Kit SDS Cover Sheet: Product Name Part Number Additional Product Information

Page 1 of 53
Kit SDS Cover Sheet

Document ID: IM1397-75: Version AF
Revision Date (year/month/day) 2020/08/05
Last Revision Date (year/month/day) 2015/05/04
Product Information
Product Name IRMA GH
Part Number IM1397
Additional Product Information
Restricted to professional users.
This kit contains coated tubes that are considered articles and thereby those coated tubes
are exempt from SDS requirements
Components
Description Wash Solution (20X)
GH I-125 Tracer
GH Calibrator 0
GH Calibrator 1 - 5
GH Control
Transport Information
Shipping Information IATA IMDG US DOT European ADR Canadian TDG
UN/ID Number 2910 2910 2910 2910 2910
Shipping Name Radioactive Material, excepted package-limited quantity of material
Hazard Class 7 Radioactive Material 7 Radioactive material 7 Radioactive material 7 Radioactive material 7 Radioactive
Materials
Subsidiary Risk None None None None None
Classification Code Not applicable Not applicable Not applicable None Not applicable
Packing Group
Special Provisions Not applicable Not applicable Not applicable Not applicable Not applicable
Additional information
IATA ERG Code 7L Not applicable Not applicable Not applicable Not applicable
EmS Not applicable F-I, S-S Not applicable Not applicable Not applicable
NAERG Code Not applicable Not applicable 161 Not applicable 161
©2020 Beckman Coulter, Inc.

Global SDS – English
Page 2 of 53
Kit SDS Cover Sheet
Document ID: IM1397-75 AF
IRMA GH Revision Date (year/month/day) 2020/08/05
Transport Information (Continued)

Environmental Hazards
Marine Pollutant Not applicable No Not applicable Not applicable Not applicable
Special Precautions for user

No special precautions for users are required.

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SAFETY DATA SHEET

Document ID: IM1397-75 Version AF
Section 1 Identification of the Substance/mixture and of the Company/undertaking

1.1 Product Identifier
Product Name Wash Solution (20X)
Part Number Component of P/N IM1397
1.2 Relevant identified uses of the substance or mixture and uses advised against
Product Use For In Vitro Diagnostic Use. See product literature for details.
1.3 Details of the supplier of the safety data sheet
Manufacturer
IMMUNOTECH s.r.o.
Radiová 1
102 27 Prague 10
Czech Republic
Tel. +420 272 017 444
e-mail address SDSNT@beckman.com

1.4 Emergency telephone number
Telephone number (24H) Chemtrec Emergency Tel No. U.S.A. 800-424-9300, International (001)
703-527-3887
Distributor and Emergency Phone No.
Refer to attached list, Document ID: 472050, for local distributor and emergency
phone numbers.
Section 2 Hazards Identification

2.1 Classification of substance or mixture
Product Description Mixture
Colorless; Clear; Liquid; Odorless
Classification according to EC 1272/2008 (CLP/GHS)
Not classified as hazardous per EC 1272/2008 (CLP/GHS)
Classification according to US-OSHA (HCS 29 CFR 1910.1200) and UN GHS
Toxic to Reproductive Category 1

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IRMA GH
SAFETY DATA SHEET
Wash Solution (20X) Revision Date (year/month/day) 2020/08/05
Section 2 Hazards Identification (Continued)

2.2 Label Elements According to US-OSHA / UN GHS
Hazardous Ingredients
Sodium Borate Decahydrate
Boric Acid
Pictogram
Signal Word
DANGER
Hazard Statements
H360 May damage fertility or the unborn child.
Precautionary Statements
P201 Obtain special instructions before use.
P280 Wear protective gloves, protective clothing and eye/face protection.
P308+P313 IF exposed or concerned: Get medical advice/attention.
P405 Store locked up.
P501 Dispose of contents/container in accordance with local/national regulations
Product label will display most significant precautionary statements.
2.3 Other hazards
.Results of PBT and vPvB assessment
PBT:
. Not applicable.
vPvB: Not applicable.
See Section 11 Toxicological Information for more detailed health information.
Section 3 Composition and Information on Ingredients

3.2 Mixtures
Hazardous Ingredients: Hazard Classification of Pure Ingredients
Chemical Name % by wt. EU 1272/2008 GHS Note
CLP/GHS
Sodium Borate Decahydrate 0.1 - 0.3 Repr. 1B, H360 Acute Tox. Dermal 5, H313 SVHC
Acute Tox. Oral 5, H303
CAS # 1303-96-4 Repr. 1B, H360
EINECS # 210-540-4 Skin Irrit. 3, H316
Index # 005-011-01-1
Boric Acid 0.1 - 0.3 Repr. 1B, H360 Acute Tox. Dermal 5, H313 SVHC
CAS # 10043-35-3 Repr. 1B, H360
Index # Not available
SVHC - Substance of very high concern
See section 8 for available Occupational exposure limits

See Section 15 for additional regulatory information
See Section 16 for description of hazard class and hazard statements

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IRMA GH
SAFETY DATA SHEET
Section 4 First Aid Measures

