Magnetic particles

Safety Data Sheet SDS n°103

according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878
Revision 00 - Revision date: 08/02/2024 – CC22-109

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

1.1. Product identifier

Product form Mixture
Trade name Magnetic particles

1.2. Relevant identified uses of the substance or mixture and uses advised against
1.2.1. Relevant identified uses
Use of the substance/mixture : For in vitro diagnostic use.

1.2.2. Uses advised against

Restrictions on use : Any other use other than that indicated as relevant.

1.3. Details of the supplier of the safety data sheet

ElitechGroup Spa
C.so Svizzera 185
10149 Torino
Italy
T +39 011 97.61.91 - F +39 011 93.676.11
E-mail address of competent person responsible for the SDS : [email protected]

1.4. Emergency telephone number

Emergency number : +39 011 97.61.91 (Office time: monday – friday; 8:30-13; 14:00-17:30; language spoken: italian)

SECTION 2: Hazards identification

2.1. Classification of the substance or mixture

Classification according to Regulation (EC) No. 1272/2008 [CLP]
Not classified

Adverse physicochemical, human health and environmental effects

To the best of our knowledge, this product does not present any particular risk, subject to compliance with general industrial hygiene rules.

2.2. Label elements

Labelling according to Regulation (EC) No. 1272/2008 [CLP]
Labelling not applicable

2.3. Other hazards

This substance/mixture does not meet the PBT criteria of the REACH Regulation, Annex XIII
This substance/mixture does not meet the vPvB criteria of the REACH Regulation, Annex XIII
Contains no PBT and/or vPvB substances ≥ 0.1% evaluated in accordance with Annex XIII of REACH

The mixture does not contain a substance(s) included in the list established in accordance with Article 59(1) of REACH for possessing endocrine
disrupting properties, or is not identified as having endocrine disrupting properties in accordance with the criteria laid down in Commission
Delegated Regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 in concentrations equal to or greater than 0,1 %.

SECTION 3: Composition/information on ingredients

3.1. Substances
Not applicable

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 Magnetic particles
Safety Data Sheet SDS n°103
according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878
Revision 00 - Revision date: 08/02/2024 – CC22-109

3.2. Mixtures

Name Product identifier Conc. % w/w Classification according to Regulation (EC)

No. 1272/2008 [CLP]
Triiron tetraoxide CAS Number: 1317-61-9 >50 Self-heat. 2, H252
CE Number: 215-277-5
Full text of H- and EUH-statements: see section 16

SECTION 4 : First aid measures

4.1. Description of first aid measures

General First-aid measures : If you feel unwell, contact a doctor.
First-aid measures after inhalation : Carry the injured person to fresh air and keep him at rest in a position conducive to
breathing.
First-aid measures after skin contact : Wash skin with plenty of water.
First-aid measures after eye contact : Wash eyes with water as a precaution.
First-aid measures after ingestion : If you feel unwell, contact a poison control centre or doctor

4.2. Most important symptoms and effects, both acute and delayed
Symptoms/effects : Although no precise data are known regarding the health effects on humans and animals, it
is believed that the inhalation of this material poses risks.
Symptoms/effects of inhalation : None under normal conditions.
Symptoms/effects in the event of skin contact None under normal conditions.
Symptoms/effects in case of eye contact None under normal conditions.
Symptoms/effects if swallowed None under normal conditions.

4.3. Indication of any immediate medical attention and special treatment needed
Treat symptomatically.

SECTION 5: Firefighting measures

5.1. Extinguishing media

Suitable extinguishing media : Water spray. Dry powder. Foam. Carbon dioxide.
Unsuitable extinguishing media : Do not use a compact jet of water.

5.2. Special hazards arising from the substance or mixture

Fire hazard : No fire risk
Danger of explosion No direct risk of explosion
Hazardous combustion products in case of fire Possible development of toxic fumes

5.3. Advice for firefighters

Extinction Instructions : Extinguish the fire from a safe distance/protected point. Do not enter the fire area without
the appropriate protective equipment, including self-contained breathing apparatus.
Protection during firefighting : Do not act without appropriate protective equipment. Self-contained breathing apparatus.
Full body protection

SECTION 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures

General measures Stop the leak if there is no danger. Inform the authorities if the product enters the sewage
system or public waters. Absorb the spillage to avoid material damage.

