SOP. No.: BDSH-824 Format No.

: SH-F-824-003-00
SAFETY, HEALTH & ENVIRONMENT
MATERIAL SAFETY DATA SHEET
Doc. no.: DSSH-10-MCL-02 DECEMBER 2015 Page 1 of 9
TITLE METHYL FLUFENAMATE

1. CHEMICAL PRODUCT/SUBSTANCE IDENTIFICATION AND

COMPANY/SUPPLIER IDENTIFICATION
1.1 Chemical Product/Substance Identification
Chemical Name : 2-[[3-(Trifluoromethyl)phenyl]amino] benzoic acid, methyl ester
Synonyms Flufenamic acid, methyl ester; N-(m-Trifluoromethylphenyl)-2-aminobenzoic acid
methyl ester; N-(α, α, α-Trifluoro-m-tolyl)anthranilic acid, methyl ester; Methyl
:
flufenamate; Benzoic acid, 2-[[3-(trifluoromethyl)phenyl]amino]-, methyl ester;
Anthranilic acid, N-(a,a,a-trifluoro-m-tolyl)-, methyl ester
Chemical Formula : C15H12F3NO2
CAS No. : 2765-91-5
EC No. : None listed.
1.2 Use of the Product/Substance
Use : As an intermediate.
1.3 Company/Supplier Identification
Manufacturer Distributor Distributor
Dishman Pharmaceuticals & Dishman Europe limited, Dishman USA
Chemicals Ltd. Suite 4, De Walden Court, 550, Union Avenue.
Bhadr-raj chambers, Swastik Cross 85 New Cavendish Street, London Suite 9
Roads, W1W 6XD Middlesex NJ 08846
Ahmedabad, India United Kingdom
Tel: +91 (0) 79 26443053 Tel: (+44) 207 3230608 Tel: +1 (0) 732 560-4300
Fax: +91 (0) 79 26420198 Fax: (+44) 207 3230609 Fax: +1 (0) 732 560-4343
Email : Email : info@dishman-europe.com Email:
dishman@dishmangroup.com dishmanusa@dishmangroup.com
Distributor
Dishman Netherlands B.V.
Nieuweweg 2a, 3901 BE Veenedaal
PO Box 70, 3900 AB Veenendaal
The Netherlands
Tel: +31 (0)318 545 754
Fax: +31 (0)318 529 374
1.4 Emergency Telephone
India United Kingdom United States of America
+91 (0) 79 26443053 +44 (0) 20 7323 0608 +1 (0) 732 560-4300
The Netherlands
+31 70 3360599

Dishman Pharmaceuticals & Chemicals Limited, Bavla.

SOP. No.: BDSH-824 Format No.: SH-F-824-003-00
SAFETY, HEALTH & ENVIRONMENT
MATERIAL SAFETY DATA SHEET
Doc. no.: DSSH-10-MCL-02 DECEMBER 2015 Page 2 of 9
TITLE METHYL FLUFENAMATE

2. HAZARD IDENTIFICATION
Hazard overview : Toxic if swallowed. Causes skin and serious eye irritation. May cause
respiratory irritation. Very Toxic to aquatic life with long lasting effects.
2.1 EC Hazard : According to Regulation EC No. According to EC Directive
classification 1272/2008 (CLP Regulation, GHS) 67/548/EEC/ (or Directive
1999/45/EC).

Skin Irritation. 2; H315 Xi, Irritant; R37/38-R41.

Eye Irritation. 2B; H319 T, Toxic; R25.
STOT - single exposure; Respiratory N, Environmenally hazardous
tract irritation.3; H335 R50/53.
Acute Toxic. Oral 3; H301
Aquatic Chronic toxicity, 1; H410
2.2 GHS Label elements
Pictograms : GHS06 GHS09

Signal word : Danger

Hazard statements : H301 : Toxic if swallowed.
H315 : Causes skin irritation.
H319 : Causes serious eye irritation.
H335 : May cause respiratory irritation.
H410 : Very Toxic to aquatic life with long lasting effects.
Precautionary : P260 : Do not breathe fume/gas/mist/vapours/spray.
statements P280 : Wear protective gloves/protective clothing/eye protection/face
protection.
P264 : Wash thoroughly after handling.
P301+310 IF SWALLOWED: Immediately call a POISON CENTER or
doctor/physician.
P304+P340 IF INHALED: Remove victim to fresh air and keep at rest in a
position comfortable for breathing.
P302+352 IF ON SKIN: Wash with plenty of soap and water.
P305+351+338 IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing.
P273 : Avoid release to the environment.
Other hazards : None

Dishman Pharmaceuticals & Chemicals Limited, Bavla.

