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Acute Oral Toxicity Test (For Agriculture and Livestock Use)

Updated: Jan 18

October 10, 2013 (Heisei 25)


Test Report


Requester: 

APA Corporation Co., Ltd.


Test Sample: 

Water-Soluble Silica Ultra-Concentrated Solution (For Agriculture and Livestock Use)


Title: 

Acute Oral Toxicity Test Using Female Mice


We hereby report the results of the above sample submitted to our center on August 29, 2013.


Acute Oral Toxicity Test Using Female Mice

Summary

An acute oral toxicity test (limit test) using female mice was conducted with the sample, Water-Soluble Silica Ultra-Concentrated Solution (for agriculture and livestock use). The test group was administered the sample at a dose of 2000 mg/kg, and the control group received injectable water as the solvent control. A single oral administration was performed, and the 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 be greater than 2000 mg/kg.


Requester:

APA Corporation Co., Ltd.


Test Sample:

Water-Soluble Silica Ultra-Concentrated Solution (For Agriculture and Livestock Use)


Test Period:

August 29, 2013 – October 10, 2013


Test Facility:

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


Person Responsible for Testing:

Yasuharu Kawamoto, Safety Test Section, Safety Test DepartmentTama Research Center, Japan Food Research Laboratories


1. Test Objective

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


2. Test Sample

Water-Soluble Silica Ultra-Concentrated Solution (for agriculture and livestock use)


3. Preparation of Test Solution

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


4. 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 ± 2°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.


5. Test Method

Test groups were set to receive the sample at 2000 mg/kg, and a control group was given injectable water as the solvent control. Each group consisted of 5 animals.

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 using an oral gavage needle.

Observation was conducted for 14 days. On the day of dosing, animals were frequently observed, and from the next day onward, observations were made once daily. Body weight was measured on days 7 and 14 after dosing, and group comparisons were performed using a t-test at a significance level of 5%. All animals were necropsied at the end of the observation period.


6. 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.


7. 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

Body weight is expressed as mean ± standard deviation (unit: g).The number of animals is shown in parentheses. 

Administration Group        Before Administration                   After administration (days)

7 Days.               14Days.

Test Group        25.7±1.0(5)          28.7±1.8(5)                30.7±2.3(5)

Control Group           25.6±1.1(5)          27.9±1.7(5)                29.6±2.1(5)

 

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

The number of animals is shown 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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