Here is a professionally structured Product Toxicology Testing Protocol specifically tailored for Agarwood (Oud) Essential Oil , intended to meet the due diligence expectations of investors, regulators, and international buyers . This protocol ensures the product’s safety for human use, especially in aromatherapy, perfumery, topical products, and incense applications .
???? Agarwood Essential Oil – Toxicology Testing Protocol
Product: Agarwood Essential Oil (Aquilaria malaccensis )Tested By: [Your Lab/Company Name or Partner Institution]Intended Use: Topical application, aromatherapy diffusion, incense combustionTesting Objective: Assess safety for consumer exposure and compliance with international regulations
???? I. Analytical & Purity Verification
Test Method Purpose Standard GC-MS Profiling Gas Chromatography–Mass Spectrometry Identify active & potentially harmful compounds ISO 11024, IFRA Refractive Index Abbe Refractometer Verify purity and consistency ISO 280 Specific Gravity Densitometer or hydrometer Confirm batch-to-batch quality Reference literature values Optical Rotation Polarimeter Detect adulteration ISO 592
???? II. Microbiological & Contaminant Testing
Test Method Purpose Limit Total Plate Count Plate culture Detect microbial load <100 CFU/g Yeast & Mold Count Culture method Ensure safety in topical use <10 CFU/g E. coli / Salmonella Culture or PCR Ensure safety for dermal use Absent Heavy Metals (Pb, Hg, As, Cd) AAS or ICP-MS Rule out contamination Below WHO cosmetic limits Pesticide Residue Test GC-MS/MS Required if wild-harvested Within safe limits
????⚕️ III. Human Safety Evaluation (Dermal and Inhalation)
Test Type Test Subjects Standard Acute Dermal Irritation Test Patch test (24–72 hrs) Human volunteers OECD TG 404 Skin Sensitization Test Repeat insult patch test (RIPT) 25–50 participants ISO 10993-10 or OECD TG 406 Inhalation Toxicity (if used in incense/diffusion) Controlled animal or in vitro exposure Rodents or reconstructed lung epithelium OECD TG 403 Phototoxicity (optional) In vitro (3T3 NRU phototoxicity) For light-exposed formulations OECD TG 432
???? IV. Product-Specific Risk Assessments
Parameter Evaluation NOAEL/LOAEL Estimation Based on available toxicological literature (e.g., sesquiterpenes) Margin of Safety (MoS) Calculated from exposure dose vs toxic threshold Acceptable Daily Intake (ADI) Estimated for ingestion or skin absorption, if applicable IFRA Compliance Check Ensure oil component levels fall within acceptable dermal/inhalation limits for perfumes/cosmetics
???? V. Documentation for Regulatory & Investor Review
Include the following in your testing report submission:
✔️ GC-MS chromatogram and interpretation
✔️ Certificate of Analysis (CoA)
✔️ Microbial & heavy metal testing reports
✔️ Toxicologist-signed Safety Assessment Report
✔️ Product Safety Summary Sheet (for investors)
✔️ IFRA Certificate of Conformity (if applicable)
???? Optional: Advanced & Region-Specific Testing
Region Requirement EU (REACH) Cosmetic Product Safety Report (CPSR), Safety Assessor Declaration US (FDA) Cosmetic ingredient review compliance; no pre-market approval required, but safety substantiation is Japan/ASEAN Ingredient registration and toxicology review per ASEAN Cosmetic Directive or Japanese MHLW
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