SAFETY DATA SHEET

iLite® Assay Ready Cells containing cryoprotective
medium from Gibco
BM4025, BM4044, BM4049, BM4050, BM4052, BM4075, BM5001, BM5004, BM5005, BM5010, BM5011,
BM5013, BM5014, BM5015, BM5016, BM5017, BM5018, BM5025, BM5026, BM5035, BM5036, BM6069,
BM6100SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/
UNDERTAKING
1.1 Product identifier
Product name:iLite® TLR4 Assay Ready Cells
iLite® TNF-alpha Xcel Assay Ready Cells
iLite® IFNI FAST Assay Ready Cells
iLite® TLR9 Assay Ready Cells
iLite® GM-CSF Assay Ready Cells
iLite® RANKL Assay Ready Cells
iLite® C5a Assay Ready Cells
iLite® ADCC Effector (V) Assay Ready Cells
iLite® ADCP Effector Assay Ready Cells
iLite® CD3 Effector Assay Ready Cells
iLite® CD19 (+) Target Assay Ready Cells
iLite® CD19 (-) Target Assay Ready Cells
iLite® CD20 (+) Target Assay Ready Cells
iLite® CD20 (-) Target Assay Ready Cells
iLite® HER2 (+) Target Assay Ready Cells
iLite® HER2 (-) Target Assay Ready Cells
iLite® mTNF-alpha (+) Target Assay Ready Cells
iLite® mTNF-alpha (-) Target Assay Ready Cells
iLite® EGFR (+) Target Assay Ready Cells
iLite® EGFR (-) Target Assay Ready Cells
iLite® mVEGF (+) Target Assay Ready Cells
iLite® mVEGF (-) Target Assay Ready Cells
iLite® AAV Responsive Reporter Assay Ready Cells

Product descriptioniLite Assay Ready Cells containing cryoprotective medium from Gibco (cat no12648-010)

Product code

BM4025, BM4044, BM4049, BN4050, BM4052, BM4075, BM5001, BM5004, BM5005,
BM5010, BM5011, BM5013, BM5014, BM5015, BM5016, BM5017, BM5018, BM5025,
BM5026, BM5035, BM5036, BM6069, BM6100

1.2 Relevant identified uses of the substance or mixture and uses advised against
Use of the product

Laboratory chemicals. For research use only.

1.3 Details of the supplier of the safety data sheet
Company
Address
Zip code/Place
Telephone
WebsiteE-mailSvar Life Science AB
Lundvägen 151
SE-212 24 Malmö, Sweden+46 40 53 76 00
www.svarlifescience.com
info@svarlifescience.com

1.4 Emergency telephone number
Emergency telephone
numberSvar Life Science AB
Lundavägen 151(Sweden) Acute: 112 – Ask for ”Giftinformation”. If less acute call: +46 010 4566700.
Other countries: Please contact local emergency telephone number.

P.O. Box 50117

info@svarlifescience.com

SE-212 24 Malmö

SE-202 11 Malmö+46 40 53 76 00

SwedenSwedenLABEL-DOC-0449 12.0
Page 1/ 10

SAFETY DATA SHEETSECTION 2: HAZARDS IDENTIFICATION
2.1 Classification of the substance or mixture
Classification according to the Regulation (EC) No. 1272/2008 (CLP):
The mixture is not to be classified according to CLP.
The mixture is covered by Directive 2009/41/EC on the contained use of genetically modified micro-organisms
and classified as a Class 1 Genetically Modified Microorganism.
The mixture is covered by Directive 2000/54/EC of 18 September 2000 on the protection of workers from risks
related to exposure to biological agents at work.

