Bisoprolol fumarate

Safety Data Sheet

according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878
Issue date: 03/04/2023 Revision date: 26/10/2023 Supersedes version of: 03/04/2023 Version: 2.0

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

1.1. Product identifier

Product form : Substance
Substance name : Bisoprolol fumarate
Product code : 202200044

1.2. Relevant identified uses of the substance or mixture and uses advised against
1.2.1. Relevant identified uses
Main use category : The product is intended for research, analysis and scientific education.
Use of the substance/mixture : For professional use only
Function or use category : Laboratory chemicals

1.2.2. Uses advised against

Restrictions on use : Do not use : Ingestion, Inhalation, Dermal

1.3. Details of the supplier of the safety data sheet

European Directorate for the Quality of Medicines & Healthcare
EDQM, Council of Europe 7, Allée Kastner, CS30026
F– 67081 Strasbourg
France
T +33(0)388412035 - F +33(0)388412771
[email protected] - www.edqm.eu

1.4. Emergency telephone number

Emergency number : +33(0)390215608

SECTION 2: Hazards identification

2.1. Classification of the substance or mixture

Classification according to Regulation (EC) No. 1272/2008 [CLP]
Acute toxicity (oral), Category 4 H302
Reproductive toxicity, Category 2 H361
Specific target organ toxicity – Repeated exposure, Category 2 H373
Full text of H- and EUH-statements: see section 16

Adverse physicochemical, human health and environmental effects

Expert judgement and weight of evidence determination.

2.2. Label elements

Labelling according to Regulation (EC) No. 1272/2008 [CLP]
Hazard pictograms (CLP) :

GHS07 GHS08
Signal word (CLP) : Warning
Hazard statements (CLP) : H302 - Harmful if swallowed.
H361 - Suspected of damaging fertility or the unborn child.
H373 - May cause damage to organs through prolonged or repeated exposure.
Precautionary statements (CLP) : P201 - Obtain special instructions before use.
P202 - Do not handle until all safety precautions have been read and understood.
P260 - Do not breathe dust/fume/gas/mist/vapours/spray.
P264 - Wash hands, forearms and face thoroughly after handling.
P270 - Do not eat, drink or smoke when using this product.

26/10/2023 (Revision date) EN (English) 1/8

Bisoprolol fumarate
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878

P280 - Wear protective gloves/protective clothing/eye protection/face protection/hearing

protection.
P301+P312 - IF SWALLOWED: Call a POISON CENTRE or doctor if you feel unwell.
P314 - Get medical advice/attention if you feel unwell.
P330 - Rinse mouth.
P405 - Store locked up.
P501 - Dispose of contents/container to hazardous or special waste collection point, in
accordance with local, regional, national and/or international regulation.
Labelling according to: exemption for inner packaging where the contents do not exceed 10ml
Hazard pictograms (CLP) :

GHS08

2.3. Other hazards

No additional information available

SECTION 3: Composition/information on ingredients

3.1. Substances

Name Product identifier % Classification according to

Regulation (EC) No. 1272/2008
[CLP]
Bisoprolol fumarate - ≤ 100 Acute Tox. 4 (Oral), H302 (ATE=940
mg/kg bodyweight)
Repr. 2, H361
STOT RE 2, H373
Full text of H- and EUH-statements: see section 16

3.2. Mixtures
Not applicable

SECTION 4: First aid measures

4.1. Description of first aid measures

First-aid measures after skin contact : Wipe off as much as possible (using a clean, soft, absorbent material).
First-aid measures after eye contact : Rinse eyes with water as a precaution.

4.2. Most important symptoms and effects, both acute and delayed
No additional information available

4.3. Indication of any immediate medical attention and special treatment needed
No additional information available

SECTION 5: Firefighting measures

5.1. Extinguishing media

Suitable extinguishing media : Extinguishing blanket.

5.2. Special hazards arising from the substance or mixture

Fire hazard : See Heading 2.2.

26/10/2023 (Revision date) EN (English) 2/8

Bisoprolol fumarate
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878

5.3. Advice for firefighters

Firefighting instructions : Use extinguishing media appropriate for surrounding fire.

