BioChiol

INCI Name Bakuchiol
Chemical Name Phenol, 4-[(1E,3S)-3-ethenyl-3, 7-demethyl-1, 6 –octadienyl]
CAS # 10309-37-2
Origin 100% Natural, Extracted and purified from edible seed kernels
Appearance Yellow to yellowish brown liquid
Purity 98% min. (typically>99%)
Solubility/Miscibility Miscible with a wide-range of Hydrophobic emollients
Stability Photochemically & Hydrolytically stable
Suggested use level 0.5 to 1%
Storage Store in original sealed container at +10 to 30 degree C; avoid exposure to light & heat
Regulatory Approved for use in all major countries
Formulation guidelines It is a Lipophilic compound miscible in a wide variety of emollients, such as, caprylic/capric triglycerides, ethyl linoleate, C12-15 alkyl benzoates, squalene, jojoba oils, olive oils, etc.it can be easily formulated into creams, lotions, oils, serums, hydro-alcoholic sprays, etc.
a) At a level of 0.5 to 1.0% w/w of finished formulation
b) The formulation after making emulsion with a processing temperature of about 50 degree C. Alternately, it can be included in the oil phase
c) Addition of small amount of a chelating agent (0.05%) is helpful in overcoming coloration issue due to the presence of iron or copper
d) The finished product must be acidic, preferable having pH below 6 and must be protected from prolong exposure to heat and light for maintaining product integrity over time.

TECHNICAL DATA

Product Name BioChiol
Botanical Name Psoralea corylifolia L.
Plant part Seeds
Active ingredient Bakuchiol
Chemical formula C18H24O
Molecular weight 256.38 g/mol
Shelf life 5 Years
S. No Parameters Specification
Physical
1 Description Light brown to honey color viscous liquid
2 Identification by TLC To match with reference standard pattern
3 Moisture by KF NMT 1.0%
4 Solubility Soluble in Alcohol & DMSO
Chemical
5 % Assay by HPLC content Bakuchiol NLT 99.0% w/w on dry basis
6 Related substances by HPLC
Content of Psoralen & Angelicin
NMT 20 ppm
Others
7 Heavy Metals NMT 10.0ppm
Lead NMT 3.0ppm
Arsenic NMT 1.0ppm
Cadmium NMT 0.3ppm
Mercury NMT 0.1ppm
8 Residual solvents Should comply by ICH/USP
9 Residual Pesticides To comply as USP for Botanicals
Microbiological Profile
10 Total plate count NMT 1000 cfu/g
Yeast and molds count NMT 100cfu/g
Escherichia coli Absent /10g
Salmonella Absent /10g
Staphylococcus aureus Absent /10g
Pseudomonas aeruginosa Absent /10g
Additional information
Storage Condition Store at room temperature
Allergen Statement Free from Allergen
GMO status GMO free
Sanitizing treatment Non-irradiated & Not treated with ETO
Since the product is derived from Natural origin, there is likely to be minor color variation because of the geographical & seasonal variations of the source of raw material

MATERIAL SAFETY DATA

Section 1: CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Product Name: BioChiol
CAS#: 10309-37-2
RTECS: Not available.
TSCA: TSCA 8(b) inventory: No products were found.
EINECS No: -NA-
Synonym: Bakuchiol 99%
Contact Information:
Bio-India Biologicals (BIB) Corporation Plot No. 16, 2nd Floor, Akbar Road,Diamond Point, Sikh Village, Hyderabad – 500 009
Tel: 0091 9392485187
Email: info@bibcorporation.com
Section 2: COMPOSITION AND INFORMATION ON INGREDIENTS
SUBSTANCES
Synonyms : 4-[(1E,3S)-3-Ethenyl-3,7-dimethyl-1,6-octadien-1-yl]-phenol
Formula : C18H24O
Molecular weight : 256.38 g/mol
CAS-No. : 10309-37-2
No components need to be disclosed according to the applicable regulations.
Toxicological Data on Ingredients: There are no known hazardous substances containing in this product.
Section 3: HAZARDS IDENTIFICATION
CLASSIFICATION OF THE SUBSTANCE OR MIXTURE

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.

LABEL ELEMENTS

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.

OTHER HAZARDS

This substance/mixture contains no components considered to be persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

Section 4: FIRST AID MEASURES
GENERAL ADVICE:

Consult a physician. Show this safety data sheet to the doctor in attendance.

IN CASE OF EYE CONTACT:

Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention if irritation occurs.

IN CASE OF SKIN CONTACT:

Due to its use in cosmetics, no adverse effects are expected

IN CASE OF SERIOUS SKIN CONTACT:

Wash off with soap and plenty of water. Consult a physician.

IN CASE OF INHALATION:

If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.

IN CASE OF INGESTION:

Do Not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing such as a collar, tie, belt or waistband.

Section 5: FIRE AND EXPLOSION DATA
Extinguishing procedures : Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Protective Equipment : Wear self-contained breathing equipment and Protective suit.
Hazardous Products of Combustion : Carbon oxides
Special Firefighting procedures : No data available
Section 6: ACCIDENTAL RELEASE MEASURES
PERSONAL PRECAUTIONS, PROTECTIVE EQUIPMENT AND EMERGENCY PROCEDURES

Use personal protective equipment. Avoid breathing vapours, mist or gas. For personal protection see section 8.

