MATERIAL SAFETY DATA SHEET

1. IDENTIFICATION OF THE SUBSTANCE / PREPARATION AND OF THE COMPANY

PROMETHAZINE HYDROCHLORIDE HARIKA DRUGS PRIVATE LIMITED
Plot No. 110, H.No.: 5-5-35/145/NR
Prasanth Nagar, Kukatpally, Hyderabad -
500072, Telangana State, India.

2. HAZARDS IDENTIFICATION
Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008 [EU-GHS/CLP]
Acute toxicity, Inhalation (Category 4)
Acute toxicity, Oral (Category 4)
Skin irritation (Category 2)
Eye irritation (Category 2)
Skin sensitization (Category 1)
Specific target organ toxicity - single exposure (Category 3)

Classification according to EU Directives 67/548/EEC or 1999/45/EC

Harmful by inhalation and if swallowed. Irritating to eyes, respiratory system and skin. May cause sensitization
by skin contact. Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Label elements
Labelling according Regulation (EC) No 1272/2008 [CLP]

Pictogram

Signal word W arning

Hazard statement(s)
H302 Harmful if swallowed.
H315 Causes skin irritation.
H317 May cause an allergic skin reaction.
H319 Causes serious eye irritation.
H332 Harmful if inhaled.
H335 May cause respiratory irritation.
H411 Toxic to aquatic life with long lasting effects.
Precautionary statement(s)
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
P280 W ear protective gloves.
P301 + P310 IF SW ALLOW ED : Immediately call a POISON CENTER or doctor/physician.
P305 + P351 + P338 IF IN EYES : Rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue rinsing.
Supplemental Hazard Statements none

May produce an allergic reaction.

According to European Directive 67/548/EEC as amended.

Hazard symbol(s)

R-phrase(s)
R20/22 Harmful by inhalation and if swallowed.
R36/37/38 Irritating to eyes, respiratory system and skin.
R43 May cause sensitization by skin contact.
R51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the
aquatic environment.
S-phrase(s)
S26 In case of contact with eyes, rinse immediately with plenty of water and
seek medical advice.
S36/37 W ear suitable protective clothing and gloves.
S61 Avoid release to the environment. Refer to special instructions/ Safety
data sheets.
Other hazards none
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3. COMPOSITION/INFORMATION ON INGREDIENTS
Substances
Formula: C17H20N2S.HCl
Molecular Weight: 320.89 g/mol

Component Concentration
10-(2-Dimethylamino-2-methylethyl) phenothiazine hydrochloride
CAS-No. 58-33-3 -
EC-No. 200-375-2

4. FIRST AID MEASURES

Description of first aid measures
General advice : Consult a physician. Show this safety data sheet to the doctor in
attendance.
If inhaled : If breathed in, move person into fresh air. If not breathing, give artificial
respiration. Consult a physician.
In case of skin contact : W ash off with soap and plenty of water. Take victim immediately to
hospital. Consult a physician.
In case of eye contact : Rinse thoroughly with plenty of water for at least 15 minutes and consult a
physician.
If swallowed : Never give anything by mouth to an unconscious person. Rinse mouth with
water. Consult a physician.
Most important symptoms and
effects, both acute and delayed : Blurred vision, Dizziness, Rash, Nausea, Vomiting, To the best of our
knowledge, the chemical, physical, and toxicological properties have not
been thoroughly investigated.
Indication of immediate medical
attention and special treatment needed : no data available
5. FIRE FIGHTING MEASURES
Extinguishing media
Suitable extinguishing media : Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Special hazards arising from
the substance or mixture : Carbon oxides, nitrogen oxides (NOx), Sulphur oxides, Hydrogen chloride gas
Precautions for fire-fighters : W ear self contained breathing apparatus for fire fighting if necessary.
Further information : no data available
6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protective equipment
and emergency procedures : W ear respiratory protection. Avoid dust formation. Avoid breathing vapors,
mist or gas. Ensure adequate ventilation. Evacuate personnel to safe
areas. Avoid breathing dust.
Environmental precautions : Prevent further leakage or spillage if safe to do so. Do not let product enter
drains. Discharge into the environment must be avoided.
Methods and materials for
Containment and cleaning up : Pick up and arrange disposal without creating dust. Sweep up and shovel.
Keep in suitable, closed containers for disposal.
Reference to other sections : For disposal see section 13.
7. HANDLING AND STORAGE

Precautions for safe handling : Avoid contact with skin and eyes. Avoid formation of dust and aerosols.
Provide appropriate exhaust ventilation at places where dust is formed.
Normal measures for preventive fire protection.
Conditions for safe storage,
including any incompatibilities : Store in cool place. Keep container tightly closed in a dry and well-
ventilated place. Air, light, and moisture sensitive.

Specific end uses : no data available

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8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Control parameters
Components with workplace
control parameters : Contains no substances with occupational exposure limit values.
Exposure controls
Appropriate engineering controls : Avoid contact with skin, eyes and clothing. W ash hands before breaks
and immediately after handling the product.
Personal protective equipment
Eye/face protection : Face shield and safety glasses Use equipment for eye protection tested
and approved under appropriate government standards.

