Conforms to Regulation (EC) No.

1907/2006 (REACH), Annex II, as amended by Commission

Regulation (EU) 2020/878

SAFETY DATA SHEET

TP Flex® reagent cartridge SDS no.: DEDM0277

SECTION 1: Identification of the substance/mixture and of the company/

undertaking
1.1 Product identifier
Product name : TP Flex® reagent cartridge
Product code : K1073, 10445167
1.2 Relevant identified uses of the substance or mixture and uses advised against
Identified uses Diagnostic agents.
Restrictions on use For professional users only.

1.3 Details of the supplier of the safety data sheet

Manufactured/supplied : Siemens Healthcare Diagnostics Limited
Park View,
Watchmoor Park,
Camberley,
Surrey,
GU15 3YL
United Kingdom

Phone: +44 (0) 345 600 1955

e-mail address of person : [email protected]
responsible for this SDS

1.4 Emergency telephone number

Poison Control:
In England and Wales:
NHS Direct – 0845 4647 or 111
In Scotland: NHS 24 – 08454 24 24 24
In the Republic of Ireland: 01 809 2166

CHEMTREC: 0870-8200418 (UK only)

+(353)-19014670 (UK & Ireland)
(International calls to the United Kingdom)

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture
Product definition : Mixture
Classification according to Regulation (EC) No. 1272/2008 [CLP/GHS]
Met. Corr. 1, H290
Skin Corr. 1, H314
Aquatic Chronic 3, H412
The product is classified as hazardous according to Regulation (EC) 1272/2008 as amended.
See Section 16 for the full text of the H statements declared above.
See Section 11 for more detailed information on health effects and symptoms.

2.2 Label elements

Hazard pictograms :

Signal word : Danger

Date of issue/Date of revision : 12/11/2022 Date of previous issue : No previous validation Version :1 1/14
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU) 2020/878

TP Flex® reagent cartridge

SECTION 2: Hazards identification

Hazard statements : H290 - May be corrosive to metals.
H314 - Causes severe skin burns and eye damage.
H412 - Harmful to aquatic life with long lasting effects.
Precautionary statements
Prevention : P234 - Keep only in original container.
P264 - Wash hands thoroughly after handling.
P280 - Wear protective gloves/protective clothing/eye protection/face protection.
P273 - Avoid release to the environment.
Response : P301 - IF SWALLOWED:
P330 - Rinse mouth.
P331 - Do NOT induce vomiting.
P303 - IF ON SKIN (or hair):
P361 - Remove/Take off immediately all contaminated clothing.
P353 - Rinse skin with water or shower.
P310 - Immediately call a POISON CENTER or doctor/physician.
P305 - IF IN EYES:
P351 - Rinse cautiously with water for several minutes.
P338 - Remove contact lenses, if present and easy to do. Continue rinsing.
P390 - Absorb spillage to prevent material damage.
Storage : Not applicable.
Disposal : P501 - Dispose of contents and container in accordance with all local, regional,
national and international regulations.
Hazardous ingredients : sodium hydroxide
Supplemental label : Not applicable.
elements
Annex XVII - Restrictions : Not applicable.
on the manufacture,
placing on the market and
use of certain dangerous
substances, mixtures and
articles

2.3 Other hazards

Product meets the criteria : This mixture does not contain any substances that are assessed to be a PBT or a
for PBT or vPvB according vPvB.
to Regulation (EC) No.
1907/2006, Annex XIII
Other hazards which do : None known.
not result in classification
Additional information : Not available.
Not available.

