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Safety Data Sheet
1. IDENTIFICATION
Product InformationProduct name Aripiprazole
Version 1.0, 04.04.2013
Jurisdiction This Safety Data Sheet was prepared in accordance with the Globally Harmonized
System of Classification and Labelling of Chemicals (GHS) for the United States ofAmerica (USA) (CFR 1910.1200), European Union (EU) (EC 1272/2008) and United
Nations (UN). The following countries utilize the UN GHS classification process:
Mexico, Brazil, China, New Zealand, Canada, Japan, Korea and Australia.
Chemical Name 2(1H)-Quinolinone,7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-
IUPAC name 7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-3,4-dihydro-1H-quinolin-2-one
Synonyms Abilify; Abilify Discmelt; Abilitat; BMS-337039-01; BMS 337039-01; OPC-31;
OPC 31; OPC-14597; OPC 14597; 3D CONCORD
Intended Uses This material is the active pharmaceutical ingredient (API) in a drug product. It is used
to treat psychotic disorders.
Company/Undertaking Identification
Address USA
Bristol-Myers Squibb CompanyP.O. Box 191
New Brunswick, New Jersey 08903
United States of America
Ireland
Bristol-Myers Squibb CompanySwords Laboratories, Watery Lane
Swords, Ireland
Emergency Phone
Number
USA (also Canada, Puerto Rico and the
Virgin Island): 1-800-424-9300
Ireland: 353-1813-9456
Other Countries: See "Section 16" for country-specific emergency phone numbers fromCHEMTREC.
2. HAZARDS IDENTIFICATION
Classification and Labelling Common to All Jurisdictions
Classification Combustible Dust
Acute Toxicity - Oral - Category 4
Carcinogenicity - Category 2
Toxic To Reproduction - Reproductive Toxicity - Category 1A
Toxic To Reproduction - Developmental Toxicity - Category 2Effects on or via lactation
Specific Target Organ Systemic Toxicity (Repeated Exposure) - Category 1Hazardous To The Aquatic Environment - Chronic Hazard - Category 1 (M=10)
Symbol
Signal Word Danger
Hazard May form combustible dust concentrations in air (during processing).
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2. HAZARDS IDENTIFICATION
Statements Harmful if swallowed.
Suspected of causing cancer.
May damage fertility (male reproductive toxicity, female reproductive toxicity) .
Suspected of damaging the unborn child (developmental toxicity) .May cause harm to breast-fed children.
Causes damage to organs (central nervous system, cardiovascular system, endocrine system)through prolonged or repeated exposure.
Very toxic to aquatic life with long lasting effects.(M=10)
Precautionary
Statements
Minimize dust generation, accumulation, and dispersal in air.
Use personal protective equipment as required.
Do not eat, drink or smoke when using this product.
Do not breathe dust/fume/gas/mist/vapours/spray.
Obtain special instructions before use.
Avoid release to the environment.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Components Concentration CAS-No.
EU only
EINECS/ELINCS/
REACHRegistration
Number
Symbol(s)/R-phrase(s)
H-code(s)
Hazardous components
Aripiprazole 100% 129722-12-9 -- T: R22,R40,
R48/25,
R60, R63,
R64, R53
H302
H351
H360FH361d
H362
H372
H410/M=10
See section 16 for Symbol, R-phrase and H-code text.
4. FIRST AID MEASURES
Eye contact Rinse immediately with plenty of water for at least 15 minutes. Keep eye wide open whilerinsing. Obtain medical attention.
Skin contact Take off contaminated clothing and shoes immediately. Wash off immediately with plenty
of water for at least 15 minutes. If skin irritation persists, call a physician.
Inhalation Move to fresh air. Oxygen or artificial respiration if needed. If exposed or concerned: Getmedical attention/advice.
Ingestion IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
Rinse mouth.
Notes to Physician Medical conditions aggravated include: depression, diabetes, cardiovascular disease,
decreased white blood cell count, kidney disorders. This product has been reported to
interact with the following medications: drugs that inhibit cytochrome P-450,
cardiovascular agents, anti-psychotic drugs, alcohol. Refer to Section 11.
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4. FIRST AID MEASURES
Medical Surveillance The need for a pre-placement physical examination and history for employees with
potential exposure to this compound is to be evaluated by a physician that is thoroughly
knowledgeable about both the toxicity of this compound and the extent of work place
exposure. Baseline testing would include: a complete blood count with differential, a bloodtest for kidney function. Based on opportunity for exposure and duration of exposure a
periodic follow-up examination may be considered. This exam should be overseen by aphysician thoroughly knowledgeable about both the toxicity of this compound and the
extent of work place exposure. It is recommended that the content be similar to the pre-
placement exam.
Employees who are pregnant, are breast-feeding, or who are concerned with other
reproductive issues should be encouraged to consult with the occupational health physician
monitoring worker's health.
5. FIRE-FIGHTING MEASURES
Flammable Properties Not available
Extinguishing Media Suitable extinguishing media: Dry chemical, Water spray, FoamUnsuitable extinguishing media: Do NOT use water jet.
Protection ofFirefighters
Specific hazards: Not availableProtective equipment: Use personal protective equipment. In the event of fire, wear self-
contained breathing apparatus.
Hazardous Combustion Products: carbon oxides (COx), nitrogen oxides (NOx), and,gaseous hydrogen chloride (HCl).
Further Information: HCl gas can form flammable or explosive mixtures with alcohols or
metals. In the event of fire and/or explosion do not breathe fumes.
Other information Decontaminate protective clothing and equipment before reuse. Avoid generating dust;
fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition
source is a potential dust explosion hazard.
6. ACCIDENTAL RELEASE MEASURES
Personal precautions Refer to protective measures listed in sections 7 and 8. Use personal protective equipment.Examples include tightly fitting safety goggles, lab coat and impervious gloves. Wear
respiratory protection. Depending on the nature of the spill (quantity and extent of spill)
additional protective clothing and equipment such as a self-contained breathing apparatus
may be needed.
Environmentalprecautions
Prevent release to drains and waterways. Prevent release to the environment.
Containment Methods Wet down any dust to prevent generation of aerosols, if appropriate. Cover with suitable
material.
Cleanup Methods Contain and collect spillage and place in container for disposal according to local
regulations (see Section 13). Use a HEPA vacuum or moisten materials to minimize dustgeneration during pick-up. Clean area with detergent and water after spill pick-up, if
appropriate. Handle waste materials, including gloves, protective clothing, contaminated
spill cleanup material, etc., as appropriate for chemically and pharmacologically similarmaterials.
Other information Dust deposits should not be allowed to accumulate on surfaces, as these may form an
explosive mixture if they are released into the atmosphere in sufficient concentration.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces with compressed air).Nonsparking tools should be used.
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7. HANDLING AND STORAGE
Handling Precautions Avoid exposure - obtain special instructions before use. Avoid formation of dust and
aerosols. Keep away from heat and sources of ignition. Prevent release to drains and
waterways. Minimize dust generation and accumulation. Routine housekeeping should be
instituted to ensure that dusts do not accumulate on surfaces. Dry powders can build staticelectricity charges when subjected to the friction of transfer and mixing operations.
Provide adequate precautions, such as electrical grounding and bonding, or inertatmospheres. Use of inert gas should be considered for process conditions to minimize the
risk of ignition. Refer also to Section 10.
ContainerRequirements
Store in sturdy containers appropriate to maintain the integrity of this material for itsintended use. Provide anti-static bags where drum liners are used.
Storage Conditions Store at 25C Protect against light. Keep away from heat, sparks and flames.
Specific use(s) Refer to Section 1
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure limit(s) Company Guideline ACGIH Germany OEL UK MEL
Aripiprazole 20 g/m3 8 hour-
TWA
-- -- --
RecommendedIndustrial Hygiene
Monitoring Methods
Contact the Bristol-Myers Squibb AIHA accredited Industrial Hygiene Laboratory at 732-227-6338.
Engineering
Controls and
Ventilation
Use process enclosures, containment technology, or other engineering controls to keep
airborne levels below recommended exposure limit. When handling quantities up to 15
milligrams, a standard laboratory with general laboratory dilution ventilation (e.g. 6-12 air
changes per hour) is appropriate. When handling quantities from 15 milligrams to 1 kilogram,work in a standard laboratory using a fume hood, biological safety cabinet(Class II, all types),
or approved vented enclosure. Quantities exceeding 1 kilogram should be handled in a
designated laboratory. A laminar flow/powder containment booth is recommended for
handling >1 kilograms of active substance. For manufacturing and pilot plant operations, use
direct coupling and closed transfer systems for all bulk transfers. Use dust tight valves asappropriate. HEPA filtration of local exhaust ventilation (LEV) is required.
It is recommended that all dust control equipment such as local exhaust ventilation and
material transport systems involved in handling of this product contain explosion relief vents
or an explosion suppression system or an oxygen deficient environment. Ensure that dust-
handling systems (such as exhaust ducts, dust collectors, vessels, and processing equipment)
are designed in an manner to prevent the escape of dust into the work area (i.e., there is no
leakage from the equipment). Use only appropriately classified electrical equipment andpowered industrial trucks.
