07.080 (Biology. Botany. Zoology) 标准查询与下载

ASTM E1439-12 爪蟾属青蛙胚胎畸形生长化验 (FETAX) 的标准指南

5.1 FETAX is a rapid test for identifying potential developmental toxicity. Data may be extrapolated to other species including mammals. FETAX might be used to prioritize samples for further tests which use mammals. Validation studies using compounds with known mammalian or human developmental toxicity, or both, suggest that the predictive accuracy will exceed 858201;% (2) . When evaluating a test material for mammalian developmental toxicity, FETAX must be used with and without a metabolic activation system (MAS). Use of this exogenous MAS should increase the predictive accuracy of the assay to approximately 958201;%. The accuracy rate compares favorably with other currently available ??? in vitro teratogenesis screening assays??? (3). Any assay employing cells, parts of embryos, or whole embryos other than in vivo mammalian embryos is considered to be an in vitro assay. 5.2 It is important to measure developmental toxicity because embryo mortality, malformation, and growth inhibition can often occur at concentrations far less than those required to affect adult organisms. 5.3 Because of the sensitivity of embryonic and early life stages, FETAX provides information that might be useful in estimating the chronic toxicity of a test material to aquatic organisms. 5.4 Results from FETAX might be useful when deriving water quality criteria for aquatic organisms (4). 5.5 FETAX results might be useful for studying structure-activity relationships between test materials and for studying bioavailability. 1.1 This guide covers procedures for obtaining laboratory data concerning the developmental toxicity of a test material. The test utilizes embryos of the African clawed frog, Xenopus laevis and is called FETAX (Frog Embryo Teratogenesis Assay-Xenopus) (1).2 Some of these procedures will be useful for conducting developmental toxicity tests with other species of frogs although numerous modifications might be necessary. A list of alternative anurans is presented in Appendix X1. 1.2 A renewal exposure regimen and the collection of the required mortality, malformation, and growth-inhibition data are described. Special needs or circumstances might require different types of exposure and data concerning other effects. Some of these modifications are listed in Appendix X2 although other modifications might also be necessary. Whenever these procedures are altered or other species used, the results of tests might not be comparable between modified and unmodified pr......

Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX)

ASTM E1705-11 生物技术标准术语

1.1 This document is composed of terms, definitions of terms, descriptions of terms, and acronyms used in ASTM documents related to the field of biotechnology. Terms that are adequately defined in a general dictionary are not defined in this terminology standard. 1.2 This standard includes terminology used in biotechnology areas, such as, but not limited to: biological drug products, materials for biotechnology, characterization and identification of biological systems, aseptic sampling, preservation of biological samples, membrane filters, molecular biology, biomass conversion, fuel manufacturing facilities, and fuel analysis.

Standard Terminology Relating to Biotechnology

ASTM E943-08 与生物效应和环境灾害相关的标准术语

1.1 This terminology document defines terms commonly used in standards developed by ASTM Committee E47 on Biological Effects and Environmental Fate. This terminology document is intended to be consistent with the use of terms in ASTM standards related to this field and, to the extent possible, with use by other organizations. 1.1.1 If a specific Committee E47 standard uses one of these terms in a different context, then the term must be defined in that standard. A term used only in a specific ASTM standard need not be included in this terminology document.

Standard Terminology Relating to Biological Effects and Environmental Fate

ASTM E2644-08 刺肩蝽Podisus maculiventris的标准规范(记述)(半翅目:蝽科)

1.1 This specification covers information on and the test method for quantification of commercial containers of the predatory bug Podisus maculiventris (Say) (Hemiptera: Pentatomidae), predator of lepidopteran and coleopteran larvae. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

Standard Specification for Podisus maculiventris (Say) (Hemiptera: Pentatomidae)

