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Contents of Product Information File (PIF)

PRODUCT SAFETY INFORMATION

  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

PRODUCT SAFETY ASSESSMENT

  Conclusion
 Warnings and Instructions for Use