Dietary administration of -ionone epoxide to Sprague-Dawley rats for 90 days.

In a 90-day GLP-compliant study groups of Sprague-Dawley rats (10/sex/group) were fed diets containing β-ionone epoxide, a fragrance material and a flavoring substance, at dietary concentrations providing target intakes of 0, 20, 40 and 80 mg/kg bw/day. There were no deaths and no adverse changes in clinical observations, ophthalmological examinations, body weight, body weight gain, food consumption, food efficiency; hematology, serum chemistry, urinalysis parameters; or in macroscopic findings attributable to β-ionone epoxide administration. Increased absolute and relative liver weights in high dose females without correlating hepatic histopathological findings were considered non-adverse.

Dietary administration of β-caryophyllene and its epoxide to Sprague-Dawley rats for 90 days.

Two independent 90-day GLP-compliant studies were conducted in Sprague-Dawley rats with β-caryophyllene or β-caryophyllene epoxide, two common flavoring and fragrance materials. Dietary concentrations of β-caryophyllene were 3500; 7000; and 21,000 ppm for males and 3500; 14,000; and 56,000 ppm for females. Dietary concentrations of β-caryophyllene epoxide were 1750; 10,500; and 21,000 ppm.

2,4-Decadienal does not induce genotoxic effects in in vivo micronucleus studies.

2,4-Decadienal (E,E-) occurs naturally in foods and is also used as a flavoring ingredient. In vivo micronucleus studies were used to evaluate the potential for 2,4-decadienal to cause genotoxic effects. Male Han Wistar rats were dosed either by intraperitoneal injection or by gavage in two independent studies.

Absence of adverse effects following the gavage administration of methyl propyl trisulfide to Sprague-Dawley rats for 90 days.

Methyl propyl trisulfide is a flavoring substance found in foods such as garlic and onions. At the request of the European Food Safety Authority (EFSA) for additional toxicological data on methyl propyl trisulfide, groups of Sprague-Dawley rats (10/sex/group) were gavaged with 0 (corn oil vehicle control), 0.5, 2, or 6 mg methyl propyl trisulfide/kg bw/day in a 90-day GLP-compliant study.

Absence of renal adverse effects from β-myrcene dietary administration in OECD guideline-compliant subchronic toxicity study.

β-Myrcene is a flavoring substance that occurs naturally in a large variety of foods. At the request of the European Food Safety Authority (EFSA) for additional toxicological data on β-myrcene, groups of Sprague Dawley rats (10/sex/group) were administered diets containing 0, 700, 2100, or 4200 ppm of β-myrcene designed to provide nominal doses of 0, 50, 150, or 300 mg/kg bw/day in a 90-day GLP-compliant study. Based on body weights, feed consumption, and substance stability data, final estimated daily intakes of β-myrcene were calculated to be 20.

Absence of adverse effects following administration of piperine in the diet of Sprague-Dawley rats for 90 days.

Piperine (E,E-) is a naturally occurring pungent and spicy constituent of black pepperand is also used as an added flavoring ingredient to foods and beverages. Piperine has been determined safe under conditions of intended use as a flavoring substance by regulatory and scientific expert bodies. While concurring with the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and Flavor and Extract Manufacturers Association (FEMA) Expert Panel on the safety of piperine, the European Food Safety Authority (EFSA) requested additional toxicological data.