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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 15193.30-2025: National food safety standard - Test of developmental neurotoxicity Status: Valid
Basic dataStandard ID: GB 15193.30-2025 (GB15193.30-2025)Description (Translated English): National food safety standard - Test of developmental neurotoxicity Sector / Industry: National Standard Classification of Chinese Standard: C53 Word Count Estimation: 11,130 Date of Issue: 2025-09-02 Issuing agency(ies): National Health Commission; State Administration for Market Regulation GB 15193.30-2025: National food safety standard - Test of developmental neurotoxicity---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB15193.30-2025National Standards of the People's Republic of China National Food Safety Standards Neurodevelopmental toxicity test Published on 2025-09-02 Implemented on 2026-03-02 National Health Commission of the People's Republic of China State Administration for Market Regulation issued National Food Safety Standards Neurodevelopmental toxicity test 1.Scope This standard specifies the basic test methods and technical requirements for neurodevelopmental toxicity. This standard is applicable to the evaluation of the neurodevelopmental toxicity of test substances. 2.Terms and Definitions 2.1 Neurodevelopmental toxicity Abnormal changes in the structure and function of the nervous system caused by exposure to the test substance during development; these changes can occur in various ways. Any stage of the life cycle. 2.2 Maternal toxicity The test substance caused direct or indirect health damage in pregnant female parent animals, manifested as reduced weight gain, functional abnormalities, and toxic effects. Symptoms, even death, etc. 2.3 No Observed Adverse Effect Dose (NOAEL) Under the specified test conditions, using existing technical means or detection indicators, no harmful effects related to exogenous chemicals were observed. The maximum dose or concentration. 2.4 Minimum Observed Adverse Effect Dose (LOAEL) Under specified test conditions, the lowest dose or concentration of an exogenous chemical that causes a certain effect in the body compared to a suitable control organism. 3.Experimental Objectives and Principles This test involves exposing pregnant and lactating laboratory animals to a test substance and evaluating the neurotoxicity of their offspring. The nervous system is typically observed. Changes in structure and function, and abnormalities in neurobehavior. This experiment can evaluate the effects of the test substance on the functional changes of the nervous system during the development of the F1 generation of animals. And/or morphological potential effects, to determine whether the test substance has neurodevelopmental toxicity and its NOAEL and/or LOAEL. 4.Instruments and reagents 4.1 Instruments/Mechanical Equipment Rat jumping platform, rat darkness avoidance device, rat shuttle box, rat Morris water maze, tuning fork, forelimb suspension device, hot plate device, rat running device Instruments, righting reflector, common laboratory dissection instruments, electronic balance, biological microscope, ophthalmoscope, blood biochemistry analyzer, blood analyzer, coagulation analyzer. Analyzers, centrifuges, pathology slide cutters, etc. 4.2 Reagents Formaldehyde, xylene, ethanol, hematoxylin, eosin, paraffin, blood cell analyzer diluent, blood biochemistry analysis reagents, coagulation analysis reagents, etc. 5.Test Methods 5.1 Test substance The test article should use the original sample whenever possible. If the original sample cannot be used, the test article should be properly treated in accordance with GB 15193.21. 5.2 Laboratory Animals 5.2.1 Animal Selection The selection of laboratory animals should comply with the relevant provisions of GB 14922.Animals with proven sensitivity to the test substance should be selected first. Select rodent rats, avoiding strains with low reproductive rates or high rates of developmental defects. The gestation and lactation days mentioned in this standard refer to... For commonly used rat strains, if other animal species are used, the corresponding number of days should be selected, and the appropriate toxicological, toxicokinetic, and/or biological parameters should be considered. Other information should explain its rationale. Laboratory animals should be labeled with their species, strain, origin, microbiological grade, sex, and weight. Zhou Ling. 5.2.2 Animal number and sex To obtain basic experimental data that meet statistical requirements and to accurately evaluate the toxic effects of test substances on the neurodevelopmental processes of animals, it is necessary to... Ensure that at least 20 litters of F1 animals are obtained in each dosage group and control group. Within 4 days after birth (Postnatal Days, PND) (on the day of birth) (PND0) The litter was standardized, and excess F1 generation animals from each litter were randomly removed to ensure that the number of F1 generation animals in each litter was as uniform as possible. The number of offspring should be consistent and should not exceed the average number of F1 offspring per litter (8-12) of the selected animal strain. Each litter should contain both female and male F1 offspring. The numbers should be as consistent as possible. Selective culling of F1 generation animals is not allowed; for example, F1 generation animals cannot be culled based on body weight. Formal experiment. Beforehand, it should be determined which F1 generation animals will be used for pre-weaning experiments and which will be used for post-weaning experiments. 