
expressed
as
mg/
l
at
°
C,
at
least
2­
5
replicates/
trial,
full
test
report
should
include
calibration
data
for
the
chosen
method
and
the
readings
for
the
test
solutions;
­
nature
of
carrier
used
for
insoluble
compounds;
­
if
the
substance
is
insoluble
in
water
the
detection
limits
of
the
analytical
method
should
be
indicated.

[
2.6.
B.]
PH
VALUE
AND
PKA
VALUE
Ref.
OECD
TG
112
­
For
pKa,
results
expressed
as
pKa
at
°
C,
at
least
3
replicates/
trial.

­
Full
report
should
include
all
measured
data
and
statistical
parameters
used
for
the
calculation
of
pKa
in
addition
to
calibration
data
for
the
chosen
method.

[
2.12]
OXIDATION
­
REDUCTION
POTENTIAL
­
OECD
Test
Guideline
is
not
available
for
the
measurement.
However
where
applicable,
indicate
the
redox
potential
and
the
conditions
under
which
it
was
measured.

[
2.13.
A.]
ADSORPTION/
DESORPTION
TO
SOIL
Ref.
OECD
TG
106
­
Koc
at
°
C,
tests
should
be
made
for
3
soil
types,
at
least
2
replicates/
trial
at
one
concentration
in
the
screening
test
and
at
4
concentration
in
the
advanced
test.

­
Result
of
adsorption
test,
desorption
test
in
the
screening
test,
mass
balance
and
adsorption
isotherm
data
should
be
included
in
the
full
report.

3.
ENVIRONMENTAL
FATE
AND
PATHWAYS
[
3.1]
STABILITY
[
3.1.1]
PHOTODEGRADATION
Ref.
OECD
TG
113
­
For
SIDS,
estimation
is
sufficient.
However,
if
a
study
is
provided,
methods
used
to
measure
degradation
over
time
(
14
days)
should
be
discussed,
including
reference
standards
(
if
used),
temperature,
method
of
analysis,
sensitivity,
reproducibility
etc.

­
Results:
changes
observed
on
treated
sample
after
testing;
if
possible,
nature
of
decomposition
products.

[
3.1.2]
STABILITY
IN
WATER
(
HYDROLYSIS)
Ref.
OECD
TG
111
­
should
be
examined
at
pH
levels
likely
to
be
found
in
the
environment
(
pH
4­
9).

Test
Methods:
should
include
information
on
identity
and
purity
of
test
compound,
reference
standards,
control,
if
used;
detailed
test
procedures
including
test
medium,
temperature,
pH,
Buffer
for
each
set
of
experiments,
extraction
method
and
recovery
data
if
an
extraction
methods
is
used;
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
4
Results:
should
be
expressed
in
terms
of
half
life
(
t
½
)
in
days,
or
for
unstable
compounds
(
in
hours).

i)
Initial
Test
­
soluble
substances,
should
be
carried
out
at
50
°
C
for
5
days
to
indicate
stability
(
solubility
>
10
­
6
g/
l)
at
a
range
of
pH
(
4.0,
7.0,
9.0).

Results:
if
<
10%
hydrolysis
is
seen
after
5
days,
(
t1/
2
>
1
year)
the
product
is
considered
hydrologically
stable
and
no
further
testing
is
required.
If
the
substance
is
unstable
at
environmentally
relevant
temperatures,
e.
g.
if
t1/
2
<
1
day
at
25
°
C,
no
further
testing
is
required.

ii)
Further
testing
For
unstable
compounds
(
1
year
>
t1/
2
>
1
day
),
further
testing
at
2­
3
appropriate
temperatures
may
be
required.

[
3.3]
TRANSPORT
AND
DISTRIBUTION
BETWEEN
ENVIRONMENTAL
COMPARTMENTS
INCLUDING
ESTIMATED
ENVIRONMENTAL
CONCENTRATIONS
AND
DISTRIBUTION
PATHWAYS
­
Methods
for
estimating
environmental
concentrations
and
fate
are
presented
in
"
Guidance
for
Initial
Assessment
of
Environmental
Exposure",
"
Report
of
the
OECD
Workshop
on
the
Application
of
Simple
Models
for
Environmental
Exposure
Assessment
(
OECD
Monograph
No.
69)"
and
"
Compendium
of
Environmental
Exposure
Assessment
Methods
for
Chemicals"
(
OECD
Environment
Monograph
No.
27).
Diskettes
of
PC
programme
of
models
in
the
guidance
document
are
available
from
the
SIDS
Contact
Points
or
the
Secretariat
(
see
Section
4.3
of
this
Manual).

­
Calculation
of
distribution
by
a
Fugacity
Level
1
type
model
should
be
provided.
[
3.5]
BIODEGRADATION
­
Choice
of
testing
protocols
should
be
determined
by
physical­
chemical
properties
(
e.
g.,
solubility,
volatility)
and
structure
of
test
substances,
e.
g.,
­
for
soluble/
insoluble
substances
tests
based
on
dissolved
organic
carbon
(
DOC)
or
oxygen
depletion
and
carbon
dioxide
generation.
For
volatile
substances
a
closed
system
may
need
to
be
employed.

Methods:
­
All
methods
should
be
reported
including
rationale,
sensitivity
and
suitability
for
test
substance;
use
of
positive
reference
standards,
(
sterile)
controls;
calculation
of
degradation
curve,
statistical
analysis,
confidence
limits,
etc.;
­
for
poorly
soluble
test
substances,
the
nature
and
concentration
of
any
vehicles
(
solvents,
processes)
used
to
enhance
the
contact
between
test
substance
and
microorganisms
should
be
given.

Results:
­
The
biodegradation
curve
should
be
calculated
and
drawn,
the
experimental
values
showing
a
rate
(%)
of
degradation
over
time
(
e.
g.
28
days)
should
be
given.
­
If
a
reference
standard
is
used,
the
biodegradation
results
and
curve
should
be
presented.
­
Any
inhibition
of
the
degradation
bacteria
should
be
reported.
­
Positive
results:
60
%
degradation
(
of
theoretical
maxima)
in
28
days
based
on
oxygen
depletion
or
CO2
generation
tests,
or
70
%
for
tests
based
on
dissolved
organic
carbon
may
be
regarded
as
biodegradable.

4.
ECOTOXICITY
[
4.1]
ACUTE/
PROLONGED
TOXICITY
TO
FISH
ACUTE
TOXICITY
TO
FISH
Ref.
OECD
TG
203
Test
Substance:
complete
identification
including
vehicles
used
to
administer
(
e.
g.
solvents).

Test
Species:
numerous,
see
list
of
recommended
species
reference
OECD
Test
Guideline
203
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
5
Methods:
complete
description
of
test
procedure
used
(
e.
g.
static,
semi­
static,
flow
through
etc.)
including
water
quality
characteristics
(
pH,
dissolved
O2
concentration,
etc,)
preparation
of
stock,
test
solutions,
experimental
procedures,
etc.
­
preferably
should
involve
5
concentrations
of
test
solutions
in
geometric
series,
10
fish/
test
group
and
control.

Results:
­
maximum
concentration
causing
no
mortality
in
test
period
(
preferably
96hr.);
­
minimum
concentration
causing
100%
mortality;
­
cumulative
mortality
at
each
concentration
and
in
controls;
­
LC50
or
EC50
at
24,
48,
72,
and
96
hours
based
preferably
on
actual,
not
nominal,
concentrations
(
with
95
per
cent
confidence
limit
at
96hr);
­
statistical
procedures
used
for
determining
the
LC50
values;
­
any
incident
that
might
affect
results;
­
abnormal
responses
of
fish;
­
%
loss
of
concentration
over
the
experiment,
especially
for
poorly
soluble
substances
(
may
affect
calculation
of
LC50s).

[
4.2]
ACUTE
TOXICITY
TO
AQUATIC
INVERTEBRATES
A.
DAPHNIA
Ref.
OECD
TG
202
ACUTE
IMMOBILIZATION
TEST
Test
Substance:
complete
identification,
including
vehicles
used
to
administer
(
e.
g.,
solvents).

Test
Organism:
Daphnia
sp.
identified
by
species
strain,
source.

Methods:
­
complete
description
including
animal
maintenance
and
housing,
preparation
of
test
and
control
solutions,
physical
regime,
experimental
procedure
including
number
of
replicates;
­
at
lease
20
Daphnia,
not
more
than
24hrs
old,
should
be
used
in
groups
of
5
each,
tested
at
concentrations
in
a
geometric
series,
in
which
highest
concentration
causes
100%
immobilisation,
and
lowest
should
give
no
observable
effect.

Results:
­
number
and
%
of
Daphnia
showing
effects
at
24
and
48
hr
at
each
concentration
and
controls,
nature
of
effect
(
immobilisation,
mortality);
­
the
24h
and
48h
EC50,
preferably
with
95
per
cent
confidence
limits,
determined
by
a
suitable
method;
­
if
possible,
the
slope
of
the
concentration
response
curve
with
its
95
per
cent
confidence
limits;
­
the
highest
concentration
tested
producing
no
immobile
Daphnia;
­
the
lowest
tested
concentration
producing
100
per
cent
immobile
Daphnia
[
4.3]
TOXICITY
TO
AQUATIC
PLANTS
e.
g.
ALGAE
(
Alga
Growth
Inhibition
Test)
Ref.
OECD
TG
201
Test
Species:
various
species
of
fast
growing
green
algae
such
as
recognised
strains
of
Selenastrum
capricornutm,
Scenedesmus
subspicatus,
Chlorella
vulgaris.

Test
Substance:
full
chemical
description
including
vehicles
used
to
administer
(
e.
g.
solvents).

Methods:
­
complete
housing,
maintenance
and
test
procedures
and
conditions;
­
install
cell
concentration;
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
6
­
5
graded
concentrations
tested,
preferably
3
replicates,
with
highest
dose
inhibiting
growth
by
50­
100
%,
lowest
dose
at
no
observed
effect
relative
to
controls.

Results:
­
calculation
of
algal
growth
over
test
period
(
3
days)
­
e.
g.
mean
cell
concentration
at
24,
48,
72
hours
for
each
time
and
dose,
plotted
to
give
growth
curves;
­
EC50
and
method
of
calculation;
­
NOEC;
­
any
observed
adverse
or
unusual
effects.

[
4.5]
CHRONIC
TOXICITY
TO
AQUATIC
ORGANISM
[
4.5.2]
CHRONIC
TOXICITY
TO
AQUATIC
INVERTEBRATES
DAPHNIA
Ref.
OECD
TG
202
PROLONGED
TOXICITY
TO
DAPHNIDS/
REPRODUCTION
TEST
Test
Substance:
complete
identification,
including
vehicles
used
to
administer
(
e.
g.,
solvents).

Test
Organism:
Daphnia
sp.
identified
by
species
strain,
source.

