SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Section 1: Identification
Product identifier:

Alendronate / Vitamin D Formulation

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
Manufacturer or supplier's details
Company: Organon & Co.
Address:

30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302

Telephone:+1-551-430-6000

Emergency telephone number :+1-215-631-6999

E-mail address

EHSSTEWARD@organon.com:

Section 2: Hazard identification
Classification of the substance or mixture
Acute toxicity (Oral): Category 4
Skin corrosion/irritation:

Category 2

Serious eye damage/eye irritation:

Category 1

Reproductive toxicity:

Category 2

Specific target organ toxicity single exposure:

Category 3

Specific target organ toxicity repeated exposure:

Category 2 (Bone, Stomach, Kidney)

GHS Label elements, including precautionary statements
Hazard pictograms:

Signal word:

DangerHazard statements:

H302 Harmful if swallowed.
1 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

H315 Causes skin irritation.
H318 Causes serious eye damage.
H335 May cause respiratory irritation.
H361d Suspected of damaging the unborn child.
H373 May cause damage to organs (Bone, Stomach, Kidney)
through prolonged or repeated exposure.
Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P271 Use only outdoors or in a well-ventilated area.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
Response:
P301 + P312 + P330 IF SWALLOWED: Call a POISONCENTER/ doctor if you feel unwell. Rinse mouth.
P302 + P352 IF ON SKIN: Wash with plenty of water.
P304 + P340 + P312 IF INHALED: Remove person to fresh air
and keep comfortable for breathing. Call a POISON CENTER/
doctor if you feel unwell.
P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously withwater for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing. Immediately call a POISONCENTER/ doctor.
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P332 + P313 If skin irritation occurs: Get medical advice/ attention.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Other hazards which do not result in classification
May form explosive dust-air mixture during processing, handling or other means.
Section 3: Composition/information on ingredients
Substance / Mixture:

MixtureComponents
Chemical name
Cellulose
Alendronate

CAS-No.
9004-34-6
121268-17-5
2 / 18

Concentration (% w/w)>= 30 -< 50>= 20 -< 30

SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22064-00023

Colecalciferol

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

67-97-0< 0.1

Section 4: First-aid measures
Description of necessary first-aid measures
General advice: In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled: If inhaled, remove to fresh air.
Get medical attention.
In case of skin contact: In case of contact, immediately flush skin with plenty of water
for at least 15 minutes while removing contaminated clothing
and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
In case of eye contact: In case of contact, immediately flush eyes with plenty of water
for at least 15 minutes.
If easy to do, remove contact lens, if worn.
Get medical attention immediately.
If swallowed: If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Never give anything by mouth to an unconscious person.
Most important symptoms and effects, both acute and delayed
Risks: Harmful if swallowed.
Causes skin irritation.
Causes serious eye damage.
May cause respiratory irritation.
Suspected of damaging the unborn child.
May cause damage to organs through prolonged or repeatedexposure.
Protection of first-aiders: First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.
Section 5: Fire-fighting measures
Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical
None known.

3 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Special hazards arising from the substance or mixture
Specific hazards during fire- : Avoid generating dust; fine dust dispersed in air in sufficient
fighting
concentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Exposure to combustion products may be a hazard to health.
Hazardous combustion products:

Carbon oxides
Nitrogen oxides (NOx)Phosphorus compounds
Metal oxides

Special protective actions for fire-fighters
Special protective equipment : In the event of fire, wear self-contained breathing apparatus.
for firefighters
Use personal protective equipment.
Specific extinguishing meth- : Use extinguishing measures that are appropriate to local cirods
cumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
Section 6: Accidental release measures
Personal precautions, protective equipment and emergency procedures
Personal precautions: Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).
Environmental precautions
Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials for containment and cleaning up
Methods for cleaning up: Surround spill with absorbents and place a damp coveringover the area to minimise entry of the material into the air.
Add excess liquid to allow the material to enter into solution.
Soak up with inert absorbent material.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
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.
Clean up remaining materials from spill with suitable absorbent.
Local or national regulations may apply to releases and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
4 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

certain local or national requirements.
Section 7: Handling and storage
Precautions for safe handlingTechnical measures:

