TEST REPORT : CHM15-LY-02

Transcription

1 Date: Tel: Fax: Client s Ref: Yang.LI@tuv-sud-psb.sg Note: This report is issued subject to the Testing and Certification Regulations of the TÜV SÜD Group and the General Terms and Conditions of Business of TÜV SÜD PSB Pte Ltd. In addition, this report is governed by the terms set out within this report. 1. GENERAL 1.1 STUDY TITLE Acute Dermal Toxicity Study of ALPHA PEST TERMINATOR in Rats 1.2 TEST ITEM IDENTIFICATION (As Declared By Sponsor in Test and Reference Items Handling Information Form) Test Item Name Lot No. : ALPHA PEST TERMINATOR : LOT; SKH P Sterilization Condition : Enzymes Quantity : 1 bottle Date of Manufacture : August 19 th 2015 Date of Expiry : Not provided Material Composition Composition : Compound Biological and enzymes Purity : 100% Enzymes Homogeneity : Pest Terminator ph : (as declared), 4.4 (as measured) Physical Features / Properties State / Color : Liquid Biological Enzymes, Light Brown 1.3 TEST ITEM SUBMISSION DATE 18 Aug SPONSOR ALPHA PROCESS SOLUTIONS 1013 GEYLANG EAST AVE 3 # SINGAPORE Laboratory: TÜV SÜD PSB Pte. Ltd. No.1 Science Park Drive Singapore Phone : Fax : testing@tuv-sud-psb.sg Co. Reg : R Regional Head Office: TÜV SÜD Asia Pacific Pte. Ltd. 3 Science Park Drive, #04-01/05 The Franklin, Singapore Page 1 of 9

2 3. TESTING FACILITY AND STAFF 3.1 TESTING FACILITY Chemical and Materials Testing Services TÜV SÜD PSB Pte Ltd 1 Science Park Drive Singapore STAFF Study Director Study Personnel The above staff are located at : Ms Li Yang : Mr Lin Xi Dr Li Baihong Dr Lim Chiaw Hwee : Chemical and Materials Testing Services TÜV SÜD PSB Pte Ltd 1 Science Park Drive Singapore STUDY SCHEDULE AND GUIDELINES 4.1 STUDY SCHEDULE Experimental commencement date 20 Aug 2015 Experimental completion date 09 Sep STUDY GUIDELINES OECD Guideline For Testing of Chemicals 402: Acute Dermal Toxicity, adopted on 24 Feb Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Fourth revised edition, United Nations, New York and Geneva, 2011, Part 3 Health Hazards, Chapter 3.1: Acute Toxicity. Page 2 of 9

3 5. MATERIAL AND METHODS 5.1 PREPARATION OF TEST SUBSTANCE (AS REQUIRED BY SPONSOR) The test substance used for dosing was 25% based on the instruction of the sponsor, prepared by diluting the test substance with sterile water. The appearance of the diluted test substance after mixing was clear, light brown, no visible particles was observed. The diluted test substance was stored in Type I glass bottle, sterile. 5.2 TEST ANIMALS Species Strain Microbiological status Age Sex Number Source Housing Condition Temperature Rats SD Murine Pathogen Free (MPF) Young adult Male and Female Male: 5 Female: 5 InVivos Pte Ltd 9 Perahu Road, Lim Chu Kang, Singapore OptiMICE Caging Systems for rats o C Humidity 30-70% Food Altromin Maintenance Diet #1324 Water Animal ID Tap water 02-M1~5 02-F1~5 5.3 TEST CONDITIONS Preparation of test animals The test animals were acclimatised for at least 5 days before the test was conducted Approximately 24 hours before the test, fur in the dorsal area of each animal s trunk was shaved. The shaved area was not less than 10 percent of the body surface On the dosing day, the animals were weighed prior to dosing. The test substance was administered by topical application on the shaved area of Page 3 of 9

4 each animal. The dose level was 2000 mg/kg based on the body weight of each animal The diluted test substance (prepared in Section 5.1) was applied uniformly over the shaved area which was approximately 10 percent of the total surface area. The diluted test substance was then held in contact with the skin using a gauze patch and occlusive dressing. The exposure was conducted for 24 hours At the end of exposure period, residual test item was removed carefully with water Rationale of selection of starting dose According to OECD Guideline for the testing of Chemicals 402, the starting dose level of 2000 mg/kg is used for the test substance which the toxicity or mortality is not expected Details of administration Administration Dose level Dose Interval Topical application 2000 mg/kg body weight Single dose The details of dose for each animal are as follows: Group No Animal ID No Dosing date Body weight (g) Amount of test item used for dosing (mg) 02-M M Male 02-M3 26 Aug M M Page 4 of 9

