Makmal Bioserasi is accredited and operating in accordance with ISO 17025 by the Department of Standards Malaysia (SAMM 479) to carry out toxicity evaluation testing on multiple scope of substances and materials.

List of MS ISO/IEC 17025 Testing

Field of Testing: Toxicity No: SAMM 479
Cytotoxic effect (in vitro)
– MTT Assay based on J. Immunol. Methods, (1983) 65:55-63 with modification, in accordance to ISO 10993-5:2009.
– MEM Elution Assay based on ISO 10993-5:2009

Genotoxicity effect – DNA damage, DNA strand breaks (in vitro)
– Alkaline Comet Assay based on Environ Mol Mutagen (2000) 35:206-221

Genotoxicity effect – Determination of reverse gene mutation effects (in vitro)
– Ames Reverse Mutation Assay (Pre-incubation Method) Test based on Test Guideline OECD 471 (1997)

Acute toxicity effect (in vivo)
– Acute Oral Toxicity Study based on Test Guideline OECD 423 (2002)
– Acute Dermal Toxicity Study based on Test Guideline OECD 402 (1987)
– Acute Systemic Toxicity Study (Intravenous) based on ISO 10993-11:2006
– Acute Systemic Toxicity Study (Intraperitoneal) based on ISO 10993-11:2006

Irritation effect of skin (in vivo)
– Primary Skin Irritation Assay based on ISO 10993-10:2010
– Primary Skin Irritation Assay based on 16 CFR 1500.41 & 1500.3 (c)(4)

Effect of skin sensitization (in vivo)
– Dermal Sensitization Assay – Maximization based on ISO 10993-10:2010
– Dermal Sensitization Assay – Maximization based on ASTM F720-13
– Dermal Sensitization Assay – Closed-Patch Test (Buehler Test) based on ISO 10993-10:2010

Raise in body temperature (in vivo)
– Rabbit Pyrogen Test – USP40, <151> (2017)