SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name:

Alendronate / Vitamin D Formulation

1.2 Relevant identified uses of the substance or mixture and uses advised against
Use of the Sub: Pharmaceuticalstance/Mixture
Recommended restrictions
on use:Not applicable

1.3 Details of the supplier of the safety data sheet
Company: Organon & Co.
30 Hudson Street, 33nd floor
07302 Jersey City, New Jersey, U.S.A
Telephone:+1-551-430-6000

E-mail address of person
responsible for the SDS:

EHSSTEWARD@organon.com

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

SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008)
Acute toxicity, Category 4
H302: Harmful if swallowed.
Skin irritation, Category 2
H315: Causes skin irritation.
Serious eye damage, Category 1
H318: Causes serious eye damage.
Reproductive toxicity, Category 2
H361d: Suspected of damaging the unborn child.
Specific target organ toxicity - single exH335: May cause respiratory irritation.
posure, Category 3
Specific target organ toxicity - repeatedH373: May cause damage to organs through proexposure, Category 2
longed or repeated exposure.
2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008)
Hazard pictograms:

Signal word:

Danger

1 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

Hazard statements:

Precautionary statements:

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

H302 Harmful if swallowed.
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 through prolonged orrepeated exposure.
Prevention:
P201 Obtain special instructions before use.
P260 Do not breathe dust.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P304 + P340 + P312 IF INHALED: Remove person to fresh
air and keep comfortable for breathing. Call a POISONCENTER/ doctor if you feel unwell.
P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiouslywith water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a
POISON CENTER/ doctor.
P308 + P313 IF exposed or concerned: Get medical advice/attention.

Hazardous components which must be listed on the label:
Alendronate
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% orhigher.
May form explosive dust-air mixture during processing, handling or other means.

SECTION 3: Composition/information on ingredients
3.2 Mixtures
Components
Chemical name

Alendronate

Colecalciferol

CAS-No.
EC-No.
Index-No.
Registration number
121268-17-5

67-97-0200-673-2
2 / 18Classification

Concentration(% w/w)

Acute Tox. 4; H302
Skin Irrit. 2; H315
Eye Dam. 1; H318
Repr. 2; H361d
STOT SE 3; H335
STOT RE 2; H373
(Bone, Stomach,
Kidney)Acute Tox. 2; H300
Acute Tox. 2; H330>= 20 - < 30>= 0,025 - <0,1

SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023
603-180-00-4

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014
Acute Tox. 2; H310
STOT RE 1; H372
(Kidney, Blood,
Bone)
Aquatic Chronic 4;
H413

For explanation of abbreviations see section 16.

SECTION 4: First aid measures
4.1 Description of 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.
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).

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.

4.2 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.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.
3 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

SECTION 5: Firefighting measures
5.1 Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical:

None known.

5.2 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

5.3 Advice for firefighters
Special protective equipment
for firefighters
Specific extinguishing methods:

Carbon oxides
Nitrogen oxides (NOx)Phosphorus compounds
Metal oxides:

In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

:

Use extinguishing measures that are appropriate to local circumstances 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
6.1 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).
6.2 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.

6.3 Methods and material for containment and cleaning up
Methods for cleaning up: Surround spill with absorbents and place a damp covering
4 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

over 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
certain local or national requirements.
6.4 Reference to other sections
See sections: 7, 8, 11, 12 and 13.

SECTION 7: Handling and storage
7.1 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 of
5 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

engineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.
7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep in properly labelled containers. Store locked up. Keepareas and containers
tightly closed. Keep in a cool, well-ventilated place. Store inaccordance with the particular national regulations.
Advice on common storage

7.3 Specific end use(s)Specific use(s):Do not store with the following product types:
Strong oxidizing agents:

No data available

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
Components
Cellulose

Alendronate

Colecalciferol

CAS-No.

Value type (Form Control parametersBasisof exposure)9004-34-6
OEL-RL
10 mg/m3
ZA OEL
Further information: Occupational Exposure Limits - Restricted Limits For
Hazardous Chemical Agents
121268-17TWA
20 µg/m3 (OEB 3)
Internal
5
Wipe limit
200 µg/100 cm²Internal
67-97-0TWA
5 µg/m3 (OEB 4)Internal
Wipe limit
50 µg/100 cm²Internal

8.2 Exposure controls
Engineering measures
All engineering controls should be implemented by facility design and operated in accordancewith GMP principles to protect 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.
Personal protective equipment
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.
Hand protection
Material:

Chemical-resistant gloves
6 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

Remarks
Skin and body protection::

Respiratory protection:

Filter type

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

Consider double gloving.
Work uniform or laboratory coat.
Additional body garments should be used based upon the task
being performed (e.g., sleevelets, apron, gauntlets, disposable
suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Particulates type (P):SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Appearance: powderColour: off-whiteOdour: odourless
Odour Threshold: No data available
pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range
Flash point:

No data available:

Not applicable

Evaporation rate:

Not applicable

Flammability (solid, gas):

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

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::

No data available
Not applicable:

No data available

Solubility(ies)
Water solubility
Partition coefficient: noctanol/water
Auto-ignition temperature

7 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

9.2 Other information
Flammability (liquids):

No data available:

No data available

Particle size

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.
10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions: May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.
10.4 Conditions to avoid
Conditions to avoid:

Heat, flames and sparks.
Avoid dust formation.