Methods:
­
complete
description
(
see
[
4.2.]
A.);
­
5
concentrations
in
geometric
series
of
test
solution,
highest
at
24
hr
EC50,
lowest
at
1/
100
24
hr
EC50;
­
at
least
40
animals,
4
groups
of
10,
at
each
concentration,:
controls
­
test
duration
14­
21
days
or
until
at
least
3
broods
of
F1
have
appeared
in
controls.

Results:
­
The
EC50
(
immobilisation)
and
EC50
(
reproduction)
values
as
far
as
possible
at
24,
48,
96
hrs,
7
days,
14
days,
and
at
the
end
of
the
test:
statistical
analysis
and
95
per
cent
confidence
limits;
­
the
length
of
time
for
the
appearance
of
the
first
brood
for
each
concentration;
­
the
number
of
young
alive
in
each
test
vessel
at
any
given
day
at
which
counts
were
made
(
the
minimum
requirement
is
for
counts
thrice
weekly);
­
the
number
of
dead
young
on
each
day
of
counting;
­
the
highest
concentration
tested
at
which
no
significant
difference
is
found
versus
the
controls
with
respect
to
mortality,
reproduction
and
other
observed
effects;
­
the
lowest
concentration
tested
with
significant
difference
versus
the
controls.

[
4.6]
TOXICITY
TO
TERRESTRIAL
ORGANISM
­
required
if
significant
exposure
is
expected
in
the
terrestrial
environment.

[
4.6.1]
TOXICITY
TO
SOIL
DWELLING
ORGANISM
Ref.
OECD
TG
207
Test
Species:
Eisenia
foetida,
adults,
mean
weight
300­
600
mg.

Test
substance:
Full
chemical
description.

Methods:
­
(
artificial)
soil
tests
are
preferred
to
contact
filter
paper
tests
as
being
more
representative
of
the
natural
habitat;
1)
Artificial
Soil
Test
­
10
worms/
vial
artificial
soil;
2)
Filter
Test
10­
20
worms/
test,
housed
separately,
­
range
finding
test
may
precede
dose
testing;
­
testing
at
5
geometric
dose
concentrations
plus
control,
reference
standard;
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
7
­
assessment
of
mortality
at
7,
14
days.

Results
should
indicate:
­
reports
of
all
test
methods,
procedures,
etc.;
­
calculation
of
LC0,
LC50,
LC100;
­
dose
response
curve;
­
statistical
analysis
and
confidence
levels;
­
any
observed
adverse
or
unusual
effects.

[
4.6.2]
TOXICITY
TO
TERRESTRIAL
PLANTS
Ref.
OECD
TG
208
Test
Species:
minimum
of
3
species
from
different
plant
types,
variety,
seed
source.

Test
Substance:
complete
identification.

Route
of
Administration:
soil,
incorporation
into
seed
bed.

Test
Conditions:
control,
plus
3
concentrations
tested
in
random
block
design,
minimum
4
replicates/
treatment;
5
seed/
replicate.

Methods:
complete
description
of
test
conditions,
including
growth
conditions,
soil
characteristics,
etc.

Results:
should
give:
­
concentration­
effect
curve;
­
LC50
for
emergence;
EC50
for
growth;
­
phytotoxic
effects
for
treatments,
control,
etc.;
­
statistical
analysis
of
results,
if
possible.

[
4.6.3]
TOXICITY
TO
OTHER
NON­
MAMMALIAN
TERRESTRIAL
SPECIES
(
INCLUDING
AVIANS)

A.
AVIAN
DIETARY
TOXICITY
TEST
Ref.
OECD
TG
205
Test
Species:
one
or
more
species,
(
mallard
duck,
Japanese
or
bobwhite
quail,
pigeon,
ring­
necked
pheasant,
redlegged
partridge)
from
healthy
known
stock,
10­
17
days
old.

Route
of
Administration:
Oral
in
diet.

Housing
Regimes:
consistent
with
good
laboratory
and
humane
practice,
details
of
housing
regime,
diet,
preparation/
maintenance,
including
test
diets,
etc..
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
8
Testing:
­
One
dose
level
testing
If
5,000
ppm
in
diet
produces
no
toxicity
within
8
days,
then
further
testing
may
be
discontinued.

­
Multiple
dose
testing
5
graduated
dose
levels,
2
controls
and
1
treatment
group/
dose,
10
birds/
group
for
5
days
followed
by
3
days
of
no
treatment;
reference
substances
(
optional).

Reporting
of
Results
­
frequency,
duration
of
observations;
­
number
of
deaths/
treatment
group
and
/
controls;
­
average
body
weights
at
beginning,
end
of
exposure
period,
end
of
test;
­
observations
on
intoxications/
behavioural
changes
including
food
consumptions;
­
LC0,
LC50,
LC100
values,
confidence
limits
and
statistical
analysis.

B.
AVIAN
REPRODUCTION
TEST
Ref.
OECD
TG
206
Test
Species:
one
or
more
species,
usually
mallard,
bob
white
or
Japanese
quail
of
healthy
individuals
from
the
same
population,
known
parentage.

Test
Substance:
complete
chemical
identification.

Route
of
Administration:
Oral
in
diet,
20
weeks.

Methods:

i)
Housing
regime:
complete
description
of
housing
conditions
including
diet/
supplements/
carriers,
frequency
of
feeding,
clearing,
etc.,
procedures
on
rearing,
acclimatization,
methods
of
identification
of
birds,
eggs,
conditions
of
egg
storage.

ii)
Test
conditions:
complete
description
including
dosing
levels,
frequency,
use
of
controls,
use
of
positive
reference
standards
(
optional)

­
should
test
at
3
dietary
concentrations,
highest
dose
at
50%
LC10
from
acute
testing,
others
at
lower
levels,
lowest
dose
no
observed
effect
level.

Results
should
give:
­
the
number
of
deaths
at
each
treatment
level,
and
in
controls;
­
all
weight
changes
in
birds
over
test
period
(
beginning
to
end
of
exposure
period
and
at
end
of
tests);
mean
weight
change;
­
frequency,
duration,
description
of
toxicity
on
adult
and
young
birds;
­
gross
pathological
results,
residue
analysis
(
if
performed);
­
egg
production,
egg
set,
viability,
hatchability
(
including
normal
hatchlings),
survival
of
young,
and
eggshell
thickness
(
in
summary
by
concentration
level
and
for
each
group
by
week
for
the
test
period);
­
no
effect
level,
and
any
statistically
significant
effect
levels;
­
any
observations
about
unusual
effects.

5.
TOXICITY
[
5.0]
GENERAL
CONSIDERATIONS
Common
general
considerations
which
should
be
reported
for
each
toxicology
study
are:

Test
Substance:
­
full
chemical
identification,
CAS
number
etc.;
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
9
­
full
identification
of
physical
characteristics
(
including:
state,
purity,
identification
of
impurities,
solubility,
stability,
solvent/
vehicles
used
in
experiment).

Test
Species:
­
adequate
numbers
of
healthy
animals
should
be
used;
­
individuals
in
test
groups
should
not
vary
more
than
+­
20%
of
mean
weight
of
the
group;
­
females
should
be
virgin;
­
common
laboratory
strains
should
be
used
wherever
possible.

Housing
Conditions
should
be
reported
indicating
housing
conditions,
routine,
consistent
care,
conventional
laboratory
diets,
unlimited
water,
consistent
conditions
of
temperature,
light,
relative
humidity
etc.

Clinical
Examinations
should
be
frequent
enough
to
ensure
observation
of
critical
signs
but
at
least
once
a
day;
should
include
records
of
all
deaths,
behavioural
changes,
necropsy
results.

[
5.1]
ACUTE
TOXICITY
Ref.
OECD
TG
401­
3,
420
Test
Species:

­
oral:
rat
(
preferred);
­
inhalation:
rat
(
preferred)
or
rabbit;
­
dermal:
rat,
rabbit,
guinea
pig
(
other
species
may
be
considered).
Commonly
used
strains,
weight
variation
of
each
animal
should
not
exceed
+­
20%
mean
weight.

Route
of
Exposure:
oral,
dermal
(
liquids,
solids),
inhalation
(
gases,
vapours,
fine
powders),
as
appropriate.

Number/
Sex
of
Test
Animals:
­
for
first
test
(
oral,
dermal)
at
least
5
healthy
young
animals/
dose
level/
all
same
sex;
­
for
inhalation
­
10
animals
(
5
of
each
sex);
­
females
should
be
virgin.

Method:
­
a
limit
test
may
be
carried
out
at
one
dose
level
(
2000
mg/
kg
body
weight)
on
groups
of
5
males
or
5
females
for
oral
or
dermal.
For
inhalation,
10
animals
should
be
tested;
if
compound­
related
mortality
is
observed,
a
full
study
may
be
needed;
­
dose
levels:
oral,
dermal:
at
least
3,
plus
controls
with
a
range
of
toxic
effects
and
mortality
rates
so
that
dose
response
curve
can
be
prepared
and
an
LD50
can
be
determined;
inhalation:
if
one
continuous
dose,
4
hr
exposure
produces
no
mortality
at
5
mg/
L,
then
further
tests
may
be
discontinued.
If
effects,
a
full
study
with
4­
hours
exposure
at
3
dose­
levels
may
be
required;
­
animals
observed
for
14
days
with
clinical
observations
daily,
including
weight
change,
pathological
examinations
reported
upon
termination
of
animals.

Results:
­
LD50
value
given
for
each
sex,
or
a
combined
LD50
if
both
sexes
are
tested.
Any
significant
difference
in
response
between
sexes
(>
2­
fold)
should
be
reported;
­
dose
mortality
curve,
confidence
limits;
­
report
all
signs
of
toxicity
(
immediate
or
delayed),
number
dead,
number
with
no
effect
for
all
dose
levels,
control;
­
necropsy
and
histopathological
effects
should
be
reported
for
those
due
to
test
substance;
­
for
dermal:
effects
(
local)
at
site
of
application
should
be
reported;
­
for
inhalation
study:
(
range
of)
particle
size
of
test
substance
should
be
reported.

[
5.4]
REPEATED
DOSE
STUDY
(
14­
28
DAY)
Ref.
OECD
TG
407,
410,
412
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
10
Test
Species:
­
oral,
inhalation:
rat
preferred,
6­
8
weeks
old;
­
dermal:
rat,
rabbit,
guinea
pig.

Route
of
exposure:
Oral
preferred,
diet,
gavage.
For
dermal
or
inhalation
reasons
should
be
given.

Number
and
sex
of
test
animals:
­
10/
dose
level
(
5
of
each
sex);
­
more,
if
interim
sacrifices.

Dose
levels:

­
limit
test:
1
dose
³
1000
mg/
kg.
If
no
observable
effects
or
evidence
of
toxicity
at
this
level,
then
a
full
study
may
not
be
required.

