Soalan DHH30103.pdf

SULIT DHH30103 SECTION A This section consists of question 1. Answer all the question. 1. a. i. State four (4) stages whereby contamination of herbal products can occur. Cultivation (1 mark), ha...

SULIT DHH30103 SECTION A This section consists of question 1. Answer all the question. 1. a. i. State four (4) stages whereby contamination of herbal products can occur. Cultivation (1 mark), harvesting (1 mark), processing (1 mark), or packaging stages (1 mark). (4 marks) ii. Explain in general, the process of Atomic Absorption Spectroscopy (AAS) process. The AAS process involves atomizing the sample (1 mark), typically through flame or graphite furnace atomization (1 mark), and then passing light through the atomized sample (1 mark). The absorption of specific wavelengths of light by the atoms is measured (1 mark), and the concentration of the element of interest is determined based on the extent of absorption (1 mark). (5 marks) b. i. State four (4) significance of accurate dosing. Reliable result (1 mark), trustworthy finding (1 mark), valid conclusion (1 mark) effective comparisons (1 mark). (4 marks) 2 [Next page SULIT SULIT DHH30103 ii. In terms of angles and target, compare subcutaneous and intraperitoneal injection. Injection Type Subcutaneous Intraperitoneal Angle 45 degree (1 mark) 90 degree (1 mark) Target Fatty tissue layer (1 Peritoneal cavity (1 mark) mark) (4 marks) c. i. State four (4) observations that should be made on rats that undergo sub-acute toxicity study. Changes in skin (1 mark) and fur (1 mark), eyes (1 mark) and mucous membranes (1 mark), body systems (1 mark), and behaviour patterns (1 mark). (4 marks) ii. State four (4) factors which may affect toxicity. Age (1 mark), gender (1 mark), species-specific (1 mark) and gender (1 mark) (4 marks) Learning Taxonomy Difficulty Item Items Topic Outcome Level Level Format (LO) 1.a i 4.0 LO1 C1: Easy Subjective Knowledge Remembering 1.a ii 4.0 LO1 C2: Medium Subjective Knowledge Understanding 1.b i 5.0 LO1 C1: Medium Subjective Knowledge Remembering 1.b ii 5.0 LO1 C2: Difficult Subjective Knowledge Understanding 1.c i 6.0 LO1 C1: Medium Subjective Knowledge Remembering 1.c.ii 6.0 LO1 C1: Easy Subjective Knowledge Remembering 3 [Next page SULIT SULIT DHH30103 SECTION B This section consists of questions 2 to 5. Answer two (2) questions only. 2. a. Define adulteration in herbal product. Intentional addition of low-quality or inferior substances to herbal products (1 mark). (1 mark) b. A factory is producing herbal transdermal patch. By using a table, state tests that should be conducted and the microbial limit for each test.. Total Aerobic Microbial Count NMT 2 X 102 (1 mark) (TAMC) (1 mark) Total Yeast and Mold Count NMT 2 X 101 (1 mark) (TYMC) (1 mark) Specified Microorganism (1 mark) Absence of Staphylococcus aureus (1 mark) (6 marks) c. i. Explain the dangers of aflatoxin. It is carcinogenic (1 mark). Exposure to aflatoxin can lead to acute toxicity (1 mark). Prolong consumption can increase of liver cancer (1 mark), immune system suppression (1 mark) and stunted growth in children. (1 mark) Any four relevant answers can be accepted (4 marks) ii. List three (3) examples of food that are commonly exposed to Aflatoxin. Ground nuts, pistachios, peanut butter, almond and others. corn, rice, wheat, millet, soy bean oil, corn oil, sunflower oil and 4 [Next page SULIT SULIT DHH30103 others. chillies, black pepper, turmeric, coriander. (Any relevant answer, 1 mark each) (3 marks) d. i. List four (4) types of heavy metals that must be quantified in herbal supplement. Mercury (1 mark), Arsenic (1 mark), Lead (1 mark) and Cadmium (1 mark). (4 marks) ii. Describe the safety limit for each type of heavy metals listed in 2d (i). Mercury Not more than 0.5 ppm (1 mark) Arsenic Not more than 5.0 ppm (1 mark) Lead Not more than 10.0 ppm (1 mark) Cadmium Not more than 0.3 ppm (1 mark) (4 marks) e. State the maximum permitted proportion in microgram per kilogram (𝜇𝑔/𝑘𝑔) of aflatoxins in milk, ready-to-eat groundnuts and groundnuts for further processing. Groundnut for further processing 15 𝜇𝑔/𝑘𝑔 (1 mark) Ready to eat groundnut 5 𝜇𝑔/𝑘𝑔 (1 mark) Milk 0.5 𝜇𝑔/𝑘𝑔 (1 mark) (3 