SOP. No.: BDSH-824 Format No.: SH-F-824-003-00
SAFETY, HEALTH & ENVIRONMENT
MATERIAL SAFETY DATA SHEET
Doc. no.: DSSH-10-MCL-02 DECEMBER 2015 Page 3 of 9
TITLE METHYL FLUFENAMATE

3. COMPOSITION/INFORMATION ON INGREDIENTS
Methyl flufenamate : NLT 99.0% Purity (By HPLC)
CAS No. : 2765-91-5
EC (EINECS) No. : None listed.
EC Hazard : See section 2.
Classification
Exposure Limits : Exposure Time : 90 Minutes
(OSHA, ACGIH) Observation Time : 3 Days
Other Ingredients : None more than 1%.

4. FIRST AID MEASURES

General : The substance is toxic, irritant and toxic to aquatic life.
considerations
4.1 First Aid Measures
Inhalation : Remove casualty from exposure ensuring one's own safety whilst doing so. If
conscious, ensure the casualty sits or lies down. If unconscious, check for
breathing and apply artificial respiration if necessary. Consult a doctor.
Skin Contact : Remove all contaminated clothes and footwear immediately unless stuck to skin.
Wash immediately with plenty of soap and water.
Eye Contact : Bathe the eye with running water for 15 minutes. Consult a doctor.
Ingestion : Wash out mouth with water. Do not induce vomiting. If conscious, give half a
litre of water to drink immediately. If unconscious, check for breathing and
apply artificial respiration if necessary. Consult a doctor.
4.2 Symptoms and Adverse Health Effects
Inhalation : There may be shortness of breath with a burning sensation in the throat.
Absorption through the lungs can occur causing symptoms similar to those of
ingestion. Convulsions may occur. There may be loss of consciousness.
Skin : There may be irritation and redness at the site of contact. Absorption through the
skin may occur causing symptoms similar to those of ingestion.
Eyes : There may be irritation and redness. The eyes may water profusely.
Ingestion : There may be soreness and redness of the mouth and throat. There may be
vomiting. Convulsions may occur. There may be loss of consciousness.

Dishman Pharmaceuticals & Chemicals Limited, Bavla.

SOP. No.: BDSH-824 Format No.: SH-F-824-003-00
SAFETY, HEALTH & ENVIRONMENT
MATERIAL SAFETY DATA SHEET
Doc. no.: DSSH-10-MCL-02 DECEMBER 2015 Page 4 of 9
TITLE METHYL FLUFENAMATE

5. FIRE FIGHTING MEASURES

Flash point of : 166.2±27.9 °C -lit.
substance
5.1 Suitable : Suitable extinguishing media for the surrounding fire should be used. Carbon
Extinguisher dioxide. Water. Alcohol or polymer foam. Water spray. Dry chemical powder.
5.2 Specific Hazards : Toxic. In combustion emits toxic and corrosive fumes of carbon dioxide, carbon
monoxide, nitrogen oxides, hydrogen fluoride and organic degradation products.
5.3 Protective : As in any fire, wear a self-contained breathing apparatus in pressure-demand,
equipment for MSHA/NIOSH (approved or equivalent), and full protective gear.
firefighters
6. ACCIDENTAL RELEASE MEASURES
6.1 Personal : Evacuate the area immediately. Mark out the contaminated area with signs and
precautions, prevent access to unauthorised personnel. If outside do not approach from
Protective equipment downwind. Do not attempt to take action without suitable protective clothing -
and emergency see section 8 of SDS. Turn leaking containers leak-side up to prevent the escape
procedures of liquid.
6.2 Environmental : Do not discharge into drains or rivers. Contain the spillage using bunding.
Precautions
6.3 Method and : Clean-up should be dealt with only by qualified personnel familiar with the
material for specific substance. Absorb into dry earth or sand. Transfer to a closable, labelled
containment and salvage container for disposal by an appropriate method.
cleaning up. Leak and
spills

7. HANDLING AND STORAGE

7.1 Precautions for : Wash thoroughly after handling. Remove contaminated clothing and wash before
safe Handling reuse. Avoid contact with eyes, skin, and clothing. Keep container tightly closed.
Avoid ingestion and inhalation. Avoid direct contact with the substance. Ensure
there is exhaust ventilation of the area. Avoid the formation or spread of mists in
the air.
7.2 Conditions for safe : Store in a tightly closed container at ambient temperature. Keep container closed
Storage when not in use. Keep away form incompatible materials. The floor of the
storage room must be impermeable to prevent the escape of liquids.
7.3 Specific Uses : Use as an intermediate.

