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Contents of Product Information File (PIF)


Quantitative and Qualitative Composition
Physical-chemical Characteristics and stability of the Product
Microbiological Quality
Impurities, Traces and Packaging Materials
Results of Stability Tests
List of Ingredients INCI-names
Normal and Reasonable Foreseeable Use
Product & Substances Exposure
Undesirable and Serious Undesirable Effects
Warnings on the Packing
GMP Compliance Statement
Toxicological Risk Assessment

  1. LD50 Toxicity
  2. Local Toxicity (Skin Sensitization)
  3. Repeated Dose Toxicity (OECD 407)
  4. IFRA Evaluation
  5. Qualitative Risk Assessment (QRA)
  6. Photo-toxicity
  7. Mutagenicity
  8. Toxicological Profile of the Ingredients
    • acute toxicity via relevant routes of exposure
    • skin irritation and skin corrosivity
    • mucous membrane irritation (eye irritation)
    • skin sensitisation
    • dermal/percutaneous absorption
    • repeated dose toxicity (normally 28- or 90-day studies)
    • mutagenicity/genotoxicity
    • carcinogenicity
    • reproduction toxicity
    • toxicokinetics (ADME studies)
    • photo-induced toxicity
  9. Quantitative Risk Assessment (QRA) Parfum Ingredients
  10. MoS Calculation (Margin of Safety)
  11. SAF Calculation (Safety Assessment Factor)
  12. Undesirable & Serious Undesirable Effects


Warnings and Instructions for Use