marks) Learning Taxonomy Difficulty Item Items Topic Outcome Level Level Format (LO) 2.a 4.0 LO1 C1: Easy Subjective Knowledge Remembering 2b 4.0 LO1 C2: Difficult Subjective Knowledge Understanding 2c 4.0 LO1 C2: Medium Subjective Knowledge Understanding 2di 4.0 LO1 C1: Medium Subjective Knowledge Remembering 5 [Next page SULIT SULIT DHH30103 2 d ii 4.0 LO1 C1: Easy Subjective Knowledge Remembering 2ei 4.0 LO1 C2: Medium Subjective Knowledge Understanding 2 e ii 4.0 LO1 C1: Medium Subjective Knowledge Remembering 3. a. State the three (3) ‘R principle’ in animal welfare. Replacement (1 mark), reduction (1 mark) and refinement (1 mark). (3 marks) b. Explain how 3R principles can be applied by researchers in promoting ethical and responsible use of animals in scientific experiment. 1. According to the replacement principle, researchers should find alternative methods that avoid or replace the use of animals (1 mark) such as through computer simulation/ in vitro studies, cell cultures (1 mark). 2. According to the reduction principle, researchers should minimize the number of animals used (1 mark) by optimizing the study design/ improve statistical techniques/ adopt innovative technology (1 mark). 3. According to the refinement principle, researchers should improve experimental procedures to minimize suffering, distress, or lasting harm that animals might experience during research (1 mark) by using anaesthesis and analgesia/ provide enrichments (1 mark). (6 marks) c. Describe three (3) techniques to reduce disruptions to rats in order to ensure their comfort. Handle rodents gently and avoid sudden movements (1 mark), stick to a consistent daily routine for feeding and cleaning (1 mark)/ avoid overcrowding in the cage (1 mark). (3 marks) d. Discuss three (3) ways for researchers to handle rodents. 6 [Next page SULIT SULIT DHH30103 Using Scruff method (1 mark) by grasping the skin at the neck (1 mark) Use Tail handling (1 mark) by grasping the base of the tail between the thumb and forefinger (1 mark). Using tunnel/ restrainer (1 mark) by guided into/lifted inside it/ for transportation to new destination. (1 mark) Cupping the animal (1 mark) with open hands (1 mark) Using v method (1 mark) place the head between your index and middle finger, as close to the base of the fingers as possible. Then place the thumb and last 2 fingers along the body to support the chest. (1 mark) Any suitable answers can be accepted. (6 marks) e. State five (5) physical or behavioural signs that indicate the rodents are in a stress condition. Increased heart rate/ hunched posture/ flattened body against surface/ piloerection/ rapid movement/ reduced movement/ altered grooming behaviour/ avoid to interact/ aggressive/ excessive startle response/ reduced exploration/ reduced appetite/ vocalization/ changes in body temperature. Any five answers can be accepted. (5 marks) 7 [Next page SULIT SULIT DHH30103 Question 3f (i) and (ii) are based on Figure 1. Figure 1 f. i. Identify the rat behaviour depicted in Figure 1. Rat building nest (1 mark). (1 mark) ii. Describe the reason of the behaviour stated in 3 (f) (i). They instinctively build nests using materials like twigs and leaves for shelter and protection. (1 mark) Learning Taxonomy Difficulty Item Items Topic Outcome Level Level Format (LO) 3a 5.0 LO1 C1: Easy Subjective Knowledge Remembering 3b 5.0 LO1 C2: Medium Subjective Knowledge Understanding 3c 5.0 LO1 C2: Easy Subjective Knowledge Understanding 3d 5.0 LO1 C2: Difficult Subjective Knowledge Understanding 3e 5.0 LO1 C1: Easy Subjective Knowledge Remembering 3f i 5.0 LO1 C1: Medium Subjective Knowledge Remembering 3f ii 5.0 LO1 C1: Medium Subjective Knowledge Remembering 8 [Next page SULIT SULIT DHH30103 4. a. Define toxicity in organism. Toxicity refers to the level of danger a substance poses to living organisms or the environment. (1 mark) (1 mark) b. Explain three (3) purposes of conducting toxicity studies. § Toxicity studies help identify and prevent harmful exposures to chemicals in products that people use every day. (1 mark) § Manufacturers rely on toxicity studies to ensure their products are safe and comply with regulations regarding harmful chemicals. (1 mark) § Pharmaceutical companies depend on toxicity studies for the safe development of new medicines. (1 mark) (3 marks) c. State six (6) importance of rodent models in toxicity studies. 