Respiratory
protection
Use and selection of respiratory protection is based upon engineering controls in use and
potential for aerosol generation. When engineering controls are not sufficient controlexposure, wear an approved respirator with NIOSH Class 100 or high efficiency particulate
(HEPA) filters or cartridges (EN 140/EN 136) when exposures are up to 10 times the exposurecontrol guideline. Wear a loose-fitting (Tyvek or helmet type) HEPA powered-air purifying
respirator (PAPR) (EN 12941) when exposures are 10-25 times the exposure control
guideline. Wear a full facepiece negative pressure respirator with Class 100 or HEPA filters
(EN 136) when exposures are 25-50 times the exposure control guideline. Wear a tight-
fitting, full facepiece HEPA PAPR (EN 12942) when exposures are 50-100 times the exposure
control guideline. Wear a hood-shroud HEPA PAPR (EN 12941) or full facepiece supplied
air respirator (EN 139) operated in a pressure demand or other positive pressure mode when
exposures are 100-1000 times the exposure control guideline.
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8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Eye protection Safety glasses with side-shields are recommended (EN 166). Face shields or chemical safety
goggles (EN 166) may be required if splash potential exists or if corrosive materials are
present. Note: Choice of eye protection may be influenced by the type of respirator which is
selected.Hand protection Impervious nitrile, rubber and latex gloves are recommended (EN 420, EN 374). If material
is handled in solution, the solvent should also be considered when selecting protective clothingmaterial. Please note that employees who are allergic to natural rubber latex should use nitrile
gloves.
Skin and body
protection
Wear a laboratory coat (EN 340) when handling quantities up to 1 kilogram. For quantities
over 1 kilogram, wear laboratory coat(EN 340)or coverall of low permeability (EN 1149-1).
For manufacturing operations, wear coverall of low permeability (EN 465/1149-1). For
manufacturing operations, wear coverall of low permeability (EN 1149-1).
Hygiene Wash hands and face before breaks and immediately after handling the product.
Environmental
exposure controls
Prevent release to drains and waterways.
9. PHYSICAL AND CHEMICAL PROPERTIES
General Information
Appearance
Physical State solidColor white to off-whiteForm crystalline, powder
Odour
Odour Not availableOdor Threshold Not available
pH Not available
Other information
Bulk density Not available
Chemical Name 2(1H)-Quinolinone,7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-
dihydro-Evaporation rate Not available
Molecular formula C23 H27 Cl2 N3 O2Hydrolysis/Photolysis Not available
Hygroscopicity Not available
Molecular Weight 448.39 g/mol
Log Octanol/Water Partition
Coeff [log Kow]
2.70 @ 24.9 - 25.2 C (pH 5)
2.95 @ 24.9 - 25.2 C (pH 7)2.86 @ 24.9 - 25.2 C (pH 9)
Surface Tension Not available
pKa Not available
Particle Size 95 % of particles are < 14.6 micronsSolubility, Water 0.0013 g/l @ 25 C
Solubility in other solvents Chloroform: 385 g/l @ 25 C
dimethyl sulfoxide: 17.1 g/l @ 25 Cethyl alcohol: 3.1 g/l @ 25 C
ether: 1.5 g/l @ 25 C
methanol: 0.93 g/l @ 25 C
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9. PHYSICAL AND CHEMICAL PROPERTIES
Specific Gravity/ Relative
density
Not available
Viscosity, dynamic Not available
Viscosity, kinematic Not available% Volatile Not available
Thermal/Stability properties
Autoignition temperature Not availableBoiling Point 139.0 - 139.5 C
Thermal decomposition Not available
Explosive Limits, LEL Not availableExplosive limits, UEL Not available
Explosiveness Non-explosive based on chemical structure.Flammability Not available
Flash point Not available
Melting Point Not available
Oxidizing Potential Non-oxidizer based on chemical structure.
Vapor Properties
Vapor Density Not availableVapor Pressure Not available
Saturated Vapor Concentration Not available
10. STABILITY AND REACTIVITY
Stability
Chemical
Stability
Stable under normal conditions.
Conditions to
avoid
Not available
Materials to
avoid
Not available
Hazardousdecomposition
products
Hazardous decomposition products formed under fire conditions.: carbon oxides (COx),nitrogen oxides (NOx), and, gaseous hydrogen chloride (HCl).
Hazardous
reactionsNone known.
Sensitivity to static discharge/Dust exp.
Explosion
Severity Factor183 m.b_/s
St1
Material exhibits weak to moderate explosion characteristics if ignited as a dust cloud.
Minimum
Ignition Energy> 3 - < 10 mJ
Material is extremely susceptible to igniting a dust cloud under certain conditions due to lowminimum ignition energy.
Volume
Resistivity
(ambient)
280.0000E+12 ohm.m
Material is highly susceptible to accumulating static charges during processing.
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10. STABILITY AND REACTIVITY
Charge decay
time (ambient)
5.5 H
Ignition
temperature
> 430 - < 450 C
Layerdecomposition
No exotherm observed.
Summary
Statements
Powder handling equipment such as dust collectors, dryers, and mills may require additional
protective measures (e.g. explosion venting, inerting, etc.). Provide suitable bonding and
grounding for containers, personnel, and process equipment to control static charges. Provide
anti-static bags where drum liners are used. Use of inert gas should be considered for process
conditions to minimize the risk of ignition. NOTE: THIS DATA IS REPRESENTATIVE
FOR THE SPECIFIC PROCESS STATE OF THE MATERIAL NOTED ON THIS SDS
ONLY. Dust explosion severity risk can vary upon processing or environmental change (e.g.milling, micronizing, sieving, blending or heating can increase the risk of explosion), and may
require additional dust explosion testing.
11. TOXICOLOGICAL INFORMATION
Routes of Entry Ingestion, inhalation, Eye contact, Skin contact
Eye Irritation Not irritating to eyes.
Skin Irritation Not irritating to skin.
Respiratory
Irritation
Not available
Sensitization Not a dermal sensitizer in an experimental study
Acute ToxicityStudy
Acute OralLD50 (rat, females): 705 mg/kg High exposure effects include: CNS depression, tremors,
uncontrolled muscle movements.
LD50 (rat, males): 953 mg/kg
LD50 (monkey, males and females): > 2,000 mg/kg High exposure effects include: CNS
depression, tremors, uncontrolled muscle movements.
Acute toxicity (other routes of administration)LD50 (dog, males and females, intramuscular): > 400 mg/kg
LD50 (dog, intramuscular, 7 Weeks): > 400 mg/kg
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11. TOXICOLOGICAL INFORMATION
Repeated Dose
Toxicity
4 weeks - 2 years oral (daily) mouse, rat, monkey study with recovery period (13 weeks)
(males and females): NOAEL (1 year, monkey) = 0.5 mg/kg; Low dose effects include:
decreased responsiveness, decreased motor activity, drooping eyelids, muscle rigidity,
tremors, hyperactivity, behavioral changes, abnormal posture, clinical signs, body weight
changes, decreased food consumption, bile changes, gall stones, fecal changes, changesin clinical chemistry parameters, adrenal hormone changes, increased prolactin, altered
estrous cycling, overt toxicity, decreased organ weights included:, liver, uterus/cervix.
Low dose microscopic effects include:mammary gland, ovary, pituitary gland, lungs,
vagina, salivary gland, eyes. After recovery, most parameters returned to normal.
Genetic Toxicity In vitroAmes reverse-mutation assay -- negative
Chromosome aberration test in vitro -- positive
DNA repair assay -- negativeForward gene mutation assay -- negative
in vivooral, Mutagenicity (micronucleus test) (mouse) -- negative
oral, Unscheduled DNA synthesis assay (rat) -- negative
Carcinogenicity 2 Years Dietary (daily) mouse study : Tumor NOAEL = 1 mg/kg (males and females).
[tumor organs: pituitary gland, mammary gland] No treatment-related tumors were
observed in males.
2 Years Dietary (daily) rat study : Tumor NOAEL = 3 mg/kg (males and females). [tumor
organs: mammary gland] No treatment-related tumors were observed in males.
Carcinogenicity AssessmentThis material has limited evidence of carcinogenic potential. These tumors are believed to bedue to a prolactin-mediated mechanism.
Carcinogenicity ACGIH IARC NTP
Aripiprazole -- -- --
ReproductiveToxicity
oral (daily) Study of Fertility and Early Embryonic Development (rat)(parent, males) LOAEL = 2 mg/kg
(embryo/fetus, females) NOAEL = 6 mg/kg
Fetal effects include: decreased body weight. Maternal effects include: increased body
weight, increase in food consumption, altered estrous cycling, ovarian changes,
preimplantation loss, delayed time to successful copulation. Paternal effects include:increased body weight, increase in food consumption.
Assessment Reproductive Toxicity
Animal studies indicate that reproductive effects can occur.
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11. TOXICOLOGICAL INFORMATION
Developmental
Toxicity
Study of Embryo-Fetal Development (rat)
(parent, females) NOAEL = 3 mg/kg/day
(F1 offspring) NOAEL = 3 mg/kg/day
Offspring effects include: decreased body weight, changes in skeletal development,
changes in sexual development. Maternal effects include: central nervous system effects,decreased weight gain, decreased food consumption, delayed delivery. Adverse effects
on the offspring occur only at doses that also cause maternal effects.
Study of Embryo-Fetal Development (rabbit)
(parent, females) LOAEL = 10 mg/kg/day
(embryo/fetus) NOAEL = 10 mg/kg/day
Fetal effects include: decreased body weight, changes in skeletal development. Maternal
effects include: decreased food consumption, decreased body weight, postimplantationloss.
oral Study of Pre- and Postnatal Development (rat)
(parent, females) NOAEL = 10 mg/kg/day
(F1 offspring) NOAEL = 10 mg/kg/dayFetal effects include: death. Offspring effects include: decreased viability, decreased
body weight. Maternal effects include: decreased weight gain, decreased foodconsumption, lactation effects.
