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Spectra Colors D & C ORANGE 5 K

INCI Name: CI 45370

Functions: Dye

Dye Type: Cosmetic Dyes, Solvent Dyes

  • TypeDocument Name
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Knowde Enhanced TDS

Identification & Functionality

CI Number
INCI Name
Cosmetic Ingredients Functions
Pharma & Nutraceuticals Functions
CAS No.
4372-02-5, 596-03-2
EC No.
224-468-2, 209-876-0

Features & Benefits

Applications & Uses

Application Format
Oral Care Applications
Applications

Use Statement : D&C Orange No. 5 may be safely used for coloring mouthwashes and dentifrices that are ingested drugs in amounts consistent with current good manufacturing practice.

Properties

Color
Physical Form
Sparingly soluble in
Alcohols
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coliAbsentin 1g
PseudomonasAbsentin 1g
SalmonellaAbsentin 10g
Staphylococcus aureusAbsentin 1g
Total Viable Bacterial Countmax. 50cfu/g
Total Yeast and Molds Countmax. 50cfu/g
Specifications
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 3ppm
DSL StatusLISTED
Lead Contentmax. 20ppm
Mercury Contentmax. 1ppm
Molecular Weight490.07
Pure Dye Contentmin. 85%

Regulatory & Compliance

Certifications & Compliance
Chemical Inventories
Regulatory
  • TSCA Status : In Compliance
  • DSL Status : Listed
  • * U.S. FDA 21 CFR part 74 - FDA Certified
  • * EU Cosmetics Directive 76/768/EEC and new EU Cosmetic Products Regulation (EC) No 1223/2009
  • * Japan MHLW Ordinance No. 126 of July 29, 2003 - Coal-Tar Colors - Check with local regulations for instructions on specific food applications
  • * Chinese Hygiene Standards for Cosmetics (2007)
  • * ASEAN Cosmetic Directive, Annex IV, part 1 - allowed to use in Cosmetic as per field of Application 1.

Safety & Health

Dosage

D&C Orange No. 5 may be safely used in externally applied drugs in amounts not exceeding 5 milligrams per daily dose of the drug.

Storage & Handling

Shelf Life
8 years (unopened container)
Storage Instructions
  • Store the product in original packaging with the original seal intact, in a dry environment, protected from heat and light.
  • Store material sealed; recommended storage temperature between 60°F and 85°F (15°C and 30°C).
  • Keep the original label intact and legible; keep container in good condition, protect from physical damage.
  • Keep all opened containers tightly sealed in an area that is secure and clean.