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Acute Oral Toxicity Test (GLM Powder)


Test Report


Client: 

APA Corporation


Test Substance: 

GLM Powder


Title: 

Acute Oral Toxicity Test Using Female Mice


We report the results of the test conducted on the above-mentioned sample, submitted to our center on December 6, 2018. When this report is published elsewhere, the publication rules of our center must be observed.


Acute Oral Toxicity Test Using Female Mice


Summary

An acute oral toxicity test (limit test) using female mice was conducted with GLM powder as the test substance. A single oral dose of 2000 mg/kg of the test substance was administered to female mice, and they were observed for 14 days. During the observation period, no abnormalities or deaths were observed.

From these results, it was concluded that the LD₅₀ of the test substance in female mice by single oral administration exceeds 2000 mg/kg.


1. Client

APA Corporation


2. Test Substance

GLM Powder


3. Testing Facility

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


4. Test Period

December 6, 2018 – January 24, 2019


5. Test Objective

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


6. Preparation of Test Solution

The test substance was dissolved in injection water to prepare a 100 mg/mL test solution.


7. Test Animals

Five-week-old female ICR mice were purchased from Japan SLC Co., Ltd. After approximately one week of acclimatization and confirmation of normal general condition, the animals were used for the test. Animals were housed five per polycarbonate cage in a room at 23°C ± 3°C with a 12-hour light/dark cycle. Standard rodent diet (Lab MR Stock, Nihon Nosan Kogyo Co., Ltd.) and tap water were provided ad libitum.


8. Test Method

A test group receiving 2000 mg/kg of the test substance and a control group receiving injection water as a solvent control were established, with five mice per group. Animals were fasted for approximately 4 hours before dosing. Body weight was measured, after which the test group received the test solution and the control group received injection water at a dose of 20 mL/kg via oral gavage.

Observations were made frequently on the day of dosing and once daily thereafter for 14 days. Body weight was measured on days 7 and 14 after dosing. Levene’s test was used to assess variance; if no significant difference in variance was observed, Student’s t-test was used for comparisons between groups; if variance differed, Welch’s t-test was used. The significance level was set at 5%. All animals were necropsied at the end of the observation period.


9. Test Results

  1. MortalityNo deaths occurred in any group during the observation period.

  2. General ConditionNo abnormalities were observed in any 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 of the animals.


10. Conclusion

An acute oral toxicity test (limit test) using female mice was conducted with the test substance. During the observation period, no abnormalities or deaths were observed. Therefore, the LD₅₀ of the test substance in female mice by single oral administration is considered to exceed 2000 mg/kg.


Table 1 – Body Weight Changes

Body weights are presented as mean ± standard deviation (unit: g). The number of animals is indicated in parentheses.


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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