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Objective: In the instructions for package inserts (PI) of prescription drugs revised in June 2017, the section “persons with reproductive potential” was established under “precautions concerning patients with specific backgrounds.” The description rules associated with contraceptive duration were modified in these. In this study, we investigated descriptions of contraceptive duration in PI that were prepared based on the revised instructions, interview forms (IF), and other proper use materials (PM).Methods: We collected PI, IF, and PM of prescription drugs containing a new active ingredient approved from April 2017 to March 2022 for which the PI were prepared based on the revised instructions and investigated descriptions of PI, contraceptive duration, and its evidence in each information material.Results: Of the 181 drugs studied, 43.1 and 12.7% required females and males to use contraception during the period of drug consumption, respectively. Among these, the ratio of drugs that had descriptions of contraceptive duration were 15.4 and 0% for females and males at PI, respectively; 51.3 and 39.1% for female sand males at IF, respectively. Anticancer drugstended to describe contraceptive duration in the PM rather than PI or IF. For some drugs, there was no description of contraceptive duration in any of the materials. Contraceptive durations ranged from the period of administration of that drug to over a year for females and approximately one week to six months for males. The reasons for these contraceptive durations were diverse.Conclusion: Contraceptive information in the PI based on revised instructions were not sufficient for use by healthcare workers, even when the IF and PM were confirmed. These results suggest that there is a need for standardizing the descriptions, types of materials to be described, and choice of evidence for contraceptive duration.
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Objective To evaluate the genetic toxicity of Wentilactone A. Methods The classical genotoxicity test combination (Ames test, in vitro CHO cell chromosome aberration test and mouse bone marrow micronucleus test) was used to detect the genotoxicity of Wentilactone A. Results Ames test suggested that Wentilactone A was not mutagenic against Salmonella typhimurium with or without the metabolic activation system (S9) at five doses of 5 000, 500, 50, 5, and 0.5 μg/dish. CHO cell chromosome aberration test suggested that the CHO cells cultured in 4 h and 24 h did not induce chromosomal aberrations in three dose groups at the final concentration of 23.74, 47.48, 94.96 μg/ml, with and without S9. The mouse bone marrow micronucleus test showed no significant difference in the bone marrow micronucleus induction rate of cells at three doses of 100, 200, and 400 mg/kg treated for 24 h and at dose of 400 mg/kg treated for 48 h compared with the solvent control group (P>0.05). Conclusion These results indicated that Wentilactone A did not exhibit genetic toxicity based on the Ames test, CHO chromosomal aberration test and micronucleus assay. It was suggested that Wentilactone A had no genetic toxicity and potential carcinogenicity.
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OBJECTIVE: To evaluate the acute toxicity and genotoxicity of agarwood extracts produced by agar-wit technology for functional food development (slices dose 0.60 g•d-1). METHODS: SD rats were used as animal model, the total dose of 10 g•kg-1 was administered to the rats twice within 24 h, activity and poisoning of rats were observed and recorded in the next 14 d, and Ames test, mammalian erythrocyte micronucleus test and in vitro mammalian cells chromosome aberration test were used to research the genotoxicity comprehensively. RESULTS: The rats showed normal activity and no poisoning symptoms appeared during acute toxicity test at 10 g•kg-1 dose. In the three genotoxicity test, extracts had no significant difference compared with the negative control (P>0.05), but significant difference compared with positive control (P<0.01). CONCLUSION: Under the condition of this study, the agarwood extracts have neither acute toxicity nor genotoxicity on rats.
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The chemical composition of PM2.5 is extremely complex and it can carry some viruses and bacteria, gather many toxic and hazardous substances. The respiratory system is the main target organ of PM2.5 exposure and impact. There are many different kinds of respiratory system diseases, which have complex etiologies and unpredictable outcomes. Previous reports have shown that PM2.5 plays an important role in the occurrence and development of respiratory obstructive, infectious, allergic and neoplastic diseases; of which mechanisms may be related to oxidative stress, inflammatory reaction, genetic toxicity, cell apoptosis, cell autophagy and cell cycle disorders.