4.1 Description of first aid measures
Inhalation If product is inhaled, move exposed individual to fresh air. If individual is not
breathing, begin artificial respiration by trained personnel and obtain medical
attention immediately.
Eye Contact If product enters eyes, rinse eyes gently with water as a precaution.
Skin Contact In case of skin contact, rinse with water as a precaution.
Ingestion If product is ingested, rinse mouth with water. If irritation or discomfort occurs,
obtain medical attention immediately.
4.2 Most important symptoms and effects, both acute and delayed
May damage fertility or the unborn child.
4.3 Indication of any immediate medical attention and special treatment needed
No further relevant information available. Refer to Section 4.1.
Section 5 Fire Fighting Measures

5.1 Extinguishing Media In case of fire use carbon dioxide (CO2), dry chemical, water spray or foam.
For large fires use extinguishing media suitable for surrounding fire.
5.2 Special hazards arising from the substance or mixture
Special Fire and Explosion Hazards
No special hazards determined.
Hazardous Combustion Products
No combustion products posing significant hazards are expected from this
product (an aqueous solution).
5.3 Advice for fire fighters
Protective Equipment Self-contained breathing apparatus is recommended for firefighters in all
chemical fire situations.
5.4 Additional information No further relevant information available.
Section 6 Accidental Release Measures

6.1 Personal precautions, protective equipment and emergency procedures
Personal Precautions Observe general safety guidelines for protection; avoid eye and skin contact.
Wear protective gloves, protective clothing and eye/face protection.
6.2 Environmental Precautions Contain spill to prevent migration.
Do not allow the undiluted product to enter sewers/surface or ground water.

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SAFETY DATA SHEET
Section 6 Accidental Release Measures (Continued)

6.3 Methods and material for containment and cleaning up
Spill and Leak Procedures Absorb spilled material with an appropriate inert, non-flammable absorbent and
dispose according to local regulations.
6.4 Reference to other sections Refer sections 8 and 13.
Section 7 Handling and Storage

7.1 Precautions for safe handling Use good laboratory procedures; avoid eye and skin contact.
7.2 Conditions for safe storage, including any incompatibilities
Store at 2 to 8°C, as directed on the product label.
To maintain product quality, store according to the instructions in the product
labeling.
Store away from strong acids, strong bases, strong oxidizers and incompatible
materials (section 10).
7.3 Specific end uses No further relevant information available.
Section 8 Exposure Controls and Personal Protection

8.1 Control parameters
Exposure Limits
US OSHA None established
ACGIH
Boric Acid 6 mg/m3 STEL (inhalable particulate matter) (listed under Borate compounds,
CAS # 10043-35-3 inorganic); 2 mg/m3 TWA (inhalable particulate matter) (listed under Borate
compounds, inorganic)
Sodium Borate Decahydrate 6 mg/m3 STEL (inhalable particulate matter) (listed under Borate compounds,
DFG MAK
Boric Acid 10 mg/m3 Peak (in case of a simultaneous presence of Boric acid and
CAS # 10043-35-3 Tetraborates 0.75 mg Boron/m3 applies) (as B) (inhalable fraction); 10 mg/m3
TWA MAK (inhalable fraction) (as B)
Ireland
Boric Acid 2 mg/m3 TWA (listed under Borate compounds inorganic); 6 mg/m3 STEL
CAS # 10043-35-3 (calculated) (listed under Borate compounds inorganic)
Sodium Borate Decahydrate 5 mg/m3 TWA (listed under Borates); 6 mg/m3 STEL (calculated) (listed under
CAS # 1303-96-4 Borates)
IOELVs None established

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IRMA GH
SAFETY DATA SHEET
Section 8 Exposure Controls and Personal Protection (Continued)

NIOSH
Sodium Borate Decahydrate 5 mg/m3 TWA
CAS # 1303-96-4
Japan None established

Sweden (AFS 2015:7 and amendments)
Sodium Borate Decahydrate 2 mg/m3 TLV; 5 mg/m3 Indicative STEL; Skin notation
CAS # 1303-96-4
8.2 Exposure controls

Engineering Controls No special engineering controls are required. Use with good general ventilation.
Eye Protection Safety
. glasses or chemical goggles should be worn to prevent eye contact.
Refer U.S. OSHA 29 CFR 1910.133, European Standard EN166 or appropriate
government standards.
Skin Protection Wear impervious gloves such as Nitrile or equivalent and protective clothing.
Refer to U.S. OSHA 29 CFR 1910.138, European Standard EN 374, EN
14605:2005+A1:2009 or appropriate government standards.
Respiratory Protection Under normal conditions, the use of this product should not require respiratory
protection. If overexposure should occur and ventilation is not adequate to
maintain airborne concentrations at acceptable levels, the use of respiratory
protection should be evaluated by a qualified professional.
Section 9 Physical and Chemical Properties

9.1 Information on basic physical and chemical properties
Physical State Liquid Specific Gravity 1.19
(Water=1.0)
Color Colorless Solubility
Transparency Clear Water Miscible
Odor Odorless Organic Not determined
pH 8.3 Partition coefficient: Not determined

n-octanol/water
Freezing Point Not determined Auto-ignition Temp. Not applicable
Boiling Point Not determined Decomposition Not determined

Temperature
Flash Point Not applicable Percent Volatiles Not applicable
Evaporation Rate Not determined Vapor Pressure Not determined
Flammability (Solid, Gas) Not applicable Viscosity Not determined
Flammability Limits Not applicable Explosive Properties Not applicable
Vapor Density Not determined Oxidizing Properties Not applicable

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SAFETY DATA SHEET
Section 9 Physical and Chemical Properties (Continued)

