SAFETY DATA SHEET

Creation Date 04-Mar-2016 Revision Date 28-Dec-2021 Revision Number 4

1. Identification
Product Name Lamotrigine

Cat No. : AC460850000; AC460850010; AC460850050

CAS No 84057-84-1
Synonyms 6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine

Recommended Use Laboratory chemicals.

Uses advised against Food, drug, pesticide or biocidal product use.

Details of the supplier of the safety data sheet

Company
UK entity/business name Acros Organics
Fisher Scientific UK One Reagent Lane
Bishop Meadow Road, Fair Lawn, NJ 07410
Loughborough, Leicestershire LE11 5RG,
United Kingdom
General info; Tel: +44 (0)1509 231166

EU entity/business name
Acros Organics BVBA
Janssen Pharmaceuticalaan 3a, 2440 Geel,
Belgium
General Info; Tel: +32-14-57 52 11
([email protected])
Technical Support; Tel +32-14-56 56 00
([email protected])

Emergency Telephone Number For information US call: 001-800-ACROS-01 / Europe call: +32 14 57 52 11
Emergency Number US:001-201-796-7100 / Europe: +32 14 57 52 99
CHEMTREC Tel. No.US:001-800-424-9300 / Europe:001-703-527-3887

2. Hazard(s) identification
Classification
This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)

Acute oral toxicity Category 3

Label Elements

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Signal Word
Danger

Hazard Statements
Toxic if swallowed

Precautionary Statements
Prevention
Wash face, hands and any exposed skin thoroughly after handling
Do not eat, drink or smoke when using this product
Ingestion
IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician
Rinse mouth
Storage
Store locked up
Disposal
Dispose of contents/container to an approved waste disposal plant
Hazards not otherwise classified (HNOC)
None identified

3. Composition/Information on Ingredients
Component CAS No Weight %
Lamotrigine 84057-84-1 >95

4. First-aid measures
General Advice Show this safety data sheet to the doctor in attendance. Immediate medical attention is
required.

Eye Contact In the case of contact with eyes, rinse immediately with plenty of water and seek medical
advice.

Skin Contact Wash off immediately with plenty of water for at least 15 minutes. Immediate medical
attention is required.

Inhalation Remove to fresh air. If not breathing, give artificial respiration. Do not use mouth-to-mouth
method if victim ingested or inhaled the substance; give artificial respiration with the aid of a
pocket mask equipped with a one-way valve or other proper respiratory medical device.
Immediate medical attention is required.

Ingestion Do NOT induce vomiting. Call a physician or poison control center immediately.

Most important symptoms and None reasonably foreseeable.

effects
Notes to Physician Treat symptomatically

5. Fire-fighting measures

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Suitable Extinguishing Media Water spray, carbon dioxide (CO2), dry chemical, alcohol-resistant foam.

Unsuitable Extinguishing Media No information available

Flash Point No information available

Method - No information available

Autoignition Temperature No information available

Explosion Limits
Upper No data available
Lower No data available
Sensitivity to Mechanical Impact No information available
Sensitivity to Static Discharge No information available

Specific Hazards Arising from the Chemical

Keep product and empty container away from heat and sources of ignition.

Hazardous Combustion Products

Carbon oxides. Hydrogen chloride. Nitrogen oxides (NOx). Carbon dioxide (CO2).
Protective Equipment and Precautions for Firefighters
As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full
protective gear. Thermal decomposition can lead to release of irritating gases and vapors.

NFPA
Health Flammability Instability Physical hazards
3 1 0 N/A

6. Accidental release measures

Personal Precautions Ensure adequate ventilation. Use personal protective equipment as required. Avoid dust
formation. Keep people away from and upwind of spill/leak. Evacuate personnel to safe
areas.
Environmental Precautions Should not be released into the environment.

Methods for Containment and Clean Sweep up and shovel into suitable containers for disposal. Avoid dust formation.
Up

7. Handling and storage

Handling Wear personal protective equipment/face protection. Do not get in eyes, on skin, or on
clothing. Avoid dust formation. Use only under a chemical fume hood. Do not breathe (dust,
vapor, mist, gas). Do not ingest. If swallowed then seek immediate medical assistance.

Storage. Keep container tightly closed in a dry and well-ventilated place. To maintain product quality:
Keep refrigerated. Store under an inert atmosphere. Incompatible Materials. Strong
oxidizing agents.

8. Exposure controls / personal protection

Exposure Guidelines This product does not contain any hazardous materials with occupational exposure
limitsestablished by the region specific regulatory bodies.

Engineering Measures Ensure adequate ventilation, especially in confined areas.

Personal Protective Equipment

Eye/face Protection Wear appropriate protective eyeglasses or chemical safety goggles as described by

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OSHA's eye and face protection regulations in 29 CFR 1910.133 or European Standard
EN166.

Skin and body protection Wear appropriate protective gloves and clothing to prevent skin exposure.

Respiratory Protection Follow the 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.

Hygiene Measures Handle in accordance with good industrial hygiene and safety practice.

9. Physical and chemical properties

Physical State Solid
Appearance White to off-white
Odor No information available
Odor Threshold No information available
pH No information available
Melting Point/Range 218 °C / 424.4 °F
Boiling Point/Range No information available
Flash Point No information available
Evaporation Rate Not applicable
Flammability (solid,gas) No information available
Flammability or explosive limits
Upper No data available
Lower No data available
Vapor Pressure No information available
Vapor Density Not applicable
Specific Gravity No information available
Solubility Insoluble in water
Partition coefficient; n-octanol/water No data available
Autoignition Temperature No information available
Decomposition Temperature No information available
Viscosity Not applicable
Molecular Formula C9 H7 Cl2 N5
Molecular Weight 256.09

10. Stability and reactivity

Reactive Hazard None known, based on information available

Stability heat sensitive. Air sensitive.

