Monascus Color Y-001, a natural food pigment produced from purpureus Y-001 fermentation, was administered orally by gavage to 4 Beagle dogs/sex/group for 90 days at doses of 0 (vehicle: 0.1% Tween 80, 10 mL/kg bw), 1, 5 and 25 mg/kg bw/day. In the clinical observations, vomiting/vomitus (dark red watery substance or undigested feed) observed males females in 25, but not 1 bw/day group relativel...

Neutralact(R), the DSM brand name of a lactase enzyme preparation, obtained from a homologous rDNA strain of Kluyveromyces lactis, was subjected to a series of toxicological tests to document the safety for use as a processing aid in the dairy industry. The enzyme preparation was examined for subacute oral toxicity and mutagenic potential. As a result of these tests, no evidence of oral toxicit...

Acute toxicity of 4-nonylphenol (NP) was examined in six freshwater species from three phyla - platyhelminthes, arthropoda and mollusca. Values of the 48-hour LC(50) of NP for six species ranged from 20 to 508 ug/L and values of the 96-hour LC(50) for four species ranged from 120 to 457 ug/L. The most sensitive species tested was a water flea, Ceriodaphnia cornuta, with a 48-hour LC(50) of 20 m...

A 90-day oral toxicity study of γ-oryzanol, a rice-derived triterpenoid ferulate, was performed by oral gavage administration to male and female Sprague-Dawley rats at doses of 0, 1000, and 2000 mg/kg body weight/day. All rats administered γ-oryzanol survived throughout the study period. Both male and female rats showed no toxicologically significant changes of the general signs, examination fi...

Pesticides are major contaminating chemicals in agriculture environment and a hazard to exposed population. These compounds are absorbed by inhalation, ingestion, and dermal contact. Their bioavailability in the individuals can lead to a variety of metabolic and systemic dysfunctions, and even outright disease states. Therefore, the tremendous usage of pesticides has promoted toxicological stud...

Two well-documented examples of studies that can be eliminated from the data requirement list without apparent impact on the quality of risk assessment are presented. Database evaluations demonstrated no clear difference in sensitivity between 3-month and 12-month dog studies. From a regulatory perspective, only two compounds were identified in which the NOAEL for the 12-month dog study was mor...

Wormwood, Artemisia absinthium, is a very bitter plant, and its extract has been used as food additives such as seasonings for food and drinks. A 13-week repeated dose toxicity study of wormwood extract was performed in both sexes of Wistar Hannover (GALAS) rats. Rats were divided into 4 groups consisting of 10 males and 10 females each, and were given water containing 0, 0.125, 0.5, or 2% worm...

Benchmark dose (BMD) modeling has been touted as a more accu­ rate method for conducting chemical risk assessments. In this issue of EHP, a team of researchers applied BMD modeling to hundreds of chemicals whose health effects are already known in an effort to optimize the approach. To calculate the highest safe oral dose of a noncarcinogenic chem­ ical, regulators must first estimate the point...