5.2.3 Animal Preparation Use healthy, unused laboratory animals (except for pooled experiments). Animals should undergo at least [number missing] treatments in the laboratory animal facility prior to the experiment. Environmental acclimatization and quarantine observation for 3-5 days. At the start of the experiment, the difference in animal weight should not exceed ±20% of the average weight, and the weight should be... Within the normal range for this animal strain. If purchasing a pregnant animal, ensure it acclimatizes for 2-3 days. Pregnant animals mated with the same male... The mice were distributed as evenly as possible among the groups, and each animal was uniquely identified. 5.2.4 Animal housing environment The housing conditions, drinking water, and feed for laboratory animals should comply with the relevant provisions of GB 14925 and GB 14924.Laboratory animals should have free access to food. Water should be provided. Mating should take place in suitable cages. After successful mating, the animals should be transferred to a birthing cage or a pregnant mouse cage for separate feeding within 15 days of gestation. Keep animals in suitable conditions, arranging cages appropriately to minimize the impact of location. Provide appropriate nesting materials for pregnant animals nearing delivery. Exercise caution when handling pregnant animals during their pregnancy. Take precautions to avoid miscarriage and reduce external stimuli such as noise. 5.3 Dosage and Grouping The experiment should include at least three dose groups and one control group. Under conditions permissible by the physicochemical and biological properties of the test substance, the highest dose should be able to... It can induce some maternal toxicity, such as clinical signs, weight loss (not exceeding 10%) and/or dose-response toxicity of target organs. The dosage is moderate, but does not cause death in animals; intermediate doses may cause mild toxicity; low doses should not cause any toxicity. Dosage group differences... The interval should ideally be 2 to 4 times. If a fourth dose group is required, a larger interval (e.g., >10 times) can be selected. 5.4 Administration of the test substance 5.4.1 Mixed into feed or water When administering the test substance by mixing it into feed or drinking water, the test substance must be thoroughly mixed with the feed (or drinking water) and the stability of the test substance formulation must be ensured. The test substance should be selected based on its properties and uniformity, ensuring it does not affect animal feed intake, nutritional balance, or water consumption. The proportion of the test substance added to feed should generally not exceed 5% (quality). The percentage of methylcellulose in the test sample should not exceed 10%. If it exceeds 5% and the test sample contains no calories or nutrients, methylcellulose should be added to the control group feed. The amount added should be the same as that in the high-dose group to maintain consistency with the nutrient levels in the high-dose group feed; alternatively, it can be added based on the caloric or nutrient content of the test substance. The nutrient levels of the adjusted dosage group feed were made consistent with those of the control group feed. (Test substance dosage unit) This refers to the number of milligrams or grams of the test substance ingested per kilogram of body weight, i.e., mg/kg body weight or g/kg body weight. When the test substance is incorporated into feed, the dosage... The unit can also be expressed as mg/kg feed or g/kg feed, and when mixed with drinking water, it is expressed as mg/mL water. When the test substance is mixed with feed or added to... When administering drinking water, record the animal's food intake and water consumption. At the end of the experiment, calculate the actual intake of the test substance based on the food intake and water consumption. dose. 5.4.2 Gavage administration When administering the test substance by gavage, it should be dissolved or suspended in a suitable solvent. Aqueous solutions or... are preferred. Suspension is the first choice, followed by the use of vegetable oil solutions or suspensions (such as olive oil, corn oil, etc.). Carboxyl groups can also be used for test substances insoluble in water or oil. Methylcellulose, starch, etc., are prepared into suspensions or pastes. The solvent, or the co-solvent added to enhance the solubility of the test substance, should consider the following. Points. Does it affect the absorption, distribution, metabolism, and accumulation of the test substance; does it affect the chemical properties of the test substance, thereby altering its toxicological characteristics; does it... It affects the animal's consumption of food and water, as well as its nutritional levels. In addition