­
full
test:
3
doses
plus
control
°
lowest
­
no
evidence
of
toxicity
°
middle
­
minimal
observable
toxic
effects
°
highest
­
toxic
effects
noted,
but
fatalities
do
not
affect
evaluation
of
results.

Methods:
­
all
information
regarding
housing,
care
of
animals,
methods
used,
experimental
procedures
should
be
reported;
­
for
the
inhalation
study,
air
flow
rates,
concentrations,
particle
size
distribution,
etc.
should
also
be
reported.

Report:
­
clinical
observations
on
animal
behaviour,
weight
change,
etc.,
laboratory
findings
on
the
number
of
dead,
sick,
affected
animals
by
sex,
dose
duration
of
exposure
for
entire
experimental
period;
­
time
of
death
or
effects
during,
after
exposure
related
to
exposure
level,
time
of
onset
of
symptoms,
duration
and
recovery,
if
any;
­
if
no
signs
of
toxicity
seen,
this
should
also
be
reported;
­
results
of
necropsy
(
all
lesions,
abnormalities,
organ
weight
changes)
should
be
reported
related
to
dose
level
and
as
a
deviation
from
controls;
haematological
tests,
clinical
biochemistry,
histopathology
should
all
be
reported
to
controls.

Note:
Combined
Repeated
Dose
Toxicity
Study
with
the
Reproduction/
Developmental
Toxicity
Screening
Test
(
OECD
Test
Guideline
421)
is
acceptable.

[
5.5]
and
[
5.6]
GENETIC
TOXICITY
(
in
vitro
and
in
vivo)

A
range
of
in
vivo
and
in
vitro
studies
are
acceptable.
Testing
should
be
sufficient
to
cover
two
different
endpoints:

(
1)
gene
mutation
(
usually
with
bacteria)
(
2)
chromosomal
aberrations/
changes
(
usually
non­
bacterial).

Although
many
mutagenicity
tests
are
available,
approximately
five
are
commonly
used;
one,
the
Salmonella
mutation
assays
is
virtually
globally
routine.
Two
to
five
tests
have
been
suggested
as
reasonable,
in
general,
the
Salmonella
reverse
mutation
assay
in
combination
with
test(
s)
for
induction
of
chromosome
aberrations.

Selection
of
test
methods
should
take
into
account
the
nature
of
the
test
material,
data
from
other
toxicological
studies,
sensitivity
of
strains
chosen,
the
potential
for
false
positives
or
negatives,
the
use
of
reference
substances
as
positive
controls,
response
with
and
without
metabolic
activation,
merits
of
in
vitro
vs.
in
vivo,
eukaryotic
vs.
prokaryotic
testing,
etc.

Chromosomal
aberrations
and
changes
can
be
determined
by
a
series
of
non­
bacterial
tests
in
vitro
or
in
vivo.
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
11
[
5.5.
A.]
BACTERIAL
TEST
Ref.
OECD
TG
471
and
472
Measures:
Gene
mutations
Cell
cultures:
Salmonella
typhimurim;
Escherichia
coli
Methods:
­
full
identification
of
bacteria
and
strains
used,
positive
reference
substances
and
negative
controls;
­
details
of
test
methods
chosen
and
procedures
followed
(
culture
conditions,
dose
levels,
rationale
for
dose
selection,
number
of
plates
per
test,
metabolic
activations
system
chosen,
media
composition;
number
of
replicates);

Results:
­
individual
plate
counts
of
strains
used,
mean
number
of
revertant
colonies/
plate;
­
report
details
of
response
(
magnitude
of
increased
revertants,
plus
any
dose
response)
in
relation
to
controls;
­
state
whether
overall
result
is
negative
or
positive
for
experiments
both
with/
without
metabolic
activation;
­
if
negative
results
obtained,
then
justification
of
dose
levels
used,
and
type
of
metabolizing
system
in
relation
to
the
structure
of
the
test
organisms,
and
whether
positive
controls
gave
satisfactory
response,
should
be
reported;
­
statistical
analysis
with
standard
deviation.

[
5.5.
B.]
NON­
BACTERIAL
IN
VITRO
TEST
i)
MAMMALIAN
CELL
GENE
MUTATION
TEST
Ref.
OECD
TG
476
Measures:
base
pair
mutations/
small
deletions.

Cell
cultures:
any
appropriate
mammalian
cell
culture,
e.
g.
L5178Y
mouse
lymphoma
cells,
CHO,
V­
79
Chinese
hamster
cells.

Methods:
­
test
should
be
designated
to
have
a
predetermined
sensitivity
and
power.
No
cells/
culture
is
usually
1/
10
expected
background
mutant
frequency;
usually
4
concentrations
of
test
substance
to
yield
concentration
­
related
toxic
effect;
­
highest
concentration
should
produce
a
low
level
of
survival;
­
positive
and
negative
controls
should
be
tested;
­
cells
should
be
exposed
to
test
both
with
and
without
metabolic
activation
over
a
(
1­
5
hr)
suitable
exposure
period.

Report:
see
also
[
5.5.
A.]
­
details
of
methods
used
(
e.
g.
individual
colony
counts/
treated
and
control
groups
survival
and
cloning
efficiencies
(%
of
controls);
mutant
frequency
(
number
of
mutants/
no
surviving
cells)
selective
agents;
­
methods
used
to
enumerate
numbers
of
viable
and
mutant
cells;
­
dose­
response
relationship
where
possible;
­
statistical
analysis
and
confidence
limits
where
possible.

Results:
as
per
[
5.5.
A.]

ii)
IN
VITRO
MAMMALIAN
CYTOGENETIC
TEST
(
CHROMOSOMAL
ABBERATIONS
/
CHANGES)
Ref.
OECD
TG
473
Culture:
a
variety
of
cells
lines,
strains
or
primary
cultures
can
be
used.

Method:
should
describe
the
test
conditions,
including
cell
culture
technique,
exposure
in
both
presence
and
absence
of
appropriate
metabolic
activation
system,
exposure
period
to
test
substance,
exposure
concentrations,
test
performance.
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
12
Report:
­
type
of
test,
time
of
fixation,
number
of
replicates,
use
of
positive
reference
substances,
controls;
­
the
type
and
number
of
aberrations
and
method
of
scoring,
for
each
treated
and
control
culture;
­
details
of
response
­
e.
g.,
type
of
structural
damage,
magnitude
of
effect,
any
dose
response,
statistical
analysis,
if
done;
­
state
whether
overall
effect
is
positive
or
negative
for
experiments
both
with
and
without
metabolic
activation.
If
there
are
data
on
the
effect
of
the
chemical
on
cell
cycle
time,
the
adequacy
of
the
selected
exposure
periods
should
be
indicated.

[
5.6]
GENETIC
TOXICITY
in
vivo
i)
SEX­
LINKED
RECESSIVE
LETHAL
TEST
DROSOPHILA
(
GENE
MUTATION)
Ref.
OECD
TG
477
Measures:
Point
mutations
and
small
deletions
in
germ
line
(
X
chromosome)
of
insect
by
sex
linked
recessive
lethal
Species:
Wild
type
males
and
females
of
Muller
5
stock
or
appropriate
strain
with
inverted
X
chromosomes.

Routes
of
exposure:
oral,
injection
of
inhalation.

Method:
­
report
all
procedures
followed,
test
conditions;
­
dose:
maximum
tolerated
concentration,
or
one
producing
some
indications
of
toxicity;
­
as
positive
reference
control
plus
blank
control.

Results:
­
report
number
of
lethal
mutations/
dose,
statistical
analysis;
­
state
whether
overall
result
is
positive
or
negative.
If
negative,
justify
that
dose
levels,
methods
are
adequate
(
by
use
structure/
reactivity
of
the
test
substance).

ii)
NON­
BACTERIAL
IN
VIVO
TESTS
(
CHROMOSOMAL
ABERRATIONS/
CHANGES)
Ref.
OECD
TG
474,
475
MICRONUCLEUS
TEST
MAMMALIAN
BONE
MARROW
CYTOGENETIC
TEST
Species:
any
appropriate
mammal,
usually
mouse,
but
also
rat,
hamster.

Route
of
Exposure:
oral,
intraperitoneal
injection
or
other
appropriate
route.

Sex:
young
healthy
animals,
usually
5/
sex,
10
animals
/
group,
treatment
and
control
groups.

Treatment
regime:
should
be
reported
including
description
of
test
conditions.

Dose:
a)
single
administration
of
maximum
tolerated
dose
or
that
producing
indication
of
cytotoxicity.
b)
repeated
dose,
sample
to
be
taken
12
hrs
after
dosing
at
intervals
to
72
hrs.
EXCH\
MANUAL\
96­
AN3.
DOC/
May
1996
13
Test
size:
­
should
score
approximately
1000
micronucleated
polychromatic
erythrocytes/
animal
(
MPE's).

Results:
­
test
report
should
include
information
on
the
animals
used
treatment,
etc.
details
of
test
conditions,
criteria
used
to
identified
MPE's;
­
a
positive
result
should
be
indicated
by:
i)
a
statistically
significant
dose­
related
increase
in
number
of
micronucleated
polychromatic
erythrocytes;
ii)
detection
of
a
reproducible
and
statistically
significant
positive
response
at
a
test
point;
­
a
negative
result
should
be
checked
to
ensure
test
substance
is
reaching
target
tissue,
to
confirm
value
of
test
as
a
mutagenicity
screen;
­
additional
mutagenicity
tests,
involving
different
parameters,
e.
g.
chromatid
exchange,
crossover,
forward
and
reverse
mutations
etc.
are
described
in
the
OECD
Test
Guidelines.

[
5.8]
TOXICITY
TO
REPRODUCTION
Ref.(
1)
One
Generation
Reproductions
Toxicity
Study
OECD
TG
415
(
2)
Two
Generation
Reproduction
Toxicity
Study
OECD
TG
416
Test
species:
Rat
or
mouse.
Route
of
Exposure:
usually
oral,
daily
from
5­
9
wks
age.
Number
of
animals/
sex:
­
enough
animals
to
give
20
pregnant
females
to
term
if
possible;
­
males
should
be
dosed
for
at
least
one
complete
spermatogenic
cycle
(
56
days
mouse;
70
days
rat);
­
p
generation
females
should
be
dosed
for
two
oestrous
cycles,
then
observed
throughout
the
entire
cycle.

Dose
levels
and
exposure:
3
treatment
groups
plus
control;
highest
level
should
induce
toxicity
but
not
mortality
medium
level
should
induce
minimal
toxic
effects,
lowest
group
no
observable
adverse
effects.

Methods:
­
one
high
dose
>
1000
mg/
kg
­
if
no
evidence
of
effects
further
studies
may
not
be
required;
­
daily
observation
noting
any
changes
or
effects.

