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Vol.
25 No. 1
January - February 2003
Concise International
Chemical Assessment Document
A
series of monographs by the International Programme on Chemical
Safety
World Health Organization,
Geneva (1998-2002)
reviewed
by John H. Duffus
Before reviewing this series
of publications, it is important to define what they are,
what their purpose is, and to describe the procedure by which
they are prepared. The procedure is particularly important
because it is designed to ensure that the Concise International
Chemical Assessment Documents (CICADs) are authoritative and
trustworthy sources of the fundamental information required
to carry out risk assessments. These assessments then lead
to effective risk management of substances used worldwide,
helping to ensure human safety and environmental protection.
The CICADs are short documents
that provide summaries of the scientific information available
on the potential effects of chemicals upon human health and/or
the environment. These documents are based on selected national
or regional evaluations or on existing International Programme
on Chemical Safety (IPCS) Environmental Health Criteria Documents
(EHCs). Before acceptance for publication as CICADs by IPCS,
the draft documents are subjected to extensive peer review
by internationally selected experts to ensure their completeness,
accuracy in how the original data are represented, and the
validity of the conclusions drawn. Unless otherwise stated,
CICADs are based on a search of the scientific literature
to the date shown in the executive summary. International
Chemical Safety Cards (ICSCs) on the relevant chemical(s)
are attached at the end of each CICAD to provide the reader
with the essential summary information on the protection of
human health and on emergency action. The ICSCs are produced
by a separate peer-reviewed procedure. Further information
may be obtained from the Poison Information Monographs, also
produced by IPCS.
The primary objective of CICADs
is to characterize the hazard and doseresponse relationship
associated with exposure to a chosen priority chemical. CICADs
are not a summary of all available data but include only the
information considered critical for characterization of risk.
Critical studies are described in sufficient detail to indicate
how they support the conclusions drawn. Risks to human health
and the environment vary depending upon the type and extent
of exposure. Users of the CICADs are encouraged to characterize
risk on the basis of appropriate locally measured or predicted
exposure scenarios. For the readers guidance, examples
of exposure estimation and risk characterization are provided
in CICADs whenever possible.
The flow chart shows the procedures
followed to produce a CICAD. The IPCS Risk Assessment Steering
Group advises the coordinator, IPCS, on the selection of chemicals
for an IPCS risk assessment, the appropriate form of the document
(i.e., EHC or CICAD), and which institution should have the
responsibility of the document production, as well as on the
type and extent of the international peer review. The first
draft is based on an existing national, regional, or international
review. Authors of the first draft are usually, but not necessarily,
from the institution that developed the original review.
The first draft undergoes
primary review by IPCS and one or more experienced authors
of criteria documents to ensure that it meets the specified
criteria for CICADs. The draft is then sent for international
peer review by scientists known for their relevant expertise
and by scientists selected from an international roster compiled
by IPCS through recommendations from IPCS National Contact
Points and from IPCS Participating Institutions.
The CICAD Final Review Board
ensures that each CICAD has been subjected to an appropriate
and thorough peer review; verifies that the peer reviewers
comments have been addressed appropriately; provides guidance
on how to resolve remaining issues if, in the opinion of the
board, the author has not adequately addressed all comments
of the reviewers; and approves CICADs for publication as trustworthy
international assessments. Board members serve in their personal
capacity, not as representatives of any organization, government,
or industry. They are selected because of their expertise
in human and environmental toxicology or because of their
experience in the regulation of chemicals and with regard
to the need for balanced geographic representation. It is
important to note that board members, authors, reviewers,
consultants, and advisers who participate in the preparation
of a CICAD are required to make a public declaration of any
real or potential conflict of interest in relation to the
subjects under discussion at any stage of the process in order
to ensure impartiality. All of these rules are designed to
ensure impartiality and give the CICADs and related documents
their authority as the most reliable sources of information
for chemical risk assessment.
But what information can you
expect to find in a CICAD? The first section is an executive
summary, followed by details relating to the identity and
physical/ chemical properties of the substance(s) considered
and the analytical methods used for monitoring. Then, there
are reviews of sources of human and environmental exposure,
of the possibilities for environmental transport, distribution,
and transformation; and of the current status of environmental
and human exposures. Next, the evidence linking exposure (dose)
to effects and to population response in laboratory animals
and in humans is described and assessed, including that from
in vitro studies and from studies of toxico-kinetics
and fundamental metabolic processes. Case studies and epidemiological
investigations are also considered.
