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Eom Sds Glycerine 99.5% Usp v4 Eu-En

The document is a Safety Data Sheet for GLYCERINE 99.5% USP, detailing its identification, uses, hazards, first aid measures, firefighting measures, handling and storage, exposure controls, physical properties, stability, toxicological information, and ecological information. Glycerine is classified as non-hazardous and is used in various applications including food, pharmaceuticals, and as a chemical intermediate. The document includes emergency contact information and guidelines for safe handling and disposal.
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0% found this document useful (0 votes)
37 views9 pages

Eom Sds Glycerine 99.5% Usp v4 Eu-En

The document is a Safety Data Sheet for GLYCERINE 99.5% USP, detailing its identification, uses, hazards, first aid measures, firefighting measures, handling and storage, exposure controls, physical properties, stability, toxicological information, and ecological information. Glycerine is classified as non-hazardous and is used in various applications including food, pharmaceuticals, and as a chemical intermediate. The document includes emergency contact information and guidelines for safe handling and disposal.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 9

Page 1/9

Safety Data Sheet


according to 1907/2006/EC, Article 31
Printing date 12.05.2023 Version number 4 (replaces version 3) Revision: 12.05.2023

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


· 1.1 Product identifier
· Trade name: GLYCERINE 99.5% USP
· Product description: 1,2,3-propanetriol
· CAS Number:
56-81-5
· EC number:
200-289-5
· Registration number
Not applicable
Exempted, Annex V(9) of EU-REACH
· 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
Chemical intermediate
Food
Moisturizing
Paint
Pharmaceutical intermediate
Plasticiser
Preservative
Solvents
Textile auxiliary
· 1.3 Details of the supplier of the safety data sheet
· Manufacturer/Supplier:
Edenor Oleochemicals (M) Sdn. Bhd. (198001009328 (63112-D)).
Lot 1, Jalan Perak, Kawasan Perusahaan,
42500, Telok Panglima Garang,
Selangor Darul Ehsan, Malaysia.
Telephone: +603 3326 8686
· Further information obtainable from:

Product Safety & Regulations


Email: [email protected]
· 1.4 Emergency telephone number:

24 hours contact number: +603-33268726 [Edenor Oleochemicals (M) Sdn. Bhd. - EOM]

* 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 Not applicable
· Hazard pictograms Not applicable
· Signal word Not applicable
· Hazard statements Not applicable
· 2.3 Other hazards
· Results of PBT and vPvB assessment
· PBT: This product is not classified as PBT.
· vPvB: This product is not classified as vPvB.
EU
(Contd. on page 2)

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Page 2/9
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 12.05.2023 Version number 4 (replaces version 3) Revision: 12.05.2023

Trade name: GLYCERINE 99.5% USP

(Contd. of page 1)

SECTION 3: Composition/information on ingredients


· 3.1 Substances
· CAS No. Description
56-81-5 Glycerol
· Identification number(s)
· EC number: 200-289-5
· Additional information: This product is not classified in accordance with the GHS.

SECTION 4: First aid measures


· 4.1 Description of first aid measures
· General information: Immediately remove any clothing soiled by the product.
· After inhalation: Supply fresh air; consult doctor in case of complaints.
· After skin contact: Immediately wash with water and soap and rinse thoroughly.
· After eye contact: Rinse opened eye for several minutes under running water. Then consult a doctor.
· After swallowing:
Rinse out mouth and then drink plenty of water.
Call a doctor immediately.
· 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:
CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.
· For safety reasons unsuitable extinguishing agents: Water with full jet.
· 5.2 Special hazards arising from the substance or mixture
Under certain fire conditions, traces of other toxic gases cannot be excluded.
· 5.3 Advice for firefighters Avoid breathing dust/fume/gas/mist/vapours/spray.
· Protective equipment:
Wear self-contained respiratory protective device.
Wear fully protective suit.