1. Similarities to human in terms of the anatomy (1 mark) 2. Susceptibility to certain chemicals (1 mark). 3. Easily available (1 mark) 4. Inexpensive (1 mark). 5. Consistency by well characterized response to numerous compounds (1 mark). 6. Widely accepted standard (1 mark). (6 marks) d. Explain about accumulative effect and reversibility in sub-acute toxicity study. Accumulative effects refer to the increase in toxicity (1 mark) with repeated exposure to a substance (1 mark). Reversibility refers to the ability to reverse the harmful effects of the substance (1 mark) once exposure is stopped (1 mark). (4 marks) 9 [Next page SULIT SULIT DHH30103 e. State four (4) doses that can be used to start the Fixed-Dose Method. 5 mg/kg (1 mark), 50 mg/kg (1 mark), 300 mg/kg (1 mark), and 2000 mg/kg (1 mark). (4 marks) f. Describe the number and sex of animals used for Repeated 28-days Oral Toxicity Study in rodents. At least 10 animals (1 mark), 5 females (1 mark), 5 males (1 mark). (3 marks) g. Compare the frequency of dose and duration of study between OECD TG420 and OECD TG407. Criteria OECD TG420 OECG TG407 Frequency of dose One time within 24 Daily dose (1 mark) hours (1 mark) Duration of study 14 days (1 mark) 28 days (1 mark) (4 marks) Learning Taxonomy Difficulty Item Items Topic Outcome Level Level Format (LO) 4a 6.0 LO1 C1: Easy Subject Knowledge Remembering ive 4b 6.0 LO1 C2: Medium Subject Knowledge Understanding ive 4c 6.0 LO1 C1: Difficult Subject Knowledge Remembering ive 4d 6.0 LO1 C2: Difficult Subject Knowledge Understanding ive 4e 6.0 LO1 C1: Easy Subject Knowledge Remembering ive 4f 6.0 LO1 C2: Medium Subject Knowledge Understanding ive 4g 6.0 LO1 C2: Easy Subject Knowledge Understanding ive 10 [Next page SULIT SULIT DHH30103 5. a. i. Name two (2) OECD guidelines that can be used for skin sensitization study. OECD TG 406 (1 mark) OECD TG 429 (1 mark) (2 marks) ii. Based on the 3R principles in animal welfare, identify the OECD guideline and the test method that is suitable for skin sensitization test. OECD TG 429 (1 mark): Local lymph node assay (1 mark) (2 marks) iii. Based on the 3R principles, justify your answer in 5 (a) (ii) by providing six (6) reasons. The 3Rs principles touch on replacement, reduction and refinement. Replacement: LLNA replace the traditional method which is GPMT study (1 mark). It employs in-vitro method (1 mark). Reduction: This study use less animal (1 mark) and shorter duration of study (1 mark) Refinement: Less suffering (1 mark) and reduce exposure (1 mark) (6 marks) iv. Illustrate the process of the test method mentioned in 5 (a) (ii). 1 mark 1 mark 1 mark 1 mark 1 mark 1 mark for each process 11 [Next page SULIT SULIT DHH30103 (5 marks) b. i. Name three (3) tests in reproductive toxicity studies. General reproductive test (1 mark), teratogenicity or embryotoxicity test (1 mark) and perinatal toxicity test.(1 mark) (3 marks) ii. Compare the differences between reproductive test and teratogenicity test in terms of the dosing time of the test substances and the deformity caused by the test. Reproductive test Before Germ cell mutation (1 mark) mating (1 mark) Teratogenicity test during Somatic cell deformation (1 sensitive periods (1 mark) mark) (4 marks) iii. State three (3) categories of carcinogenicity test. Short term studies (in vitro/in vivo test) (1 mark), long term studies (1 mark), human epidemiology survey (1 mark). Any two purposes. Any two answers only. (3 marks) Learning Taxonomy Difficulty Item Items Topic Outcome Level Level Format (LO) 5a i 7.0 LO1 C1: Easy Subjective Knowledge Remembering 5a ii 7.0 LO1 C2: Difficult Subjective Knowledge Understanding 5.a iii 7.0 LO1 C2: Medium Subjective Knowledge Understanding 5.a iv 7.0 LO1 C2: Medium Subjective Knowledge Understanding 5.b i 7.0 LO1 C1: Easy Subjective Knowledge Remembering 5.b.ii 7.0 LO1 C2: Medium Subjective Knowledge Understanding 5.b.iii 7.0 LO1 C1: Easy Subjective Knowledge Remembering END OF MARKING SCHEME 12 [Next page SULIT