ASTM F748-06 选择材料和装置用一般生物试验方法标准实施规程

The objective of this practice is to recommend sufficient biological testing to establish a reasonable level of confidence concerning the biological response to a material or device, while at the same time avoiding unnecessary testing. This practice is intended to provide guidance to the materials investigator in selecting the proper procedures to be carried out for the screening of new or modified materials. Because each material and each implant situation involves its own unique circumstances, these recommendations should be modified as necessary and do not constitute the only testing that will be required for a material nor should these guidelines be interpreted as minimum requirements for any particular situation. While an attempt has been made to provide recommendation for different implant circumstances, some of the recommended testing may not be necessary or reasonable for a specific material or application.1.1 This practice recommends generic biological test methods for materials and devices according to end-use applications. While chemical testing for extractable additives and residual monomers or residues from processing aids is necessary for most implant materials, such testing is not included as part of this practice. The reader is cautioned that the area of materials biocompatibility testing is a rapidly evolving field, and improved methods are evolving rapidly, so this practice is by necessity only a guideline. A thorough knowledge of current techniques and research is critical to a complete evaluation of new materials.1.2 These test protocols are intended to apply to materials and medical devices for human application. Biological evaluation of materials and devices, and related subjects such as pyrogen testing, batch testing of production lots, and so on, are also discussed. Tests include those performed on materials, end products, and extracts. Rationale and comments on current state of the art are included for all test procedures described.1.3 The biocompatibility of materials used in single or multicomponent medical devices for human use depends to a large degree on the particular nature of the end-use application. Biological reactions that are detrimental to the success of a material in one device application may have little or no bearing on the successful use of the material for a different application. It is, therefore, not possible to specify a set of biocompatibility test methods which will be necessary and sufficient to establish biocompatibility for all materials and applications.1.4 The evaluation of tissue engineered medical products (TEMPs) may, in some cases, involve different or additional testing beyond those suggested for non-tissue-based materials and devices. Where appropriate, these differences are discussed in this practice and additional tests described.1.5 The ethical use of research animals places the obligation on the individual investigator to determine the most efficient methods for performing the necessary testing without undue use of animals. Where adequate prior data exists to substantiate certain types of safety information, these guidelines should not be interpreted to mean that testing should be unnecessarily repeated.1.6 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.

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

ASTM E2360-04 孟氏隐唇瓢虫Mulsant规范

1.1 This specification covers information on and the test method for determining purity, sex ratio, and number of adults in shipments of the predatory beetle Cryptolaemus montrouzieri.

Specification for Cryptolaemus montrouzieri Mulsant (Coleoptera: Coccinellidae)

ASTM F2131-02(2007) 使用W-20小鼠基质细胞系的重组人骨形态发生蛋白-2（rhBMP-2）体外生物活性的标准试验方法

1.1 This test method describes the method used and the calculation of results for the determination of the in vitro biological activity of rhBMP-2 using the mouse stromal cell line W-20 clone 17 (W-20-17). This clone was derived from bone marrow stromal cells of the W++ mouse strain.1.2 This test method (assay) has been qualified and validated based upon the International Committee on Harmonization assay validation guidelines (with the exception of interlaboratory precision) for the assessment of the biological activity of rhBMP-2. The relevance of this in vitro test method to in vivo bone formation has also been studied. The measured response in the W-20 bioassay, alkaline phosphatase induction, has been correlated with the ectopic bone-forming capacity of rhBMP-2 in the in vivo Use Test (UT). rhBMP-2 that was partially or fully inactivated by targeted peracetic acid oxidation of the two methionines was used as a tool to compare the activities. Oxidation of rhBMP-2 with peracetic acid was shown to be specifically targeted to the methionines by peptide mapping and mass spectrometry. These methionines reside in a hydrophobic receptor binding pocket on rhBMP-2. Oxidized samples were compared alongside an incubation control and a native control. The 62, 87, 98, and 100 % oxidized samples had W-20 activity levels of 62, 20, 7, and 5 %, respectively. The incubation and native control samples maintained 100 % activity. Samples were evaluated in the UT and showed a similar effect of inactivation on bone-forming activity. The samples with 62 % and 20 % activity in the W-20 assay demonstrated reduced levels of bone formation, similar in level with the reduction in W-20 specific activity, relative to the incubation control. Little or no ectopic bone was formed in the 7 and 5 % active rhBMP-2 implants.1.3 Thus, modifications to the rhBMP-2 molecule in the receptor binding site decrease the activity in both the W-20 and UT assays. These data suggest that a single receptor binding domain on rhBMP-2 is responsible for both in vitro and in vivo activity and that the W-20 bioassay is a relevant predictor of the bone-forming activity of rhBMP-2.1.4 The values stated in SI units are to be regarded as standard.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.

Standard Test Method forIn Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line

