ASTRA BIOPLANT LTD.

Certificate HU09/4475

SDS
SAFETY DATA SHEET

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

MSDS Version No 03 Issue Date 03 January 2011

1. Identification of the substance/preparation and of the

company/undertaking

Product information
Trade name: Biodiesel (FAME)

EC number: 267-015-4

CAS number: 67762-38-3

Company: Astra Bioplant Ltd., Bulgaria, 7060, Slivo pole, 23, Bulgaria Blvd.

Telephone: +359 82 817 500

Telefax: +359 82 817 517

Email address: astra_bioplant@abv.bg

Emergency telephone number: +359 82 817 505

Use of substance: Fuels and fuel additives

Function: component in diesel fuel

REACH Reference No: 01-2119471664-32-0115

2. Hazards identification
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Biodiesel factory: Slivo pole 23 Bulgaria Str Rousse, Bulgaria tel: +359 (082) 817 500 fax: +359 (082) 817 517
Office: Rousse 100 Tutrakan Blvd tel/ fax: + 359 (082) 817 400/ +359 (082) 844 862
 ASTRA BIOPLANT LTD. Certificate HU09/4475

Classification as per Directive 67/548/EC or Regulation 1272/2008

The substance is not classified as dangerous according to the criteria of the Dangerous Substances
Directive (67/548/EEC) and CLP (Regulation CE 1272/2008). Specific Risk Management Measures
are therefore not required. Nevertheless, the exposure of workers during and after normal operations
should be minimised by the use of good industrial hygiene practice.

3. Composition/information on ingredients:

Chemical nature

The substance Fatty acids, C16-18 and C18-unsatd., Me esters is a UVCB substance, not univocal
structural formula available.

Composition of the substance:

Constituent EC number Concentration range

Methyl decanoate 203-766-6 >= 0.0 < 2.0 % (w/w)
Methyl Laurate 203-911-3 >= 0.0 < 2.0 % (w/w)
Methyl Myristate 204-680-1 >= 0.0 < 2.0 % (w/w)
methyl palmitate 203-966-3 >= 2.0 <= 62.0 % (w/w)
methyl (Z)-hexadec-9-enoate 214-303-2 >= 0.0 < 2.0 % (w/w)
Methyl heptadecanoate 217-055-3 > 0.0 <= 2.0
Methyl Stearate 203-990-4 >= 1.0 <= 40.0 % (w/w)
Methyl Oleate 203-992-5 >= 13.0 <= 95.0 % (w/w)
Methyl Linoleate 203-993-0 >= 1.0 <= 40.0 % (w/w)
Methyl Linolenate 206-102-3 >= 1.0 <= 20.0 % (w/w)
Methyl Icosanoate 214-304-8 >= 0.0 < 2.0 % (w/w)
methyl cis-icos-11-enoate 219-226-8 >= 0.0 < 2.0
methyl docosanoate 213-207-8 >= 0.0 < 2.0 % (w/w)
methyl (Z)-docos-13-enoate 214-305-3 >= 0.0 < 2.0
methyl tetracosanoate 219-475-2 >= 0.0 < 2.0 % (w/w)
methyl (Z)-tetracos-15-enoate 220-352-0 >= 0.0 < 2.0 % (w/w)
methanol 200-659-6 >= 0.0 < 0.2 % (w/w)

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Biodiesel factory: Slivo pole 23 Bulgaria Str Rousse, Bulgaria tel: +359 (082) 817 500 fax: +359 (082) 817 517
Office: Rousse 100 Tutrakan Blvd tel/ fax: + 359 (082) 817 400/ +359 (082) 844 862
 ASTRA BIOPLANT LTD. Certificate HU09/4475

Constituent EC number Concentration range

Glycerol, monoglycerides, >= 0.0 < 3.5 % (w/w)
diglycerides, triglycerides of
Fatty acids, C16-C18 and C18-
unsatd.
Unknow coloured impurities < >= 0.0 < 0.05 % (w/w)
0.05%

4. FIRST AID MEASURES

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.
INGESTION
Do not induce vomiting. Wash out mouth with water. If conscious, give half a litre of water to drink
immediately.

5. FIRE FIGHTING MEASURES

EXTINGUISHING MEDIA
Carbon dioxide. Alcohol resistant foam. Dry chemical powder.

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

PROTECTION OF FIRE-FIGHTERS
Wear self-contained breathing apparatus. Wear protective clothing to prevent contact with skin and
eyes.

