CAS No. 3844-45-9
SAFETY DATA SHEET
SECTION 1: PRODUCT IDENTIFICATION
PRODUCT NAME FD & C BLUE NO.1 (Brilliant Blue FCF) (Powder)
PRODUCT CODE 1055
SUPPLIER MEDISCA Inc.
Tel.: 1.800.932.1039 | Fax.: 1.855.850.5855
661 Route 3, Unit C, Plattsburgh, NY, 12901
3955 W. Mesa Vista Ave., Unit A-10, Las Vegas, NV, 89118
6641 N. Belt Line Road, Suite 130, Irving, TX, 75063
MEDISCA Pharmaceutique Inc.
Tel.: 1.800.665.6334 | Fax.: 514.338.1693
4509 Rue Dobrin, St. Laurent, QC, H4R 2L8
21300 Gordon Way, Unit 153/158, Richmond, BC V6W 1M2
MEDISCA Australia PTY LTD
Tel.: 1.300.786.392 | Fax.: 61.2.9700.9047
Unit 7, Heritage Business Park
5-9 Ricketty Street, Mascot, NSW 2020
CHEMTREC Day or Night Within USA and Canada: 1-800-424-9300
NSW Poisons Information Centre: 131 126
EMERGENCY PHONE
USES Colouring agent
SECTION 2: HAZARDS IDENTIFICATION
GHS CLASSIFICATION Based on available data, the classification criteria are not met.
PICTOGRAM Not Applicable
SIGNAL WORD Not applicable
HAZARD STATEMENT(S) Not applicable
AUSTRALIA-ONLY HAZARDS Not applicable
PRECAUTIONARY STATEMENT(S) Prevention Not applicable
Response Not applicable
Storage Not applicable
Disposal Not applicable
HMIS CLASSIFICATION Health Hazard 0 Flammability 0
Reactivity 0 Personal Protection B
SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS
Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)
(2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt,disodium salt
CHEMICAL NAME
BOTANICAL NAME Not applicable
SYNONYM Brilliant Blue FCF, C.I.; Acid Blue 9, disodium salt; E133; C.I. No: 42090 ; C.I. Name: Food Blue 002
CHEMICAL FORMULA C₃₇H₃₄N₂Na₂O₉S₃
CAS NUMBER 3844-45-9
Last Revision: 10/2018 FD & C BLUE NO.1 (Brilliant Blue FCF) (Powder) Page 1 of 6
SAFETY DATA SHEET
ALTERNATE CAS NUMBER Not applicable
MOLECULAR WEIGHT 792.86
CHEMICAL NAME CAS NUMBER % BY WEIGHT
FD & C BLUE NO.1 (Brilliant Blue 3844-45-9 100
FCF)
COMPOSITION
There are no additional ingredients present which, within the current knowledge of the supplier and in the
concentrations applicable, are classified as health hazards and hence require reporting in this section.
NOTES Chemical Family:Triarylmethane.
SECTION 4: FIRST-AID MEASURES
Flush with copious amounts of water for 15 minutes, separating eyelids with fingers. If irritation persists seek
medical aid.
IN CASE OF EYE CONTACT
IN CASE OF SKIN CONTACT Wash with soap & water for 15 minutes. If irritation persists seek medical aid.
IF SWALLOWED Call a physician. Wash out mouth with water. Do not induce vomiting without medical advice.
Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a
physician
IF INHALED
SYMPTOMS AND EFFECTS Not expected to present a significant hazard under anticipated conditions of normal use.
SECTION 5: FIREFIGHTING MEASURES
SPECIFIC HAZARDS ARISING FROM Dust can form explosive mixtures with air.
THE CHEMICAL
FLAMMABLE PROPERTIES May be combustible at high temperature.
HAZARDOUS COMBUSTION PRODUCTS Under fire conditions, hazardous fumes will be present.
Small fire: dry chemical, CO₂ or water spray. Large fire: dry chemical, CO₂, alcohol resistant foam or water
spray. Do not get water inside containers.
EXTINGUISHING MEDIA
PROTECTIVE EQUIPMENT AND Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes.
PRECAUTIONS FOR FIREFIGHTERS
SECTION 6: ACCIDENTAL RELEASE MEASURES
Wear respiratory protection. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate
ventilation. Evacuate personnel to safe areas. Avoid breathing dust.
