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Chemicals -- Test method of acute dermal toxicity -- Fixed dose procedure
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GB/T 27823-2011
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Basic data | Standard ID | GB/T 27823-2011 (GB/T27823-2011) | | Description (Translated English) | Chemicals -- Test method of acute dermal toxicity -- Fixed dose procedure | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A80 | | Classification of International Standard | 13.300; 11.100 | | Word Count Estimation | 15,168 | | Date of Issue | 2011-12-30 | | Date of Implementation | 2012-08-01 | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 23 of 2011 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This standard specifies the chemical fixed dose acute dermal toxicity test methods terms, definitions and abbreviations, test principles, test methods, test data and reports. This standard applies to the fixed dose method testing dermal toxicity of chemicals. |
GB/T 27823-2011: Chemicals -- Test method of acute dermal toxicity -- Fixed dose procedure---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Chemicals. Test method of acute dermal toxicity. Fixed dose procedure
ICS 13.300; 11.100
A80
National Standards of People's Republic of China
Acute dermal toxicity of chemicals
Fixed-dose test methods
Issued on. 2011-12-30
2012-08-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The Standards and Organisation for Economic Co-operation and Development (OECD) chemical testing methods No.434 (2004) "fixed dose acute dermal toxicity
Law "(in English) The content of the technical.
This standard configuration and do the following editorial changes.
--- Increasing the range chapter (see Chapter 1);
--- Change the unit of measure of legal units of measurement;
--- The OECD434 Appendix 1, "Definitions" as Chapter 2 of this standard;
--- The OECD434 "before the test should be considered the" introduction into this standard.
This standard is managed by the National Standardization Technical Committee chemicals dangerous (SAC/TC251) and focal points.
This standard was drafted. Chinese Center for Disease Prevention and Control of Occupational Health and Poison Control, Tianjin Exit Inspection and Quarantine, in China
Technology Development Center Industry Economy, Jiangsu CIQ.
The main drafters of this standard. Hou powder Xia, Wang Hua, Zhang Yuan, Xu Bin, Yang Ting, Zhao Zhuo, Liu Wei, Tang Lijun.
Introduction
According to the scientific development and animal welfare requirements, the need for periodic testing of chemicals OECD guidelines for review visits. acute
Dermal toxicity Guide TG402 [1] was adopted in 1987. In the revised acute oral toxicity test fixed dose method (FDP)
(OECD420 [2]) after the start of use, and in December 2001 began after the abolition OECD Guideline 401, proposed fixed dose acute percutaneous
Law (FDP) is appropriate. The main method is to use several fixed-dose exposure, the use of single-sex animal (generally use a female) to
Detection of acute dermal toxicity.
Traditional methods in the evaluation of acute toxicity often with death as the only animal toxicity endpoints. In 1984, the British made a toxicology
New acute toxicity test items, that is, choose a fixed dose of the test substance exposure [3]. This method avoids the animal death as a final observation
Point, but in a few fixed-dose dose of obvious symptoms of end point, this is also a test dose toxicity stars
Level basis. This test also using the above method. OECD guidelines in order to achieve the end point of the humanitarian requirements [4], it is recommended to test side
Optimization method so that animal suffering is minimized as much as possible to reduce the use of animals. FDP test statistical rationality has been
Mathematical models were evaluated [5].
This method provides information on hazardous properties of the test substance. For can cause acute toxicity of the test substance, according to the results of this test, press
Global harmonized classification and labeling of chemicals according to the United Nations (GHS) for the test substance toxicity grading and classification [6].
All information should be considered prior to the test subjects was obtained, such as the name of the test substance, chemical structure, physical and chemical properties, and any other body
Within or in vitro toxicity tests, quantitative - structure activity relationship (Quantitativestructure-activityrelationship, QSAR) data,
Structurally similar chemical toxicological data, the intended use of the test substance and the possible extent of human exposure to the test substance. With the above information, the election
Choose a suitable initial dose tested.
Acute dermal toxicity of chemicals
Fixed-dose test methods
1 Scope
This standard specifies the terms, definitions and abbreviations, principles of testing, test methods chemicals fixed dose acute dermal toxicity test method,
Test data and reports.
This standard applies to fixed-dose dermal toxicity test method chemicals.
2 terms, definitions and abbreviations
The following terms, definitions and abbreviations apply to this document.
2.1 Terms and Definitions
2.1.1
Acute dermal toxicity acutedermaltoxicity
The harmful effects of the test substance in a short time (24h or less) disposable percutaneous exposure generated.
2.1.2
Significant toxicity evidenttoxicity
Significant toxicity manifestations animals after exposure, if using higher fixed concentration exposure, most of the animals are expected to be significant pain
Suffering, and even death near-death state.
2.1.3
Dose dose
The dose of the test substance. Test expressed as a volume per body weight given test animals (e.g., mg/kg).
2.1.4
Moribund impendingdeath
A manifestation of animals dead or moribund before appearing. Performance rodent approach of death include convulsions, lateral, recumbency and tremors.
2.1.5
Median lethal dose LD50
The oral administration of disposable substance causing 50% of the dose animal deaths occurred. LD50 value of the test substance with the amount of weight of test animal unit
(Mg/kg) Fig. Statistical derivatives.
2.1.6
Limit dose limitdose
The upper limit of the test dose (2000mg/kg or 5000mg/kg).
2.1.7
Moribund status moribundstatus
Even in the case of treatment given, the animals are still dying or unable to survive the state.
2.1.8
Foreseeable death predictabledeath
The clinical manifestations of certain animals prompted the end of the test at some time prior to death, for example, loss of drinking water and eating
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