Safety data sheet

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BASF Safety data sheet according to UN GHS 4th rev.
Date / Revised: 06.09.2022 Version: 3.0
Product: Dexpanthenol Ph.Eur.
(ID no. 30276997/SDS_GEN_00/EN)
Date of print 09.01.2025

1. Identification
Product identifier

Dexpanthenol Ph.Eur.
Chemical name: Dexpanthenol
CAS Number: 81-13-0

Relevant identified uses of the substance or mixture and uses advised against

Relevant identified uses: Pharmaceutical agent

Details of the supplier of the safety data sheet

Company:
BASF SE
67056 Ludwigshafen
GERMANY
Operating Division Nutrition and Health

Telephone: +49 621 60-48434

E-mail address: [email protected]

Emergency telephone number

International emergency number:

Telephone: +49 180 2273-112

2. Hazards Identification

Classification of the substance or mixture

According to UN GHS criteria

No need for classification according to GHS criteria for this product.

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Safety data sheet according to UN GHS 4th rev.
Date / Revised: 06.09.2022 Version: 3.0
Product: Dexpanthenol Ph.Eur.
(ID no. 30276997/SDS_GEN_00/EN)
Date of print 09.01.2025

Label elements

Globally Harmonized System (GHS)

The product does not require a hazard warning label in accordance with GHS criteria.

Other hazards

According to UN GHS criteria

If applicable information is provided in this section on other hazards which do not result in
classification but which may contribute to the overall hazards of the substance or mixture.

3. Composition/Information on Ingredients
Substances

Chemical nature

Dexpanthenol
CAS Number: 81-13-0
EC-Number: 201-327-3

Hazardous ingredients (GHS)

According to UN GHS criteria

D-Pantolactone
Content (W/W): >= 1 % - < 3 % Acute Tox. 5 (oral)
CAS Number: 599-04-2 Eye Dam./Irrit. 2A
EC-Number: 209-963-3 H319, H303

3-Aminopropan-1-ol
Content (W/W): >= 0,3 % - < 1 % Acute Tox. 4 (oral)
CAS Number: 156-87-6 Skin Corr./Irrit. 1B
EC-Number: 205-864-4 Eye Dam./Irrit. 1
Aquatic Acute 3
H302, H314, H402

For the classifications not written out in full in this section the full text can be found in section 16.

Mixtures

Not applicable
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Safety data sheet according to UN GHS 4th rev.
Date / Revised: 06.09.2022 Version: 3.0
Product: Dexpanthenol Ph.Eur.
(ID no. 30276997/SDS_GEN_00/EN)
Date of print 09.01.2025
4. First-Aid Measures
Description of first aid measures
Remove contaminated clothing.

If inhaled:
Keep patient calm, remove to fresh air.

On skin contact:
Wash thoroughly with soap and water

On contact with eyes:

Wash affected eyes for at least 15 minutes under running water with eyelids held open.

On ingestion:
Rinse mouth and then drink 200-300 ml of water.

Most important symptoms and effects, both acute and delayed

Symptoms: (Further) symptoms and / or effects are not known so far

Indication of any immediate medical attention and special treatment needed

Treatment: Symptomatic treatment (decontamination, vital functions).

5. Fire-Fighting Measures
Extinguishing media
Suitable extinguishing media:
Water in copious quantities, carbon dioxide, foam

Special hazards arising from the substance or mixture

carbon oxides, harmful vapours
The substances/groups of substances mentioned can be released in case of fire.

Advice for fire-fighters

Special protective equipment:
Wear a self-contained breathing apparatus.

Further information:
Dispose of fire debris and contaminated extinguishing water in accordance with official regulations.
Cool endangered containers with water-spray.

6. Accidental Release Measures

Personal precautions, protective equipment and emergency procedures
Use personal protective clothing. Information regarding personal protective measures, see section 8.

Environmental precautions
Do not discharge into drains/surface waters/groundwater.

Methods and material for containment and cleaning up

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Safety data sheet according to UN GHS 4th rev.
Date / Revised: 06.09.2022 Version: 3.0
Product: Dexpanthenol Ph.Eur.
(ID no. 30276997/SDS_GEN_00/EN)
Date of print 09.01.2025
For small amounts: Pick up with suitable absorbent material (e.g. sand, sawdust, general-purpose
binder, kieselguhr).
For large amounts: Dike spillage. Pump off product.
Dispose of absorbed material in accordance with regulations.

7. Handling and Storage

Precautions for safe handling
Handle in accordance with good industrial hygiene and safety practice.

Protection against fire and explosion:

Take precautionary measures against static discharges. Avoid all sources of ignition: heat, sparks,
open flame.

Conditions for safe storage, including any incompatibilities

Further information on storage conditions: Keep container tightly closed in a cool, well-ventilated
place.