PERSONAL PRECAUTIONS
METHODS & MATERIAL FOR On land, sweep or shovel into suitable containers. Minimize generation of dust.
CONTAINMENT
Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. Wear
respirator, chemical safety goggles, rubber boots and heavy rubber gloves. Stop leak if you can do it without
risk. Prevent entry into waterways, sewers, basements or confined areas. Shut off all sources of ignition.
Evacuate the area. If necessary, employ water fog to disperse the vapors. Absorb the matter with compatible
vermiculite or other absorbing material. Place in a suitable container and retain for disposal. Ventilate and clean
the affected area. Do not flush into sewerage system or to drains.
CLEANUP PROCEDURE
SECTION 7: HANDLING AND STORAGE
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SAFETY DATA SHEET
Do not inhale. Avoid contact with eyes, skin and clothing. Avoid prolonged or repeated exposure. Wash
thoroughly after handling. Store away from incompatible materials, in a well-ventilated area. Eliminate all
sources of ignition. Store in accordance with local regulations. Do not store in unlabelled containers.
Containers that have been opened must be carefully resealed and kept upright to prevent leakage. Use
appropriate containment to avoid environmental contamination.
PRECAUTIONS FOR SAFE HANDLING
Store in original container, tightly sealed, protected from direct sunlight and moisture.
Preserve in tight containers.
STORAGE CONDITIONS
SECTION 8: EXPOSURE CONTROLS/ PERSONAL PROTECTION
Chemical Name: FD & C BLUE NO.1 (Brilliant Blue FCF) CAS #: 3844-45-9
TWA Ceiling STEL REL IDLH Remarks
Safe Work Australia HSIS N/L N/L N/L - - -
HSE N/L N/L N/L - - -
OSHA PEL N/L N/L - - - -
ACGIH TLV N/L N/L N/L - - -
NIOSH N/L N/L N/L N/L N/L -
AIHA WEEL N/L N/L N/L - - -
N/L = Not Listed
Consult local authorities for provincial or state exposure limits. Particulates not otherwise regulated, respirable
fraction: 5 mg/m³
EXPOSURE GUIDELINES
Eyes: Wear appropriate protective eyeglasses or chemical safety goggles as described by WHMIS or OSHA's
eye and face protection regulations in 29 CFR 1910.133 or European Standard EN166. Skin: Wear appropriate
gloves to prevent skin exposure. Clothing: Wear appropriate protective clothing to minimize contact with skin.
Respirators: Follow WHMIS or OSHA respirator regulations found in 29 CFR 1910.134 or European Standard
EN 149. Use a NIOSH/MSHA or European Standard EN 149 approved respirator if exposure limits are
exceeded or if irritation or other symptoms are experienced.
PERSONAL PROTECTIVE EQUIPMENT
SPECIFIC ENGINEERING CONTROLS Adequate mechanical ventilation. Fumehood, eye wash station, and safety shower.
SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES
PHYSICAL STATE Solid
DESCRIPTION Dark purple to bronze powder or granules.
SOLUBILITY Soluble in water; sparingly soluble in alcohol.
ODOR Odorless
FLAMMABILITY May be combustible at high temperature
ODOR THRESHOLD Not available pH Not available MELTING POINT Not available
BOILING POINT Not available FREEZING POINT Not available FLASH POINT Not available
SPECIFIC GRAVITY 0.64 EVAPORATION RATE Not available EXPLOSIVE LIMIT Not available
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SAFETY DATA SHEET
UPPER FLAMMABLE/ Not available Not available Not available
EXPLOSIVE LIMIT(S)
LOWER FLAMMABLE/
EXPLOSIVE LIMIT(S)
VAPOR PRESSURE
VAPOR DENSITY Not available Not available - 0.320
(AIR = 1)
RELATIVE DENSITY
(WATER = 1)
log P
(OCTANOL-WATER)
Not available DECOMPOSITION Not available Not available
TEMPERATURE
AUTO-IGNITION VISCOSITY
TEMPERATURE
NOTES The physical data presented above are typical values and should not be construed as a specification.
SECTION 10: STABILITY AND REACTIVITY
REACTIVITY Not established
STABILITY Stable under recommended storage condition. Color remains stable at pH: 2 �" 11.
MATERIALS TO AVOID Strong oxidants and reducing agents may destroy color.
HAZARDOUS DECOMPOSITION Toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides and other gases may occur.
