SAFETY DATA SHEET
Invivoscribe® ABI Assays

Catalog Number

Description

11000031

IGH + IGK B-Cell Clonality Assay for ABI Fluorescence Detection

11000041

IGH + IGK B-Cell Clonality Assay MegaKit for ABI Fluorescence Detection

11010061

IGH Gene Clonality Assay for ABI Fluorescence Detection

11010081

IGH Gene Clonality Assay MegaKit for ABI Fluorescence Detection

11010051

IGH Gene Rearrangement Assay for ABI Fluorescence Detection

11010071

IGH Gene Rearrangement Assay MegaKit for ABI Fluorescence Detection

11020021

IGK Gene Clonality Assay for ABI Fluorescence Detection

11020031

IGK Gene Clonality Assay MegaKit for ABI Fluorescence Detection

11030011

IGL Gene Clonality Assay for ABI Fluorescence Detection

11030021

IGL Gene Clonality Assay MegaKit for ABI Fluorescence Detection

12050011

TCRB Gene Clonality Assay for ABI Fluorescence Detection

12050021

TCRB Gene Clonality Assay MegaKit for ABI Fluorescence Detection

12060011

TCRD Gene Clonality Assay for ABI Fluorescence Detection

12060021

TCRD Gene Clonality Assay MegaKit for ABI Fluorescence Detection

12070051

T-cell Receptor Gamma Gene Rearrangement Assay for ABI Fluorescence Detection

12070101

T-cell Receptor Gamma Gene Rearrangement Assay 2.0 for ABI Fluorescence Detection

12070111

T-cell Receptor Gamma Gene Rearrangement Assay 2.0 MegaKit for ABI Fluorescence Detection

13100031

BCR/ABL t(9;22) Translocation Assay for ABI Fluorescence Detection

13110011

PML/RARA t(15;17) Translocation Assay for ABI Fluorescence Detection

14120031

FLT3 Mutation Assay for ABI Fluorescence Detection

51010031

IGH Somatic Hypermutation Assay v2.0 for ABI Fluorescence Detection

51010041

IGH Somatic Hypermutation Assay MegaKit v2.0 for ABI Fluorescence Detection

SDS – Invivoscribe ABI Assays (CLP)-EN Rev. A | December 2023

1 / 21SAFETY DATA SHEETThis safety data sheet was created pursuant to the requirements of:Regula�on (EC) No. 1907/2006 as amended by Commission Regula�on (EU)2020/878 and Regula�on (EC) No. 1272/2008
Issuing Date 27-Apr-2023

Revision Date 27-Apr-2023

Revision Number 1

SECTION 1: Iden�ﬁca�on of the substance/mixture and of the company/undertaking
1.1.

Product iden�ﬁer
Product Code(s)Product Name

Synonyms

40880190

IVS-0004 Clonal Control DNA

None

40880370

IVS-0007 Clonal Control DNA

None

40880430

IVS-0008 Clonal Control DNA

None

40880490

IVS-0009 Clonal Control DNA

None

40880550

IVS-0010 Clonal Control DNA

None

40880730

IVS-0013 Clonal Control DNA

None

40880970

IVS-0017 Clonal Control DNA

None

40881090

IVS-0019 Clonal Control DNA

None

40881210

IVS-0021 Clonal Control DNA

None

40881390

IVS-0024 Clonal Control DNA

None

40881690

IVS-0029 Clonal Control DNA

None

40881750

IVS-0030 Clonal Control DNA

None

40881810

IVS-0031 Clonal Control DNA

None

40883320

5% TCRG Posi�ve Control DNA

None

Pure substance/mixture

Mixture1.2.

Relevant iden�ﬁed uses of the substance or mixture and uses advised against
Recommended use
Assay reagent
Uses advised against
For professional use only

1.3.

Details of the supplier of the safety data sheet
Importer
Invivoscribe Technologies
Zeppelinstrasse 185399 Hallbergmoos
Germany
Phone: +49 89 904 299 800

Supplier
Invivoscribe, Inc.
10222 Barnes Canyon Rd
Bldg. 1San Diego, CA 92121
Phone: +1 858-224-6600

Distributor
Invivoscribe Technologies, SARL
c/o Ficorec Domicilia�on Services
132, Boulevard Michelet
Hall Nord – 5ème étage
13008 Marseille
FRANCE
Tel: +33 (0)4 42 01 78 10

For further informa�on, please contact
E-mail address
customerservice@invivoscribe.com
1.4.

Emergency telephone number
Emergency telephone+49 89 904 299 800 (M-F 8:00 – 16:30 CET)Emergency telephone - §45 - (EC)1272/2008
Europe112

SECTION 2: Hazards iden�ﬁca�on
2.1.

Classiﬁca�on of the substance or mixture
Classiﬁcation according to Regulation (EC) No. 1272/2008 [CLP]SDS – Invivoscribe ABI Assays (CLP)-EN Rev. A | December 2023

2 / 21

Invivoscribe® ABI Assays

SECTION 2: Hazards iden�ﬁca�onThis substance is classiﬁed as not hazardous according to regula�on (EC) 1272/2008 [CLP].
2.2.

Label elements
Hazard statements
Not classiﬁed.
Unknown aqua�c toxicity

2.3.

Other hazards
No informa�on available.
Endocrine Disruptor
Informa�on

Contains 0 % of components with unknown hazards to the aqua�c environment.

This product does not contain any known or suspected endocrine disruptors.

SECTION 3: Composi�on/informa�on on ingredients
3.1

Substances
The product contains no substances which at their given concentra�on, are considered to be hazardous to health.
Full text of H- and EUH-phrases: see sec�on 16
Acute Toxicity Estimate
If LD50/LC50 data is not available or does not correspond to the classiﬁcation category, then the appropriate conversion value from
CLP Annex I, Table 3.1.2, is used to calculate the acute toxicity estimate (ATEmix) for classifying a mixture based on its components
This product does not contain candidate substances of very high concern at a concentra�on >=0.1% (Regula�on (EC) No. 1907/2006(REACH), Ar�cle 59)

SECTION 4: First aid measures
4.1.

