RESUMO
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). Specific testing included mainstream cigarette smoke chemistry studies; in vitro studies included genotoxicity (Ames and sister chromatid exchange) and cytotoxicity studies (neutral red); in vivo studies included a 13-week inhalation study in Sprague-Dawley rats and a 30-week dermal tumor promotion study in SENCAR mice. Collectively, data indicated that cigarettes with and without BCPT had a similar toxicological profile in this test battery.
Assuntos
Nicotiana/toxicidade , Papel , Fumaça/efeitos adversos , Tecnologia , Indústria do Tabaco/métodos , Administração por Inalação , Administração Tópica , Animais , Células CHO/efeitos dos fármacos , Células CHO/metabolismo , Células CHO/patologia , Sobrevivência Celular/efeitos dos fármacos , Cricetinae , Cricetulus , Relação Dose-Resposta a Droga , Feminino , Imunossupressores/toxicidade , Masculino , Camundongos , Camundongos Endogâmicos SENCAR , Vermelho Neutro , Ratos , Ratos Sprague-Dawley , Salmonella typhimurium/efeitos dos fármacos , Salmonella typhimurium/genética , Troca de Cromátide Irmã/efeitos dos fármacos , Troca de Cromátide Irmã/genética , Neoplasias Cutâneas/induzido quimicamente , Neoplasias Cutâneas/patologia , Fumaça/análise , Alcatrões/química , Alcatrões/toxicidade , Nicotiana/química , Testes de ToxicidadeRESUMO
This study compared the toxicological responses of Sprague-Dawley rats exposed nose-only to mainstream smoke (MS) from Test cigarettes (1, 2, and 3) to those of Control cigarettes without banded cigarette paper technologies (BCPT). Test cigarettes 1 and 2 had bands based on one technology (different band weight application) while Test cigarette 3 had bands based on another technology. The banded papers are representative of current marketed technologies. Rats were exposed to humidified HEPA filtered air (Sham) or to MS at concentrations of 0.06, 0.20, or 0.80 mg wet total particulate matter per liter air. Each exposure group contained 30 animals/sex (sentinel had 20 animals/sex). The study had two phases (13 weeks each): MS exposure (1 h/day, 5 days/week) and recovery without smoke exposure. Endpoints included clinical observations, respiratory physiology, hematology, serum chemistry, blood carboxyhemoglobin (COHb), serum nicotine, body/organ weights, gross pathology, and histopathology. Comparisons conducted were: Sham exposed vs. all cigarettes, Control cigarette vs. all Test cigarettes, and Test 1 vs. Test 2. Control and Test MS had comparable effects on respiratory physiology, COHb, serum nicotine, serum chemistry, and hematology. While some minor differences were observed, Control and Test MS had comparable effects on clinical signs, body/organ weights, and gross pathology/histopathology. Consequently, exposure of rats to equivalent MS concentrations from the four cigarettes induced similar toxicological responses in this study.