PRODUCTS
HAZARDOUS POLYMERIZATION Will not occur.
POSSIBLITY OF HAZARDOUS Not established.
REACTION
CONDITIONS TO AVOID Moisture, sunlight and extreme temperatures.
SECTION 11: TOXICOLOGICAL INFORMATION
Oral: Rat: LD50: (mg/kg): > 20 400
Dermal: Rabbit LD50: (mg/kg): Not available
Inhalation: Rat: LC50: (mg/L/4hr): Not available
ACUTE TOXICITY
SKIN CORROSION/IRRITATION Due to lack of data the classification is not possible.
SERIOUS EYE DAMAGE/EYE Due to lack of data the classification is not possible.
IRRITATION
RESPIRATORY OR SKIN Due to lack of data the classification is not possible.
SENSITIZATION
Based on available data, the classification criteria are not met.
Suspected mutagen: CAESAR Mutagenicity model in VEGA (Q)SAR platform predicts that the chemical is
Mutagen (moderate reliability); KNN Mutagenicity model in VEGA (Q)SAR platform predicts that the chemical is
Mutagen (moderate reliability); SARPY Mutagenicity model in VEGA (Q)SAR platform predicts that the chemical
is Mutagen (moderate reliability)
GERM CELL MUTAGENICITY
CARCINOGENICITY OSHA FD & C BLUE NO.1 (Brilliant Blue FCF) is not listed.
NTP FD & C BLUE NO.1 (Brilliant Blue FCF) is not listed.
FD & C BLUE NO.1 (Brilliant Blue FCF) is listed in group 3 (not classifiable as to its
carcinogenicity to humans).
IARC
This product does not contain any chemicals known to the State of California to cause
cancer, birth defects, or any other reproductive harm.
California
Proposition 65
ADDITIONAL CARCINOGENICITY
INFORMATION
Due to lack of data the classification is not possible.
REPRODUCTIVE TOXICITY Due to lack of data the classification is not possible.
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SAFETY DATA SHEET
SPECIFIC TARGET ORGAN TOXICITY - Due to lack of data the classification is not possible.
SINGLE EXPOSURE
SPECIFIC TARGET ORGAN TOXICITY - Due to lack of data the classification is not possible.
REPEATED EXPOSURE
ASPIRATION HAZARDS Based on available data, the classification criteria are not met.
Not expected to present a significant hazard under anticipated conditions of normal use.
Overexposure may cause breathing problems. Ingestion may potentially worsen liver or kidney disorders.
SIGNS AND SYMPTOMS OF
EXPOSURE
POTENTIAL HEALTH EFFECTS Inhalation May be harmful if inhaled. May cause respiratory tract irritation.
Ingestion May be harmful if swallowed.
Skin May be harmful if absorbed through skin. May cause skin irritation.
Eyes May cause eye irritation.
SECTION 12: ECOLOGICAL INFORMATION
EC50: 48 Hr: Crustacea: (mg/L): Not available
LC50: 96 Hr: Fish: (mg/L): Not available
EC50: 72 or 96 Hr: Algae (or other aqua plants): (mg/L): Not available
TOXICITY
PERSISTENCE AND DEGRADABILITY Not available
BIOACCUMULATIVE POTENTIAL Low: Log Pow: -0.320
MOBILITY IN SOIL Soluble in water.
OTHER ADVERSE EFFECTS Not available
This product is not intended to be released into the environment
SECTION 13: DISPOSAL CONSIDERATIONS
WASTE DISPOSAL Dispose of in accordance with federal / local laws and regulations. Avoid release into the environment.