SECTION 6: Accidental release measures


· 6.1 Personal precautions, protective equipment and emergency procedures
Wear protective clothing.
Use respiratory protective device against the effects of fumes/dust/aerosol.
· 6.2 Environmental precautions:
Do not allow product to reach sewage system or any water course.
Inform respective authorities in case of seepage into water course or sewage system.
Dilute with plenty of water.
Do not allow to enter sewers/ surface or ground water.
· 6.3 Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Dispose contaminated material as waste according to section 13.
· 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.
EU
(Contd. on page 3)

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Page 3/9
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 12.05.2023 Version number 4 (replaces version 3) Revision: 12.05.2023

Trade name: GLYCERINE 99.5% USP

(Contd. of page 2)

SECTION 7: Handling and storage


· 7.1 Precautions for safe handling
Keep receptacles tightly sealed.
Store in cool, dry place in tightly closed receptacles.
Keep away from heat and direct sunlight.
· Information about fire - and explosion protection:
Keep ignition sources away - Do not smoke.
Keep respiratory protective device available.
· 7.2 Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and receptacles: Store only in the original receptacle.
· Information about storage in one common storage facility: Store away from oxidising agents.
· Further information about storage conditions:
Keep container tightly sealed.
Protect from heat and direct sunlight.
· 7.3 Specific end use(s) No further relevant information available.

* SECTION 8: Exposure controls/personal protection


· 8.1 Control parameters
· Ingredients with limit values that require monitoring at the workplace:
56-81-5 Glycerol
AGW (Germany) Long-term value: 200 E mg/m³
2 (I);DFG, Y
· Additional information: The lists valid during the making were used as basis.
· 8.2 Exposure controls
· Appropriate engineering controls No further data; see section 7.
· Individual protection measures, such as personal protective equipment
· General protective and hygienic measures:
The usual precautionary measures are to be adhered to when handling chemicals.
Immediately remove all soiled and contaminated clothing
Wash hands before breaks and at the end of work.
Avoid contact with the eyes and skin.
· Respiratory protection: Suitable respiratory protective device recommended.
· Hand protection

S
_ Protective gloves

The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.
Selection of the glove material on consideration of the penetration times, rates of diffusion and the degradation
· Material of gloves
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 through time has to be found out by the manufacturer of the protective gloves and has to be
observed.
· Eye/face protection Safety glasses

* SECTION 9: Physical and chemical properties


· 9.1 Information on basic physical and chemical properties
· General Information
· Physical state Fluid
(Contd. on page 4)
EU

56.0.21
Page 4/9
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 12.05.2023 Version number 4 (replaces version 3) Revision: 12.05.2023

Trade name: GLYCERINE 99.5% USP

(Contd. of page 3)
· Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· Melting point/freezing point: 18.2 °C (Glycerol Handbook 1953)
· Boiling point or initial boiling point and boiling range 290 °C (Glycerol Handbook 1953)
· Flammability Not applicable.
· Lower and upper explosion limit
· Lower: Not determined.
· Upper: Not determined.
· Flash point: 177 °C (Cleveland open cup)
· Auto-ignition temperature: 370 °C
· Decomposition temperature: Not determined.
· pH-value: Not determined.
· Viscosity:
· Dynamic at 20 °C: 1.412 mPas (OECD 114)
· Solubility
· water at 25 °C: 1000000 mg/L (CRC Handbook 1997)
Fully miscible.
· Partition coefficient n-octanol/water (log value) -1.75 Log Pow (OECD 107)
· Vapour pressure at 20 °C: 0.0001 hPa
· Density and/or relative density
· Density at 20 °C: 1.26 g/cm³
· Relative density ≥ 1.249 (USP)
· 9.2 Other information
· Appearance:
· Form: Viscous
· Explosive properties: Product does not present an explosion hazard.
· Refractive index (n20D) ≥ 1.4731 (APAG GL 006)
· Change in condition
· Evaporation rate Not determined.