Conditions to Avoid Incompatible products. Exposure to air. Heat.

Incompatible Materials Strong oxidizing agents

Hazardous Decomposition Products Carbon oxides, Hydrogen chloride, Nitrogen oxides (NOx), Carbon dioxide (CO2)

Hazardous Polymerization Hazardous polymerization does not occur.

Hazardous Reactions None under normal processing.

11. Toxicological information

Acute Toxicity

Product Information
Component Information
Component LD50 Oral LD50 Dermal LC50 Inhalation
Lamotrigine LD50 = 205 mg/kg ( Rat ) Not listed Not listed

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Toxicologically Synergistic No information available

Products
Delayed and immediate effects as well as chronic effects from short and long-term exposure

Irritation No information available

Sensitization No information available

Carcinogenicity The table below indicates whether each agency has listed any ingredient as a carcinogen.

Component CAS No IARC NTP ACGIH OSHA Mexico

Lamotrigine 84057-84-1 Not listed Not listed Not listed Not listed Not listed
Mutagenic Effects No information available

Reproductive Effects No information available.

Developmental Effects No information available.

Teratogenicity No information available.

STOT - single exposure None known

STOT - repeated exposure None known

Aspiration hazard No information available

Symptoms / effects,both acute and No information available

delayed

Endocrine Disruptor Information No information available

Other Adverse Effects The toxicological properties have not been fully investigated.

12. Ecological information

Ecotoxicity
Do not empty into drains.

Persistence and Degradability Insoluble in water

Bioaccumulation/ Accumulation No information available.

Mobility Is not likely mobile in the environment due its low water solubility.

13. Disposal considerations

Waste Disposal Methods Chemical waste generators must determine whether a discarded chemical is classified as a
hazardous waste. Chemical waste generators must also consult local, regional, and
national hazardous waste regulations to ensure complete and accurate classification.

14. Transport information

DOT
UN-No UN2811
Proper Shipping Name TOXIC SOLIDS, ORGANIC, N.O.S.
Technical Name Lamotrigine
Hazard Class 6.1
Packing Group III
TDG
UN-No UN2811
Proper Shipping Name Toxic solid, organic, n.o.s.
Hazard Class 6.1

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Packing Group III

IATA
UN-No UN2811
Proper Shipping Name Toxic solid, organic, n.o.s.
Hazard Class 6.1
Packing Group III
IMDG/IMO
UN-No UN2811
Proper Shipping Name Toxic solid, organic, n.o.s.
Hazard Class 6.1
Packing Group III
15. Regulatory information
United States of America Inventory

Component CAS No TSCA TSCA Inventory notification - TSCA - EPA Regulatory

Active-Inactive Flags
Lamotrigine 84057-84-1 - - -

Legend:
TSCA US EPA (TSCA) - Toxic Substances Control Act, (40 CFR Part 710)
X - Listed
'-' - Not Listed

TSCA 12(b) - Notices of Export Not applicable

International Inventories
Canada (DSL/NDSL), Europe (EINECS/ELINCS/NLP), Philippines (PICCS), Japan (ENCS), Japan (ISHL), Australia (AICS), China (IECSC), Korea
(KECL).

Component CAS No DSL NDSL EINECS PICCS ENCS ISHL AICS IECSC KECL
Lamotrigine 84057-84-1 - - 281-901-8 - - X - - -

KECL - NIER number or KE number (http://ncis.nier.go.kr/en/main.do)

U.S. Federal Regulations

SARA 313 Not applicable

SARA 311/312 Hazard Categories See section 2 for more information

CWA (Clean Water Act) Not applicable

Clean Air Act Not applicable

OSHA - Occupational Safety and Not applicable

Health Administration

CERCLA Not applicable

California Proposition 65 This product does not contain any Proposition 65 chemicals.

U.S. State Right-to-Know Not applicable

Regulations

U.S. Department of Transportation

Reportable Quantity (RQ): N
DOT Marine Pollutant N

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DOT Severe Marine Pollutant N

U.S. Department of Homeland This product does not contain any DHS chemicals.
Security

Other International Regulations

Mexico - Grade No information available

Authorisation/Restrictions according to EU REACH

Safety, health and environmental regulations/legislation specific for the substance or mixture

Component CAS No OECD HPV Persistent Organic Ozone Depletion Restriction of

Pollutant Potential Hazardous
Substances (RoHS)
Lamotrigine 84057-84-1 Not applicable Not applicable Not applicable Not applicable

Component CAS No Seveso III Directive Seveso III Directive Rotterdam Basel Convention
(2012/18/EC) - (2012/18/EC) - Convention (PIC) (Hazardous Waste)
Qualifying Quantities Qualifying Quantities
for Major Accident for Safety Report
Notification Requirements
Lamotrigine 84057-84-1 Not applicable Not applicable Not applicable Not applicable

16. Other information

Prepared By Regulatory Affairs
Thermo Fisher Scientific
Email: [email protected]

Creation Date 04-Mar-2016

Revision Date 28-Dec-2021
Print Date 28-Dec-2021
Revision Summary This document has been updated to comply with the US OSHA HazCom 2012 Standard
replacing the current legislation under 29 CFR 1910.1200 to align with the Globally
Harmonized System of Classification and Labeling of Chemicals (GHS).

Disclaimer
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the
date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage,
transportation, disposal and release and is not to be considered a warranty or quality specification. The information
relates only to the specific material designated and may not be valid for such material used in combination with any other
materials or in any process, unless specified in the text

End of SDS

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