SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name:Lynestrenol 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.
Shotton Lane
NE23 3JU Cramlington NU - Great Britain
Telephone:+44 1 670 59 32 05

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) as amended by GB-CLP Regulation, UK
SI 2019/720, and UK SI 2020/1567)
Germ cell mutagenicity, Category 1B
Carcinogenicity, Category 2
Reproductive toxicity, Category 1ASpecific target organ toxicity - repeatedexposure, Category 2

H340: May cause genetic defects.
H351: Suspected of causing cancer.
H360Fd: May damage fertility. Suspected of damaging the unborn child.
H373: May cause damage to organs through prolonged or repeated exposure.

2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008) as amended by GB-CLP Regulation, UK SI
2019/720, and UK SI 2020/1567)

1 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Hazard pictograms:

Signal word:

DangerHazard statements

:

H340
H351
H360FdH373

Precautionary statements:

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

May cause genetic defects.
Suspected of causing cancer.
May damage fertility. Suspected of damaging theunborn child.
May cause damage to organs through prolonged
or repeated exposure.

Prevention:
P201
Obtain special instructions before use.
P260
Do not breathe dust.
P280
Wear protective gloves/ protective clothing/ eyeprotection/ face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
Storage:
P405

Store locked up.

Hazardous components which must be listed on the label:
Lynestrenol
EUH208
Contains Tocopherol. May produce an allergic reaction.
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.
Dust contact with the eyes can lead to mechanical irritation.
Contact with dust can cause mechanical irritation or drying of the skin.
May form explosive dust-air mixture during processing, handling or other means.

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

CAS-No.
EC-No.
Index-No.
Registration number
52-76-6
200-151-4

2 / 22

Classification

Concentration(% w/w)

Acute Tox. 4; H302
Muta. 1B; H340
Carc. 2; H351>= 1 - < 10

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Tocopherol

10191-41-0
233-466-0
Substances with a workplace exposure limit :Starch
9005-25-8
232-679-6
Talc
14807-96-6
238-877-9
Glycerine
56-81-5
200-289-5

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021
Repr. 1A; H360Fd
STOT RE 1; H372
(Blood, Mammary
gland, Uterus (including cervix),
Ovary)
Skin Sens. 1B;
H317>= 0.1 - < 1>= 20 - < 30>= 1 - < 10>= 1 - < 10

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 soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.

In case of eye contact:

If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.

If swallowed:

If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.

4.2 Most important symptoms and effects, both acute and delayed
Risks: May cause genetic defects.
Suspected of causing cancer.
3 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

May damage fertility. Suspected of damaging the unborn
child.
May cause damage to organs through prolonged or repeatedexposure.
Contact with dust can cause mechanical irritation or drying of
the skin.
Dust contact with the eyes can lead to mechanical irritation.
May produce an allergic reaction.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.

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:

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.

4 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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.
If spillage enters rivers or watercourses, inform the Environment Agency (emergency telephone number 0800 807060).

6.3 Methods and material for containment and cleaning up
Methods for cleaning up: Sweep up or vacuum up spillage and collect in suitable container for disposal.
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.
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:

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.
Avoid contact with 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
5 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Hygiene measures:

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Keep container tightly closed.
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.

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. Store in accordance 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
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

:

No data available

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
dust of any kind
10 mg/m3
Value type (Form of exposure): TWA (Inhalable)
Basis: GB EH40
4 mg/m3
Value type (Form of exposure): TWA (Respirable fraction)
Basis: GB EH40
Components

CAS-No.

Starch

9005-25-8

Value type (Formof exposure)
TWA (inhalable
dust)
TWA (Respirable
6 / 22Control parameters

Basis

10 mg/m3

GB EH40

4 mg/m3

GB EH40SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Lynestrenol

52-76-6

Talc

14807-96-6

Glycerine

56-81-5

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

dust)
TWA
Wipe limit
TWA (Respirable
dust)
TWA (Mist)

1 µg/m3 (OEB 4)
10 µg/100 cm²
1 mg/m3

Internal
Internal
GB EH40

10 mg/m3

GB EH40

Derived No Effect Level (DNEL):
Substance name

End UseExposure routes

Glycerine

Workers

Inhalation

Consumers

Ingestion

Consumers

Inhalation

Workers
Workers

Inhalation
Skin contact

Consumers
Consumers

Inhalation
Skin contact

Consumers

Ingestion

Tocopherol

Potential health effects
Long-term local effects
Long-term systemic
effects
Long-term local effects