Developmental Toxicity AssessmentSeveral studies were conducted. Compound produced effects on the fetus at doses similar to
those which produced effects on the maternal animal. This compound and/or its metabolites
may be excreted into the milk. Compounds in this drug class have adverse effects on
reproduction.
Human experience Experiences with Human ExposureGeneral effects low exposure - acute effects include: headache, nausea, vomiting,
constipation, incontinence, sleepiness, dizziness, weakness, restlessness, tremors,abnormal coordination, anxiety, irritability, agitation, behavioral changes, sweating,
breathing difficulties, salivation, lightheadedness, disorganized thought, suicidal
thoughts, fever, uncontrolled muscle movements, muscle rigidity, convulsions,
difficulty swallowing, pain, swelling, cough, congestion, blurred vision, changes in
blood pressure, cardiac irregularities, changes in clinical chemistry parameters,
increased weight gain. low exposure - long term exposure effects include: increased
prolactin, reproductive function changes, degeneration of skeletal muscle, kidney
failure, hyperglycemia, hepatitis.
Acute Overdose low exposure - acute effects include: vomiting, sleepiness, dizziness,tremors, uncontrolled muscle movements, difficulty swallowing, behavioral
changes, confusion, agitation, electrolyte disturbance, changes in clinical chemistryparameters, cardiac irregularities, changes in blood pressure, headache, skin
sensation changes, unconsciousness, convulsions, respiratory arrest, coma.
Target Organs central nervous system, cardiovascular system, endocrine system
Symptoms See "Human Experience".
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11. TOXICOLOGICAL INFORMATION
Pharmacokinetics/
Toxicokinetics
Absorption: Not available
Distribution: Not available
Metabolism: Not available
Elimination: Half-life = 75 Hour(s) (Human).
Other ToxicityInformation
Not available
12. ECOLOGICAL INFORMATION
Ecotoxicity effects
Acute Toxicity to Fish
LC50 (Oncorhynchus mykiss (rainbow trout), 96 H) : > 0.12 mg/l. (highest mean concentration tested)NOEC (Oncorhynchus mykiss (rainbow trout), 96 H) : 0.047 mg/l.
Acute Toxicity to Aquatic InvertebratesNOEC (Daphnia magna (Water flea), 48 H) : 0.031 mg/l.
Toxicity to aquatic plantsEC50 (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae biomass and
growth rate, 72 H) : > 0.14 mg/l (highest mean concentration tested)
NOEC (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae biomass, 72 H) :
0.026 mg/l
NOEC (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae growth rate, 72
H) : 0.14 mg/l
Toxicity to microorganisms
Respiration inhibition, EC50 (Activated Sludge, 3 H) : > 1,000 mg/l
Chronic toxicity to fishEarly-life Stage NOEC (Pimephales promelas (fathead minnow)) : 0.0058 mg/l
Chronic toxicity to aquatic invertabratesNOEC (Daphnia magna (Water flea)) : 0.00261 mg/l (reproduction rate)
Toxicity to soil dwelling organisms
EC50 (Eisenia foetida, 14 days) : > 1,000 mg/kg soil dm
Mobility Not available
Persistence and degradability
Biodegradation
Ready biodegradation (42 D) : 10 % ; Not Readily Biodegradable - unlikely to undergo rapid
biodegradation in the environment
Koc (Batch equilibrium, Activated Sludge) : 10,270 (water)
Kd (Batch equilibrium, Activated Sludge) : 2,783 (water)
immobileKoc (Batch equilibrium, Activated Sludge) : 2,850 (calcium chloride solution)
Kd (Batch equilibrium, Activated Sludge) : 772 (calcium chloride solution)
immobile
Summary Statements
Aquatic toxicityExperimental data indicate low potential for acute harm to aquatic organisms.
Chemical Fate
Not readily biodegradable. Immobile in soil.
Bioaccumulative potentialBioconcentration factor (BCF): 53.9 - 85.7
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12. ECOLOGICAL INFORMATION
PBT and vPvB Assessment: Not available
13. DISPOSAL CONSIDERATIONS
Advice On Disposal And Packaging Disposal should be in accordance with applicable regional, national and locallaws and regulations. Local regulations may be more stringent than regional
or national requirements. This information presented only applies to the
material as supplied.
Other information Disposal by incineration is recommended.
14. TRANSPORT INFORMATIONThis material is not a dangerous good for the purpose of transportation in all modes.
15. REGULATORY INFO MATION
United States of America313 Toxic ReleaseInventory
No components listed on the SARA 313 inventory.
TSCA Inventory Not listed. Food, drug and cosmetic products are exempt from TSCA.
EU Directive 67/548/EEC
Symbol(s) T: Toxic
R-phrase(s) R22: Harmful if swallowed.
R40: Limited evidence of a carcinogenic effect.
R48/25: Toxic: danger of serious damage to health by prolonged exposure if swallowed.
R60: May impair fertility.R63: Possible risk of harm to the unborn child.R64: May cause harm to breastfed babies.
R53: May cause long-term adverse effects in the aquatic environment.
S-phrase(s) S22: Do not breathe dust.
S36/37/39: Wear suitable protective clothing, gloves and eye/face protection.
S45: In case of accident or if you feel unwell, seek medical advice immediately (show label
where possible).
S53: Avoid exposure - obtain special instructions before use.
S60: This material and its container must be disposed of as hazardous waste.
S61: Avoid release to the environment. Refer to special instructions/ Safety data sheets.
Regulatory
Authorizations and
Restrictions:
Not available
16. OTHER INFORMATIONText of Symbol(s), R-phrase(s) and H-code(s) mentioned in Section 3
H302 Harmful if swallowed.H351 Suspected of causing cancer.
H360F May damage fertility
H361d Suspected of damaging the unborn child
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H362 May cause harm to breast-fed children.
H372 Causes damage to organs through prolonged or repeated exposure.
H410/M=10 Very toxic to aquatic life with long lasting effects.(M=10)
R22 Harmful if swallowed.
R40 Limited evidence of a carcinogenic effect.
R48/25 Toxic: danger of serious damage to health by prolonged exposure ifswallowed.
R53 May cause long-term adverse effects in the aquatic environment.R60 May impair fertility.
R63 Possible risk of harm to the unborn child.R64 May cause harm to breastfed babies.
T Toxic
Recommended Restrictions for Use:
Not available
SDS preparation information
Prepared by Research and Development Environment, Health and Safety 1-732-227-7380
Prepared on 04.04.2013 DD/MM/YYYYThis Safety Data Sheet has been revised. This data sheet contains changes from the
previous version in section(s): 1, 11, 12, and 16.
Other information
HMIS Health 1*
Flammability 1
Reactivity Not Determined (ND)
Personal protective equipment Not Determined (ND)
NFPA
Health 1
Fire 1
Reactivity ND
Special ND1
1
ND
ND
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Country- Specific Emergency
Phone Numbers
The information contained in this SDS is believed to be accurate and represents the best information reasonably
available at the time of preparation. However, we make no warranty, express or implied, with respect to such
information. and we assume no liability from its use. Refer to NFPA 654, Standard for the Prevention of Fire andDust Explosions from the Manufacturing, Processing, and Handling of Combustible Particle Solids, for safe handling.
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Safety Data Sheet
1. PRODUCT AND COMPANY IDENTIFICATION
Product InformationProduct name ABILIFY 2, 5, 10, 15, 20 and 30 mg Tablets - Bulk
Version 1.0, 05.02.2010
Jurisdiction This Safety Data Sheet was prepared for the European Union (EU).
Active substance Aripiprazole
Synonyms Abilify; Abiligize; Abilitat; Otsuka Abilify, Aripiprazole
Intended Uses This material is a bulk drug product.
Registration Number: Not available
Company/Undertaking Identification
Address Swords LaboratoriesWatery Lane
Swords
Ireland
353-1813-9456
E-mail: [email protected]
Emergency Phone
NumberIn the EU, call 353-1813-9456.
2. HAZARDS IDENTIFICATIONEmergency Overview
EU Globally Harmonized System (GHS) EC Reg # 1272/2008
Classification Carcinogenicity - Category 2Toxic To Reproduction - Male Reproductive Toxicity - Category 1A
Toxic To Reproduction - Female Reproductive Toxicity - Category 1A
Toxic To Reproduction - Developmental Toxicity - Category 2Effects on or via lactation
Specific Target Organ Systemic Toxicity (Repeated Exposure) - Category
1
Labeling
Symbol
Signal Word Danger
Hazard Statements Suspected of causing cancer.
May damage fertility or the unborn child(male reproductive toxicity,
female reproductive toxicity) .
Suspected of damaging fertility or the unborn child(Developmental
Toxicity) .May cause harm to breast-fed children.
Causes damage to organs (central nervous system, cardiovascular system,
endocrine system) through prolonged or repeated exposure.
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2. HAZARDS IDENTIFICATION
Precautionary Statements Do not breathe dust/fume/gas/mist/vapours/spray. Obtain special
instructions before use. Do not handle until all safety precautions have
been read and understood. Avoid contact during pregnancy/while nursing.
