Zinc Undecylenate, Zinc Undecenoate, 557-08-4

Zinc Undecylenate, Zinc Undecenoate, 557-08-4

ZINC UNDECYLENATE

SECTION 1: PRODUCT IDENTITY AND CHEMICAL IDENTIFICATION

SECTION 2: CHEMICAL STRUCTURE

        CH₂=CH—(CH₂)₈—COO⁻
                              Zn²⁺
        CH₂=CH—(CH₂)₈—COO⁻

    Zinc Undecylenate
    Zinc undec-10-enoate
    C₂₂H₃₈O₄Zn

Simplified Structure:

    [CH₂=CH—(CH₂)₈—COO]₂Zn

    Zinc Undecylenate
    (Undecylenic Acid Zinc Salt)

SECTION 3: PHYSICAL AND CHEMICAL PROPERTIES

SECTION 4: PHARMACOLOGICAL PROPERTIES AND MECHANISM OF ACTION

SECTION 5: COMMERCIAL GRADES AND VARIANTS

SECTION 6: COMMERCIAL PRODUCT COMPARISON

SECTION 7: MAIN APPLICATION AREAS

SECTION 8: FORMULATION GUIDELINES

SECTION 9: QUALITY SPECIFICATIONS

SECTION 10: SAFETY PROFILE AND TOXICOLOGICAL ASSESSMENT

SECTION 11: GHS CLASSIFICATION AND LABELING

GHS Classification (in accordance with 1272/2008/EC):

Signal Word: None (Not classified as hazardous) or Warning (optional)

Hazard Pictograms: None (generally) or GHS07 (Exclamation mark)

NFPA 704 Hazard Classification:

SECTION 12: PRECAUTIONARY STATEMENTS (P-CODES)

SECTION 13: FIRST AID MEASURES

SECTION 14: FIREFIGHTING MEASURES

SECTION 15: STORAGE AND SHELF LIFE

SECTION 16: PACKAGING OPTIONS

SECTION 17: TRANSPORTATION INFORMATION

SECTION 18: REGULATORY STATUS

SECTION 19: OTHER NAMES AND SYNONYMS

SECTION 20: SUMMARY TABLE

SECTION 21: CRITICAL WARNINGS AND BEST PRACTICES

CRITICAL WARNINGS:

1. External Use Only: For external use only. Not for ingestion. Avoid contact with eyes, mouth, and mucous membranes.

2. Allergy: Do not use in patients with sensitivity to undecylenic acid or zinc salts.

3. Oxidation Sensitivity: Contains a double bond; sensitive to oxidation. Protect from light and air.

4. Side Effects: If local irritation, redness, or itching occurs, discontinue use and consult a physician.

5. Pregnancy: Safety during pregnancy and lactation is not well established; use only if clearly necessary.

6. Children: Do not use in children under 2 years of age without medical supervision.

7. Treatment Duration: Even if symptoms resolve, continue regular use for 2-4 weeks.

BEST PRACTICE RECOMMENDATIONS:

1. Concentration: Typical concentration in topical formulations is 10-25%. 20% is common in OTC products.

2. Formulation: Dissolve in oil phase at 60-70°C. Do not add directly to the water phase.

3. Antioxidant Use: Add BHT (0.01-0.1%) or Vitamin E (0.05-0.2%) to prevent oxidation.

4. pH Adjustment: Maintain formulation pH at 5.0-7.0.

5. Penetration Enhancement: Add propylene glycol (5-20%) or ethanol (5-10%) to improve penetration.

6. Emulsion Type: O/W (oil-water) emulsions are preferred; W/O (water-oil) emulsions can also be used.

7. Stability Studies: Perform stability studies under oxidation, temperature, and light effects.

8. Quality Control: Regularly perform assay (titrimetric/ICP), zinc content, melting point, peroxide value, microbiological purity tests.

9. Patient Education: Inform patients that the product is for external use only, regular application, and treatment duration.

10. Storage: Store in cool, dry, light-proof containers. Keep tightly closed after opening to minimize air exposure.

LEGAL DISCLAIMER:

The information provided in this document is based on our current knowledge and experience and is presented in good faith. However, as all conditions of use are beyond our control, it does not constitute a binding specification or guarantee. This Technical Data Sheet is for informational purposes only and does not constitute medical advice. Users are responsible for testing suitability for their own applications and for complying with all local, regional, and national regulations. For complete safety, storage, use, handling, waste, and regulatory compliance information, please refer to the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier. Zinc Undecylenate is an OTC (over-the-counter) topical antifungal agent; its use should be according to a healthcare professional's recommendation.