Results:
should
include:
­
species,
strain
used;
­
toxic
response
data
by
sex
and
dose,
including
fertility,
gestation,
and
viability
indices;
­
time
of
death
during
the
study
or
whether
animals
survived
to
termination;
­
table
presenting
the
weights
of
each
litter,
the
mean
pup
weights
and
the
individual
weights
of
the
pups
at
termination;
­
toxic
or
other
effects
on
reproduction,
offsprings,
postnatal
growth,
etc.;
­
the
data
of
observation
of
each
abnormal
sign
and
its
subsequent
course;
­
body
weight
data
for
p
generation
animals;
­
necropsy
findings,
a
detailed
description
of
gross
necroscopy
and
histopathology,
of
all
reproductive
organs;
­
statistical
analysis
of
results;
­
no
effect
level
and
adverse
effects
on
reproduction,
parturition,
lactation
and
post
natal
growth.

Note:
Combined
Repeated
Dose
Toxicity
Study
with
the
Reproduction/
Developmental
Toxicity
Screening
Test
(
OECD
Test
Guideline
422)
and
Reproduction/
Developmental
Toxicity
Screening
Test
(
OECD
Test
Guideline
421)
are
also
acceptable.
EXCH\
MANUAL\
97­
AN4.
DOC/
July
1997
1
ANNEX
4
OECD's
Guidelines
for
the
Testing
of
Chemicals
Currently
Available
Guidelines,
Draft
Guidelines,
and
Guidance
and
Review
Documents
(
List
Revised:
May
1997)

I.
ADOPTED
GUIDELINES
Section
1
­
Physical­
Chemical
Properties
(
blue
pages)

Summary
of
Considerations
in
the
Report
from
the
OECD
Expert
Group
on
Physical
Chemistry
(
1981)

101
UV­
VIS
Absorption
Spectra
(
Original
Guideline,
adopted
12th
May
1981)
102
Melting
Point/
Melting
Range
(
Updated
Guideline,
adopted
27th
July
1995)
103
Boiling
Point
(
Updated
Guideline,
adopted
27th
July
1995)
104
Vapour
Pressure
(
Updated
Guideline,
adopted
27th
July
1995
105
Water
Solubility
(
Updated
Guideline,
adopted
27th
July
1995)
106
Adsorption/
Desorption
(
Original
Guideline,
adopted
12th
May
1981)
107
Partition
Coefficient
(
n­
octanol/
water):
Shake
Flask
Method
(
Updated
Guideline,
adopted
27th
July
1995)
108
Complex
Formation
Ability
in
Water
(
Original
Guideline,
adopted
12th
May
1981)
109
Density
of
Liquids
and
Solids
(
Updated
Guideline,
adopted
27
July
1995)
110
Particle
Size
Distribution/
Fibre
Length
and
Diameter
Distributions
(
Original
Guideline,
adopted
12th
May
1981)
111
Hydrolysis
as
a
Function
of
pH
(
Original
Guideline,
adopted
12th
May
1981)
112
Dissociation
Constants
in
Water
(
Original
Guideline,
adopted
12th
May
1981)
113
Screening
Test
for
Thermal
Stability
and
Stability
in
Air
(
Original
Guideline,
adopted
12th
May
1981)
114
Viscosity
of
Liquids
(
Original
Guideline,
adopted
12th
May
1981)
115
Surface
Tension
of
Aqueous
Solutions
(
Updated
Guideline,
adopted
27th
July
1995)
116
Fat
Solubility
of
Solid
and
Liquid
Substances
(
Original
Guideline,
adopted
12th
May
1981)
117
Partition
Coefficient
(
n­
octanol/
water),
HPLC
Method
(
Original
Guideline,
adopted
30th
March
1989)
118
Determination
of
the
Number­
Average
Molecular
Weight
and
the
Molecular
Weight
Distribution
of
Polymers
using
Gel
Permeation
Chromatography
(
Original
Guideline,
adopted
14th
June
1996)
119
Determination
of
the
Low
Molecular
Weight
Content
of
a
Polymer
Using
Gel
Permeation
Chromatography
(
Original
Guideline,
adopted
14th
June
1996)
120
Solution/
Extraction
Behaviour
of
Polymers
in
Water
(
Original
Guideline,
adopted
14th
June
1996)

Section
2
­
Effects
on
Biotic
Systems
(
green
pages)
EXCH\
MANUAL\
97­
AN4.
DOC/
July
1997
2
Summary
of
Considerations
in
the
Report
from
the
OECD
Expert
Group
on
Ecotoxicology
(
1981)

201
Alga,
Growth
Inhibition
Test
(
Updated
Guideline,
adopted
7th
June
1984)
202
Daphnia
sp.
Acute
Immobilisation
Test
and
Reproduction
Test
(
Updated
Guideline,
adopted
4th
April
1984)
203
Fish,
Acute
Toxicity
Test
(
Updated
Guideline,
adopted
17th
July
1992)
204
Fish,
Prolonged
Toxicity
Test:
14­
Day
Study
(
Original
Guideline,
adopted
4th
April
1984)
205
Avian
Dietary
Toxicity
Test
(
Original
Guideline,
adopted
4th
April
1984)
206
Avian
Reproduction
Test
(
Original
Guideline,
adopted
4th
April
1984)
207
Earthworm,
Acute
Toxicity
Tests
(
Original
Guideline,
adopted
4th
April
1984)
208
Terrestrial
Plants,
Growth
Test
(
Original
Guideline,
adopted
4th
April
1984)
209
Activated
Sludge,
Respiration
Inhibition
Test
(
Original
Guideline,
adopted
4th
April
1984)
210
Fish,
Early­
Life
Stage
Toxicity
Test
(
Original
Guideline,
adopted
17th
July
1992)

Section
3
­
Degradation
and
Accumulation
(
yellow
pages)

Summary
of
Considerations
in
the
Report
from
the
OECD
Expert
Group
on
Degradation/
Accumulation
(
1981)

301
Ready
Biodegradability
A:
DOC
Die­
Away
Test
B:
CO2
Evolution
Test
C:
Modified
MITI
Test
(
I)
D:
Closed
Bottle
Test
E:
Modified
OECD
Screening
Test
F:
Manometric
Respirometry
Test
(
Updated
Guideline,
adopted
17th
July
1992)
302A
Inherent
Biodegradability:
Modified
SCAS
Test
(
Original
Guideline,
adopted
12th
May
1981)
302B
Inherent
Biodegradability:
Zahn­
Wellens/
EMPA
Test
(
Updated
Guideline,
adopted
17th
July
1992)
302C
Inherent
Biodegradability:
Modified
MITI
Test
(
II)
(
Original
Guideline,
adopted
12th
May
1981)
303A
A
Simulation
Test
­
Aerobic
Sewage
Treatment:
Coupled
Units
Test
(
Original
Guideline,
adopted
12th
May
1981)
EXCH\
MANUAL\
97­
AN4.
DOC/
July
1997
3
304A
A
Inherent
Biodegradability
in
Soil
(
Original
Guideline,
adopted
12th
May
1981)
305
Bioconcentration:
Flow­
through
Fish
Test
(
Updated
Guideline,
adopted
14th
June
1996)
306
Biodegradability
in
Seawater
(
Original
Guideline,
adopted
17th
July
1992)

Section
4
­
Health
Effects
(
pink
pages)

Summary
of
Considerations
in
the
Report
from
the
OECD
Expert
Groups
on
Short
and
Long
Term
Toxicology
(
1981)

401
Acute
Oral
Toxicity
(
Updated
Guideline,
adopted
24th
February
1987)
402
Acute
Dermal
Toxicity
(
Updated
Guideline,
adopted
24th
February
1987)
403
Acute
Inhalation
Toxicity
(
Original
Guideline,
adopted
12th
May
1981)
404
Acute
Dermal
Irritation/
Corrosion
(
Updated
Guideline,
adopted
17th
July
1992)
405
Acute
Eye
Irritation/
Corrosion
(
Updated
Guideline,
adopted
24th
February
1987)
406
Skin
Sensitisation
(
Updated
Guideline,
adopted
17th
July
1992)
407
Repeated
Dose
28­
day
Oral
Toxicity
Study
in
Rodents
(
Updated
Guideline,
adopted
27th
July
1995)
408
Subchronic
Oral
Toxicity
­
Rodent:
90­
day
Study
(
Original
Guideline,
adopted
12th
May
1981)
409
Subchronic
Oral
Toxicity
­
Non­
Rodent:
90­
day
Study
(
Original
Guideline,
adopted
12th
May
1981)
410
Repeated
Dose
Dermal
Toxicity:
21/
28­
day
Study
(
Original
Guideline,
adopted
12th
May
1981)
411
Subchronic
Dermal
Toxicity:
90­
day
Study
(
Original
Guideline,
adopted
12th
May
1981)
412
Repeated
Dose
Inhalation
Toxicity:
28­
day
or
14­
day
Study
(
Original
Guideline,
adopted
12th
may
1981)
413
Subchronic
Inhalation
Toxicity:
90­
day
Study
(
Original
Guideline,
adopted
12th
May
1981)
414
Teratogenicity
(
Original
Guideline,
adopted
12th
May
1981)
415
One­
Generation
Reproduction
Toxicity
Study
(
Original
Guideline,
adopted
26th
May
1983)
416
Two­
Generation
Reproduction
Toxicity
Study
(
Original
Guideline,
adopted
26th
May
1983)
417
Toxicokinetics
(
Updated
Guideline,
adopted
4th
April
1984)
418
Delayed
Neurotoxicity
of
Organophosphorus
Substances
Following
Acute
Exposure
(
Updated
Guideline,
adopted
27th
July
1995)
419
Delayed
Neurotoxicity
of
Organophosphorus
Substances:
28­
day
Repeated
Dose
Study
(
Updated
Guideline,
adopted
27th
July
1995)
420
Acute
Oral
Toxicity
­
Fixed
Dose
Method
(
Original
Guideline,
adopted
17th
July
1992)
421
Reproduction/
Developmental
Toxicity
Screening
Test
(
Original
Guideline,
adopted
27th
July
1995)
422
Combined
Repeated
Dose
Toxicity
Study
with
the
Reproduction/
Developmental
Toxicity
Screening
Test
(
Original
Guideline,
adopted
22nd
March
1996)
423
Acute
Oral
toxicity
­
Acute
Toxic
Class
Method
(
Original
Guideline,
adopted
22nd
March
1996)
451
Carcinogenicity
Studies
EXCH\
MANUAL\
97­
AN4.
DOC/
July
1997
4
(
Original
Guideline,
adopted
12th
May
1981)
452
Chronic
Toxicity
Studies
(
Original
Guideline,
adopted
12th
May
1981)
453
Combined
Chronic
Toxicity/
Carcinogenicity
Studies
(
Original
Guideline,
adopted
12th
May
1981)

Introduction
to
the
OECD
Guidelines
on
genetic
toxicology
testing
and
guidance
on
the
selection
and
application
of
assays
(
1986)

