Intracutaneous Irritation Test for USP <88> Class VI Plastic Materials
USP <88> Biological Reactivity Tests, In Vivo
1. Test Article Extraction: Four types of extracts (polar and non-polar solvents)
2. Test Groups:
Test Group: Saline, 1:20 Ethanol/Saline, PEG 400, Cottonseed oil extracts
Control Group: Saline, 1:20 Ethanol/Saline, PEG 400, Cottonseed oil
Control Group: Saline, 1:20 Ethanol/Saline, PEG 400, Cottonseed oil
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 8 rabbits
5. Route of Administration: Intracutaneous injection
6. Dosing Frequency: Single administration
7. Study Duration: 3 days (excluding quarantine and acclimation period)
8. Evaluation Items:
4. Number of Animals: 8 rabbits
5. Route of Administration: Intracutaneous injection
6. Dosing Frequency: Single administration
7. Study Duration: 3 days (excluding quarantine and acclimation period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Observations and scoring for irritation will be performed prior to dosing and at 1, 24, 48, and 72 hours post-dosing
(2) Observations and scoring for irritation will be performed prior to dosing and at 1, 24, 48, and 72 hours post-dosing
Acute Systemic Toxicity Study for USP <88> Class VI Plastic Materials
USP <88> Biological Reactivity Tests, In Vivo
1. Test Article Extraction: Four types of extracts (polar and non-polar solvents)
2. Test Groups:
Test Group: Saline, 1:20 Ethanol/Saline, PEG 400, Cottonseed oil extracts
Control Group: Saline, 1:20 Ethanol/Saline, PEG 400, Cottonseed oil
Control Group: Saline, 1:20 Ethanol/Saline, PEG 400, Cottonseed oil
3. Test Animals: ICR Mice
4. Number of Animals: 40 mice
5. Route of Administration: Tail vein injection
6. Dosing Frequency: Single administration
7. Study Duration: 3 days (excluding quarantine and acclimation period)
8. Evaluation Items:
4. Number of Animals: 40 mice
5. Route of Administration: Tail vein injection
6. Dosing Frequency: Single administration
7. Study Duration: 3 days (excluding quarantine and acclimation period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Observations and scoring for irritation will be performed prior to dosing and at 1, 24, 48, and 72 hours post-dosing
(2) Observations and scoring for irritation will be performed prior to dosing and at 1, 24, 48, and 72 hours post-dosing
Muscle Implantation Study for USP <88> Class VI Plastic Materials
USP <88> Biological Reactivity Tests, In Vivo
1. Test Article Implantation: The size will conform to the standards and will be professionally evaluated by Master Laboratory Co., Ltd.
2. Test Groups:
Test Group: Test Article
Control Group: Negative control
Control Group: Negative control
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 2 animals
5. Route of Administration: Surgical muscle implantation
6. Dosing Frequency: Single surgical implantation
7. Study Duration: (To be professionally evaluated by Master Laboratory Co., Ltd.)
8. Evaluation Items:
4. Number of Animals: 2 animals
5. Route of Administration: Surgical muscle implantation
6. Dosing Frequency: Single surgical implantation
7. Study Duration: (To be professionally evaluated by Master Laboratory Co., Ltd.)
8. Evaluation Items:
(1) Daily clinical observations
(2) Daily clinical observations following surgery, gross necropsy observations at termination, and histological evaluation and scoring will be performed by a qualified pathologist
(2) Daily clinical observations following surgery, gross necropsy observations at termination, and histological evaluation and scoring will be performed by a qualified pathologist
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