Descrip�on of ﬁrst aid measures
Inhala�on
Remove to fresh air. Get medical aten�on if symptoms occur.
Eye contact
Rinse thoroughly with plenty of water for at least 15 minutes, li�ing lower and upper eyelids. Consult
a physician.
Skin contact
Wash skin with soap and water. Get medical aten�on if symptoms occur.
Inges�on
Do NOT induce vomi�ng. Never give anything by mouth to an unconscious person. Rinse mouth. Get
medical aten�on if symptoms occur.

4.2.

Most important symptoms and eﬀects, both acute and delayed
Symptoms
None known.
Eﬀects of Exposure
No informa�on available.

4.3.

Indica�on of any immediate medical aten�on and special treatment needed
Note to physicians
Treat symptoma�cally.

SECTION 5: Fireﬁgh�ng measures
5.1.

Ex�nguishing media
Suitable Ex�nguishing Media
Unsuitable ex�nguishing media

Use ex�nguishing measures that are appropriate to local circumstances and thesurrounding environment.
No informa�on available.

5.2.

Special hazards arising from the substance or mixture
Speciﬁc hazards arising from the chemical
No informa�on available.

5.3.

Advice for ﬁreﬁghters

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SECTION 5: Fireﬁgh�ng measures
Special protec�ve equipment andprecau�ons for ﬁre-ﬁghters

Fireﬁghters should wear self-contained breathing apparatus and full ﬁreﬁgh�ng
turnout gear. Use personal protec�on equipment.

SECTION 6: Accidental release measures
6.1.

Personal precau�ons, protec�ve equipment and emergency procedures
Personal precau�ons
Ensure adequate ven�la�on.
For emergency responders
Use personal protec�on recommended in Sec�on 8.

6.2.

Environmental precau�ons
Environmental precau�ons

See Sec�on 12 for addi�onal Ecological Informa�on.

6.3.

Methods and material for containment and cleaning up
Methods for containment
Prevent further leakage or spillage if safe to do so.
Methods for cleaning up
Dam up. Soak up with inert absorbent material. Take up mechanically, placing in appropriate
containers for disposal.
Preven�on of secondary hazards
Clean contaminated objects and areas thoroughly observing environmental regula�ons.

6.4.

Reference to other sec�ons
Reference to other sec�ons

See sec�on 8 for more informa�on See sec�on 13 for more informa�on

SECTION 7: Handling and storage
7.1.

Precau�ons for safe handling
Advice on safe handling
General hygiene considera�ons

Handle in accordance with good industrial hygiene and safety prac�ce.
Handle in accordance with good industrial hygiene and safety prac�ce.

7.2.

Condi�ons for safe storage, including any incompa�bili�esStorage Condi�ons
Keep containers �ghtly closed in a dry, cool and well-ven�lated place.
Storage class (TRGS 510)
Storage class 10.

7.3.

Speciﬁc end use(s)Speciﬁc use(s)The iden�ﬁed uses for this product are detailed in Sec�on 1.2.

SECTION 8: Exposure controls/personal protec�on
8.1.

Control parameters
Exposure Limits

This product, as supplied, does not contain any hazardous materials with occupa�onal exposure
limits established by the region speciﬁc regulatory bodies.

Biological occupa�onal exposure limits
This product, as supplied, does not contain any hazardous materials with biological limits established by the region-speciﬁc regulatory
bodies.
Derived No Eﬀect Level (DNEL) - Workers
No informa�on available.
Derived No Eﬀect Level (DNEL) - General Public
No informa�on available.
Predicted No Eﬀect Concentra�on (PNEC)
No informa�on available.
8.2.

Exposure controls
Engineering controls

Showers
Eyewash sta�ons
Ven�la�on systems.

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SECTION 8: Exposure controls/personal protec�on
Personal protec�ve equipment
Eye/face protec�on
Hand protec�on
Skin and body protec�on
Respiratory protec�onGeneral hygiene considera�ons
Environmental exposure controls

Wear safety glasses with side shields (or goggles). Eye protec�on must conform to standard
EN 166.
Wear suitable gloves. Gloves must conform to standard EN 374.
Wear suitable protec�ve clothing. (EN ISO 6529).
No protec�ve equipment is needed under normal use condi�ons. If exposure limits are
exceeded or irrita�on is experienced, ven�la�on and evacua�on may be required.
Handle in accordance with good industrial hygiene and safety prac�ce.
No informa�on available.

SECTION 9: Physical and chemical proper�es
9.1.

Informa�on on basic physical and chemical proper�es
Appearance
Physical state
LiquidColor
Colorless
Odor
Odorless
Odor thresholdNo informa�on available
PropertyMel�ng point / freezing pointIni�al boiling point and boiling range
Flammability
Flammability Limit in Air
Upper ﬂammability or explosive limits
Lower ﬂammability or explosive limits
Flash point
Autoigni�on temperature
Decomposi�on temperaturepH
pH (as aqueous solu�on)
Kinema�c viscosity
Dynamic viscosity
Water solubility
Solubility(ies)Par��on coeﬃcient
Vapor pressure
Rela�ve density
Bulk density
Liquid density
Rela�ve vapor densityPar�cle characteris�cs
Par�cle sizePar�cle size distribu�on

9.2.

ValuesRemarks • Method
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available
No data available

Other informa�on
9.2.1.

Information with regard to physical hazard classes
Not applicable

9.2.2.

Other safety characteristics
No informa�on available

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SECTION 10: Stability and reac�vity
10.1. Reac�vity
Reac�vity

None under normal use condi�ons.

10.2. Chemical stability
Stability
Explosion data

Stable under normal condi�ons.

Sensi�vity to mechanical impact

None.

Sensi�vity to sta�c discharge

None.

10.3. Possibility of hazardous reac�ons
Possibility of hazardous reac�ons

None under normal processing.

10.4. Condi�ons to avoid
Condi�ons to avoid

None known based on informa�on supplied.

10.5. Incompa�ble materials
Incompa�ble materials

None known based on informa�on supplied.

10.6. Hazardous decomposi�on products
Hazardous decomposi�on products

None known based on informa�on supplied.