Odor Threshold Not applicable
9.2 Other Information No further relevant information available.
Section 10 Stability and Reactivity

10.1 Reactivity No further relevant information available.
10.2 Chemical Stability The product is stable in accordance with recommended storage conditions.
10.3 Possibility of hazardous reactions
No further relevant information available.
10.4 Conditions to Avoid To maintain product performance keep away from strong acids, strong bases,
strong oxidizers.
Avoid exposure to heat and direct sunlight.
10.5 Incompatible materials No further relevant information available.
10.6 Hazardous Decomposition Products
No decomposition products posing significant hazards would be expected from
this product (an aqueous solution).
Section 11 Toxicological Information

11.1 Information on toxicological effects
Toxicity Data for Hazardous Ingredients
Boric Acid Dermal LD50 Rabbit >2000 mg/kg; Inhalation LC50 Rat >0.16 mg/L 4 h (no deaths
CAS # 10043-35-3 occurred); Oral LD50 Rat 2660 mg/kg
Sodium Borate Decahydrate Dermal LD50 Rabbit >10000 mg/kg; Inhalation LC50 Rat >2 mg/m3 4 h; Oral
CAS # 1303-96-4 LD50 Rat 3493 mg/kg
Primary Routes of Exposure Eye contact, ingestion, inhalation, and skin contact.
Acute Toxicity Not classified based on available data.
Skin Corrosion/Irritation Not classified based on available data.
Serious eye damage/eye Not classified based on available data.

irritation
Respiratory/skin sensitization Not classified based on available data.
Carcinogenicity No ingredients in this product are listed as carcinogens by ACGIH, IARC, NTP,
OSHA or 1272/2008 EC regulation.
Germ cell mutagenicity Not classified based on available data.
Reproductive Toxicity May damage fertility or the unborn child.

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SAFETY DATA SHEET
Section 11 Toxicological Information (Continued)

Specific target organ toxicity – single exposure
Not classified based on available data.
Specific target organ toxicity – repeated exposure
Aspiration hazard Not classified based on available data.
Other Information No further relevant information available.
Section 12 Ecological Information

12.1 Ecotoxicity
Fresh Water Species No information available.
Microtox No information available.
Water Flea
Boric Acid 48 h EC50 Daphnia magna: 115 - 153 mg/L
CAS # 10043-35-3
Fresh Water Algae No information available.
12.2 Persistence and degradability Not determined for the product.
12.3 Bioaccumulation Not determined for the product.
12.4 Mobility in soil Not determined for the product.
12.5 Results of PBT and vPvB assessment
Not determined for the product. PBT: Not applicable, vPvB: Not applicable.
12.6 Other Adverse Effects No further relevant information available.
Section 13 Disposal Considerations

13.1 Waste treatment methods
Product Waste Disposal Chemical residues and remains should be routinely handled as special waste. This
must be disposed of in compliance with anti-pollution and other laws of the country
concerned. To ensure compliance we recommend that you contact the relevant
(local) authorities and/or an approved waste-disposal company for information.
Package disposal Dispose of waste product, unused product and contaminated packaging in
compliance with federal, state and local regulations. If unsure of the applicable
requirements, contact the authorities for information.
13.2 Additional information Suggested European waste catalogue 18 01 07 - chemicals other than those
mentioned in 18 01 06. Dispose in accordance with national, state and local
waste regulations.

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SAFETY DATA SHEET
Section 14 Transport Information

Transportation of this product is not regulated under ICAO, IATA DGR, IMDG, US DOT, European ADR and RID or
Canadian
.. TDG.
14.1
.. UN/ID Number: Not regulated for transportation
14.2
.. Shipping Name: Not regulated for transportation
14.3
.. Hazard Class: Not regulated for transportation
..14.4 Packing Group: Not regulated for transportation

..14.5 Environmental Hazards: Not regulated for transportation
14.6
.. Special Precautions for user: None
14.7 Transport in bulk according to Annex II of MARPOL and the IBC Code: Not applicable
Section 15 Regulatory Information

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
US Federal and State Regulations
SARA 313 (Section 313, Title III reporting requirements)
No ingredients listed.
CERCLA (The Comprehensive Environmental Response, Compensation, and Liability Act) 40 CFR
302.4
California Proposition 65
Chemical which is known to the State of California to cause cancer
Chemical which is known to the State of California to cause development toxicity
Chemical which is known to the State of California to cause male reproductive toxicity
Chemical which is known to the State of California to cause female reproductive toxicity
Massachusetts Right To Know (RTK) List
CAS # 1303-96-4 Sodium Borate Decahydrate
New Jersey Dept. of Health Right To Know (RTK) List
CAS # 10043-35-3 Boric Acid

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IRMA GH
SAFETY DATA SHEET
Section 15 Regulatory Information (Continued)

Pennsylvania Right To Know (RTK) List
EU Regulations
This SDS complies with EC Regulations 1907/2006 (REACH) and amendments.
Water Hazard Class (Germany)
WGK 1, low water endangering
REACH 1907/2006 EC - Annex XIV - list of substances subject to authorization.
Refer to Section 3
Canada
This product is exempt from WHMIS label and SDS requirements.
15.2 Chemical Safety Assessment
A Chemical Safety Assessment has not been carried out.
Some hazardous ingredients listed in Section 15 are below the cutoff limits of 0.1% for carcinogen, mutagen and reproductive toxin and 1% for
other health hazards required for reporting in Section 3.
Section 16 Other Information