Dishman Pharmaceuticals & Chemicals Limited, Bavla.

SOP. No.: BDSH-824 Format No.: SH-F-824-003-00
SAFETY, HEALTH & ENVIRONMENT
MATERIAL SAFETY DATA SHEET
Doc. no.: DSSH-10-MCL-02 DECEMBER 2015 Page 5 of 9
TITLE METHYL FLUFENAMATE

8. EXPOSURECONTROLS/PERSONAL PROTECTION
8.1 Exposure Limit Values
Exposure Time : 90 Minutes
Exposure Limits :
Observation Time : 3 Days
8.2 Exposure Controls
8.2.1 Occupational Exposure Controls
Engineering Controls : Ensure there is exhaust ventilation of the area. The floor of the storage room
must be impermeable to prevent the escape of liquids.

8.2.2 Individual protection measures

Respiratory Protection Gas/vapour filter, type A: organic vapours (EN141). Self-contained breathing
:
apparatus must be available in case of emergency.
Hand Protection Impermeable gloves. Nitrile gloves. Breakthrough time of the glove material > 8
:
hours.
Eye Protection : Safety glasses with side-shields. Face-shield. Ensure eye bath is to hand.
Skin Protection : Impermeable protective clothing.
8.2.3 Environmental Exposure Controls
Control Methods : Contain residues for disposal and avoid release to the environment.

Dishman Pharmaceuticals & Chemicals Limited, Bavla.

SOP. No.: BDSH-824 Format No.: SH-F-824-003-00
SAFETY, HEALTH & ENVIRONMENT
MATERIAL SAFETY DATA SHEET
Doc. no.: DSSH-10-MCL-02 DECEMBER 2015 Page 6 of 9
TITLE METHYL FLUFENAMATE

9. PHYSICAL & CHEMICAL PROPERTIES

Chemical Formula : C15H12F3NO2
Appearance : Greenish yellow color oil.
Odor : Odorless.
Odor threshold : No data available
pH (10% aq Sol.) : Water immiscible.
Melting Point : No data available
Boiling Point : 351.2±42.0 °C Press: 760 Torr -lit.
Flash point : 166.2±27.9 °C -lit.
Evaporation Rate : Slow
Flammability : No data available
Explosive properties : No data available
Vapor Pressure : 4.18E-5 Torr Temp: 25 °C -lit.
Vapor density : No data available
Density : 1.301±0.06 g/cm3 Temp: 20 °C Press: 760 Torr -lit.
Water solubility : Water immiscible.
Partition Coefft.
: No data available
(n-Octanol/water)
Auto-ignition
: No data available
temperature
Decomposition
: No data available
temperature
Viscosity : Highly viscous
Other information : Miscible in methanol, ethanol, toluene, ethylacetate.

Dishman Pharmaceuticals & Chemicals Limited, Bavla.

SOP. No.: BDSH-824
Doc. no.: DSSH-10-MCL-02
TITLE
10. STABILITY & REACTIVITY
Reactivity
Chemical Stability
Possibility of
Hazardous Reactions
Conditions to avoid
Incompatible materials
Hazardous
decomposition products
11. TOXICOLOGICAL INFORMATION
11.1 Information on
acute toxicological effects
11.2 Health Effects by Routes of Exposure
Inhalation
Skin Contact
Eye Contact
Ingestion:
11.3 Long terms effects
Dishman Pharmaceuticals & Chemicals Limited, Bavla.
Format No.: SH-F-824-003-00
SAFETY, HEALTH & ENVIRONMENT
MATERIAL SAFETY DATA SHEET
DECEMBER 2015 Page 7 of 9
METHYL FLUFENAMATE
: Reacts with Strong oxidising agents. Strong acids. Strong bases.
: Stable under normal conditions.
Hazardous reactions will not occur under normal transport or storage
: conditions. Decomposition may occur on exposure to conditions or materials
listed below.
: Incompatible materials. Heat. Flames.
: Strong oxidising agents. Strong acids. Strong bases.
In combustion emits toxic and corrosive fumes of carbon dioxide, carbon
: monoxide, nitrogen oxides, hydrogen fluoride and organic degradation
products.
: ORAL RAT LD50 : 292 (Etofenamate) mg/kg
Approx toxicity Data :
Oral toxicity LD50 Dermal toxicity (Rabbit) Inhalation toxicity by dusts
(mg/kg) LD50 (mg/kg) and mists LC50 (mg/L)
> 50 but ≤ 500 > 200 but ≤ 1000 > 2 but ≤ 10
Relevant hazards for substance:
Hazard Route Route
Acute toxicity (ac. tox. 3) ING Hazardous: calculated
Skin corrosion/irritation DRM Hazardous: calculated
Serious eye damage/irritation OPT Hazardous: calculated
STOT-single exposure INH Hazardous: calculated
: There may be shortness of breath with a burning sensation in the throat.
Absorption through the lungs can occur causing symptoms similar to those of
ingestion. Convulsions may occur. There may be loss of consciousness.
: There may be irritation and redness at the site of contact. Absorption through
the skin may occur causing symptoms similar to those of ingestion.
: There may be irritation and redness. The eyes may water profusely.
: There may be soreness and redness of the mouth and throat. There may be
vomiting. Convulsions may occur. There may be loss of consciousness.
: No data available
SOP. No.: BDSH-824 Format No.: SH-F-824-003-00
SAFETY, HEALTH & ENVIRONMENT
MATERIAL SAFETY DATA SHEET
Doc. no.: DSSH-10-MCL-02 DECEMBER 2015 Page 8 of 9
TITLE METHYL FLUFENAMATE