ASTM F2131-02 使用W-20老鼠基质细胞系的重组体人骨形态形成蛋白-2(rhBMP-2)在实验室条件下的生物活性的标准试验方法

1.1 This test method describes the method used and the calculation of results for the determination of the in vitro biological activity of rhBMP-2 using the mouse stromal cell line W-20 clone 17 (W-20-17). This clone was derived from bone marrow stromal cells of the W++ mouse strain.1.2 This test method (assay) has been qualified and validated based upon the International Committee on Harmonization assay validation guidelines (with the exception of interlaboratory precision) for the assessment of the biological activity of rhBMP-2. The relevance of this in vitro test method to in vivo bone formation has also been studied. The measured response in the W-20 bioassay, alkaline phosphatase induction, has been correlated with the ectopic bone-forming capacity of rhBMP-2 in the in vivo Use Test (UT). rhBMP-2 that was partially or fully inactivated by targeted peracetic acid oxidation of the two methionines was used as a tool to compare the activities. Oxidation of rhBMP-2 with peracetic acid was shown to be specifically targeted to the methionines by peptide mapping and mass spectrometry. These methionines reside in a hydrophobic receptor binding pocket on rhBMP-2. Oxidized samples were compared alongside an incubation control and a native control. The 62, 87, 98, and 100 % oxidized samples had W-20 activity levels of 62, 20, 7, and 5 %, respectively. The incubation and native control samples maintained 100 % activity. Samples were evaluated in the UT and showed a similar effect of inactivation on bone-forming activity. The samples with 62 % and 20 % activity in the W-20 assay demonstrated reduced levels of bone formation, similar in level with the reduction in W-20 specific activity, relative to the incubation control. Little or no ectopic bone was formed in the 7 and 5 % active rhBMP-2 implants.1.3 Thus, modifications to the rhBMP-2 molecule in the receptor binding site decrease the activity in both the W-20 and UT assays. These data suggest that a single receptor binding domain on rhBMP-2 is responsible for both in vitro and in vivo activity and that the W-20 bioassay is a relevant predictor of the bone-forming activity of rhBMP-2.1.4 The values stated in SI units are to be regarded as standard.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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method forIn Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line

ASTM F2131-02(2007)e1 使用W-20老鼠基质细胞系的重组体人骨形态形成蛋白-2(rhBMP-2)在实验室条件下的生物活性的标准试验方法

Although the test method can be used for assessment of the bioactivity of crude preparations of rhBMP-2, it has only been validated for use with highly pure (>98 % by weight protein purity) preparations of rhBMP-2.1.1 This test method describes the method used and the calculation of results for the determination of the in-vitro biological activity of rhBMP-2 using the mouse stromal cell line W-20 clone 17 (W-20-17). This clone was derived from bone marrow stromal cells of the W++ mouse strain.1.2 This test method (assay) has been qualified and validated based upon the International Committee on Harmonization assay validation guidelines (with the exception of interlaboratory precision) for the assessment of the biological activity of rhBMP-2. The relevance of this in vitro test method to in vivo bone formation has also been studied. The measured response in the W-20 bioassay, alkaline phosphatase induction, has been correlated with the ectopic bone-forming capacity of rhBMP-2 in the in vivo Use Test (UT). rhBMP-2 that was partially or fully inactivated by targeted peracetic acid oxidation of the two methionines was used as a tool to compare the activities. Oxidation of rhBMP-2 with peracetic acid was shown to be specifically targeted to the methionines by peptide mapping and mass spectrometry. These methionines reside in a hydrophobic receptor binding pocket on rhBMP-2. Oxidized samples were compared alongside an incubation control and a native control. The 62, 87, 98, and 100 % oxidized samples had W-20 activity levels of 62, 20, 7, and 5 %, respectively. The incubation and native control samples maintained 100 % activity. Samples were evaluated in the UT and showed a similar effect of inactivation on bone-forming activity. The samples with 62 % and 20 % activity in the W-20 assay demonstrated reduced levels of bone formation, similar in level with the reduction in W-20 specific activity, relative to the incubation control. Little or no ectopic bone was formed in the 7 and 5 % active rhBMP-2 implants.1.3 Thus, modifications to the rhBMP-2 molecule in the receptor binding site decrease the activity in both the W-20 and UT assays. These data suggest that a single receptor binding domain on rhBMP-2 is responsible for both in-vitro and in-vivo activity and that the W-20 bioassay is a relevant predictor of the bone-forming activity of rhBMP-2.1.4 The values stated in SI units are to be regarded as standard.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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method forIn Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line

