Inhaled products classification

Excipients are sub-divided into various functional classifications, depending on the role that they are intended to play in the resultant formulation, for example, fillers, disintegrants, binders, lubricants and glidants. An added complexity is the fact that certain excipients can have different functional roles in different formulation types. Thus, lactose is widely used as a filler or diluent in solid oral dosage forms, for example, tablets and capsules [2] and as a carrier for inhalation products [3]. 

NIOSH REL (Arsine) CL 2 ng(As)/mVl5M DOT CLASSIFICATION 2.3 Label Poison Gas, Flammable Gas SAFETY PROFILE Confirmed human carcinogen. Poison by inhalation. Human red blood cell, gastrointestinal system, central nervous system, and other systemic effects by inhalation. Flammable when exposed to flame. Moderately explosive when exposed to CI2, HNO3, (K + NH3), open flame, or powerful shock. Dangerous, more toxic than its oxidation product. When heated to decomposition it emits highly toxic fumes of arsenic. See also ARSENIC, ARSENIC COMPOUNDS, and HYDRIDES. 

DOT CLASSIFICATION 6.1 Label KEEP AWAY FROM FOOD SAFETY PROFILE Poison by ingestion and intraperitoneal routes. Moderately toxic by inhalation. Experimental reproductive effects. A severe eye irritant. Questionable carcinogen with experimental tumorigenic data. Mutation data reported. A chemosterilant for rodents. Combustible when exposed to heat or flame. Reaction with perchloric acid forms a sensitive explosive product more powerful than glyceryl nitrate. When heated to decomposition it emits toxic fumes of Cl". 

DOT CLASSIFICATION 6.1 Label Poison SAFETY PROFILE A poison. Moderately toxic by ingestion, inhalation, and intraperitoneal routes. Mildly toxic by skin contact. Mutation data reported. Combustible when exposed to heat or flame. To fight fire, use CO2, dr) chemical, foam. The residue from vacuum distillation may explode spontaneously. Reacts with sodium to form an ignitable product. 

DOT CLASSIFICATION 8 Label Corrosive SAFETY PROFILE Poison by inhalation. Moderately toxic by ingestion. A severe eye, skin, and mucous membrane irritant. Corrosive to body tissues. Flammable by chemical reaction. Explosive reaction with chlorine dioxide + chlorine, sodium, urea + heat. Reacts to form explosive products with carbamates, 3 -methyl-2-nitroben2anilide (product explodes on contact with air). Ignites on contact with fluorine. Reacts violently with moisture, CIO3, hydroxyl-amine, magnesium oxide, nitrobenzene, phosphorus(III) oxide, K. To fight fire, use CO2, dry chemical. Incompatible with aluminum, chlorine dioxide, chlorine. 

Benz [a] anthracene alone is not regulated however, all polycyclic aromatic hydrocarbons or volatile coal tar products together are regulated. The World Health Organization has established 0.2 pgH as the limit for aromatic hydrocarbons in a domestic water supply. The US Occupational Safety and Health Administration limit in workplace air (coal tar volatiles) is 0.2 mg m The US Environmental Protection Agency weight-of-evidence classification for benz [a] anthracene is B2, a probable human carcinogen, for both oral and inhalation exposure based on adequate animal evidence and no human evidence. 

Patients at risk (stage 0) have normal spirometry but experience chronic symptoms of cough or sputum production and a history of exposure to risk factors. Patients in the remaining four stages of classification all exhibit the hallmark finding of airflow obstruction, i.e., a reduction in the FEVi/FVC ratio to less than 70%. FVC is the total amount of air exhaled after a maximal inhalation. The extent of reduction in FEVi further defines the patient with mild, moderate, severe, or very severe disease. ... 

Coal Tar Products. Evaluations of human exposure during employment in coal tar plants indicated significant increases in cancer-related deaths (TOMA 1982). No specific type of cancer was predominant. Nevertheless, no clear relationship could be established because exposure routes in addition to dermal were likely, such as inhalation and oral. Also, the ability to relate death to coal tar exposure was further confounded by the possibility that the subjects were also exposed to other chemicals and cigarette smoke (TOMA 1982). Additional limitations were identified in this study, including absence of data on smoking habits, short cut-off date of 10 days of employment, unknown race classification for 20 of participants, use of U.S. male mortality rates for comparison as opposed to regional mortality rates, and the relationship between the cohort and production history was not explored. 

Occupational health research classifies harmful substances in workplace air on the basis of several criteria, i.e., MAC, LD50 for intragastric entry, application to skin, inhalation exposure LC50, coefficient of possible inhalation poisoning (CPIP), and acute and chronic action zones (Sanotsky and Ulanova 1975). These criteria formed the basis for classification of substances by the USSR State Standard (GOST 12.1.007-76), which is mandatory to ensure worker safety by identifying harmful substances in raw materials, products, byproducts, and industrial wastes. The classification is also used to set standards for such substances in the workplace (Table 3). 

The World Health Organization (WHO) classification (shown in Table 5) also makes a distinction between toxicity and hazard and recognizes that liquid formulations are more hazardous. This international classification is based on a comparative analysis of the standards adopted by different countries for classifying pesticide toxicity. One new aspect in the WHO classification is the evaluation of pesticide products by concentration of active ingredient and formulation (solid or liquid). Other special considerations are products that cause irreversible effects, those for which the hazard of inhalation exceeds that of oral or skin entry, and those for which human health risks are greater than the risk to animals. 

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