Wash thoroughly after handling. Do not eat, drink or smoke when using
this product. Use personal protective equipment as required. Store locked
up.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Components Concentration CAS-No.
EINECS/ELINCS
/RegistrationNumber
Symbol(s) R-phrase(s)
Hazardous components
Aripiprazole 2 - 16 % 129722-12-9 -- T R22, R40,
R48/22,
R60, R63,
R64, R53
Corn Starch < 15 % 9005-25-8 232-679-6 -- --
Microcrystalline Cellulose < 15 % 9004-34-6 232-674-9 Xi R37Other ingredients
Magnesium Stearate < 1% 557-04-0 209-150-3 -- --
Red Iron Oxide 0 - < 0.1% 1309-37-1 215-168-2 -- --
Non-Hazardous Ingredients < 80% Not available -- -- --
See section 16 for R-Phrase text.
4. FIRST AID MEASURES
Eye contact IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing. If eye irritation persists, get medicaladvice/attention.
Skin contact Take off contaminated clothing and shoes immediately. Wash off immediately with
plenty of water for at least 15 minutes. If skin irritation occurs, get medicaladvice/attention.
Inhalation IF exposed or concerned: Get medical attention/advice.
Ingestion IF exposed or concerned: Get medical attention/advice.
Notes to Physician This product has been reported to interact with the following medications: drugs that
inhibit cytochrome P-450, cardiovascular agents, anti-psychotic drugs, and, alcohol.
Refer to Section 11. Pregnant or nursing women should avoid exposure.
Medical Surveillance A pre-placement physical examination and history for employees with potentialexposure to this compound is recommended. Baseline testing would include: a
complete blood count with differential, a blood test for kidney function. Based on
opportunity for exposure and duration of exposure a periodic follow-up examination
may be considered. This exam should be overseen by a physician thoroughlyknowledgeable about both the toxicity of this compound and the extent of work place
exposure. It is recommended that the content be similar to the pre-placement exam.
Employees who are pregnant, are breast-feeding, or who are concerned with other
reproductive issues should be encouraged to consult with the occupational health
physician monitoring worker's health.
Other information Precautionary risk management may be different from the exposure categories in the
annex.
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5. FIRE-FIGHTING MEASURES
Flammable Properties Not available
Extinguishing Media Suitable extinguishing media: Dry chemical, Water spray, Foam
Unsuitable extinguishing media: Do NOT use water jet.
Protection of Firefighters Specific hazards: Respiratory Irritant Developmental Toxicity
Protective equipment: Use personal protective equipment. In the event of fire, wearself-contained breathing apparatus.
Hazardous Combustion Products: carbon oxides(COx), nitrogen oxides (NOx), and,
gaseous hydrogen chloride (HCl).
Further Information: HCl gas can form flammable or explosive mixtures with
alcohols or metals. In the event of fire and/or explosion do not breathe fumes.
Other information Decontaminate protective clothing and equipment before reuse.
6. ACCIDENTAL RELEASE MEASURES
Personal precautions Refer to protective measures listed in sections 7 and 8. Use personal protective
equipment. Examples include tightly fitting safety goggles, lab coat and impervious
gloves. Wear respiratory protection. Depending on the nature of the spill (quantity and
extent of spill) additional protective clothing and equipment such as a self-contained
breathing apparatus may be needed.
Environmental
precautions
Prevent release to drains and waterways. Prevent release to the environment.
Containment Methods Wet down any dust to prevent generation of aerosols, if appropriate. Cover with
suitable material.
Cleanup Methods Contain and collect spillage and place in container for disposal according to localregulations (see Section 13). Use a HEPA vacuum or moisten materials to minimize
dust generation during pick-up. Clean area with detergent and water after spill pick-up,if appropriate. Handle waste materials, including gloves, protective clothing,
contaminated spill cleanup material, etc., as appropriate for chemically and
pharmacologically similar materials.
7. HANDLING AND STORAGE
Handling Precautions Avoid exposure - obtain special instructions before use. Avoid formation of dust andaerosols. Keep away from heat and sources of ignition. Prevent release to drains and
waterways.
Container
Requirements
Store in sturdy containers appropriate to maintain the integrity of this material for its
intended use.
Storage Conditions Store at 25C Protect against light. Keep away from heat, sparks and flames.
Specific use(s) Refer to Section 1
8. EXPOSURE CONTROLS / PERSONAL PROTECTIONExposure limit(s) Company
Guideline
ACGIH Germany OEL UK MEL
Aripiprazole 20 g/m3 -- -- --
Corn Starch -- 10 mg/m3 TWA -- --
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8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Microcrystalline
Cellulose
-- 10 mg/m3 TWA -- --
Magnesium Stearate -- 10 mg/m3 TWA -- --
Red Iron Oxide -- 5 mg/m3 TWA
dust and
fume, as Fe
1 mg/m3 TWA
as Fe
6 mg/m3 TWA
respirable
fraction
1.5 mg/m3 MAK
respirable
fraction
10 mg/m3 STEL
fume, as Fe
2 mg/m3 STEL
as Fe
5 mg/m3 TWA
fume, as Fe1 mg/m3 TWA
as Fe
Corn Starch Occupational Exposure Limits have been established by:
- Belgium - Switzerland - Czech Republic - Spain - Greece - Ireland - Portugal
Microcrystalline
Cellulose
Occupational Exposure Limits have been established by:
- Belgium - Switzerland - Estonia - Spain - France - Ireland - Portugal
Magnesium Stearate Occupational Exposure Limits have been established by:
- Belgium - Spain - Ireland - Portugal - Sweden
Red Iron Oxide Occupational Exposure Limits have been established by:
- Austria - Belgium - Switzerland - Czech Republic - Denmark - Estonia - Spain -Finland - France - Greece - Hungary - Ireland - The Netherlands - Norway - Poland
- Portugal - Sweden
Exposure Control Band Aripiprazole
3-- The established company exposure guideline falls within Exposure
Control Band 3 (range 10-
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8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Engineering Controls and
Ventilation
Use process enclosures, containment technology, or other engineering
controls to keep airborne levels below recommended exposure limit.
When handling quantities up to 15 milligrams, a standard laboratory withgeneral laboratory dilution ventilation (e.g. 6-12 air changes per hour) is
appropriate. When handling quantities from 15 milligrams to 1 kilogram,
work in a standard laboratory using a fume hood, biological safety
cabinet(Class II, all types), or approved vented enclosure. Quantities
exceeding 1 kilogram should be handled in a designated laboratory. A
laminar flow/powder containment booth is recommended for handling >1
kilograms of active substance. For manufacturing and pilot plantoperations, use direct coupling and closed transfer systems for all bulk
transfers. Use dust tight valves as appropriate. HEPA filtration of local
exhaust ventilation (LEV) is required.
Respiratory protection Use and selection of respiratory protection is based upon engineering
controls in use and potential for aerosol generation. When engineering
controls are not sufficient control exposure, wear an approved respirator
with NIOSH Class 100 or high efficiency particulate (HEPA) filters or
cartridges (EN 140/EN 136) when exposures are up to 10 times theexposure control guideline. Wear a loose-fitting (Tyvek or helmet type)
HEPA powered-air purifying respirator (PAPR) (EN 12941) when
exposures are 10-25 times the exposure control guideline. Wear a full
facepiece negative pressure respirator with Class 100 or HEPA filters (EN136) when exposures are 25-50 times the exposure control guideline.
Wear a tight-fitting, full facepiece HEPA PAPR (EN 12942) when
exposures are 50-100 times the exposure control guideline. Wear a hood-
shroud HEPA PAPR (EN 12941) or full facepiece supplied air respirator
(EN 139) operated in a pressure demand or other positive pressure mode
when exposures are 100-1000 times the exposure control guideline.
Eye protection Safety glasses with side-shields are recommended (EN 166). Face
shields or chemical safety goggles (EN 166) may be required if splash
potential exists or if corrosive materials are present. Note: Choice of eyeprotection may be influenced by the type of respirator which is selected.
Hand protection Impervious nitrile, rubber and latex gloves are recommended (EN 420, EN374). If material is handled in solution, the solvent should also be
considered when selecting protective clothing material. Please note that
employees who are allergic to natural rubber latex should use nitrile
gloves.
Skin and body protection Wear a laboratory coat (EN 340) when handling quantities up to 1
kilogram. For quantities over 1 kilogram, wear laboratory coat(EN
340)or coverall of low permeability (EN 1149-1). For manufacturing
operations, wear coverall of low permeability (EN 465/1149-1). For
manufacturing operations, wear coverall of low permeability (EN 1149-1).
Hygiene Wash hands and face before breaks and immediately after handling theproduct.
Environmental exposure controls Prevent release to drains and waterways.
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9. PHYSICAL AND CHEMICAL PROPERTIES
General Information
Appearance
Physical State solid
Color green blue pink yellow or whiteForm tablet
Odour
Odour Not available
Odor Threshold Not available
pH Not available
Other information
Bulk density Not available
Evaporation rate Not available
Molecular formula Not applicable
Hydrolysis/Photolysis Not available
Hygroscopicity Not availableMolecular Weight Not available
Log Octanol/Water Partition
Coeff [log Kow]
Not available
Surface Tension Not available
pKa Not available
Particle Size Not availableSolubility, Water Not available
Specific Gravity/ Relative
density
Not available
Viscosity, dynamic Not available
Viscosity, kinematic Not available
% Volatile Not available
Thermal/Stability propertiesAutoignition temperature Not available
Boiling Point Not available
Thermal decomposition Not available
Explosive Limits, LEL Not availableExplosive limits, UEL Not available
Explosiveness Not available
Flammability Not availableFlash point Not available
Melting Point Not available
Oxidizing Potential Not available
Vapor Properties
Vapor Density Not available
Vapor Pressure Not availableSaturated Vapor Concentration Not available
10. STABILITY AND REACTIVITY
Stability
Chemical Stability Stable under normal conditions.