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Revision date: 08/02/2024 SDS 103
 Magnetic particles
Safety Data Sheet SDS n°103
according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878
Revision 00 - Revision date: 08/02/2024 – CC22-109

6.1.1. For non-emergency personnel

Protective equipment : Wear the recommended personal protective equipment.
Emergency procedures : Ventilate the spill area.

6.1.2. For emergency responders

Protective equipment : Do not act without appropriate protective equipment. For more information, see section 8:
'Exposure control-personal protection'.
Emergency procedures Remove unnecessary personnel. Stop the leak if there is no danger.

6.2. Environmental precautions

Avoid release to the environment.

6.3. Methods and material for containment and cleaning up

Methods for containment : Collect spilled material. Retain any spills with dikes or absorbents to prevent leakage or
penetration into sewers or watercourses. Stop spillage if possible without risk.
Methods for cleaning up : Absorb spilled liquid with absorbent material. Inform the authorities if the product enters the
sewage system or public waters.
Other information : Dispose of materials or solid residues at an authorized site.

6.4. Reference to other sections

See section 13 for information on disposal.

SECTION 7: Handling and storage

7.1. Precautions for safe handling

Additional hazards in processing : It is not expected to present a significant risk under expected conditions of normal use.
Precautions for safe handling : Ensure good ventilation of the workplace. Wear personal protective equipment.
Hygiene measures : Do not eat, drink or smoke when using this product. Always wash hands after handling the
product.

7.2. Conditions for safe storage, including any incompatibilities

Technical measures : Ground the container and the receiving device.
Storage Conditions : Store in a cool place. Protect from the sun's rays.
Packaging materials : Always store the product in a container of the same type as the original one.

7.3. Specific end use(s)

Magnetic particles is intended for in vitro diagnostic use. Use the product in accordance with the Good Laboratory Practice.

SECTION 8: Exposure controls/personal protection

8.1. Control parameters

8.1.1 National occupational exposure and biological limit values

Triiron tetroxide (1317-61-9)

Poland - Occupational Exposure Limit Values

Local name Tetratlenek triżelaza

NDS (OEL TWA) 5 mg/m³ w przeliczeniu na Fe: frakcja wdychalna

2,5 mg/m³ w przeliczeniu na Fe: frakcja respirabilna

NDSCh (OEL STEL) 10 mg/m³ w przeliczeniu na Fe: frakcja wdychalna

5 mg/m³ w przeliczeniu na Fe: frakcja respirabilna

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 Magnetic particles
Safety Data Sheet SDS n°103
according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878
Revision 00 - Revision date: 08/02/2024 – CC22-109

Triiron tetroxide (1317-61-9)

Comment Frakcja wdychalna – frakcja aerozolu wnikająca przez nos i usta, która po zdeponowaniu
w drogach oddechowych stwarza zagrożenie dla zdrowia. Frakcja respirabilna – frakcja
aerozolu wnikająca do dróg oddechowych, która stwarza zagrożenie dla zdrowia po
zdeponowaniu w obszarze wymiany gazowej.

Normative reference Dz. U. 2018 poz. 1286 wraz z późn. zm.

8.1.2. Recommended monitoring procedures

Monitoring Methods
Monitoring Methods The measurement of substances in the working environment must be carried out by
standardised methods or, in their absence, by appropriate methods.

8.1.3. Air contaminants formed

No additional information available

8.1.4. DNEL and PNEC

No additional information available

8.1.5. Control banding

No additional information available

8.2. Exposure controls

8.2.1. Appropriate engineering controls

Suitable technical controls:

Ensure good ventilation of the workplace.

8.2.2. Personal protection equipment

Personal protective equipment:

Wear recommended personal protective equipment.
Personal Protective Equipment Symbol(s):

8.2.2.1. Eye and face protection

Eye protection:
Safety glasses.

8.2.2.2. Skin protection

Skin and body protection:
Use suitable protective clothing.

Hand protection:
Wear protective gloves.