5 Group No Animal ID No Dosing date Body weight Amount of test item used for dosing (mg) 02-F F Female 02-F3 26 Aug F F Feed and water frequency Feed was given throughout dosing and observation period. Feed was given in the chamber in the cage. Water was given ad libitum during dosing and observation period. Water was given through plastic bottle Observation The observation was conducted on each animal during the first 30 minutes, 1, 2 and 4 hours, and daily thereafter to 14 days. The body weight of each animal was measured once a week. On the termination day, all the test animals were euthanized by CO 2 inhalation. Gross necropsy was conducted on each test animal. Page 5 of 9

6 6. TEST RESULTS 6.1 OBSERVATION OF EACH TEST ANIMAL Group Animal ID Observation during 14-day period Male 02-M1 02-M2 02-M3 02-M4 02-M5 Group Animal ID Observation during 14-day period Female 02-F1 02-F2 02-F3 02-F4 02-F5 6.2 BODY WEIGHT (BW, IN GRAM) AND BODY WEIGHT CHANGES (CHANGE, IN GRAM) OF EACH ANIMAL Group Male Animal ID 0-02-M M M M M5 Day 0 (before dosing) (26 Aug 2015) Day 7 (02 Sept 2015) Day 14 (Termination Day) (09 Sept 2015) BW BW CH BW CH Page 6 of 9

7 Group Female Animal ID 0-02-F F F F F5 Day 0 (before dosing) (26 Aug 2015) Day 7 (02 Sept 2015) Day 14 (Termination Day) (09 Sept 2015) BW BW CH BW CH No obvious body weight loss (>10%) was found in all animals. 6.3 DEATH PRIOR TO ENDPOINT No animals died before the endpoint, i.e. 14 days after dosing. 6.4 ONSET OF TOXICITY AND REVERSAL No toxicity effect was observed on all the test animals during dosing and observation period. 6.5 NECROPSY FINDINGS No abnormality was observed on all the test animals. 7. DISCUSSION Based on the above study, a) No animal died during the study. b) No adverse effect was observed on all the test animals during the study. c) No obvious body weight loss (>10%) was observed during the study. d) No abnormality was observed on all animals during the necropsy. Page 7 of 9

8 8. CONCLUSION Under the condition of this study, the LD 50 value of the 25% diluted test substance - ALPHA PEST TERMINATOR, Lot No: LOT; SKH P in water is more than 2000 mg/kg body weight. Based on Globally Harmonised System of Classification and Labelling of Chemicals (GHS) for acute toxicity hazard categories, the 25% diluted test substance - ALPHA PEST TERMINATOR, Lot No: LOT; SKH P in water can be allocated to Category 5 or unclassified. REMARK(S): The above test results relate to the samples of test item as received. DR LIM CHIAW HWEE STUDY PERSONNEL CHEMICAL AND MATERIALS TESTING SERVICES MS LI YANG STUDY DIRECTOR CHEMICAL AND MATERIALS TESTING SERVICES Page 8 of 9

9 Please note that this Report is issued under the following terms: 1. This report applies to the sample of the specific product/equipment given at the time of its testing/calibration. The results are not used to indicate or imply that they are applicable to other similar items. In addition, such results must not be used to indicate or imply that TÜV SÜD PSB approves, recommends or endorses the manufacturer, supplier or user of such product/equipment, or that TÜV SÜD PSB in any way guarantees the later performance of the product/equipment. Unless otherwise stated in this report, no tests were conducted to determine long term effects of using the specific product/equipment. 2. The sample/s mentioned in this report is/are submitted/supplied/manufactured by the Client. TÜV SÜD PSB therefore assumes no responsibility for the accuracy of information on the brand name, model number, origin of manufacture, consignment or any information supplied. 3. Nothing in this report shall be interpreted to mean that TÜV SÜD PSB has verified or ascertained any endorsement or marks from any other testing authority or bodies that may be found on that sample. 4. This report shall not be reproduced wholly or in parts and no reference shall be made by the Client to TÜV SÜD PSB or to the report or results furnished by TÜV SÜD PSB in any advertisements or sales promotion. 5. Unless otherwise stated, the tests were carried out in TÜV SÜD PSB Pte Ltd, No.1 Science Park Drive Singapore July 2011 Page 9 of 9