EHC 226: Palladium
viii
10. EVALUATION OF HUMAN HEALTH RISKS AND EFFECTS ON
THE ENVIRONMENT
138
10.1
Evaluation of human health risks
138
10.1.1
Exposure levels
138
10.1.1.1 General population exposure
138
10.1.1.2 Occupational exposure
139
10.1.2
Fate in the body
140
10.1.3
Health hazards
140
10.1.4
Dose–response relationships
141
10.1.5
Health-based guidance value
142
10.2
Evaluation of effects on the environment
142
10.2.1
Exposure levels
142
10.2.2
Persistence, fate and transport
143
10.2.3
Toxicity and dose–effect/response
relationships
143
10.2.4
Guidance value
144
11. CONCLUSIONS AND RECOMMENDATIONS FOR
PROTECTION OF HUMAN HEALTH AND THE
ENVIRONMENT
145
11.1
Dental health
145
11.2
Occupational health
145
11.3
Analysis
146
11.4
Environment
146
12. FURTHER RESEARCH
147
13. PREVIOUS EVALUATIONS BY INTERNATIONAL BODIES
148
REFERENCES
149
RESUME
173
RESUMEN
188
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NOTE TO READERS OF THE CRITERIA MONOGRAPHS
Every effort has been made to present information in the criteria
monographs as accurately as possible without unduly delaying their
publication. In the interest of all users of the Environmental Health Criteria
monographs, readers are requested to communicate any errors that may have
occurred to the Director of the International Programme on Chemical Safety,
World Health Organization, Geneva, Switzerland, in order that they may be
included in corrigenda.
* * *
A detailed data profile and a legal file can be obtained from the
International Register of Potentially Toxic Chemicals, Case postale 356, 1219
Châtelaine, Geneva, Switzerland (telephone no. + 41 22 – 9799111, fax no. +
41 22 – 7973460, E-mail irptc@unep.ch).
* * *
This publication was made possible by grant number 5 U01 ES02617-15
from the National Institute of Environmental Health Sciences, National
Institutes of Health, USA, and by financial support from the Federalö
Ministry for the Environment, Nature conservation and Nuclear Safety,
Germany.
x
Environmental Health Criteria
P R E A M B L E
Objectives
In 1973, the WHO Environmental Health Criteria Programme was
initiated with the following objectives:
(i)
to assess information on the relationship between exposure to
environmental pollutants and human health, and to provide guidelines for
setting exposure limits;
(ii)
to identify new or potential pollutants;
(iii)
to identify gaps in knowledge concerning the health effects of pollutants;
(iv)
to promote the harmonization of toxicological and epidemiological
methods in order to have internationally comparable results.
The first Environmental Health Criteria (EHC) monograph, on mercury,
was published in 1976, and since that time an ever-increasing number of
assessments of chemicals and of physical effects have been produced. In
addition, many EHC monographs have been devoted to evaluating toxicological
methodology, e.g., for genetic, neurotoxic, teratogenic and nephrotoxic effects.
Other publications have been concerned with epidemiological guidelines,
evaluation of short-term tests for carcinogens, biomarkers, effects on the
elderly and so forth.
Since its inauguration, the EHC Programme has widened its scope, and
the importance of environmental effects, in addition to health effects, has been
increasingly emphasized in the total evaluation of chemicals.
The original impetus for the Programme came from World Health
Assembly resolutions and the recommendations of the 1972 UN Conference
on the Human Environment. Subsequently, the work became an integral part
of the International Programme on Chemical Safety (IPCS), a cooperative
xi
programme of UNEP, ILO and WHO. In this manner, with the strong support
of the new partners, the importance of occupational health and environmental
effects was fully recognized. The EH C monographs have become widely
established, used and recognized throughout the world.
The recommendations of the 1992 UN Conference on Environment and
Development and the subsequent establishment of the Intergovernmental
Forum on Chemical Safety with the priorities for action in the six programme
areas of Chapter 19, Agenda 21, all lend further weight to the need for EHC
assessments of the risks of chemicals.
Scope
The criteria monographs are intended to provide critical reviews on the
effects on human health and the environment of chemicals and of combinations
of chemicals and physical and biological agents. As such, they include and
review studies that are of direct relevance for the evaluation. However, they
do not describe every study carried out. Worldwide data are used and are
quoted from original studies, not from abstracts or reviews. Both published
and unpublished reports are considered, and it is incumbent on the authors to
assess all the articles cited in the references. Preference is always given to
published data. Unpublished data are used only when relevant published data
are absent or when they are pivotal to the risk assessment. A detailed policy
statement is available that describes the procedures used for unpublished
proprietary data so that this information can be used in the evaluation without
compromising its confidential nature (WHO (1999) Revised Guidelines for the
Preparation of Environmental Health Criteria Monographs. PCS/99.9, Geneva,
World Health Organization).
In the evaluation of human health risks, sound human data, whenever
available, are preferred to animal data. Animal and in vitro studies provide
support and are used mainly to supply evidence missing from human studies.
It is mandatory that research on human subjects is conducted in full accord
with ethical principles, including the provisions of the Helsinki Declaration.
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