Specific end use(s)

For the relevant identified use(s) listed in Section 1 the advice mentioned in this section 7 is to be
observed.

8. Exposure Controls/Personal Protection

Control parameters

Components with occupational exposure limits

156-87-6: 3-Aminopropan-1-ol

Exposure controls
Personal protective equipment
Respiratory protection:
Respiratory protection in case of vapour/aerosol release. Particle filter with medium efficiency for
solid and liquid particles (e.g. EN 143 or 149, Type P2 or FFP2)

Hand protection:
Chemical resistant protective gloves (EN ISO 374-1)

Eye protection:
Safety glasses with side-shields (frame goggles) (e.g. EN 166)

Body protection:
Body protection must be chosen based on level of activity and exposure.

General safety and hygiene measures

Handle in accordance with good industrial hygiene and safety practice. Wearing of closed work
clothing is recommended. No eating, drinking, smoking or tobacco use at the place of work. Hands
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Safety data sheet according to UN GHS 4th rev.
Date / Revised: 06.09.2022 Version: 3.0
Product: Dexpanthenol Ph.Eur.
(ID no. 30276997/SDS_GEN_00/EN)
Date of print 09.01.2025
and/or face should be washed before breaks and at the end of the shift. Store work clothing
separately.

9. Physical and Chemical Properties

Information on basic physical and chemical properties

Form: highly viscous, liquid to semi-crystalline

Colour: colourless to slightly yellow
Odour: almost odourless
Odour threshold:
not determined
pH value: 10,5
(100 g/l, 25 °C)
Freezing point: -25 °C (OECD Guideline 102)
(995 hPa)
Boiling point: 235,6 °C (OECD Guideline 103)
(995 hPa)
The substance / product does not
decompose.
Flash point: 150,5 °C (ASTM D93)
Evaporation rate:
not determined
Flammability: hardly combustible (derived from flash - and boiling
point)
Lower explosion limit:
For liquids not relevant for
classification and labelling., The
lower explosion point may be 5 - 15
°C below the flash point.
Upper explosion limit:
For liquids not relevant for
classification and labelling.
Ignition temperature: > 400 °C (Directive 84/449/EEC, A.15)
Vapour pressure: < 0,01 hPa
(25 °C)
Density: 1,162 g/cm3
(25 °C)
Relative vapour density (air):> 1 (calculated)
(20 °C)
Heavier than air.
Solubility in water: (OECD Guideline 105)
509 g/l
(22 °C, pH 9,3)
Solubility (qualitative) solvent(s): organic solvents
soluble
Partitioning coefficient n-octanol/water (log Kow): -1,92 (calculated)
(25 °C)
Self ignition: Based on its structural properties the Test type: Spontaneous self-
product is not classified as self- ignition at room-temperature.
igniting.

Thermal decomposition: 270 °C

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Safety data sheet according to UN GHS 4th rev.
Date / Revised: 06.09.2022 Version: 3.0
Product: Dexpanthenol Ph.Eur.
(ID no. 30276997/SDS_GEN_00/EN)
Date of print 09.01.2025
Viscosity, dynamic: 1.000.000 mPa.s
(20 °C)
Explosion hazard: Based on the chemical structure
there is no indication of explosive
properties.
Fire promoting properties: Based on its structural properties
the product is not classified as
oxidizing.

Other information

Self heating ability: not applicable, the product is a liquid

Bulk density:
not applicable
Adsorption/water - soil: log KOC: 1,0 (calculated)
Surface tension:
Based on chemical structure, surface
activity is not to be expected.
Grain size distribution: The substance / product is marketed or used in a non solid or
granular form.
Molar mass: 205,25 g/mol

10. Stability and Reactivity

Reactivity

Corrosion to metals: No data available.

Formation of Remarks: Forms no flammable gases in the
flammable gases: presence of water.

Possibility of hazardous reactions

No hazardous reactions if stored and handled as prescribed/indicated.

Conditions to avoid
See SDS section 7 - Handling and storage.

Incompatible materials

Substances to avoid:
No substances known that should be avoided.

Hazardous decomposition products

Hazardous decomposition products:

No hazardous decomposition products if stored and handled as prescribed/indicated.

11. Toxicological Information

Information on toxicological effects

Acute toxicity
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Safety data sheet according to UN GHS 4th rev.
Date / Revised: 06.09.2022 Version: 3.0
Product: Dexpanthenol Ph.Eur.
(ID no. 30276997/SDS_GEN_00/EN)
Date of print 09.01.2025

Assessment of acute toxicity:

Virtually nontoxic after a single ingestion. The inhalation of a highly enriched/saturated vapor-air-
mixture represents an unlikely acute hazard. Virtually nontoxic after a single skin contact.