8.2.2.3. Respiratory protection

Respiratory protection:
In case of insufficient ventilation, use a suitable respiratory device.

8.2.2.4. Thermal hazards

No additional information available

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 Magnetic particles
Safety Data Sheet SDS n°103
according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878
Revision 00 - Revision date: 08/02/2024 – CC22-109

8.2.3. Environmental exposure controls

Environmental exposure controls:

Avoid release to the environment.
Other information:
Appropriate technical exposure control measures, to be taken in the workplace, must be selected and applied following the risk assessment carried
out by the employer, in relation to his work activity (in accordance with Directive 98/24/EEC, implemented by Legislative Decree 81 of 9 April 2008
as amended and supplemented).

SECTION 9: Physical and chemical properties

9.1. Information on basic physical and chemical properties

Physical state : Solid
Colour : Not available
Odour : Not available.
Odour threshold : Not available
Melting point : Not applicable
Freezing point : Not available
Boiling point : Not available
Flammability : Non-flammable
Explosive properties : Not available
Oxidising properties : Not available
Lower explosion limit : Not available
Upper explosion limit : Not available
Flash point : Not available
Auto-ignition temperature : Not available
Decomposition temperature : Not available
pH : Not available
Viscosity, kinematic : Not available
Solubility : Not available
Partition coefficient n-octanol/water (Log Kow) : Not available
Vapour pressure : Not available
Vapour pressure at 50°C : Not available
Density : Not available
Relative density : Not available
Relative vapour density at 20°C : Not available
Particle characteristics : Not applicable

9.2. Other information

9.2.1. Information with regard to physical hazard classes
No additional information available

9.2.2. Other safety characteristics

No additional information available

SECTION 10: Stability and reactivity

10.1. Reactivity
The product is non-reactive under normal conditions of use, storage and transport.

10.2. Chemical stability

Stable under normal conditions.

10.3. Possibility of hazardous reactions

No knowledge of dangerous reactions under normal conditions of use.

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Revision date: 08/02/2024 SDS 103
 Magnetic particles
Safety Data Sheet SDS n°103
according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878
Revision 00 - Revision date: 08/02/2024 – CC22-109

10.4. Conditions to avoid

None under recommended storage and handling conditions (see section 7).

10.5. Incompatible materials

No further information available.

10.6. Hazardous decomposition products

Under normal conditions of storage and use, no hazardous decomposition products should be created.

SECTION 11: Toxicological information

11.1. Information on hazard classes as defined in Regulation (EC) No 1272/2008

Acute toxicity (oral) : Not classified (Based on available data, the classification criteria are not met)
Acute toxicity (dermal) : Not classified (Based on available data, the classification criteria are not met)
Acute toxicity (inhalation) : Not classified (Based on available data, the classification criteria are not met)
Triiron tetroxide (1317-61-9)
DL50 oral rat > 2000 mg/kg

CL50 Inhalation - Rat > 640 mg/m³ no deaths; Study OCSE 403
Skin corrosion/irritation : Not classified (Based on available data, the classification criteria are not met)
Serious eye damage/irritation : Not classified (Based on available data, the classification criteria are not met)
Respiratory or skin sensitisation : Not classified (Based on available data, the classification criteria are not met)
Germ cell mutagenicity : Not classified (Based on available data, the classification criteria are not met)
Carcinogenicity : Not classified (Based on available data, the classification criteria are not met)
Reproductive toxicity : Not classified (Based on available data, the classification criteria are not met)
STOT-single exposure : Not classified (Based on available data, the classification criteria are not met)
STOT-repeated exposure : Not classified (Based on available data, the classification criteria are not met)
Aspiration hazard : Not classified (Based on available data, the classification criteria are not met)

11.2. Information on other hazards

11.2.1. Endocrine disrupting properties
Adverse health effects caused by endocrine : The mixture does not contain a substance(s) included in the list established in accordance
disrupting properties with Article 59(1) of REACH for possessing endocrine disrupting properties, or is not
identified as having endocrine disrupting properties in accordance with the criteria laid down
in Commission Delegated Regulation (EU) 2017/2100 or Commission Regulation (EU)
2018/605