SECTION 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures

6.1.1. For non-emergency personnel
Emergency procedures : Avoid all unnecessary exposure.

6.1.2. For emergency responders

No additional information available

6.2. Environmental precautions

No additional information available

6.3. Methods and material for containment and cleaning up

No additional information available

6.4. Reference to other sections

No additional information available

SECTION 7: Handling and storage

7.1. Precautions for safe handling

No additional information available

7.2. Conditions for safe storage, including any incompatibilities

No additional information available

7.3. Specific end use(s)

See Heading 1.

SECTION 8: Exposure controls/personal protection

8.1. Control parameters

8.1.1 National occupational exposure and biological limit values
No additional information available

8.1.2. Recommended monitoring procedures

No additional information available

8.1.3. Air contaminants formed

No additional information available

8.1.4. DNEL and PNEC

No additional information available

8.1.5. Control banding

No additional information available

8.2. Exposure controls

8.2.1. Appropriate engineering controls

Appropriate engineering controls:

Keep in a well-ventilated room. Both local exhaust and general room ventilation are usually required.

26/10/2023 (Revision date) EN (English) 3/8

Bisoprolol fumarate
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878

8.2.2. Personal protection equipment

8.2.2.1. Eye and face protection

No additional information available

8.2.2.2. Skin protection

Skin and body protection:

Lab coat

Hand protection:
Protective gloves

8.2.2.3. Respiratory protection

No additional information available

8.2.2.4. Thermal hazards

No additional information available

8.2.3. Environmental exposure controls

No additional information available

SECTION 9: Physical and chemical properties

9.1. Information on basic physical and chemical properties

Physical state : Solid
Colour : Not available
Odour : Not available
Odour threshold : Not available
Melting point : Not available
Freezing point : Not available
Boiling point : Not available
Flammability : Not available
Explosive limits : Not applicable
Lower explosion limit : Not applicable
Upper explosion limit : Not applicable
Flash point : Not applicable
Auto-ignition temperature : Not applicable
Decomposition temperature : Not available
pH : 6 – 7 (50 g/l)
pH solution : Not available
Viscosity, kinematic : Not applicable
Solubility : Water: > 1000 g/l
Partition coefficient n-octanol/water (Log Kow) : Not available
Vapour pressure : Not available
Vapour pressure at 50°C : Not available
Density : Not available
Relative density : Not available
Relative vapour density at 20°C : Not applicable
Particle size : Not available

9.2. Other information

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

9.2.2. Other safety characteristics

No additional information available

26/10/2023 (Revision date) EN (English) 4/8

Bisoprolol fumarate
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878

SECTION 10: Stability and reactivity

10.1. Reactivity
Stable under normal conditions.

10.2. Chemical stability

No additional information available

10.3. Possibility of hazardous reactions

None known.

10.4. Conditions to avoid

No additional information available

10.5. Incompatible materials

None under normal use. See Section 7.

10.6. Hazardous decomposition products

When heated to decomposition, emits dangerous fumes.

SECTION 11: Toxicological information

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

Acute toxicity (oral) : Harmful if swallowed.
Acute toxicity (dermal) : Not classified (Lack of data)
Acute toxicity (inhalation) : Not classified (Lack of data)

Bisoprolol fumarate
LD50 oral rat 940 mg/kg (RTECS No: UB8390000)
Skin corrosion/irritation : Not classified (Based on available data, the classification criteria are not met)
pH: 6 – 7 (50 g/l)
Serious eye damage/irritation : Not classified (Based on available data, the classification criteria are not met)
pH: 6 – 7 (50 g/l)
Respiratory or skin sensitisation : Not classified (Lack of data)
Germ cell mutagenicity : Not classified (Based on available data, the classification criteria are not met)
Carcinogenicity : Not classified (Based on available data, the classification criteria are not met)
Reproductive toxicity : Suspected of damaging fertility or the unborn child.
STOT-single exposure : Not classified (Lack of data)
STOT-repeated exposure : May cause damage to organs through prolonged or repeated exposure.
Aspiration hazard : Not classified (Technical impossibility to obtain the data)

