Schedule

Issue date: 8 February 2024

Valid until: 19 October 2025

NO: SAMM 479

(Issue 3, 8 February 2024 replacement
of SAMM 479 dated 10 April 2023)
Page: 1 of 3

LABORATORY LOCATION: MAKMAL BIOSERASI

(PERMANENT LABORATORY) CENTRE FOR NATURAL AND PHYSICAL
LABORATORY MANAGEMENT UKM (ALAF-UKM)
UNIVERSITI KEBANGSAAN MALAYSIA
43600 UKM BANGI, SELANGOR
MALAYSIA
FIELD OF TESTING: TOXICITY

This laboratory has demonstrated its technical competence to operate in accordance with
MS ISO/IEC 17025:2017 (ISO/IEC 17025:2017).
Scan this QR Code or visit www.jsm.gov.my/cab-directories for the current scope of accreditation

This laboratory’s fulfillment of the requirements of ISO/IEC 17025 means the laboratory meets
both the technical competence requirements and management system requirements that are
necessary for it to consistently deliver technically valid test results and calibrations. The
management system requirements in ISO/IEC 17025 are written in language relevant to
laboratory operations and operate generally in accordance with the principles of ISO 9001 (see
Joint ISO-ILAC-IAF Communiqué dated April 2017).

SCOPE OF TESTING: TOXICITY

Type of Test/
Materials/ Standard Test Methods/
Properties Measured/
Products Tested Equipment/Techniques
Range of Measurement

Medical Devices / Herbal MTT Assay based on J. Immunol.

Formulations / Pesticides / Cytotoxic effect (in vitro) Methods. (1983) 65:55-63 with
Waste / Chemicals / Food modification.
Ingredients / Cosmetic
Formulations / Biologicals / Genotoxicity effect – DNA Alkaline Comet Assay based on
Pharmaceuticals damage, DNA strand breaks (in Environ Mol Mutagen (2000) 35:206-
vitro) 221

Genotoxicity effect – Bacterial Reverse Mutation Test

Determination of reverse gene based on Test Guideline OECD 471
mutation effects (in vitro) (2020)

Acute Oral Toxicity Study based on

Test Guideline OECD 423 (2002)
Acute toxicity effect (in vivo)
Acute Dermal Toxicity Study based
on Test Guideline OECD 402 (1987)

Medical Devices / Herbal Animal Irritation Test based on ISO

Formulations / Pesticides / 10993-23:2021, Single-Exposure
Waste / Chemicals / Test
Irritation effect of skin (in vivo)
Cosmetic Formulations /
Biologicals / Primary Skin Irritation Assay based
Pharmaceuticals on 16 CFR 1500.41 & 1500.3 (c)(4)

SKIM AKREDITASI MAKMAL MALAYSIA (SAMM)

LABORATORY ACCREDITATION SCHEME OF MALAYSIA
 Schedule
Issue date: 8 February 2024
Valid until: 19 October 2025

NO: SAMM 479

(Issue 3, 8 February 2024 replacement
of SAMM 479 dated 10 April 2023)
Page: 2 of 3

SCOPE OF TESTING: TOXICITY

Type of Test/
Materials/ Standard Test Methods/
Properties Measured/
Products Tested Equipment/Techniques
Range of Measurement

Medical Devices / Herbal Skin Sensitization Test – Guinea Pig

Formulations / Pesticides / Maximization Test based on ISO
Chemicals / Cosmetic 10993-10:2021
Formulations / Biologicals /
Pharmaceuticals
Dermal Sensitization Assay –
Scan this QR Code or visit www.jsm.gov.my/cab-directories for the current scope of accreditation

Effect of skin sensitization (in Maximization based on ASTM F720-

vivo) 13

Skin Sensitization Test - Closed-

Patch Test (Buehler Test) based on
ISO 10993-10:2021

Medical Devices / Herbal

Formulations / Chemicals /
Cytotoxic effect (in vitro) MEM Elution Assay based on ISO
Cosmetic Formulations /
10993-5:2009
Pharmaceuticals

Medical Devices / Chemicals

/ Cosmetic Formulations / Acute Systemic Toxicity Study
Acute toxicity effect (in vivo)
Biologicals / (Intravenous) based on ISO 10993-
Pharmaceuticals 11:2017

Medical Devices / Chemicals

/ Food Ingredients / Acute Systemic Toxicity Study
Acute toxicity effect (in vivo)
Biologicals / (Intraperitoneal) based on ISO
Pharmaceuticals 10993-11:2017

Medical Devices / Rabbit Pyrogen Test based on USP.

Pharmaceuticals Raise in body temperature (in General Chapter,<151> Pyrogen
vivo) Test. USP-NF, Rockville, MD:United
States Pharmacopeia. Official as 1
May 2017

Medical Devices MTT Assay (Annex C) based on ISO

Cytotoxic effect (in vitro)
10993-5:2009

Animal Irritation Test by

Intracutaneous reactivity of the
Intracutaneous (Intradermal)
skin (in vivo)
Administration ISO 10993-23:2021

SKIM AKREDITASI MAKMAL MALAYSIA (SAMM)

LABORATORY ACCREDITATION SCHEME OF MALAYSIA
 Schedule
Issue date: 8 February 2024
Valid until: 19 October 2025

NO: SAMM 479

(Issue 3, 8 February 2024 replacement
of SAMM 479 dated 10 April 2023)
Page: 3 of 3

Signatories:

1. Prof. Dr. Nor Fadilah Rajab (in vitro and in vivo)

2. Associate Prof. Dr. Razinah Sharif @ Mohd Sharif (in vitro and in vivo)
3. Mimi Norhilda Mohd Hatta (in vivo)
4. Dr. Siew Ee Ling (in vitro)
5. Dr. Nurrul Shaqinah Nasruddin (in vivo)
6. Nur Zahira Kasmini (in vivo)
7. Noorain Mohamad Ramli (in vitro)
8. Hasnizawati Mohamed Dahlan (in vitro)
Scan this QR Code or visit www.jsm.gov.my/cab-directories for the current scope of accreditation

9. Faten Najjah Bt. Tuan Hussain (in vitro)

SKIM AKREDITASI MAKMAL MALAYSIA (SAMM)

LABORATORY ACCREDITATION SCHEME OF MALAYSIA