Value
56 mg/m3
229 mg/kg
bw/day33 mg/m3
44 mg/m3
125 mg/kg
bw/day10.8 mg/m3
62.5 mg/kg
bw/day6.25 mg/kg
bw/dayPredicted No Effect Concentration (PNEC):
Substance name
Glycerine

Environmental Compartment
Fresh water
Marine waterIntermittent use/release
Sewage treatment plant
Fresh water sediment
Marine sediment
Soil

Value
0.885 mg/l
0.0885 mg/l
8.85 mg/l
1000 mg/l
3.3 mg/kg dryweight (d.w.)
0.33 mg/kg dryweight (d.w.)
0.141 mg/kg dryweight (d.w.)

8.2 Exposure controls
Engineering measures
Containment technologies suitable for controlling compounds are required to control at source
and to prevent migration of the compound to uncontrolled areas (e.g., vacuum conveying from aclosed system, packout head with inflatable seal from stationary container, ventilated enclosure,etc.).
All engineering controls should be implemented by facility design and operated in accordancewith GMP principles to protect products, workers, and the environment.
Essentially no open handling permitted.
Use closed processing systems or containment technologies.
Personal protective equipment
Eye/face protection: Wear safety glasses with side shields or goggles.
7 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

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

Remarks
Skin and body protection::

Respiratory protection:

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.
Equipment should conform to BS EN 14387
Combined particulates and organic vapour type (A-P)

Filter type:

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Appearance: powderColour: No data available
Odour: No data available
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
8 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Relative density:

No data available

Density:

No data available::

No data available
Not applicable:

No data available

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

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

9 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

SECTION 11: Toxicological information
11.1 Information on toxicological effects
Information on likely routes of : Inhalation
exposure
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

Acute toxicity estimate: > 2,000 mg/kg
Method: Calculation method:

LD50: > 1,000 - 8,000 mg/kg

Components:
Lynestrenol:
Acute oral toxicity

Acute toxicity (other routes of :administration)

LD50 (Mouse): 110 mg/kg
Application Route: Intraperitoneal

Tocopherol:
Acute oral toxicity:

LD50 (Rat): > 4,000 mg/kg

Acute dermal toxicity:

LD50 (Rat): > 3,000 mg/kg
Assessment: The substance or mixture has no acute dermal
toxicity

Starch:Acute oral toxicity:

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

Acute dermal toxicity:

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

Talc:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Remarks: Based on data from similar materials

Glycerine:
Acute oral toxicity:

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

Acute dermal toxicity:

LD50 (Guinea pig): > 5,000 mg/kg

Skin corrosion/irritation
Not classified based on available information.

10 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Components:
Tocopherol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Talc:
SpeciesResult::RabbitNo skin irritation

Glycerine:
SpeciesResult::RabbitNo skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Tocopherol:
Species
MethodResult:::RabbitOECD Test Guideline 405
No eye irritation

Starch:SpeciesResult::RabbitNo eye irritation

Talc:
SpeciesResult::RabbitNo eye irritation

Glycerine:
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:
Tocopherol:
Test Type:

Local lymph node assay (LLNA)
11 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Exposure routes
Species
MethodResult::::Skin contact
Mouse
OECD Test Guideline 429
positive

Assessment:

Probability or evidence of low to moderate skin sensitisation
rate in humans

Starch:Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

Talc:
Exposure routes
SpeciesResult:::Skin contact
Humansnegative:

Test Type: Chromosome aberration test in vitro
Result: positive

Germ cell mutagenicity
May cause genetic defects.
Components:
Lynestrenol:
Genotoxicity in vitro

Test Type: sister chromatid exchange assay
Result: positive
Genotoxicity in vivo:

Test Type: Mutagenicity (in vivo mammalian bone-marrowcytogenetic test, chromosomal analysis)
Species: Mouse
Application Route: Intraperitoneal injection
Result: positive
Test Type: sister chromatid exchange assay
Species: Mouse
Application Route: Intraperitoneal injection
Result: positive
Test Type: dominant lethal test
Species: Mouse
Application Route: Intraperitoneal
Result: positive

Germ cell mutagenicity- Assessment:

Positive result(s) from in vivo somatic cell mutagenicity tests in
mammals. Evidence that the substance has potential to cause
mutations to germ cells

12 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Tocopherol:
Genotoxicity in vitro:

Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative
Remarks: Based on data from similar materials

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials

Starch:Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

Talc:
Genotoxicity in vitro:

Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative

Genotoxicity in vivo:

Test Type: Chromosome aberration test in vitro
Species: Rat
Application Route: Ingestion
Result: negative

Glycerine:
Genotoxicity in vitro:

Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosome aberration test in vitro
Result: negative
Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative

Carcinogenicity
Suspected of causing cancer.
Components:
Lynestrenol:
Species
Application RouteExposure time

:
:
:

Mouse
Oral
80 weeks
13 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

ResultTumor Type
Remarks:::

positive
breast tumors, Liver
Benign and malignant tumor(s)Species
Application RouteExposure time
ResultTumor Type

:
:
:
:
:

Rat
Oral
80 weeks
positive
breast tumors

Carcinogenicity - Assessment:

Limited evidence of carcinogenicity in animal studies

Tocopherol:
Species
Application RouteExposure time
ResultRemarks

:
:
:
:
:

Rat
Ingestion
104 weeks
negative
Based on data from similar materials

Talc:
Species
Application RouteExposure time
Result

:
:
:
:

Mouse
inhalation (dust/mist/fume)
2 Years
negative

Glycerine:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative

Reproductive toxicity
May damage fertility. Suspected of damaging the unborn child.
Components:
Lynestrenol:
Effects on fertility:

Test Type: Fertility/early embryonic development
Species: Rat, males
Application Route: Oral
Fertility: LOAEL: 20 mg/kg body weight
Remarks: Impaired spermatogenesis
Test Type: Fertility/early embryonic development
Species: Rat, females
Application Route: Oral
Fertility: LOAEL: 375 µg/kg
Result: Maternal toxicity observed., Effects on fertility
Test Type: Fertility/early embryonic development
14 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Species: Rabbit
Application Route: Oral
Fertility: LOAEL: 1,300 µg/kg
Result: Effects on fertility, Postimplantation loss.
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 0.1 mg/kg body weight
Result: Effects on foetal development
Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: LOAEL: 0.1 mg/kg body weight
Result: Effects on foetal development, Postimplantation loss.

Reproductive toxicity - Assessment:

Some evidence of adverse effects on development, based onanimal experiments., Positive evidence of adverse effects on
sexual function and fertility from human epidemiological studies.

Tocopherol:
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rabbit
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials

Talc:
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Ingestion
Result: negative:

Test Type: Two-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative:

Test Type: Embryo-foetal development
Species: Rat
Application Route: Ingestion
Result: negative

Glycerine:
Effects on fertility

Effects on foetal development

STOT - single exposure
Not classified based on available information.

15 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

STOT - repeated exposure
May cause damage to organs through prolonged or repeated exposure.
Components:
Lynestrenol:
Target Organs
Assessment::

Blood, Mammary gland, Uterus (including cervix), Ovary
Causes damage to organs through prolonged or repeatedexposure.

Tocopherol:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
500 mg/kg
Ingestion
90 DaysBased on data from similar materials

Starch:Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
>= 2,000 mg/kg
Skin contact
28 Days
OECD Test Guideline 410

Glycerine:
Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

Rat
0.167 mg/l
0.622 mg/l
inhalation (dust/mist/fume)
13 Weeks

Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
8,000 - 10,000 mg/kg
Ingestion
2 yrSpecies
NOAEL
Application RouteExposure time

:
:
:
:

Rabbit
5,040 mg/kg
Skin contact
45 Weeks

Repeated dose toxicity
Components:

Aspiration toxicity
Not classified based on available information.