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. W ash and dry hands.

Body Protection : Complete suit protecting against chemicals, the type of protective
equipment must be selected according to the concentration and amount
of the dangerous substance at the specific workplace.

Respiratory protection : W here risk assessment shows air-purifying respirators are appropriate
use a full-face particle respirator type N99 (US) or type P2 (EN 143)
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.
9. PHYSICAL AND CHEMICAL PROPERTIES
Information on basic physical and chemical properties
a) Appearance Form solid k) Vapour pressure no data available
b) Odour no data available l) Vapour density no data available
c) Odour Threshold no data available m) Relative density no data available
d) pH no data available n) W ater solubility no data available
e) Melting/freezing point o) Partition coefficient:
Melting point/range 227 - 230 °C n-noctanol/water no data available
f) Initial boiling point and p) Autoignition temperature no data available
boiling range no data available q) Decomposition temperature no data available
g) Flash point no data available r) Viscosity no data available
h) Evaporation rate no data available s) Explosive properties no data available
i) Flammability (solid, gas) no data available t) Oxidizing properties no data available
j) Upper/lower flammability u) Other safety information no data available
or explosive limits no data available
10. STABILITY AND REACTIVITY
Reactivity : no data available
Chemical stability : no data available
Possibility of hazardous reactions : no data available
Conditions to avoid : Air, light, and moisture sensitive.
Incompatible materials : Strong oxidizing agents
Hazardous decomposition products : Other decomposition products - no data available
11. TOXICOLOGICAL INFORMATION
Information on toxicological effects
Acute toxicity : LD50 Oral - mouse - 255 mg/kg
Remarks: Behavioral: Convulsions or effect on seizure threshold.
Lungs, Thorax, or Respiration: Other changes. LD50 Oral - rat - 765
mg/kg
Skin corrosion/irritation : no data available
Serious eye damage/eye irritation : no data available
Respiratory or skin sensitization : May cause sensitization by skin contact.
Germ cell mutagenicity : No data available
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.
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Reproductive toxicity : Reproductive toxicity - rat – Oral Effects
on Fertility: Other measures of fertility
Developmental Toxicity - rat – Oral
Effects on Embryo or Fetus: Fetotoxicity
(except death, e.g., stunted fetus).
Specific target organ toxicity –single exposure : Inhalation - May cause respiratory irritation.
Specific target organ toxicity –repeated exposure : No data available
Aspiration hazard : No data available
Potential health effects
Inhalation : Harmful if inhaled. Causes respiratory tract irritation.
Ingestion : Harmful if swallowed.
Skin : May be harmful if absorbed through skin. Causes skin
irritation.
Eyes : Causes serious eye irritation.
Signs and Symptoms of Exposure : Blurred vision, Dizziness, Rash, Nausea, Vomiting, To
the best of our knowledge, the chemical, physical, and
toxicological properties have not been thoroughly
investigated.
Additional Information : RTECS: SO8225000

12. ECOLOGICAL INFORMATION

Toxicity Product is not
Toxicity to fish EC50 - Fish - 2 mg/l readily
- 96 h biodegradable.
Toxicity to daphnia and other
aquatic invertebrates. EC50 - Daphnia Bioaccumulative potential No data available
magna (W ater flea) - 1.5 mg/l - 48 h Mobility in soil No data available
Persistence and degradability
Biodegradability Result: 2 % -
According to the Results of PBT and vPvB
results of tests of Assessment No data available
biodegradability this Other adverse effects Toxic to aquatic life.
13. DISPOSAL CONSIDERATIONS
W aste treatment methods
Product : Offer surplus and non-recyclable solutions to a licensed disposal company. Contact a
licensed professional waste disposal service to dispose of this material. Dissolve or mix the
material with a combustible solvent and burn in a chemical incinerator equipped with an
afterburner and scrubber.
Contaminated packaging : Dispose of as unused product.
14. TRANSPORT INFORMATION
UN-Number ADR/RID : 3077 IMDG: 9 IATA: 9
UN proper shipping name ADR/RID : ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S. (10-(2-Dimethylamino-2-methylethyl)phenothiazine hydrochloride)
IMDG: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.
(10-(2-Dimethylamino-2-methylethyl)phenothiazine hydrochloride)
IATA: Environmentally hazardous substance, solid, n.o.s.
(10-(2-Dimethylamino-2-methylethyl)phenothiazine hydrochloride)
Transport hazard class(es) ADR/RID: 9 IMDG: 9 IATA: 9
Packaging group ADR/RID: III IMDG: III IATA: III
Environmental hazards ADR/RID: yes IMDG Marine pollutant: yes IATA: yes
Special precautions for users no data available
15. REGULATORY INFORMATION
This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006. Safety, health and
environmental regulations/legislation specific for the substance or mixture: No data available
Chemical Safety Assessment : no data available

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16. OTHER INFORMATION
Further information
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. Harika Drugs Private Limited shall not be held liable for any damage resulting from
handling or from contact with the above product.

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