(EU) No.

453/2010

MATERIAL SAFETY DATA SHEET Revision: 3

Valid from: 26.8.2016

FAME No. of pages 15

This MSDS is not required by Article 31 of Regulation (EC) 1907/2006 (REACH) as the relevant
substance is not classified as hazardous, however, to comply with Article 32 of REACH
Regulation and provide customers with relevant information, the format of the MSDS according
to Commission Regulation (EU) No. 453/2010 has been used.

1. Identification of the substance/mixture and of the company/undertaking

1.1 Product identifier

Substance name CAS No. EC No. Registration number

Fatty acids, C16-18 and C18-unsatd., Me 67762-38-3 267-015-4 01-2119471664-32-0021

esters

1.2 Relevant identified uses of the substance or mixture and uses advised against
Uses Substance/mixture/ Industrial user/professional
article user/consumer
Use of Biodiesel In a mixture Professional users/consumers
Formulation for Gasoil production Substance Industrial user
Use of Gasoil In a mixture Professional users/consumers
The substance is not classified as hazardous under Regulation on Classification, Labelling and Packaging
(CLP) EC 1272/2008, therefore there are not uses advised against.

1.3 Details of the supplier of the safety data sheet

 PREOL a.s.
Terezínská 1214 Tel: +420 416 564 830
410 02 Lovosice Fax: +420 416 562 087
Czech Republic Contact person (MSDS): [email protected]

1.4 Emergency telephone number

 Toxicological Information Centre (TIC – Czech Republic)
Na bojišti 1,
12808 Praha 2;
Tel. (24h): +420 224 91 92 93; +420 224 91 54 02; +420 224 91 45 75; +420 224 97 11 11

 Transport Information and Emergency System (TRINS - Czech Republic)

It provides continuous training and practical assistance in dealing with emergencies associated with
the transport or storage of hazardous chemicals in the Czech Republic. The assistance is provided
via fire operational brigade (HZS) centers or via the national coordination center of Chemopetrol,
a.s. in Litvinov.

Contact telephone TRINS: + 4 2 0 4 7 6 7 0 9 8 2 6

1
 (EU) No. 453/2010

2. Hazards identification

2.1 Classification of the substance or mixture

Classification under Regulation (EC) No 1272/2008 (CLP)

No classification

Most important adverse physicochemical, human health and environmental effects

Substance is not classified as hazardous.
See also section 2.3.

2.2 Label elements

Label elements according to Regulation (EC) No. 1272/2008 (CLP)

Not relevant, substance is not classified as hazardous.

2.3 Other hazards

PBT (Persistent, Bioaccumulative and Toxic) or vPvB (very Persistent and very Bioaccumulative) criteria
Substance does not meet the criteria to be considered PBT neither vPvB

Other hazards
May cause minor eye irritation.
Vapors produced by heating, or finely misted materials may irritate the mucous membranes and cause
dizziness, and nausea.
Thermal burns are possible on contact with material at elevated temperatures.

3. Composition/information on ingredients

3.1 Substances
Chemical identity of the main constituent of the substance

Main constituent

EC name: Fatty acids, C16-18 and C18-unsatd., Me esters

EC number: 267-015-4

CAS number (EC inventory): 67762-38-3

CAS name: UVCB substance, for CAS name information it is possible to refer to the
different composition substances.

IUPAC name: UVCB substance, no IUPAC name available.

2
 (EU) No. 453/2010

Description: This substance is identified by SDA Substance Name: C16-C18 and C18
unsaturated alkyl carboxylic acid methyl ester and SDA Reporting
Number: 11-010-00.

The following other substances may fall within the same description:
Fatty acids, rape oil, Me esters - EINECS 287-828-8 - CAS 85586-25-0
Soybean oil, Me esters - EINECS 267-055-2 - CAS 67784-80-9
Fatty acids, soya, Me esters - EINECS 272-898-4 - CAS 68919-53-9
Fatty acids, sunflower-oil, Me esters - EINECS 272-900-3 - CAS 68919-54-0
Fatty acids, palm-oil, Me esters - EINECS 293-086-6 - CAS 91051-34-2

The substance is synthesized by transesterification of natural oils with

methanol to produce methylesters and glycerin. In this description enter all
substances generated by natural oils with fatty acid chains lengths focused on
C16, C18 and C18 unsatd. above 2%. Examples of such raw materials are
rapeseed oil, soya oil, soybean oil, sunflower oil, palm oil and all analogous
derivatives.

Molecular formula: UVCB substance, not univocal molecular formula available

Molecular weight range: ca. 296.0

Chemical identity of any relevant impurity, stabilizing additive, or individual constituent other than the main
constituent
None.

