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GB 15193.22-2014 English PDF

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GB 15193.22-2014: National food safety standard - 28 days oral toxicity test
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
GB 15193.22-2014	English	169	Add to Cart	3 days [Need to translate]	National food safety standard - 28 days oral toxicity test	Valid	GB 15193.22-2014

PDF similar to GB 15193.22-2014

Standard similar to GB 15193.22-2014

GB 15193.29 GB 15193.28 GB 15193.1 GB 15193.15 GB 15193.11 GB 15193.14

Basic data

Standard ID	GB 15193.22-2014 (GB15193.22-2014)
Description (Translated English)	National food safety standard - 28 days oral toxicity test
Sector / Industry	National Standard
Classification of Chinese Standard	C53
Classification of International Standard	67.020
Word Count Estimation	7,740
Date of Issue	12/1/2014
Date of Implementation	5/1/2015
Regulation (derived from)	National Health and Family Planning Committee Announcement 2014 No. 19
Issuing agency(ies)	National Health and Family Planning Commission of the People's Republic of China
Summary	This Standard specifies the experimental animals 28 days of basic test methods and technical requirements for oral toxicity tests. This Standard applies to the evaluation of short-term toxic effects of the test substance.

GB 15193.22-2014: National food safety standard - 28 days oral toxicity test

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(National Food Safety Standard 28 days oral toxicity test) Book People's Republic of China National Standard National Food Safety Standard 28 days oral toxicity test (To be issued) Issued on. 2014-12-01 2015-05-01 implementation People's Republic of China National Health and Family Planning Commission released Book GB 15193.22-2014 National Food Safety Standard 28 days oral toxicity test

1 Scope

This standard specifies the experimental animals 28 days of basic technical requirements and test methods for oral toxicity tests. This standard applies to the evaluation of short-term toxic effects of the test substance.

2 Terms and definitions

2.1 28 days repeated dose oral toxicity Experimental animals for 28 days after the oral health damage effect caused by contact with the test substance. 2.2 No observed adverse effect level Through animal experiments, the existing technical means and detection index was not observed any of the test substance-related toxic effects maximum dose. 2.3 Minimum observed adverse effect level Under specified conditions, the test substance causing a minimal effect dose animal tissue morphology, function, growth and development, and other harmful effects. 2.4 target organ Organ by the test substance caused significant toxic effects of experimental animals. 2.5 Satellite Group In toxicity studies in the design and implementation of additional group of animals, animal handling and feeding conditions and its main research similar to the test for interim Or test convalescence observation and testing can also be used to observe and testing does not include other indicators and parameters in the main study.

3 test purposes and principles

Determine toxic effects after 28 days of continuous oral exposure caused by the test substance, understand the test substance dose - response relationship and cytotoxicity target device Officer, determined 28 days after oral minimal observed adverse effect level (LOAEL) and not observed adverse effect level (NOAEL), preliminary evaluation Test substance orally security, and provide longer-term and chronic toxicity test dose, observed indicators, toxicity endpoint selection for the next step in accordance with.

4 instruments and reagents

4.1 Instruments/Devices Anatomy of commonly used laboratory instruments, electronic balance, biological microscope, ophthalmoscope, biochemical analyzer, blood analyzer, blood coagulation analyzer, urine Analyzers, centrifuges, paraffin section machines. 4.2 Reagents Formaldehyde, xylene, ethanol, hematoxylin-eosin, paraffin, blood analyzer diluent, biochemical analysis reagents, coagulation analyzer reagents, urine points Analysis of reagents.