SECTION 3: Composition/information on ingredients

3.2 Mixtures : Mixture
Specific Conc.
Product/ingredient name Identifiers % Classification Type
Limits, M-factors
and ATEs
sodium hydroxide EC: 215-185-5 ≤10 Skin Corr. 1A, H314 Skin Corr. 1A, [1] [2]
CAS: 1310-73-2 H314: C ≥ 5%
Index: 011-002-00-6 Skin Corr. 1B,
H314: 2% ≤ C < 5%
Skin Irrit. 2, H315:
0.5% ≤ C < 2%

copper sulphate EC: 231-847-6 <2.5 Acute Tox. 4, H302 ATE [Oral] = 500 [1] [2]
CAS: 7758-98-7 Eye Dam. 1, H318 mg/kg
Index: 029-004-00-0 Aquatic Acute 1, H400 M [Acute] = 10
Aquatic Chronic 1, M [Chronic] = 1
H410

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Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU) 2020/878

TP Flex® reagent cartridge

SECTION 3: Composition/information on ingredients

See Section 16 for
the full text of the H
statements declared
above.
Type
[1] Substance classified with a health or environmental hazard
[2] Substance with a workplace exposure limit
Occupational exposure limits, if available, are listed in Section 8.

SECTION 4: First aid measures

4.1 Description of first aid measures
Eye contact : Get medical attention immediately. Call a poison center or physician. Immediately
flush eyes with plenty of water, occasionally lifting the upper and lower eyelids.
Check for and remove any contact lenses. Continue to rinse for at least 10 minutes.
Chemical burns must be treated promptly by a physician.
Inhalation : Get medical attention immediately. Call a poison center or physician. Remove
victim to fresh air and keep at rest in a position comfortable for breathing. If it is
suspected that fumes are still present, the rescuer should wear an appropriate
mask or self-contained breathing apparatus. If not breathing, if breathing is
irregular or if respiratory arrest occurs, provide artificial respiration or oxygen by
trained personnel. It may be dangerous to the person providing aid to give mouth-
to-mouth resuscitation. If unconscious, place in recovery position and get medical
attention immediately. Maintain an open airway. Loosen tight clothing such as a
collar, tie, belt or waistband.
Skin contact : Get medical attention immediately. Call a poison center or physician. Flush
contaminated skin with plenty of water. Remove contaminated clothing and shoes.
Wash contaminated clothing thoroughly with water before removing it, or wear
gloves. Continue to rinse for at least 10 minutes. Chemical burns must be treated
promptly by a physician. Wash clothing before reuse. Clean shoes thoroughly
before reuse.
Ingestion : Get medical attention immediately. Call a poison center or physician. Wash out
mouth with water. Remove dentures if any. If material has been swallowed and the
exposed person is conscious, give small quantities of water to drink. Stop if the
exposed person feels sick as vomiting may be dangerous. Do not induce vomiting
unless directed to do so by medical personnel. If vomiting occurs, the head should
be kept low so that vomit does not enter the lungs. Chemical burns must be treated
promptly by a physician. Never give anything by mouth to an unconscious person.
If unconscious, place in recovery position and get medical attention immediately.
Maintain an open airway. Loosen tight clothing such as a collar, tie, belt or
waistband.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training. If it
is suspected that fumes are still present, the rescuer should wear an appropriate
mask or self-contained breathing apparatus. It may be dangerous to the person
providing aid to give mouth-to-mouth resuscitation. Wash contaminated clothing
thoroughly with water before removing it, or wear gloves.

4.2 Most important symptoms and effects, both acute and delayed
Over-exposure signs/symptoms
Eye contact : Adverse symptoms may include the following:
pain
watering
redness
Inhalation : No specific data.
Skin contact : Adverse symptoms may include the following:
pain or irritation
redness
blistering may occur
Ingestion : Adverse symptoms may include the following:
stomach pains

4.3 Indication of any immediate medical attention and special treatment needed
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TP Flex® reagent cartridge

SECTION 4: First aid measures

Notes to physician : Treat symptomatically. Contact poison treatment specialist immediately if large
quantities have been ingested or inhaled.
Specific treatments : No specific treatment.

