Material Safety Data Sheet (MSDS)
According to Regulations (EC) n° 1907/2006 REACH and 453/2010
VERSION 03 REVISION DATE 01.10.21
BIOTEK srl Via R. Farneti 8 20129 Milano Italy P.I. 10911780152
SECTION 1 - PRODUCT AND COMPANY IDENTIFICATION
Trade name BIOTEK
Product name ORANGE RED
Product code E15-24 18ml / E5-24 7ml
Description Mixture for use in tattoos or permanent make-up
Manufacturer BIOTEK srl Milano Via R. Farneti 8 Italy P.I. 10911780152
Contact Phone +39.02.7380144 security@biotek.it
Product use PMU and dermopigmention for professional use
Content 18ml 0.61 fl.oz / 7ml 0.24 fl.oz
Contact the local poison center
ITALY Centro CAV Milano 02.66101029
Emergency https://preparatipericolosi.iss.it/cav.aspx#_blank
US 1 (800) 222-1222 American Association Poison Control
Center
SECTION 2 - HAZARDS IDENTIFICATION
Emergency Class
This product is basically considered non-hazardous as per EC Regulation n.1272/2008
Product without risk classification to health and the environment according to CLP Regulation (CE)
n.1272/2008.
Information applicable to the quantities normally used in accordance with the practice of the treatment and
on the basis of tests performed.
Potential Health Effects, Signs and Symptoms of Exposure:
Eyes In some sensitive individuals, symptoms may include mildly to moderately irritation,
redness, itching and watering.
Ingestion If product is swallowed may cause nausea, vomiting and/or diarrhea.
Inhalation High concentration of vapors can cause drowsiness, dizziness, headaches and/or nausea.
SECTION 3 - COMPOSITION AND INGREDIENTS INFORMATION
Mixtures General Information
Concentrated dispersion of pigments in water solution of distilled water and glycerin.
The components of this product is not listed in Annex 3.1/
Regulation (CE) n.1272/2008 except: ETHANOL
CAS 64-17-5 EINECS 200-578-6, R 11 (flammable)
MSDS Material Safety Data Sheet - Version 03 Revision Date 01.10.2021 pag 1/6
Listed in
FDA
Chemical EU class Exposure Limits Annex 3.1
CAS number INCI name %
Identity % OSHA ACGIH Reg.(CE)
1272/2008
Liquid fraction (DILUENT)
Propylene Propylene Glycol 25% - 50% B N/E N/E
57-55-6 NOT
Glycol
Distilled water 7732-18-5 Aqua 10% - 25% C N/E N/E NOT
Ethanol 64-17-5 Alcohol 5% - 10% D 1000ppm* 1000ppm YES
PVP 9003-39-8 PVP P.F. P.F. N/E N/E NOT
Ricin Oil 9083-41-4 Ricin Oil P.F. P.F. N/E N/E NOT
Aloe Aloe Barbadensis P.F. P.F. N/E N/E
85507-69-3 NOT
Barbadensis
Hamamelis Hamamelis P.F. P.F. N/E N/E
84696-19-5 Virginiana NOT
Virginiana
Polysorbate 9005-64-5 Polysorbate 20 P.F. P.F. N/E N/E NOT
Magnesium Magnesium
Aluminium 1327-43-1 Aluminium NOT
Silicate P.F. P.F. N/E N/E
Silicate
Solid fraction (PIGMENT)
Titanium dioxide 13463-67-7 77891 P.F. P.F. N/E N/E NOT
Red 242 52238-92-3 20067 P.F. P.F. N/E N/E NOT
N/E = NOT ESTABILISHED
N/R = NOT REVIEWED
N/DA = NO DATA AVAILABLE
N/A = NON AVAILABLE
P.F. = PROPRIETARY FORMULA
* Listed substance potentially hazardous as defined by OSHA Hazard Communication Standard
(29 CFR 1910.1200) OSHA in suspension in a gas if inhaled in excess of 1000ppm.