2.2 Label elements
None

2.3 Other hazards
Other hazards which do Contain Fetal Bovine serum, which is derived from cattle with US origin. The Certificate
not result inof Analysis for FBS show that the substance has been analyzed for Blue tongue Virus,
classification
Bovine Adenovirus, Bovine Parvovirus, Rabies Virus, Reovirus, BRSV Fluorescent
Antibody, BVDV Fluorescent Antibody, Cytopathogenic agents and Hemadsorbing
agents with a negative result.
The products are considered to be biological agents in group 1 (ie. a biological agent thatis unlikely to cause human infection). As a precaution, it is recommended that the work is
carried out under measures similar to Group 2 in Council Directive 2000/54/EC.
Substance meets the criteria for PBT/ vPvB under
Regulation EC No. 1907/2006, appendix XIIIPBT/ vPvB: No

Endocrine disrupting properties

The substances are not identified as having endocrine
disrupting properties in accordance with the criteria set
out in Regulation 2017/2100 or Regulation 2018/605.

SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS
3.2 Mixtures
Assay Ready Cells suspended in cryoprotective medium from Gipco containing the following substances:
No

Product/ingredient nameEC-number

CASnumberConc.
(%w/w)--

REACH
registration
number--

10

Classification
Regulation (EC) No.
1272/2008 [CLP]NoneFetal Bovine Serum(Heat inactivated FBS)
Dimethyl Sulfoxid (DMSO)-200-664-3

67-68-5

--

10

None

SECTION 4: FIRST-AID MEASURES
4.1 Description of first aid measures
On suspicion of possible infection from biological agents – seek medical advice!
Inhalation:
Skin contact:
Eye contact:
Ingestion

Move to fresh air. Keep at rest and under surveillance. If needed: seek medical advice.
Remove contaminated clothing at once. Flush skin and wash thoroughly with soap andwater.
Keep eyelids well apart. Rinse with water for a couple of minutes, remember to remove
contact lenses if any. If irritation persists: Seek medical advice.
Rinse mouth and drink plenty of water. If needed or if larger amounts has beenswallowed: Seek medical advice.

4.2 Most important symptoms and effects, both acute and delayed
Skin contact:
Eye contact:
Inhalation

Svar Life Science AB
Lundavägen 151

May cause irritation of skin.
May cause irritation of eyes.
Prolonged or frequent exposure to vapours of volatile organic compounds may result indamage on liver, kidneys, blood or central nervous system (including brain damage).

P.O. Box 50117

info@svarlifescience.com

SE-212 24 Malmö

SE-202 11 Malmö+46 40 53 76 00

SwedenSwedenLABEL-DOC-0449 12.0
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SAFETY DATA SHEET
4.3 Indication of any immediate medical attention and special treatment neededShow this safety data sheet to a physician or emergency ward

SECTION 5: FIREFIGHTING MEASURES
5.1 Extinguishing media
Suitable extinguishingmedia
Unsuitable
extinguishing media

Use water spray, carbon dioxide, dry chemical or foam.
Waterjet

5.2 Special hazards arising from the substance or mixture
Hazards from thesubstance or mixture
Hazardous thermal
decomposition
products

None
Decomposition products may include the following materials: oxides of carbon andsulphur.

5.3 Advice for firefighters
Special protective
Promptly isolate the scene by removing all persons from the vicinity of the incident if
actions for fire-fighters there is a fire. No action shall be taken involving any personal risk or without suitabletraining.
Special protective
Fire-fighters should wear appropriate protective equipment and self-contained breathing
equipment for fireapparatus (SCBA) with a full face-piece operated in positive pressure mode. Clothing forfighters
fire-fighters (including helmets, protective boots and gloves) conforming to European
standard EN 469 will provide a basic level of protection for chemical incidents.
Further information
Not applicable

SECTION 6: ACCIDENTAL RELEASE MEASURES
6.1 Personal precautions, protective equipment and emergency procedures
For non-emergency
personnel

For emergency
responders

Use personal protective equipment – see section 8. No action shall be taken involving
any personal risk or without suitable training. Evacuate surrounding areas. Keep
unnecessary and unprotected personnel from entering. Do not touch or walk throughspilt material. The employees or the company’s occupational health and safety
organization must be informed immediately of any accident or incident that may haveresulted in the release of biological agents, which may cause disease in humans.
If specialized clothing is required to deal with the spillage, take note of any information in
Section 8 on suitable and unsuitable materials. See also Section 8 for additional
information on hygiene measures.