ASTM F2131-02(2012) 使用W-20老鼠基质细胞系测定重组人骨形态发生蛋白-2 (rhBMP-2) 体外生物活性的标准试验方法

1.1 This test method describes the method used and the calculation of results for the determination of the in-vitro biological activity of rhBMP-2 using the mouse stromal cell line W-20 clone 17 (W-20-17). This clone was derived from bone marrow stromal cells of the W++ mouse strain.2 1.2 This test method (assay) has been qualified and validated based upon the International Committee on Harmonization assay validation guidelines3 (with the exception of interlaboratory precision) for the assessment of the biological activity of rhBMP-2. The relevance of this in vitro test method to in vivo bone formation has also been studied. The measured response in the W-20 bioassay, alkaline phosphatase induction, has been correlated with the ectopic bone-forming capacity of rhBMP-2 in the in vivo Use Test (UT). rhBMP-2 that was partially or fully inactivated by targeted peracetic acid oxidation of the two methionines was used as a tool to compare the activities. Oxidation of rhBMP-2 with peracetic acid was shown to be specifically targeted to the methionines by peptide mapping and mass spectrometry. These methionines reside in a hydrophobic receptor binding pocket on rhBMP-2. Oxidized samples were compared alongside an incubation control and a native control. The 62, 87, 98, and 1008201;% oxidized samples had W-20 activity levels of 62, 20, 7, and 58201;%, respectively. The incubation and native control samples maintained 1008201;% activity. Samples were evaluated in the UT and showed a similar effect of inactivation on bone-forming activity. The samples with 628201;% and 208201;% activity in the W-20 assay demonstrated reduced levels of bone formation, similar in level with the reduction in W-20 specific activity, relative to the incubation control. Little or no ectopic bone was formed in the 7 and 58201;% active rhBMP-2 implants. 1.3 Thus, modifications to the rhBMP-2 molecule in the receptor binding site decrease the activity in both the W-20 and UT assays. These data suggest that a single receptor binding domain on rhBMP-2 is responsible for both in-vitro and in-vivo activity and that the W-20 bioassay is a relevant predictor of the bone-forming activity of rhBMP-2. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with ......

Standard Test Method for In Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line

ASTM E1853M-98 用指示器基因测试系统测定感应CYPIA的共面有机化合物的存在的标准指南

1.1 This guide covers the recommended guidelines for perfoming a test for presence of organic compounds that bind to the Ah Receptor and induce the CYP1A locus on the vertebrate chromosome. Under appropriate test conditions, expose to one or more of these xenobiotic organic coimpounds, including dioxins, furans, coplanar PCBs, and several polycyclic aromatic hydrocarbons (PAHs). Detection of induction has been made simple and rapid by the stable integration of the firefly plasmid such that Ah-receptor binding results in the production of luciferase. Luciferase production is a function of both the potency of the compound(s) and the concentration. This type of Reporter Gene System (RGS) has shown concentration-response relationships using 2,3,7,8-TCDD, 5 coplanar PCBs, and several polycyclic aromatic hydrocarbons (PAHs) (1,2). This guide describes test conditions under which solvent extracts of environmental samples (water, tissue, soil, or sediments) may be tested for the presence of CYP1A-inducing organic compounds. 1.2 The test procedures presented in this guide have been published previously (1-3). These references shoud be consulted to obtain details regarding the construction and maintenance of the cell line, and the response of the cells to various organic substances. 1.3 All laboratory health and safety procedures should be followed. This includes the use of glasses, gloves, and other protective clothing, when handling the reagents. Information on toxicity, handling procedures and waste procedures should be reviewed prior to use of all chemicals. 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.

Guide for Measuring the Presence of Planar Organic Compounds Which Induce CYP1A, Using Reporter Gene Test Systems

ASTM E1439-98 进行蛙胚胎畸形发生鉴定非洲蟾蜍属(FETAX)的标准指南

1.1 This guide describes procedures for obtaining laboratory data concerning the developmental toxicity of a test material. The test utilizes embryos of the South African clawed frog, Xenopus laevis and is called FETAX (Frog Embryo Teratogenesis Assay- Xenopus ) (1). Some of these procedures will be useful for conducting developmental toxicity tests with other species of frogs although numerous modifications might be necessary. A list of alternative anurans is presented in Appendix X1. 1.2 A renewal exposure regimen and the collection of the required mortality, malformation, and growth-inhibition data are described. Special needs or circumstances might require different types of exposure and data concerning other effects. Some of these modifications are listed in Appendix X2 although other modifications might also be necessary. Whenever these procedures are altered or other species used, the results of tests might not be comparable between modified and unmodified procedures. Any test that is conducted using modified procedures should be reported as having deviated from the guide. 1.3 These procedures are applicable to all chemicals either individually or in formulations, commercial products or mixtures that can be measured accurately at the necessary concentrations in water. With appropriate modification these procedures can be used to conduct tests on temperature, dissolved oxygen, pH, physical agents, and on materials such as aqueous effluents (see Guide E1192), leachates, aqueous extracts of water-insoluble materials, particulate matter, sediment, and surface waters. 1.4 This standard does not purport to address all of the safety problems, 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. 1.5 This guide is arranged as follows:

Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX)