Beckman Coulter Safety Rating Flammability: 0 Code
Health: 3 0=None
Reactivity with Water: 0 1=Slight
Physical Contact: 3 2=Caution
3=Severe
Revision Changes Changed kit product name.
Updated additional product information on kit cover sheet.
Removed the classification of EC Directives 1999/45/EC and 67/548/EEC from
Sec. 2.1. Sec 3.2 and 15.1
Updated Section 1.
Updated Section 2, 4, 8, 9, 11, 12, 14 - 16.
Document version and issue/revision date
Document ID: IM1397-75
Version: AF
Description of hazard Class and hazard statements from Section 3
Acute Tox. Dermal 5 - Acute Toxicity Dermal, Category 5
Acute Tox. Oral 5 - Acute Toxicity Oral, Category 5
Skin Irrit. 3 - Skin Irritation Category 3
Repr. 1B - Toxic to Reproductive Category 1B
H303 - May be harmful if swallowed.
H313 - May be harmful in contact with skin
H316 - Causes mild skin irritation.
H360 - May damage fertility or the unborn child.

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SAFETY DATA SHEET
Section 16 Other Information (Continued)

Abbreviations and Acronyms ACGIH - American Conference of Governmental Industrial Hygienists
ADR and RID - European Agreement Concerning The International Carriage Of
Dangerous Goods By Road and Rail
CERCLA - The Comprehensive Environmental Response, Compensation, and
Liability Act
CLP - Classification, Labeling and Packaging
DFGMAK - Republic Germany's maximum exposure limit
GHS - Globally Harmonized System
HCS - Hazard Communication Standard
IARC - International Agency for Research on Cancer
IATA DGR - International Air Transport Association Dangerous Goods Regulation
ICAO - International Civil Aviation Organization
IMDG - International Maritime Dangerous Goods
IOELVs - European Unions' Indicative Occupational Exposure Limit Values
NIOSH - National Institute for Occupational Safety and Health
NTP - National Toxicology Program
OSHA - Occupational Safety and Health Administration
PBT - Persistent bioaccumulative and toxic substances
SARA - Superfund Amendments and Reauthorization Act
TDG - Canadian Transportation Of Dangerous Goods Regulations.
UN GHS - United Nations Globally Harmonized System
US DOT - United States Department of Transportation
WHMIS - Workplace Hazardous Material Information System
vPvB - Very persistent and very bioaccumulative substances
LD50 - Lethal Dose, 50%
LC50 - Lethal Concentration, 50%
EC50 - Effective Concentration, 50%
For further information, please contact your local Beckman Coulter, Inc. representative.
WHILE BECKMAN COULTER, INC. BELIEVES THE INFORMATION CONTAINED HEREIN IS VALID AND ACCURATE, BECKMAN COULTER, INC. MAKES NO WARRANTY OR REPRESENTATION AS TO ITS VALIDITY,
ACCURACY, OR CURRENCY. BECKMAN COULTER, INC. SHALL NOT BE LIABLE OR OTHERWISE RESPONSIBLE IN ANY WAY FOR USE OF EITHER THIS INFORMATION OR MATERIALS TO WHICH IT APPLIES.
DISPOSAL OF HAZARDOUS MATERIALS MAY BE SUBJECT TO LOCAL LAWS OR REGULATIONS.

Page 13 of 53
SAFETY DATA SHEET


Product Name GH I-125 Tracer
Manufacturer
IMMUNOTECH s.r.o.
Radiová 1
102 27 Prague 10
Czech Republic
Tel. +420 272 017 444

703-527-3887
phone numbers.

Red; Clear; Liquid; Odorless
Not classified as hazardous per US-OSHA HCS 2012 and UN GHS

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IRMA GH
SAFETY DATA SHEET
GH I-125 Tracer Revision Date (year/month/day) 2020/08/05

2.2 Label Elements According to EC 1272/2008 (CLP/GHS), US-OSHA and UN GHS
Not classified as hazardous per EC 1272/2008 (CLP/GHS), US-OSHA and GHS
Supplemental labeling information
Radioactive
2.3 Other hazards

This product contains concentrations of azide below the hazardous level which
with repeated contact with lead and copper commonly found in plumbing drains
may result in the build up of shock sensitive compounds. Sodium azide forms
explosive compounds with heavy metals.
This product contains material(s) of animal origin. Observe general safety
guidelines for protection when handling this product.
Iodine-125 is a gamma-rays and X-rays emitter. Radiation can be protected by
1mm of lead. Half-life: 60.1 days.
Results
. of PBT and vPvB assessment
PBT:
. Not applicable.

3.2 Mixtures
CLP/GHS
Sodium Azide < 0.1 Acute Tox. Oral 2, H300 Acute Tox. Oral 2, H300 2, 8
Aquatic Acute 1, H400 Aquatic Acute 1, H400
CAS # 26628-22-8 Aquatic Longterm 1, H410 Aquatic Longterm 1, H410
EINECS # 247-852-1
Index # 011-004-00-7
2 - Substance with Community workplace exposure limits

8 - Present at concentration below the cut-off limits.


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SAFETY DATA SHEET

Eye Contact If product enters eyes, rinse eyes gently with water for 15 minutes or longer,
making sure that the eyelid is held open. If pain or irritation occurs, obtain medical
advice/attention.
Skin Contact In case of skin contact, rinse with plenty of water. Remove contaminated clothing
and shoes. If pain or irritation occurs, obtain medical advice/attention.
No adverse symptoms or effects have been identified.
No specific medical attention or treatment required.

product (an aqueous solution).