11.2.2. Other information

No further information available

SECTION 12: Ecological information

12.1. Toxicity
Ecology - general : The product is not considered hazardous to aquatic organisms and does not cause any
long-term undesirable effects on the environment.
Hazardous to the aquatic environment, short–term : Not classified (Based on available data, the classification criteria are not met)
(acute)
Hazardous to the aquatic environment, long–term : Not classified (Based on available data, the classification criteria are not met)
(chronic)
Triiron tetroxide (1317-61-9)
CL50 - Fish [1] > 100 g/l

CE50 - Crustaceans [1] > 10 g/l

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 Magnetic particles
Safety Data Sheet SDS n°103
according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878
Revision 00 - Revision date: 08/02/2024 – CC22-109

Triiron tetroxide (1317-61-9)

CE50 72h - Algae [1] > 20 mg/l

12.2. Persistence and degradability

Triiron tetroxide (1317-61-9)

Persistence and degradability Not rapidly degradable

CI 77499 Inorganic substance, ready biodegradability studies not applicable.

12.3. Bioaccumulative potential

No further information available.

12.4. Mobility in soil

No further information available.

12.5. Results of PBT and vPvB assessment

Magnetic particles
This substance/mixture does not meet the PBT criteria of the REACH Regulation, Annex XIII

This substance/mixture does not meet the vPvB criteria of the REACH Regulation, Annex XIII

12.6. Endocrine disrupting properties

Adverse effects on the environment caused by : The mixture does not contain a substance(s) included in the list established in accordance
endocrine disrupting properties with Article 59(1) of REACH for possessing endocrine disrupting properties, or is not
identified as having endocrine disrupting properties according to the criteria laid down in
Commission Delegated Regulation (EU) 2017/2100 or Commission Regulation (EU)
2018/605.

12.7. Other adverse effects

No further information available.

SECTION 13: Disposal considerations

13.1. Waste treatment methods

Regional waste regulation Disposal in accordance with legal requirements.
Waste treatment methods : Dispose of the contents/container in accordance with the sorting instructions of the
authorised collector.
Sewerage Recommendations Disposal in accordance with legal requirements.
Advice on Disposal of Product/Packaging Disposal in accordance with legal requirements.
Further indications Do not reuse empty containers.

SECTION 14: Transport information

In accordance with ADR / IMDG / IATA / RID
ADR IMDG IATA RID

14.1. UN number or ID number

Not applicable Not applicable Not applicable Not applicable

14.2. UN proper shipping name

Not applicable Not applicable Not applicable Not applicable

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Safety Data Sheet SDS n°103
according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878
Revision 00 - Revision date: 08/02/2024 – CC22-109

ADR IMDG IATA RID

14.3. Transport hazard class(es)

Not applicable Not applicable Not applicable Not applicable

14.4. Packing group

Not applicable Not applicable Not applicable Not applicable

14.5. Environmental hazards

Not applicable Not applicable Not applicable Not applicable

No supplementary information available

14.6. Special precautions for user

Overland transport
Not applicable

Transport by sea
Not applicable

Air transport
Not applicable

Rail transport
Not applicable

14.7. Maritime transport in bulk according to IMO instruments

Not applicable

SECTION 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
15.1.1. EU-Regulations

REACH Annex XVII (Restriction List)

Contains no substance(s) listed on REACH Annex XVII (Restriction Conditions)

REACH Annex XIV (Authorisation List)

Contains no substance(s) listed on Annex XIV of REACH (Authorisation List).

REACH Candidate List (SVHC)

Contains no substance(s) listed on REACH candidate list.

PIC Regulation (Prior Informed Consent)

Contains no substance(s) listed on the PIC list (Regulation EU 649/2012 concerning the export and import of hazardous chemicals)

POP Regulation (Persistent Organic Pollutants)

Contains no substance(s) listed on the POP list (Regulation EU 2019/1021 on persistent organic pollutants)

Ozone Regulation (1005/2009)

Contains no substance(s) listed on the Ozone Depletion list (Regulation EU 1005/2009 on substances that deplete the ozone layer)

Dual-Use Regulation (428/2009)

Contains no substance(s) subject to COUNCIL REGULATION (EC) No 428/2009 of 5 May 2009 setting up a Community regime for the control of
exports, transfer, brokering and transit of dual-use items.