5 Test methods

5.1 test substance The test substance should be used in the original sample, if it can not use the original sample, the test should be treated in accordance with the principles of the test substance for proper disposal. will Test was incorporated into feed, drinking water or gavage administration. 5.2 Experimental Animals 5.2.1 animal selection Experimental animals should be selected in line with the relevant provisions of GB GB 14922.2 and 14922.1 of. Select has been documented on the test substance sensitive Species and strains are generally preferred rodents rats, dogs preferred non-rodent (usually chosen Beagle dogs). Recommended-week-old rats Not more than 6 weeks, weighing 50g ~ 100g. Start of the test animals of each sex difference should not exceed the weight of the average weight ± 20%. each Group number of animals less than 20, male and female; if the end of the test program to do the recovery observed, should increase the number of animals (control and high dose increase Satellite groups of 10, male and female). Dogs should be used for 4 months to 6 months puppy, start of the test animal body weight of each sex was not Should be more than the average weight of ± 20%, the number of animals in each group at least eight, male and female; if the end of the test program to do the recovery period observation, should be increased Number of animals (control and high dose increased satellite groups of four, male and female). Sex and number of animals in the control group should be the same group with a test substance. 5.2.2 Animal Preparation Before the test, rats in the experimental animal room should be at least 3d ~ 5d (dogs 7d ~ 14d) and adaptation to the environment quarantine observation. 5.2.3 Animal Feeding Animal breeding conditions should be consistent with GB 14925, drinking water should be consistent with GB 5749, feed should comply with the relevant provisions of GB 14924. During the test animals free access to water and food, recommend a single caged rat cage can also be components of sex are reared in groups, the number of animals per cage (usually no more than 3) shall meet the minimum space required for experimental animals in order not to affect the free movement of animals and the animals were observed for signs appropriate. During each test Non-animal test should be less than 10% of mortality, dying animal blood biochemical tests should be carried out as far as possible, the gross anatomy and pathology group Histological examination of biological specimens each loss rate should be less than 10%. 5.3 dose 5.3.1 Packet The experiment included at least three doses of the test substance group, a negative (vehicle) control group, if necessary, additional untreated control group. If the end of the trial do Recovery was observed in the control and high dose for an additional satellite group. In addition to the control group not given the test substance, the rest are treated with the test substance dose group. 5.3.2 Design of dose High doses of the principle 5.3.2.1 should make some animals appear more obvious toxicity, but does not cause death; low dose should not have any concept of Observed toxic effects (equivalent NOAEL), and higher than the actual human exposure levels; dose ranging between, there may be mild toxic effect It should be to arrive at LOAEL. Group spacing generally declining doses 2 to 4 times with appropriate, such total dose of test substance is too large span, the dose can be added provided group. The reference design test dose acute toxicity LD50 dose and the actual human intake of conduct. 5.3.2.2 LD50 test substance can be determined to LD50 10% to 25% as 28 days oral toxicity test of the highest dose group, the LD50 Select the percentage of the main reference LD50 dose - response curve slope. Then this dose group consists of several doses, at least the lowest dose group Three times the expected human intake. 5.3.2.3 not seek LD50 test substance, the test dose should be possible to cover the expected intake of 100 times the human dose, without affecting animals Under the premise of feeding and nutritional balance should try to improve dose high dose group. Intended for human intake of larger test substance, the high-dose group also To give the maximum amount by design. 5.4 Test procedure and outcome measures 5.4.1 The test is administered 5.4.1.1 according to the characteristics of the test substance and test purposes, select the test was incorporated into feed, water or orally administered. If the test was its driving Was palatability, should be given orally. The test substance should be administered continuously for 28 days. 5.4.1.2 test was orally administered to the test substance is dissolved or suspended in a suitable vehicle, the preferred solvent is water, water-insoluble test substance You can use vegetable oils (such as olive oil, corn oil, etc.), do not dissolve in water or oil can also make use of the test substance carboxymethyl cellulose, starch, etc. dubbed suspended Liquid or paste and the like. The test substance should now use the existing, data show that except for its storage solution or suspension stabilizer. Should be daily during the same period Gavage once weighed twice weekly gavage volume weight adjustment. Gavage volume of generally not more than 10mL/kg body weight, such as a water-soluble When liquid, the maximum volume of rats fed up to 20mL/kg of body weight, dogs 15mL/kg body weight; the case of an oily liquid, the volume should not exceed gavage 4mL/kg body weight; each group was given a consistent volume. 