SECTION 11: Toxicological informa�on
11.1. Informa�on on hazard classes as deﬁned in Regula�on (EC) No 1272/2008
Informa�on on likely routes of exposure
Product Informa�on
Inhala�on
Speciﬁc test data for the substance or mixture is not available.
Eye contact

Speciﬁc test data for the substance or mixture is not available. Contact with eyes may cause irrita�on.

Skin contact

Speciﬁc test data for the substance or mixture is not available.

Inges�on

Speciﬁc test data for the substance or mixture is not available.

Symptoms related to the physical, chemical and toxicological characteris�cs
Symptoms
None known.
Acute toxicity
Numerical measures of toxicity
Based on available data, the classiﬁca�on criteria are not met.
Component Informa�on
Delayed and immediate eﬀects as well as chronic eﬀects from short and long-term exposure
Skin corrosion/irrita�on
Serious eye damage/eye irrita�on
Respiratory or skin sensi�za�onGerm cell mutagenicity
Carcinogenicity
Reproduc�ve toxicity
STOT - single exposure
STOT - repeated exposure
Aspira�on hazard

Based on available data, the classiﬁca�on criteria are not met.
Based on available data, the classiﬁca�on criteria are not met.
Based on available data, the classiﬁca�on criteria are not met.
Based on available data, the classiﬁca�on criteria are not met.
Based on available data, the classiﬁca�on criteria are not met.
Based on available data, the classiﬁca�on criteria are not met.
Based on available data, the classiﬁca�on criteria are not met.
Based on available data, the classiﬁca�on criteria are not met.
Based on available data, the classiﬁca�on criteria are not met.

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SECTION 11: Toxicological informa�on
11.2. Informa�on on other hazards
11.2.1.
Endocrine disrupting properties
Endocrine disrup�ng proper�es
11.2.2.
Other information
Other adverse eﬀects

This product does not contain any known or suspected endocrine disruptors.
No informa�on available.

SECTION 12: Ecological informa�on
12.1. Toxicity
Ecotoxicity
Unknown aqua�c toxicity

Based on available data, the classiﬁca�on criteria are not met. Based on available data, theclassiﬁca�on criteria are not met.
Contains 0 % of components with unknown hazards to the aqua�c environment.

12.2. Persistence and degradability
Persistence and degradability

No informa�on available.

12.3. Bioaccumula�ve poten�al
Bioaccumula�on

No informa�on available.

12.4. Mobility in soil
Mobility in soil

No informa�on available.

12.5. Results of PBT and vPvB assessment
PBT and vPvB assessment
The product does not contain any substance(s) classiﬁed as PBT or vPvB.
12.6. Endocrine disrup�ng proper�es
Endocrine disrup�ng proper�esThis product does not contain any known or suspected endocrine disruptors.

12.7. Other adverse eﬀects
Other adverse eﬀects

No informa�on available.

SECTION 13: Disposal considera�ons
13.1. Waste treatment methods
Waste from residues/unused
products
Contaminated packaging
Waste codes / waste
designa�ons according to EWC/ AVV

Dispose of in accordance with local regula�ons. Dispose of waste in accordance withenvironmental legisla�on.
Do not reuse empty containers.
According to the European Waste Catalog, Waste Codes are not product speciﬁc, but applica�on
speciﬁc. Waste codes should be assigned by the user based on the applica�on for which the
product was used.

SECTION 14: Transport informa�on
IMDG
14.1
14.2
14.3
14.4
14.5
14.6
14.7

UN number or ID number
UN proper shipping name
Transport hazard class(es)Packing group
Environmental hazards
Special Precau�ons for Users
Special Provisions
Mari�me transport in bulk according to IMO instruments

SDS – Invivoscribe ABI Assays (CLP)-EN Rev. A | December 2023

Not regulated
Not regulated
Not regulated
Not regulated
Not applicableNot applicable
None
No information available
7 / 21

Invivoscribe® ABI Assays

SECTION 14: Transport informa�on
RID

ADR

IATA

14.1
14.2
14.3
14.4
14.5
14.6

14.1
14.2
14.3
14.4
14.5
14.6

14.1
14.2
14.3
14.4
14.5
14.6

Not regulated
Not regulated
Not regulated
Not regulated
Not applicableNot applicable

UN numberUN proper shipping name
Transport hazard class(es)Packing group
Environmental hazards
Special Precau�ons for Users
Special Provisions

None
Not regulated
Not regulated
Not regulated
Not regulated
Not applicableNot applicable

UN number or ID number
UN proper shipping name
Transport hazard class(es)Packing group
Environmental hazards
Special Precau�ons for Users
Special Provisions

None
Not regulated
Not regulated
Not regulated
Not regulated
Not applicableNot applicable

UN number or ID number
UN proper shipping name
Transport hazard class(es)Packing group
Environmental hazards
Special Precau�ons for Users
Special Provisions

None

Note:

None

SECTION 15: Regulatory informa�on
15.1. Safety, health and environmental regula�ons/legisla�on speciﬁc for the substance or mixtureNa�onal regula�ons
Germany
Water hazard class (WGK)
non-hazardous to water (nwg)
European Union
Take note of Direc�ve 98/24/EC on the protec�on of the health and safety of workers from the risks related to chemical agents at
work.
Authoriza�ons and/or restric�ons on use:
This product does not contain substances subject to authoriza�on (Regula�on (EC) No. 1907/2006 (REACH), Annex XIV) This productdoes not contain substances subject to restric�on (Regula�on (EC) No. 1907/2006 (REACH), Annex XVII)Persistent Organic Pollutants
Not applicable
Ozone-deple�ng substances (ODS) regula�on (EC) 1005/2009
Not applicable
Interna�onal Inventories
Contact supplier for inventory compliance status
15.2. Chemical safety assessment
Chemical Safety Report