SECTION 10: Stability and reactivity


· 10.1 Reactivity No further relevant information available.
· 10.2 Chemical stability Stable at environment temperature.
· 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 See Section 7 for information of safe handling.
· 10.5 Incompatible materials: See Section 7 for information of safe handling.
· 10.6 Hazardous decomposition products: Carbon monoxide and carbon dioxide

* SECTION 11: Toxicological information


· 11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008
· Acute toxicity Based on available data, the classification criteria are not met.
· LD/LC50 values relevant for classification:
56-81-5 Glycerol
Oral LD50 27,200 mg/kg bw (Rat, Long-Evans) (Standard Acute Method)
Dermal LD50 56,750 mg/kg bw (Guinea pig) (Standard acute method)
Inhalative LC50 (4h) 5.85 mg/L (Rat, Sprague-Dawley) (OECD 412 Subacute Inhalation Toxicity)
· Conclusion / Summary No adverse effect observed.
· Skin corrosion / irritation
No irritant effect.
(Contd. on page 5)
EU

56.0.21
Page 5/9
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 12.05.2023 Version number 4 (replaces version 3) Revision: 12.05.2023

Trade name: GLYCERINE 99.5% USP

(Contd. of page 4)
56-81-5 Glycerol
Irritation of skin Irritation / Corrosion 0 score (Human) (Skin - Patch Test)
· Serious eye damage / irritation
No irritating effect.
56-81-5 Glycerol
Irritation of eyes Irritation / Corrosion ≤ 2 score (Rabbit) (In vivo, fully reversible)
· Respiratory or skin sensitisation
Not sensitising
56-81-5 Glycerol
Sensitisation Respiratory / skin sensitization < 3 SI value (mus) (OECD 429, in vivo, LLNA)
· Germ cell mutagenicity
No mutagenic effect.
56-81-5 Glycerol
Mutagenicity Negative (Chinese hamster) (OECD 476, In vitro, SCE Assay)
· Carcinogenicity
No adverse effect observed.
56-81-5 Glycerol
Oral NOAEL 8,000 mg/kg bw/day (Rat, Long-Evans) (Carcinogenic Potential Examination)
· Reproductive toxicity
No adverse effect observed.
56-81-5 Glycerol
Oral NOAEL (dev/fert/repro) > 2,000 mg/kg bw/day (Rat) (Two-generation Reproductive Toxicity)
NOAEL (embr/tera) > 1,180 mg/kg bw/day (Rabbit) (OECD 414)
· 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.
· Additional toxicological information:
· Repeated dose toxicity
56-81-5 Glycerol
Oral NOAEL (chronic toxicity) > 8,000 mg/kg bw/day (Rat, Long-Evans) (ECHA)
· 11.2 Information on other hazards
· Endocrine disrupting properties
Substance is not listed.

* SECTION 12: Ecological information


· 12.1 Toxicity
· Aquatic toxicity:
No adverse effect observed.
56-81-5 Glycerol
Acute LC50 (96h) (static) 54,000 mg/L (Fish, Oncorhynchus mykiss) (ECHA)
Acute LC50 (48h) (static) 1,955 mg/L (Aquatic invertebrates,Daphnia magna) (ECHA)
Acute NOEC (16h) (static) > 10,000 mg/L (Microorganism, Pseudomonas putida) (ECHA)
Chronic EC3 (8d) (static) > 10,000 mg/L (Algae, Scenedesmus quadricauda) (ECHA)
· 12.2 Persistence and degradability
Readily biodegradable.
56-81-5 Glycerol
Biodegradation in water 94 % degradation (226 mg/L, Aerobic,ECHA)
· 12.3 Bioaccumulative potential Does not accumulate in organisms
· 12.4 Mobility in soil No further relevant information available.
· 12.5 Results of PBT and vPvB assessment
· PBT: This product is not classified as PBT.
(Contd. on page 6)
EU

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Page 6/9
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 12.05.2023 Version number 4 (replaces version 3) Revision: 12.05.2023

Trade name: GLYCERINE 99.5% USP

(Contd. of page 5)
· vPvB: This product is not classified as vPvB.
· 12.6 Endocrine disrupting properties
The product does not contain substances with endocrine disrupting properties.
· 12.7 Other adverse effects
· Additional ecological information:
· General notes:
Water hazard class 1 (German Regulation) : slightly hazardous for water
Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage system.