SECTION 5: Firefighting measures

5.1 Extinguishing media
Suitable extinguishing : Use an extinguishing agent suitable for the surrounding fire.
media
Unsuitable extinguishing : None known.
media

5.2 Special hazards arising from the substance or mixture

Hazards from the : In a fire or if heated, a pressure increase will occur and the container may burst.
substance or mixture This material is harmful to aquatic life with long lasting effects. Fire water
contaminated with this material must be contained and prevented from being
discharged to any waterway, sewer or drain.
Hazardous combustion : Decomposition products may include the following materials:
products carbon dioxide
carbon monoxide
sulfur oxides
metal oxide/oxides

5.3 Advice for firefighters

Special protective actions : Promptly isolate the scene by removing all persons from the vicinity of the incident if
for fire-fighters there is a fire. No action shall be taken involving any personal risk or without
suitable training.
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained
equipment for fire-fighters breathing apparatus (SCBA) with a full face-piece operated in positive pressure
mode. Clothing for fire-fighters (including helmets, protective boots and gloves)
conforming to European standard EN 469 will provide a basic level of protection for
chemical incidents.

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures
For non-emergency : No action shall be taken involving any personal risk or without suitable training.
personnel Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilt material. Do not breathe vapour or
mist. Provide adequate ventilation. Wear appropriate respirator when ventilation is
inadequate. Put on appropriate personal protective equipment.
For emergency responders : If specialised clothing is required to deal with the spillage, take note of any
information in Section 8 on suitable and unsuitable materials. See also the
information in "For non-emergency personnel".

6.2 Environmental : Avoid dispersal of spilt material and runoff and contact with soil, waterways, drains
precautions and sewers. Inform the relevant authorities if the product has caused
environmental pollution (sewers, waterways, soil or air). Water polluting material.
May be harmful to the environment if released in large quantities.

6.3 Methods and material for containment and cleaning up

Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and
mop up if water-soluble. Alternatively, or if water-insoluble, absorb with an inert dry
material and place in an appropriate waste disposal container. Absorb spillage to
prevent material damage. Dispose of via a licensed waste disposal contractor.

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Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU) 2020/878

TP Flex® reagent cartridge

SECTION 6: Accidental release measures

Large spill : Stop leak if without risk. Move containers from spill area. Absorb spillage to
prevent material damage. Approach the release from upwind. Prevent entry into
sewers, water courses, basements or confined areas. Wash spillages into an
effluent treatment plant or proceed as follows. Contain and collect spillage with non-
combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous earth
and place in container for disposal according to local regulations. Dispose of via a
licensed waste disposal contractor. Contaminated absorbent material may pose the
same hazard as the spilt product.

6.4 Reference to other : See Section 1 for emergency contact information.

sections See Section 8 for information on appropriate personal protective equipment.
See Section 13 for additional waste treatment information.

SECTION 7: Handling and storage

7.1 Precautions for safe handling
Protective measures : Put on appropriate personal protective equipment (see Section 8). Do not get in
eyes or on skin or clothing. Do not breathe vapour or mist. Do not ingest. Avoid
release to the environment. If during normal use the material presents a respiratory
hazard, use only with adequate ventilation or wear appropriate respirator. Keep in
the original container or an approved alternative made from a compatible material,
kept tightly closed when not in use. Keep away from acids. Empty containers
retain product residue and can be hazardous. Do not reuse container. Absorb
spillage to prevent material damage.
Advice on general : Eating, drinking and smoking should be prohibited in areas where this material is
occupational hygiene handled, stored and processed. Workers should wash hands and face before
eating, drinking and smoking. Remove contaminated clothing and protective
equipment before entering eating areas. See also Section 8 for additional
information on hygiene measures.

