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. Makmal Bioserasi also has been inspected and found to be operating in compliance to the OECD Principles of Good Laboratory Practice and Standard Malaysia GLP Compliance Programme. We are compliant for the Test Item category of Industrial Chemicals and Pesticide in the area of expertise of Toxicity and Mutagenicity testing by the Department of Standards Malaysia with GLP 008 on 10 January 2019.

 

We also provide histological analysis since 2021.

We provide qualitative and semi-quantitative analysis of histology slides.

Description:

Histological analysis service is an assessment on histological slides stained with H&E staining or other type of special staining. This analysis is carried out to identify the changes as a result of the treatment given. It is also performed to identify changes at cellular level that lead to the formation of abnormalities, disease and death. This histological analysis is carried out using a light microscope by an appointed pathologist.

List of MS ISO/IEC 17025 Testing

Field of Testing: Toxicity No: SAMM 479

In Vitro
1. Cytotoxic effect

– 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

 

2. Genotoxicity effect in DNA damage, DNA strand breaks

– Alkaline Comet Assay based on Environ Mol Mutagen (2000) 35:206-221

 

3. Genotoxicity effect- determination of reverse gene mutation effects

– Ames Reverse Mutation Assay (Pre-incubation Method) Test based on Test Guideline OECD 471 (2020)

 

In Vivo
1. Acute toxicity effect

– Acute Oral Toxicity Study based on Test Guideline OECD 423 (2002)

– Acute Systemic Toxicity Study (Intravenous) based on ISO 10993-11:2017

– Acute Systemic Toxicity Study (Intraperitoneal) based on ISO 10993-11:2017

 

2. Irritation effect of skin

– Primary Skin Irritation Assay based on ISO 10993-10:2010 Clause 6.3.5.2 Single-Exposure Test

– Primary Skin Irritation Assay based on 16 CFR 1500.41 & 1500.3 (c)(4)

 

3. Effect of skin sensitization

– 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

 

4. Raise in body temperature

– Rabbit Pyrogen Test – USP40, <151> (2017)