3.2 Mixtures
Not relevant as substance is not a mixture.

4. First aid measures

4.1 Description of first aid measures

First aid instructions

EYES
Irrigate eyes with a heavy stream of water for at least 15 to 20 minutes
SKIN
Wash immediately with plenty of soap and water. Remove all contaminated clothes and footwear immediately
unless stuck to skin.
INHALATION
Remove casualty from exposure ensuring one's own safety whilst doing so; seek medical attention if
symptoms persist.
INGESTION
Do not induce vomiting. Wash out mouth with water. If conscious, give half a liter of water to drink
immediately. If gastro-intestinal symptoms develop, consult medical personnel. (Never give anything by mouth
to an unconscious person)

3
 (EU) No. 453/2010

4.2 Most important symptoms and effects, both acute and delayed

Most important symptoms and effects.

Minor eye irritation possible.
Vapors produced by heating, or finely misted materials may irritate the mucous membranes and cause
dizziness, and nausea.
Thermal burns are possible on contact with material at elevated temperatures.

4.3 Indication of any immediate medical attention and special treatment needed

Indication of any immediate medical attention and special treatment needed

Not relevant for this substance.

5. Fire fighting measures

5.1 Extinguishing media

Extinguishing media

Appropriate extinguishing media.

Dry chemical powder, alcohol resistant foam, halon (may not be permissible in some countries), CO 2, water
spray (fog).
Unsuitable extinguishing media
Water stream may splash the burning liquid and spread fire

5.2 Special hazards arising from the substance or mixture

Special hazards

In combustion emits toxic fumes of carbon dioxide / carbon monoxide.

Biodiesel soaked rags or spill absorbents (i.e. oil dry, polypropylene socks, sand, etc.) can cause spontaneous
combustion if stored near combustibles and not handled properly.

5.3 Advice for firefighters

Advice for firefighters

Fire-fighters should use self-contained breathing apparatus to avoid exposure to smoke and vapour. Wear
protective clothing to prevent contact with skin and eyes.

Protective equipment
Fire-resistant clothing, self-contained breathing apparatus

Additional information
Flammable Class IV. according to ČSN 65 0201

4
 (EU) No. 453/2010

6. Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures
6.1.1 For non-emergency personnel

Personal precautions, protective equipment and emergency procedures.

Prevent contamination of clothes and shoes; avoid contact with the skin and eyes.

Eliminate all sources of ignition. If outside do not approach from downwind. Evacuate all personnel who do not
take part in the cleaning/emergency procedure. Mark out the contaminated area with signs and prevent access
to unauthorised personnel.
6.1.2 For emergency responders

Advice for firefighters

Wear self-contained breathing apparatus. Wear protective clothing to prevent contact with skin and eyes.
Flammable Class IV. according to ČSN 650201

6.2 Environmental precautions

Environmental precautions
Prevent any leakage. Do not discharge into communal sewerage, drains or waters.

6.3 Methods and material for containment and cleaning up

6.3.1 Spill containment

Contain any spillage using bounding.

6.3.2 Spill clean-up

Pick up small spills with absorbent materials and dispose of properly to avoid spontaneous combustion.
Disposal must be carried out according to valid legislation on wastes and residues.
Recover large spills for appropriate treatment and reutilization or for disposal according to legislation. Wash
hard surfaces with safety solvent or detergent to remove remaining oil film. Greasy nature will result in a
slippery surface.

6.3.3 Other information

Not relevant for this substance

6.4 Reference to other sections

Reference to other sections

See also sections 8 and 13

5
 (EU) No. 453/2010

7. Handling and storage

7.1 Precautions for safe handling

7.1.1 Recommendations for safe handling.

For safe handling is recommended to avoid direct contact with the substance.

Note: Substance Fatty acids, C16-18 and C18-unsaturated, Methyl esters is not classified as hazardous
according to the criteria of CLP Regulation (EC) No. 1272/2008. Specific Risk Management Measures are
therefore not required. Nevertheless, the exposure of workers during and after normal operations should be
minimized by the use of good industrial hygiene practice for handling chemical substances and mixtures.

7.1.2 Occupational hygiene advice.

Do not eat, drink or smoke in work areas; wash hands after use; and remove contaminated clothing and
protective equipment before entering eating areas.

7.2 Conditions for safe storage, including any incompatibilities

Safe storage conditions

Store in cool, well ventilated area. Keep away from sources of ignition, excessive heat and oxidizing agents.
Keep container tightly closed. Storage life, ~2 years. Protect from frost. Protect against static electricity. Store
at +15°C to +25°C.

