Developmental & Reproductive Toxicity (DART) Reports
About Technical Reports
Long-term NTP toxicology and carcinogenicity studies usually involve exposing laboratory animals (rats and mice) to a substance for a period of two years. These studies are designed and conducted to characterize and evaluate the toxicologic potential, including carcinogenic activity, of selected substances. Substances selected for NTP toxicology and carcinogenesis studies are chosen primarily on the basis of human exposure, level of production, and chemical structure. Substance selection is not an indicator of a substance's carcinogenic potential.
The methods, results, and conclusions of these studies are published in NTP's Technical Report (TR) series after undergoing peer review. The interpretive conclusions presented in Technical Reports and Abstracts are based only on the results of these NTP studies.
Learn More About NTP Technical Reports
The studies described in the Technical Reports are performed under the direction of NTP and adhere to the following standards:
- Studies are conducted in compliance with NTP laboratory health and safety requirements.
- Studies meet or exceed all applicable federal, state, and local health and safety regulations.
- Animal care and use are in accord and compliance with the Public Health Service Policy on Humane Care and Use of Animals.
- Studies are also conducted in compliance with Food and Drug Administration Good Laboratory Practice Regulations (21 CFR, Part 58).
Abstracts are taken from the technical reports and include a link to the full report at the start of the abstracts. When available, the abstracts also link to supporting pathology tables, survival and growth curves; target organs and tumor incidences; and 2-D structures at the end of each abstract.
Definition of Carcinogenicity Results
For more information, contact the NTP Web Team:
- NTP Web Team
- P.O. Box 12233, MD K2-05 Research Triangle Park, NC 27709
- 984-287-3211
- [email protected] or use our contact form
AIDS Therapeutics Toxicity Studies Program
Infection with human immunodeficiency virus (HIV) causes suppression of the immune system. Infection leads to acquired immunodeficiency syndrome (AIDS) with a broad spectrum of opportunistic infections. Treatment of AIDS generally involves combination therapies of antiretroviral agents with antimicrobial drugs specific for the opportunistic infections.
The National Institute of Environmental Health Sciences (NIEHS), under the AIDS research program, collaborated with other institutes of the NIH, other government agencies, and pharmaceutical companies to evaluate facets of AIDS therapeutics including:
- Reproductive/developmental toxicity
- General toxicity
- Immunotoxicity
- Neurotoxicity
These evaluations included single therapeutic agents or combination therapies when the toxic potential of these substances in animal models was not available or was incomplete. The studies with combination therapies were very important. They were vital because they increased awareness and understanding of interactions between antiretroviral therapies and other drugs/substances that HIV-infected individuals use.
AIDS Publication Abstracts
- Sanders VM, Elwell MR, Heath JE, Collins BJ, Dunnick JK, Rao GN, Prejean D, Lindamood C 3rd, Irwin RD. Induction of thymic lymphoma in mice administered the dideoxynucleoside ddC. Fundam Appl Toxicol. 1995;27(2):263-269.
- Rao GN, Collins BJ, Giles HD, Heath JE, Foley JF, May RD, Buckley LA. Carcinogenicity of 2',3'-dideoxycytidine in mice. Cancer Res. 1996;;56(20):4666-4672.
- Rao GN, Lindamood C 3rd, Heath JE, Farnell DR, Giles HD. Subchronic toxicity of human immunodeficiency virus and tuberculosis combination therapies in B6C3F1 mice. Toxicol Sci. 1998;45(1):113-127.
Other AIDS Information Sites
- Division of Acquired Immune Deficiency Syndrome – National Institute of Allergy and Infectious Diseases
- AIDS Information Resources – The National Library of Medicine
- NIH Office of AIDS Research (OAR) – National Institutes of Health
- CDC National Prevention Information Network – Centers for Disease Control and Prevention
- The Joint United Nations Program on HIV/AIDS
- AIDS Hotlines and Service Organizations
About Toxicity Reports
The NTP Toxicity Report Series (TOX) includes reports about short-term studies. These studies usually involve exposing laboratory animals (rats and mice) for 3 months to evaluate the toxicity, but exposure can be any duration less than one year. Substances selected for short-term studies are chosen primarily on the basis of human exposure, level of production, and chemical structure. The selection of a substance is not an indicator of its carcinogenic potential.
The report abstracts in the NTP Toxicity Report Series include brief descriptions of the findings, but a link to the full report is listed at the end of each abstract. In some cases, the short-term studies for a particular substance may be reported with longer term studies and not included in the TOX report series.
The NTP Toxicity Reports are peer-reviewed by at least two external experts, typically in the fields of toxicology, pathology, or other field applicable to the study. NTP also maintains a list of studies undergoing review.
Learn More About Short-Term Studies
Because short-term study experiments are conducted under a limited set of conditions, relating the findings from short-term studies to human health requires additional information and possibly further testing. Positive short-term study findings mean that a substance is toxic for laboratory animals and that exposure to the substance is potentially hazardous to humans. Negative short-term study results mean that study animals did not have a greater incidence of toxicity than control animals; however, negative results do not necessarily mean that a substance is not toxic.