6.2 Environmental precautions
Do not empty into drains – see section 12. Inform appropriate authorities in accordance with local regulations.

6.3 Methods and material for containment and cleaning up
Small spill

Large spill

Stop leak if without risk. Move containers from spill area. Wipe up spillage etc. with paper
towels. Use wet towels to finish cleaning up. Follow the laboratory’s generaldecontamination procedure for infectious waste. Flush area of decontamination withwater. Further handling of spillage – see section 13.
Stop leak if without risk. Move containers from spill area. Prevent entry into sewers,
water courses, basements or confined areas. Contain and collect spillage with absorbent
material as vermiculite. Further handling of spillage – see section 13.

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

Svar Life Science AB
Lundavägen 151

P.O. Box 50117

info@svarlifescience.com

SE-212 24 Malmö

SE-202 11 Malmö+46 40 53 76 00

SwedenSwedenLABEL-DOC-0449 12.0
Page 3/ 10

SAFETY DATA SHEETSECTION 7: HANDLING AND STORAGE
7.1 Precautions for safe handlingProtective measures

Advice on general
occupational hygiene

Before use, a workplace assessment of the safety and health conditions at the working
place must be carried out according to the general specifications mentioned in the EU
Directive 2000/54/EC on biological agents and work. Work must be planned, organized
and carried out so that the influence of biological agents is avoided as much as possible.
Use laboratory facilities, which generally qualify for handling of biological agents. No toolor used material should after end use be placed on tables or similar but collected
immediately in special sealed containers. Recycling of tools should only take place after
proper disinfecting and purification. If appliances are contaminated, washing must be
made with appropriate disinfectant before further use.
Eating, drinking and smoking should be prohibited in areas where this material ishandled. Avoid contact with skin, eyes and clothing. Always wash hands with soap andwater after completing work, and when leaving the laboratory (e.g. before going to thetoilet and at the end of the workday). Do not pipette by mouth pipetting. See also Section
8 for additional information on hygiene measures.

7.2 Conditions for safe storage, including any incompatibilities
Storage:
Further information:

Upon receipt confirm that adequate dry-ice is present and the cells are frozen.
Immediately transfer to -80 °C (do not store at any other temperature). Cells should be
used within 30 min of thawing and should be diluted immediately after thawing.
Not applicable

7.3 Specific end use(s)Laboratory chemicals for research use only.

SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
8.1 Control parameters
Occupational exposure limits - DMSOEuropean Union: None
UK: None
Sweden:NGV
50 ppm = 150 g/cm3
H: Skin permeable

KGV
Comments
150 ppm = 500 g/cm3
H,V
V: Indicative short-term exposure limit

Germany, MAK: 50 ppm = 160 mg/m 3
Denmark: 50 ppm = 160 mg/m3
Finland: 50 ppm (8h)Austria: 50 ppm = 160 mg/m3
Switzerland: 50 ppm = 160 mg/m3
Recommended
monitoring procedure

Not relevant

Derived effect levels
Product/ingredient
name
--

Type

Exposure

Value

Population

Effects

--

--

--

--

--

Predicted effectconcentrations
PNEC Summary

Not available

Svar Life Science AB
Lundavägen 151

Not available – No CSR

P.O. Box 50117

info@svarlifescience.com

SE-212 24 Malmö

SE-202 11 Malmö+46 40 53 76 00

SwedenSwedenLABEL-DOC-0449 12.0
Page 4/ 10

SAFETY DATA SHEET
8.2 Exposure controls
Appropriate engineering
controls
Hygiene measures

Sufficient ventilation.

Respiratory protection

Not relevant during normal condition.

Eye/face protection

Use safety glasses (according to EN166) when there is risk of splashes.