7.3 Specific end use(s)

Specific end use

The product is designed especially for use as fuel for diesel engines.

Reference to other sections

See section 1.2

8. Exposure controls/personal protection

8.1 Control parameters

Control parameters
Exposure limits are not established.

8.2 Exposure controls

8.2.1 Appropriate engineering controls

No relevant engineering controls.

6
 (EU) No. 453/2010

8.2.2 Individual protection measures

RESPIRATORY PROTECTION:
If vapours or mists are generated, wear a NIOSH approved organic vapour/mist respirator.
PROTECTIVE CLOTHING:
Safety glasses, goggles, or face shield recommended to protect eyes from mists or splashing. PVC coated
gloves recommended to prevent skin contact.
OTHER PROTECTIVE MEASURES:
Employees must practice good personal hygiene, washing exposed areas of skin several times daily and
laundering contaminated clothing before re-use.

8.2.3 Environmental exposure controls

Prevent product from entering sewerages. Is not allowed to pour any amount of the product to the sewerage
or water pipes. See also 6.2

9. Physical and chemical properties

9.1 Information on basic physical and chemical properties

Overview of physicochemical properties

Appearance Green/yellow liquid oil

Odour Mild

Odour threshold N/A

pH N/A

Melting point/freezing point 6.29°C at 1 atm

The range of melting temperature goes from -16.92°C to +15.59°C.

Initial boiling point and boiling range 354.3°C at 1 atm

Flash point 173°C +/- 1°C

Evaporation rate N/A

Flammability (solid, gas) According to Regulation (EC) No 1272/2008 (CLP): Not flammable
According to ČSN 650201: Flammable Class IV.

Upper/lower flammability or explosive N/A

limits
4.2 m Bar at 25°C
Vapour pressure
420 Pa, at 25°C

7
 (EU) No. 453/2010

Overview of physicochemical properties

3.6 m Bar at 20°C

Vapour density N/A

Relative density 0.8881 g/cm3 at 20°C

Solubility(ies) < 0,023 mg/l Instrumental detection limit

Partition coefficient: n-octanol/water Log Kow = 6.2 at 25°C

Auto-ignition temperature 261°C +/- 5°C

The ignition delay observed at this temperature was 60 seconds
and a Temperature increase at middle of the flask was 14°C.

Decomposition temperature N/A

Viscosity 6.1 mPa*s at 20°C

Explosive properties Not explosive. In accordance with column 2 of REACH Annex VII,
the study does not need to be conducted since there are no
chemical groups associated with explosive proprieties present in the
molecule.

Oxidising properties Not oxidizing. In accordance with column 2 of REACH Annex VII,
the study does not need to be conducted since the substance is
incapable of reacting exothermically with combustible materials
based on the chemical structure

9.2 Other information

Other information
Chemical characteristics: It is a complex mixture of fatty acid methyl C16-18 and C18 unsaturated fatty acids.
To improve certain properties may contain appropriate additives as depressants when used at low
temperatures, corrosion inhibitors, etc. in different concentrations of the order to 0.1%.

10. Stability and reactivity

10.1 Reactivity

Reactivity hazards
This product is stable and hazardous reaction will not occur under appropriate handling and storage.

8
 (EU) No. 453/2010

10.2 Chemical stability

Chemical stability
The substance is stable under normal ambient and hazardous reaction will not occur under appropriate
handling and storage. Store in cool, well ventilated area. Storage life, ~2 years. Protect from frost. Store at
+15°C to +25°C. Keep away from oxidizing agents, excessive heat, and ignition sources.

10.3 Possibility of hazardous reactions

Possibility of hazardous reactions

The substance reacts with strong bases to produce methanol.

10.4 Conditions to avoid

Conditions to avoid
See 10.5.

10.5 Incompatible materials

Incompatible materials
Strong oxidizing agents. Strong bases.
10.6 Hazardous decomposition products

Hazardous decomposition products

Combustion produces carbon monoxide, carbon dioxide along with thick smoke.

11. Toxicological information

11.1 Information on toxicological effects

Information on the following hazard classes: Fatty acids, C16-C18 and C18 unsaturated methyl ether

Hazard class Result Test method

Acute toxicity Oral: LD50 > 5000 mg/kg/bw (male/female) Study is closely comparable
to OECD guideline 401 and
There are 2 mains is GLP).
studies related to Dermal : LD50 has been tested in a fixed dose test EPA OPPTS 870.1200
acute toxicity. at 2000 mg/kg/bw on rabbit with fatty
acids C6 -C12 methyl esters with no sigh
of toxicity

9
 (EU) No. 453/2010

Information on the following hazard classes: Fatty acids, C16-C18 and C18 unsaturated methyl ether

Hazard class Result Test method

Skin corrosion/irritation; In general, esters of long-chain fatty OECD Guideline 404
acids are always negative with relation to
irritation (from C18 onward), while esters
of short-chain fatty acids are always
(slightly) positive (up to C10).