No informa�on available

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SECTION 16: Other informa�on
Key or legend to abbrevia�ons and acronyms used in the safety data sheet
Legend
ATE: Acute Toxicity Es�mate
SVHC: Substances of Very High Concern for Authoriza�on:
PBT: Persistent, Bioaccumula�ve, and Toxic (PBT) Substances
vPvB: Very Persistent and very Bioaccumula�ve (vPvB) Substances
Legend Sec�on 8: Exposure controls/personal protec�on
TWA
TWA (�me-weighted average)
Ceiling
Maximum limit value
SCBA
Self-contained breathing apparatus
Classiﬁca�on procedure
Classiﬁca�on according to Regula�on (EC) No. 1272/2008 [CLP]
Acute oral toxicity
Acute dermal toxicity
Acute inhala�on toxicity - gas
Acute inhala�on toxicity - vapor
Acute inhala�on toxicity - dust/mist
Skin corrosion/irrita�on
Serious eye damage/eye irrita�on
Respiratory sensi�za�on
Skin sensi�za�on
Mutagenicity
Carcinogenicity
Reproduc�ve toxicity
STOT - single exposure
STOT - repeated exposure
Acute aqua�c toxicity
Chronic aqua�c toxicity
Aspira�on hazard
Ozone

STEL
*

STEL (Short Term Exposure Limit)
Skin designa�on

Method Used
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
On basis of test data
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method

Key literature references and sources for data used to compile the SDS
Agency for Toxic Substances and Disease Registry (ATSDR)
U.S. Environmental Protec�on Agency ChemView Database
European Food Safety Authority (EFSA)
European Chemicals Agency (ECHA) Commitee for Risk Assessment (ECHA_RAC)
European Chemicals Agency (ECHA) (ECHA_API)
EPA (Environmental Protec�on Agency)
Acute Exposure Guideline Level(s) (AEGL(s))
U.S. Environmental Protec�on Agency Federal Insec�cide, Fungicide, and Roden�cide Act
U.S. Environmental Protec�on Agency High Produc�on Volume Chemicals
Food Research Journal
Hazardous Substance Database
Interna�onal Uniform Chemical Informa�on Database (IUCLID)
Japan GHS Classiﬁca�onAustralia Na�onal Industrial Chemicals No�ﬁca�on and Assessment Scheme (NICNAS)

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SECTION 16: Other informa�on
NIOSH (Na�onal Ins�tute for Occupa�onal Safety and Health)Na�onal Library of Medicine's ChemID Plus (NLM CIP)
Na�onal Library of Medicine’s PubMed database (NLM PUBMED)
United States of America Na�onal Toxicology Program (NTP)New Zealand's Chemical Classiﬁca�on and Informa�on Database (CCID)
Organiza�on for Economic Co-opera�on and Development Environment, Health, and Safety
Publica�ons Organiza�on for Economic Co-opera�on and Development High Produc�on Volume
Chemicals Program Organiza�on for Economic Co-opera�on and Development Screening Informa�on
Data Set
World Health Organiza�on
Issuing Date
Revision Date
Revision Note

27-Apr-2023
27-Apr-2023
Ini�al Release.

This safety data sheet complies with the requirements of Commission Regula�on (EU) 2020/878 of 18 June 2020 amending Regula�on (EC)No. 1907/2006
Disclaimer
The informa�on provided in this Safety Data Sheet is correct to the best of our knowledge, informa�on and belief at the date of its
publica�on. The informa�on given is designed only as a guidance for safe handling, use, processing, storage, transporta�on, disposal andrelease and is not to be considered a warranty or quality speciﬁca�on. The informa�on relates only to the speciﬁc material designated andmay not be valid for such material used in combina�on with any other materials or in any process, unless speciﬁed in the text.

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SAFETY DATA SHEETThis safety data sheet was created pursuant to the requirements of:Regula�on (EC) No. 1907/2006 as amended by Commission Regula�on (EU)2020/878 and Regula�on (EC) No. 1272/2008
Issuing Date 27-Apr-2023

Revision Date 27-Apr-2023

Revision Number 1

SECTION 1: Iden�ﬁca�on of the substance/mixture and of the company/undertaking
1.1.

Product iden�ﬁer
Product Code(s)20960011
20960021
21010011
21010031
21010041
21010051
21010061
21010081
21010091
21010101
2101017121010181
21020011
21020021
21030011
22050011
22050021
22050031
22060011
22070021
22070071
22070091
23100010
23100020
23100030
23100041
23100051
23100061
23100071
23100081
23100101
23110011
23110020
23110031
23110041
24120011
24120031
30000000
31010380
Pure substance/mixture

Product Name
Ampliﬁca�on Control - 6FAM for ABI Fluorescence Detec�onSpecimen Control Size Ladder - 6FAM for ABI Fluorescence Detec�on
IGH Tube A - 6FAM for ABI Fluorescence Detec�on
IGH Tube C - HEX for ABI Fluorescence Detec�on
IGH Tube D - HEX for ABI Fluorescence Detec�on
IGH Tube E - 6FAM Fluorescence Detec�on
IGH Framework 1 (FR1) - 6FAM for ABI Fluorescence Detec�on
IGH Framework 3 (FR3) - HEX for ABI Fluorescence Detec�on
IGH Framework 2 (FR2) - 6FAM for ABI Fluorescence Detec�on
IGH Tube B - 6FAM for ABI Fluorescence Detec�onHypermuta�on Mix 1 v2.0 - 6FAM for ABI Fluorescence Detec�onHypermuta�on Mix 2 v2.0 6FAM for ABI Fluorescence Detec�on
IGK Tube A - 6FAM for ABI Fluorescence Detec�on
IGK Tube B - 6FAM for ABI Fluorescence Detec�on
IGL Tube - 6FAM for ABI Fluorescence Detec�on
TCRB Tube A - 6FAM & HEX for ABI Fluorescence Detec�on
TCRB Tube B - 6FAM for ABI Fluorescence Detec�on
TCRB Tube C - 6FAM & HEX for ABI Fluorescence Detec�on
TCRD Tube - 6FAM & HEX for ABI Fluorescence
T Cell Receptor Gamma Mix 2 - HEX for ABI Fluorescence Detec�on
T-Cell Receptor Gamma Mix 1 - 6FAM for ABI Fluorescence Detec�on
TCRG - 6FAM
BCR/ABL t(9;22) Mix 1a for Gel Detec�on
BCR/ABL t(9;22) Mix 2a for Gel Detec�on
BCR/ABL t(9;22) Mix 3a for Gel Detec�on
BCR/ABL t(9;22) Mix 1b - HEX for ABI Fluorescence Detec�on
BCR/ABL t(9;22) Mix 2b - HEX for ABI Fluorescence Detec�on
BCR/ABL t(9;22) Mix 2c - HEX for ABI Fluorescence Detec�on
BCR/ABL t(9;22) Mix 3b - 6FAM for ABI Fluorescence Detec�on
BCR/ABL t(9;22) Mix 3c - 6FAM for ABI Fluorescence Detec�on
BCR/ABL t(9;22) Mix 3d - 6FAM for ABI Fluorescence Detec�on
PML/RARA t(15;17) Mix 1 - HEX for ABI Fluorescence Detec�on
PML/RARA t(15;17) Mix 2a for Gel Detec�on
PML/RARA t(15;17) Mix 2b - HEX for ABI Fluorescence Detec�on
PML/RARA t(15;17) Mix 2c - HEX for ABI Fluorescence Detec�on
FLT3 ITD Master Mix - 6FAM & HEX for ABI Fluorescence Detec�on
FLT3 D835 Master Mix - 6FAM for ABI Fluorescence Detec�onPrimer Hypermuta�on 100 μM - Unlabeled
IGH JH Primer 100 μM - Unlabeled