Personal Precautions This product contains a material of animal origin. Observe general safety
guidelines for protection during clean up procedures.

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SAFETY DATA SHEET

6.2 Environmental Precautions Isolate area and absorb spill with sand, vermiculite or other inert absorbent
material. Place absorbed material in container suitable for disposal.
Dispose of all waste material in accordance with local and facility guidelines.
Spill and Leak Procedures As a precautionary measure, treat spilled material with a 1:10 bleach/water
solution. Absorb liquid and place in container suitable for disposal. Avoid
generation of aerosols during clean up. Comply with applicable waste disposal
regulations.
Radioactive material is subject to the regulations of each country.
Dispose of all waste material in accordance with local guidelines.

7.1 Precautions for safe handling This product should be handled as though capable of transmitting infectious
diseases. Universal precautions should be followed when using this product.
labeling.

Exposure Limits
ACGIH
Sodium Azide 0.29 mg/m3 Ceiling (as Sodium azide); 0.11 ppm Ceiling (as Hydrazoic acid vapor)
CAS # 26628-22-8
DFG MAK
Sodium Azide 0.4 mg/m3 Peak (inhalable fraction); 0.2 mg/m3 TWA MAK (inhalable fraction)
CAS # 26628-22-8
Ireland
Sodium Azide 0.1 mg/m3 TWA; 0.3 mg/m3 STEL; Potential for cutaneous absorption
CAS # 26628-22-8

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IRMA GH
SAFETY DATA SHEET

IOELVs
Sodium Azide Possibility of significant uptake through the skin; 0.3 mg/m3 STEL; 0.1 mg/m3 TWA
CAS # 26628-22-8
NIOSH None established

Sodium Azide 0.1 mg/m3 TLV; 0.3 mg/m3 Binding STEL
CAS # 26628-22-8

Engineering Controls Place vial behind a metal shield, away from the user.

Physical State Liquid Specific Gravity ≈ 1.01 @20°C
(Water=1.0)
Color Red Solubility
Odor Odorless Organic Not applicable
pH ≈ 7.2 Partition coefficient: Not determined

n-octanol/water

Temperature

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IRMA GH
SAFETY DATA SHEET
Section 9 Physical and Chemical Properties (Continued)



Sodium azide forms explosive compounds with heavy metals. Repeated contact
of low concentrations of azide with lead and copper commonly found in plumbing
drains may result in the build up of shock sensitive compounds.
10.4 Conditions to Avoid Avoid contact with incompatible materials.
10.5 Incompatible materials Metals and metallic compounds
No decomposition products posing significant hazards would be expected from
this product (an aqueous solution).

Sodium Azide Dermal LD50 Rabbit 20 mg/kg; Oral LD50 Rat 27 mg/kg
CAS # 26628-22-8
Primary Routes of Exposure Common routes of entry include inhalation, ingestion and eye/skin contact.
Specific paths of concern for potentially infectious materials are skin puncture,
contact with broken skin, contact with mucous membranes and inhalation of
aerosolized material.

irritation
Carcinogenicity This product does not contain a reportable concentration (≥ 0.1%) of any ingredient
listed as carcinogen by ACGIH, IARC, NTP, OSHA or 1272/2008 EC regulation.

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SAFETY DATA SHEET

Reproductive Toxicity Not classified based on available data.

Other Information This product contains material(s) of animal origin. Observe general safety

12.1 Ecotoxicity
Fresh Water Species
Sodium Azide 96 h LC50 Oncorhynchus mykiss: 0.8 mg/L; 96 h LC50 Lepomis macrochirus:
CAS # 26628-22-8 0.7 mg/L; 96 h LC50 Pimephales promelas: 5.46 mg/L [flow-through]
Water Flea No information available.
12.6 Other Adverse Effects This product contains environmentally hazardous substance below the cutoff
level. Refer section 3 for ingredient information. Do not allow undiluted product to
enter sewer/surface or ground water.

Sodium azide preservative may form explosive compounds in metal drain lines.
See
. NIOSH Bulletin: Explosive Azide Hazard (8/16/76).
To avoid the possible build-up of azide compounds, flush wastepipes with water
after the disposal of undiluted reagent. Sodium azide disposal must be in
accordance with appropriate local regulations.

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IRMA GH
SAFETY DATA SHEET
Dispose of as potentially biohazardous waste and in compliance with

anti-pollution and other laws of the country concerned. To ensure compliance we
recommend that you contact the relevant (local) authorities and/or and approved
waste-disposal company for information.
waste regulations.