471
Genetic
Toxicology:
Salmonella
typhimurium,
Reverse
Mutation
Assay
(
Original
Guideline,
adopted
26th
May
1983)
472
Genetic
Toxicology:
Escherichia
coli,
Reverse
Mutation
Assay
(
Original
Guideline,
adopted
26th
May
1983)
473
Genetic
Toxicology:
In
vitro
Mammalian
Cytogenetic
Test
(
Original
Guideline,
adopted
26th
May
1983)
474
Genetic
Toxicology:
Micronucleus
Test
(
Original
Guideline,
adopted
26th
May
1983)
475
Genetic
Toxicology:
In
vivo
Mammalian
Bone
Marrow
Cytogenetic
Test
­
Chromosomal
Analysis
(
Updated
Guideline,
adopted
4th
April
1984)
476
Genetic
Toxicology:
In
vitro
Mammalian
Cell
Gene
Mutation
Tests
(
Updated
Guideline,
adopted
4th
April
1984)
477
Genetic
Toxicology:
Sex­
Linked
Recessive
Lethal
Test
in
Drosophila
melanogaster
(
Updated
Guideline,
adopted
4th
April
1984)
478
Genetic
Toxicology:
Rodent
Dominant
Lethal
Test
(
Updated
Guideline,
adopted
4th
April
1984)
479
Genetic
Toxicology:
In
vitro
Sister
Chromatid
Exchange
Assay
in
Mammalian
Cells
(
Original
Guideline,
adopted
23rd
October
1986)
480
Genetic
Toxicology:
Saccharomyces
cerevisiae,
Gene
Mutation
Assay
(
Original
Guideline,
adopted
23rd
October
1986)
481
Genetic
Toxicology:
Saccharomyces
cerevisiae,
Mitotic
Recombination
Assay
(
Original
Guideline,
adopted
23rd
October
1986)
482
Genetic
Toxicology:
DNA
Damage
and
Repair,
Unscheduled
DNA
Synthesis
in
Mammalian
Cells
in
vitro
(
Original
Guideline,
adopted
23rd
October
1986)
483
Genetic
Toxicology:
Mammalian
Germ
Cell
Cytogenetic
Assay
(
Original
Guideline,
adopted
23rd
October
1986)
484
Genetic
Toxicology:
Mouse
Spot
Test
(
Original
Guideline,
adopted
23rd
October
1986)
485
Genetic
Toxicology:
Mouse
Heritable
Translocation
Assay
(
Original
Guideline,
adopted
23rd
October
1986)
EXCH\
MANUAL\
97­
AN4.
DOC/
July
1997
5
II.
GUIDANCE
AND
REVIEW
DOCUMENTS
(
OECD
Monograph
Series
on
Testing
and
Assessment)

1
Guidance
Document
for
the
Development
of
OECD
Guidelines
for
Testing
of
Chemicals
(
Environment
Monograph
No.
76,
Published
December
1993;
Reprinted
June
1995)
2
Detailed
Review
Paper
on
Biodegradability
Testing
(
Environment
Monograph
No.
98,
Published
June
1995)
3
Guidance
Document
for
Aquatic
Effects
Assessment
(
Environment
Monograph
No.
92,
Published
1995)
4
Report
of
the
OECD
Workshop
on
Environmental
Hazard/
Risk
Assessment
(
Environment
Monograph
No.
105,
Published
1995)
5
Report
of
the
SETAC/
OECD
Workshop
on
Avian
Toxicity
Testing
(
Published
December
1996)
6
Report
of
the
Final
Ring
Test
of
the
Daphnia
magna
Reproduction
Test
(
Published
February
1997)
7
Direct
Phototransformation
of
Chemicals
in
Water
(
Published
February
1997)

III.
DRAFT
GUIDELINES
Section
1
­
Physical­
Chemical
Properties
106
Adsorption/
Desorption
(
Draft
Updated
Guideline,
January
1997)
***
Screening
Method
for
the
Determination
of
the
Adsorption
Coefficient
on
Soil
(
Koc)
using
High
Performance
Liquid
Chromatography
(
HPLC)
(
Draft
New
Guideline,
April
1994)

Section
2
­
Effects
on
Biotic
Systems
205
Avian
Dietary
Toxicity
Test
(
Draft
Updated
Guideline,
in
preparation)
206
Avian
Reproduction
Test
(
Draft
Updated
Guideline,
in
preparation)
211
Daphnia
magna
Reproduction
Test
(
Draft
New
Guideline,
April
1997)
212
Fish,
Toxicity
Test
on
Egg
and
Sac­
Fry
Stages
(
Draft
New
Guideline,
April
1997)
213
Honeybees,
Acute
Oral
Toxicity
Test
(
Draft
New
Guideline,
April
1997)
214
Honeybees,
Acute
Contact
Toxicity
Test
(
Draft
New
Guideline,
April
1997)
***
Fish,
Juvenile
Growth
Test
­
28
Days
(
Draft
New
Guideline,
November
1994)
***
Avian
Acute
Toxicity
Test
­
Oral
Toxicity
(
Draft
New
Guideline,
in
preparation)
***
Soil
Microorganisms,
Nitrogen
Mineralisation
Test
(
Draft
New
Guideline,
June
1996)
***
Soil
Microorganisms,
Carbon
Mineralisation
Test
(
Draft
New
Guideline,
June
1996)
EXCH\
MANUAL\
97­
AN4.
DOC/
July
1997
6
Section
3
­
Degradation
and
Accumulation
303
Simulation
Test
­
Aerobic
Sewage
Treatment
(
Draft
Updated
Guideline,
September
1996)
303A:
Activated
Sludge
Units
303B:
Treatability
of
Chemicals:
Prediction
of
Concentration
in
Activated
Sludges
and
Assessment
of
Kinetic
Constants
303C:
Biofilms
***
Performance
of
Out­
door
Lysimeter
Studies
(
Draft
New
Guideline,
November
1996)

Section
4
­
Health
Effects
403
Acute
Inhalation
Toxicity
(
Draft
Updated
Guideline,
August
1996)
408
Repeated
Dose
90­
Day
Oral
Toxicity
Study
in
Rodents
(
Draft
Updated
Guideline,
April
1997)
409
Repeated
Dose
90­
Day
Oral
Toxicity
Study
in
Non­
Rodents
(
Draft
Updated
Guideline,
April
1997)
414
Prenatal
Developmental
Toxicity
Study
(
Draft
Updated
Guideline,
June
1996)
416
Two­
Generation
Reproduction
Toxicity
Study
(
Draft
Updated
Guideline,
April
1996)
424
Neurotoxicity
(
Draft
New
Guideline,
February
1997)
425
Acute
Oral
Toxicity:
Up­
and­
Down
Procedure
(
Draft
New
Guideline,
April
1997)
471/
472
Reverse
Mutation
Assay
using
Bacteria
(
Draft
Updated
Guideline,
February
1997)
473
In
vitro
Mammalian
Chromosomal
Aberration
Test
(
Draft
Updated
Guideline,
February
1997)
474
Mammalian
Erythrocyte
Micronucleus
Test
(
Draft
Updated
Guideline,
February
1997)
475
Mammalian
Bone
Marrow
Chromosomal
Aberration
Test
(
Draft
Updated
Guideline,
February
1997)
476
In
vitro
Mammalian
Cell
Gene
Mutation
Test
(
Draft
Updated
Guideline,
February
1997)
483
Mammalian
Germ­
cell
Chromosomal
Aberration
Test
(
Draft
Updated
Guideline,
February
1997)
486
Unscheduled
DNA
Synthesis
(
UDS)
Test
with
Mammalian
Liver
Cells
in
vivo
(
Draft
New
Guideline,
February
1997)
***
Somatic
Mutation
and
Recombination
Tests
(
SMART)
in
Drosophila
melanogaster
(
Draft
New
Guideline,
May
1994)
***
Percutaneous
Absorption:
in
vitro
Method
(
Draft
New
Guideline,
May
1996)
***
Percutaneous
Absorption:
in
vivo
Method
(
Draft
New
Guideline,
June
1996)
***
Acute
Dermal
Photoirritation
Screening
Test
(
Draft
New
Guideline,
February
1995)
***
Acute
Dermal
Photoirritation
Dose­
Response
Test
(
Draft
New
Guideline,
February
1995)
EXCH\
MANUAL\
97­
AN4.
DOC/
July
1997
7
***
In
Vitro
Syrian
Hamster
Embryo
(
SHE)
Cell
Transformation
Assay
(
Draft
New
Guideline,
March
1996)
***
Acute
Dermal
Irritation
Study
in
Human
Volunteers
(
Draft
New
Guideline,
April
1997)

IV.
DRAFT
GUIDANCE
AND
REVIEW
DOCUMENTS
(
OECD
Monograph
Series
on
Testing
and
Assessment)

****
Guidance
Document
for
the
Conduct
of
Studies
of
Occupational
Exposure
to
Pesticides
During
Agricultural
Application
(
Submitted
for
derestriction,
March
1997)
****
Guidance
for
Acceptance/
Palatability
Tests
in
Birds
(
In
preparation)
****
Aquatic
Testing
Methods
for
Pesticides
and
Industrial
Chemicals
(
Circulated
for
comment,
December
1995)
****
Freshwater
Lentic
Field
Tests
(
Circulated
for
comment,
July
1996)
****
Draft
Detailed
Review
Paper:
Appraisal
of
Test
Methods
for
Sex
Hormone
Disrupting
Chemicals
(
Circulated
for
comment,
March
1997)
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
1
ANNEX
5
An
Example
of
the
Format
for
Gathering
Detailed
Exposure
Information
The
information
set
out
in
the
provisional
form
in
this
Annex
has
been
developed
and
used
by
the
US.
This
is
referred
to
in
the
conclusions
and
recommendations
of
the
Task
Force
Meeting
in
Dortmund,
Germany,
in
June
1995
as
an
example
of
information
to
be
collected
in
post­
SIDS
work
when
necessary.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
2
PROVISIONAL
FORM
FOR
SUBMISSION
OF
DETAILED
EXPOSURE
INFORMATION
DEVELOPED
BY
US
(
EPA/
CMA/
SOCMA)
*

General
Instructions
The
attached
form
is
intended
to
provide
information
for
the
review
of
potential
chemical
concerns.
It
requests
information
on
chemical
releases
and
worker
exposures
at
sites
where
the
company
manufactures
the
chemical
and
descriptive
information
on
the
uses
for
which
the
chemical
is
distributed
to
other
sites.

Completion
of
the
form
is
voluntary,
and
should
be
based
on
readily
available
data
and
reasonable
estimates.
The
data
can
be
qualified
by
indicating
the
evaluation
of
its
accuracy
(
e.
g.
release
estimate
to
water
+/­
50%).

Parts
I
through
VI
of
the
form
are
site­
specific.
If
reporting
for
more
than
one
facility,
complete
these
sections
for
each.
Cover
all
activities
at
the
site.
For
example,
if
the
chemical
is
manufactured
and
subsequently
formulated
into
consumer
products
at
the
facility,
the
release
and
exposure
data
should
cover
both
activities.