Synonyms
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None

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Invivoscribe® ABI Assays

SECTION 1: Iden�ﬁca�on of the substance/mixture and of the company/undertaking
1.2.

Relevant iden�ﬁed uses of the substance or mixture and uses advised against
Recommended use
Assay reagent
Uses advised against
For professional use only

1.3.

Details of the supplier of the safety data sheet
ImporterSupplier
Invivoscribe
Invivoscribe, Inc.
Technologies
10222 Barnes Canyon Rd
Bldg. 1
Zeppelinstrasse 1
San Diego, CA 92121
85399 Hallbergmoos
Germany
Phone: +1 858-224-6600
Phone: +49 89 904
299 800
For further informa�on, please contact
E-mail address
customerservice@invivoscribe.com

1.4.

Emergency telephone number
Emergency telephone+49 89 904 299 800 (M-F 8:00 – 16:30 CET)Emergency telephone - §45 - (EC)1272/2008
Europe112

Distributor
Invivoscribe Technologies, SARL
c/o Ficorec Domicilia�on Services
132, Boulevard Michelet
Hall Nord – 5ème étage
13008 Marseille
FRANCE
Tel: +33 (0)4 42 01 78 10

SECTION 2: Hazards iden�ﬁca�on
2.1.

Classiﬁca�on of the substance or mixture
Classiﬁcation according to Regulation (EC) No. 1272/2008 [CLP]This mixture is classiﬁed as not hazardous according to regula�on (EC) 1272/2008 [CLP]

2.2.

Label elements
Hazard statements

2.3.

Not classiﬁed.
Unknown aqua�c toxicity

Contains 0 % of components with unknown hazards to the aqua�c environment.

Other hazards
Endocrine Disruptor Informa�on

This product does not contain any known or suspected endocrine disruptors.

SECTION 3: Composi�on/informa�on on ingredients
3.1

Substances
Not applicable

3.2

Mixtures
Chemical name

Weight%REACH
registra�onnumberEC No (EU
Index No)Classiﬁca�onaccording toRegula�on (EC) No.
1272/2008 [CLP][C]

Speciﬁcconcentra�onlimit (SCL)

MFactorDimethyl sulfoxide
1-5
No data
200-664-3
67-68-5
available
Classiﬁcation according to Regulation (EC) No. 1272/2008 [CLP] - Notes[C] - Components with occupational exposure limits and/or biological occupational exposure limits requiring monitoring

M-Factor(long-term)-

Full text of H- and EUH-phrases: see sec�on 16

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SECTION 3: Composi�on/informa�on on ingredients
Acute Toxicity Estimate
If LD50/LC50 data is not available or does not correspond to the classiﬁcation category, then the appropriate conversion value from
CLP Annex I, Table 3.1.2, is used to calculate the acute toxicity estimate (ATEmix) for classifying a mixture based on its components
Chemical name
Oral LD50 mg/kg
Dermal LD50
Inhala�on LC50 - 4
Inhala�on LC50 - 4
Inhala�on LC50 - 4
mg/kg
hour - dust/mist hour - vapor - mg/Lhour - gas - ppm
mg/L
Dimethyl sulfoxide
28300
40000
5.3353No data available
No data available
67-68-5This product does not contain candidate substances of very high concern at a concentra�on >=0.1% (Regula�on (EC) No. 1907/2006(REACH), Ar�cle 59)

SECTION 4: First aid measures
4.1.

Descrip�on of ﬁrst aid measures
Inhala�on
Remove to fresh air. Get medical aten�on if symptoms occur.
Eye contact
Rinse thoroughly with plenty of water, also under the eyelids. Get medical aten�on if symptoms occur.
Skin contact
Wash skin with soap and water. Get medical aten�on if symptoms occur.
Inges�on
Do NOT induce vomi�ng. Never give anything by mouth to an unconscious person. Rinse mouth. Get medicalaten�on if symptoms occur.

4.2.

Most important symptoms and eﬀects, both acute and delayed
Symptoms
None known.
Eﬀects of Exposure
No informa�on available.

4.3.

Indica�on of any immediate medical aten�on and special treatment needed
Note to physicians
Treat symptoma�cally.

SECTION 5: Fireﬁgh�ng measures
5.1.

Ex�nguishing media
Suitable Ex�nguishing MediaUse ex�nguishing measures that are appropriate to local circumstances and thesurrounding environment.
No informa�on available.

Unsuitable ex�nguishing media
5.2.

Special hazards arising from the substance or mixture
Speciﬁc hazards arising from the chemical
No informa�on available.

5.3.

Advice for ﬁreﬁghters
Special protec�ve equipment and precau�ons
for ﬁre-ﬁghters

Fireﬁghters should wear self-contained breathing apparatus and full ﬁreﬁgh�ng
turnout gear. Use personal protec�on equipment.

SECTION 6: Accidental release measures
6.1.

Personal precau�ons, protec�ve equipment and emergency procedures
Personal precau�ons
Ensure adequate ven�la�on.
For emergency responders
Use personal protec�on recommended in Sec�on 8.

6.2.

Environmental precau�ons
Environmental precau�ons

6.3.