5.4.1.3 incorporated into feed or drinking water test substance administered to the test substance and feed (or water) and mixed well to ensure the stability of the test substance formulation Qualitative and uniformity, without affecting the animal feeding, nutritional balance and water intake to the principle of the test substance incorporated into feed ratio is generally less than the mass fraction 5%, while if more than 5% (maximum not more than 10%), the control diet was adjusted nutrient levels (when the test substance no heat or nutrients, and When you add a proportion of more than 5% in the control group diet should be filled methyl cellulose, incorporated in an amount equivalent to the high dose), and it was tested nutritional group Hormone levels consistent, while additional untreated control group; also depends on the subject matter of heat or nutrient status of the test substance dose adjustment feed Nutrient levels, making it consistent with the control group diet nutrient levels. Test substance dosage units per kilogram of body weight is ingested the test substance Mg (or g) number, namely mg/kg body weight (or g/kg body weight), when the test was incorporated into feed dosage unit can be expressed as mg/kg (or g / kg) of feed, the incorporation of water is expressed as mg/mL of water. When the test was incorporated into the feed, the need to test substance dose (mg/kg body weight) by each animal Food intake, body weight of 100g converted into animal feed test concentration (mg/kg feed), usually 28 days oral toxicity test according to the daily food intake of rats Weight 10% conversion. 5.4.2 General Clinical Observation Observation period 28d, assuming that the recovery observed after administration of the test animals should stop was to continue to observe 14d, to observe the test substances toxic Reversibility, persistence and delayed effects. Usually observed at least once daily during the clinical manifestations of animal testing and record animals poisoning Signs, and the extent and duration of death. Observation includes hair, skin, eyes, mucous membranes, secretions, excretions, respiratory system, nervous System, autonomic activity (eg. lacrimation, piloerection reaction, pupil size, unusual respiratory) and behavior (eg. gait, posture, response to treatment, there is No tonic or clonic activity, stereotyped reactions, abnormal behavior, etc.). Of weak constitution animals should be isolated, dying and dead animals should be Anatomy. 5.4.3 Body weight and food intake, and water consumption Weekly record weight, food consumption, food utilization calculation; at the end of the test, calculated animal weight gain, total food intake, total food use rate. The test was administered in drinking water, it should be recorded daily water intake. As the test was administered by incorporation of feed or water shall be calculated and reported for each test substance The actual dose administered dose. 5.4.4 eye examination Before the test, and at the end of the test, at least for the high-dose group and the control group, the experimental animals were eye (cornea, conjunctiva, iris) inspection, dogs Sodium fluorescein to check if the animals have found that high doses of the eye changes, the response of all animals to be checked. 5.4.5 Hematology Rats end of the test, the recovery period end (satellite group) hematological parameters were measured; dogs before the test, the test ends, the end of the recovery period (satellite Group) were hematological parameters were measured. Recommended indicators for the white blood cell count and classification (at least three categories), red blood cell count, hemoglobin concentration, red Hematocrit, platelet count, prothrombin time (PT), activated partial thromboplastin time (APTT) and the like. If you have shadow on the blood system Response, should be added to measure reticulocytes, bone marrow smear cytology. 5.4.6 blood biochemical examination Rats end of the test, the recovery period end (satellite group) blood biochemical parameters were measured; dogs before the test, the test ends, the end of the recovery period (guard Star Group) blood biochemical tests should be fasting blood. Determination of indicators should include electrolyte balance, carbohydrate, fat and protein metabolism, liver (thin Cells, bile duct) and other aspects of renal function. Comprising at least alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamyl Peptidase (GGT), alkaline phosphatase (AKP), urea (Urea), creatinine (Cre), glucose (Glu), total protein (TP), albumin (Alb), total cholesterol Sterol (TC), triglyceride (TG), chlorine, potassium, sodium targets. If necessary, it can detect calcium, phosphorus, uric acid (UA), cholinesterase, sorbitol dehydrogenase, Total bile acid (TBA), methemoglobin, hormones and other indicators. Test content should be increased according to the characteristics of toxicity test substance or structure-activity relationships. 5.4.7 Urine Rat urine routine examination at the end of the test, the end of the recovery period (for satellite), the dogs before the test, the test ends, the end of the recovery period (guard Star group) urine routine examination. Including urinary protein, the relative density, pH, glucose, occult blood and so on. If the expected toxic reaction indications, should be increased Urine microscopy, cell analysis and other relevant items, such as urine. 5.4.8 body temperature, ECG Dogs before the test, the test ends, the end of the recovery period (satellite group) should be body temperature, ECG. 5.4.9 pathology 5.4.9.1 Gross anatomy At the end of the test must be carried out to check all animals in general, including the surface, cranial, thoracic and abdominal cavity and its organs, and that heart, thymus, adrenal Absolute weight gland, liver, kidney, spleen, testes, and calculate the relative weight (dirty/body weight ratio). 5.4.9.2 Histopathological examination You can be of the highest dose group and the control group of animals following organ histopathology, detection of disease and then to the lower dose group phase Organs and tissues should be checked. Detecting organs include the brain, thyroid, thymus, heart, liver, spleen, kidney, adrenal, stomach, duodenum, knot Intestine, pancreas, mesenteric lymph nodes, ovaries, testicles, bladder, necessary, to add measured spinal cord (cervical, thoracic, lumbar), pituitary gland, esophagus, jejunum, ileum, rectum, saliva Liquid gland, cervical lymph node, trachea, lungs, arteries, uterus, mammary gland, epididymis, prostate, bone and bone marrow, the sciatic nerve and muscle, skin, and eye and other groups Woven organs. Lesions or suspected lesions visible histopathological examination, issued by histopathological examination report, lesions Given histological picture. 5.4.10 Other indicators If necessary, depending on the nature of the test substance and toxicity observed, add other indicators (such as neurotoxicity, immunotoxicity, endocrine toxicity Indicators).