ASTM E1439-98(2004) 进行蛙胚胎畸形发生鉴定非洲蟾蜍属(FETAX)的标准指南

FETAX is a rapid test for identifying developmental toxicants. Data may be extrapolated to other species including mammals. FETAX might be used to prioritize samples for further tests which use mammals. Validation studies using compounds with known mammalian or human developmental toxicity, or both, suggest that the predictive accuracy will exceed 85 % (2). When evaluating a test material for mammalian developmental toxicity, FETAX must be used with and without a metabolic activation system (MAS). Use of this exogenous MAS should increase the predictive accuracy of the assay to approximately 95 %. The accuracy rate compares favorably with other currently available “ in vitro teratogenesis screening assays” (3). Any assay employing cells, parts of embryos, or whole embryos other than in vivo mammalian embryos is considered to be an in vitro assay. It is important to measure developmental toxicity because embryo mortality, malformation, and growth inhibition can often occur at concentrations far less than those required to affect adult organisms. Because of the sensitivity of embryonic and early life stages, FETAX provides information that might be useful in estimating the chronic toxicity of a test material to aquatic organisms. Results from FETAX might be useful when deriving water quality criteria for aquatic organisms (4). FETAX results might be useful for studying structure-activity relationships between test materials and for studying bioavailability.1.1 This guide covers procedures for obtaining laboratory data concerning the developmental toxicity of a test material. The test utilizes embryos of the South African clawed frog, Xenopus laevis and is called FETAX (Frog Embryo Teratogenesis Assay- Xenopus) (). Some of these procedures will be useful for conducting developmental toxicity tests with other species of frogs although numerous modifications might be necessary. A list of alternative anurans is presented in . 1.2 A renewal exposure regimen and the collection of the required mortality, malformation, and growth-inhibition data are described. Special needs or circumstances might require different types of exposure and data concerning other effects. Some of these modifications are listed in although other modifications might also be necessary. Whenever these procedures are altered or other species used, the results of tests might not be comparable between modified and unmodified procedures. Any test that is conducted using modified procedures should be reported as having deviated from the guide.1.3 These procedures are applicable to all chemicals either individually or in formulations, commercial products or mixtures that can be measured accurately at the necessary concentrations in water. With appropriate modification these procedures can be used to conduct tests on the effects of temperature, dissolved oxygen, pH, physical agents, and on materials such as aqueous effluents (see Guide E 1192), surface and ground waters, leachates, aqueous extracts of water-insoluble materials, and solid phase samples, such as soils and sediments, particulate matter, sediment, and whole bulk soils and sediment.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.

Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX)

ASTM F748-98 材料和装置用一般生物试验方法的选择

1.1 This practice recommends generic biological test methods for materials and devices according to end-use applications. While chemical testing for extractable additives and residual monomers or residues from processing aids is necessary for most implant materials, such testing is not included as a part of this practice. The reader is cautioned that the area of materials biocompatibility testing is a rapidly evolving field, and improved methods are evolving rapidly, so this practice is by necessity only a guideline. A thorough knowledge of current techniques and research is critical to a complete evaluation of new materials. 1.2 These test protocols are intended to apply to materials and medical devices for human application. Biological evaluation of materials and devices, and related subjects such as pyrogen testing, batch testing of production lots, and so forth, are also discussed. Tests include those performed on materials, end products, and extracts. Rationale and comments on current state of the art are included for all test procedures described. 1.3 The biocompatibility of materials used in single-component or multicomponent medical devices for human use depends to a large degree on the particular nature of the end-use application. Biological reactions that are detrimental to the success of a material in one device application may have little or no bearing on the successful use of the material for a different application. It is, therefore, not possible to specify a set of biocompatibility test methods which will be necessary and sufficient to establish biocompatibility for all materials and applications. 1.4 The ethical use of research animals places the obligation on the individual investigator to determine the most efficient methods for performing the necessary testing without undue use of animals. Where adequate prior data exists to substantiate certain types of safety information, these guidelines should not be interpreted to mean that testing should be repeated unnecessarily.