Shipping IATA IMDG US DOT European ADR Canadian TDG
Information
14.1 UN/ID Number 2910 2910 2910 2910 PIN - 2910
14.2 Shipping Name Radioactive Material, excepted package-limited quantity of material
14.3 Hazard Class 7 Radioactive Material 7 Radioactive material 7 Radioactive material 7 Radioactive material 7 Radioactive
Materials
Subsidiary Risk None None None None None
Classification Code Not applicable Not applicable Not applicable None Not applicable
14.4 Packing Group
Special Provisions Not applicable Not applicable Not applicable Not applicable Not applicable
Additional information
IATA ERG Code 7L Not applicable Not applicable Not applicable Not applicable
EmS Not applicable F-I, S-S Not applicable Not applicable Not applicable
NAERG Code Not applicable Not applicable 161 Not applicable 161
14.5 Environmental Hazards
Marine Pollutant Not applicable No Not applicable Not applicable Not applicable
14.6 Special Precautions for user

No special precautions for users are required.
14.7 Transport in bulk according to Annex II of MARPOL and the IBC Code
Not applicable


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SAFETY DATA SHEET

CAS # 123-91-1 1,4-Dioxane 0.1% de minimis concentration
CAS # 75-21-8 Ethylene Oxide 0.1% de minimis concentration
CAS # 26628-22-8 Sodium Azide 1.0% de minimis concentration
CAS # 75-07-0 Acetaldehyde 0.1% de minimis concentration
302.4
CAS # 14158-31-7 Iodine 125
CAS # 123-91-1 1,4-Dioxane
CAS # 7558-79-4 Sodium Phosphate, Dibasic
CAS # 75-21-8 Ethylene Oxide
CAS # 26628-22-8 Sodium Azide
CAS # 75-07-0 Acetaldehyde
WARNING This product can expose you to chemical which is known to the State of California to
cause cancer and/or reproductive harm. For more information go to www.P65Warnings.ca.gov
CAS # 14158-31-7 Iodine 125
CAS # 123-91-1 1,4-Dioxane
CAS # 123-91-1 1,4-Dioxane

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SAFETY DATA SHEET

CAS # 123-91-1 1,4-Dioxane
CAS # 14158-31-7 Iodine 125
CAS # 123-91-1 1,4-Dioxane
EU Regulations
Water Hazard Class (Germany)
WGK 1, low water endangering
Refer to Section 3
Canada

Health: 2 0=None
3=Severe
Revision Changes Changed product name.
Changed kit product name.
Sec. 2.1. Sec 3.2 and 15.1
Revised Beckman Coulter safety rating.
Updated Section 2.

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SAFETY DATA SHEET

Updated Section 4, 8, 11, 12, 15
Updated Section 16.
Version: AF
Aquatic Acute 1 - Aquatic Hazard Acute, Category 1
Aquatic Longterm 1 - Aquatic Hazard Long term, Category 1
H300 - Fatal if swallowed.
H400 - Very toxic to aquatic life.
H410 - Very toxic to aquatic life with long lasting effects.
Liability Act

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SAFETY DATA SHEET


Product Name GH Calibrator 0
Manufacturer
IMMUNOTECH s.r.o.
Radiová 1
102 27 Prague 10
Czech Republic
Tel. +420 272 017 444

703-527-3887
phone numbers.

Light brown; Clear; Liquid; Odorless
Not classified as hazardous per US-OSHA HCS 2012 and UN GHS
2.2 Label Elements According to EC 1272/2008 (CLP/GHS), US-OSHA and UN GHS
Not classified as hazardous per EC 1272/2008 (CLP/GHS), US-OSHA and GHS

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SAFETY DATA SHEET
GH Calibrator 0 Revision Date (year/month/day) 2020/08/05

2.3 Other hazards
PBT:
. Not applicable.
This product contains concentrations of azide below the hazardous level which
with repeated contact with lead and copper commonly found in plumbing drains
may result in the build up of shock sensitive compounds. Sodium azide forms
explosive compounds with heavy metals.

3.2 Mixtures
CLP/GHS
Sodium Azide <0.1 Acute Tox. Oral 2, H300 Acute Tox. Oral 2, H300 2, 8
Aquatic Acute 1, H400 Aquatic Acute 1, H400
CAS # 26628-22-8 Aquatic Longterm 1, H410 Aquatic Longterm 1, H410
EINECS # 247-852-1
Index # 011-004-00-7
2 - Substance with Community workplace exposure limits

8 - Present at concentration below the cut-off limits.


No adverse symptoms or effects have been identified.

Page 26 of 53
IRMA GH
SAFETY DATA SHEET
Section 4 First Aid Measures (Continued)

No specific medical attention or treatment required.

product.

Dispose of contents/container in accordance with local regulations
Spill and Leak Procedures As a precautionary measure, treat spilled material with a 1:10 bleach/water
solution. Absorb liquid and place in container suitable for disposal. Avoid
generation of aerosols during clean up. Comply with applicable waste disposal
regulations.


Page 27 of 53
IRMA GH
SAFETY DATA SHEET
Section 7 Handling and Storage (Continued)

labeling.

Exposure Limits
ACGIH
Sodium Azide 0.29 mg/m3 Ceiling (as Sodium azide); 0.11 ppm Ceiling (as Hydrazoic acid vapor)
CAS # 26628-22-8
DFG MAK
Sodium Azide 0.4 mg/m3 Peak (inhalable fraction); 0.2 mg/m3 TWA MAK (inhalable fraction)
CAS # 26628-22-8
Ireland
Sodium Azide 0.1 mg/m3 TWA; 0.3 mg/m3 STEL; Potential for cutaneous absorption
CAS # 26628-22-8
IOELVs
Sodium Azide Possibility of significant uptake through the skin; 0.3 mg/m3 STEL; 0.1 mg/m3 TWA
CAS # 26628-22-8

Sodium Azide 0.1 mg/m3 TLV; 0.3 mg/m3 Binding STEL
CAS # 26628-22-8

Skin Protection Wear protective clothing and impervious gloves, as appropriate.
protection.