11.2. Information on other hazards

No additional information available

SECTION 12: Ecological information

12.1. Toxicity
Ecology - general : Presents no specific risk for the environment.
Hazardous to the aquatic environment, short–term : Not classified (Based on available data, the classification criteria are not met)
(acute)
Hazardous to the aquatic environment, long–term : Not classified (Inconclusive data)
(chronic)
Not rapidly degradable

26/10/2023 (Revision date) EN (English) 5/8

Bisoprolol fumarate
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878

12.2. Persistence and degradability

No additional information available

12.3. Bioaccumulative potential

No additional information available

12.4. Mobility in soil

No additional information available

12.5. Results of PBT and vPvB assessment

No additional information available

12.6. Endocrine disrupting properties

No additional information available

12.7. Other adverse effects

No additional information available

SECTION 13: Disposal considerations

13.1. Waste treatment methods

No additional information available

SECTION 14: Transport information

In accordance with ADR / IMDG / IATA
ADR IMDG IATA

14.1. UN number or ID number

Not applicable Not applicable Not applicable

14.2. UN proper shipping name

Not applicable Not applicable Not applicable

14.3. Transport hazard class(es)

Not applicable Not applicable Not applicable

14.4. Packing group

Not applicable Not applicable Not applicable

14.5. Environmental hazards

Not applicable Not applicable Not applicable

No supplementary information available

14.6. Special precautions for user

Overland transport
Not applicable

Transport by sea
Not applicable

Air transport
Not applicable

26/10/2023 (Revision date) EN (English) 6/8

Bisoprolol fumarate
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878

14.7. Maritime transport in bulk according to IMO instruments

Not applicable

SECTION 15: Regulatory information

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

REACH Annex XVII (Restriction List)

Not listed on REACH Annex XVII

REACH Annex XIV (Authorisation List)

Not listed on REACH Annex XIV (Authorisation List)

REACH Candidate List (SVHC)

Not listed on the REACH Candidate List

PIC Regulation (Prior Informed Consent)

Not applicable.

POP Regulation (Persistent Organic Pollutants)

Not applicable.

Ozone Regulation (1005/2009)

Not listed on the Ozone Depletion list (Regulation EU 1005/2009)

Explosives Precursors Regulation (2019/1148)

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

Drug Precursors Regulation (273/2004)

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

15.1.2. National regulations

No additional information available

15.2. Chemical safety assessment

No additional information available

SECTION 16: Other information

Indication of changes
Section Changed item Change Comments

Revision date Added

Reason for no classification Added

Reason for no classification Added

Supersedes version of Added

1.1 Name Modified

9.1 pH Added

11.1 Reason for no classification Added

11.1 LD50 oral rat Modified

11.1 ATE CLP (oral) Modified

26/10/2023 (Revision date) EN (English) 7/8

Bisoprolol fumarate
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878

Full text of H- and EUH-statements:

Acute Tox. 4 (Oral) Acute toxicity (oral), Category 4

H302 Harmful if swallowed.

H361 Suspected of damaging fertility or the unborn child.

H373 May cause damage to organs through prolonged or repeated exposure.

Repr. 2 Reproductive toxicity, Category 2

STOT RE 2 Specific target organ toxicity – Repeated exposure, Category 2

Safety Data Sheet (SDS), EU

DISCLAIMER OF LIABILITY The EDQM has created this SDS as a downstream user for regulatory compliance to rules applicable to chemicals
only. This article is intended only for small-volume laboratory analysis and other routine testing prescribed in the pharmacopoeia or EDQM study
protocol, under controlled conditions and by professionals only. Any other use of this article or the SDS information is the sole responsibility of the
user. This substance is present in articles in quantities totalling under 10 kg per year. There is no human or environmental exposure under intended
and foreseeable conditions of use. The user has the responsibility for handling, storage, use conditions and disposal of this article and for any use
of the information in this SDS. The information has been obtained from suppliers and is without any warranty, express or implied, regarding its
correctness. For this and other reasons, we do not assume responsibility and expressly disclaim liability for loss, damage or expense arising out of
or in any way connected with the handling, storage, use or disposal of the article.

26/10/2023 (Revision date) EN (English) 8/8