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

ASTM E1242-97(2003) 使用辛醇水分配系数估计由于麻醉使鱼类半致死浓度的标准规程

This procedure can be used to limit the need for screening tests prior to performing a test for estimating the LC50 of a non-reactive and non-electrolytic chemical to the fathead minnow. By eliminating the screening test, fewer fish need be tested. The time used for preparing and performing the screening test can also be saved. The value obtained in this procedure can be used as the preliminary estimate of the LC50 in a full-scale test. Estimates can be used to set testing priority of groups of non-reactive and non-electrolytic chemicals. If the estimated value is more than 0.3 times the experimental value, the mechanism of action is probably narcosis. If less, the effect concentration is considered to reflect a different mechanism of action. This practice estimates a maximum LC50, that is, non-reactive and non-electrolytic chemicals are at least as toxic as the practice predicts, but may have a lower LC50 if acting by a more specific mechanism. Data on a chemical indicating a lower toxicity than predicted should be considered suspect or an artifact because of limited solubility of the test material.1.1 This practice covers a procedure for estimating the fathead minnow (Pimephales promelas) 96-h LC50 of nonreactive (that is, covalently bonded without unsaturated residues) and nonelectrolytic (that is, require vigorous reagents to facilitate substitution, addition, replacement reactions and are non-ionic, non-dissociating in aqueous solutions) organic chemicals acting solely by narcosis, also referred to as Meyer-Overton toxicity relationship.1.2 This procedure is accurate for organic chemicals that are toxic due to narcosis and are non-reactive and non-electrolytic. Examples of appropriate chemicals are: alcohols, ketones, ethers, simple halogenated aliphatics, aromatics, and aliphatic substituted aromatics. It is not appropriate for chemicals whose structures include a potential toxiphore (that structural component of a chemical molecule that has been identified to show mammalian toxicity, for example CN is known to be reponsible for inactivation of enzymes, NO2 for decoupling of oxidative phosphorylation, both leading to mammalian toxicity). Examples of inappropriate chemicals are: carbamates, organophosphates, phenols, beta-gamma unsaturated alcohols, electrophiles, and quaternary ammonium salts.

Standard Practice for Using Octanol-Water Partition Coefficient to Estimate Median Lethal Concentrations for Fish Due to Narcosis

ASTM E1242-97 用辛醇水分配系数测定鱼因麻醉的中长致死浓度

1.1 This practice covers a procedure for estimating the fathead minnow (Pimephales promelas) 96-h LC50 of nonreactive (that is, covalently bonded without unsaturated residues) and nonelectrolytic (that is, require vigorous reagents to facilitate substitution, addition, replacement reactions and are non-ionic, non-dissociating in aqueous solutions) organic chemicals acting solely by narcosis, also referred to as Meyer-Overton toxicity relationship.1.2 This procedure is accurate for organic chemicals that are toxic due to narcosis and are non-reactive and non-electrolytic. Examples of appropriate chemicals are: alcohols, ketones, ethers, simple halogenated aliphatics, aromatics, and aliphatic substituted aromatics. It is not appropriate for chemicals whose structures include a potential toxiphore (that structural component of a chemical molecule that has been identified to show mammalian toxicity, for example CN is known to be reponsible for inactivation of enzymes, NO2 for decoupling of oxidative phosphorylation, both leading to mammalian toxicity). Examples of inappropriate chemicals are: carbamates, organophosphates, phenols, beta-gamma unsaturated alcohols, electrophiles, and quaternary ammonium salts.

Standard Practice for Using Octanol-Water Partition Coefficient to Estimate Median Lethal Concentrations for Fish Due to Narcosis

ASTM E729-96(2002) 用鱼, 大型无脊椎动物和两栖动物的试验用材料进行剧毒毒性试验的标准指南

1.1 This guide (1) describes procedures for obtaining laboratory data concerning the adverse effects (for example, lethality and immobility) of a test material added to dilution water, but not to food, on certain species of freshwater and saltwater fishes, macroinvertebrates, and amphibians during 2 to 8-day exposures, depending on the species. These procedures will probably be useful for conducting acute toxicity tests with many other aquatic species, although modifications might be necessary.1.2 Other modifications of these procedures might be justified by special needs or circumstances. Although using appropriate procedures is more important than following prescribed procedures, results of tests conducted using unusual procedures are not likely to be comparable to results of many other tests. Comparison of results obtained using modified and unmodified versions of these procedures might provide useful information concerning new concepts and procedures for conducting acute tests.1.3 This guide describes tests using three basic exposure techniques: static, renewal, and flow-through. Selection of the technique to use in a specific situation will depend on the needs of the investigator and on available resources. Tests using the static technique provide the most easily obtained measure of acute toxicity, but conditions often change substantially during static tests; therefore, static tests should not last longer than 96 h, and test organisms should not be fed during such tests. Static tests should probably not be conducted on materials that have a high oxygen demand, are highly volatile, are rapidly transformed biologically or chemically in aqueous solution, or are removed from test solutions in substantial quantities by the test chambers or organisms during the test. Because the pH and concentrations of dissolved oxygen and test material are maintained at desired levels and degradation and metabolic products are removed, tests using renewal and flow-through methods are preferable and may last longer than 96 h; test organisms may be fed during renewal and flow-through tests. Although renewal tests might be more cost-effective, flow-through tests are generally preferable.1.4 Acute tests may be performed to meet regulatory data requirements or to obtain time-independent estimates of toxicity.1.4.1 If the objective is to obtain data to meet regulatory requirements, it may be necessary to limit the number of observation times based on stipulations of the regulatory agency and cost considerations.1.4.2 If the objective of an acute toxicity test is to determine a time-independent (that is, incipient, threshold, or asymptotic) toxicity level, an appropriate number of observations must be taken over an exposure duration of sufficient length to establish the shape of the toxicity curve or allow the direct or mathematically estimated determination of a time-independent toxicity value (2), or both.1.5 In the development of these procedures, an attempt was made to balance scientific and practical considerations and to ensure that the results will be sufficiently accurate and precise for the applications for which they are commonly used. A major consideration was that the common uses of the results of acute toxicity tests do not require or justify stricter requirements than those set forth herein. Although the tests may be improved by using more organisms, longer acclimation times, and so forth, the requirements presented herein should usually be sufficient.1.6 Results of acute toxicity tests should usually be reported in terms of an LC50 (median lethal concentration) or EC50 (median effective concentration) at the end of the test, but it is desirable to provide information concerning the dependence of adverse effects on both time and concentration. Thus, when feasible, flow-through and renewal tests should be conducted so that LC50s or EC50s can be reported from 6 ......