Part
VII
requests
more
general
information
about
the
end
uses
of
the
subject
chemical
which
may
occur
at
other
facilities
or
by
consumers.
This
part
can
be
a
composite
of
all
activities
for
which
the
company
distributes
the
chemical.
Alternatively,
this
part
may
be
completed
for
only
that
portion
of
use(
s)
supported
by
the
site's
production.

(
Instructions
for
submittal
of
Confidential
Business
Information
are
abbreviated
here.)

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.

*
This
form
was
developed
for
use
in
a
pilot
project
to
provide
information
on
releases
and
use
of,
and
exposure
to,
specific
chemicals
undertaken
by
US
EPA,
the
US
Chemical
Manufacturers
Association
and
the
US
Synthetic
Organic
Chemical
Manufacturers
Association,
begun
in
August
1993.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
3
Chemical
Name:
Company:
page
1
....................................................................................................................................................................................................

I.
CHEMICAL
IDENTIFICATION
Identify
the
chemical
you
are
submitting
information
on:

Chemical
name:

CAS
number:

II.
COMPANY
IDENTIFICATION
Identify
the
company
and
location
of
the
facility
submitting
information:

Company
name:

Site
location:

Identify
a
company
technical
contact
that
can
respond
to
inquiries
about
the
information
submitted:

Technical
contact:

Phone:

Address:

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
4
Chemical
Name:
Company:
page
2
....................................................................................................................................................................................................

III.
ON­
SITE
ACTIVITIES
Using
ranges
if
necessary
to
avoid
CBI,
estimate
the
amount
of
the
subject
chemical
for
the
last
calendar
year
that
your
site:

°
imported
lb/
yr
°
manufactured
lb/
yr
If
you
have
already
provided
the
above
information
to
EPA
and
it
is
still
representative
please
reference
that
submission
here:

Estimate
the
amount
of
subject
chemical
distributed
off­
site:

%
of
manufacture/
import
Narrative
Description:
(
This
description
will
be
used
to
determine
release
and
exposure
scenarios
that
may
require
evaluation
by
EPA.)

Use
the
following
page
to
provide
a
narrative
description
of
on­
site
activities,
providing
information
that
gives
an
understanding
of
the
nature
and
extent
of
potential
exposures
to
the
subject
chemical.
The
narrative
description
should
provide
a
process
flow
schematic
of
major
unit
operations
and
chemical
conversions
for
manufacturing
and
on­
site
uses,
if
applicable.
The
schematic
should
show
the
points
of
release
of
the
subject
chemical
in
the
workplace
and
to
the
environment.
The
narrative
should
provide
insight
into
why
and
how
releases
are
caused
by
the
process.
In
the
event
the
subject
chemical
is
used
in
many
different
processes,
provide
information
on
each
major
process
instead
of
each
individual
process.
Attach
additional
pages
if
desired.
See
sample
form
for
additional
guidance.

..........................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
5
Chemical
Name:
Company:
page
3
....................................................................................................................................................................................................

III.
ON­
SITE
ACTIVITIES
(
continued)

Narrative
Description:
(
see
instructions
on
previous
page)

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
6
Chemical
Name:
Company:
page
4
....................................................................................................................................................................................................

IV.
SITE
RELEASE
AND
TRANSFER
INFORMATION
FOR
TRI
CHEMICALS
(
Skip
this
part
if
you
have
not
reported
on
the
subject
chemical
for
TRI**.)

If
the
subject
chemical
is
a
TRI
chemical
and
you
submitted
a
TRI
form
for
the
most
recent
calendar
year,
fill
out
this
section
and
skip
section
V.
Your
TRI
report
already
contains
all
of
the
information
requested
in
section
V.
Your
TRI
report
already
contains
all
of
the
information
requested
in
section
V,
except
for
number
of
release
and
transfer
days/
year.
Please
estimate
the
following
information
on
days/
year
of
releases
and
transfers
to
supplement
your
TRI
report
and
then
fill
out
sections
VI
and
VII:

AIR
RELEASES
°
Number
of
days/
year
the
release
occurs:

°
Fugitive
(
non­
point):

°
Stack
(
point):

WATER
RELEASES
°
Number
of
days/
year
release
occurs:

TRANSFER
TO
PUBLICLY
OWNED
TREATMENT
WORKS
(
POTW)

°
Number
of
days/
year
the
release
occurs:

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.

**
Toxic
Release
Inventory
in
the
US
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
7
Chemical
Name:
Company:
page
5
....................................................................................................................................................................................................

V.
SITE
RELEASE
AND
TRANSFER
INFORMATION
FOR
NON­
TRI
CHEMICAL
(
For
manufacturing
and
on­
site
processing/
use
if
applicable)

The
information
requested
in
this
section
will
assist
the
competent
authority
in
determining
the
likely
human
and
ecological
exposures
from
the
chemical
releases
to
the
environment.
Information
will
ensure
a
more
accurate
representation
of
potential
exposures.
Where
ranges
are
provided,
and
in
the
absence
of
better
information,
estimates
of
exposures
may
be
based
on
the
value
in
the
range
which
maximizes
exposure.

In
this
section
estimate
the
total
media
specific
releases
of
the
chemical
from
your
facility.
You
may
estimate
the
releases
by
using
monitoring
data
or
any
other
method
you
believe
appropriate.
Estimates
should
be
reported
in
pounds
per
year
for
the
last
calendar
year.
Enter
the
values
as
whole
numbers
to
not
more
than
two
significant
figures.
For
example,
if
your
annual
releases
are
estimated
to
be
92,360
lb,
an
estimate
of
92,000
lb
should
be
sufficient.

If
desired,
you
can
approximate
the
accuracy
of
the
annual
release
estimates
as
a
percent.
For
example,
an
estimate
of
stack
(
point)
air
releases
of
1000
pounds
with
an
accuracy
of
+
20
percent
would
indicate
that
the
releases
could
range
from
800
to
1200
pounds
per
year,
but
not
outside
this
range.

Estimate
the
number
of
days
per
year
the
release
occurs.
Enter
a
whole
number
with
a
maximum
of
2
significant
figures.

Insert
"
NA"
for
release
activities
not
associated
with
the
chemical
of
"
0"
for
releases
less
than
0.5
pounds
per
year.

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
8
Chemical
Name:
Company:
page
6
....................................................................................................................................................................................................

(
Part
V
continued)

A.
ON­
SITE
AIR
RELEASES
Estimate
the
total
fugitive
or
non­
point
releases
to
air
and
the
number
of
days/
year
the
releases
occur.
This
would
include:
equipment
leaks
from
valves,
pump
seals,
flanges,
compressors,
sampling
connections,
open­
ended
lines;
evaporative
losses
from
surface
impoundments
and
spills;
releases
from
building
ventilation
systems;
and
any
other
fugitive
or
non­
point
air
emission.

In
addition,
estimate
the
total
releases
that
occur
through
stacks,
vents,
pipes,
or
other
confined
air
streams
as
stack
or
point
source
releases.
Include
storage
tank
emissions
and
releases
from
pollution
control
equipment.

If
desired,
you
can
provide
estimates
of
the
accuracies
of
your
release
estimates.

Estimated
Total
Annual
Releases
(
lbs.)
Estimated
%
Accuracy
of
Estimate
(
Optional)
Number
of
days/
years
release
occurs
Fugitive
(
non­
point)

Stack
(
point)

Comments:
(
This
section
is
available
to
clarify
responses
given.
Attach
additional
pages
if
desired.)

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
9
Chemical
Name:
Company:
page
7
....................................................................................................................................................................................................

(
Part
V
continued)

B.
WATER
RELEASES
FROM
SITE
Estimate
the
total
releases
of
the
chemical
leaving
the
fenceline
of
your
facility
from
all
discharge
points
to
all
streams
or
water
bodies.
Include
all
discharges
from
process
outfalls
such
as
pipes,
open
trenches,
releases
from
on­
site
wastewater
treatment,
and
contribution
from
storm
water
runoff,
if
applicable.
Do
not
include
discharges
to
a
POTW
or
other
off­
site
wastewater
treatment
facilities.
If
desired,
you
can
provide
an
estimate
of
the
accuracy
of
your
estimate
of
releases.

Estimated
Total
Annual
Releases
(
lbs.)
Estimated
%
Accuracy
of
Estimate
(
Optional)

Water
releases
Number
of
days/
year
release
occurs:...........................................................................................................................................

Receiving
Water
Name:..............................................................................................................................................................

Comments:
(
This
section
is
available
to
clarify
responses
given.
Attach
additional
pages
if
desired.)

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
10
Chemical
Name:
Company:
page
8
....................................................................................................................................................................................................

(
Part
V
continued)

C.
ON­
SITE
LAND
RELEASES
Estimate
the
total
releases
of
the
chemical
for
each
category
of
land
disposal,
if
applicable.
Estimate
only
on­
site
release.
Do
not
estimate
leaks
from
landfills
separately.
This
should
accounted
for
in
your
estimate
of
total
landfill
release.

Releases
to
Land
Treatment/
Land
Amendment
includes
all
waste
containing
the
chemical
that
is
applied
or
incorporated
into
soil
on­
site.
Do
not
include
waste
that
is
landfilled.

Surface
impoundments
are
natural
topographic
depressions,
man­
made
excavations,
diked
areas
formed
primarily
of
earthened
materials
designed
to
hold
an
accumulation
of
the
chemical.

Other
releases
include
any
amount
of
the
chemical
that
is
released
to
land
other
than
those
listed.
An
example
may
be
the
accidental
release
of
the
chemical
from
an
underground
pipeline
or
storage
tank.

Estimated
Total
Annual
Releases
(
lbs.)
Estimated
%
Accuracy
of
Estimate
(
Optional)

Landfill
Land
Treatment/
Land
Amendment
Surface
Impoundments
Underground
Injection
Other
(
specify):

Comments:
(
This
section
is
available
to
clarify
responses
given.
Attach
additional
pages
if
desired.)

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
11
Chemical
Name:
Company:
page
9
....................................................................................................................................................................................................

(
Part
V
continued)

D.
OFF­
SITE
TRANSFERS
Estimates
of
off­
site
transfers
should
be
similar
in
accuracy
and
precision
as
earlier
release
estimates.

D1.
Transfer
to
Publicly
Owned
Treatment
Works
(
POTW)

Number
of
days/
years
the
release
occurs:

Estimate
the
total
quantity
of
the
subject
chemical,
not
the
waste
stream,
transferred
to
the
POTW.
Complete
section
V.
A.
for
each
POTW
to
which
your
facility
discharges
wastewater
containing
the
chemical.

Annual
Transfer
(
lb):

Estimated
%
Accuracy
of
Transfer
Estimate
(
optional)
(%):

POTW
Name:

Street
Address:

City:
Country:

State:
Zip
Code:

Comments:
(
This
section
is
available
to
clarify
responses
given.
Attach
additional
pages
if
desired.)