The studies described in the NTP Toxicity Report Series are performed under the direction of NTP. The short-term studies:
- Comply with NTP laboratory health and safety requirements.
- Meet or exceed all applicable federal, state, and local health and safety regulations.
- Comply with the Public Health Service Policy on Humane Care and Use of Animals.
- Comply with Food and Drug Administration Good Laboratory Practice Regulations (21 CFR, Part 58).
Abstracts are taken from the published reports for the individual studies. A link to the full report is listed at the end of each abstract.
For more information, contact the NTP Web Team:
- NTP Web Team
- P.O. Box 12233, MD K2-05 Research Triangle Park, NC 27709
- 984-287-3211
- [email protected] or use our contact form
About Research Reports
NTP research reports cover research and literature-analysis activities that do not fall under the scope of existing report series.
About Immunotoxicity Reports
NTP has developed a range of techniques and testing regimens for evaluating the potential of environmental and occupational substances to damage the immune system. These materials may include:
- Food additives
- Natural products such as mycotoxins
- Products used in the pharmaceutical, farming, chemical, or consumer product industries
Immunotoxicity tests are designed to evaluate immune function and hypersensitivity. These tests are carried out using rodent models, cultured mammalian cells, and other in vitro methods.
About Genetically Modified Model Reports
Genetically modified model reports evaluate the toxicologic potential, including carcinogenic activity, of selected agents in laboratory animals that have been genetically modified. There are two animal types used:
TG.AC: This mouse model has an alteration of specific tumor suppressor genes that have been shown to be associated with induced tumors in rodents and in human malignancies.
P53 deficient: This mouse model has an alteration of the p53 tumor suppressor gene, which is critical to cell cycle control and DNA repair.
About Developmental & Reproductive Toxicity (DART) Reports
NTP has developed a range of techniques and testing regimes to evaluate the potential of environmental and occupational substances to affect development and damage reproductive systems.
Prenatal developmental toxicity studies identify substances that may pose a risk to the developing fetus if pregnant women are exposed. Regulatory agencies use the results of well-conducted animal studies to help set human exposure guidelines.
We have also developed methods for evaluating the potential toxic effects of exposure to environmental and occupational substances on the reproductive system. These studies are carried out primarily using rodent models.
Note on Accessibility: Persons with disabilities or using assistive technology may find some documents are not fully accessible. For assistance, email us or use our contact form and identify the documents/pages for which access is required. We will assist you in accessing the content of these files. NIEHS has helpful information on accessibility.
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| Abstract | Full Text | Report Title | Year | Type |
|---|---|---|---|---|
| DART-08 | PDF (5.82 MB) | Modified One-Generation Study of Bisphenol AF (CASRN 1478-61-1) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley SD) Rats with Prenatal, Reproductive Performance, and Subchronic Assessments in F1 Offspring | 2022 | Developmental & Reproductive Toxicity |
| DART-07 | PDF (1.59 MB) | Prenatal Development Studies of 2-((1-(4-Phenoxyphenoxy)propan-2-yl)oxy)pyridine (CASRN 95737-68-1) in Sprague Dawley (Hsd:Sprague Dawley SD) Rats and New Zealand White (Hra:NZW SPF) Rabbits | 2022 | Developmental & Reproductive Toxicity |
| DART-06 | PDF (5.17 MB) | Modified One-Generation Study of 2-Ethylhexyl p-Methoxycinnamate (CASRN 5466-77-3) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley SD) Rats with Prenatal, Reproductive Performance, and Subchronic Assessments in F1 Offspring | 2022 | Developmental & Reproductive Toxicity |
| DART-05 | PDF (5.97 MB) | Modified One-Generation Study of 2-Hydroxy-4-methoxybenzophenone (CASRN 131-57-7) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley SD) Rats with Prenatal and Reproductive Performance Assessments in F1 Offspring | 2022 | Developmental & Reproductive Toxicity |
| DART-04 | PDF (1006.3 KB) | Prenatal Development Studies of Dimethylaminoethanol Bitartrate (CASRN 5988-51-2) in Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Gavage Studies) | 2020 | Developmental & Reproductive Toxicity |
| DART-03 | PDF (1.17 MB) | Prenatal Development Studies of Vinpocetine (CASRN 42971-09-5) in Sprague Dawley (Hsd:Sprague Dawley SD) Rats and New Zealand White (Hra:Nzw Spf) Rabbits (Gavage Studies) | 2020 | Developmental & Reproductive Toxicity |
| DART-02 | PDF (1.09 MB) | Prenatal Development Studies of 4-Methylcyclohexanemethanol (CASRN 34885-03-5) in Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Gavage Studies) | 2020 | Developmental & Reproductive Toxicity |
| DART-01 | PDF (937.57 KB) | Prenatal Development Studies of Tris(chloropropyl) Phosphate (CASRN 13674-84-5) in Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Gavage Studies) | 2020 | Developmental & Reproductive Toxicity |