Local/Total ventilation:

Advice on safe handling:

Hygiene measures:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe dust.
Do not swallow.
Do not get in eyes.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Keep container tightly closed.
Already sensitised individuals, and those susceptible
to asthma, allergies, chronic or recurrent respiratory disease,should consult their physician regarding working with respiratory irritants or sensitisers.
Minimize dust generation and accumulation.
Keep container closed when not in use.
Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

Conditions for safe storage, including any incompatibilities
Conditions for safe storage: Keep in properly labelled containers.
Store locked up.
Keep tightly closed.
Keep in a cool, well-ventilated place.
Store in accordance with the particular national regulations.
Materials to avoid: Do not store with the following product types:
Strong oxidizing agents

5 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Section 8: Exposure controls/personal protection
Control parameters
Occupational Exposure Limits
Components

CAS-No.

Cellulose

9004-34-6

Alendronate

121268-17-5

Colecalciferol

67-97-0

Appropriate engineering
control measures:

Value type
(Form ofexposure)
PEL (long
term)
TWA
TWA
Wipe limit
TWA
Wipe limit

Control parameters / Permissible
concentration
10 mg/m3

Basis

10 mg/m3
20 µg/m3 (OEB 3)
200 µg/100 cm²
5 µg/m3 (OEB 4)
50 µg/100 cm²

ACGIHInternal
Internal
Internal
Internal

SG OELAll engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Containment technologies suitable for controlling compounds
are required to control at source and to prevent migration of
the compound to uncontrolled areas (e.g., open-face containment devices).
Minimize open handling.

Individual protection measures, such as personal protective equipment (PPE)
Eye/face protection: Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Skin protection: Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Filter type
: Particulates type
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Consider double gloving.

Section 9: Physical and chemical properties

6 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Appearance:

powderColour:off-white

Odour

:

odourlessOdour Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

Not applicable

Evaporation rate:

Not applicable

Flammability (solid, gas):

May form explosive dust-air mixture during processing, handling or other means.

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapour pressure:

Not applicable

Relative vapour density:

Not applicable

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Auto-ignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

7 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle characteristics
Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

Heat, flames and sparks.
Avoid dust formation.
Oxidizing agents
No hazardous decomposition products are known.

Section 10: Stability and reactivity

Section 11: Toxicological information
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Harmful if swallowed.
Product:
Acute oral toxicity:

Acute toxicity estimate: 1,965 mg/kg
Method: Calculation method

Cellulose:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 5.8 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg

Alendronate:
Acute oral toxicity:

LD50 (Rat): 552 - 626 mg/kg

Components:

LD50 (Mouse): 966 - 1,280 mg/kg

8 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Acute inhalation toxicity:

Remarks: No data available

Acute dermal toxicity:

Remarks: No data available

Colecalciferol:
Acute oral toxicity:

LD50 (Rat, male): 35 mg/kg

Acute inhalation toxicity:

Acute toxicity estimate: 0.05 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: Expert judgement

Acute dermal toxicity:

Acute toxicity estimate: 50 mg/kg
Method: Expert judgement::

RabbitSevere skin irritation

Skin corrosion/irritation
Causes skin irritation.
Components:
Alendronate:
Species
Remarks

Serious eye damage/eye irritation
Causes serious eye damage.
Components:
Alendronate:
SpeciesResult::RabbitSevere irritation

Colecalciferol:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Alendronate:
Remarks:

No data available

9 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

Colecalciferol:
Test Type
Exposure routes
SpeciesResultSDS Number:
22064-00023

:
:
:
:

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Maurer optimisation test
Skin contact
Guinea pig
negative

Germ cell mutagenicity
Not classified based on available information.
Components:
Cellulose:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Ingestion
Result: negative

Alendronate:
Genotoxicity in vitro:

Test Type: Alkaline elution assay
Test system: rat hepatocytes
Result: negative
Test Type: Bacterial reverse mutation assay (AMES)
Metabolic activation: with and without metabolic activation
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Chromosomal aberration
Test system: Chinese hamster ovary cells
Result: equivocal

Genotoxicity in vivo:

Test Type: Chromosomal aberration
Species: Mouse
Result: negative

Colecalciferol:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: equivocal
Test Type: In vitro mammalian cell gene mutation test
10 / 18

SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Method: OECD Test Guideline 476
Result: negative
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative
Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 474
Result: negative
Test Type: In vivo mammalian alkaline comet assay
Species: Rat
Application Route: Ingestion
Result: positive

Germ cell mutagenicity Assessment:

Weight of evidence does not support classification as a germ
cell mutagen.

Carcinogenicity
Not classified based on available information.
Components:
Cellulose:
Species
Application RouteExposure time
ResultAlendronate:
Species
Application RouteExposure timeTarget Organs
Remarks

:
:
:
:

Rat
Ingestion
72 weeks
negative

:
:
:
:
:
:
:

Rat, maleOral
2 Years
1 mg/kg body weight
3.75 mg/kg body weight
Thyroid
The mechanism or mode of action may not be relevant in humans.

Reproductive toxicity
Suspected of damaging the unborn child.
Components:
Cellulose:
Effects on fertility:

Test Type: One-generation reproduction toxicity study
Species: Rat
11 / 18

SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Application Route: Ingestion
Result: negative
Effects on foetal development

Alendronate:
Effects on fertility

Effects on foetal development:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Ingestion
Result: negative:

Test Type: Fertility
Species: Rat, male and female
Application Route: Oral
Fertility: NOAEL: 5 mg/kg body weight
Result: Animal testing did not show any effects on fertility.

:

Test Type: Development
Species: Rat, female
Application Route: Oral
Developmental Toxicity: LOAEL: 1 - 15 mg/kg body weight
Symptoms: Reduced number of viable fetuses, Reduced bodyweight, Skeletal malformations
Result: Embryotoxic effects and adverse effects on the offspring were detected.
Test Type: Development
Species: Rabbit, female
Application Route: Oral
Developmental Toxicity: NOAEL: 40 mg/kg body weight
Result: No adverse effects

Reproductive toxicity - Assessment:

Some evidence of adverse effects on development, based onanimal experiments.

STOT - single exposure
May cause respiratory irritation.
Components:
Alendronate:
Assessment:

May cause respiratory irritation.

STOT - repeated exposure
May cause damage to organs (Bone, Stomach, Kidney) through prolonged or repeated exposure.
Components:
Alendronate:
Target Organs
Assessment::

Bone, Stomach, Kidney
May cause damage to organs through prolonged or repeatedexposure.

12 / 18

SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

Colecalciferol:
Exposure routes
Target Organs
Assessment

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014:::

Ingestion
Kidney, Blood, BoneShown to produce significant health effects in animals at concentrations of 10 mg/kg bw or less.

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
>= 9,000 mg/kg
Ingestion
90 Days

Alendronate:
Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Rat
2.5 mg/kg> 2.5 mg/kg
Intravenous
53 Weeks
StomachSpecies
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
0.01 mg/kg
Intravenous
3 yr
Stomach, Bone, KidneySpecies
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:
:

Dog
2 mg/kg
4 mg/kgOral
53 Weeks
KidneyColecalciferol:
Species
NOAEL
LOAEL
Application RouteExposure time
Method

:
:
:
:
:
:

Rat
0.06 mg/kg
0.3 mg/kg
Ingestion
90 Days
OECD Test Guideline 408

Repeated dose toxicity
Components:

Aspiration toxicity
Not classified based on available information.