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Objective: To evaluate the safety of allantoin extract from Cistanches Herba,so as to provide scientific support for subsequent utilization and development of allantoin extract from Cistanches Herba.Method: According to the national standard procedures and methods in food safety and toxicological evaluation,a series of toxicological studies on allantoin extract from Cistanches Herba were conducted,including genetic toxicity and subacute toxicity tests.Result: In the Ames test,with or without mammalina liver microsomal enzymes (S9),allantoin extract from Cistanches Herba in 40,200,1 000,5 000 μg·dish-1 dose range for four bacteria showed no dose-dependent increase.In the micronucleus test,there was no statistically significant difference among each dose group and the negative control group.In the test of mouse sperm aberration,there was no significant difference in the sperm aberration rate among the allantoin extract group and the negative control group.The results of three genotoxicity tests were all negative,indicating no genotoxicity in allantoin extract.The results of 30 days test showed no death and abnormal clinical sign in rats of control group and each dose group (1.100,0.550,0.275 g·kg-1).The body weight,food intake,weekly and total food utilization,weight increment,organ/body ratios,blood biochemical indexes and blood routine indexes had no significant difference among the control group and dose groups.There was no abnormal pathological change in heart,liver,spleen,lung,kidney and testicle of rats in treatment group.Conclusion: Allantoin extract from Cistanches Herba is a non-toxic substance without any genetic toxicity but with a high edible safety.This study provides scientific experimental basis for its safety.
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Objective@# To evaluate the safety of a herbal pilatory for external use.@*Methods @#An acute eye irritation test were employed to detect the eye irritation of the herbal pilatory;a skin irritation test,a skin sensitization test and a skin phototoxicity test were employed to detect the dermal toxicity;Salmonella typhimurium reverse mutation assay（Ames test）and chromosome aberration test in CHL cells were employed to detect the effects of the pilatory on gene mutation and chromosome aberration in prokaryotic and eukaryotic cells. @*Results@# When the eyes of rabbits exposed to the pilatory without rinse during the first 24 hours,the conjunctiva showed congestion and edema with the highest score of 2,corneal opacity was observed with the highest score of 1;however,these symptoms returned to normal within 72 hours,with the score reduced to 0. No irritation to the skin of rabits was found after exposed to the pilatory for fourteen days,no skin sensitization was introduced by Buehler test and no skin phototoxicity on guinea pigs was detected. There was no abnormal growth of reverse mutation colonies induced by the pilatory under S9 acitivation or not. There was no statistically significant rise of chromosome aberration rate in the exposed CHL cells compared to the control groups（P>0.05）. @*Conclusion @#Under the condition,the herbal pilatory showed mild and reversible irritation to eyes,while no dermal toxicity and genetic toxicity were observed. The safety of the herbal pilatory for external use is acceptable.
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Objective: To evaluate the toxicological safety of over-ground parts of Glycyrrhiza uralensis, in order to provide basis for the rational utilization of over-ground parts of Glycyrrhizae Radix et Rhizoma recourses.Method: Mice acute oral toxicity test, micronucleus test of mice bone marrow, mice sperm shape abnormality test and toxicological test based on chronic nonbacterial prostatitis model were carried out.Result: Maximal tolerable dose(MTD) of over-ground parts of G.uralensis water extract (WE) and alcohol extract (AE) were 96,128 g·kg-1, respectively. Macro-porous resin enriched product of AE was harmful to mice, with gender differences. Micronucleus rates of each dose(8,16,32 g·kg-1) group and control group for female mouse were 0.28%, 0.34%, 0.26% and 0.22%, respectively. Micronucleus rates of each dose(8,16,32 g·kg-1) group and control group for male mouse were 0.32%, 0.30%, 0.36% and 0.28%, respectively. Sperm shape abnormality rates of each dose group and control group were 3.16%, 3.01%, 2.67% and 3.23%, respectively. Micronucleus rate and sperm shape abnormality rate had no significant increase compared with the negative control. The 30-day repeated intragastric WE and AE had no effect on the general conditions of the model rats. Compared with normal group, AE group showed a significant decrease in heart weight, and significant increases in liver weight, liver index and kidney index (PPConclusion: The results indicated that both of WE and AE have potential toxicity. WE does not show any genetic toxicity to mice. Therefore, further studies shall be made for toxicological safety of over-ground parts of G. uralensis.