6 Data processing and evaluation of results

6.1 Data Processing Keep all data and results are summarized in tabular form, listing the number of animals in each group before the start of the animals died during the trial and the number of dead Dead time, the number of animal toxicity appears, listing seen toxicities, including the time of occurrence of toxic effects, duration and extent. The count The amount of information given by the mean, standard deviation. Animal body weight, food intake, water intake (the test was administered in drinking water), food efficiency, hematology, Blood biochemical examination, urinalysis, organ weights and dirty body ratio, pathology and other results should be an appropriate method of statistical analysis. general Case, the measurement data variance analysis, were compared between the plurality of test and control groups, classified data using Fisher exact distribution Test, chi-square test, rank sum test, ranked data using Ridit analysis, rank sum test and so on. 6.2 Evaluation Results Clinical observation should, growth and development, hematology, blood biochemical examination, urinalysis, gross anatomy, organ weight and dirty body ratio Values, and other histopathological examination results, combined with a comprehensive analysis of the statistical results, preliminary judgment test substance toxicity characteristics, the degree of the target device Officer, dose - response, the dose - response relationship, such as satellite recovery group is provided, but also to determine the reversibility of the test substance toxicity. In a comprehensive analysis of Foundation obtained 28 days oral toxicity LOAEL and (or) NOAEL. Preliminary evaluation of the test substance orally security and for further toxicity Trial to provide evidence.

7 Test report

7.1 Name of test, the test unit name and contact details, report number. 7.2 Test Requester name and contact information, sample acceptance date. 7.3 Test start and end dates, test project manager, technical director of the test unit, date of issue. 7.4 test summary. 7.5 test substance. name, lot number, dosage form, the state (including organoleptic, properties, package integrity, identification), the number of pre-treatment method, solvent. 7.6 Experimental animals. species, strain, level, quantity, weight, sex, origin (supplier name, animal production license number), animal inspection Phytophthora, adaptation, breeding environment (temperature, relative humidity, using experimental animal facility license number), feed sources (supplier name, laboratory animals Animal feed production license number). 7.7 Test method. the test group, the number of animals in each group, according to dose selection, route of administration and duration of the test substance, observed indicators, statistical methods. 7.8 Test Results. The animal growth activity, toxicity characteristics (including the presence of time and outcome), weight gain, food consumption, food Lee Use rate, eye examination, blood tests, blood biochemical examination, urinalysis, gross anatomy, organ weight and dirty body ratio, histopathological examination result. As the test was incorporated into feed or by incorporation of water give, the reports of the actual dose administered dose. 7.9 Test Conclusion. The test was 28 days after oral toxicity characteristics, dose-response relationship, the target organ and reversibility. And came 28 days oral toxicity Of NOAEL and (or) LOAEL conclusions. Explanation 8 trial 28 days oral toxicity test provides a test substance in a relatively short time due to repeated administration of toxic effects, toxicity characteristics and target organs Relevant information. Due to the presence of animal and human species differences, results extrapolated to man has some limitations, but may be a preliminary estimate of the crowd allowed Exposure levels provide valuable information.

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