Hand protection

Wear protective gloves (according to EN374) of butyl rubber or nitrile rubber.

Body protection

Wear suitable protective clothing.

Environmental exposure
controls

Not applicable

Wash hands thoroughly after handling chemical products, before eating, drinking,smoking and using the lavatory and at the end of the working period. Appropriatetechniques 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.

SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES
9.1 Information on basic physical and chemical properties
Physical state:
Colour:Odour:
Melting point/freezing point (°C):
Boiling point or initial boiling point and boiling range (°C):
Flammability (solid, gas):
Lower and upper explosion limit (vol-%):Flash point (°C):
Auto-ignition temperature (°C):
Decomposition temperature (°C):
pH:
Kinematic viscosity:
Solubility:
Partition coefficient n-octanol/water (log value):
Vapour pressure:
Density and/or relative density:
Relative vapour density:
Particle characteristics:

Liquid
n.d
n.d
n.d
n.d
n.a
n.d
n.d
n.d
n.d
n.d
n.d
n.d
n.d
n.d
n.d
n.d
n.a

n.d = not determined
n.a = not applicable

9.2 Other information
Not applicable

Svar Life Science AB
Lundavägen 151

P.O. Box 50117

info@svarlifescience.com

SE-212 24 Malmö

SE-202 11 Malmö+46 40 53 76 00

SwedenSwedenLABEL-DOC-0449 12.0
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SAFETY DATA SHEETSECTION 10: STABILITY AND REACTIVITY
10.1 Reactivity

No available information

10.2 Chemical stability

Stabile at recommended storage conditions – see section 7.

10.3 Possibility of hazardous reactions

No available information.

10.4 Condition to avoid

No available information.

10.5 Incompatible materials

No available information.

10.6 Hazardous decomposition products

When heated to high temperatures (decomposition) toxic fumes
are emitted: Oxides of carbon and sulphur.

SECTION 11: TOXICOLOGICAL INFORMATION
In addition to the hazardous properties mentioned below, the risk of infection from the biologicalagents present in the product must also be taken into account.
11.1 Information on toxicological effects
Hazard class
Data (DMSO)
Acute toxicity:
LD50 (rat) > 2 mg/l/4h
Inhalation
LDLo (rat) > 40000 mg/kg
DermalLD50 (rat) = 14500 mg/kg
Oral
Corrosion/irritation Mild eye and skin irritation, rabbit
Sensitization
CMR

No skin sensitization, guinea pig
No mutagenicity, carcinogenicity, genotoxicity

Test

Reference

No information
No information
No information
OECD 404, EU
Method B.5
Buehler
SeveralIUCLIDIUCLIDIUCLIDECHAIUCLID
Merck/IUCLID

Acute toxicity
Assessment for other reagents than DMSO: No data available.

Irritation/Corrosion
Assessment for other reagents than DMSO: No data available.

Sensitization by inhalation/skin contact
Assessment for other reagents than DMSO: No data available.

Germ cell mutagenicity
Assessment for other reagents than DMSO: The chemical structure of the different reagents doesn’t indicate any
mutagenic effects.

Carcinogenicity
Assessment for other reagents than DMSO: The chemical structure of the different reagents doesn’t indicate any
carcinogenic effects.

Reproduction toxicity
Assessment for other reagents than DMSO: The chemical structure of the different reagents doesn’t indicate any
reproduction toxic effects.

Developmental toxicity
Assessment for other reagents than DMSO: The chemical structure of the different reagents doesn’t indicate any
teratogenic effects.
Svar Life Science AB
Lundavägen 151

P.O. Box 50117

info@svarlifescience.com

SE-212 24 Malmö

SE-202 11 Malmö+46 40 53 76 00

SwedenSwedenLABEL-DOC-0449 12.0
Page 6/ 10

SAFETY DATA SHEETSpecific target organ toxicity (single exposure)
STOT assessment single dose toxicity: No data available.