There are 2 relevant tests, for C16-C18

and C18 unsaturated me esters and fatty
acids, rape oil, me esters, showing no
irritation that support this conclusion.
Eye irritation tests are negative too and it
is unlikely that a substance would be less
irritating to eyes than the skin.
Serious eye damage/irritation; Conjunctivae effects were observed 1 OECD guideline 405
hour after exposure. Slight chemosis and
slight conjunctivae were observed in two
animals and four animals, respectively.
Two animals presented conjunctivae with
diffuse, crimson colour and individual
vessels not easily discernible. These
effects were fully reversible within 1 day.
Sensitisation; Respiratory No information but no respiratory
sensitisation sensitisation is expected.
Skin In a dermal sensitization study, Sterol C The study was performed
sensitisation; in corn oil was tested using the Guinea according to OECD
pig maximization test. guideline 406 and GLP

No clinical signs and no deaths were

noted during the study. No cutaneous
reactions were observed after the
challenge application. Under the
experimental conditions of the study, it is
concluded that Sterol C does not induce
delayed contact hypersensitivity in
guinea pig.
Germ cell Reverse gene Strains of Salmonellatyphimurium were This study satisfies the
mutagenicity; mutation exposed to Sterol C in the presence and requirement for Test
assay absence of mammalian metabolic Guideline OECD 471 for in
activation. The positive controls induced vitro mutagenicity
the appropriate responses in the (bacterial reverse gene
corresponding strains. No noteworthy mutation) data.
increase in the number of revertants was
induced in all tested strains with and
without metabolic activation.
In vitro Primary lymphocyte cultures were OECD Guideline 473 (In
cytogenicity exposed to Sterol C with and without vitro Mammalian
test metabolic activation. Positive controls Chromosome Aberration
induced the appropriate response. There Test)
was no evidence of chromosome
aberration was induced over background.

10
 (EU) No. 453/2010

Information on the following hazard classes: Fatty acids, C16-C18 and C18 unsaturated methyl ether

Hazard class Result Test method

In vitro Methyl myristate alone had no mitogenic EU Method B.17
mammalian activity. In combination with (Mutagenicity - In Vitro
cell mutation phytohemagglutinin, however, a Mammalian Cell Gene
test. comitogenic activity was found. Mutation Test).
Carcinogenicity; Two fatty acid methyl esters, methyl EU Method B.32
oleate and methyl 12-oxo-trans-10- (Carcinogenicity Test)
octadecenoate, have been tested for
carcinogenicity by oral and subcutaneous
administration in ST/a mice of both
sexes. A positive effect of methyl oleate
could not be assessed, while the results
pointed to a promoter effect of methyl
oxo-octadecenoate. Given in the diet,
this compound increased the incidence
and number of forestomach papillomas
within 83 weeks after initiation by 4-
nitroguinoline 1-oxide.
Reproductive Development The tested substance revealed no effect OECD Guideline 422
toxicity; al effects in Screening for reproduction for a dose (Combined Repeated Dose
Fertility of until 1000 mg/kg/bw Toxicity Study with the
effects Reproduction /
Developmental Toxicity
Screening Test)
STOT-single exposure; No information No information
STOT-repeated exposure; The tested substance revealed no effect OECD Guideline 422
in Repeated dose oral toxicity for a dose (Combined Repeated Dose
of until 1000 mg/kg/bw Toxicity Study with the
Reproduction /
Developmental Toxicity
Screening Test)
Aspiration hazard. No information No information

CMR (Carcinogenic, Mutagenic and Repro-toxic) properties assessment

An assessment of the above information leads to a conclusion that no CMR properties are expected.

Effects of the substance/mixture via each possible route of exposure

See section 2.

Potential adverse health effects and symptoms

See section 2.

Information on whether delayed or immediate effects

See section 2.

11
 (EU) No. 453/2010

Interactions

None expected.

Other information

See section 2 for effects of the substance

12. Ecological information

12.1 Toxicity

Fatty acids, C16-C18 and C18 unsaturated methyl ether

OECD Guideline 202 (Daphnia sp. EC50 (48 hour): 2504 mg/l
Acute Immobilisation Test)

OECD Guideline 201 (Alga, Growth ErC50 (72 hour): > 0.131 mg/L or 72h-ErLR50>100mg/L (expressed
Inhibition Test) as loading rate).