Page 28 of 53
IRMA GH
SAFETY DATA SHEET

Physical State Liquid Specific Gravity 1 @20°C
(Water=1.0)
Color Light brown Solubility
pH ≈6-8 Partition coefficient: Not determined

n-octanol/water

Temperature


Sodium azide forms explosive compounds with heavy metals. Repeated contact
of low concentrations of azide with lead and copper commonly found in plumbing
drains may result in the build up of shock sensitive compounds.
10.4 Conditions to Avoid Avoid contact with incompatible materials.
10.5 Incompatible materials Metals and metallic compounds
When stored as labeled, no known hazardous decomposition products are formed
during the shelf-life of this product.

Page 29 of 53
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SAFETY DATA SHEET

Sodium Azide Dermal LD50 Rabbit 20 mg/kg; Oral LD50 Rat 27 mg/kg
CAS # 26628-22-8

irritation
Reproductive Toxicity Not classified based on available data.


12.1 Ecotoxicity
Fresh Water Species
Sodium Azide 96 h LC50 Oncorhynchus mykiss: 0.8 mg/L; 96 h LC50 Lepomis macrochirus:
CAS # 26628-22-8 0.7 mg/L; 96 h LC50 Pimephales promelas: 5.46 mg/L [flow-through]
Water Flea No information available.

Page 30 of 53
IRMA GH
SAFETY DATA SHEET
Section 12 Ecological Information (Continued)

12.6 Other Adverse Effects This product contains environmentally hazardous substance below the cutoff
level. Refer section 3 for ingredient information. Do not allow undiluted product to
enter sewer/surface or ground water.

Sodium azide preservative may form explosive compounds in metal drain lines.
See
. NIOSH Bulletin: Explosive Azide Hazard (8/16/76).
To avoid the possible build-up of azide compounds, flush wastepipes with water
after the disposal of undiluted reagent. Sodium azide disposal must be in
accordance with appropriate local regulations.
waste regulations.

Canadian
.. TDG.
14.1
14.2
14.3

14.6

Page 31 of 53
IRMA GH
SAFETY DATA SHEET

CAS # 26628-22-8 Sodium Azide 1.0% de minimis concentration
302.4
EU Regulations
Refer to Section 3
Canada

Page 32 of 53
IRMA GH
SAFETY DATA SHEET

Health: 1 0=None
3=Severe
Revision Changes Removed the classification of EC Directives 1999/45/EC and 67/548/EEC from
Sec. 2.1. Sec 3.2 and 15.1
Changed kit product name.
Changed product name.
Updated Section 1.3 and 1.4 in Croatian language.
Updated Section 4 - 6, 8, 10 - 12, 14 - 16.
Updated Section 2.
Version: AF
Aquatic Acute 1 - Aquatic Hazard Acute, Category 1
Aquatic Longterm 1 - Aquatic Hazard Long term, Category 1
H300 - Fatal if swallowed.
H400 - Very toxic to aquatic life.
H410 - Very toxic to aquatic life with long lasting effects.
Liability Act

Page 33 of 53
IRMA GH
SAFETY DATA SHEET


Page 34 of 53
SAFETY DATA SHEET


Product Name GH Calibrator 1 - 5
Manufacturer
IMMUNOTECH s.r.o.
Radiová 1
102 27 Prague 10
Czech Republic
Tel. +420 272 017 444

703-527-3887
phone numbers.

Colorless; Translucent; Lyophilized Powder; Odorless

Page 35 of 53
IRMA GH
SAFETY DATA SHEET
GH Calibrator 1 - 5 Revision Date (year/month/day) 2020/08/05

Boric Acid
Pictogram
Signal Word
DANGER
Hazard Statements
2.3 Other hazards
PBT:
. Not applicable.

3.2 Mixtures
CLP/GHS
CAS # 10043-35-3 Repr. 1B, H360


Page 36 of 53
IRMA GH
SAFETY DATA SHEET


product.


Page 37 of 53
IRMA GH
SAFETY DATA SHEET

Spill and Leak Procedures If the product is solid or lyophilized form, use vacuum or carefully sweep up spilled
material and place in container for suitable disposal. Avoid generating dust.
If the product is liquid form, as a precautionary measure, treat spilled material with
a 1:10 bleach/water solution. Absorb liquid and place in container suitable for
disposal. Avoid generation of aerosols during clean up. Comply with applicable
waste disposal regulations.

labeling.

Exposure Limits
ACGIH
DFG MAK
Ireland

Page 38 of 53
IRMA GH
SAFETY DATA SHEET

None established

Physical State Lyophilized Powder Specific Gravity 1 @20°C
(Water=1.0)
Transparency Translucent Water Miscible

n-octanol/water
Melting Point Not determined Auto-ignition Temp. Not applicable

Temperature


Page 39 of 53
IRMA GH
SAFETY DATA SHEET

strong oxidizers.


irritation


Page 40 of 53
IRMA GH
SAFETY DATA SHEET


12.1 Ecotoxicity
Water Flea
CAS # 10043-35-3

waste regulations.