SECTION 14: TRANSPORT INFORMATION
UNITED STATES & CANADA
UN PROPER SHIPPING NAME Not dangerous good
UN NUMBER Not applicable
CLASS Not applicable
PACKING GROUP Not applicable
AUSTRALIA
UN PROPER SHIPPING NAME Not dangerous good
UN NUMBER Not applicable
CLASS Not applicable
PACKING GROUP Not applicable
HAZCHEM Not applicable
ENVIRONMENTAL HAZARDS Not available
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SAFETY DATA SHEET
SPECIAL SHIPPING INFORMATION Not applicable
SECTION 15: REGULATORY INFORMATION
CERCLA
40 CFR
Part 302.4
SARA (Title III)
40 CFR
Part 372.65
California
New Jersey Massachusetts Prop 65
Right-to-know
Pennsylvania
EPA 40 CFR Part 355
Appendix A Appendix B
Chemical Name
& CAS
FD & C BLUE NO.1 (Brilliant N/L N/L N/L N/L N/L N/L X N/L
Blue FCF) 3844-45-9
N/L = Not Listed; X = Listed
AUSTRALIAN REGULATIONS
Poisons and Therapeutic
Goods Regulation
Therapeutic Goods
Act
Chemical Name
& CAS
Code of Practices -
Illicit Drug
Precursors
FD & C BLUE NO.1 (Brilliant
Blue FCF) 3844-45-9
N/L N/L N/L
SECTION 16: OTHER INFORMATION
REFERENCES Available upon request
CAS �" Chemical Abstract Service; GHS �" Global Harmonized System; OSHA PEL �" Occupational Safety &
Health Administration Permissible Exposure Limits; TWA �" Time Weighted Average; HSIS �" Hazardous
Substances Information System; STEL �" Short Term Exposure Limit; AIHA WEEL �" American Industrial
Hygiene Association Workplace Environment Exposure Levels; LD50 �" Lethal Dose, 50%; IARC �" International
Agency for Research on Cancer; NTP �" National Toxicology Program; WHMIS �" Workplace Hazardous
Materials Information System; SARA �" Superfund Amendments and Reauthorization Act; EPA �" Environmental
Protection Agency; CERCLA �" Comprehensive Environmental Response, Compensation, and Liability Act;
HMIS �" Hazardous Materials Information System; NIOSH �" National Institute for Occupational Safety and
Health; MSHA - Mine Safety and Health Administration; ACGIH - American Conference of Governmental
Industrial Hygienists; IDHL - Immediately Dangerous to Health or Life; TLV �" Threshold Limit Value; HSE �"
Health and Safety Executive; REL - Recommended Exposure Limit
ABBREVIATIONS AND ACRONYMS
LAST REVISION 10/2018
SUPERSEDES 09/2015
This document was created in accordance with OSHA, Safe Work Australia and WHMIS regulations. The above
information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide.
The information in this document is based on the present state of our knowledge and is applicable to the
product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of
the product. MEDISCA® shall not be held liable for any damage resulting from handling or from contact with the
above product. Recipients of the product must take responsibility for observing existing laws and regulations.
DISCLAIMER
Last Revision: 10/2018 FD & C BLUE NO.1 (Brilliant Blue FCF) (Powder) Page 6 of 6
ALLERGEN DECLARATION
Please be advised that Medisca has not tested for the presence of the above stated allergens. Therefore, this statement is provided
for informational purposes only, as instructed to Medisca by the manufacturer, and is not meant to be a guarantee of absence of
the above stated allergens.
Prepared by: Linda Trang
Title: QA Specialist Signature:
Version: 01
Issued Date: 02/07/2019
Supersedes Date: Not applicable
PRODUCT NAME: FD & C BLUE NO.1 (Brilliant Blue FCF) (Powder)
1. The starting material (source) is:
All-natural Animal-based:
Synthetic
Mineral-based:
Vegetable-based:
Other:
Please note that there may be several steps before the raw material is produced and access to data on manufacturing raw materials
is not easily obtained for the starting materials and intermediates used in the production process.
No raw material sourced or derived from animals are used in the manufacturing. Hence, the materials used in the production of
have demonstrated compliance with the note for the guidance on minimizing the risk of transmitting animal spongiform
encephalopathy agents via human and veterinary medicinal products.
The following items are not used in the manufacturing process of the product, and although manufacturer does not specifically
assay for the presence of the items below, it is unlikely that any traces of these items are present in the starting materials or in the
end product �"
2. The product is unlikely to contain the following -
Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof
Crustaceans and products thereof
Corn
Celery and products thereof
Soybeans and products thereof
Yeast
Fish and products thereof,
Eggs and products thereof
Dairy Products(Milk, Lactose, Caseinates, Whey)
Sugar
Sodium/ Salt
Peanuts and products thereof
Tree nuts (oils) or derivatives
Mustard and products thereof
Sesame Oil
Sunflower Oil
Sulfites/Bisulfites
Artificial Colours and Flavours
Genetically-modified organisms (GMOs)
Beef/Chicken/Pork derivatives
Seafood derivatives
3. The product is made via:
Chemical Synthesis Chemical Extraction Other: n/a