OECD Guideline 203 (Fish, Acute Visible abnormalities (loss of equilibrium, changes in swimming
Toxicity Test) behaviour, respiratory function, pigmentation, etc.) were not
observed in Fish exposed to an average measured loading rate of
0.26 mg/L (limit test),

Other aquatic/terrestrial toxicological No information.

end points

12.2 Persistence and degradability

N/A

12.3 Bioaccumulative potential

Fatty acids, C16-C18 and C18 unsaturated methyl ether

ISO 10712 All methyl esters of fatty acids are readily biodegradable in water, soil and sediments. They
pass the 10 days windows with 62% of degradation. Half-life in the three compartment is
less than 2 -3 days. In some case even less than 1 day.

12.4 Mobility in soil

N/A
12.5 Results of PBT and vPvB assessment
Substance is not considered PBT either vPvB.
12.6 Other adverse effects
N/A

12
 (EU) No. 453/2010

13. Disposal considerations

13.1 Waste treatment methods

Waste treatment methods

Disposal of waste and unused residues must be in accordance with the applicable legislation (Act no. 185/2001
Coll. on Wastes). Unusable product residues usually are disposed of by combustion in incinerators.
Due to biodegradability, contaminated absorbent material may be stored on approved landfills.
Wastes can be disposed of only by authorized personnel.

14. Transport information

Transport information for Fatty acids, C16-18 and C18-unsaturated, Methyl esters

Land transport (ADR/RID/)

UN number Not classified

Class Not classified

Classification code Not classified

Packaging group Not classified

Labels Not classified

Inland waterway transport (AND(R))

UN number Not classified

Class Not classified

Classification code Not classified

Packaging group Not classified

Labels Not classified

Marine transport (IMDG)

UN number Not classified

Proper shipping name and description Not classified

Chemical name Not classified

Class Not classified

Packaging group Not classified

EmS number Not classified

Labels Not classified

13
 (EU) No. 453/2010

Marine pollutant no

Air transport ICAO/IATA

UN number Not classified

Proper shipping name and description Not classified

Chemical name Not classified

Class Not classified

Packaging group Not classified

Labels Not classified

15. Regulatory information

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

Specific safety, health and environmental regulations/legislation for the substance.

IATA - International Air Transport Association

RID - Regulations for international rail transport of dangerous goods.
ADR - European Agreement concerning international carriage of dangerous goods by road.
ČSN 650201 - Flammable liquids. Plants and warehouses.
Gov. Regulation no. 361/2007 Coll., laying down conditions for the protection of health of workers at
work as amended.
Act no. 201/2012 Coll. on Air Protection, as amended.
Act no. 350/2011 Coll. on chemical substances and mixtures, and amending certain laws (Chemical Law)
Decree no. 93/2016 Coll. on waste catalogue
Act no. 111/1994 Coll. on road transport, as amended
Act no. 185/2001 Coll. on wastes, as amended
Act no. 254/2001 Coll. on waters, as amended
EC Regulation no. 1907/2006 Registration, evaluation, authorization and restriction of chemicals,
establishing a European Chemicals Agency (REACH)
EC Regulation no. 453/2010. Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH -
MSDS)
EC Regulation no. 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP)

14
 (EU) No. 453/2010

15.2 Chemical safety assessment

Chemical Safety Assessment (CSA)

Chemical Safety Assessment is available for the substance ES No. 267-015-4 (the substance is not classified as
hazardous and is not a PBT/vPvB).

16. Other information

ATTENTION: This safety data sheet reflects our present knowledge and describes the product
as to its safety requirements. It does not assure any characteristics but gives recommendations
for safe storage and handling measures. Receivers have to observe any legal regulation in their
own responsibility.

SDS revision information

First edition of the document: revision 0 from 1. 1. 2011 - document edition in MSDS version
Second edition of the document: revision 1 from 31. 1. 2013 - document edition in MSDS version
Third edition of the document: revision 2 from 31. 5. 2015 - document edition in MSDS version
Fourth edition of the document: revision 3 from 26. 8. 2016 - document edition in MSDS version

Key/Abbreviations
CSA: Chemical Safety Assessment
PBT: Substance with Persistent, Bioaccumulative and Toxic properties.
vPvB: Substance with very Persistent and very Bioaccumulative properties.

Key References
ECHA - European Chemical Agency - Information on chemicals
http://echa.europa.eu/information-on-chemicals

Classification information for mixtures

Not relevant

List of relevant hazard statements and/or precautionary statements.

Not relevant. Described in Sections 2 to 15.

Advice on appropriate training for employees

Regular training in the scope safety handling, health and environment.

15