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GB/T 27825-2011: Chemicals -- Test method for skin absorption -- In vivo
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| GB/T 27825-2011 | English | 259 |
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Chemicals -- Test method for skin absorption -- In vivo
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GB/T 27825-2011
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Basic data | Standard ID | GB/T 27825-2011 (GB/T27825-2011) | | Description (Translated English) | Chemicals -- Test method for skin absorption -- In vivo | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A80 | | Classification of International Standard | 13.300; 11.100 | | Word Count Estimation | 11,125 | | 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 chemicals absorbed through the skin in vivo test method terminology and definitions, test principles, test methods, test data and reports. This standard applies to chemicals in vivo percutaneous absorption. | GB/T 27825-2011: Chemicals -- Test method for skin absorption -- In vivo---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 for skin absorption. In vivo
ICS 13.300; 11.100
A80
National Standards of People's Republic of China
Test methods for in vivo skin absorption of chemicals
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.427 (2004) "Skin absorption. in vivo test method"
Unanimously (in English) of technical content.
The standard structure and made the following editorial changes.
--- Increasing the range a chapter;
--- The OECD427 original in the "Introduction" and "initial consideration" as part of this standard "Introduction";
--- The OECD427 original "Appendix" as part of the standard "2 Terms and definitions" content;
--- A unit of measurement unity to our legal units of measurement.
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, People's Republic of China Hubei Entry-Exit Inspection
Quarantine Bureau, China Chemical Technology Development Center.
The main drafters of this standard. Liuqing Jun, Chao-lin, Lin Zheng, Cengxian Dong, Yang Ting, Zhang Jianfeng, Guo star, Chen Jianjun, Zhao Hui, Pinghan Li,
Fed.
Introduction
This standard mainly with reference to the technical content of the Organisation for Economic Co-operation and Development (OECD) Chemical Test Methods Guide No.427 (2004),
This guide provides an in vivo test methods for chemical testing of skin absorption.
Human exposure to chemicals is the main route through the skin, and now the majority of toxicological studies using experimental animals exposed by oral way.
This guide describes test methods for in vivo percutaneous absorption from the oral test extrapolated percutaneous exposure to chemical safety assessments inevitable
contact.
Chemicals need to penetrate through layers of skin cells is available to reach the circulatory system. For most substances, the stratum corneum consisting of dead cells summary
Given its skin penetration rate. Chemical permeation of the skin depends both on the chemical itself lipophilic, the thickness of the outer layer of the epidermis
And the relative molecular mass of the matter concentration and other factors. In general, better than the rat and rabbit skin permeability of human skin, and guinea pigs,
Pigs and monkeys is more similar to human skin permeability.
Test chemical method by percutaneous absorption include two kinds of in vitro in vivo. In vivo test method can provide different species of animals percutaneous absorption
Good information. In recent years, in vitro test methods have also made progress. In vitro test for chemical substances mainly through full or partial thickness
Of animal or human skin reaches a predetermined liquid storage. Test Method for in vitro test method OECD guidelines as otherwise described separately [1].
Under certain circumstances, OECD skin absorption study guide [2] can be used as a reference to select the appropriate test method, which provided more information on body
Within and in vitro test methods for applicability details.
In vivo test method described in this guide can test substance through the skin into the body parts of penetration is measured, the method has been widely
Pan used for years [3-7]. Although many cases lower body Percutaneous absorption studies can be applied, but in some cases only through the study of in vivo tests
It is available to provide the necessary data.
Advantages in vivo test method is that it uses physiological and metabolic complete systems, using a variety of toxicity studies in experimental animals generally applicable
Species of the genus, and appropriate modifications can be applied to other species. Of course, this method also has its drawbacks. the use of live animals, required the use of isotopically labeled
Marking material to obtain reliable results, it is difficult to determine the early stages of skin absorption and preferred species (rat) and human skin permeability there is a difference
different. In general, animal skin permeability is better, so the test may overestimate human percutaneous absorption [6,8-9]. In addition, acid and other corrosive substances
Also not suitable for live animals experiments.
Test methods for in vivo skin absorption of chemicals
1 Scope
This standard specifies the test methods for in vivo skin absorption of chemical terms and definitions, principles of testing, test methods, test data and reports.
This standard applies to test in vivo percutaneous absorption of chemicals.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Not absorbed dose unabsorbeddose
After exposure, rinse down from the surface of the skin and the amount of test substance in the cover means, including exposure during evaporate from the skin surface
Amount.
2.2
Absorbed dose (in vivo) absorbeddose (invivo)
After removal of the test site of the skin test substance, including urine, cages washing fluid, feces, exhaled air (if the test), blood, tissues (if
There were collected) and the retention of the test substance in the body.
2.3
Absorbable dose absorbabledose
After washing, the amount left in the skin surface or skin tissue test substance.
3 Test principle
Test substance (preferably isotopically labeled) was applied to the hair of an animal skin, a representative set of test one or more suitable agents
Volume group. Within a predetermined exposure time, appropriate (non-closed, semi-closed or closed) covering means covering, the skin contact of the test preparation.
Before exposure, during exposure and after exposure, the test animals were reared in individual metabolic cages and collect animal waste and exhaled gas; exposure colorectal
When the beam, removing the cover device with suitable detergent wash the skin, to retain the cover device and the cleaning fluid for analysis. Typically, each agent
Set in the amount set several groups of animals. a group at the end of the exposure period that is sacrificed, followed by the other groups were killed after a predetermined time interval [2], end of sampling
When the rest of the group of animals were sacrificed, blood was collected, remove the skin test sites were analyzed and analyzed to determine the amount of body excretion of the test substance is not.
Samples collected in an appropriate method of analysis and the percutaneous absorption of the test substance to assess the extent of [6,8-9].
Test Method 4
4.1 animal selection
Rats are the most common species, can also be used with the human skin absorption rates more similar to strains of hairless series [3,6-9]. Generally used in experiments
Common Room strain male healthy adult animals. When the trial began, animal weight difference does not exceed the average weight of ± 20%, for example, a large male
Suitable for rats weighed 200g ~ 250g, especially in the upper part of this range.
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