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
12
Chemical
Name:
Company:
page
10
....................................................................................................................................................................................................

D2.
TRANSFERS
TO
OTHER
OFF­
SITE
LOCATIONS
In
this
section
estimate
the
quantity
of
the
subject
chemical,
not
the
waste
stream,
transferred
and
the
accuracy
of
the
estimate
for
each
category
listed.
If
your
facility
sends
the
subject
chemical
in
waste
to
an
off­
site
location
where
some
of
the
chemical
is
to
be
recycled
while
the
remainder
to
be
treated,
estimate
each
separately
(
i.
e.,
waste
treatment
and
recycle
activities).

Estimated
Annual
Transfers
(
lbs.)
Estimated
%
Accuracy
of
Estimate
(
Optional)

Incineration
Wastewater
Treatment
(
excluding
POTW)

Underground
Injection
Hazardous
Waste
landfill
Other
landfill
Recycle
or
Recovery
Unknown
or
Other
Comments:
(
This
section
is
available
to
clarify
responses
given.
Attach
additional
pages
if
desired.)

..........................................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
13
Chemical
Name:
Company:
page
11
....................................................................................................................................................................................................

VI.
ON­
SITE
WORKPLACE
EXPOSURE
This
information
will
assist
the
competent
authority
in
characterizing
the
number
of
workers
potentially
exposed
and
the
magnitude,
frequency,
and
duration
of
potential
exposure.
When
providing
monitoring
data,
ensure
that
data
is
linked
with
worker
activities
described
in
question
2.

1.
Estimate
the
number
of
workers
potentially
exposed
routinely
to
the
subject
chemical
for
each
of
the
exposure
duration
times.
If
a
worker
is
involved
in
more
than
one
activity,
enter
only
his/
her
most
typical
activity
in
the
table.
Don't
count
a
worker
more
than
once.
The
total
number
in
the
table
should
equal
the
total
number
of
workers
potentially
exposed.

hrs/
day
Days/
year
<
10
10­
100
100­
250
>
250
<.
25
.25
­
1
1
­
8
>
8
2.
Describe
the
routine
worker
activities
to
which
the
workers
in
question
1
are
exposed:
sampling,
removal
of
filter
cake,
and
drumming
of
liquids,
manufacture
an
article,
etc.
For
these
activities
describe
the
physical
state
of
the
subject
chemical:
liquid,
gas,
particulate,
or
aerosol,
etc.,
and
if
in
a
mixture,
the
chemical's
concentration:

...........................................................................................................................................................................

...........................................................................................................................................................................

...........................................................................................................................................................................

...........................................................................................................................................................................

...........................................................................................................................................................................

...........................................................................................................................................................................

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
14
Chemical
Name:
Company:
page
12
....................................................................................................................................................................................................

(
Part
VI
continued)

3.
Provide
industrial
hygiene
monitoring
data,
if
available,
with
a
brief
description
of
the
sampling
method
and
exposure
scenario
monitored,
e.
g.
described
the
specific
worker
activities
performed
by
the
individuals
monitored:

...........................................................................................................................................................................

...........................................................................................................................................................................

...........................................................................................................................................................................

...........................................................................................................................................................................

4.
Briefly
describe
the
engineering
controls
used
to
minimize
exposure
to
this
chemical:

...........................................................................................................................................................................

...........................................................................................................................................................................

...........................................................................................................................................................................

...........................................................................................................................................................................

5.
Briefly
describe
the
personal
protective
equipment
your
workers
regularly
wear
to
prevent
exposure
of
this
chemical:

...........................................................................................................................................................................

...........................................................................................................................................................................

...........................................................................................................................................................................

...........................................................................................................................................................................

Comments:
(
This
section
is
available
to
clarify
responses
given.
Attach
additional
pages
if
desired.)

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
15
Chemical
Name:
Company:
page
13
....................................................................................................................................................................................................

VI.
CHEMICAL
END
USES
The
Chemical
End
Uses
section
provides
the
competent
authority
information
which
the
agency
can
use
to
identify
likely
exposure
scenarios
and
estimate
exposure
levels
for
populations
of
interest.
The
information
in
the
form
alerts
the
competent
authority
to
the
presence
of
the
chemical
of
interest
in
a
consumer,
commercial,
or
industrial
product
that
may
lead
to
exposure
either
directly
through
use
or
indirectly
through
release
to
the
environment.
Knowledge
that
a
chemical
is
consumed
as
an
intermediate
or
is
a
catalyst
that
never
leaves
the
user's
site
tells
the
competent
authority
that
the
chemical
is
a
product
where
no
further
exposure
occurs.
The
physical
form
of
the
chemical
and
the
percent
concentration
can
be
used
to
estimate
exposure
concentrations.

A.
END
USE
AS
AN
INTERMEDIATE
CONSUMED
TO
MAKE
OTHER
CHEMICALS
List
your
major
product
chemical
classes
that
consume
the
highest
volume
of
the
subject
chemical
on­
site
(
A1)
and
off­
site
(
A2).
If
you
manufacture
a
small
number
of
distinct
chemicals
using
the
subject
chemical,
you
may
prefer
to
list
specific
chemical
names
rather
than
chemical
classes.
Distinguish
between
on­
site
use
as
an
intermediate
and
off­
site
use
as
an
intermediate.
Also
provide,
for
each
use,
a
percentage
of
the
total
volume
manufactured
or
imported,
using
total
reported
in
Part
III,
page
2.
You
may
wish
to
provide
ranges
for
this
data
to
avoid
revealing
CBI.

A1.
On­
site
Uses
as
an
Intermediate:

This
information
will
be
used
by
EPA
to
develop
a
sense
of
the
extent
of
manufacturing
and
processing
operations
at
your
facility
that
may
lead
to
potential
exposures
to
the
subject
chemical.

Product
chemical
class
or
product
chemical
(
Include
CAS
number
if
appropriate)
%
of
total
(
as
reported
in
Part
III,
p.
2)
volume
of
subject
chemical
manufactured
or
imported
1.
%

2.
%

3.
%

4.
%

5.
%

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
16
Chemical
Name:
Company:
page
14
....................................................................................................................................................................................................

(
Part
VII.
A
continued)

A2.
Off­
site
Uses
as
an
Intermediate:

This
information
will
be
used
by
the
competent
authority
to
identify
downstream
use
of
the
chemical
as
an
intermediate.
This
information
will
be
used
to
identify
the
potential
for
additional
exposures
to
the
subject
chemical.

Product
chemical
class
or
product
chemical
(
Include
CAS
number
if
appropriate)
%
of
total
(
as
reported
in
Part
III,
p.
2)
volume
of
subject
chemical
manufactured
or
imported
1.
%

2.
%

3.
%

4.
%

5.
%

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
17
Chemical
Name:
Company:
page
15
....................................................................................................................................................................................................

(
Part
VII
continued)

B.
END
USES
OTHER
THAN
AS
A
CONSUMED
INTERMEDIATE
Please
complete
an
end
use
section
on
the
following
page
(
page
16)
for
each
known
non­
intermediate
end
use
of
the
chemical.
Please
copy
page
16
to
allow
for
completion
of
as
many
end
use
sections
as
necessary
to
account
for
all
nonintermediate
end
uses
of
the
chemical
known
to
you.

Describe,
as
far
as
you
know,
the
function,
the
application,
and
the
setting
for
each
of
the
non­
intermediate
end
uses
of
the
chemical.
End
Use
here
means
the
final
product
or
article
in
which
the
chemical
occurs
prior
to
ultimate
treatment,
disposal
or
recycling.

EXAMPLES:

1)
An
adhesive
(
function)
for
wood
products
fabrication
of
underlayment
(
application)
used
in
residential
dwellings
(
setting).

2)
A
filler
(
function)
in
caulking
(
application)
used
in
construction
of
marine
vessels
(
setting).

3)
A
solvent
(
function)
used
in
paint
strippers
(
application)
in
an
industrial
setting
(
setting).

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN5.
DOC/
July
1997
18
Chemical
Name:
Company:
page
16
....................................................................................................................................................................................................

B.
END
USES
OTHER
THAN
AS
CONSUMED
INTERMEDIATE
(
copy
to
cover
all
non­
intermediate
end
uses)

Use
Number_______________
of
_____________

Description
of
chemical
end
use..................................................................................................
....................................................................................................................................................
....................................................................................................................................................
....................................................................................................................................................
....................................................................................................................................................

Percent
of
total
manufactured
or
imported
volume
going
to
this
use
______%_________%
If
used
in
a
mixture
check
appropriate
box
to
indicate
weight
fraction.
Average
values
are
acceptable:

o
<
1%
o
­
30%
o
30­
60%
o
60­
90%
o
>
90%
Check
all
physical
forms
of
this
use:

o
Aerosol
o
Dry
Powder
o
Pellets
or
large
crystals
o
Water­
or
solvent­
wet
solid
o
Gas­
or
vapor
o
Liquid
solution
o
Other
(
Please
explain.).....................................
..............................................................................
..............................................................................

Use
Number_______________
of
_____________

Description
of
chemical
end
use..................................................................................................
....................................................................................................................................................
....................................................................................................................................................
....................................................................................................................................................
....................................................................................................................................................

Percent
of
total
manufactured
or
imported
volume
going
to
this
use
______%_________%
If
used
in
a
mixture
check
appropriate
box
to
indicate
weight
fraction.
Average
values
are
acceptable:

o
<
1%
o
1­
30%
o
30­
60%
o
60­
90%
o
>
90%
Check
all
physical
forms
of
this
use:

o
Aerosol
o
Dry
Powder
o
Pellets
or
large
crystals
o
Water­
or
solvent­
wet
solid
o
Gas­
or
vapor
o
Liquid
solution
o
Other
Please
explain.)...................................
..............................................................................
..............................................................................