7.2 Conditions for safe storage, including any incompatibilities

Store in accordance with local regulations. Store in original container protected from direct sunlight in a dry, cool and
well-ventilated area, away from incompatible materials (see Section 10) and food and drink. Store in corrosive
resistant container with a resistant inner liner. Store locked up. Separate from acids. Keep away from metals. Keep
container tightly closed and sealed until ready for use. Containers that have been opened must be carefully resealed
and kept upright to prevent leakage. Do not store in unlabelled containers. Use appropriate containment to avoid
environmental contamination. See Section 10 for incompatible materials before handling or use.

7.3 Specific end use(s)

Recommendations : Not available.
Industrial sector specific : Not available.
solutions

SECTION 8: Exposure controls/personal protection

The information in this section contains generic advice and guidance. Information is provided based on typical
anticipated uses of the product. Additional measures might be required for bulk handling or other uses that could
significantly increase worker exposure or environmental releases.
8.1 Control parameters
Occupational exposure limits
No exposure limit value known.

Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace
procedures atmosphere or biological monitoring may be required to determine the effectiveness
of the ventilation or other control measures and/or the necessity to use respiratory
protective equipment. Reference should be made to monitoring standards, such as
the following: European Standard EN 689 (Workplace atmospheres - Guidance for
the assessment of exposure by inhalation to chemical agents for comparison with
limit values and measurement strategy) European Standard EN 14042 (Workplace
atmospheres - Guide for the application and use of procedures for the assessment
of exposure to chemical and biological agents) European Standard EN 482
(Workplace atmospheres - General requirements for the performance of
procedures for the measurement of chemical agents) Reference to national

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TP Flex® reagent cartridge

SECTION 8: Exposure controls/personal protection

guidance documents for methods for the determination of hazardous substances
will also be required.
DNELs/DMELs
Product/ingredient name Type Exposure Value Population Effects
sodium hydroxide DNEL Long term 1 mg/m³ General Local
Inhalation population
DNEL Long term 1 mg/m³ Workers Local
Inhalation
copper sulphate DNEL Long term Oral 0.041 mg/ General Systemic
kg bw/day population
DNEL Short term Oral 0.082 mg/ General Systemic
kg bw/day population
DNEL Long term 1 mg/m³ Workers Local
Inhalation
DNEL Long term 1 mg/m³ Workers Systemic
Inhalation
DNEL Long term Dermal 137 mg/kg Workers Systemic
bw/day
PNECs
No PNECs available

8.2 Exposure controls

Appropriate engineering : If user operations generate dust, fumes, gas, vapour or mist, use process
controls enclosures, local exhaust ventilation or other engineering controls to keep worker
exposure to airborne contaminants below any recommended or statutory limits.
Individual protection measures
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products,
before eating, smoking and using the lavatory and at the end of the working period.
Appropriate techniques should be used to remove potentially contaminated clothing.
Wash contaminated clothing before reusing. Ensure that eyewash stations and
safety showers are close to the workstation location.
Eye/face protection : Safety eyewear complying with an approved standard should be used when a risk
assessment indicates this is necessary to avoid exposure to liquid splashes, mists,
gases or dusts. If contact is possible, the following protection should be worn,
unless the assessment indicates a higher degree of protection: chemical splash
goggles and/or face shield. If inhalation hazards exist, a full-face respirator may be
required instead.
Skin protection
Hand protection : Chemical-resistant, impervious gloves complying with an approved standard should
be worn at all times when handling chemical products if a risk assessment
indicates this is necessary. Considering the parameters specified by the glove
manufacturer, check during use that the gloves are still retaining their protective
properties. It should be noted that the time to breakthrough for any glove material
may be different for different glove manufacturers. In the case of mixtures,
consisting of several substances, the protection time of the gloves cannot be
accurately estimated.
Impervious gloves (e.g. butyl, nitrile, etc.) are recommended if skin contact is
possible and for processing operations. Protective gloves must meet the standards
in accordance with CEN EN374, ASTM F1001 or international equivalent.
Body protection : Personal protective equipment for the body should be selected based on the task
being performed and the risks involved and should be approved by a specialist
before handling this product.
Other skin protection : Appropriate footwear and any additional skin protection measures should be
selected based on the task being performed and the risks involved and should be
approved by a specialist before handling this product.
Respiratory protection : Based on the hazard and potential for exposure, select a respirator that meets the
appropriate standard or certification. Respirators must be used according to a
respiratory protection program to ensure proper fitting, training, and other important
aspects of use.