Methods and material for containment and cleaning up
Methods for containment
Prevent further leakage or spillage if safe to do so.
Methods for cleaning up
Dam up. Soak up with inert absorbent material. Take up mechanically, placing in appropriate
containers for disposal.

See Sec�on 12 for addi�onal Ecological Informa�on.

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SECTION 6: Accidental release measures
6.4.

Preven�on of secondary hazards

Clean contaminated objects and areas thoroughly observing environmental regula�ons.

Reference to other sec�ons
Reference to other sec�ons

See sec�on 8 for more informa�on See sec�on 13 for more informa�on

SECTION 7: Handling and storage
7.1.

Precau�ons for safe handling
Advice on safe handling
General hygiene considera�ons

7.2.

Condi�ons for safe storage, including any incompa�bili�esStorage Condi�ons
Keep containers �ghtly closed in a dry, cool and well-ven�lated place.
Storage class (TRGS 510)
Storage class 10.

7.3.

Speciﬁc end use(s)Speciﬁc use(s)Handle in accordance with good industrial hygiene and safety prac�ce.
Handle in accordance with good industrial hygiene and safety prac�ce.

The iden�ﬁed uses for this product are detailed in Sec�on 1.2.

SECTION 8: Exposure controls/personal protec�on
8.1.

Control parameters
Exposure Limits
Chemical name
Dimethyl sulfoxide
67-68-5

European Union-

Austria
TWA: 50 ppm
TWA: 160 mg/m3
H*
Czech Republic-

Belgium-

Bulgaria-

Croa�a-Denmark
TWA: 50 ppm
TWA: 160 mg/m3
STEL: 100 ppm
STEL: 320 mg/m3

Estonia
TWA: 50 ppm
TWA: 150 mg/m3
STEL: 150 ppm
STEL: 500 mg/m3
A*
Greece-Finland
TWA: 50 ppm
iho*

Latvia-Lithuania
O*
TWA: 50 ppm
TWA: 150 mg/m3
STEL: 150 ppm
STEL: 500 mg/m3
Spain-

Chemical name
Dimethyl sulfoxide
67-68-5

Cyprus-Chemical name
Dimethyl sulfoxide
67-68-5

France-Germany TRGS
TWA: 50 ppm
TWA: 160 mg/m3
H*

Chemical name
Dimethyl sulfoxide
67-68-5

Ireland-

Italy MDLPS-

Germany DFG
TWA: 50 ppm
TWA: 160 mg/m3
Peak: 100 ppm
Peak: 320 mg/m3*
Italy AIDII-

Chemical name
Dimethyl sulfoxide
67-68-5

Portugal-

Romania-

Slovakia-

Chemical name

SwedenSDS – Invivoscribe ABI Assays (CLP)-EN Rev. A | December 2023

Switzerland

Hungary-

Slovenia
TWA: 160 mg/m3
TWA: 50 ppm
STEL: 100 ppm
STEL: 320 mg/m3
K*
United Kingdom

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Invivoscribe® ABI Assays

SECTION 8: Exposure controls/personal protec�onDimethyl sulfoxide
67-68-5

NGV: 50 ppm
NGV: 150 mg/m3
Vägledande KGV: 150 ppm
Vägledande KGV: 500 mg/m3
H*

TWA: 50 ppm
TWA: 160 mg/m3
STEL: 100 ppm
STEL: 320 mg/m3
H*-

Biological occupa�onal exposure limits
This product, as supplied, does not contain any hazardous materials with biological limits established by the region speciﬁc regulatory
bodies.
Derived No Eﬀect Level (DNEL) - Workers
Chemical name
Dimethyl sulfoxide
67-68-5
Notes
[4]
[5]
[6]
[7]

Oral
-

Dimethyl sulfoxide
67-68-5

17 mg/L

Chemical nameFreshwater
sediment
13.4 mg/kg
sediment dw

Dimethyl sulfoxide
67-68-5
8.2.

Exposure controls
Engineering controls

Inhala�on
484 mg/m3 [4] [6]265 mg/m3 [5] [6]

Systemic health eﬀects.
Local health eﬀects.
Long term.
Short term.

Derived No Eﬀect Level (DNEL) - General Public
Chemical name
Dimethyl sulfoxide
67-68-5
Notes
[4]
[5]
[6]
[7]
Predicted No Eﬀect Concentra�on (PNEC)
Chemical nameFreshwater

Dermal200 mg/kg bw/day [4] [6]Oral
60 mg/kg
bw/day [4] [6]Dermal-Inhala�on
120 mg/m3 [4] [6]47 mg/m3 [5] [6]

Systemic health eﬀects.
Local health eﬀects.
Long term.
Short term.
Freshwater(intermitent
release)-Marine waterAir

1.7 mg/L

Marine water(intermitent
release)-Marine sediment

Sewage treatment

Soil

Food chain-

11 mg/L

3.02 mg/kg soil dw

0.7 g/kg food-Showers
Eyewash sta�ons
Ven�la�on systems.

Personal protec�ve equipment
Eye/face protec�on
Hand protec�on
Skin and body protec�on
Respiratory protec�on

Wear safety glasses with side shields (or goggles). Eye protec�on must conform tostandard EN 166.
Wear suitable gloves. Gloves must conform to standard EN 374.
Wear suitable protec�ve clothing (EN ISO 6529).
No protec�ve equipment is needed under normal use condi�ons. If exposure limits
are exceeded or irrita�on is experienced, ven�la�on and evacua�on may berequired.

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Invivoscribe® ABI Assays

SECTION 8: Exposure controls/personal protec�onGeneral hygiene considera�ons
Environmental exposure controls

Handle in accordance with good industrial hygiene and safety prac�ce.
No informa�on available.

SECTION 9: Physical and chemical proper�es
9.1.