Explosives Precursors Regulation (2019/1148)

Contains no substance(s) listed on the Explosives Precursors list (Regulation EU 2019/1148 on the marketing and use of explosives precursors)

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Revision date: 08/02/2024 SDS 103
 Magnetic particles
Safety Data Sheet SDS n°103
according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878
Revision 00 - Revision date: 08/02/2024 – CC22-109

Drug Precursors Regulation (273/2004)

Contains no substance(s) listed on the Drug Precursors list (Regulation EC 273/2004 on the manufacture and the placing on market of certain
substances used in the illicit manufacture of narcotic drugs and psychotropic substances)

15.1.2. National regulations

No further information available

15.2. Chemical safety assessment

No chemical safety assessment has been carried out

SECTION 16: Other information

Indication of changes:

Issue date: 08/02/2024

Revision 00: 08/02/2024, CC22-109: update of sections 1-16, according to Regulation 2020/878.

Abbreviations and acronyms:

ACGIH American Conference of Governmental Industrial Hygienists

ADN European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways

ADR European Agreement concerning the International Carriage of Dangerous Goods by Road

BCF Bioconcentration factor

BEI Biological Esposure Indices

BLV Biological limit value

CAS Chemical Abstract Service (division of the American Chemical Society)

EC50 Median effective concentration

LC50 Median lethal concentration

CLP Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008

LD50 Median lethal dose

DMEL Derived Minimal Effect level

DNEL Derived-No Effect Level

ED Endocrine disrupting properties

EINECS European Inventory of Existing Commercial Substances

EPA US Environmental Protection Agency

IATA International Air Transport Association

IMDG International Maritime Dangerous Goods

LOAEL Lowest Observed Adverse Effect Level

NOAEC No-Observed Adverse Effect Concentration

NOAEL No-Observed Adverse Effect Level

NOEC No-Observed Effect Concentration

NTP National Toxicology Program

OECD Organisation for Economic Co-operation and Development

OEL Occupational Exposure Limit

OSHA Occupational Safety and Health Administration

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Revision date: 08/02/2024 SDS 103
 Magnetic particles
Safety Data Sheet SDS n°103
according to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878
Revision 00 - Revision date: 08/02/2024 – CC22-109

Abbreviations and acronyms:

PBT Persistent Bioaccumulative Toxic

PNEC Predicted No-Effect Concentration

PPE Personal protective Equipment

REACH Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (EC) No 1907/2006

RID Regulations concerning the International Carriage of Dangerous Goods by Rail

SDS Safety Data Sheet

ATE Acute Toxicity Estimate

STP Sewage treatment plant

TLV/TWA Threshold Limit Value/Threshold Weighted Average

vPvB Very Persistent and Very Bioaccumulative

SVHC: substance of very high concern

SVHC: substance of very high concern

Data sources : ECHA database

Training advice : Adequately train workers potentially exposed to this substance on the basis of the contents
of this safety data sheet. The training of workers must include contents, updates and
duration according to the risk profiles assigned to the working sectors to which they belong,
according to the procedures provided for by Legislative Decree 81/2008.
Full text of hazard statements H and EUH:
H252 Self-heating in large quantities; may ignite

Self-heat. 2 Self-heating substances and mixtures, category 2

Safety Data Sheet (SDS), EU

This document is intended to provide guidance for the appropriate and precautionary handling of this product by qualified personnel or under the
supervision of personnel experienced in handling chemicals. The product should not be used for purposes other than those indicated in section 1
unless adequate written information on how to handle the material has been received. The person responsible for this document cannot give
warnings about all hazards arising from use or interaction with other chemicals or materials. It is the responsibility of the user to ensure the safe use
of the product, the suitability of the product for the use for which it is applied and the proper disposal. The information below is not intended to be a
representation or warranty, either expressed or implied, of merchantability, fitness for a particular purpose, quality, or any other nature. The
information contained in this SDS complies with Regulation (EU) 2020/878.

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