Standard Guide for Conducting Acute Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and Amphibians

ASTM E729-96(2007) 用鱼、大型无脊椎动物和两栖动物进行剧毒毒性试验的标准指南

An acute toxicity test is conducted to obtain information concerning the immediate effects on test organisms of a short-term exposure to a test material under specific experimental conditions. An acute toxicity test does not provide information about whether delayed effects will occur, although a post-exposure observation period, with appropriate feeding, if necessary, might provide such information. Results of acute toxicity tests might be used to predict acute effects likely to occur on aquatic organisms in field situations as a result of exposure under comparable conditions, except that (1) motile organisms might avoid exposure when possible, and (2) toxicity to benthic organisms might be dependent on sorption or settling of the test material onto the substrate. Results of acute tests might be used to compare the acute sensitivities of different species and the acute toxicities of different test materials, and to study the effects of various environmental factors on results of such tests. Results of acute toxicity tests might be an important consideration when assessing the hazards of materials to aquatic organisms (see Guide E 1023) or when deriving water quality criteria for aquatic organisms (2). Results of acute toxicity tests might be useful for studying the biological availability of, and structure-activity relationships between, test materials. Results of acute toxicity tests will depend on the temperature, composition of the dilution water, condition of the test organisms, exposure technique, and other factors.1.1 This guide () describes procedures for obtaining laboratory data concerning the adverse effects (for example, lethality and immobility) of a test material added to dilution water, but not to food, on certain species of freshwater and saltwater fishes, macroinvertebrates, and amphibians during 2 to 8-day exposures, depending on the species. These procedures will probably be useful for conducting acute toxicity tests with many other aquatic species, although modifications might be necessary.1.2 Other modifications of these procedures might be justified by special needs or circumstances. Although using appropriate procedures is more important than following prescribed procedures, results of tests conducted using unusual procedures are not likely to be comparable to results of many other tests. Comparison of results obtained using modified and unmodified versions of these procedures might provide useful information concerning new concepts and procedures for conducting acute tests.1.3 This guide describes tests using three basic exposure techniques: static, renewal, and flow-through. Selection of the technique to use in a specific situation will depend on the needs of the investigator and on available resources. Tests using the static technique provide the most easily obtained measure of acute toxicity, but conditions often change substantially during static tests; therefore, static tests should not last longer than 96 h, and test organisms should not be fed during such tests. Static tests should probably not be conducted on materials that have a high oxygen demand, are highly volatile, are rapidly transformed biologically or chemically in aqueous solution, or are removed from test solutions in substantial quantities by the test chambers or organisms during the test. Because the pH and concentrations of dissolved oxygen and test material are maintained at desired levels and degradation and metabolic products are removed, tests using renewal and flow-through methods are preferable and may last longer than 96 h; test organisms may be fed during renewal and flow-through tests. Although renewal tests might be more cost-effective, flow-through tests are generally......

