A summary of toxicological and chemical data relevant to the evaluation of cast sheet tobacco.

A tiered testing strategy based on a comparative chemical and biological testing program has been developed to evaluate the potential of tobacco processes, ingredients, or other technological developments to change the biological activity that results from burning tobacco. Cast sheet tobacco is a specific type of reconstituted tobacco sheet that can be used in the manufacture of cigarettes. The comparative chemical and biological testing program was used to compare the mainstream smoke and cigarette smoke condensate (CSC) from a Reference cigarette that did not contain cast sheet to that collected from Test cigarettes containing cast sheet at a final blend level of either 10% or 15%.

Toxicological evaluation of cigarettes with two banded cigarette paper technologies.

A tiered testing strategy has been employed to evaluate the potential of tobacco processes, ingredients, or technological developments to change the biological activity resulting from burning cigarette tobacco. The strategy is based on comparative chemical and biological testing. The introduction of banded cigarette papers in cigarettes to meet New York state "Fire Safety Standards for Cigarettes" constitutes an example of a technological development evaluated utilizing this tiered testing strategy that included a comparison of the chemical and biological effects of cigarettes with and without the banded cigarette paper technologies (BCPT) (representative of current marketed technologies).

Comparative 13-week inhalation study of cigarette smoke from cigarettes containing cast sheet tobacco.

A subchronic, nose-only inhalation study was conducted to compare the effects of mainstream smoke from a reference cigarette containing conventional reconstituted tobacco sheet at 30% of the finished blend to mainstream smoke from cigarettes containing 10% or 15% cast sheet (a specific type of reconstituted tobacco sheet) substituted for part of the conventional reconstituted tobacco. Male and female Sprague-Dawley rats were exposed for 1 h/day, 5 d/wk, for 13 wk to mainstream smoke at 0, 0.06, 0.

DBA/2 mouse skin is unresponsive to dermal tumor promotion by cigarette smoke condensate.

Previous studies demonstrated that repetitive application of cigarette smoke condensate (CSC) to 7,12-dimethylbenz[a]anthracene (DMBA)-initiated SENCAR mouse skin for 29 weeks at doses of 10, 20 and 40 mg "tar"/application results in time- and dose-dependent dermal tumor formation. To evaluate CSC-induced tumor promotion in other mouse skin models, male DBA/2 mice were treated with N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) (300 microg) or DMBA (75 or 150 microg) followed by promotion with 1R4F CSC at concentrations ranging from 9 to 45 mg "tar"/application. Both MNNG and DMBA have previously been shown to adequately initiate tumor development.

Safety assessment of high fructose corn syrup (HFCS) as an ingredient added to cigarette tobacco.

A tiered testing strategy has been developed to evaluate the potential for new ingredients, tobacco processes, and technological developments to alter the biological activity that results from burning tobacco. A series of studies was initially conducted with cigarettes containing 3% high fructose corn syrup (HFCS) as an alternate tobacco casing material to corn syrup/invert sugar, including determination of selected mainstream cigarette smoke (MS) constituent yields, Ames assay, sister chromatid exchange (SCE) assay in Chinese hamster ovary (CHO) cells, a 30-week dermal tumor-promotion evaluation of cigarette smoke condensate (CSC) in SENCAR mice, and a 13-week subchronic inhalation study of MS in Sprague-Dawley rats. A second series of studies was conducted with cigarettes containing 3%, 4% and 5% HFCS including MS chemistry, Ames assay, SCE assay in CHO cells, and a neutral red cytotoxicity assays.

Comparative study of smoke condensates from 1R4F cigarettes that burn tobacco versus ECLIPSE cigarettes that primarily heat tobacco in the SENCAR mouse dermal tumor promotion assay.

Numerous chemical and toxicological studies indicate that smoke from ECLIPSE, a cigarette that primarily heats rather than burns tobacco, is simplified and reduced in specific chemicals believed to be associated with smoking-related diseases, and demonstrates reduced smoke toxicity and biological activity in vitro when compared to conventional tobacco burning cigarettes. These data led to the hypothesis that cigarette smoke condensate (CSC) from ECLIPSE should have lower tumorigenicity than 1R4F condensate in the SENCAR mouse dermal tumor promotion assay. Female SENCAR mice were initiated with a single topical application of 7,12-dimethylbenz[a]anthracene (DMBA) followed by promotion with ECLIPSE or 1R4F CSC.

Toxicological evaluation of expanded shredded tobacco stems.

A tiered testing strategy has been developed to evaluate the potential of tobacco processes, ingredients, or technological developments to change the biological activity resulting from burning tobacco. The strategy is based on comparative chemical and biological testing. Expanded shredded tobacco stems (ESS) constitute an example of a common tobacco components expansion process currently used in the manufacture of cigarettes to increase the tobacco blend filling capacity.

Toxicological evaluation of dry ice expanded tobacco.

A tiered testing strategy has been developed to evaluate the potential of tobacco processes, ingredients, or technological developments to change the biological activity resulting from burning tobacco. The strategy is based on comparative chemical and biological testing. Dry ice expanded tobacco (DIET) is an example of a common tobacco expansion process currently used in the manufacture of cigarettes to increase tobacco filling capacity.

Toxicological evaluation of propane expanded tobacco.

A tiered testing strategy has been developed to evaluate the potential for tobacco processes, ingredients, and other technological developments to increase or decrease the biological activity resulting from burning tobacco. The strategy is based on comparative chemical and biological testing. Propane expanded tobacco is an example of a processed tobacco used in the modern manufacture of cigarettes.

Toxicological evaluation of honey as an ingredient added to cigarette tobacco.

A tiered testing strategy has been developed to evaluate the potential for new ingredients, tobacco processes, and technological developments to increase or reduce the biological activity that results from burning tobacco. In the manufacture of cigarettes, honey is used as a casing ingredient to impart both aroma and taste. The primary objective of this document is to summarize and interpret chemical and toxicological studies that have been conducted to evaluate the potential impact of honey on the biological activity of either mainstream cigarette smoke or cigarette smoke condensate.