1 Scope This clause of part 1 is replaced by: This standard deals with the safety of electric oral hygiene appliances for household and similar purposes, their rated voltage being not more than 250 V. NOTE 1 - Examples of appliances covered by thi

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5.1 This test method is of principal value in minimizing the number of animals required to estimate the acute oral toxicity (LD50). It also incorporates measures of variance (95 % CI) and a slope from which to make relative toxicity comparisons.5.2 This test method is inappropriate for materials typically producing death two or more days after administration of the test compound unless the observation time between dosages is increased. This test method can be successfully applied, however, for materials producing only an occasional death two or more days after administration.5.3 The LD50 is valuable as a measure of the relative acute toxicity of a material and can be used to make an estimate of potential hazard to humans when pesticides, other chemicals, or mixtures are ingested.5.4 This test method allows for observation of signs of toxicity in addition to mortality. This information can be useful in planning additional toxicity testing.1.1 This test method determines the lethality (LD50 value, slope and 95 % confidence interval (CI)) and signs of acute toxicity from a material using a limited number of rats. The technique used in this test method is referred to as the “Stagewise, Adaptive Dose Method.”2 This test method is an alternative to the classical LD50 test and is applicable to both liquids and solids.1.2 This test method is not recommended for test materials which typically produce deaths beyond two days postdosing.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 The approaches to the evaluation of toothbrushes and toothpaste recommended in this guide can be used to assess the sensory characteristics of toothpaste in use and after use (or a series of uses). This guide is meant to address the evaluation of standalone toothbrush and toothpaste products and does not address packaging, product/package interaction, dispensing, or overall clinical effect or benefit of the product. The procedures outlined in this guide are to be used by assessors that have been specifically screened for sensory and descriptive ability and trained in the evaluation of toothbrushes or toothpaste or both. The procedures described in this guide can be used to guide product development within a manufacturer and communicate information regarding the product to the consumer through the media or on product packaging.5.2 Additionally, language and ideas from two additional ASTM International sensory guides (Guides E1490 and E2082) as well as the Lexicon for Sensory Evaluation: Aroma, Flavor, Texture, and Appearance (DS72-2ND)4 are used throughout this guide.1.1 This guide provides guidelines for the selection and training of expert assessors for the sensory evaluation of toothpaste and toothbrushes as well as a basic framework for the sensory evaluation of the same. Sensory evaluation of toothpaste and toothbrushes can be used to define the sensory attributes of the products and then to measure those attributes quantitatively for the purposes of new product development, product optimization, competitive benchmarking, and claims substantiation.1.2 A general framework for both toothpaste and toothbrush descriptive analysis is provided to guide the reader in the design and execution (including sample preparation and presentation, facility and testing environment, and specific evaluation protocols) for such evaluations.1.3 This guide provides suggested protocols and approaches to the evaluation of the indicated products/samples and in no way excludes any alternate approaches that may be effective in providing such perceptual evaluations.1.4 This guide does not address other oral care products including, but not limited to, whitening agents, oral rinses, mouthwashes, dental flosses, denture adhesive, floss picks, or other oral care products.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 This test method should generate data to identify the majority of chronic effects and shall serve to define long-term dose response relationships. In addition the test should allow for the detection of general toxic effects including neurological, physiological, biochemical, and hematological effects and exposure-related morphological (pathology) effects.5.2 This test method should provide information on target organs, the possibilities of accumulation, and may be used for establishing safety criteria for human exposure. It provides information on potential health hazards likely to arise from repeated exposure over a long period of time.1.1 This test method covers a long-term study to determine the effects of a substance in a mammalian species such as the rat following prolonged and repeated oral exposure. Under the conditions of the chronic toxicity test, effects that require a long latency period or that are cumulative should become manifest.1.2 This test method assumes that the user is knowledgeable in mammalian toxicology and related pertinent areas, and relies heavily on the judgment of the evaluator.1.3 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. For specific hazard statements, see Section 6.

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