In addition, any information
on effects on other organisms in the laboratory and in the
field is collated and, finally, an effects evaluation is carried
out. This evaluation may lead to suggested criteria for setting
tolerable exposure limits or guidance values and suggestions
for further research to clarify points of importance. A final
section summarizes previous evaluations by international bodies.
There is then a list of the references used in preparing the
document followed by appendices describing the main source
document and listing the members of the peer review group
and of the final review board. The relevant ICSCs and French
and Spanish translations of the executive summary complete
the document.
At the time of writing, more
than 40 CICADs have been published and these are listed below.
The Concise International
Chemical Assessment Documents
- Acrylonitrile (No. 39,
2002)
- Azodicarbonamide (No.
16, 1999)
- Barium and barium compounds
(No. 33, 2001)
- Benzoic acid and sodium
benzoate (No. 26, 2000)
- Benzyl butyl phthalate
(No. 17, 1999)
- Beryllium and beryllium
compounds (No. 32, 2001)
- Biphenyl (No. 6, 1999)
- 1,3-Butadiene: human health
aspects (No. 30, 2001)
- 2-Butoxyethanol (No. 10,
1998)
- Chloral hydrate (No. 25,
2000)
- Chlorinated naphthalenes
(No. 34, 2001)
- Chlorine dioxide (No.
37, 2002)
- Crystalline silica, quartz
(No. 24, 2000)
- Cumene (No. 18, 1999)
- 1,2-Diaminoethane (No.
15, 1999)
- 3,3-Dichlorobenzidine
(No. 2, 1998)
- 1,2-Dichloroethane (No.
1, 1998)
- 2,2-Dichloro-1,1,1-trifluoroethane
(HCFC-123) (No. 23, 2000)
- Diethylene glycol dimethyl
ether (No. 41, 2002)
- N,N-Dimethylformamide
(No. 31, 2001)
- Diphenylmethane diisocyanate
(MDI) (No. 27, 2001)
- Ethylenediamine (No. 15,
1999)
- Ethylene glycol: environmental
aspects (No. 22, 2000)
- Formaldehyde (No. 40,
2002)
- 2-Furaldehyde (No. 21,
2000)
- Limonene (No. 5, 1998)
- Manganese and its compounds
(No. 12, 1999)
- N-Methyl-2-pyrrolidone
(No. 35, 2001)
- Methyl and ethyl cyanoacrylates
(No. 36, 2001)
- Methyl chloride (No. 28,
2001)
- Methyl methacrylate (No.
4, 1998)
- Mononitrophenols (No.
20, 2000)
- N-nitrosodimethylamine
(No. 38, 2002)
- Phenylhydrazine (No. 19,
2000)
- N-Phenyl-1-naphthylamine
(No. 9, 1998)
- 1,1,2,2-Tetrachloroethane
(No. 3, 1998)
- 1,1,1,2-Tetrafluoroethane
(No. 11, 1998)
- o-Toluidine (No.
7, 1998)
- Tributyltin oxide (No.
14, 1999)
- Triglycidyl isocyanurate
(No. 8, 1998)
- Triphenyltin compounds
(No. 13, 1999)
- Vanadium pentoxide and
other inorganic vanadium compounds (No. 29, 2001)
It is clear that the CICADs
are extremely valuable sources of information for anyone concerned
with any aspect of chemical safety. They should be the first
resource for valid, independently assessed information against
which to judge the often poorly founded assertions made by
those who have vested interests in exaggerating risks or in
playing them down. Many of the CICADs are available on the
IPCS Web site <www.inchem.org>.
For those interested in the safe use of chemicals, this site
contains a treasure chest of freely available information.
www.who.int/dsa/cicads.htm
| www.inchem.org
John
H. Duffus <[email protected]>
worked at the Edinburgh Centre for Toxicology in Edinburgh,
United Kingdom.
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last modified 21 December 2002.
Copyright © 2002 International Union of Pure and Applied
Chemistry.
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