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TP Flex® reagent cartridge

SECTION 8: Exposure controls/personal protection

Environmental exposure : Emissions from ventilation or work process equipment should be checked to
controls ensure they comply with the requirements of environmental protection legislation.
In some cases, fume scrubbers, filters or engineering modifications to the process
equipment will be necessary to reduce emissions to acceptable levels.

SECTION 9: Physical and chemical properties

The conditions of measurement of all properties are at standard temperature and pressure unless otherwise indicated.

9.1 Information on basic physical and chemical properties

Appearance
Physical state : Liquid.
Colour : Not available.
Odour : Not available.
Odour threshold : Not relevant/applicable due to nature of the product.
Melting point/freezing point : Not relevant/applicable due to nature of the product.
Softening point : Not relevant/applicable due to nature of the product.
Sublimation temperature : Not relevant/applicable due to nature of the product.
Initial boiling point and : Not available.
boiling range
Flammability : Not relevant/applicable due to nature of the product.
Lower and upper explosion : Not available.
limit
Flash point : [Product does not sustain combustion.]
Auto-ignition temperature : Not relevant/applicable due to nature of the product.
Decomposition temperature : Not relevant/applicable due to nature of the product.
pH : 13.3 [Conc. (% w/w): 0.48%]
Viscosity : Not available.
Solubility(ies) :
Media Result
cold water Easily soluble

Solubility in water : Not relevant/applicable due to nature of the product.

Miscible with water : Not relevant/applicable due to nature of the product.
Partition coefficient: n-octanol/ : Not relevant/applicable due to nature of the product.
water
Vapour pressure :
Vapour Pressure at 20˚C Vapour pressure at 50˚C
Ingredient name mm Hg kPa Method mm Hg kPa Method
water 23.8 3.2

Evaporation rate : Not relevant/applicable due to nature of the product.

Relative density : Not available.
Vapour density : Not available.
Explosive properties : Not available.
Oxidising properties : Not available.
Particle characteristics
Median particle size : Not applicable.

Burning time : Not relevant/applicable due to nature of the product.

Fundamental burning velocity : Not relevant/applicable due to nature of the product.
Burning rate : Not relevant/applicable due to nature of the product.

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TP Flex® reagent cartridge

SECTION 9: Physical and chemical properties

SADT : Not relevant/applicable due to nature of the product.
SAPT : Not relevant/applicable due to nature of the product.
Heat of reaction : Not relevant/applicable due to nature of the product.
Heat of combustion : Not relevant/applicable due to nature of the product.
Flow time (ISO 2431) : Not relevant/applicable due to nature of the product.

SECTION 10: Stability and reactivity

10.1 Reactivity : No specific test data related to reactivity available for this product or its ingredients.

10.2 Chemical stability : The product is stable.

10.3 Possibility of : Under normal conditions of storage and use, hazardous reactions will not occur.
hazardous reactions

10.4 Conditions to avoid : No specific data.

10.5 Incompatible materials : Reactive or incompatible with the following materials:

acids
metals

10.6 Hazardous : Under normal conditions of storage and use, hazardous decomposition products
decomposition products should not be produced.