Page 41 of 53
IRMA GH
SAFETY DATA SHEET

Canadian
.. TDG.
14.1
14.2
14.3

14.6

302.4

Page 42 of 53
IRMA GH
SAFETY DATA SHEET

EU Regulations
Refer to Section 3
Canada

Health: 3 0=None
3=Severe
Sec. 2.1. Sec 3.2 and 15.1
Updated Section 1, 2, 4 - 6, 8 - 11, 14 - 16.
Updated Section 12.
Version: AF

Page 43 of 53
IRMA GH
SAFETY DATA SHEET

Liability Act

Page 44 of 53
SAFETY DATA SHEET


Product Name GH Control
Manufacturer
IMMUNOTECH s.r.o.
Radiová 1
102 27 Prague 10
Czech Republic
Tel. +420 272 017 444

703-527-3887
phone numbers.

Colorless; Translucent; Lyophilized Powder; Odorless

Page 45 of 53
IRMA GH
SAFETY DATA SHEET
GH Control Revision Date (year/month/day) 2020/08/05

Boric Acid
Pictogram
Signal Word
DANGER
Hazard Statements
2.3 Other hazards
PBT:
. Not applicable.

3.2 Mixtures
CLP/GHS
CAS # 10043-35-3 Repr. 1B, H360


Page 46 of 53
IRMA GH
SAFETY DATA SHEET


product.


Page 47 of 53
IRMA GH
SAFETY DATA SHEET

Spill and Leak Procedures If the product is solid or lyophilized form, use vacuum or carefully sweep up spilled
material and place in container for suitable disposal. Avoid generating dust.
If the product is liquid form, as a precautionary measure, treat spilled material with
a 1:10 bleach/water solution. Absorb liquid and place in container suitable for
disposal. Avoid generation of aerosols during clean up. Comply with applicable
waste disposal regulations.

labeling.

Exposure Limits
ACGIH
DFG MAK
Ireland

Page 48 of 53
IRMA GH
SAFETY DATA SHEET

None established

Physical State Lyophilized Powder Specific Gravity 1 @20°C
(Water=1.0)
Transparency Translucent Water Miscible

n-octanol/water
Melting Point Not determined Auto-ignition Temp. Not applicable

Temperature


Page 49 of 53
IRMA GH
SAFETY DATA SHEET

strong oxidizers.


irritation


Page 50 of 53
IRMA GH
SAFETY DATA SHEET


12.1 Ecotoxicity
Water Flea
CAS # 10043-35-3

waste regulations.

Page 51 of 53
IRMA GH
SAFETY DATA SHEET

Canadian
.. TDG.
14.1
14.2
14.3

14.6

302.4

Page 52 of 53
IRMA GH
SAFETY DATA SHEET

EU Regulations
Refer to Section 3
Canada

Health: 3 0=None
3=Severe
Sec. 2.1. Sec 3.2 and 15.1
Updated Section 1, 2, 4 - 6, 8 - 11, 14 - 16.
Updated Section 12.
Version: AF

Page 53 of 53
IRMA GH
SAFETY DATA SHEET

Liability Act


Kit SDS Cover Sheet: Product Name Part Number Additional Product Information

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Page 1 of 53

Kit SDS Cover Sheet

UN/ID Number 2910 2910 2910 2910 2910

Shipping Name Radioactive Material, excepted package-limited quantity of material

Subsidiary Risk None None None None None

©2020 Beckman Coulter, Inc.

Transport Information (Continued)

Special Precautions for user

©2020 Beckman Coulter, Inc.

SAFETY DATA SHEET

Section 1 Identification of the Substance/mixture and of the Company/undertaking

e-mail address SDSNT@beckman.com

Section 2 Hazards Identification

©2020 Beckman Coulter, Inc.

Section 2 Hazards Identification (Continued)

Section 3 Composition and Information on Ingredients

SVHC - Substance of very high concern

See section 8 for available Occupational exposure limits

©2020 Beckman Coulter, Inc.

Section 4 First Aid Measures

Section 5 Fire Fighting Measures

Section 6 Accidental Release Measures

©2020 Beckman Coulter, Inc.

Section 6 Accidental Release Measures (Continued)

Section 7 Handling and Storage

Section 8 Exposure Controls and Personal Protection

©2020 Beckman Coulter, Inc.

Section 8 Exposure Controls and Personal Protection (Continued)

Japan None established

8.2 Exposure controls

Section 9 Physical and Chemical Properties

Odor Odorless Organic Not determined

pH 8.3 Partition coefficient: Not determined

Boiling Point Not determined Decomposition Not determined

Evaporation Rate Not determined Vapor Pressure Not determined

Flammability (Solid, Gas) Not applicable Viscosity Not determined

Flammability Limits Not applicable Explosive Properties Not applicable

Vapor Density Not determined Oxidizing Properties Not applicable

©2020 Beckman Coulter, Inc.

Section 9 Physical and Chemical Properties (Continued)

Section 10 Stability and Reactivity

Section 11 Toxicological Information

Acute Toxicity Not classified based on available data.

Skin Corrosion/Irritation Not classified based on available data.

Serious eye damage/eye Not classified based on available data.

Reproductive Toxicity May damage fertility or the unborn child.

©2020 Beckman Coulter, Inc.

Section 11 Toxicological Information (Continued)

Other Information No further relevant information available.

Section 12 Ecological Information

Section 13 Disposal Considerations

©2020 Beckman Coulter, Inc.

Section 14 Transport Information

..14.4 Packing Group: Not regulated for transportation

Section 15 Regulatory Information

©2020 Beckman Coulter, Inc.

Section 15 Regulatory Information (Continued)

Section 16 Other Information

©2020 Beckman Coulter, Inc.