to water, the toxicity characteristics of the solvent must be clearly understood to avoid using solvents that inherently possess these properties. Potentially toxic solvents (such as acetone, dimethyl sulfoxide). The test substance should be prepared immediately before use, and data should indicate that its solution or suspension is stable during storage. except. When the test substance is administered by gavage, if the solvent is water, the gavage volume should generally not exceed 10 mL/kg body weight, and the maximum gavage volume should not exceed [a certain value]. The gavage volume should be greater than 20 mL/kg body weight; if it is an oily liquid, the gavage volume should not exceed 4 mL/kg body weight; the gavage volume should be consistent across all groups of animals. Daily Gavage should be administered at the same time. Laboratory animals should be weighed at least twice a week, and the gavage volume adjusted according to their weight. It is recommended that the mother not receive any intrauterine treatment on the day of parturition. Administer gavage or other treatments. 5.5 Test Methods Nulliparous female and male rats at puberty (PND60-70) were selected as the F0 generation to avoid inbreeding (litter mating). Female rats were found... The day on which sperm is detected on a vaginal plug and/or vaginal smear is defined as day 0 of gestation (Gestation Days, GD). F0 generation animals are considered to have gestational age from conception and implantation. (GD6) throughout the lactation period (PND21), the test substance was administered daily at the designed exposure dose. After weaning of the F1 generation, the F0 generation female rats could be treated. Gross anatomical dissection and organ coefficient testing were performed. Male and female pups were assigned to evaluation cohorts according to the testing objectives. The testing time for each cohort was... There are three schemes for determining the time, number of offspring used for testing, and testing indicators. One scheme can be selected. See Tables 1 to 3 for each scheme. Table 1.Grouping and testing indicators for each litter of F1 generation animals (Scheme 1) The littermate's offspring numbered a male and female Indicators for detecting the number of offspring mice 40 animals (20 females and 20 males) 20 animals (10 females and 10 males) 20 animals (10 females and 10 males) Individual behavioral development PND22 brain mass, neuropathology, morphology PND22 brain mass Table 1.Grouping and testing indicators of each litter of F1 generation animals (Scheme 1) (continued) The littermate's offspring numbered a male and female Indicators for detecting the number of offspring mice 40 animals (20 females and 20 males) 40 animals (20 females and 20 males) 40 animals (20 females and 20 males) 40 animals (20 females and 20 males) 40 animals (20 females and 20 males) 20 animals (10 females and 10 males) Clinical observation athletic ability sexual maturity Sensorimotor function PND25 Learning and Memory PND70 brain mass, neuropathology, morphology 40 animals (20 females and 20 males) 20 animals (10 females and 10 males) PND70 Learning and Memory PND70 brain quality 4.8 - Animals retained for replacement trials due to problems or other additional trials. In this example, after culling each litter, 4 female and 4 male pups were retained; the female pups were numbered 1-4; and the male pups were numbered 5-8. Table 2.Grouping and testing indicators for each litter of F1 generation animals (Scheme 2) The littermate's offspring numbered a male and female Indicators for detecting the number of offspring mice 40 animals (20 females and 20 males) 20 animals (10 females and 10 males) Individual behavioral development PND11 brain mass, neuropathology, morphology 40 animals (20 females and 20 males) 40 animals (20 females and 20 males) 40 animals (20 females and 20 males) 40 animals (20 females and 20 males) 20 animals (10 females and 10 males) Clinical observation athletic ability sexual maturity Sensorimotor function PND70 brain mass, neuropathology, morphology 20 (10 females and 10 males) 20 (10 females and 10 males) PND23 Learning and Memory PND70 learning and memory, brain quality 4.8 - Animals retained for replacement trials due to problems or other additional trials. In this example, after culling each litter, 4 female and 4 male pups were retained; the female pups were numbered 1-4; and the male pups were numbered 5-8. bPND23 and PND70 selected pups from different litters for learning and memory tests (e.g., pups were selected based on whether the litter number was odd or even). Table 3.Grouping and testing indicators for each litter of F1 generation animals (Scheme 3) The littermate's offspring numbered a male and female Indicators for detecting the number of offspring mice 20 animals (10 females and 10 males) 20 animals (10 females and 10 males) PND11 brain mass, neuropathology, morphology PND11 brain quality 40 animals (20 females and 20 males) 40 animals (20 females and 20 males) 40 animals (20 females and 20 males) 40 animals (20 females and 20 males) Individual behavioral development athletic ability sexual maturity PND27 Learning and Memory ...... 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