Conditions to avoid Not available
Materials to avoid Not available
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10. STABILITY AND REACTIVITY
Hazardous decomposition
products
Hazardous decomposition products formed under fire conditions.: carbon
oxides(COx), nitrogen oxides (NOx), and, gaseous hydrogen chloride
(HCl).
Hazardous reactions None known.
Sensitivity to static discharge/Dust exp.
Summary Statements Although material has not been specifically tested, fine dust suspended in
air in sufficient concentration and in the presence of an ignition source
may pose a potential explosion hazard. Provide appropriate bonding and
grounding protection to control static charge. Powder handling equipmentsuch as dust collectors, dryers, and mills may require additional protective
measures (e.g. explosion venting, inerting, etc.).
11. TOXICOLOGICAL INFORMATION
Routes of Entry Ingestion, Inhalation, Eye contact, Skin contact
Eye Irritation AripiprazoleNot irritating to eyes.
Microcrystalline Cellulose
Mildly irritating to eyes.
Skin Irritation Aripiprazole
Not irritating to skin.Microcrystalline Cellulose
Not irritating to skin.
Respiratory Irritation Microcrystalline Cellulose
Respiratory Irritant
Sensitization Aripiprazole
Not a dermal sensitizer in an experimental study
Microcrystalline CelluloseNot a dermal sensitizer
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11. TOXICOLOGICAL INFORMATION
Acute Toxicity Study Acute OralAripiprazole
LD50 (rat, females): 705 mg/kg High exposure effects include: CNS depression, tremors,
uncontrolled muscle movements.
LD50 (rat, males): 953 mg/kg
LD50 (monkey, males and females): > 2,000 mg/kg High exposure effects include: CNS
depression, tremors, uncontrolled muscle movements.
Microcrystalline CelluloseLD50 (rat, males and females): > 5,000 mg/kg
Acute DermalMicrocrystalline Cellulose
LD50 (rat, males and females): > 2,000 mg/kg
Acute inhalation toxicityMicrocrystalline Cellulose
LC50 (rat, males and females): > 5350 mg/m3/4 H
Acute toxicity (other routes of administration)Aripiprazole
LD50 (dog, males and females, intramuscular): > 400 mg/kg
LD50 (dog, intramuscular, 7 Weeks): > 400 mg/kg
Microcrystalline Cellulose
LD50 (rat, males, Intraperitoneal): > 3,160 mg/kg
Repeated Dose Toxicity Aripiprazole
4 weeks - 2 years Oral (daily) mouse, rat, monkey study with recovery period (13 weeks):
NOAEL = 0.5 mg/kg (males and females). Low dose effects include: decreased
responsiveness, decreased motor activity, drooping eyelids, muscle rigidity, tremors,hyperactivity, behavioral changes, abnormal posture, clinical signs, body weight
changes, decreased food consumption, bile changes, gall stones, fecal changes,
changes in clinical chemistry parameters, adrenal hormone changes, increased
prolactin, altered estrous cycling, overt toxicity, decreased organ weights included:,
liver, uterus/cervix. Low dose microscopic effects include:mammary gland, ovary,
pituitary gland, lungs, vagina, salivary gland, eyes. After recovery, most parametersreturned to normal.
Genetic Toxicity Aripiprazole
in vitroAmes reverse-mutation assay -- negative
Chromosome aberration test in vitro -- positiveDNA repair assay -- negative
Forward gene mutation assay -- negative
in vivoOral, Mutagenicity (micronucleus test) (mouse) -- negative
Oral, Unscheduled DNA synthesis assay (rat) -- negative
Microcrystalline Cellulose
Mutagenicity AssessmentThis material was negative in a battery of in vivo and in vitro genotoxicity assays.
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11. TOXICOLOGICAL INFORMATION
Carcinogenicity Aripiprazole
2 Years Dietary (daily) mouse study : Tumor NOAEL = 1 mg/kg (males and females).
[tumor organs: pituitary gland, mammary gland] No treatment-related tumors were
observed in males.
2 Years Dietary (daily) rat study : Tumor NOAEL = 3 mg/kg (males and females).
[tumor organs: mammary gland] No treatment-related tumors were observed in
males.
Microcrystalline CelluloseCarcinogenicity AssessmentThis material did not show carcinogenic potential in animal studies. Not classifiable as toits carcinogenicity to humans.
Carcinogenicity ACGIH IARC NTP
Aripiprazole -- -- --
Microcrystalline
Cellulose
-- -- --
Reproductive Toxicity Aripiprazole
Oral (daily) Study of Fertility and Early Embryonic Development (rat) (parent, males andfemales) LOAEL = 2 mg/kg Effects include: increased body weight, increase in
food consumption, altered estrous cycling, ovarian changes, preimplantation loss,
delayed time to successful copulation. Fetal effects include: decreased body weight.
Oral (daily) Reproductive and developmental study (rat) (parent, males) NOAEL = 20
mg/kg Effects include: impaired spermatogenesis, atrophy of the male reproductive
organs.
Assessment Reproductive ToxicityAnimal studies indicate that reproductive effects can occur.
Microcrystalline Cellulose
Assessment Reproductive ToxicityData indicate that this compound is not a reproductive hazard.
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11. TOXICOLOGICAL INFORMATION
Developmental Toxicity Aripiprazole
Study of Embryo-Fetal Development (rat)
(parent, females) NOAEL = 3 mg/kg/day
(F1 offspring) NOAEL = 3 mg/kg/day
Offspring effects include: decreased body weight, changes in skeletal development,
changes in sexual development. Maternal effects include: central nervous system
effects, decreased weight gain, decreased food consumption, delayed delivery.
Adverse effects on the offspring occur only at doses that also cause maternal effects.
Study of Embryo-Fetal Development (rabbit)(parent, females) LOAEL = 10 mg/kg/day
(embryo/fetus) NOAEL = 10 mg/kg/day
Fetal effects include: decreased body weight, changes in skeletal development.Maternal effects include: decreased food consumption, decreased body weight,
postimplantation loss.
Oral Study of Pre- and Postnatal Development (rat)
(parent, females) NOAEL = 10 mg/kg/day
(F1 offspring) NOAEL = 10 mg/kg/day
Fetal effects include: death. Offspring effects include: decreased viability, decreased
body weight. Maternal effects include: decreased weight gain, decreased foodconsumption, lactation effects.
Developmental Toxicity AssessmentSeveral studies were conducted. Compound produced effects on the fetus at doses similar
to those which produced effects on the maternal animal. This compound and/or its
metabolites may be excreted into the milk. Compounds in this drug class have adverseeffects on reproduction.
Microcrystalline Cellulose
Developmental Toxicity AssessmentAvailable data do not indicate a potential for selective developmental toxicity.
Human experience Experiences with Human ExposureAripiprazole
General effects Low exposure - acute effects include: headache, nausea, vomiting,
constipation, incontinence, sleepiness, dizziness, weakness, restlessness,
tremors, abnormal coordination, anxiety, irritability, agitation, behavioral
changes, sweating, breathing difficulties, salivation, lightheadedness,
disorganized thought, suicidal thoughts, fever, uncontrolled muscle movements,muscle rigidity, convulsions, difficulty swallowing, pain, swelling, cough,
congestion, blurred vision, changes in blood pressure, cardiac irregularities,
changes in clinical chemistry parameters, increased weight gain. Low exposure -
long term exposure effects include: increased prolactin, reproductive function
changes, degeneration of skeletal muscle, kidney failure, hyperglycemia,hepatitis.
Acute Overdose Low exposure - acute effects include: vomiting, sleepiness,dizziness, tremors, uncontrolled muscle movements, difficulty swallowing,
behavioral changes, confusion, agitation, electrolyte disturbance, changes in
clinical chemistry parameters, cardiac irregularities, changes in blood pressure,
headache, skin sensation changes, unconsciousness, convulsions, respiratory
arrest, coma.
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11. TOXICOLOGICAL INFORMATION
Target Organs Aripiprazole
central nervous system, cardiovascular system, endocrine system
Symptoms Aripiprazole
See "Human Experience".Microcrystalline Cellulose
labored respiration, noisy respiration, chest pain, breathing difficulties, shortness of breath,
lung inflammation
Pharmacokinetics/Toxic
okinetics
Aripiprazole
Absorption: Not available
Distribution: Not available
Metabolism: Not available
Elimination: Half-life = 75 hours (Human).
Other Toxicity
Information
Not available
12. ECOLOGICAL INFORMATIONEcotoxicity effects
Acute Toxicity to FishAripiprazole
LC50 (Oncorhynchus mykiss (rainbow trout), 96 H) : > 0.12 mg/l. (highest mean concentrationtested)
NOEC (Oncorhynchus mykiss (rainbow trout), 96 H) : 0.047 mg/l.
Acute Toxicity to Aquatic Invertebrates
Aripiprazole
NOEC (Daphnia magna (Water flea), 48 H) : 0.031 mg/l.