SECTION 11: Toxicological information

11.1 Information on toxicological effects
Acute toxicity
Product/ingredient name Result Species Dose Exposure
copper sulphate LD50 Oral Rat - Female 300 mg/kg -
Conclusion/Summary : Not available.
Acute toxicity estimates
Product/ingredient name Oral (mg/ Dermal Inhalation Inhalation Inhalation
kg) (mg/kg) (gases) (vapours) (dusts
(ppm) (mg/l) and mists)
(mg/l)
TP Flex® reagent cartridge 23250 N/A N/A N/A N/A
copper sulphate 500 N/A N/A N/A N/A
Irritation/Corrosion
Product/ingredient name Result Species Score Exposure Observation
sodium hydroxide Eyes - Mild irritant Rabbit - 400 ug -
Eyes - Severe irritant Monkey - 24 hours 1 % -
Eyes - Severe irritant Rabbit - 1% -
Eyes - Severe irritant Rabbit - 0.5 minutes -
1 mg
Eyes - Severe irritant Rabbit - 24 hours 50 -
ug
Skin - Mild irritant Human - 24 hours 2 % -
Skin - Severe irritant Rabbit - 24 hours 500 -
mg
Conclusion/Summary : Not available.
Sensitisation
Conclusion/Summary : Not available.
Mutagenicity
Conclusion/Summary : Not available.

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TP Flex® reagent cartridge

SECTION 11: Toxicological information

Carcinogenicity
Conclusion/Summary : Not available.
Reproductive toxicity
Conclusion/Summary : Not available.
Teratogenicity
Conclusion/Summary : Not available.
Specific target organ toxicity (single exposure)
Not available.
Specific target organ toxicity (repeated exposure)
Not available.
Aspiration hazard
Not available.

Information on likely routes : Routes of entry anticipated: Dermal, Inhalation.

of exposure Routes of entry not anticipated: Oral.
Potential acute health effects
Eye contact : Causes serious eye damage.
Inhalation : No known significant effects or critical hazards.
Skin contact : Causes severe burns.
Ingestion : No known significant effects or critical hazards.

Symptoms related to the physical, chemical and toxicological characteristics

Eye contact : Adverse symptoms may include the following:
pain
watering
redness
Inhalation : No specific data.
Skin contact : Adverse symptoms may include the following:
pain or irritation
redness
blistering may occur
Ingestion : Adverse symptoms may include the following:
stomach pains

Delayed and immediate effects as well as chronic effects from short and long-term exposure
Short term exposure
Potential immediate : Not available.
effects
Potential delayed effects : Not available.
Long term exposure
Potential immediate : Not available.
effects
Potential delayed effects : Not available.
Potential chronic health effects
Not available.
Conclusion/Summary : Not available.
General : No known significant effects or critical hazards.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Reproductive toxicity : No known significant effects or critical hazards.

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TP Flex® reagent cartridge

SECTION 11: Toxicological information

11.2 Information on other hazards
11.2.1 Endocrine disrupting properties
Not available.
11.2.2 Other information
Not available.

SECTION 12: Ecological information

12.1 Toxicity
Product/ingredient name Result Species Exposure
sodium hydroxide Acute EC50 40.38 mg/l Fresh water Crustaceans - Ceriodaphnia 48 hours
dubia - Neonate
Acute LC50 125 ppm Fresh water Fish - Gambusia affinis - Adult 96 hours
copper sulphate Acute EC50 0.4 μg/l Marine water Algae - Isochrysis galbana 72 hours
Acute EC50 16.2 μg/l Fresh water Aquatic plants - Lemna 96 hours
aequinoctialis
Acute EC50 1.4 μg/l Fresh water Crustaceans - Bosmina 48 hours
longirostris - Neonate
Acute LC50 0.01 ng/ml Fresh water Daphnia - Daphnia magna - 48 hours
Neonate
Acute LC50 0.057 μg/l Fresh water Fish - Cirrhinus mrigala 96 hours
Chronic NOEC 0.0003 mg/l Marine Algae - Entomoneis punctulata - 72 hours
water Exponential growth phase
Chronic NOEC 0.0018 mg/l Fresh Aquatic plants - Lemna minor 96 hours
water
Chronic NOEC 5.06 μg/l Marine water Crustaceans - Moina mongolica 21 days
- Neonate
Chronic NOEC 10 μg/l Fresh water Daphnia - Daphnia magna - 21 days
Instar
Chronic NOEC 0.46 μg/l Fresh water Fish - Acipenser transmontanus 53 days
- Larvae
Conclusion/Summary : Not available.