6. ACCIDENTAL RELEASE MEASURES

PERSONAL PRECAUTIONS
Eliminate all sources of ignition. If outside do not approach from downwind. If outside keep bystanders
upwind and away from danger point. Mark out the contaminated area with signs and prevent access to
unauthorised personnel. Turn leaking containers leak-side up to prevent the escape of liquid.

ENVIRONMENTAL PRECAUTIONS
Do not discharge into drains or rivers. Contain the spillage using bunding.

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Biodiesel factory: Slivo pole 23 Bulgaria Str Rousse, Bulgaria tel: +359 (082) 817 500 fax: +359 (082) 817 517
Office: Rousse 100 Tutrakan Blvd tel/ fax: + 359 (082) 817 400/ +359 (082) 844 862
 ASTRA BIOPLANT LTD. Certificate HU09/4475

CLEAN-UP PROCEDURES
Absorb into dry earth or sand. Transfer to a suitable container.

7. HANDLING AND STORAGE

HANDLING REQUIREMENTS
Avoid direct contact with the substance.

STORAGE CONDITIONS
Store in cool, well ventilated area. Keep away from sources of ignition. Keep container tightly closed.
Below normal ambient temperatures material willstart to solidify Storage life, ~1 year. Protect from
frost. Store at +15C to +25C

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

EYE PROTECTION
Safety Glasses, goggles or face shield recommended to protect eyes from mists or plashing.
PROTECTIVE MASURES
Employees must practice good personal hygiene, washing exposed areas of skin several
times daily and laundering contaminated clothing before re-use.

9. PHYSICAL AND CHEMICAL PROPERTIES

Property Results Value used for CSA / Discussion

Physical state at liquid
20C and 1013
Form: oils
hPa
Colour: Green/yellow
Odour: mild

Melting / freezing 6.29C at 1 atm The range of melting temperature goes

point from -16.92C to +15.59C
Boiling point 354.3C at 1 atm
Relative density 0.8881 g/cm3 at 20C
Vapour pressure 4.2 m Bar at 25C
420 Pa, at 25C
3.6 m Bar at 20C
Surface tension NR In accordance with column 2 of REACH
Annex VII, the study does not need to
be conducted since the substance has
a water solubility < 1 mg/L at 20C,
based on structure, surface activity is

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Biodiesel factory: Slivo pole 23 Bulgaria Str Rousse, Bulgaria tel: +359 (082) 817 500 fax: +359 (082) 817 517
Office: Rousse 100 Tutrakan Blvd tel/ fax: + 359 (082) 817 400/ +359 (082) 844 862
 ASTRA BIOPLANT LTD. Certificate HU09/4475

Property Results Value used for CSA / Discussion

not expected or predicted and it is not a
desired property of the material.
Water solubility < 0,023 mg/l Instrumental detection limit
Partition coefficient Log Kow = 6.2 at 25C
n-octanol/water
(log value)
Flash point 173C +/- 1C
Flammability Not flammable For the definition of flammability,
REACH refers to regulation 67/548.
According to this regulation flammability
is not required for liquids if the flash
point is above 60C. The flash point of
this substance is 170C, well above the
limit of 60C.
Explosive Not explosive In accordance with column 2 of REACH
properties Annex VII, the study does not need to
be conducted since there are no
chemical groups associated with
explosive proprieties present in the
molecule.
Self-ignition 261C +/- 5C The ignition delay observed at this
temperature temperature was 60 seconds and a
Temperature increase at middle of the
flask was 14C.
Oxidising Not oxidizing In accordance with column 2 of REACH
properties Annex VII, the study does not need to
be conducted since the substance is
incapable of reacting exotermically with
combustible materials based on the
chemical structure
Granulometry NR In accordance with column 2 of REACH
Annex VII, the study does not need to
be conducted since the substance in
not placed on the market in solid or
granular form
Stability in organic Stable The study is not required because the
solvents and stability of the substance is not
identity of relevant considered to be critical (Annex IX of
degradation REACH regulation point 7.15 column 1)
products based on the chemical structure.
Dissociation NR According to the guideline on
constant information requirements R7a , this
property is important for ionizable
organic substances only. The
substance is not ionizable in water
unless under strong acid or basic
conditions and high temperature.
Viscosity 6.1 mPa*s at 20C

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Biodiesel factory: Slivo pole 23 Bulgaria Str Rousse, Bulgaria tel: +359 (082) 817 500 fax: +359 (082) 817 517
Office: Rousse 100 Tutrakan Blvd tel/ fax: + 359 (082) 817 400/ +359 (082) 844 862
 ASTRA BIOPLANT LTD. Certificate HU09/4475

10. STABILITY AND REACTIVITY

Physical and chemical properties doesn't reveal any hazard. The substance is a high boiling liquid,
insoluble, very stable, with low density and very low vapour pressure; not flammable, nor explosive,
not oxidising.

