SN/T 3882-2014Chemicals - Skin sensitization - Local Lymph Node Assay: BrdU-ELISA (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

The content of the technical standards and the United Nations Organisation for Economic Co-operation and Development (OECD) Chemicals Test Method 442B (2010) "Skin sensitization Test. regional lymph nodes method. BrdU-ELISA "(Skinsensitization. LocalLymphNodeAssay. BrdU-ELISA) content Basically the same.

This standard is proposed and managed by the National Certification and Accreditation Administration Committee.

This standard was drafted. People's Republic of China Shanghai Entry-Exit Inspection and Quarantine Bureau, People's Republic of China Tianjin Entry-Exit Inspection and Quarantine Bureau.

1 Scope

This standard specifies the test principle animal skin sensitization test, the test preparation, test procedure, observation, calculation results, data and reports.

This standard is applicable to the detection of chemicals, including nano-grade chemicals and particles detection of skin sensitization.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB 14924.1 animal feed common quality standards GB 14925 Laboratory Animal Facilities and Environment

3 Terms, definitions and abbreviations

The following terms, definitions and abbreviations apply to this document.

Accuracy

Detection methods and the results disclosed in reference degree of consistency. It is a measure of test method procedures and applicability. This term is often also as "a Consistency, "refer to the same extent with the correct test results.

Benchmark was benchmarktestsubstance One kind of non-sensitized sensitized material as the standard to compare with the test substance. Benchmark substance should have the following properties. a stable source available by; the substance to be detected in the classification structure and function similar; physical/chemical properties of clear; the known effects of supporting data; known expected response.

False negative A test object is a detection method or incorrectly identified as negative or no activity, but in fact it is positive or active.

False positive A test object is a detection method incorrectly identified as positive or active, but in fact it is negative or or no activity.

Hazard

Not conducive to health or ecological capacity. Only adequate levels of exposure to adverse impact.

Inter-laboratory reproducibility in different qualified laboratories measuring range, the same test was detected using the same method, can produce qualitatively and quantitatively similar to knot fruit. Reproducibility between laboratories in pre-validation and verification process to determine, which indicates a degree of detection can be successfully transferred between laboratories, the same when also refers reproducibility (between-laboratoryreproducibility) between laboratories.