Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity (2001) / Chapter Skim
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Appendix B: Ascertaining Information on the Reproductive and Developmental Tocicity of Agent Exposures
Appendix B: Ascertaining Information on the Reproductive and Developmental Tocicity of Agent Exposures
Pages 168-197
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From page 168... ...
Some resources include only information published in the open literature; others emphasize studies, often unpublished, that have been submitted for regulatory review. This appendix describes many of the information resources available on reproductive and developmental toxicology that should be useful to the Navy for conducting evaluations.
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From page 171... ...
The final section describes additional sources of information that might be useful for assessing agent exposures for potential reproductive and developmental toxicity. Quality control, including the extent of peer review, is noted for each source, as well as the subcomm~ttee's evaluation of the usefulness of the source in identifying exposures that pose a substantial risk of reproductive or developmental toxicity in humans.
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From page 172... ...
Reproductive and Developmental Toxicity The DART Identification Committee evaluated each selected agent for male and female reproductive toxicity and developmental toxicity in humans and experimental animals. It also reviews other types of available toxicity data (e.g., acute and carcinogenicity)
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From page 173... ...
integrating the reproductive and developmental toxicity data with information derived from the review of toxicological and biological properties, including pharmacokinetic data and exposure information; and (5) determining the certainty of the judgments about an agent's potential reproductive and developmental risk to humans.
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From page 174... ...
Center for the Evaluation of Risks to Human Reproduction will provide comprehensive, unbiased, and scientifically sound assessments of reproductive hearth hazards (including developmental health hazards) associated with human exposures to environmental agents.
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From page 175... ...
Reproductive and Developmental Toxicity Reproductive Hazards of Industrial Chemicals provides detailed discussions of the full range of reproductive toxicity. Data from animal studies and investigations in humans are considered separately.
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From page 176... ...
Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental Toxicity in Humans Reproductive Hazards of Industrial Chemicals is a valuable guide to information available prior to 1982 on the reproductive toxicity of the chemicals included. Unfortunately, the book is out of date and has not been revised.
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From page 177... ...
The primary intended audience is obstetricians and other physicians. Quality Control REPROTOX is written by clinical teratologists who have recognized expertise in the interpretation of reproductive and developmental toxicology studies in the context of actual human exposures.
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From page 178... ...
Usefulness in identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental Toxicity in Humans REPROTOX is useful civically. It provides succinct, authoritative overviews of the reproductive and developmental toxicity of a large number of chemical exposures, including many important occupational exposures.
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From page 179... ...
Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental Toxicity in Humans This book provides a useful overview of mammalian teratology studies on many important occupational exposures. When extensive data are available, they are interpreted in the context of human reproductive hazards.
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From page 180... ...
Reproductive and Developmental Toxicity TERIS is designed to assist in counseling pregnant women about possible developmental risks; other forms of reproductive toxicity are not considered. In addition to brief critical reviews and references to the peer-reviewed literature, each TERIS summary contains an assessment of the risk of teratogenic effects in children of women with typical exposures during pregnancy.
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From page 181... ...
. DART has more extensive coverage of the reproductive and developmental toxicology literature than Medlars Online (MEDLINE)
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From page 182... ...
Many of them, but not all, have been subjected to conventional peer review prior to publication. Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental Toxicity in Humans DART is an essential toot in identifying recent published literature on reproductive and developmental toxicology, but considerable expertise is required to interpret the information obtained in terms of risks related to actual human exposures.
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From page 183... ...
Many of them, but not all, have been subjected to conventional peer review prior to publication. Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive and Developmental Toxicity in Humans ETTCBACK is a useful tool in identifying older published literature on reproductive and developmental toxicology, but considerable expertise is required to interpret the information obtained in terms of risks related to actual human exposures.
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From page 184... ...
The studies are conducted in experimental animals and are designed to determine a dose-response relationship and to detect potential for reproductive toxicity. This information can be used to provide a basis for human risk assessment.
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From page 185... ...
The study reports are evaluated by a standing subcommittee of the NTP Board of Scientific Counselors. Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive and Developmental Toxicity in Humans The studies are designed to test selected agent exposures for reproductive toxicity, but considerable expertise is required to extrapolate the findings to humans.
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From page 186... ...
The results can be used to select chemicals for further study, to delineate the relative toxicities of structurally related chemicals, and to identify the proper dose range for subsequent toxicity studies. Quality Control The results of all NTP studies undergo rigorous public peer review.
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From page 187... ...
Usefulness in [den tifying Exposures That Pose a Substantial Risk of Reproductive or Developmental Toxicity in Humans Information presented in the profiles can be useful for identifying and summarizing studies relevant to reproductive and developmental toxicity. Significant exposures to substances are reported.
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From page 188... ...
Human data and animal studies are considered separately and assessed in terms of potential implications for human occupational exposures. Quality Control NIOSH criteria documents are developed by NIOSH staff and reviewed by external expert consultants.
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From page 189... ...
Reproductive and Developmental Toxicity Each agent evaluation has a section that briefly summarizes reproductive and developmental effects using the traditional TARC format of presenting human data separately from data in experimental systems. Quality Control {ARC working groups are composed of individuals with expertise related to cancer.
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From page 190... ...
TPCS Environmental Health Criteria Documents reflect the collective view of an international group of experts and do not necessarily represent the decision or stated policy of UNEP, ILO, or WHO. The reports summarize and interpret the pertinent published literature.
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From page 191... ...
IS lSSUe~. Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental Toxicity in Humans The Environmental Health Criteria Documents provide information on reproductive and developmental effects for selected agents that can be useful for identifying important studies.
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From page 192... ...
Quality Control Draft IRTS summaries and support documents undergo rigorous internal and external peer review, followed by an agency-scientific consensus review. The TRTS program manager oversees the consensus process and provides quality control of all documents.
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From page 193... ...
Reproductive and Developmental Toxicity Available reproductive and developmental toxicity data are reviewed and summarized. Quality Control All NCEA documents undergo internal and external peer review according to EPA, ORD, and NCEA policies.
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From page 194... ...
There is no formal external peer review of the summaries. Usefulness in identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental Toxicity in Humans The book provides a short, authoritative overview of the information available on the occupational toxicology of many important chemical exposures.
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From page 195... ...
PUBMED can be accessed on the Internet at: http://www.ncbi.nIm.nih.gov/entrez/ query.fcg~. Primary Data National Toxicology Program Toxicology Report Series Description Acute or repeated dose studies of up to 90 days are conducted in rats and mice on selected agents under the direction of NTEHS.
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From page 196... ...
Organization for Economic Cooperation and Development Screening Information Data Set Profiles Description The Organization for Economic Cooperation and Development (OECD) has committed to the development and assessment of a core
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From page 197... ...
Dossiers are subsequently reviewed by an international committee of experts. Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental Toxicity in Humans The STDS profiles rank chemical substances based on their potential environmental and human health effects.
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