* SECTION 13: Disposal considerations


· 13.1 Waste treatment methods
· Recommendation
Must not be disposed together with household garbage. Do not allow product to reach sewage system.
Must be specially treated adhering to official regulations.
· Uncleaned packaging:
· Recommendation: Disposal must be made according to official regulations.

* SECTION 14: Transport information


· 14.1 UN number or ID number
· ADR/RID/ADN, IMDG, IATA Not regulated
· 14.2 UN proper shipping name
· ADR/RID/ADN, ADN, IMDG, IATA Not regulated
· 14.3 Transport hazard class(es)
· ADR/RID/ADN, ADN, IMDG, IATA
· Class Not regulated
· 14.4 Packing group
· ADR/RID/ADN, IMDG, IATA Not regulated
· 14.5 Environmental hazards: Not applicable.
· 14.6 Special precautions for user Not applicable.
· 14.7 Maritime transport in bulk according to IMO
instruments Product name : Glycerine
Pollution category: Z
Ship type: 3
· UN "Model Regulation": Not regulated

* SECTION 15: Regulatory information


· 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
· TSCA (Toxic Substances Control Act)
Substance is listed.
ACTIVE
· Canadian Domestic Substances List (DSL)
Substance is listed.
· Philippines Inventory of Chemicals and Chemical Substances
Substance is listed.
· Chinese Chemical Inventory of Existing Chemical Substances
Substance is listed.
(Contd. on page 7)
EU

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Page 7/9
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 12.05.2023 Version number 4 (replaces version 3) Revision: 12.05.2023

Trade name: GLYCERINE 99.5% USP

(Contd. of page 6)
· Australian Inventory of Industrial Chemicals
Substance is listed.
· ECHA EC Inventory Database:
EINECS No.: 200-289-5
· Korean Existing Chemical Inventory
Substance is listed.
KE-29297
· New Zealand Inventory of Chemicals
Substance is listed.
· Existing Chemical Directory of Thailand (DIW)
Substance is listed.
· TCSI - Taiwan Chemical Substance Inventory
Substance is listed.
· Mexico - National Inventory of Chemical Substances
Substance is listed.
· Malaysia - EHS reference list
Substance is not listed.
· Russia - Register of Eurasian industrial products
Substance is listed.
· Japan - Existing Chemical Substances
Substance is listed.
2-242
· Vietnam - National Existing Chemical Inventory
Substance is listed.
· Labelling according to Regulation (EC) No 1272/2008 Not applicable
· Hazard pictograms Not applicable
· Signal word Not applicable
· Hazard statements Not applicable
· Directive 2012/18/EU
· Named dangerous substances - ANNEX I Substance is not listed.
· DIRECTIVE 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and
electronic equipment – Annex II
Substance is not listed.
· REGULATION (EU) 2019/1148
· Annex I - RESTRICTED EXPLOSIVES PRECURSORS (Upper limit value for the purpose of licensing under
Article 5(3))
Substance is not listed.
· Annex II - REPORTABLE EXPLOSIVES PRECURSORS
Substance is not listed.
· Regulation (EC) No 273/2004 on drug precursors
Substance is not listed.
· Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and
third countries in drug precursors
Substance is not listed.
· National regulations:
· Waterhazard class: WGK Identification No. 116 for glycerol
· 15.2 Chemical safety assessment: A Chemical Safety Assessment has been carried out.
EU
(Contd. on page 8)

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Page 8/9
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 12.05.2023 Version number 4 (replaces version 3) Revision: 12.05.2023

Trade name: GLYCERINE 99.5% USP

(Contd. of page 7)