Class % indicates the range of concentrations as per CPNP portal according to EC Regulation 1223/2009
% FDA indicates the range as per the "Guide for Cosmetic Notification Form" - FDA / Health Canada
The% are expressed according to the weight / volume ratio
FDA-codes:
A1 = 75 – 100 % A2 = 50 – 75 % B = 25 – 50 % C = 10 – 25 % D = 5 – 10 % E = 1 – 5 % F = 0,1 – 1 % G = < 0,1
SECTION 4 - FIRST AID MEASURES
There are no known harm to the authorized staff to use the product. No self-protection is needed.
However, in case of need, you should take the following general measures and in the case of severe and
not expected symptoms, consult a doctor.
First aid for Eye Flush with plenty of water for 15 minutes or use eyewash lotion. Seek medical
attention.
First aid for Skin First aid is not normally required, however, it is good practice for exposed area to
be cleaned with soap and water.
First aid for Inhalation Remove individual from the contact with substance and move to fresh air.
First aid for Ingestion Do not induce to vomiting. Flush mouth with water. Contact anti-poison
centre. Seek medical advice.
MSDS Material Safety Data Sheet - Version 03 Revision Date 01.10.2021 pag 2/6
SECTION 5 - FIRE FIGHTING MEASURE
Special hazards arising from the substance or mixture: none known or to be expected.
FLASH POINT FLAMMABLE LIMIT AUTO IGNITION
> 105° C NO DATA 425° C
The point of auto-ignition is dependent only on the component of isopropyl alcohol
Extinguishing Use carbon dioxide (CO2) or dry chemical extinguisher
Method or aqueous foam or water for large fires.
Instructions Use self-breathing device and personal protection equipment.
Prohibited None.
extinguisher
SECTION 6 - ACCIDENTAL RELEASE MEASURE
No harm expected. Wear appropriate equipment/clothing during clean-up.
In case of fire, extinguish the sources of ignition or heat. Cover the spillage with absorbent material (eg
vermiculite), collect most of the resulting mass and discard the remainder by spraying water.
If the product has escaped into a stream, into the drainage system, or has contaminated the ground or
vegetation, notify the competent authorities. For waste disposal see additionally section 13.
SECTION 7 - HANDLING AND STORAGE
Do not eat, drink and/or smoke during handling. Clean already opened packages after usage. Follow the
mandatory shelf life of the products before and after opening. Wash hands prior to use and follow local
hygiene measures. Store sealed containers in a cool, dry place away from light and heat. Avoid direct
exposure to the sun. The containers and empty containers can contain product residue and must be
managed properly. Place the containers in such a way that the labels are clearly visible.
SECTION 8 - EXPOSURE CONTROLS/PERSONAL PROTECTION
No special precaution must be adopted for normal use.
Follow the techniques of good personal hygiene. Do not eat, drink or smoke while using the product.
Precautionary measures Allow adequate ventilation to the premises where the product is stored and / or
handled.
Eye /face Protection Use chemical splash goggles
Skin Protection Use protective gloves made of natural latex, neoprene, PVC vinyl or Nitrile.
Respiratory Protection Not needed for normal use
The exposure limit for ethanol content, if inhaled by air is:
ACGIH-TLV 1000 ppm - OSHA-PEL 1000 ppm - TLV TWA 1000 ppm - 983 mg/m3
Eye/face protection Wear safety goggles where there is risk of eye contact.
Skin protection Wear suitable gloves.
Respiratory protection Provide adequate ventilation.
SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES
Appearance Creamy liquid
Odor Neutral to slightly alcoholic
Color Orange
Ph 4,5 - 7,5
Solubility in water Diluent soluble in water at 20 ° C - Pigment insoluble.
Flammability Non flammable
MSDS Material Safety Data Sheet - Version 03 Revision Date 01.10.2021 pag 3/6
SECTION 10 - STABILITY AND REACTIVITY
The product is stable in normal conditions of use and storage. We are not aware of specific conditions that
may result in hazardous reactions. The product is non-reactive and does not polymerize. At temperatures
above 100 ° C it causes the evaporation of the liquid component of the product Incompatible substances
are not identified. Do not allow the product to come into contact with acids, bases, oxidizing and reducing
agents that can cause a dangerous reaction.
SECTION 11 - TOXICOLOGICAL INFORMATION
The product does not have any known toxic or comparable adverse effects on human health.
Information on likely routes of exposure
Ingestion Ingestion may cause irritation and malaise.
Inhalation Inhalation may irritate respiratory system.