Informa�on on basic physical and chemical proper�es
Appearance
Clear liquid
Physical state
LiquidColor
Colorless. Light blue, light yellow, light pink. or light orange
Odor
Odorless
Odor thresholdNo informa�on available
PropertyMel�ng point / freezing point

ValuesRemarks • Method
No data available

Ini�al boiling point and boiling range

No data available

Flammability

No data available

Flammability Limit in Air
Upper ﬂammability or explosive limits

No data available

Lower ﬂammability or explosive limits

No data available

Flash point

No data available

Autoigni�on temperature

No data available

Decomposi�on temperaturepH
pH (as aqueous solu�on)

No data available
7

-

9.5

Kinema�c viscosity

No data available

Dynamic viscosity

No data available

Water solubility
Solubility(ies)

No data available
No data available

Par��on coeﬃcient

No data available

Vapor pressure

No data available

Rela�ve density

No data available

Bulk density

No data available

Liquid Density

No data available

Rela�ve vapor density

No data availablePar�cle characteris�cs
Par�cle Size

No data availablePar�cle Size Distribu�on
9.2.

No data available
No data available

No data available

Other informa�on
9.2.1.
9.2.2.

Information with regard to physical hazard classes
Not applicable
Other safety characteristics
No informa�on available

SECTION 10: Stability and reac�vity
10.1. Reac�vity
Reac�vity

None under normal use condi�ons.

10.2. Chemical stability
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Invivoscribe® ABI Assays

SECTION 10: Stability and reac�vity
Stability
Explosion data

Stable under normal condi�ons.

Sensi�vity to mechanical impact

None.

Sensi�vity to sta�c discharge

None.

10.3. Possibility of hazardous reac�ons
Possibility of hazardous reac�ons

None under normal processing.

10.4. Condi�ons to avoid
Condi�ons to avoid

None known based on informa�on supplied.

10.5. Incompa�ble materials
Incompa�ble materials

None known based on informa�on supplied.

10.6. Hazardous decomposi�on products
Hazardous decomposi�on products

None known based on informa�on supplied.

SECTION 11: Toxicological informa�on
11.1. Informa�on on hazard classes as deﬁned in Regula�on (EC) No 1272/2008
Informa�on on likely routes of exposure
Product Informa�on
Inhala�on

Speciﬁc test data for the substance or mixture is not available.

Eye contact

Speciﬁc test data for the substance or mixture is not available. Contact with eyes may cause irrita�on.

Skin contact

Speciﬁc test data for the substance or mixture is not available.

Inges�on

Speciﬁc test data for the substance or mixture is not available.

Symptoms related to the physical, chemical and toxicological characteris�cs
Symptoms
None known.
Acute toxicity
Numerical measures of toxicity
Based on available data, the classiﬁca�on criteria are not met.
Component Informa�on
Chemical name
Dimethyl sulfoxide

Oral LD50= 28300 mg/kg( Rat )

Dermal LD50
= 40000 mg/kg ( Rat )Inhala�on LC50
> 5.33 mg/L ( Rat ) 4 h

Delayed and immediate eﬀects as well as chronic eﬀects from short and long-term exposure
Skin corrosion/irrita�on
Based on available data, the classiﬁca�on criteria are not met.
Serious eye damage/eye irrita�on
Based on available data, the classiﬁca�on criteria are not met.
Respiratory or skin sensi�za�on
Based on available data, the classiﬁca�on criteria are not met.
Germ cell mutagenicity
Based on available data, the classiﬁca�on criteria are not met.
Carcinogenicity
Based on available data, the classiﬁca�on criteria are not met.
Reproduc�ve toxicity
Based on available data, the classiﬁca�on criteria are not met.
STOT - single exposure
Based on available data, the classiﬁca�on criteria are not met.
STOT - repeated exposure
Based on available data, the classiﬁca�on criteria are not met.
Aspira�on hazard
Based on available data, the classiﬁca�on criteria are not met.
11.2. Informa�on on other hazards
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SECTION 11: Toxicological informa�on
11.2.1.
11.2.2.

Endocrine disrupting properties
Endocrine disrup�ng proper�es
Other information
Other adverse eﬀects

This product does not contain any known or suspected endocrine disruptors.
No informa�on available.

SECTION 12: Ecological informa�on
12.1. Toxicity
Ecotoxicity

Based on available data, the classiﬁca�on criteria are not met. Based on available data, theclassiﬁca�on criteria are not met.
Contains 0 % of components with unknown hazards to the aqua�c environment.

Unknown aqua�c toxicity
Chemical name
Dimethyl sulfoxide
67-68-5

Algae/aqua�cplants
-12.2. Persistence and degradability
Persistence and degradability

Fish
LC50: =34000mg/L (96h, Pimephales promelas)
LC50: 33 - 37g/L (96h, Oncorhynchus mykiss)
LC50: >40g/L (96h, Lepomis macrochirus)
LC50: =41.7g/L (96h, Cyprinus carpio)

Toxicity to
microorganisms-

Crustacea-

No informa�on available.

12.3. Bioaccumula�ve poten�al
Bioaccumula�onComponent Informa�on
Chemical name
Dimethyl sulfoxide
12.4. Mobility in soil
Mobility in soilPar��on coeﬃcient-1.35

No informa�on available.

12.5. Results of PBT and vPvB assessment
PBT and vPvB assessment
The product does not contain any substance(s) classiﬁed as PBT or vPvB.
Chemical name
Dimethyl sulfoxide
67-68-5

PBT and vPvB assessment
The substance is not PBT / vPvB

12.6. Endocrine disrup�ng proper�es
Endocrine disrup�ng proper�esThis product does not contain any known or suspected endocrine disruptors.

12.7. Other adverse eﬀects
Other adverse eﬀects

No informa�on available.

SECTION 13: Disposal considera�ons
13.1. Waste treatment methods
Waste from residues/unused productsContaminated packaging
Waste codes / waste designa�ons
according to EWC / AVV

Dispose of in accordance with local regula�ons. Dispose of waste in accordance withenvironmental legisla�on.
Do not reuse empty containers.
According to the European Waste Catalog, Waste Codes are not product speciﬁc, but
applica�on speciﬁc. Waste codes should be assigned by the user based on theapplica�on for which the product was used.