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Objective: To evaluate the genetic toxicity of Thuja essential oil by salmonella reversion test (AMES test) and mammal micronucleus test.Methods: TA97, TA98, TA100 and TA102 were used in AMES test to evaluate the mutagenesis of Thuja essential oil.Mouse bone marrow micronucleus test was conducted to assess the chromosome toxicity of the drug.Results: Both in S9 present and absent situations, the numbers of reverse mutation of Thuja essential oil at different doses for the four strains were all less than 1-fold of that of solvent control, and the difference had no statistical significance (P>0.05), suggesting negative mutation.The micronucleus test indicated that Thuja essential oil had no influence on the rate of mouse bone marrow micronucleus (P>0.05).Conclusion: Thuja essential oil shows no obvious genetic toxicity.
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In vivo Mammalian Bone Marrow Micronucleus Test is included in the standard battery genotoxicity testing,with great application prospects in medicine,public health,food and drug safety evaluation fields.Establishing standardized experimental methods and conditions in GLP condition and accumulating a certain range of background data could effectively ensure the reliability of the test system,and also provide strong basis to support the experimental data.We herein summarized the background data of mouse and rat bone marrow micronucleus tests performed from 2007 to 2015,to expound the standardized data collection method for rodent animal bone marrow micronucleus test.
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Objective: To evaluate toxicological safety of Cordyceps sinensis and Panax quinquefolium compound according to the genetic toxicity study. Methods: Mice acute oral toxicity test, Salmonella typhimurium reverse mutation test, micronucleus test of mice bone marrow and mice sperm shape abnormality test were carried out in the compound. Results: The MTD of the compound was greater than 12.0 g/kg BW for both male and female mice in the acute oral toxicity test, which shows non-toxic substance. The reverse mutation number of Salmonella typhimurium reverse mutation test in five dose groups did not exceed 2-fold of the spontaneous revertant colony number, nor was there a dose-response relationship, the result of Ames test was negative. Micronucleus rate of each dose group for female mouse were 0.32%, 0.36%, and 0.40%, respectively. Micronucleus rate of each dose group for male mouse were 0.30%, 0.32%, and 0.40%, respectively. Sperm shape abnormality rate of each dose group were 2.4%, 2.3%, and 2.3%, respectively. Micronucleus rate and sperm shape abnormality rate had no significant increase compared with the negative control. The results of micronucleus test of mice bone marrow and mice sperm shape abnormality test were negative. Conclusion: Under this experimental condition, the genetic toxicity of the compound is not found, and it is classified as non-toxic.
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Objective To evaluate the safety of the Eucommia folium and to provide the basis of the rational use ofEucommia folium resource.Methods According to < Technical Standards for Testing & Assessment of Health Food>,version 2003, acute safety test/micronucleus test of born marrow in mice/sperm shape abnormality test in mice/Ames test andthirty-day feeding test were all performed after water extract concentrations of Eucommia folium treatment (1 mLconcentrations equal to 1.5 g Eucommia folium) . Results On the acute toxicity test, the MTD of rats and mice were both40.0 mL/kgbw. The results of genetic toxicity test were all negative in the dosage of 10 g/kg bw(according to the dosage ofEucommia folium) .The results of thirty-day feeding test indicated that there have no significant differences in body weight,blood cytology indexes, blood biochemical indexes, organ/body ratio and pathematology examination in the rats in all thegroups (0.83, 1.67, 3.30 mL/kg) as compared to the control group(P>0.05) . Conclusion Under this experimentalcondition, no obvious abnormity and toxic reaction were observed.