12.2 Persistence and degradability

Conclusion/Summary : Not available.

12.3 Bioaccumulative potential

Not available.

12.4 Mobility in soil

Soil/water partition : Not available.
coefficient (KOC)
Mobility : Not available.

12.5 Results of PBT and vPvB assessment

This mixture does not contain any substances that are assessed to be a PBT or a vPvB.

12.6 Endocrine disrupting properties

Not available.

12.7 Other adverse effects

No known significant effects or critical hazards.

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TP Flex® reagent cartridge

SECTION 13: Disposal considerations

13.1 Waste treatment methods
Product
Methods of disposal : The generation of waste should be avoided or minimised wherever possible.
Disposal of this product, solutions and any by-products should at all times comply
with the requirements of environmental protection and waste disposal legislation
and any regional local authority requirements. Dispose of surplus and non-
recyclable products via a licensed waste disposal contractor. Waste should not be
disposed of untreated to the sewer unless fully compliant with the requirements of
all authorities with jurisdiction.
Hazardous waste : The classification of the product may meet the criteria for a hazardous waste.
Packaging
Methods of disposal : The generation of waste should be avoided or minimised wherever possible. Waste
packaging should be recycled. Incineration or landfill should only be considered
when recycling is not feasible.
Special precautions : This material and its container must be disposed of in a safe way. Care should be
taken when handling emptied containers that have not been cleaned or rinsed out.
Empty containers or liners may retain some product residues. Avoid dispersal of
spilt material and runoff and contact with soil, waterways, drains and sewers.

SECTION 14: Transport information

ADR/RID
14.1 UN number UN1824

14.2 UN proper Sodium hydroxide solution

shipping name
14.3 Transport 8
hazard class(es)

14.4 Packing II
group
14.5 No.
Environmental
hazards
Additional -
information
ADN
14.1 UN number UN1824

14.2 UN proper Sodium hydroxide solution

shipping name
14.3 Transport 8
hazard class(es)

14.4 Packing II
group
14.5 No.
Environmental
hazards
Additional -
information

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Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU) 2020/878

TP Flex® reagent cartridge

SECTION 14: Transport information

IMDG
14.1 UN number UN1824

14.2 UN proper SODIUM HYDROXIDE, SOLUTION

shipping name
14.3 Transport 8
hazard class(es)

14.4 Packing II
group
14.5 No.
Environmental
hazards
Additional -
information
IATA
14.1 UN number UN1824

14.2 UN proper SODIUM HYDROXIDE, SOLUTION

shipping name
14.3 Transport 8
hazard class(es)

14.4 Packing II
group
14.5 No.
Environmental
hazards
Additional -
information

14.6 Special precautions for : Transport within user’s premises: always transport in closed containers that are
user upright and secure. Ensure that persons transporting the product know what to do
in the event of an accident or spillage.

14.7 Transport in bulk : Not applicable.

according to IMO
instruments

Notes : A “-“ = not applicable.

SECTION 15: Regulatory information

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

EU Regulation (EC) No. 1907/2006 (REACH)

Annex XIV - List of substances subject to authorisation
Annex XIV
None of the components are listed.