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Invivoscribe® ABI Assays

SECTION 14: Transport informa�on
IMDG
14.1
14.2
14.3
14.4
14.5
14.6
14.7
RID

Not regulated
Not regulated
Not regulated
Not regulated
Not applicableNot applicable

UN number or ID number
UN proper shipping name
Transport hazard class(es)Packing group
Environmental hazards
Special Precau�ons for Users
Special Provisions

None

Mari�me transport in bulk according
to IMO instruments

Not regulated
Not regulated
Not regulated
Not regulated
Not applicableNot applicable

14.1 UN number
14.2 UN proper shipping name14.3 Transport hazard class(es)14.4 Packing group
14.5 Environmental hazards
14.6 Special Precau�ons for Users
Special Provisions

ADR

14.1
14.2
14.3
14.4
14.5
14.6

IATA
14.1
14.2
14.3
14.4
14.5
14.6

None
Not regulated
Not regulated
Not regulated
Not regulated
Not applicableNot applicable

UN number or ID number
UN proper shipping name
Transport hazard class(es)Packing group
Environmental hazards
Special Precau�ons for Users
Special Provisions

None
Not regulated
Not regulated
Not regulated
Not regulated
Not applicableNot applicable

UN number or ID number
UN proper shipping name
Transport hazard class(es)Packing group
Environmental hazards
Special Precau�ons for Users
Special Provisions

Note:

No informa�on available

None
None

SECTION 15: Regulatory informa�on
15.1. Safety, health and environmental regula�ons/legisla�on speciﬁc for the substance or mixtureNa�onal regula�ons
FranceOccupa�onal Illnesses (R-463-3, France)
Chemical nameFrench RG number
Dimethyl sulfoxide
RG 84
67-68-5
Germany
Water hazard class (WGK)

non-hazardous to water (nwg)

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Invivoscribe® ABI Assays

SECTION 15: Regulatory informa�on
European Union
Take note of Direc�ve 98/24/EC on the protec�on of the health and safety of workers from the risks related to chemical agents at
work.
Authoriza�ons and/or restric�ons on use:
This product contains one or more substance(s) subject to restric�on (Regula�on (EC) No. 1907/2006 (REACH), Annex XVII)
Chemical nameRestricted substance per REACH Annex
Substance subject to authoriza�on per
XVII
REACH Annex XIV
Dimethyl sulfoxide - 67-68-5
75.
Persistent Organic Pollutants
Not applicable
Ozone-deple�ng substances (ODS) regula�on (EC) 1005/2009
Not applicable
Interna�onal Inventories
Contact supplier for inventory compliance status
15.2. Chemical safety assessment
Chemical Safety Report

No informa�on available

SECTION 16: Other informa�on
Key or legend to abbrevia�ons and acronyms used in the safety data sheet
Legend
ATE: Acute Toxicity Es�mate
SVHC: Substances of Very High Concern for Authoriza�on:
PBT: Persistent, Bioaccumula�ve, and Toxic (PBT) Substances
vPvB: Very Persistent and very Bioaccumula�ve (vPvB) Substances
Legend Sec�on 8: Exposure controls/personal protec�on
TWA
TWA (�me-weighted average)
Ceiling
SCBA

Maximum limit value
Self-contained breathing apparatus

Classiﬁca�on procedure
Classiﬁca�on according to Regula�on (EC) No. 1272/2008 [CLP]
Acute oral toxicity
Acute dermal toxicity
Acute inhala�on toxicity - gas
Acute inhala�on toxicity - vapor
Acute inhala�on toxicity - dust/mist
Skin corrosion/irrita�on
Serious eye damage/eye irrita�on
Respiratory sensi�za�on
Skin sensi�za�on
Mutagenicity
Carcinogenicity
Reproduc�ve toxicity
SDS – Invivoscribe ABI Assays (CLP)-EN Rev. A | December 2023

STEL*

STEL (Short Term Exposure
Limit)
Skin designa�on

Method Used
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
On basis of test data
Calcula�on method
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SECTION 16: Other informa�on
STOT - single exposure
STOT - repeated exposure
Acute aqua�c toxicity
Chronic aqua�c toxicity
Aspira�on hazard
Ozone

Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method
Calcula�on method

Key literature references and sources for data used to compile the SDS
Agency for Toxic Substances and Disease Registry (ATSDR)
U.S. Environmental Protec�on Agency ChemView Database
European Food Safety Authority (EFSA)
European Chemicals Agency (ECHA) Commitee for Risk Assessment (ECHA_RAC)
European Chemicals Agency (ECHA) (ECHA_API)
EPA (Environmental Protec�on Agency)
Acute Exposure Guideline Level(s) (AEGL(s))
U.S. Environmental Protec�on Agency Federal Insec�cide, Fungicide, and Roden�cide Act
U.S. Environmental Protec�on Agency High Produc�on Volume Chemicals
Food Research Journal
Hazardous Substance Database
Interna�onal Uniform Chemical Informa�on Database (IUCLID)
Japan GHS Classiﬁca�onAustralia Na�onal Industrial Chemicals No�ﬁca�on and Assessment Scheme (NICNAS)
NIOSH (Na�onal Ins�tute for Occupa�onal Safety and Health)Na�onal Library of Medicine's ChemID Plus (NLM CIP)
Na�onal Library of Medicine’s PubMed database (NLM PUBMED)
United States of America Na�onal Toxicology Program (NTP)New Zealand's Chemical Classiﬁca�on and Informa�on Database (CCID)
Organiza�on for Economic Co-opera�on and Development Environment, Health, and Safety Publica�ons
Organiza�on for Economic Co-opera�on and Development High Produc�on Volume Chemicals Program
Organiza�on for Economic Co-opera�on and Development Screening Informa�on Data Set
World Health Organiza�on
Issuing Date

27-Apr-2023

Revision Date

27-Apr-2023

Revision Note

Ini�al Release.

This safety data sheet complies with the requirements of Commission Regula�on (EU) 2020/878 of 18 June 2020 amending Regula�on (EC)No. 1907/2006
Disclaimer
The informa�on provided in this Safety Data Sheet is correct to the best of our knowledge, informa�on and belief at the date of its
publica�on. The informa�on given is designed only as a guidance for safe handling, use, processing, storage, transporta�on, disposal andrelease and is not to be considered a warranty or quality speciﬁca�on. The informa�on relates only to the speciﬁc material designated andmay not be valid for such material used in combina�on with any other materials or in any process, unless speciﬁed in the text.
End of Safety Data SheetSDS – Invivoscribe ABI Assays (CLP)-EN Rev. A | December 2023

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