13 / 18

SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Components:
Alendronate:
Not applicable
Experience with human exposure
Components:
Alendronate:
Inhalation
Skin contact
Eye contact
Ingestion::::

Symptoms: respiratory tract irritation
Symptoms: Severe irritation, skin blistering
Symptoms: Severe irritation
Symptoms: Gastrointestinal disturbance, musculoskeletal pain

Section 12: Ecological information
Toxicity
Components:
Cellulose:
Toxicity to fish:

LC50 (Oryzias latipes (Japanese medaka)): > 100 mg/l
Exposure time: 48 h
Remarks: Based on data from similar materials

Alendronate:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): 27 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
LC50 (Oncorhynchus mykiss (rainbow trout)): > 1,000 mg/l
Exposure time: 96 h
Method: FDA 4.11

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 170 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

ErC50 (Pseudokirchneriella subcapitata (green algae)): > 10
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
NOEC (Pseudokirchneriella subcapitata (green algae)): 4 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 1.1 mg/l
Exposure time: 32 d
Method: OECD Test Guideline 210
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SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
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Revision Date:
06.04.2024

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

LOEC (Pimephales promelas (fathead minnow)): 1.9 mg/l
Exposure time: 32 d
Method: OECD Test Guideline 210
Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)
Colecalciferol:
Toxicity to fish

NOEC (Daphnia magna (Water flea)): 4.7 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211:

LL50 (Danio rerio (zebra fish)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EL50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:EL50 (Scenedesmus capricornutum (fresh water algae)): >100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 201

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Alendronate:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 70.3 %Exposure time: 7 dStability in water:

Degradation half life (DT50): 375 d
Method: OECD Test Guideline 111

Colecalciferol:
Biodegradability:

Result: Not readily biodegradable.
Biodegradation: <= 7 %Exposure time: 28 d
Method: OECD Test Guideline 301C

Bioaccumulative potential
Components:
Alendronate:

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SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

Partition coefficient: noctanol/water
Colecalciferol:
Partition coefficient: noctanol/water

SDS Number:
22064-00023

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014:

log Pow: -1.73:

log Pow: > 6.2
Method: OECD Test Guideline 107

Mobility in soil
No data available
Other adverse effects
No data available
Section 13: Disposal considerations
Disposal methods
Waste from residues:

Contaminated packaging:

Do not dispose of waste into sewer.
Dispose of in accordance with local regulations.
Empty containers should be taken to an approved waste handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

Section 14: Transport information
International Regulations
UNRTDGUN numberUN proper shipping name
Transport hazard class(es)Subsidiary risk
Packing group
LabelsEnvironmentally hazardous
IATA-DGR
UN/ID No.
UN proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN numberUN proper shipping nameClass
Subsidiary risk

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable
no

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:

Not applicableNot applicableNot applicableNot applicable
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SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

Packing group
LabelsEmS Code
Marine pollutant

SDS Number:
22064-00023

:
:
:
:

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Not applicableNot applicableNot applicableNot applicable

Transport in bulk according to IMO instruments
Not applicable for product as supplied.
Special precautions for user
Not applicable
Section 15: Regulatory information
Safety, health and environmental regulations specific for the product in question
Workplace Safety and Health Act and Workplace Safety and Health (General Provisions) Regulations: This product is subjected to the SDS, labelling, PEL and other requirements in the
Act/Regulations.
Environmental Protection and Management Act and: Not applicable
Environmental Protection and Management (Hazardous Substances) Regulations
Fire Safety (Petroleum and Flammable Materials)
Regulations:

Not applicable

The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

Revision Date:

06.04.2024

Further information
Sources of key data used tocompile the Safety Data
Sheet

:

Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Section 16: Other information

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
Date format:

dd.mm.yyyy

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
SG OEL: Singapore. Workplace Safety and Health (General Provisions)
Regulations - First Schedule Permissible Exposure Limits of
Toxic Substances.
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SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

ACGIH / TWA
SG OEL / PEL (long term)

SDS Number:
22064-00023::

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

8-hour, time-weighted average
Permissible Exposure Level (PEL) Long Term

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
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 is designed only as a guidance forsafe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
SG / EN

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