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Aim To assay the mutagenicity of Enphorbia lunulata(EL) decoction and to modify the Ames test for evaluation the mutagenicity of herbal medicine samples.Method The mutagenicity of EL decoction was assayed by standard Ames test; the teratogenicity was done by mammalian bone marrow chromosomal aberration test. In modified Ames test system,the influence of histidine EL decoction was excluded by additional negative control, in which the test media was supplied with histidine (histidine amount equaled to the histidine in different concentration of EL decoction).Result The mutagenicity of EL decoction was positive in the standard Ames test. The teratogenicity of EL decoction was negative in mammalian bone marrow chromosomal aberration test. By the modified Ames tests,the mutagenicity of EL decoction was negative.Conclusion The standard Ames test is not suitable for evaluating the mutagenicity of EL decoction, but the modified Ames test is. The mutagenicity in vitro and the teratogenicity in vivo of EL decoction are all negative.
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Objective To study the genetic toxicity of aluminium trichloride on reproductive cells of male mice.Methods Twenty healthy male KM mice were randomly divided into four groups,the experimental groups(50,75,100 mg/kg AlCl3 respectively) and the normal control group(0.9% NS),all of the groups were exposed by intraperitoneal injection,2 consecutive days with one day interval,for 2 weeks.The variation of body weight and index of testicle was observed,olive tail moment was evaluated by comet assay while sperm nucleus immaturity rate was examined by fluorescent staining sperm nucleus.Results Compared with the negative control group,the index of testicle in each AlCl3 treated group decreased significantly(P
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Social rapid progress aggravates air pollution, particulate matter (PM) which obviously affects human health and living quality is the prominent one of pollutants. Particulate air pollutant may increase obviously the incidence of cardiovascular diseases and lung diseases, also has genetic toxicity. Research advance in the field of genetic toxicity of PM has been reviewed in the article.
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Objective To study the genetic toxicity of carbon tetrachloride for male mice and assess the potential genetic toxic effect on mankind. Methods Micronucleus test and sperm malformation test were used respectively to determine the change of micronucleus cell frequencies (MNCF) and the rate of sperm deformity of germ cell induced by carbon tetrachloride in male mice. Carbon tetrachloride was given through intraperitoneal injection at does of 5,15,25 mg/kg respectively for 24 h and 48 h, the rates of micronucleus in the bone marrow cell and sperm deformity of germ cell of male mice were investigated by counting the number of micronucleus cells per 5 000 polychromatic erythrocyte (PCE) in bone marrow and sperm deformity cells per 5 000 germ cells from male mice. Results The micronucleus rates of PCE in bone marrow and sperms deformity frequencies in carbon tetrachloride treated groups were much higher than the control group (P
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Objective To investigate the protective effects of soybean isoflavone(SI) on genetic toxicity induced by di-n-butul phthalate(DBP) in mice.Method(1) Micronucleus test:40 male 7 w old Kunming mice were randomized into 4 groups:High and low dose SI intervention groups,DBP model group,and solvent control group.SI intervention groups were given different doses of SI(50,100mg/kg) for 30 d,meanwhile,the DBP group and solvent group were given 0.5% sodium carboxymethyl cellulose.Then all groups were treated by 0.5g/kg DBP for 5d except solvent group.Mice were sacrificed 6 hour after last treatment,and then counting micronucleated cells in bone marrow.(2) Sperm malformation test:40 male 6w old Kunming mice were grouped and treated the same as micronucleus test.Mice were sacrificed at 35 day after the first treatment,and then sperm quantity,motility,viability and abnormality rate were calculated.Result Micronucleus rate and sperm abnormality rate of SI intervention group were lower than DBP model group,while sperm motility and viability were higher than DBP model group.Conclusion SI can relieve the genetic toxicity induced by DBP in mice.