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Safety data sheet Printing date 07.06.2019

according to 1907/2006/EC, Article 31 Revision: 07.06.2019
Version number 10

· 1.1 Product identifier

· Trade name: Stearic Acid
Acidum stearicum
· Article number: 100058
· EC number:
200-313-4
· 1.2 Relevant identified uses of the substance or mixture and uses advised against
No further relevant information available.
· Application of the substance / the mixture
Additive for cosmetic or pharmaceutic preparations
Pharmaceutical production and analysis.
· 1.3 Details of the supplier of the safety data sheet
· Manufacturer/Supplier:
Fagron UK Ltd
4B Coquet St
Newcastle upon Tyne
England NE1 2QB
· Further information obtainable from:
Emergency response telephone number:
+44 (0) 845 652 2525
· 1.4 Emergency telephone number:
Emergency response telephone number:
+44 (0) 845 652 2525

* SECTION 2: Hazards identification

· 2.1 Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008
The substance is not classified, according to the CLP regulation.
· 2.2 Label elements
· Labelling according to Regulation (EC) No 1272/2008 Void
· Hazard pictograms Void
· Signal word Void
· Hazard statements Void
· 2.3 Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* SECTION 3: Composition/information on ingredients

· 3.1 Chemical characterisation: Substances Formula: C18H36O2 M: 284.48 g/mol
· CAS No. Description
Octadecanoic acid
· Identification number(s)
· EC number: 200-313-4

* SECTION 4: First aid measures

· 4.1 Description of first aid measures
· General information: No special measures required.
(Contd. on page 2)
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Safety data sheet Printing date 07.06.2019
according to 1907/2006/EC, Article 31 Revision: 07.06.2019
Version number 10

Trade name: Stearic Acid

Acidum stearicum

(Contd. of page 1)
· After inhalation: Supply fresh air; consult doctor in case of complaints.
· After skin contact: Generally the product does not irritate the skin.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: Rinse out mouth and then drink plenty of water. Consult a doctor.
· 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available.
· 4.3 Indication of any immediate medical attention and special treatment needed
No further relevant information available.

* SECTION 5: Firefighting measures

· 5.1 Extinguishing media
· Suitable extinguishing agents:
Foam
Use fire extinguishing methods suitable to surrounding conditions.
· 5.2 Special hazards arising from the substance or mixture
During heating or in case of fire poisonous gases are produced.
· 5.3 Advice for firefighters
· Protective equipment: Wear self-contained respiratory protective device.

* SECTION 6: Accidental release measures

· 6.1 Personal precautions, protective equipment and emergency procedures
Wear protective equipment. Keep unprotected persons away.
· 6.2 Environmental precautions: No special measures required.
· 6.3 Methods and material for containment and cleaning up: Pick up mechanically.
· 6.4 Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for disposal information.

* SECTION 7: Handling and storage

· 7.1 Precautions for safe handling Prevent formation of dust.
· Information about fire - and explosion protection: No special measures required.
· 7.2 Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and receptacles: No special requirements.
· Information about storage in one common storage facility: Store away from foodstuffs.
· Further information about storage conditions: Store in dry conditions.
· 7.3 Specific end use(s) No further relevant information available.

* SECTION 8: Exposure controls/personal protection

· Additional information about design of technical facilities: No further data; see item 7.
(Contd. on page 3)
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 Page 3/7
Safety data sheet Printing date 07.06.2019
according to 1907/2006/EC, Article 31 Revision: 07.06.2019
Version number 10

Trade name: Stearic Acid

Acidum stearicum

(Contd. of page 2)

· 8.1 Control parameters

· Ingredients with limit values that require monitoring at the workplace: Not required.
· Additional information: The lists valid during the making were used as basis.
· 8.2 Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
The usual precautionary measures are to be adhered to when handling chemicals.
· Respiratory protection: Fresh air mask
· Protection of hands:
The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.
Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/
the chemical mixture.
Selection of the glove material on consideration of the penetration times, rates of diffusion and the
degradation
· Material of gloves
Nitrile rubber, NBR
The selection of the suitable gloves does not only depend on the material, but also on further marks of quality
and varies from manufacturer to manufacturer.
· Penetration time of glove material
The exact break trough time has to be found out by the manufacturer of the protective gloves and has to be
observed.
In full contact
Layer thickness: 0.11.
Breakthrough time: >480 Min.
In splash contact
Layer thickness: >480 Min.
· Eye protection: Not required.
· Body protection: Protective work clothing

* SECTION 9: Physical and chemical properties

· 9.1 Information on basic physical and chemical properties
· General Information
· Appearance:
Form: Solid
Colour: White
· Odour: Recognisable
· Odour threshold: Not determined.
· pH-value: Not applicable.
· Change in condition
Melting point/freezing point: 67 °C
Initial boiling point and boiling range: 383 °C
· Flash point: 196 °C
· Flammability (solid, gas): Product is not flammable.
(Contd. on page 4)
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Safety data sheet Printing date 07.06.2019
according to 1907/2006/EC, Article 31 Revision: 07.06.2019
Version number 10

Trade name: Stearic Acid

Acidum stearicum

(Contd. of page 3)

· Ignition temperature: 395 °C

· Decomposition temperature: Not determined.
· Auto-ignition temperature: Not determined.
· Explosive properties: Product does not present an explosion hazard.
· Explosion limits:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density at 20 °C: 0.94 g/cm³
· Bulk density: ~400-500 kg/m³
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
water at 20 °C: - g/l
· Partition coefficient: n-octanol/water: Not determined.
· Viscosity:
Dynamic: Not applicable.
Kinematic: Not applicable.
· 9.2 Other information No further relevant information available.