Experimental/calculated data:
LD50 rat (oral): > 10.000 mg/kg (similar to OECD guideline 401)
No mortality was observed.

rat (by inhalation): 7 h (IRT)

No mortality was observed. Inhalation-risk test (IRT): No mortality within 7 hours as shown in animal
studies. The inhalation of a highly saturated vapor-air mixture represents no acute hazard.

LD50 rat (dermal): > 2.000 mg/kg (Directive 92/69/EEC, B.3)

No mortality was observed. The product has not been tested. The statement has been derived from
substances/products of a similar structure or composition.

Irritation

Assessment of irritating effects:

Not irritating to eyes and skin.

Experimental/calculated data:
Skin corrosion/irritation rabbit: non-irritant (OECD Guideline 404)

Serious eye damage/irritation rabbit: non-irritant (BASF-Test)

Serious eye damage/irritation rabbit: non-irritant (OECD Guideline 405)

Respiratory/Skin sensitization

Assessment of sensitization:
Skin sensitizing effects were not observed in animal studies.

Experimental/calculated data:
Buehler test guinea pig: Non-sensitizing. (OECD Guideline 406)
The product has not been tested. The statement has been derived from substances/products of a
similar structure or composition.

Germ cell mutagenicity

Assessment of mutagenicity:
The substance was not mutagenic in bacteria. The substance was not mutagenic in mammalian cell
culture. The product has not been fully tested. The statements have been derived in parts from
products of a similar structure or composition.

Carcinogenicity

Assessment of carcinogenicity:
No data available concerning carcinogenic effects.

Reproductive toxicity

Assessment of reproduction toxicity:

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Safety data sheet according to UN GHS 4th rev.
Date / Revised: 06.09.2022 Version: 3.0
Product: Dexpanthenol Ph.Eur.
(ID no. 30276997/SDS_GEN_00/EN)
Date of print 09.01.2025
Repeated oral uptake of the substance did not cause damage to the reproductive organs. The
product has not been tested. The statement has been derived from substances/products of a similar
structure or composition.

Developmental toxicity

Assessment of teratogenicity:
No indications of a developmental toxic / teratogenic effect were seen in animal studies. The product
has not been tested. The statement has been derived from substances/products of a similar
structure or composition.

Specific target organ toxicity (single exposure)

Assessment of STOT single:

Based on the available information there is no specific target organ toxicity to be expected after a
single exposure.

Repeated dose toxicity and Specific target organ toxicity (repeated exposure)

Assessment of repeated dose toxicity:

Repeated oral uptake of the substance did not cause substance-related effects. The product has not
been tested. The statement has been derived from substances/products of a similar structure or
composition.

Aspiration hazard

not applicable

12. Ecological Information

Toxicity

Assessment of aquatic toxicity:

There is a high probability that the product is not acutely harmful to aquatic organisms. The inhibition
of the degradation activity of activated sludge is not anticipated when introduced to biological
treatment plants in appropriate low concentrations.

Toxicity to fish:
LC50 (96 h) > 1.000 mg/l, Oncorhynchus mykiss (OECD Guideline 203, static)
The details of the toxic effect relate to the nominal concentration.

Aquatic invertebrates:
EC50 (48 h) > 100 mg/l, Daphnia magna (OECD Guideline 202, part 1, static)
The details of the toxic effect relate to the nominal concentration.

Aquatic plants:
EC50 (72 h) > 100 mg/l (growth rate), Desmodesmus subspicatus (OECD Guideline 201, static)
The details of the toxic effect relate to the nominal concentration.

Microorganisms/Effect on activated sludge:

EC10 (17 h) > 10.000 mg/l, Pseudomonas putida (DIN 38412 Part 8, aerobic)
The details of the toxic effect relate to the nominal concentration.
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Safety data sheet according to UN GHS 4th rev.
Date / Revised: 06.09.2022 Version: 3.0
Product: Dexpanthenol Ph.Eur.
(ID no. 30276997/SDS_GEN_00/EN)
Date of print 09.01.2025
EC20 (30 min) > 800 mg/l, activated sludge (DIN EN ISO 8192-OECD 209-88/302/EEC,P. C,
aerobic)

Chronic toxicity to fish:

No data available regarding toxicity to fish.

Chronic toxicity to aquatic invertebrates:

No observed effect concentration (21 d) >= 100 mg/l, Daphnia magna (OECD Guideline 202, part 2,
semistatic)
The details of the toxic effect relate to the nominal concentration. The product has not been tested.
The statement has been derived from substances/products of a similar structure or composition.

Assessment of terrestrial toxicity:

No data available.

Persistence and degradability

Assessment biodegradation and elimination (H2O):

Readily biodegradable (according to OECD criteria).