Toxicity to aquatic plants
AripiprazoleEC50 (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae biomass and
growth rate, 72 H) : > 0.14 mg/l (highest mean concentration tested)
NOEC (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae biomass, 72
H) : 0.026 mg/lNOEC (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae growth rate,
72 H) : 0.14 mg/l
Toxicity to microorganisms
Aripiprazole
Respiration inhibition, EC50 (Activated Sludge, 3 H) : > 1,000 mg/l
Chronic toxicity to fish
AripiprazoleEarly-life Stage NOEC (Pimephales promelas (fathead minnow)) : 0.0058 mg/l
Chronic toxicity to aquatic invertabrates
AripiprazoleNOEC (Daphnia magna (Water flea)) : 0.00261 mg/l (reproduction rate)
Mobility Not available
Persistence and degradabilityBiodegradation
Aripiprazole
Ready biodegradation (42 D) : 10 % ; Not Readily Biodegradable - unlikely to undergo rapid
biodegradation in the environment
Aripiprazole
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12. ECOLOGICAL INFORMATIONKoc (Batch equilibrium, Activated Sludge) : 10,270 (water)
Kd (Batch equilibrium, Activated Sludge) : 2,783 (water)immobile
Koc (Batch equilibrium, Activated Sludge) : 2,850 (calcium chloride solution)
Kd (Batch equilibrium, Activated Sludge) : 772 (calcium chloride solution)
immobile
Summary Statements
Aquatic toxicityAripiprazole
Experimental data indicate low potential for acute harm to aquatic organisms.
Chemical FateAripiprazole
Not readily biodegradable. Immobile in soil.
PBT and vPvB Assessment: Not available
13. DISPOSAL CONSIDERATIONS
Advice On Disposal And Packaging Disposal should be in accordance with applicable regional, national and
local laws and regulations. Local regulations may be more stringent than
regional or national requirements. This information presented onlyapplies to the material as supplied.
Other information Disposal by incineration is recommended.
14. TRANSPORT INFORMATIONThis material is not a dangerous good for the purpose of transportation.
15. REGULATORY INFORMATION
EINECS/ELINCS/RegistrationNumber
Corn Starch: 232-679-6Microcrystalline Cellulose: 232-674-9
Magnesium Stearate: 209-150-3
FD&C Blue No. 2 Aluminum Lake: 240-589-3
Yellow Iron Oxide: 257-098-5
Red Iron Oxide: 215-168-2
EU Globally Harmonized System (GHS) EC Reg # 1272/2008
Classification Carcinogenicity - Category 2
Toxic To Reproduction - Male Reproductive Toxicity - Category 1A
Toxic To Reproduction - Female Reproductive Toxicity - Category 1A
Toxic To Reproduction - Developmental Toxicity - Category 2
Effects on or via lactation
Specific Target Organ Systemic Toxicity (Repeated Exposure) - Category
1
Labeling
Symbol
Signal Word Danger
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15. REGULATORY INFORMATION
Hazard Statements Suspected of causing cancer.
May damage fertility or the unborn child(male reproductive toxicity,
female reproductive toxicity) .
Suspected of damaging fertility or the unborn child(DevelopmentalToxicity) .
May cause harm to breast-fed children.Causes damage to organs (central nervous system, cardiovascular system,
endocrine system) through prolonged or repeated exposure.
Precautionary Statements Do not breathe dust/fume/gas/mist/vapours/spray. Obtain special
instructions before use. Do not handle until all safety precautions have
been read and understood. Avoid contact during pregnancy/while
nursing. Wash thoroughly after handling. Do not eat, drink or smoke
when using this product. Use personal protective equipment as required.Store locked up.
R&S Labeling
Symbol(s) T: Toxic
R-phrase(s) R40: Limited evidence of a carcinogenic effect.R48/22: Harmful: danger of serious damage to health by prolonged
exposure if swallowed.
R60: May impair fertility.
R63: Possible risk of harm to the unborn child.
R64: May cause harm to breastfed babies.
S-phrase(s) S22: Do not breathe dust.
S36/37/39: Wear suitable protective clothing, gloves and eye/face
protection.S38: In case of insufficient ventilation, wear suitable respiratory
equipment.
S45: In case of accident or if you feel unwell, seek medical adviceimmediately (show label where possible).
S53: Avoid exposure - obtain special instructions before use.
Regulatory Authorizations and
Restrictions:
Not available
UN Globally Harmonized System (GHS)
Classification Acute Toxicity - Oral - Category 5
Mild Eye Irritation - Category 2B
Carcinogenicity - Category 2
Toxic To Reproduction - Male Reproductive Toxicity - Category 1A
Toxic To Reproduction - Female Reproductive Toxicity - Category 1AToxic To Reproduction - Developmental Toxicity - Category 2
Effects On Or Via Lactation
Specific Target Organ Systemic Toxicity (Repeated Exposure) - Category
1Hazardous To The Aquatic Environment - Chronic Hazard - Category 1
Labeling
Symbol
Signal Word Danger
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15. REGULATORY INFORMATION
Hazard Statements May be harmful if swallowed.
Causes eye irritation.
Suspected of causing cancer.
May damage fertility or the unborn child (male reproductive toxicity,female reproductive toxicity) .
Suspected of damaging fertility or the unborn child (DevelopmentalToxicity) .
May cause harm to breast-fed children.
Causes damage to organs (central nervous system, cardiovascular system,endocrine system) through prolonged or repeated exposure.
Very toxic to aquatic life with long lasting effects.
Precautionary Statements Refer to HAZARDS IDENTIFICATION section.
16. OTHER INFORMATIONText of R phrases mentioned in Section 3
R22: Harmful if swallowed.
R40: Limited evidence of a carcinogenic effect.R48/22: Harmful: danger of serious damage to health by prolongedexposure if swallowed.
R60: May impair fertility.
R63: Possible risk of harm to the unborn child.
R64: May cause harm to breastfed babies.
R53: May cause long-term adverse effects in the aquatic environment.
R37: Irritating to respiratory system.
Recommended Restrictions for Use:Not available
MSDS preparation information
Prepared by Research and Development Pharmaceutical Quality and Environment,Health and Safety 1-732-227-7380
Prepared on 05.02.2010
This is the first EU Safety Data Sheet issued for this material.
The information contained in this MSDS is believed to be accurate and represents the best information
reasonably available at the time of preparation. However, we make no warranty, express or implied, with respect
to such information. and we assume no liability from its use.
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Continued
Material Safety Data Sheet
1. PRODUCT AND COMPANY IDENTIFICATION
Product InformationProduct name ABILIFY 2, 5, 10, 15, 20 and 30 mg Tablets - Bulk
Version 1.0, 02/05/2010
Jurisdiction This Material Safety Data Sheet was prepared for the jurisdiction USA.
Active substance Aripiprazole
Synonyms Abilify; Abiligize; Abilitat; Otsuka Abilify, Aripiprazole
Intended Uses This material is a bulk drug product.
Company/Undertaking Identification
Address Bristol-Myers Squibb CompanyP.O. Box 191
New Brunswick, New Jersey 08903United States of America
1-732-227-7380
Emergency Phone
Number
CHEMTREC 1-800-424-9300. For all international transportation emergencies call
CHEMTREC at 1-703-527-3887. Collect calls accepted.
2. COMPOSITION/INFORMATION ON INGREDIENTS
Components Concentration CAS-No.
Hazardous components
Aripiprazole 2 - 16% 129722-12-9
Corn Starch
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Continued
3. HAZARDS IDENTIFICATION
Precautionary Measures Do not breathe dust/fume/gas/mist/vapours/spray. Obtain special
instructions before use. Do not handle until all safety precautions have
been read and understood. Avoid contact during pregnancy/while
nursing. Wash thoroughly after handling. Do not eat, drink or smoke
when using this product. Use personal protective equipment as required.
Store locked up.
Potential Health Effects
Eyes Possible mild eye irritant
Skin Experimental data indicate that this material has low potential to cause
skin reactions.
Ingestion Causes damage to organs through prolonged or repeated exposure.
Inhalation May cause respiratory irritation.
Target Organs central nervous system, cardiovascular system, endocrine system
Signs and Symptoms Refer to Section 11.
Medical Conditions Aggravated
Include:
depression, diabetes, cardiovascular disease, decreased white blood cell
count, kidney disorders
Environmental Effects Very toxic to aquatic life with long lasting effects. Refer to Section 12
4. FIRST AID MEASURES
Eye contact IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing. If eye irritation persists, get medical
advice/attention.
Skin contact Take off contaminated clothing and shoes immediately. Wash off immediately with
plenty of water for at least 15 minutes. If skin irritation occurs, get medical
advice/attention.
Inhalation IF exposed or concerned: Get medical attention/advice.
Ingestion IF exposed or concerned: Get medical attention/advice.
Notes to Physician This product has been reported to interact with the following medications: drugs that
inhibit cytochrome P-450, cardiovascular agents, anti-psychotic drugs, and, alcohol.Refer to Section 11. Pregnant or nursing women should avoid exposure.
Medical Surveillance A pre-placement physical examination and history for employees with potential
exposure to this compound is recommended. Baseline testing would include: acomplete blood count with differential, a blood test for kidney function. Based onopportunity for exposure and duration of exposure a periodic follow-up examination
may be considered. This exam should be overseen by a physician thoroughlyknowledgeable about both the toxicity of this compound and the extent of work place
exposure. It is recommended that the content be similar to the pre-placement exam.