Standard Guide for Conducting Acute Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and Amphibians

ASTM E1022-94(2007) 用鱼和海水双壳类软体动物进行生物浓缩试验

1.1 This guide describes procedures for obtaining laboratory data concerning bioconcentration of a test material added to dilution water8212;but not to food8212;by freshwater and saltwater fishes and saltwater bivalve mollusks using the flow-through technique. These procedures also should be useful for conducting bioconcentration tests with other aquatic species, although modifications might be necessary.1.2 Other modifications of these procedures might be justified by special needs or circumstances. Although using appropriate procedures is more important than following prescribed procedures, the results of tests conducted using unusual procedures are not likely to be comparable to those of many other tests. The comparison of results obtained using modified and unmodified versions of these procedures might provide useful information concerning new concepts and procedures for conducting bioconcentration tests.1.3 These procedures are applicable to all chemicals that can be measured accurately at the necessary concentrations in water and in appropriate tissues. Bioconcentration tests are usually conducted on individual chemicals but can be conducted on mixtures if appropriate measurements can be made. Some techniques described in this guide were developed for tests on non-ionizable organic chemicals (see 11.1.2.1) and might not apply to ionizable or inorganic chemicals.1.4 Results of bioconcentration tests should usually be reported in terms of apparent steady-state and projected steady-state bioconcentration factors (BCFs) and uptake and depuration rate constants. Results should be reported in terms of whole body for fishes and in terms of total soft tissue for bivalve mollusks. For fishes and scallops consumed by humans, some results should also be reported in terms of the edible portion, especially if ingestion of the test material by humans is a major concern. For tests on organic and organometallic chemicals, the percent lipids of the tissue should be reported.1.5 This guide is arranged as follows:SectionReferenced Documents2Terminology3Summary of Guide4Significance and Use5Safety Precautions7Apparatus6Facilities6.1Construction Materials6.2Metering System6.3Test Chambers6.4Cleaning6.4.4Acceptability6.5Dilution Water8Requirements8.1Source8.2Treatment8.3Characterization8.4Test Material9General9.1Radiolabeled Material9.2Stock Solution9.3Test Concentration(s)9.4Test Organisms10Species10.01Size10.02Source10.03Care and Handling10.04Feeding10.05Disease Treatment10.06Holding10.07Acclimation10.08Quality10.09Procedure11Experimental Design11.1Dissolved Oxygen11.2Temperature11.3Loading11.4Beginning the Test11.5Care of Organisms11.6Feeding11.7Cleaning11.8Biological Data11.9Measurements on Test Solutions11.10

Standard Guide for Conducting Bioconcentration Tests with Fishes and Saltwater Bivalve Mollusks

ASTM E1022-94(2013) 用鱼和海水双壳类软体动物进行生物浓缩试验的标准指南

5.1 A bioconcentration test is conducted to obtain information concerning the ability of an aquatic species to accumulate a test material directly from water. This guide provides guidance for designing bioconcentration tests on the properties of the test material so that each material is tested in a cost-effective manner. 5.2 Because steady-state is usually approached from the low side and the definition of apparent steady-state is based on a statistical hypothesis test, the apparent steady-state BCF will usually be lower than the steady-state BCF. With the variation and sample sizes commonly used in bioconcentration tests, the actual steady-state BCF will usually be no more than twice the apparent BCF. 5.3 When both are determined in the same test, the projected steady-state BCF will usually be higher than the apparent steady-state BCF because the models used to calculate the projected BCF assume that the BCF steadily increases until infinite time. 5.4 The BCFs and rates and extents of uptake and depuration will depend on temperature, water quality, the species and its size, physiological condition, age, and other factors (1).3 Although organisms are fed during tests, uptake by means of sorption onto food is probably negligible during tests. 5.5 Results of bioconcentration tests are used to predict concentrations likely to occur in aquatic organisms in field situations as a result of exposure under comparable conditions, except that mobile organisms might avoid exposure when possible. Under the experimental conditions, particulate matter is deliberately minimized compared to natural water systems. Exposure conditions for the tests may therefore not be comparable for an organic chemical that has a high octanol-water partition coefficient or for an inorganic chemical that sorbs substantially onto particulate matter. The amount of the test substance in solution is thereby reduced in both cases, and therefore the material is less available to many organisms. However, sorption might increase bioaccumulation by aquatic species that ingest particulate matter (2), or food may be a more important source of residues in fish than water per se for stable neutral organic chemicals that have a Log K ow between 4 and 6 (3) . 5.6 Results of bioconcentration tests can be used to compare the propensity of different materials to be accumulated. Nonionizable organic chemicals can also be ranked for bioconcentration using correlations that have been reported between steady-state BCFs and physical–chemical properties, such as the octanol–water partition coefficient and solubility in water (4). However, when such predictions are impossible, exceed the demonstrated limits of the correlation, or might be otherwise questionable (1,

Standard Guide for Conducting Bioconcentration Tests with Fishes and Saltwater Bivalve Mollusks