Repeated dose toxicity and specific organ toxicity (repeated exposure)
Prolonged or frequent exposure to vapours of volatile organic compounds may result in damage on liver, kidneys,
blood or central nervous system (including brain damage).

11.2. Information on other hazards:
None known.

SECTION 12: ECOLOGICAL INFORMATION
12.1 Toxicity
12.1.1 Acute toxicity in the aquatic environment for DMSO

Test

Value/unit (mg/l)

Test method

Exp. time (h)Species

Fish LC50
Daphnia EC50
Algae EC50

32000
7000
12350-25500

Static (FW)No info. (FW)No info. (SW)

96
24
96

Oncorhynchus mykiss
Daphnia sp.
Skeletonema costatum

12.1.2 Acute toxicity in the aquatic environment other reagents than DMSO
No data available.
12.1.3 Ecotoxicity
No data available.

12.2 Persistence and degradability
Conclusion/SummaryDMSO is not readily degradable (3.1% after 14 days in OECD 301C test).

12.3 Bioaccumulative potential
Conclusion/Summary

DMSO: Log Kow -1,35 – No significant bioaccumulation.

12.4 Mobility in soil
Soil/water partition
coefficient (KOC)
Mobility

DMSO: Koc (calculated) < 10 – Very high mobility expected in soil environments.
No available data

12.5 Results of PBT and vPvB assessment
PBT
vPvB

The substance is not considered PBT according to criteria in Annex XIIII.
The substance is not considered vPvB according to criteria in Annex XIIII.

12.6. Endocrine disrupting properties
None known.

12.7 Other adverse effects
None known.

Svar Life Science AB
Lundavägen 151

P.O. Box 50117

info@svarlifescience.com

SE-212 24 Malmö

SE-202 11 Malmö+46 40 53 76 00

SwedenSwedenLABEL-DOC-0449 12.0
Page 7/ 10

SAFETY DATA SHEETSECTION 13: DISPOSAL CONSIDERATIONS
13.1 Waste treatment methods
Method of disposal

Hazardous waste

Biological agents are considered hazardous waste. Disposal should be according tolocal, state or national legislation.
Note! Waste containers containing biological material must be labeled with:(blacksymbol on yellow background).
The generation of waste should be avoided or minimized wherever possible. This
material and its container must be disposed of in a safe way by incineration.
Within the present knowledge of the supplier, this product is regarded ashazardous waste, as defined by EU Directive 2008/98/EC.

European Waste Catalogue (EWC)
EWC Waste CodeType of waste
Wastes whose collection and disposal is subject to special
18 01 03
15 02 02

requirements in order to prevent infection
Absorbent material containing residues of or contaminated by dangerous substances

Packaging
Method of disposal
Special precautions

Incineration.
None.

SECTION 14: TRANSPORT INFORMATION
Product is not classified as dangerous goods.
14.1 UN number or ID number
14.2 UN proper shipping name14.3 Transport hazard class(es)14.4 Packing Group14.5 Environmental hazards
14.6 Special precautions for user
14.7 Maritime transport in bulk
according to IMO instruments
Additional information

ADR/RID

ADN/ADNR

IMDG

IATA

-----No
Not applicable-----No
Not applicable-----No
Not applicable-----No
Not applicable

Waste containing used biological agents may be considered as
dangerous goods;
UN 3291, CLINICAL WASTE, UNSPECIFIED; N.O.S., or (BIO)
MEDICAL WASTE N.O.S. or REGULATED MEDICAL WASTE, N.O.S.
Class 6.2 Packing Group II

