The approach to safety evaluation is strongly influenced by the standard of safety to which one aspires. Practical considerations demand that realistic limits be set to the attainable assurances of freedom from anticipated hazard under actual conditions of use of a product. The fact is that, in the interests of consumer health, more can be expected from a flexible, intelligent, and experienced approach to safety evaluation than from efforts at conformity with a set of rigidly standardized requirements that are theoretically all-encompassing. Establishment of safety demands a wide background of information about the properties and likely uses of the product; above all, knowledge of the chemical composition of the product and its impurities, degradation products, and metabolites is essential. Lack of such information is a frequent source of errors in safety evaluation. Based on a secure foundation of this sort, a program of investigations may be designed, aimed at establishing the basic biological properties of the material. Determination of the metabolic dynamics of the principal chemical agent or agents makes possible the emergence of a clear picture of the behavior of the compound(s) in the body and paves the way for more specialized studies of long term toxicity, carcinogenicity, effects on reproduction and teratogenesis, and investigations of multitest mutagenic potential. Emphasis is laid on the problems of interpretation of results in terms of hazard to man and on the crucial contribution that experience of human exposure can make toward assuring safety-in-use. Decisions on acceptable risk are the joint responsibility of many individuals but an essential element in reaching such decisions is contributed by the depth of understanding and broad experiences of the toxicologist.

Accident Prevention↗

PubMed1975

Chromatographic methods for the analysis of hexachlorobenzene and possible metabolites in monkey fecal samples.

The separation and identification of hexachlorobenzene (HCB), pentachlorobenzene (QCB), and pentachlorophenol (PCP) by thin layer, high-pressure liquid, and gas chromatography are reported. Satisfactory results were obtained with reverse phase thin layer and high-pressure liquid chromatography. The 2 gas chromatographic columns tested gave adequate separation of HCB and QCB. A PCP methylation process using dimethyl sulfate was attempted. Procedures are presented for extraction, cleanup, separation, and identification of HCB and possible metabolites from feces of a rhesus monkey treated with 14C-HCB. Recovery of radioactivity in excess of 96% was attained in extracts from feces by these methods. Preliminary evidence suggests the formation of PCP and possibly other polar metabolites from HCB in the rhesus monkey.

Animals↗

PubMed1974