Skin contact No adverse effects known or expected.
Eye contact Direct contact may irritate the eyes.
SECTION 12 - ECOLOGICAL INFORMATION
Environmental stability Use according to good working practices, avoiding disposal in the
environment. Inform the relevant authorities if the product in large
quantities, has reach waterways or sewers, and if it has contaminated soil
or vegetation.
Effects on plants and animals Not available.
Effects on aquatic life Not available.
SECTION 13 - DISPOSAL CONSIDERATION
This product is not identified as a hazardous waste under RCRA 40 CFR 261, and is not regulated by CERCLA
(Superfund). Dispose of residual waste should be in accordance with local regulations.
SECTION 14 - TRASPORTATION INFORMATION
IMGD (maritime): not hazardous material
ADR (road transport): not hazardous material
RID (transport by rail): not hazardous material
IATA Regulation (transport by air): Not hazardous material
Transport / Additional information: The product is not dangerous
SECTION 15 - REGULATORY INFORMATION
EC Directive 1907/2006 REACH and amendments
EU Regulation ResAp(2008)1 on requirements and criteria for the safety of tattoos and pmu
TätowiermittelVerordung 13.11.2008
EC Directive 1272/2008/EC Classification, labeling and packaging of substances and mixtures
EC Regulation 453/2010
EC Directive 2008/128/CE Colors for use in foodstuffs
EC Regulation No 1223/2009 on Cosmetic Products
OSHA Hazard Communication Standard - non-hazardous under 29 CFR 1910.1200
MSDS Material Safety Data Sheet - Version 03 Revision Date 01.10.2021 pag 4/6
SECTION 16 - OTHER INFORMATION
Carefully follow the directions and recommendations of the MSDS.
Store in a cool place. Keep the original packing. Keep out of the reach of children.
The information and recommendations contained in this safety data sheet are based on data and sources
believed to be accurate, and report the most reasonable and correct at time of preparation of the sheet.
However, we do not grant any express or implied warranty as to the accuracy of the data or results
obtained from the use of this product.
This data sheet gives the most important parameters and safety standards commonly accepted and cannot
be considered an exhaustive document on the risks.
The information is provided in good faith and it is your responsibility to evaluate the correct conditions of
use and applicable safety and environmental protection.
The company assumes no responsibility for personal injury and damage to persons and / or property
damage caused by the product.
Instruction for use
Carefully follow the instructions on the label. The product is for professional use only. Avoid any use not
expected by the manufacturer. Proper professional title of qualification is required for use.
To be used in combination with sterile /disposable accessories.
Do not reuse the product after having poured from the original container.
The professional must inform the customer about the message contained in the precautions and about the
possible allergic reactions. Use prohibited for children under 18 years.
Label information
Product Name
Composition (INCI Nomination)
Batch number
Expiration Date (hourglass symbol)
Shelf life after opening product
REFERENCES
ResAP (2008) 1
HSDB
U.S. Department of Health and Human Services - NTP
NIOSH - Registry of Toxic Effects of Chemicals Substances
SAX - Dangerous Properties of Industrial Materials
MSDS Material Safety Data Sheet - Version 03 Revision Date 01.10.2021 pag 5/6
DEFINITIONS OF TERMS AND LABELS
On the MSDS sheet appears many abbreviations, acronyms and labels. Some of the most used are listed
below:
CAS No. Chemical Abstract Service Number
EXPOSURE THRESHOLD IN AIR
ACGIH American Conference Gov.Ind.Hygienists
TLV Threshold Limit Value
OSHA Occupation Safety Health Administration
PEL Permissible Exposure Limit
IDLH Immediately Dangerous Life and Health
OTHER STANDARD ABBREVIATIONS
NA Not Available
NR No Results
NE Not Estabilished
ND Not Determinated
ML Maximum Limit
TOXICOLOGICAL INFORMATION
LD 50 Lethal dose (liquid) which kills 50% of exposed animals
LC 50 Lethal concentration (gas) which kills 50% of exposed animals
ppm Concentration expressed in parts per million
Tdlo Lowest dose to cause a symptom
Tclo Lowest concentration to cause a symptom
MSDS Material Safety Data Sheet - Version 03 Revision Date 01.10.2021 pag 6/6
