Toxicity, acute subacute

Japan. In Japan, registration of dmgs for aquatic species requires the same data as those required for dmgs on other animals. The Ministry of Agriculture, Eorests, and Eisheries and the Ministry of Welfare control the use of chemicals in aquaculture in Japan (17). The preclinical data requirements include product chemistry, toxicity (acute, subacute, special) using rats and mice, safety to target animals, and metaboHsm. The requirements for clinical data include avadabiHty and residues. As of July 1990, more chemicals were registered for aquacultural use in Japan than in any other country (Table 4). 

Intracutaneous reactivity Systemic toxicity (acute) Subacute/subchronic toxicity Genotoxicity Implantation Hemocompatibility Chronic toxicity Carcinogenicity Reproductive toxicity Biodegradation Toxicokinetics Immunotoxicity... 

Scientific information for the process of establishing OELs may come from human or animal data obtained using different methods, from studies of acute, subacute, and chronic toxicity through various routes of entry. Human data, which is usually the best source, is not easily available, and frequently it is incomplete or inadequate due to poor characterization of exposure and clear dose-response relationships. Human data falls into one of the following categories ... 

Toxicological Chronic toxicity Carcinogenicity Fertility study (multi-generation) Embryotoxicity (non-rodent) Acute/subacute toxicity in 2nd species Toxicokinetics... 

Ecotoxicological Prolonged fish toxicity (including reproduction) Avian acute/subacute toxicity Accumulation, degradation and mobility tests... 

Borelli G, Bertoli D Acute, subacute, chronic toxicity and mutagenicity studies of rifaximin (L/105) in rats. Chemioterapia (Florence)... 

AALAC certified laboratory. In-housing testing included acute, subacute, and subchronic oral, dermal and inhalation studies and specialty reproductive, behavioural, haematological and renal function toxicity studies. Preparation of risk assessment, submissions and presentations to regulatory agencies and trade association. 

D. Data on acute, subacute and chronic toxicity, teratogenicity and other types of toxicity... 

Oberst FW, Comstock CC, Hackley EB Inhalation toxicity of ninety per cent hydrogen peroxide vapor—acute, subacute, and chronic exposures of laboratory animals. AMA Arch Ind Hyg Occup Med 10 319-327, 1954... 

Bruckner JV, MaKenzie WF, Muralidhara S, et al. 1986. Oral toxicity of carbon tetrachloride acute, subacute and subchronic studies in rats. Fund AppI Toxicol 6 16-34. 

Lithium toxicity (chronic, subacute, or acute) can be secondary to any factor that reduces body clearance, or secondary to acute or sustained elevated doses (and therefore plasma levels) (342). The degree of toxicity can be classified as follows ... 

Toxicology, including an integrated summary of toxicological effects of the drug, including results from acute, subacute, chronic, and in vitro toxicity tests, the effects on reproduction and the fetus and special toxicity tests. A detailed tabulation of toxicity data for each study should be included. 

Toxicological studies—acute, subacute, and chronic toxicity carcinogenicity ... 

Toxicity studies consist of acute, subacute, and chronic phases, which come under preclinical evaluation in species to asses the extent of toxicity by using various parameters (e.g., hematology, biochemical, histopathologic, body weight, food intake, water intake, general behavior). General requirements of a toxicity study are given in Appendixes I and II. 

Mengs, U., Clare, C., and Poiley, J. 1991. Toxicity of Echinacea purpurea. Acute, subacute and genotoxicity studies. Arzneim.-Forsch. (Drug Res.) 41, 1076—1081. 

Body Contact (see 4.1) Contact Duration A Limited (24 h) B Prolonged (24 h to 30 days) C Permanent (>30 days) Cytotoxicity Sensitization Irritation or Intracutaneous Reactivity System Toxicity (Acute) Subchronic toxicity (Subacute Toxicity) Genotoxicity Implantation Haemocompatibility... 

IPCS Environmental Health Criteria Documents reflect the collective view of an international group of experts and do not necessarily represent the decision or stated policy of UNEP, ILO, or WHO. The reports summarize and interpret the pertinent published literature. Unpublished information is used when published information is absent or when data are pivotal to the risk assessment. Adequate human data are preferred to animal data. Topics include physical chemistry sources of exposure environmental fate and transport concentrations in the environment and in humans pharmacokinetics effects from acute, subacute, and long-term exposure toxic effects on skin, eye, and reproduction mutagenesis and cancer. 

Toxicity test procedure in higher animals (e.g., rats, mice, rabbits, dogs, and monkeys) is different from that in lower animals because the number of available animals usually is limited. As mentioned earlier, it is not economical or practical to use a few hundred mammals for the evaluation of a single toxicity test. The limitation in number has necessitated several adjustments to assure the validity of toxicity determinations in higher animals. Typically, in the pesticide industry, three types of tests are required acute, subacute, and chronic. 

Adverse drug reactions can be classified simply according to their onset or severity. ADRs are occasionally classified as acute/ subacute/ or latent. Acute events are those observed within 60 minutes after the administration of a medication and include anaphylactic shock/ severe bronchoconstrictioii/ and nausea or vomiting (17). Subacute reactions occur within 1 to 24 hours and include maculopapular rasly serum sicknesS/ allergic vasculitiS/ and antibiotic-associated diarrhea or colitis. Latent reactions require 2 or more days to become apparent and include eczematous eruptions/ organ toxicity/ and tardive dyskinesia. 

In Japan, Uchiyama has recently published requirements for the safety evaluation of new excipients. These requirements include studies on acute, subacute, and chronic toxicity, mutagenicity, effects on reproduction, dependency, antigenicity, carcinogenicity, and local irritation (human patch test). The first five of these tests are mandatory. With the exception of the local irritation test, for which a domestic trial is required, non-Japanese data are acceptable for these studies. Even if a material has been used in a pharmaceutical product outside Japan, the material is treated as a new excipient if there has been no prior use in Japan, although relevant overseas data for the material are acceptable for regulatory submission. A material is treated as a new excipient when the route of administration differs or the dose level exceeds that of prior use even after approval for the Japanese market.f ... 

Toxicological report (acute, subacute, subchronic, chronic toxicity, accumulation). 

Oser BL and Oser M (1960) 2-(p-tert-Butylphenoxy(isopropyl 2-chloroethyl sulfite (Aramite). I. Acute, subacute, and chronic oral toxicity. Toxicology and Applied Pharmacology 2 441-457. 

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