12. ECOLOGICAL INFORMATION

Toxicity Ecotoxicity values:
Species Test Value Units
:
Daphnia magna 48H EC50 <1 (Etofenamate) mg/l
FISH 96H LC50 <1 (Etofenamate) mg/l
Persistance &
: Biodegradable.
degradability
Bio-accumulative
: Bioaccumulation potential.
Potential
Mobility : Non-volatile. Insoluble in water.
13. DISPOSAL CONSIDERATIONS
Waste disposal : Recover, recycle and re-use, where possible. Otherwise, transfer to a suitable
container and arrange for collection by specialised disposal company. Burn in a
chemical incinerator equipped with afterburners and scrubbers.
14. TRANSPORT INFORMATION
UN Number : UN2810
Transport Hazard : Toxic liquid
Classification
(U.S. DOT),(IMDG), Proper shipping name: Toxic liquid, organic, N.O.S (Methyl Flufenamate)
(IATA/ICAO), Hazard class:6.1 and PG : III
(RID/ADR) Tunnel code: E
Transport category: 2
Marine Pollutant : Yes
Other Information : No data available
15. REGULATORY INFORMATION
Substance giving rise : Methyl flufenamate
to classification
CAS Number :
2765-91-5
EC (EINECS) No. : None listed.
15.1 Other National Regulatory Information
U.S. TSCA listings : No data available
DOT classification : UN2810, Toxic liquid.
OSHA, CERCLA
: No data available
SARA TITLE III
Other Information : No data available

Dishman Pharmaceuticals & Chemicals Limited, Bavla.

SOP. No.: BDSH-824 Format No.: SH-F-824-003-00
SAFETY, HEALTH & ENVIRONMENT
MATERIAL SAFETY DATA SHEET
Doc. no.: DSSH-10-MCL-02 DECEMBER 2015 Page 9 of 9
TITLE METHYL FLUFENAMATE

16. OTHER INFORMATION

EC Hazard : According to Regulation EC No. According to EC Directive
Statements & Risk 1272/2008 (CLP Regulation, GHS) 67/548/EEC/ (or Directive
Phrases 1999/45/EC).
H301 : Toxic if swallowed. R37/38: Irritating respiratory system and
H315 : Causes skin irritation. skin.
H319 : Causes serious eye irritation. R41 : Risk of serious damage to eyes.
H335 : May cause respiratory R25 : Toxic if swallowed.
irritation. R50/53 : Very toxic to aquatic organisms
H410 : Very Toxic to aquatic life with long-term adverse effects.
with long lasting effects.
U.S. HMIS Ratings : No data available
Information on this : This MSDS complies with data requirements contained in European Directive
MSDS 67/548/EEC and certain new requirements contained in Regulation (EC) No
1272/2008. This MSDS also complies with United States Federal Regulations as
contained in Standards-29CFR.
Latest Revision : MSDS first issued :
1st (& current) Revision :
This revision has been made to meet certain new EC requirements contained in
Regulation (EC)No 1272/2008.
Legal disclaimers :
The above information is believed to be correct but does not purport to be all inclusive and shall be used only
as a guide. DISHMAN PHARMACEUTICALS & CHEMICALS LTD shall not be held liable for any
damage from handling or from contact with the above product.

Name Designation Signature Date

Prepared Dr. Komal Pandya Research associate, Scientific
Senior Research associate,
Reviewed Mr. Vishal Parikh
Scientific
Approved V. C. Vishnoi Senior V.P. – SHE

Dishman Pharmaceuticals & Chemicals Limited, Bavla.