Employees who are pregnant, are breast-feeding, or who are concerned with otherreproductive issues should be encouraged to consult with the occupational health
physician monitoring worker's health.
5. FIRE-FIGHTING MEASURES
Flammable Properties Not available
Extinguishing Media Suitable extinguishing media: Dry chemical, Water spray, Foam
Unsuitable extinguishing media: Do NOT use water jet.
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5. FIRE-FIGHTING MEASURES
Protection of Firefighters Specific hazards: Respiratory Irritant Developmental Toxicity
Protective equipment: Use personal protective equipment. In the event of fire, wear
self-contained breathing apparatus.Hazardous Combustion Products: carbon oxides(COx), nitrogen oxides (NOx), and,
gaseous hydrogen chloride (HCl).
Further Information: HCl gas can form flammable or explosive mixtures with
alcohols or metals. In the event of fire and/or explosion do not breathe fumes.
Other information: Decontaminate protective clothing and equipment before reuse.
6. ACCIDENTAL RELEASE MEASURES
Personal precautions Refer to protective measures listed in sections 7 and 8. Use personal protective
equipment. Examples include tightly fitting safety goggles, lab coat and imperviousgloves. Wear respiratory protection. Depending on the nature of the spill (quantity andextent of spill) additional protective clothing and equipment such as a self-contained
breathing apparatus may be needed.
Environmental
precautions
Prevent release to drains and waterways. Prevent release to the environment.
Containment Methods Wet down any dust to prevent generation of aerosols, if appropriate. Cover with
suitable material.
Cleanup Methods Contain and collect spillage and place in container for disposal according to local
regulations (see Section 13). Use a HEPA vacuum or moisten materials to minimize
dust generation during pick-up. Clean area with detergent and water after spill pick-up,
if appropriate. Handle waste materials, including gloves, protective clothing,
contaminated spill cleanup material, etc., as appropriate for chemically and
pharmacologically similar materials.
7. HANDLING AND STORAGE
Handling Precautions Avoid exposure - obtain special instructions before use. Avoid formation of dust andaerosols. Keep away from heat and sources of ignition. Prevent release to drains and
waterways.
Storage Conditions Store at 25C Protect against light. Keep away from heat, sparks and flames.
Container
Requirements
Store in sturdy containers appropriate to maintain the integrity of this material for its
intended use.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure limit(s) Company
Guideline
ACGIH OSHA NIOSH
Aripiprazole 20 g/m3 -- -- --
Corn Starch -- 10 mg/m3 TWA 15 mg/m3 TWAtotal
5 mg/m3 TWA
10 mg/m3 TWA5 mg/m3 TWA
Microcrystalline
Cellulose
-- 10 mg/m3 TWA 15 mg/m3 TWA
total
5 mg/m3 TWA
10 mg/m3 TWA
5 mg/m3 TWA
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8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Magnesium Stearate -- 10 mg/m3 TWA -- --
Red Iron Oxide -- 5 mg/m3 TWA
dust and fume,
as Fe1 mg/m3 TWA
as Fe
10 mg/m3 TWA 2,500 mg/m3
IDLH
dust and fume,as Fe
5 mg/m3 TWA
dust and fume,
as Fe1 mg/m3 TWA
as Fe
Exposure Control Band Aripiprazole
3-- The established company exposure guideline falls within Exposure
Control Band 3 (range 10-1
kilograms of active substance. For manufacturing and pilot plant
operations, use direct coupling and closed transfer systems for all bulk
transfers. Use dust tight valves as appropriate. HEPA filtration of local
exhaust ventilation (LEV) is required.
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8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Respiratory protection Use and selection of respiratory protection is based upon engineering
controls in use and potential for aerosol generation. When engineering
controls are not sufficient to control exposure, wear an approvedrespirator with NIOSH Class 100 or high efficiency particulate (HEPA)
filters or cartridges when exposures are up to 10 times the exposure
control guideline. Wear a loose-fitting (Tyvek or helmet type) HEPA
powered-air purifying respirator (PAPR) when exposures are 10-25 times
the exposure control guideline. Wear a full facepiece negative pressure
respirator with Class 100 or HEPA filters when exposures are 25-50 times
the exposure control guideline. Wear a tight-fitting, full facepiece HEPAPAPR when exposures are 50-100 times the exposure control guideline.
Wear a hood-shroud HEPA PAPR or full facepiece supplied air respirator
operated in a pressure demand or other positive pressure mode when
exposures are 100-1000 times the exposure control guideline.
Eye protection Safety glasses with side-shields are recommended. Face shields or
chemical safety goggles may be required if splash potential exists or if
corrosive materials are present. Note: Choice of eye protection may be
influenced by the type of respirator which is selected.Hand protection Impervious nitrile, rubber and latex gloves are recommended. If material
is handled in solution, the solvent should also be considered when
selecting protective clothing material. Please note that employees who areallergic to natural rubber latex should use nitrile gloves.
Skin and body protection Wear a laboratory coat when handling quantities up to 1 kilogram. For
quantities over 1 kilogram, wear laboratory coat or coverall of low
permeability. For manufacturing operations, wear coverall of low
permeability.
Hygiene Wash hands and face before breaks and immediately after handling the
product.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Physical State solid
Color green blue pink yellow or white
Form tablet
Other information
Molecular Weight Not available
Molecular formula Not applicable
Bulk density Not available
Evaporation rate Not available
Hydrolysis/Photolysis Not available
Hygroscopicity Not availableLog Octanol/Water Partition
Coeff [log Kow]
Not available
Surface Tension Not available
Odor Not available
Odor Threshold Not available
pH Not available
pKa Not available
Particle Size Not available
Solubility, Water Not available
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9. PHYSICAL AND CHEMICAL PROPERTIES
Specific Gravity/ Relative
density
Not available
Viscosity Not available
Thermal/Stability properties
Autoignition temperature Not availableBoiling Point Not available
Thermal decomposition Not available
Explosive Limits, LEL Not available
Explosive limits, UEL Not available
Explosiveness Not available
Flammability Not available
Flash point Not available
Melting Point Not available
Oxidizing Potential Not available
Vapor Properties
Vapor Density Not available
Vapor Pressure Not availableSaturated Vapor Concentration Not available
10. STABILITY AND REACTIVITY
Stability
Chemical Stability Stable under normal conditions.
Conditions to avoid Not available
Incompatible products Not available
Hazardous decomposition
productsHazardous decomposition products formed under fire conditions.: carbon
oxides(COx), nitrogen oxides (NOx), and, gaseous hydrogen chloride
(HCl).
Hazardous reactions None known.
Sensitivity to static discharge/Dust exp.
Summary Statements Although material has not been specifically tested, fine dust suspended in
air in sufficient concentration and in the presence of an ignition source
may pose a potential explosion hazard. Provide appropriate bonding andgrounding protection to control static charge. Powder handling equipment
such as dust collectors, dryers, and mills may require additional protective
measures (e.g. explosion venting, inerting, etc.).
11. TOXICOLOGICAL INFORMATION
Routes of Entry Ingestion, Inhalation, Eye contact, Skin contact
Eye Irritation AripiprazoleNot irritating to eyes.
Microcrystalline CelluloseMildly irritating to eyes.
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11. TOXICOLOGICAL INFORMATION
Skin Irritation Aripiprazole
Not irritating to skin.
Microcrystalline Cellulose
Not irritating to skin.
Respiratory Irritation Microcrystalline Cellulose
Respiratory Irritant
Sensitization Aripiprazole
Not a dermal sensitizer in an experimental study
Microcrystalline Cellulose
Not a dermal sensitizer
Acute Toxicity Study Acute OralAripiprazoleLD50 (rat, females): 705 mg/kg High exposure effects include: CNS depression, tremors,
uncontrolled muscle movements.
LD50 (rat, males): 953 mg/kg
LD50 (monkey, males and females): > 2,000 mg/kg High exposure effects include: CNSdepression, tremors, uncontrolled muscle movements.
Microcrystalline Cellulose
LD50 (rat, males and females): > 5,000 mg/kg
Acute Dermal
Microcrystalline CelluloseLD50 (rat, males and females): > 2,000 mg/kg
Acute inhalation toxicityMicrocrystalline Cellulose
LC50 (rat, males and females): > 5350 mg/m3/4 H
Acute toxicity (other routes of administration)Aripiprazole
LD50 (dog, males and females, intramuscular): > 400 mg/kg
LD50 (dog, intramuscular, 7 Weeks): > 400 mg/kg
Microcrystalline Cellulose
LD50 (rat, males, Intraperitoneal): > 3,160 mg/kg
Repeated Dose Toxicity Aripiprazole
4 weeks - 2 years Oral (daily) mouse, rat, monkey study with recovery period (13 weeks):
NOAEL = 0.5 mg/kg (males and females). Low dose effects include: decreased
responsiveness, decreased motor activity, drooping eyelids, muscle rigidity, tremors,
hyperactivity, behavioral changes, abnormal posture, clinical signs, body weightchanges, decreased food consumption, bile changes, gall stones, fecal changes,
changes in clinical chemistry parameters, adrenal hormone changes, increased
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11. TOXICOLOGICAL INFORMATION
prolactin, altered estrous cycling, overt toxicity, decreased organ weights included:,
liver, uterus/cervix. Low dose microscopic effects include:mammary gland, ovary,
pituitary gland, lungs, vagina, salivary gland, eyes. After recovery, most parameters
returned to normal.