Date of issue/Date of revision : 12/11/2022 Date of previous issue : No previous validation Version :1 12/14
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU) 2020/878

TP Flex® reagent cartridge

SECTION 15: Regulatory information

Substances of very high concern
None of the components are listed.
Annex XVII - Restrictions : Not applicable.
on the manufacture,
placing on the market
and use of certain
dangerous substances,
mixtures and articles
Other EU regulations
Industrial emissions : Not listed
(integrated pollution
prevention and control) -
Air
Industrial emissions : Not listed
(integrated pollution
prevention and control) -
Water
Ozone depleting substances (1005/2009/EU)
Not listed.
Prior Informed Consent (PIC) (649/2012/EU)
Not listed.
Persistent Organic Pollutants
Not listed.
Seveso Directive
This product is not controlled under the Seveso Directive.
National regulations
International regulations
Montreal Protocol
Not listed.
Stockholm Convention on Persistent Organic Pollutants
Not listed.
Rotterdam Convention on Prior Informed Consent (PIC)
Not listed.

UNECE Aarhus Protocol on POPs and Heavy Metals

Not listed.

15.2 Chemical safety : Not applicable.

assessment

SECTION 16: Other information

Indicates information that has changed from previously issued version.
Abbreviations and : ATE = Acute Toxicity Estimate
acronyms CLP = Classification, Labelling and Packaging Regulation [Regulation (EC) No.
1272/2008]
DMEL = Derived Minimal Effect Level
DNEL = Derived No Effect Level
EUH statement = CLP-specific Hazard statement
PBT = Persistent, Bioaccumulative and Toxic
PNEC = Predicted No Effect Concentration
RRN = REACH Registration Number
vPvB = Very Persistent and Very Bioaccumulative

Date of issue/Date of revision : 12/11/2022 Date of previous issue : No previous validation Version :1 13/14
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU) 2020/878

TP Flex® reagent cartridge

SECTION 16: Other information

ASTM = American Society of Testing Materials
CEN = European Committee on Standardization
ECHA = European Chemicals Agency
RTECS = Registry of Toxic Effects of Chemical Substances
Key literature references : This SDS was prepared on the basis of sheets of individual components, literature
and sources for data data, online databases (e.g. ECHA, RTECS) as well as our knowledge and
experience, taking into account current legislation.

Procedure used to derive the classification according to Regulation (EC) No. 1272/2008 [CLP/GHS]
Classification Justification
Met. Corr. 1, H290 On basis of test data
Skin Corr. 1, H314 On basis of test data
Aquatic Chronic 3, H412 Calculation method
Full text of abbreviated H statements
H290 May be corrosive to metals.
H302 Harmful if swallowed.
H314 Causes severe skin burns and eye damage.
H318 Causes serious eye damage.
H400 Very toxic to aquatic life.
H410 Very toxic to aquatic life with long lasting effects.
H412 Harmful to aquatic life with long lasting effects.
Full text of classifications [CLP/GHS]
Acute Tox. 4 ACUTE TOXICITY - Category 4
Aquatic Acute 1 SHORT-TERM (ACUTE) AQUATIC HAZARD - Category 1
Aquatic Chronic 1 LONG-TERM (CHRONIC) AQUATIC HAZARD - Category 1
Aquatic Chronic 3 LONG-TERM (CHRONIC) AQUATIC HAZARD - Category 3
Eye Dam. 1 SERIOUS EYE DAMAGE/EYE IRRITATION - Category 1
Met. Corr. 1 CORROSIVE TO METALS - Category 1
Skin Corr. 1 SKIN CORROSION/IRRITATION - Category 1
Skin Corr. 1A SKIN CORROSION/IRRITATION - Category 1A
Training advice : Provide workers with adequate training to assure that chemicals are handled safely
in accordance with national and community legislation.
Date of printing : 12/11/2022
Date of issue/ Date of : 12/11/2022
revision
Date of previous issue : No previous validation
Version : 1
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above-
named supplier, nor any of its subsidiaries, assumes any liability whatsoever for the accuracy or
completeness of the information contained herein.
Final determination of suitability of any material is the sole responsibility of the user. All materials may
present unknown hazards and should be used with caution. Although certain hazards are described herein,
we cannot guarantee that these are the only hazards that exist.

Date of issue/Date of revision : 12/11/2022 Date of previous issue : No previous validation Version :1 14/14