ENVIRONMENTAL PRECAUTIONS

Do not let product enter drains.

METHODS AND MATERIALS FOR CONTAINMENT AND CLEANING UP

Soak up with inert absorbent material and dispose of as hazardous waste. Keep in suitable, closed containers for disposal.

REFERENCE TO OTHER SECTIONS

For disposal see section 13.

Section 7: HANDLING AND STORAGE
PRECAUTIONS

Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk; evaporate the residue under a fume hood. Ground all equipment containing material. Do not breathe dust.

STORAGE

Store in cool place. Keep container tightly closed in a dry and well-ventilated place.
Store under room temperature not exceeding 25oC.

HANDLING

No restrictions

Suitable packing material

Aluminum/SS Containers, tightly sealed container

Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
EXPOSURE CONTROLS
APPROPRIATE ENGINEERING CONTROLS

Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.

PERSONAL PROTECTIVE EQUIPMENT
EYE/FACE PROTECTION

Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).

SKIN PROTECTION

Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands.
The selected protective gloves have to satisfy the specifications of Regulation (EU) 2016/425 and the standard EN 374 derived from it.

BODY PROTECTION

Impervious clothing, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace

RESPIRATORY PROTECTION

Where risk assessment shows air-purifying respirators are appropriate use a fullface respirator with multi-purpose combination (US) or type ABEK (EN 14387) respirator cartridges as a backup to engineering controls. If the respirator is the sole means of protection, use a full-face supplied air respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).

Section 9: PHYSICAL AND CHEMICAL PROPERTIES
Physical state : Light brown to honey color viscous liquid
Moisture by KF : NLT 1.0%
Solubility : Soluble in Alcohol and DMSO
Initial boiling point and boiling range : 145 - 147 °C
Relative density : 0.96 g/cm3 at 20 °C at 1013 hPa
Flash point : 108 °C - Closed cup
Further information refers COA.
Section 10: STABILITY AND REACTIVITY DATA
Conditions to avoid : High temperature& high humidity.
Incompatibility : Incompatible with strong acids, alkalis and oxidizing agents
Hazardous decomposition : None (Biodegradable)
Chemical Stability : Stable under recommended storage conditions

Section 11: TOXICOLOGICAL INFORMATION
INFORMATION ON TOXICOLOGICAL EFFECTS
ACUTE TOXICITY

LD50 Oral - Rat - 2560,0 mg/kg

LD50 Intraperitoneal - Mouse - 94 mg/kg

LD50 Intravenous - Mouse - 31 mg/kg

SKIN CORROSION/IRRITATION

Skin - Human

Result: No skin irritation

(Patch Test 24 Hrs. on humans: No detectable irritation.)

SERIOUS EYE DAMAGE/EYE IRRITATION

Respiratory or skin sensitisation

Patch test on human volunteers did not demonstrate sensitisation properties.

CARCINOGENICITY

IARC: No component of this product present at levels greater than or equal to 0.1%

is identified as probable, possible or confirmed human carcinogen by IARC.

GERM CELL MUTAGENICITY

No data available

Human lymphocytes

Result: negative

S. typhimurium

Result: negative

REPRODUCTIVE TOXICITY

No data available

SPECIFIC TARGET ORGAN TOXICITY - SINGLE EXPOSURE

No data available.

SPECIFIC TARGET ORGAN TOXICITY - REPEATED EXPOSURE

No data available

ASPIRATION HAZARD

No data available

ADDITIONAL INFORMATION

RTECS: SL3785000
To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.

Section 12: ECOLOGICAL INFORMATION
Mobility : Free
Persistence/Degradability : Bio-degradable
Bio-accumulation : none
Eco-toxicity : none
RESULTS OF PBT AND VPVB ASSESSMENT
This substance/mixture contains no components considered to be persistent, bio accumulative and toxic (PBT), or very persistent and very bio accumulative (vPvB) at levels of 0.1% or higher.
Section 13: DISPOSAL CONSIDERATIONS
Waste Disposal:

Waste must be disposed of in accordance with federal, state and local environmental control regulations.

WASTE TREATMENT METHODS
PRODUCT

Offer surplus and non-recyclable solutions to a licensed disposal company.

CONTAMINATED PACKAGING

Dispose of as unused product.


Section 14: TRANSPORT INFORMATION
References : Not a DOT controlled material (United States).
UN PROPER SHIPPING NAME
ADR/RID : Not dangerous goods
IMDG : Not dangerous goods
IATA : Non-Regulated as per IATA
Special Provisions for Transport: By Road/Air/Sea.
ENVIRONMENTAL HAZARDS
ADR/RID : No
IMDG Marine pollutant : No
IATA : No
Section 15: OTHER REGULATORY INFORMATION
SAFETY, HEALTH AND ENVIRONMENTAL REGULATIONS/LEGISLATION SPECIFIC FOR THE SUBSTANCE OR MIXTURE
This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006.
Specific International regulation : Complies with Natural Pharmaceutical Regulations.
Hazard symbols : Not applicable.
CHEMICAL SAFETY ASSESSMENT
For this product a chemical safety assessment was not carried out


Section 16: OTHER INFORMATION
Specific International regulation : Not available
Other Special Considerations : Not available.
Last Updated On: 06.03.2019
The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. Bio-India Biologicals (BIB) Corporation shall not be held liable for any Damage resulting from handling or from contact with the above the product.