....................................................................................................................................................................................................
Please
do
not
submit
Confidential
Business
Information
(
CBI)
on
this
form.
Please
uses
ranges
and
generic
descriptions
to
provide
as
much
non­
CBI
information
as
possible.
If
no
information
can
be
provided
without
revealing
CBI,
write
the
letters
"
CBI"
in
the
corresponding
space
on
the
form.
See
instructions
for
submittal
of
CBI
in
a
separate
mailing.
EXCH\
MANUAL\
97­
AN6.
DOC/
July
1997
1
ANNEX
6
List
of
SIDS
Contact
Points
July
1997
AUSTRALIA
Ms.
Lesley
Onyon
Manager,
Existing
Chemicals
Assessment
Worksafe
Australia
Existing
Chemicals
Division
92
Parramatta
Road
Camperdown
Sydney
NSW
2050
·
Tel:
(
61­
2)
577­
9417
·
Fax:
(
61­
2)
577­
9465
EM:
lonyojn@
worksafe.
gov.
au
AUSTRIA
Mr.
Heinrich
Kohlmann
Director
Federal
Ministry
of
Environment,
Youth
and
Family
Affairs
Stubenbastei
5
A­
1010
Wien
·
Tel:
(
43­
1)
515
22
2353
·
Fax:
(
43­
1)
515
22
7352
EM:
heinrich.
kohlmann@
bmu.
gv.
at
BELGIUM
Ms.
Thaly
Lakhanisky
Institut
Scientifique
deSanté
Publique
Louis
Pasteur
14,
rue
Juliette
Wijtsman
B­
1050
Bruxelles
·
Tel:
(
32­
2)
642­
5104
·
Fax:
(
32­
2)
642­
5224
EM:
Thaly.
Lakhanisky@
toxico.
ihe.
be
CANADA
Mr
Mark
Lewis
Environment
Canada
Commercial
Chemicals
Branch
Place
Vincent
Massey
351
St.
Joseph
Boulevard
Ottawa,
K1A
OH3
·
Tel:
(
1)
819
953
7199
·
Fax:
91)
819
953
4936
EM:
mark.
lewis@
ec.
gc.
ca
EXCH\
MANUAL\
97­
AN6.
DOC/
July
1997
2
CZECH
REPUBLIC
Mr.
Joseph
Hasa
Senior
Officer,
Ministry
of
the
Environment
Environmental
Risks
Department
Vrsovicka
65
100
10
Praha
10
·
Tel:
(
42­
2)
67122015
·
Fax:
(
42­
2)
6310308
Em:
hasa@
env.
cz
OLIS
DENMARK
Mr.
Jay
Niemela
Ministry
of
the
Environment
National
Agency
of
Environmental
Protection
29
Strandgade
DK­
1401
Copenhagen
K
·
Tel:
(
45­
32)
660­
100
·
Fax:
(
45­
32)
660­
479
EM:

FINLAND
Mr.
Jukka
Malm
Finnish
Environment
Agency
Chemicals
Division
P.
O.
Box
140
00251
Helsinki
·
Tel:
(
358­
0)
40
300
528
·
Fax:
(
358­
0)
40
300
591
EM:
JUKKA.
MALM@
VYH.
FI
FRANCE
Mme.
Laurence
Musset
Bureau
des
substances
et
préparations
chimiques
Ministère
de
l'environnement
20
avenue
de
Ségur
75302
Paris
07
SP
·
Tel:
(
33­
1)
42­
19­
15­
44
·
Fax:
(
33­
1)
42­
19­
14­
68
Em:
dppr.
sdpdl@
environnement.
gouv.
fr
OLIS
GERMANY
Dr
Ahlers
Jan
Federal
Environmental
Agency
Existing
Chemicals
Division
Bismarck
platz.
1
D­
14193
Berlin
·
Tel:
(
49­
30)
89033120
·
Fax:
(
49­
30)
89033129
Em:
jan.
ahlers@
uba.
de
Mr.
Reiner
Arndt
Bundesanstalt
fur
Arbeitsschutz
und
Anmeldestelle
Chemikaliengesetz
Friedrich
Henkel
Wej
1­
25
D­
44149
Dortmund
1
·
Tel:
(
49­
231)
9071­
279
·
Fax:
(
49­
231)
9071­
679
Em:
reiner.
arndt@
fernuni­
hagen.
de
OLIS
EXCH\
MANUAL\
97­
AN6.
DOC/
July
1997
3
GREECE
Ms
Kassandra
Dimitriou
Hellenic
Republic
Ministry
of
Finance
Division
of
Environment
An.
Tsocha
16.
Athens
11521
·
Tel:
301
6428211
·
Fax:
301
6465123
Em:

Ms
Angeliki
Tsatsou­
Dritsa
Division
of
Environment
General
Chemical
State
Laboratory
16,
An.
Tsocha
str.
1115
21
Athens
·
Tel:
301
6466917
·
Fax:
301
6465123
Em:

IRELAND
Ms.
Iona
Pratt
Health
&
Safety
Authority
10
Hogan
Place
Dublin
2
·
Tel:
(
353­
1)
662­
0400
·
Fax:
(
353­
1)
662­
0417
EM:
iona@
hsa.
ie
ITALY
Mr.
Roberto
Binetti
Istituto
Superiore
di
Sanita
Laboratory
of
Applied
Toxicology
Viale
Regina
Elena
299
I­
00161
Roma
·
Tel:
(
39­
6)
4990
2593
·
Fax:
(
39­
6)
4938
7170
EM:
binetti@
dns.
istsan.
interbusiness.
it
JAPAN
Mr.
Kenichi
Suganuma
Ministry
of
Foreign
Affairs
Economic
Affairs
Bureau
Second
International
Organisations
Div.
2­
2­
1
Kasumigaseki,
Chiyoda­
ku
Tokyo
100
·
Tel:
(
81­
3)
3581
0018
·
Fax:
(
81­
3)
3581
9470
EM:

MEXICO
Ms
Cristina
Cortinas
de
Nava
Advisor
National
Institute
of
Ecology
Av.
Revolucion
1452
Nivel
34
Mexico
D.
F.
01040
·
Tel:
525
6243389
·
Fax:
525
6243595
EM:
mcortina@
chajul.
ine.
gob.
mx
EXCH\
MANUAL\
97­
AN6.
DOC/
July
1997
4
THE
NETHERLANDS
Mrs.
Joke
E.
M.
van
Koten­
Vermeulen
National
Institute
of
Public
Health
and
Environmental
Protection
Toxicology
Advisory
Centre
P.
O.
Box
1
NL­
3720
BA
Bilthoven
·
Tel:
(
31­
30)
274­
2989
·
Fax:
(
31­
30)
274
4401
EM:
joke.
van.
koten@
rivm.
nl
NORWAY
Mr.
Geir
Jorgensen
State
Pollution
Control
Authority
P.
O.
Box
8100
Dep.
N­
0032
Oslo
1
·
Tel:
(
47­
22)
573­
400
·
Fax:
(
47­
22)
676­
706
EM:

SLOVAK
REPUBLIC
Mrs
Jana
Kovacicova
Institute
of
Preventative
&
Clinical
Medicine
Head
of
Department
of
Quality
Assurance
Limbova
14
833
01
Bratislava
·
Tel:
42
1
7373560
x
285
·
Fax:
42
1
73788815
EM:
kovacic@
enigma.
upkm.
sammet.
sk
Mr
Miroslav
Lacuska
Slovak
Environmental
Agency
Hanulova
5
D
Bratislava
844
40
·
Tel:
42
1
7769
924
·
Fax:
42
1
7782683
EM:

SPAIN
Mr.
Francisco
Vargas
Marcos
Ministerio
de
Sanidat
y
Consumo
P
°
del
Prado
18/
20
E­
28014
Madrid
·
Tel:
(
34­
1)
596
20
84/
5
·
Fax:
(
34­
1)
596
44
09
EM:

SWEDEN
Mr.
Ivar
Lundbergh
The
National
Chemicals
Inspectorate
P.
O.
Box
1384
S­
171
27
Solna
·
Tel:
(
46­
8)
730­
5700
·
Fax:
(
46­
8)
735­
7698
EM:
EXCH\
MANUAL\
97­
AN6.
DOC/
July
1997
5
SWITZERLAND
Mr.
Georg
Karlaganis­
Meyer
Office
federal
de
l'environnement
des
forets
et
du
paysage
Hallwylstrasse
4
CH­
3003
Berne
·
Tel:
(
41­
31)
322­
6955
·
Fax:
(
41­
31)
324­
7978
EM:
Georg.
Karlaganis@
buwal.
admin.
ch
UNITED
KINGDOM
Dr
Stephen
Robertson
The
Environment
Agency
Chemicals
Assessment
Unit
Steel
House,
Tothill
Street
London
SW1H
9NF
·
Tel:
(
44­
71)
664
6888
·
Fax:
(
44­
71)
276
8333
OLIS
UNITED
STATES
Mr.
Charles
Auer
US
EPA
(
7405)
Office
of
Pollution
Prevention
&
Toxics
401
M
Street,
S.
W.
Washington,
D.
C.
20460
·
Tel:
(
1­
202)
260­
3749
·
Fax:
(
1­
202)
260­
8168
EM:
auer.
charles@
epamail.
epa.
gov
Ms
Vanessa
Vu
Deputy
Director
Office
of
Pollution
Prevention
and
Toxics
US­
EPA
(
7403)
401
M
Street
Washington
D.
C.
20460
·
Tel:
(
1­
202)
260
3442
·
Fax:
(
1­
202)
260
1216
EM:
vu.
vanessa@
epamail.
epa.
gov
BIAC
Ms.
Sharon
Bially
BIAC
13­
15
Chaussée
de
la
Muette
75016
Paris
FRANCE
·
Tel:
(
33­
1)
42­
30­
09­
60
·
Fax:
(
33­
1)
42­
88­
78­
38
EM:
account.
biac@
oecd.
org
Mr
Lammert
Rinzema
Manager
Environmental
Affairs
DOW
EUROPE
Technical
Centre
Bachtobelstrasse
3
CH­
8810
Horgen
·
Tel:
(
41­
1)
728
2878
·
Fax:
(
41­
1)
728
2965
EM:
EXCH\
MANUAL\
97­
AN6.
DOC/
July
1997
6
TUAC
Mr.
John
Evans
TUAC
26
ave
de
la
Grande
Armée
75017
Paris
·
Tel:
(
33­
1)
47­
63­
42­
63
·
Fax:
(
33­
1)
47­
54­
98­
28
EM:

EUROPEAN
COMMISSION
Mr.
Patrick
McCutcheon
European
Commission
DG
XI
200
rue
de
la
Loi
B­
1049
Bruxelles
BELGIUM
·
Tel:
(
32­
2)
296­
3849
·
Fax:
(
32­
2)
295­
6117
EM:
patrick.
mccutcheon@
dg11.
cec.
be
WHO
­
IPCS
M.
Maged
Younes
IPCS
WHO
European
Centre
for
Environment
and
Health
CH­
1211
Geneve
27
SUISSE
·
Tel:
(
41­
22)
791
3574
·
Fax:
(
41­
22)
791
4848
EM:
younesm@
who.
ch
IRPTC­
UNEP
Ms.
Fatoumata
Ouane
IRPTC­
UNEP
Case
Postale
356
15
Chemin
de
Anemones
CH­
1219
Geneve
SWITZERLAND
·
Tel:
(
41­
22)
979­
9161
·
Fax:
(
41­
22)
797­
3460
EM:
fouane@
unep.
ch
OECD
OECD
Environmental
Health
and
Safety
Division
(
Attn.
Mr.
Kazu
Chikazawa)
2
rue
André­
Pascal
75775
Paris
Cedex
16
Paris
FRANCE
·
Tel:
(
33­
1)
45­
24­
98­
49
·
Fax:
(
33­
1)
45­
24­
16­
75
EM:
kazuhiko.
chikazawa@
oecd.
org