Results of all the following tests performed on “Green Barley” by Yamamoto Kanpoh Pharmaceutical CO., LTD. consistently confirm that the ingredients are safe.
【Summary】
1 group of 5 male and female rats each was administered a single 2000mg/kg oral dose and observed for 14 days. As a result, no fatal case was seen and there was no change that was attributed to the green barley powder dose administration for the observed general condition, weight, and autopsy result.
Therefore, it is determined that the LD50 value for the green barley powder exceeds 2000mg/kg for both male and female rats.
【Test Facility】
Panapharm Laboratories, Co., Ltd. (General consignment research institute)
Postal code 869-0425 1285 Kurisakicho, Uto City, Kumamoto Prefecture
【Summary】
28 days of repeated dose oral toxicity test was executed to 1 group of 10 male and female rats each by orally administering 250, 500 and 1000mg/kg and Japanese Pharmacopoeia injection water for comparison. The general conditions of the rats were observed and their weights were measured during the administration of the dose, and the hematologic test and macroscopic and histopathological examinations of organs and tissues after the administration of the dose were conducted. As a result, there was no change that was attributed to the green barley powder dose administration for all the cases.
Therefore, it is determined that the No-Observed-Adverse-Effect Level for the green barley powder exceeds 2000mg/kg for both male and female rats.
【Test Facility】
Panapharm Laboratories, Co., Ltd. (General consignment research institute)
Postal code 869-0425 1285 Kurisakicho, Uto City, Kumamoto Prefecture
【Summary】
13 weeks of repeated dose oral toxicity test was executed to 1 group of 5 male and female rats each by orally administering 250, 500 and 1000mg/kg and Japanese Pharmacopoeia injection water for comparison.
No fatal case was recognized during the observed period and there was no change that was thought to be attributed to the green barley powder dose administration for the observed general condition, weight, hematologic examination, and the macroscopic and histopathological examinations of organs and tissues.
Therefore, it is determined that the No-Observed-Adverse-Effect Level from 13 weeks of repeated dose oral administration of the green barley powder exceeds 1000mg/kg for rats, and it is thought that there is no manifestation of severe toxicity by the repeated administration.
【Test Facility】
Environmental Biological Life Science Research Center（General consignment organization for nonclinical tests）
Posta code 528-0052 555 Ugawa, Mizuguchicho, Koga City, Shiga Prefecture
【Summary】
A reverse mutation test of the green barley powder using Salmonella typhimurium and Escherichia coli is conducted in order to investigate the genetic mutagenicity in bacteria. As a result of executing the test with pre-incubation method in the absence (direct method) and presence of metabolic activation (S9mix), the green barley powder is determined not to possess genetic mutagenicity for the tested strains in this test condition.
【Test Facility】
Safety Research Institute for Chemical Compounds Co., Ltd. (Safety test of nonclinical test operations)
Postal code 004-0839 High-tech Hill Shin’ei , 363-24 Shin’ei, Kiyota-ku, Sapporo City
【Summary】
Micronucleus test was conducted using male mouse in order to investigate the in vivo clastogenicity of the green barley powder. As a result, it is determined that the green barley powder does not induce micronucleus in this test condition.
【Test Facility】
Safety Research Institute for Chemical Compounds Co., Ltd. (Safety test of nonclinical test operations)
Postal code 004-0839 High-tech Hill Shin’ei , 363-24 Shin’ei, Kiyota-ku, Sapporo City
【Summary】
The in vivo clastogenicity of the green barley powder was investigated using the cells derived from Chinese hamster. As a result, the green barley powder is determined not to possess clastogenicity toward mammalian cultured cells in this test condition.
【Test Facility】
Safety Research Institute for Chemical Compounds Co., Ltd. (Safety test of nonclinical test operations)
Postal code 004-0839 High-tech Hill Shin’ei , 363-24 Shin’ei, Kiyota-ku, Sapporo City
Note) Test 2, 3 and 4 are the tests conducted when the existence of carcinogens was suspected in Agaricus mushroom.
【Summary】
32 test subjects (1 males and 31 females) ingested 6g of green barley powder every 2 days for 12 weeks and the improvement effect on bowel movement and feculent condition by the long term intake of the “Green Barley Powder” and its safety were investigated. As a result, there was no particular problematic symptoms found in the accessory symptoms (frustration, hypobulia, loss of appetite, abdominal pain, vomiting, abdominal bloating, etc.), survey of emergency events, urine analysis and blood test, and the food product is considered to be safe.
As a result of ingesting for 12 weeks, the stool frequency, number of bowel movement days and defecation amount improved. However, the constipation symptom was seen again 4 weeks after terminating the intake of the green barely powder.
【Test Facility】
SOUKEN (Clinical testing consignment organization for specially designated health foods)
Postal code 105-0012 Shiba NBF Tower 4F, 1-1-30 Shibadaimon, Minato-ku, Tokyo
【Summary】
23 test subjects (3 males and 20 females) consisting of 16 subjects with tendency toward slight constipation and 7 healthy subjects ingested 19g of the green barley powder per day for 4 weeks to investigate the safety of excessive intake of the green barley powder. As a result, there was no particular problematic symptoms found in the accessory symptoms (frustration, hypobulia, loss of appetite, abdominal pain, vomiting, abdominal bloating, etc.), survey of emergency events, urine analysis and blood test. Therefore, it is verified that ingesting 3 times the normal amount of the green barley powder is safe.
As a result of ingesting for 4 weeks, the stool frequency, number of bowel movement days and defecation amount improved. However, the constipation symptom was seen again 4 weeks after terminating the intake of the green barely powder.
【Test Facility】
SOUKEN (Clinical testing consignment organization for specially designated health foods)
Postal code 105-0012 Shiba NBF Tower 4F, 1-1-30 Shibadaimon, Minato-ku, Tokyo