Nominations in Review 2009 (Fall)
* Note: The terms "initial toxicological characterization" and "comprehensive toxicological characterization" in this table refer to the approximate scope of a research program to address toxicological data needs. The types of toxicological studies that would be considered by NTP staff during the conceptualization and design of a research program for each are:
- Initial toxicological characterization: biomolecular screening, in vitro mechanistic, in vitro and in vivo genotoxicity, absorption, disposition, metabolism, and elimination, and short-term repeat dose (2-4 weeks) in vivo studies
- Comprehensive toxicological characterization: all of the aforementioned plus subchronic toxicity (13-26 weeks), chronic toxicity (1-2 years), carcinogenicity in conventional or genetically modified rodent models, organ systems toxicity (immunotoxicity, reproductive and developmental toxicity, neurotoxicity), in vivo mechanistic, toxicokinetics, and other special studies as appropriate (e.g. chemistry, toxicogenomics, phototoxicity).
Learn more about NTP Study Types.
For information, questions or comments, contact:
Dr. Scott A. Masten
Director, Office of Nomination and Selection
Division of the National Toxicology Program
National Institute of Environmental Health Sciences
Research Triangle Park, NC 27709
(919) 541-5710 (voice)
(301) 451-5599 (fax)
| Substance [CAS No.] |
Nomination Source | Nomination Rationale (Principles) |
Preliminary Study Recommendations |
|---|---|---|---|
Butterbur (Petasites hybridus) extract
 (760 KB)[90082-63-6] |
NIEHS | Use as a dietary supplement; lack of toxicological data; suspicion of toxicity based on pharmacological activity of constituents; potential presence of toxic pyrrolizidine alkaloids | Comprehensive toxicological characterization |
| Substance [CAS No.] |
Nomination Source | Nomination Rationale (Principles) |
Preliminary Study Recommendations |
|---|---|---|---|
|
Evening primrose oil (Oenothera biennis L.) extract
(532 KB) [90028-66-3] |
NIEHS | Use as a dietary supplement, particularly for immune conditions; lack of adequate toxicological data |
-Initial toxicological characterization -Immunotoxicity studies -Reproductive toxicity studies |
| Substance [CAS No.] |
Nomination Source | Nomination Rationale (Principles) |
Preliminary Study Recommendations |
|---|---|---|---|
|
Hydroquinone
(452 KB) [123-31-9] |
U.S. Food and Drug Administration | Use in drugs and cosmetics; evidence of carcinogenicity from oral exposures in prior NTP studies; insufficient toxicological data for regulatory hazard determination |
-Dermal toxicity and carcinogenicity studies -Reproductive toxicity studies |
| Substance [CAS No.] |
Nomination Source | Nomination Rationale (Principles) |
Preliminary Study Recommendations |
|---|---|---|---|
|
Silica flour
(700 KB) [14808-60-7] |
Private Individual | Use in industrial and consumer products; inhalation exposures associated with autoimmune disease; lack of toxicity data for oral and dermal exposures; insufficient data to evaluate dose-response for renal and autoimmune effects by any route of exposure |
-Initial toxicological characterization via oral and dermal routes of administration -Immunotoxicity studies |
| Substance [CAS No.] |
Nomination Source | Nomination Rationale (Principles) |
Preliminary Study Recommendations |
|---|---|---|---|
|
Valerian (Valeriana officinalis L.) root extract
(1.5 MB) [8057-49-6] Valerian oil (1.5 MB)[8008-88-6] |
NIEHS | Use as a dietary supplement; lack of toxicological data; concern for adverse developmental and reproductive effects | Comprehensive toxicological characterization |
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