Genetic Toxicity Aripiprazole
in vitroAmes reverse-mutation assay -- negativeChromosome aberration test in vitro -- positive
DNA repair assay -- negative
Forward gene mutation assay -- negative
in vivoOral, Mutagenicity (micronucleus test) (mouse) -- negative
Oral, Unscheduled DNA synthesis assay (rat) -- negative
Microcrystalline Cellulose
Mutagenicity AssessmentThis material was negative in a battery of in vivo and in vitro genotoxicity assays.
Carcinogenicity Aripiprazole2 Years Dietary (daily) mouse study : Tumor NOAEL = 1 mg/kg (males and females).
[tumor organs: pituitary gland, mammary gland] No treatment-related tumors were
observed in males.
2 Years Dietary (daily) rat study : Tumor NOAEL = 3 mg/kg (males and females).
[tumor organs: mammary gland] No treatment-related tumors were observed in
males.
Carcinogenicity AssessmentThis material has limited evidence of carcinogenic potential. These tumors are believed to
be due to a prolactin-mediated mechanism.
Microcrystalline Cellulose
Carcinogenicity AssessmentThis material did not show carcinogenic potential in animal studies. Not classifiable as to
its carcinogenicity to humans.
Carcinogenicity ACGIH OSHA NTP IARC
Aripiprazole -- -- -- --
Microcrystalline
Cellulose
-- -- -- --
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11. TOXICOLOGICAL INFORMATION
Reproductive Toxicity Aripiprazole
Oral (daily) Study of Fertility and Early Embryonic Development (rat) (parent, males and
females) LOAEL = 2 mg/kg Effects include: increased body weight, increase in
food consumption, altered estrous cycling, ovarian changes, preimplantation loss,
delayed time to successful copulation. Fetal effects include: decreased body weight.
Oral (daily) Reproductive and developmental study (rat) (parent, males) NOAEL = 20
mg/kg Effects include: impaired spermatogenesis, atrophy of the male reproductive
organs.
Assessment Reproductive ToxicityAnimal studies indicate that reproductive effects can occur.
Microcrystalline Cellulose
Assessment Reproductive ToxicityData indicate that this compound is not a reproductive hazard.
Developmental Toxicity Aripiprazole
Study of Embryo-Fetal Development (rat)
(parent, females) NOAEL = 3 mg/kg/day
(F1 offspring) NOAEL = 3 mg/kg/dayOffspring effects include: decreased body weight, changes in skeletal development,
changes in sexual development. Maternal effects include: central nervous system
effects, decreased weight gain, decreased food consumption, delayed delivery.
Adverse effects on the offspring occur only at doses that also cause maternal effects.
Study of Embryo-Fetal Development (rabbit)
(parent, females) LOAEL = 10 mg/kg/day
(embryo/fetus) NOAEL = 10 mg/kg/dayFetal effects include: decreased body weight, changes in skeletal development.
Maternal effects include: decreased food consumption, decreased body weight,
postimplantation loss.
Oral Study of Pre- and Postnatal Development (rat)
(parent, females) NOAEL = 10 mg/kg/day(F1 offspring) NOAEL = 10 mg/kg/day
Fetal effects include: death. Offspring effects include: decreased viability, decreased
body weight. Maternal effects include: decreased weight gain, decreased food
consumption, lactation effects.
Developmental Toxicity AssessmentSeveral studies were conducted. Compound produced effects on the fetus at doses similar
to those which produced effects on the maternal animal. This compound and/or itsmetabolites may be excreted into the milk. Compounds in this drug class have adverse
effects on reproduction.
Microcrystalline CelluloseDevelopmental Toxicity Assessment
Available data do not indicate a potential for selective developmental toxicity.
Human experience Experiences with Human ExposureAripiprazole
General effects Low exposure - acute effects include: headache, nausea, vomiting,
constipation, incontinence, sleepiness, dizziness, weakness, restlessness,
tremors, abnormal coordination, anxiety, irritability, agitation, behavioral
changes, sweating, breathing difficulties, salivation, lightheadedness,disorganized thought, suicidal thoughts, fever, uncontrolled muscle movements,
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11. TOXICOLOGICAL INFORMATION
muscle rigidity, convulsions, difficulty swallowing, pain, swelling, cough,
congestion, blurred vision, changes in blood pressure, cardiac irregularities,
changes in clinical chemistry parameters, increased weight gain. Low exposure -
long term exposure effects include: increased prolactin, reproductive function
changes, degeneration of skeletal muscle, kidney failure, hyperglycemia,
hepatitis.
Acute Overdose Low exposure - acute effects include: vomiting, sleepiness,
dizziness, tremors, uncontrolled muscle movements, difficulty swallowing,
behavioral changes, confusion, agitation, electrolyte disturbance, changes inclinical chemistry parameters, cardiac irregularities, changes in blood pressure,
headache, skin sensation changes, unconsciousness, convulsions, respiratory
arrest, coma.
Target Organs Aripiprazolecentral nervous system, cardiovascular system, endocrine system
Symptoms Aripiprazole
See "Human Experience".
Microcrystalline Cellulose
labored respiration, noisy respiration, chest pain, breathing difficulties, shortness of breath,
lung inflammation
Pharmacokinetics/Toxic
okinetics
Aripiprazole
Absorption: Not available
Distribution: Not available
Metabolism: Not available
Elimination: Half-life = 75 hours (Human).
Other Toxicity
Information
Not available
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12. ECOLOGICAL INFORMATIONEcotoxicological Information (Aquatic)
Acute Toxicity to FishAripiprazole
LC50 (Oncorhynchus mykiss (rainbow trout), 96 H) : > 0.12 mg/l. (highest mean concentration
tested)
NOEC (Oncorhynchus mykiss (rainbow trout), 96 H) : 0.047 mg/l.Acute Toxicity to Aquatic Invertebrates
Aripiprazole
NOEC (Daphnia magna (Water flea), 48 H) : 0.031 mg/l.
Toxicity to aquatic plantsAripiprazole
EC50 (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae biomass and
growth rate, 72 H) : > 0.14 mg/l (highest mean concentration tested)
NOEC (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae biomass, 72H) : 0.026 mg/l
NOEC (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae growth rate,
72 H) : 0.14 mg/l
Toxicity to microorganisms
Aripiprazole
Respiration inhibition, EC50 (Activated Sludge, 3 H) : > 1,000 mg/l
Chronic toxicity to fishAripiprazole
Early-life Stage NOEC (Pimephales promelas (fathead minnow)) : 0.0058 mg/l
Chronic toxicity to aquatic invertabrates
AripiprazoleNOEC (Daphnia magna (Water flea)) : 0.00261 mg/l (reproduction rate)
Ecotoxicological Information (Terrestrial) Not available
Chemical fate information
Biodegradation
Aripiprazole
Ready biodegradation (42 D) : 10 % ; Not Readily Biodegradable - unlikely to undergo rapid
biodegradation in the environmentsorption/desorption
Aripiprazole
Koc (Batch equilibrium, Activated Sludge) : 10,270 (water)
Kd (Batch equilibrium, Activated Sludge) : 2,783 (water)
immobileKoc (Batch equilibrium, Activated Sludge) : 2,850 (calcium chloride solution)
Kd (Batch equilibrium, Activated Sludge) : 772 (calcium chloride solution)
immobile
Summary Statements
Aquatic toxicityAripiprazole
Experimental data indicate low potential for acute harm to aquatic organisms.Chemical Fate
Aripiprazole
Not readily biodegradable. Immobile in soil.
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13. DISPOSAL CONSIDERATIONS
Advice On Disposal And Packaging Disposal should be in accordance with applicable regional, national and
local laws and regulations. Local regulations may be more stringent than
regional or national requirements. This information presented only
applies to the material as supplied.
Other information Disposal by incineration is recommended.
14. TRANSPORT INFORMATIONThis material is not a dangerous good for the purpose of transportation.
15. REGULATORY INFORMATIONUnited States of America
OSHA Hazard Classification Respiratory Irritant
Reproductive Toxicity
Developmental ToxicityTarget Organs
313 Toxic Release Inventory.
Listed Chemicals/Compounds
No components listed on the SARA 313 inventory.
TSCA Inventory Not listed. Food, drug and cosmetic products are exempt from TSCA.
International
Canada
WHMIS D2A: Very Toxic Material Causing Other Toxic Effects
D2B Toxic Material Causing Other Toxic Effects
DSL/NDSL Not listed.
Mexico
Mexico Classification Health classification - Moderate Hazard 2 - Substances that may cause
temporary disability or residual harm under emergency conditions
Carcinogenicity
Reproductive Toxicity
Developmental Toxicity
Europe
EINECS/ELINCS/Registra
tion Number
Corn Starch: 232-679-6
Microcrystalline Cellulose: 232-674-9
Magnesium Stearate: 209-150-3
FD&C Blue No. 2 Aluminum Lake: 240-589-3
Yellow Iron Oxide: 257-098-5
Red Iron Oxide: 215-168-2
Symbol(s) T: Toxic
R-phrase(s) R40: Limited evidence of a carcinogenic effect.
R48/22: Harmful: danger of serious damage to health by prolongedexposure if swallowed.
R60: May impair fertility.
R63: Possible risk of harm to the unborn child.
R64: May cause harm to breastfed babies.
S-phrase(s) S22: Do not breathe dust.S36/37/39: Wear suitable protective clothing, gloves and eye/face
pr