GB 30000.25-2013Rules for classification and labelling of chemicals - Part 25: Specific target organ toxicity - Single exposure (English PDF)

5.2.1 Substance Category 1 and Category 2

5.2.1.1 In all available weight of evidence, based on expert judgment, including the use of recommended guidance values (see 5.2.1.10), respectively, according to Immediate or delayed effects of the substance should be classified. Then, based on observations of the nature and severity of effects, the substances classified as category 1 and category 2, see Table 1. Table 1 after the first contact with specific target organ toxicity hazard classification Category

1 Humans produce significant toxic substances, or according to experimental evidence from animal studies, may be assumed after the first contact Human significant toxic substances. The substance is classified according to the following categories 1.

--- Human cases or reliable and good quality evidence obtained in epidemiological studies;

--- Appropriate observation studies in experimental animals. In the trial, at generally low exposure concentrations produced human health Off significant and/or severe toxic effects. Guidance dose/concentration values are provided below (see 5.2.1.10) can be used to the weight of evidence Use part of the assessment Category

2 According to experimental evidence from animal studies it can be assumed after a contact may produce substances on human health hazards. According to observations appropriate studies in experimental animals substance is classified in Category 2, generally moderate exposure concentrations produced with people Class health-related significant and/or severe toxic effects. The following provides guidance for the dose/concentration values (see 5.2.1.10), to help feed Classify. In exceptional cases, human evidence can also be used substance is classified in Category 2 (see 5.2.1.10) Category

3 Transient target organ effects Some target organ effects may not meet the criteria of the substance/mixture classified above Category 1 or Category 2 standards. After contacting these effects Harmful changes in human functions within a short time, but humans may recover without leaving significant organization or work within a reasonable period of time Changed. This category only includes narcotic effects and respiratory tract irritation. Substances/mixtures may be classified according to specific discussion in

5.3.2 The effect of having these categories NOTE. For these categories, it can be determined mainly by the influence of substances classified Specific target organ/system, or may be a substance classified as a general poison. Really Given the major target organ/system and classify, such as liver poison, nerve poison. Carefully evaluate the data and, where possible, not include secondary It shall take effect, such as the liver or nervous system toxicant may produce secondary effects in the gastrointestinal system.

5.2.1.2 should determine the classification of hazardous substances relevant route of exposure.

5.2.1.3 should be based on weighing all available evidence, including the guidance provided below, by expert judgment to classify.

5.2.1.4 Classification of all evidence available to the right weight (including the guidance provided below) basis, based on expert judgment. Even containing human Events and epidemiological and experimental animal studies, including all data, weight of evidence, to demonstrate that it is necessary to classify specific target organ toxicity Effect.

5.2.1.5 target organ toxicity assessments required information can be obtained from the first contact with humans, for example, at home, in the workplace or the environment The contact can also be obtained from experimental animal studies. Standard animal studies provide such information is a rat or mouse acute toxicity studies, this Class can include clinical observations and detailed macroscopic and microscopic examination to enable the toxic effects on target tissues/organs. Other species Results of acute toxicity studies conducted may also provide relevant information.

5.2.1.6 In exceptional cases, based on expert judgment, there may be some substance human evidence of target organ toxicity classified Category 2.

a) when the weight of human evidence is not sufficiently convincing to warrant Category 1; and/or

b) Depending on the nature and severity of effects. In the classification should reference the human dose/concentration levels in animal studies and any available evidence should be consistent with the Category 2 classification. In other words, if there are also animal data available on the chemical that warrant Category 1 is justified, then the substance should be classified as Category 1.

5.2.2 Category 3

5.2.2.1 respiratory irritation standard Respiratory tract irritation classified as Category 3 criteria.

a) functional damage and symptoms of cough, pain, choking, and breathing difficulties and other respiratory tract irritation (characterized by localized redness, edema, Pruritus and/or pain). It recognized that this evaluation is based primarily on human data.

b) subjective human observations could be supplemented to clear respiratory tract irritation (RTI) objective measurement (such as electrophysiological responses, nose or Bronchoalveolar lavage fluid biomarkers of inflammation). Human symptoms

c) should also be symptoms observed in the exposed population will usually produce, not just particular individuals with hypersensitive airways Isolated idiosyncratic reaction will produce. Just say "stimulus" Ambiguous reports should be excluded. As the term is generally used to describe various Variety of sensations including smell, unpleasant taste, itching and thirst, etc., which do not belong to this classification endpoint range.

d) There is no specific respiratory irritation involves effective animal tests, however, from the first and repeated inhalation toxicity tests to get there With information. For example, animal studies may be clinical signs of toxicity (dyspnoea, rhinitis etc) and histopathology (for example charge Blood, edema, slight inflammation, thickened mucous layer) to provide useful information, since these symptoms are reversible and may be reflective Characteristics of the clinical symptoms. Such animal studies can be used as part of the right to re-evaluate the evidence.

e) This special classification would not only observed when more severe organ effects including respiratory effects use.

5.2.2.2 narcosis standard Narcotic effects as Category 3 criteria.

a) central nervous system depression including narcotic effects humans such as drowsiness, narcosis, reduced alertness, reflection funeral Loss, lack of muscle coordination, and vertigo are included. Manifestation of these effects may be severe headache or nausea, and can lead Caused by reduced judgment, dizziness, irritability, fatigue, impaired memory function, perception and slow muscle coordination, reaction time, or sleepiness.

b) Narcotic effects observed in animal studies may include lethargy, lack of coordination righting reflex, narcosis, and loss of motor function Tone. If these effects are not transient in nature, then they should be classified as Category 1 or Category 2.

5.3 Classification criteria for mixtures

5.3.1 General Principles The mixture can be used the same criteria with substance classification, or alternatively as described below classification. With substances, mixtures Can be classified as a specific target organ toxicant exposure, repeated exposure target organ toxicant, or both.

5.3.2 There mixture Classification of mixtures when data If, as the criteria for substances, mixtures are reliable and good quality evidence of experience or appropriate studies in experimental animals from humans, that What can re-assessment of the mixture was classified by weight of evidence data. When evaluating data on mixtures should be careful, dose, duration, Observation or analysis, do not render the results inconclusive. No mixture

5.3.3 Classification of mixtures when data are. bridging principles

5.3.3.1 Data Use If the mixture itself has not been tested to determine its specific target organ toxicity, but the individual components of the mixture has been done and Similar testing of the mixture have been mastered sufficient data to adequately characterize the hazards of the mixture, then in accordance with the following agreed bridging The principle of the use of these data. This ensures that the classification process to maximize the use of existing data to determine the hazardous properties of the mixture without the necessity for Additional testing in animals.

5.3.3.2 Dilution If the tested mixtures to be diluted with a diluent, the diluent toxic and least toxic original ingredient in the same category or specific It is less, and is not expected to affect the toxicity of other ingredients, then the new diluted mixture may be classified as the original tested mixtures to the same category.

5.3.3.3 Batches The mixture had done a production batch of toxicity tests can be considered substantially the same manufacturer or under their control swells Another production of the same commercial product without testing the toxicity of the same production batch, unless there is reason believe that the untested productio...