Svar Life Science AB
Lundavägen 151

P.O. Box 50117

info@svarlifescience.com

SE-212 24 Malmö

SE-202 11 Malmö+46 40 53 76 00

SwedenSwedenLABEL-DOC-0449 12.0
Page 8/ 10

SAFETY DATA SHEETSECTION 15: REGULATORY INFORMATION
15.1 Safety, health and environmental regulations/legislation specific for the substance or
mixtureMust not be used by persons under 18 years of age (Directive 94/33/EC).
The employer shall assess the working conditions and, if there is any risk to the safety or health andany effects on the pregnancy or breastfeeding of workers, take the necessary measures to adjust theworking conditions (Directive 92/85/EEC)
The mixture is covered by:
Directive 2009/41/EC on the contained use of genetically modified micro-organisms
Directive 2000/54/EC – biological agents at work
EU Regulation (EC) No. 1272/2008 (CLP): Not classified.
EU Regulation (EC) No. 1907/2006 (REACH)
Annex XIV – List of substances subject to authorization
Substances of very high concern
None of the components are listed.

Annex XVII – Restrictions on the manufacture, placing on the market and use of certain
dangerous substances, mixtures and articles
Not applicable15.2 Chemical Safety Assessment
No CSR.

Other information
Tariff Code harmonizedsystemThe EU Seveso Directive

Not applicableNot applicable

International regulations
Chemical Weapons Convention
List
Schedule I Chemicals
Not regulated

Chemical Weapons Convention
List
Schedule II Chemicals
Not regulated

Chemical Weapons Convention
List
Schedule III Chemicals
Not regulated

SECTION 16: OTHER INFORMATION
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II.
LIST OF HAZARD STATEMENTS MENTIONED UNDER SECTION 3: None
Abbreviations:
BRSV = Bovine Respiratory Syncytial Virus
BVDV = Bovine Viral Diarrhea Virus
CMR = Carcinogenicy, Mutagenicity, and Reproduction toxicity
CSR = Chemical Safety Report
DNEL = Derived No-Effect Level
EC50 – Half maximal effective concentration
FW = Fresh Water (Färskvatten)
KGV = Korttidsvärde (Swedish for short term exposure limit)
LC50 = Lethal Concentration 50 %LD50 = Lethal Dose 50 %MAK = Maximale Arbeitsplatzkonzentrationen (German for maximum workplace concentration)
NGV = Nivågränsvärde (Swedish for exposure limit)
PBT = Persistent, Bioaccumulative, Toxic
PNEC = Predicted No-Effect Concentration
vPvB = very Persistent, very Bioaccumulative
Svar Life Science AB
Lundavägen 151

P.O. Box 50117

info@svarlifescience.com

SE-212 24 Malmö

SE-202 11 Malmö+46 40 53 76 00

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SAFETY DATA SHEET
Literature:
Merck (Safety Data Sheet)
IUCLID = International Uniform ChemicaL Information Database
ECHA = European Chemicals Agency
Other information
No special training is required. However, the user should be well instructed in the execution of his/her task, befamiliar with this Safety Data Sheet and have normal training in the use of personal protective equipment.
Revisions

VersionValid from (date)

Changes

1.0
2.0
3.0
4.0
5.0
6.0

14-Mar-2019
15-Oct-2019
18-Mar-2020
14-May-2020
24-Sep-2020
21-Jun-2021

7.0
8.0

08-Oct-2021
11-Jan-2022

9.0
10.0

28-Jun-2022
08-Mar-2023

11.0
12.0

16-Jun-2023
20-May-2024

New document
Addition of BM5017 and BM5018
Addition of BM4052
Addition of BM4075
Addition of BM4073
Addition of BM4025. Template updated in compliance with
Regulation 2020/878
Addition of BM6069. Removal of BM4073
Addition of BM4050, BM5004, BM5005, BM5025, BM5026,
BM6001, and BM6002
Addition of BM4049
Removal of BM6001. Addition of BM6005, BM6006, BM6008,
BM6009, and BM6100
Removal of BM6002, BM6005, BM6006, BM6008, and BM6009
Addition of BM4044

Svar Life Science AB
Lundavägen 151

P.O. Box 50117

info@svarlifescience.com

SE-212 24 Malmö

SE-202 11 Malmö+46 40 53 76 00

SwedenSwedenLABEL-DOC-0449 12.0
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