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Acute Oral Toxicity Test (umo Concentrated Solution M)

July 24, 2018 (Heisei 30)


Test Report


Requester: 

APA Corporation Co., Ltd.


Test Sample: 

umo Concentrated Solution


Title: 

Acute Oral Toxicity Test Using Female Mice


We hereby report the results of the above sample submitted to our center on June 12, 2018. This report must comply with the publication regulations of our center if used elsewhere.


Acute Oral Toxicity Test Using Female Mice


Summary

An acute oral toxicity test (limit test) using female mice was conducted with the sample, umo Concentrated Solution. The test group was administered the sample at a dose of 2000 mg/kg via a single oral administration, and animals were observed for 14 days. During the observation period, no abnormalities or deaths were observed.

From the above results, in a single oral administration using mice, the LD50 of the sample in females was evaluated to exceed 2000 mg/kg.


1. Requester

APA Corporation Co., Ltd.


2. Test Sample

umo Concentrated Solution


3. Test Facility

Tama Research Center, Japan Food Research Laboratories6-11-10, Nagayama, Tama City, Tokyo


4. Test Period

June 12, 2018 – July 24, 2018


5. Test Objective

To examine the acute oral toxicity of the test sample in female mice in accordance with OECD Guideline for Testing of Chemicals 420 (2001).


6. Preparation of Test Solution

The test sample was diluted with injectable water to prepare a 100 mg/mL dosing solution.


7. Test Animals

Female ICR mice, 5 weeks old, were purchased from Japan SLC Co., Ltd. After approximately 1 week of preliminary housing, animals were confirmed to be in normal condition and then used for the test.

The animals were housed 5 per polycarbonate cage in a room maintained at 23°C ± 3°C with 12 hours of light per day. Standard feed for mice and rats (Lab MR Stock, Japan Farm Products Co., Ltd.) and tap water were provided ad libitum.


8. Test Method

A test group receiving 2000 mg/kg of the test sample and a control group receiving injectable water as the solvent control were established, with 5 animals per group.

Animals were fasted for approximately 4 hours before dosing. After measuring body weight, the test group received the test solution, and the control group received injectable water at a dosing volume of 20 mL/kg via oral gavage for a single administration.

Observation was conducted for 14 days. On the day of dosing, animals were observed frequently, and from the following day onward, observations were made once daily. Body weight was measured on days 7 and 14 after dosing. Levene’s test was performed to check variance homogeneity; since no variance difference was observed, group comparisons were conducted using Student’s t-test at a significance level of 5%. All animals were necropsied at the end of the observation period.


9. Test Results

  1. MortalityNo deaths were observed in any dosing group during the observation period.

  2. General ConditionNo abnormalities were observed in any dosing group during the observation period.

  3. Body Weight Changes (Table-1)Body weight measurements on days 7 and 14 after dosing showed no differences between the test and control groups.

  4. Necropsy FindingsAt the end of the observation period, necropsy revealed no abnormalities in any animals.


10. Conclusion

An acute oral toxicity test (limit test) using female mice was conducted for the test sample. During the observation period, no abnormalities or deaths were observed.

From the above, in a single oral administration using mice, the LD50 of the sample in females was evaluated to exceed 2000 mg/kg.


Table-1 Body Weight Changes


Administration Group        Before Administration                   After administration (days)

7 Days.                       14Days.

Test Group        27.1±1.0(5)          30.6±1.4(5)                32.7±2.3(5)

Control Group           27.5±0.9(5)          29.2±1.6(5)                31.9±2.0(5)


Body weight is expressed as mean ± standard deviation (unit: g).

The number of animals is shown in parentheses.

 

End of Report


Note: This paper is translated from the following URL. The content is provided for reference on the scientific research of the raw material only. Whether APA raw materials are used or not, we hope this research will help increase understanding and awareness of body minerals.



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