SECTION 16: Other information


This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific
product features and shall not establish a legally valid contractual relationship.
· Department issuing SDS: Product Safety & Regulations Department
· Contact:
Product Safety & Regulations
Email: [email protected]
· Date of previous version: 14.03.2023
· Version number of previous version: 3
· Abbreviations and acronyms:
RA: Read-across
LLNA : Local Lymph Node Assay
NOAEL : No Observed Adverse Effect Level
NOEC : No Observed Effect Concentration
SCE : Sister Chromatid Exchange
OECD : Organisation for Economic Co-operation and Development
ADN : European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways
DNEL : Derived No-Effect Level
PNEC : Predicted No-Effect Concentration
STP : Sewage Treatment Plant
ADG : The Australian Code for the Transport of Dangerous Goods by Road & Rail
LoS : Limit of Solubility
SCL: Specific Concentration Limit
LOEC : Lowest Observed Effect Concentration
SSWL : Surface water loss through the skin
ECHA : European Chemicals Agency
ADR: Accord relatif au transport international 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
· Sources
CAS No. 56-81-5 Glycerol
Annex 12 of Resolution MEPC.225(64) 2012 Amendments to The International Code For The Construction and
Equipment of Ships Carrying Dangerous Chemicals in Bulk (IBC Code).
ECHA Registered Subtances Database, CAS No. 56-81-5.
Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Sixth & Seventh Revised Edition.
HSDB for CAS No. 56-81-5.
ICOP (2014). The Industry Code of Practice on Chemical Classification and Hazard Communication.
ICOP (2019). The Industry Code of Practice on Chemical Classification and Hazard Communication (Amendment).
ICSC (International Chemical Safety Card) 0624 (April 2006) Glycerol.
IMO (2020). IMDG Code International Maritime Dangerous Goods Code. Incorporating Amendment 40-20.
Official Journal of the European Union Commission Regulation (EU) No 453/2010.
Official Journal of the European Union Commission Regulation (EU) 2015/830.
Official Journal of the European Union Commission Regulation (EU) 2020/878.
Official Journal of the European Union Regulation (EC) No 1272/2008.
Official Journal of the European Union Regulation (EC) No 1907/2006.
P.U. (A) 310/2013. Occupational Safety Health (Classification, Labelling and Safety Data Sheet of Hazardous
Chemicals) Regulations.
· * Data compared to the previous version altered.
GLYCERINE 99.5% USP (EU)

Revision 1 (May 25, 2022)


New issuance of GHS SDS according to ChemGes.

Revision 2 (November 23, 2022)


Section 1 - Update Trade name from GLYCERINE 99.5% USP to REFINED GLYCERINE 99.5% USP to be line
with Technical Data Sheet (TDS).

Revision 3 (March 14, 2023)


Update SDS format according to Commission Regulation (EU) 2020/878.
(Contd. on page 9)
EU

56.0.21
Page 9/9
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 12.05.2023 Version number 4 (replaces version 3) Revision: 12.05.2023

Trade name: GLYCERINE 99.5% USP

(Contd. of page 8)
Section 1 - Heading – Version number 2 changes to Version number 2 (replaces version 1).
Section 1 - Update Trade name from REFINED GLYCERINE 99.5% USP to GLYCERINE 99.5% USP to be line
with Technical Data Sheet (TDS).
Section 9 - Activate heading 9.2 Other information.
Section 11 - Activate heading 11.2 Information on the other hazards.
Section 12 - Activate heading 12.6 Endocrine disrupting properties and heading 12.7 Other adverse effects.
Section 15 - Report ECHA EC Inventory list.
Section 16 - Activate heading Date of previous version and Version number of previous version.

Revision 4 (May 12, 2023)


Section 1 - Remove (Formerly known as Emery Oleochemicals (M) Sdn. Bhd.) remark.
Section 9 - Water solubility : Revise from 1000 g/L to 1 000 000 mg/L.
EU

56.0.21

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