Elimination information:
90 - 100 % DOC reduction (21 d) (OECD 301 A (new version)) (aerobic, activated sludge, domestic)

Assessment of stability in water:

No data available.
Bioaccumulative potential

Assessment bioaccumulation potential:

No significant accumulation in organisms is expected as a result of the distribution coefficient of n-
octanol/water (log Pow).

Bioaccumulation potential:
Because of the n-octanol/water distribution coefficient (log Pow) accumulation in organisms is not to
be expected.

Mobility in soil

Assessment transport between environmental compartments:

Volatility: The substance will not evaporate into the atmosphere from the water surface.
Adsorption in soil: Adsorption to solid soil phase is not expected.

Results of PBT and vPvB assessment

According to Annex XIII of Regulation (EC) No.1907/2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH): The product does not fulfill the criteria for PBT
(Persistent/bioaccumulative/toxic) and vPvB (very persistent/very bioaccumulative).

Other adverse effects

The substance is not listed in Regulation (EC) 1005/2009 on substances that deplete the ozone
layer.
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Safety data sheet according to UN GHS 4th rev.
Date / Revised: 06.09.2022 Version: 3.0
Product: Dexpanthenol Ph.Eur.
(ID no. 30276997/SDS_GEN_00/EN)
Date of print 09.01.2025
13. Disposal Considerations

Waste treatment methods

Observe national and local legal requirements.

Contaminated packaging:
Uncontaminated packaging can be re-used.
Packs that cannot be cleaned should be disposed of in the same manner as the contents.

14. Transport Information

Land transport

ADR
Not classified as a dangerous good under transport regulations
UN number or ID number: Not applicable
UN proper shipping name: Not applicable
Transport hazard class(es): Not applicable
Packing group: Not applicable
Environmental hazards: Not applicable
Special precautions for None known
user

RID
Not classified as a dangerous good under transport regulations
UN number or ID number: Not applicable
UN proper shipping name: Not applicable
Transport hazard class(es): Not applicable
Packing group: Not applicable
Environmental hazards: Not applicable
Special precautions for None known
user

Inland waterway transport

ADN
Not classified as a dangerous good under transport regulations
UN number or ID number: Not applicable
UN proper shipping name: Not applicable
Transport hazard class(es): Not applicable
Packing group: Not applicable
Environmental hazards: Not applicable
Special precautions for None known
user:

Transport in inland waterway vessel

Not evaluated
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Safety data sheet according to UN GHS 4th rev.
Date / Revised: 06.09.2022 Version: 3.0
Product: Dexpanthenol Ph.Eur.
(ID no. 30276997/SDS_GEN_00/EN)
Date of print 09.01.2025

Sea transport

IMDG
Not classified as a dangerous good under transport regulations
UN number or ID number: Not applicable
UN proper shipping name: Not applicable
Transport hazard class(es): Not applicable
Packing group: Not applicable
Environmental hazards: Not applicable
Special precautions for None known
user

Air transport

IATA/ICAO
Not classified as a dangerous good under transport regulations
UN number or ID number Not applicable
UN proper shipping name: Not applicable
Transport hazard class(es): Not applicable
Packing group: Not applicable
Environmental hazards: Not applicable
Special precautions for None known
user

Maritime transport in bulk according to IMO instruments

Maritime transport in bulk is not intended.

15. Regulatory Information

Safety, health and environmental regulations/legislation specific for the substance or
mixture

If other regulatory information applies that is not already provided elsewhere in this safety data
sheet, then it is described in this subsection.

16. Other Information

Any other intended applications should be discussed with the manufacturer. Corresponding
occupational protection measurements must be followed.

Full text of classifications, hazard symbols and hazard statements, if mentioned in section 2 or 3:
Acute Tox. Acute toxicity
Eye Dam./Irrit. Serious eye damage/eye irritation
Skin Corr./Irrit. Skin corrosion/irritation
Aquatic Acute Hazardous to the aquatic environment - acute
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Safety data sheet according to UN GHS 4th rev.
Date / Revised: 06.09.2022 Version: 3.0
Product: Dexpanthenol Ph.Eur.
(ID no. 30276997/SDS_GEN_00/EN)
Date of print 09.01.2025
H319 Causes serious eye irritation.
H303 May be harmful if swallowed.
H302 Harmful if swallowed.
H314 Causes severe skin burns and eye damage.
H402 Harmful to aquatic life.

The data contained in this safety data sheet are based on our current knowledge and experience and
describe the product only with regard to safety requirements. This safety data sheet is neither a
Certificate of Analysis (CoA) nor technical data sheet and shall not be mistaken for a specification
agreement. Identified uses in this safety data sheet do neither represent an agreement on the
corresponding contractual quality of the substance/mixture nor a contractually designated use. It is the
responsibility of the recipient of the product to ensure any proprietary rights and existing laws and
legislation are observed.

Vertical lines in the left hand margin indicate an amendment from the previous version.