* SECTION 10: Stability and reactivity

· 10.1 Reactivity No further relevant information available.
· 10.2 Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· 10.3 Possibility of hazardous reactions No dangerous reactions known.
· 10.4 Conditions to avoid No further relevant information available.
· 10.5 Incompatible materials: No further relevant information available.
· 10.6 Hazardous decomposition products: No dangerous decomposition products known.

* SECTION 11: Toxicological information

· 11.1 Information on toxicological effects
· Acute toxicity Based on available data, the classification criteria are not met.
· LD/LC50 values relevant for classification:
Dermal LD50 >5,000 mg/kg (Rabbit)
· Primary irritant effect:
· Skin corrosion/irritation Irritant to skin and mucous membranes.
· Serious eye damage/irritation Based on available data, the classification criteria are not met.
(Contd. on page 5)
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Safety data sheet Printing date 07.06.2019
according to 1907/2006/EC, Article 31 Revision: 07.06.2019
Version number 10

Trade name: Stearic Acid

Acidum stearicum

(Contd. of page 4)
· Respiratory or skin sensitisation Based on available data, the classification criteria are not met.
· Additional toxicological information:
After inhalation: In high doses: Irritation symptoms ain the
respiratory tract.
After skin contact: Possible effect after contact with substance:
slight irritation symptoms.
Naturally occuring substance.
· CMR effects (carcinogenity, mutagenicity and toxicity for reproduction)
· Germ cell mutagenicity Based on available data, the classification criteria are not met.
· Carcinogenicity Based on available data, the classification criteria are not met.
· Reproductive toxicity Based on available data, the classification criteria are not met.
· STOT-single exposure Based on available data, the classification criteria are not met.
· STOT-repeated exposure Based on available data, the classification criteria are not met.
· Aspiration hazard Based on available data, the classification criteria are not met.

* SECTION 12: Ecological information

· 12.1 Toxicity
· Aquatic toxicity: No further relevant information available.
· 12.2 Persistence and degradability No further relevant information available.
· Degree of elimination: BOD 4% from TOD/5d.
· Behaviour in environmental systems:
· Components:
Distribution: log p(o/w): 8.23
An appreciable bioaccumulation potential is to be expected
(log P(o/w)>3).
· 12.3 Bioaccumulative potential No further relevant information available.
· 12.4 Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Not hazardous for water.
· 12.5 Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· 12.6 Other adverse effects No further relevant information available.

* SECTION 13: Disposal considerations

· 13.1 Waste treatment methods
· Recommendation Smaller quantities can be disposed of with household waste.
· Uncleaned packaging:
· Recommendation: Disposal must be made according to official regulations.
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(Contd. on page 6)

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Safety data sheet Printing date 07.06.2019
according to 1907/2006/EC, Article 31 Revision: 07.06.2019
Version number 10

Trade name: Stearic Acid

Acidum stearicum

(Contd. of page 5)

* SECTION 14: Transport information

· 14.1 UN-Number
· ADR, ADN, IMDG, IATA Void
· 14.2 UN proper shipping name
· ADR, ADN, IMDG, IATA Void
· 14.3 Transport hazard class(es)
· ADR, ADN, IMDG, IATA
· Class Void
· 14.4 Packing group
· ADR, IMDG, IATA Void
· 14.5 Environmental hazards: Not applicable.
· 14.6 Special precautions for user Not applicable.
· 14.7 Transport in bulk according to Annex II of Marpol
and the IBC Code Not applicable.
· Transport/Additional information: Not dangerous according to the above specifications.
· UN "Model Regulation": Void

* SECTION 15: Regulatory information

· 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
· Directive 2012/18/EU
· Named dangerous substances - ANNEX I Substance is not listed.
· 15.2 Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* SECTION 16: Other information

This SDS is intended to provide a brief summary of our knowledge and guidance regarding the use of this
material. The information contained here has been compiled from sources considered to be dependable and is
accurate to the best of the Company’s knowledge. However, the information is provided without any
representation or warranty, expressed or implied regarding its accuracy or correctness. The Company cannot
assume responsibility for adverse events which may occur in the use and/or misuse of this product and
expressly disclaims liability for loss, damage and/or expense arising out of or in any way connected with the
handling, storage, use and/or disposal of this product.
· Department issuing SDS:
Fagron UK
Quality Assurance
· Contact: [email protected]
· Abbreviations and acronyms:
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the
International Transport of Dangerous Goods by Rail)
ICAO: International Civil Aviation Organisation
(Contd. on page 7)
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Safety data sheet Printing date 07.06.2019
according to 1907/2006/EC, Article 31 Revision: 07.06.2019
Version number 10

Trade name: Stearic Acid

Acidum stearicum

(Contd. of page 6)
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International
Carriage of Dangerous Goods by Road)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
GHS: Globally Harmonised System of Classification and Labelling of Chemicals
EINECS: European Inventory of Existing Commercial Chemical Substances
CAS: Chemical Abstracts Service (division of the American Chemical Society)
LC50: Lethal concentration, 50 percent
LD50: Lethal dose, 50 percent
PBT: Persistent, Bioaccumulative and Toxic
vPvB: very Persistent and very Bioaccumulative
· * Data compared to the previous version altered.
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