16 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Experience with human exposure
Components:
Lynestrenol:
Ingestion:

Target Organs: Uterus (including cervix)
Target Organs: breasts
Target Organs: ovaries
Target Organs: Blood
Symptoms: Headache, Nausea, Abdominal pain, Rash, Dizziness, Tremors, Sweating, Vomiting, migraine, acne, breast
tenderness, gynecomastia, menstrual irregularities, ovariancysts
Remarks: Used to prevent pregnancy

SECTION 12: Ecological information
12.1 Toxicity
Components:
Tocopherol:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Remarks: Based on data from similar materials

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 23.53 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202
Remarks: No toxicity at the limit of solubility

Toxicity to algae/aquaticplants:NOEC (Pseudokirchneriella subcapitata (green algae)): 25.8
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility
EC50 (Pseudokirchneriella subcapitata (green algae)): > 25.8
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
Remarks: No toxicity at the limit of solubility

Toxicity to microorganisms:

EC50 : > 937 mg/l
Exposure time: 30 min
Method: ISO 8192
Remarks: Based on data from similar materials

Toxicity to fish (Chronic toxicity):

NOEC: > 100 mg/l
Exposure time: 28 dSpecies: Oncorhynchus mykiss (rainbow trout)
Remarks: Based on data from similar materials
17 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

Talc:
Toxicity to fish:

LC50 (Brachydanio rerio (zebrafish)): > 100,000 mg/l
Exposure time: 24 h

Glycerine:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): 54,000 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 1,955 mg/l
Exposure time: 48 h

Toxicity to microorganisms:

NOEC (Pseudomonas putida): > 10,000 mg/l
Exposure time: 16 h
Method: DIN 38 412 Part 8

12.2 Persistence and degradability
Components:
Tocopherol:
Biodegradability:

Result: Not readily biodegradable.
Biodegradation: 20 %Exposure time: 28 d
Method: OECD Test Guideline 301F

Glycerine:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 92 %Exposure time: 30 d
Method: OECD Test Guideline 301D:

log Pow: -1.75

12.3 Bioaccumulative potential
Components:
Glycerine:
Partition coefficient: noctanol/water
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.

18 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

12.6 Other adverse effects
Product:
Endocrine disrupting potential:

This substance/mixture does not contain components considered to have endocrine disrupting properties for environment
according to UK REACH Article 57(f).

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

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 good

14.2 UN proper shipping name14.3 Transport hazard class(es)14.4 Packing group19 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

ADN:

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

14.5 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
Relevant EU provisions transposed through retained EU law
UK REACH List of restrictions (Annex 17): Not applicable
UK REACH Candidate list of substances of very high: Not applicableconcern (SVHC) for Authorisation
The Persistent Organic Pollutants Regulations (retained : Not applicable
Regulation (EU) 2019/1021 as amended for Great Britain)
Regulation (EC) No 1005/2009 on substances that de: Not applicableplete the ozone layer
UK REACH List of substances subject to authorisation: Not applicable(Annex XIV)GB Export and import of hazardous chemicals - Prior: Not applicable
Informed Consent (PIC) Regulation
Control of Major Accident Hazards Regulations 2015 (COMAH)
Not applicable
Other regulations:
Take note of The Management of Health and Safety at Work Regulations 1999 (requirements
relating to new and expectant mothers at work contained in Regulation 16 to 18) and of thePregnant Workers Directive 92/85/EEC.
Take note of The Management of Health and Safety at Work Regulations 1999 (requirements
relating to protection of young people at work contained in Regulation 19) and of Directive
94/33/EC on the protection of young people at work.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined
20 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

IECSC

SDS Number:
9372565-00007:

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

not determined15.2 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
H302
H317
H340
H351
H360Fd

:
:
:
:
:

H372

:

Harmful if swallowed.
May cause an allergic skin reaction.
May cause genetic defects.
Suspected of causing cancer.
May damage fertility. Suspected of damaging the unborn
child.
Causes damage to organs through prolonged or repeatedexposure.

Full text of other abbreviations
Acute Tox.
: Acute toxicity
Carc.
: Carcinogenicity
Muta.
: Germ cell mutagenicity
Repr.
: Reproductive toxicity
Skin Sens.
: Skin sensitisation
STOT RE: Specific target organ toxicity - repeated exposure
GB EH40: UK. EH40 WEL - Workplace Exposure Limits
GB EH40 / TWA: Long-term exposure limit (8-hour TWA reference period)
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 - International 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) Ef21 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Lynestrenol Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9372565-00007

Date of last issue: 30.09.2023
Date of first issue: 27.08.2021

fect 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:

Muta. 1B

H340

Calculation method

Carc. 2

H351

Calculation method

Repr. 1A

H360FdCalculation method

STOT RE 2

H373

Calculation method

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.
GB / EN

22 / 22