10.5 Incompatible materials
Materials to avoid:

Oxidizing agents

10.6 Hazardous decomposition products
No hazardous decomposition products are known.

SECTION 11: Toxicological information
11.1 Information on toxicological effects
Information on likely routes of : Inhalation
exposure
Skin contact
Ingestion
Eye contact
Acute toxicity
Harmful if swallowed.
Product:
Acute oral toxicity:

Acute toxicity estimate: 1.965 mg/kg
8 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

Method: Calculation method
Components:
Alendronate:
Acute oral toxicity:

LD50 (Rat): 552 - 626 mg/kg
LD50 (Mouse): 966 - 1.280 mg/kg

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.

9 / 18SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

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

No data available

Colecalciferol:
Test Type
Exposure routes
SpeciesResult::::Maurer optimisation test
Skin contact
Guinea pig
negative

Germ cell mutagenicity
Not classified based on available information.
Components:
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
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
10 / 18

SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

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:
Alendronate:
Species
Application RouteExposure timeTarget Organs
Remarks

:
:
:
:
:
:
:

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:
Alendronate:
Effects on fertility

Effects on foetal development:

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
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SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

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 through prolonged or repeated exposure.
Components:
Alendronate:
Target Organs
Assessment::

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

Colecalciferol:
Exposure routes
Target Organs
Assessment:::

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

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
KidneyRepeated dose toxicity
Components:

12 / 18

SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

Colecalciferol:
Species
NOAEL
LOAEL
Application RouteExposure time
MethodSDS Number:
22066-00023

:
:
:
:
:
:

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

Rat
0,06 mg/kg
0,3 mg/kg
Ingestion
90 Days
OECD Test Guideline 408

Aspiration toxicity
Not classified based on available information.
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
12.1 Toxicity
Components:
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
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SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

Method: OECD Test Guideline 201
Toxicity to fish (Chronic toxicity):

NOEC: 1,1 mg/l
Exposure time: 32 d
Species: Pimephales promelas (fathead minnow)
Method: OECD Test Guideline 210
LOEC: 1,9 mg/l
Exposure time: 32 d
Species: Pimephales promelas (fathead minnow)
Method: OECD Test Guideline 210

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)

Colecalciferol:
Toxicity to fish

NOEC: 4,7 mg/l
Exposure time: 21 dSpecies: Daphnia magna (Water flea)
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

12.2 Persistence and degradability
Components:
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

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SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

12.3 Bioaccumulative potential
Components:
Alendronate:
Partition coefficient: noctanol/water:log Pow: -1,73

Colecalciferol:
Partition coefficient: noctanol/water:log Pow: > 6,2
Method: OECD Test Guideline 107

12.4 Mobility in soil
No data available
12.5 Results of PBT and vPvB assessment
Product:
Assessment:

This substance/mixture contains no components considered
to be either persistent, bioaccumulative and toxic (PBT), orvery persistent and very bioaccumulative (vPvB) at levels of
0.1% or higher.

:

The substance/mixture does not contain components considered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

12.6 Other adverse effects
Product:
Endocrine disrupting potential

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

Contaminated packaging:

Dispose of in accordance with local regulations.
According to the European Waste Catalogue, Waste Codes
are not product specific, but application specific.
Waste codes should be assigned by the user, preferably in
discussion with the waste disposal authorities.
Do not dispose of waste into sewer.
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
14.1 UN number
ADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good
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SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA (Cargo):

Not regulated as a dangerous good

IATA (Passenger):

Not regulated as a dangerous good

14.2 UN proper shipping name14.3 Transport hazard class(es)14.4 Packing group

14.5 Environmental hazards
Not regulated as a dangerous good
14.6 Special precautions for user
Not applicable
14.7 Transport in bulk according to Annex II of Marpol and the IBC CodeRemarks: Not applicable for product as supplied.

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined
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SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

15.2 Chemical safety assessment
A Chemical Safety Assessment has not been carried out.

SECTION 16: Other information
Other information:

Items where changes have been made to the previous version
are highlighted in the body of this document by two verticallines.

Full text of H-Statements
H300
H302
H310
H315
H318
H330
H335
H361d
H372

:
:
:
:
:
:
:
:
:

H373

:

H413

:

Fatal if swallowed.
Harmful if swallowed.
Fatal in contact with skin.
Causes skin irritation.
Causes serious eye damage.
Fatal if inhaled.
May cause respiratory irritation.
Suspected of damaging the unborn child.
Causes damage to organs through prolonged or repeatedexposure.
May cause damage to organs through prolonged or repeatedexposure.
May cause long lasting harmful effects to aquatic life.

Full text of other abbreviations
Acute Tox.
: Acute toxicity
Aquatic Chronic: Long-term (chronic) aquatic hazard
Eye Dam.
: Serious eye damage
Repr.
: Reproductive toxicity
Skin Irrit.
: Skin irritation
STOT RE: Specific target organ toxicity - repeated exposure
STOT SE: Specific target organ toxicity - single exposure
ZA OEL: South Africa. The Regulations for Hazardous Chemical
Agents, Occupational Exposure LimitsZA OEL / OEL-RL: Occupational Exposure Limit Restricted limit - 8- hour exposure or equivalent (12 hour shifts)
ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by
Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standardof the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA European Chemicals Agency; EC-Number - European Community number; 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; 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 and Equipment 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 - Interna17 / 18

SAFETY DATA SHEET

Alendronate / Vitamin D Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22066-00023

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

tional Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified;NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof 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; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
SVHC - Substance of very high concern; TCSI - Taiwan Chemical Substance Inventory; 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
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/

Classification of the mixture:

Classification procedure:

Acute Tox. 4

H302

Calculation method

Skin Irrit. 2

H315

Calculation method

Eye Dam. 1

H318

Calculation method

Repr. 2

H361d

Calculation method

STOT SE 3

H335

Calculation method

STOT RE 2

H373

Calculation method

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
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.
ZA / EN

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