11. TOXICOLOGICAL INFROMATION

1. Acute toxicity: oral Non toxic

LD50: > 5000 mg/kg bw (male/female)

rat (Sprague-Dawley/ Crl: CD (SD) BR) male/female

AFNOR NF T 03-021
equivalent or similar to OECD Guideline 401 (Acute
Oral Toxicity)

2. Acute toxicity: inhalation Non toxic

Inhalation route is not relevant because exposure of

humans via inhalation is not likely taking into account
the vapour pressure of the substance: 420 Pa at
25C.

3. Acute toxicity: dermal Non toxic

rabbit
EPA OPPTS 870.1200 (Acute Dermal Toxicity)

LD50: > 2000 mg/kg bw

4. Skin irritation: Not irritant

Erythema score:
> 0 < 0.33 of max. 4 (mean) (Time point: 24, 48,
72h) (fully reversible within: 48h)

Edema score:

0 of max. 4 (mean) (Time point: 24, 48, 72h)

rabbit (New Zealand White: Hy/Cr)

5. Eye irritation: Not irritant

Cornea score:
0 of max. 4 (mean) (Time point: 24, 48, 72h) (no
effect)
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Biodiesel factory: Slivo pole 23 Bulgaria Str Rousse, Bulgaria tel: +359 (082) 817 500 fax: +359 (082) 817 517
Office: Rousse 100 Tutrakan Blvd tel/ fax: + 359 (082) 817 400/ +359 (082) 844 862
 ASTRA BIOPLANT LTD. Certificate HU09/4475

Iris score:
0 of max. 2 (mean) (Time point: 24, 48, 72h) (no
effect)

Conjunctivae score:
0.16 of max. 3 (mean) (Time point: 24, 48, 72h) (fully
reversible within: 1 day)

Chemosis score:
0 of max. 4 (mean) (Time point: 24, 48, 72 h) (no
effect)
rabbit (New Zealand White: Hy/Cr)

6. Sensitisation: not sensitising

No. with positive reactions:

1st reading: 0 out of 20 (test group); 24 h after chall.;
dose: 0.5 ml (undiluted test substance)
2nd reading: 0 out of 20 (test group); 48 h after chall.;
dose: 0.5 ml (undiluted test substance)
1st reading: 0 out of 5 (control group); 24 h after chall.
2nd reading: 0 out of 5 (control group); 48 h after
chall.
guinea pig (Hartley / Crl: (HA) Br) male/female
EU Method B.6 (Skin Sensitisation)

OECD Guideline 406 (Skin Sensitisation)

7. Repeated dose toxicity: oral

NOAEL: > 1000 mg/kg bw/day (actual dose received)
(male/female) based on: test mat. (absence of overall
effects

clinical signs; no mortality; no changement in body

weight; regular food consumption and food efficiency;
regular water consumption and compound intake;
gross pathologynegative; organ weights normal;
histopathologynegative;)

rat (Sprague-Dawley) male/female

combined repeated dose and reproduction /

developmental screening (oral: gavage)

0 mg/kg/day (actual ingested)

100 mg/kg/day (actual ingested)

300 mg/kg/day (actual ingested)

1000 mg/kg/day (actual ingested)

Exposure: 4 weeks for males,

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Biodiesel factory: Slivo pole 23 Bulgaria Str Rousse, Bulgaria tel: +359 (082) 817 500 fax: +359 (082) 817 517
Office: Rousse 100 Tutrakan Blvd tel/ fax: + 359 (082) 817 400/ +359 (082) 844 862
 ASTRA BIOPLANT LTD. Certificate HU09/4475

2 weeks before pairing, during pairing, during

gestation and until 4 days post partum for female
(Once daily)

OECD Guideline 422 (Combined Repeated Dose

Toxicity Study with the Reproduction / Developmental
Toxicity Screening Test)

8. In vitro genotoxicity Not mutagenic

S. typhimurium, other: TA 1535, TA 1537, TA 98, TA

100 and TA 102 (met. act.: with and without)

Negative

OECD Guideline 471 (Bacterial Reverse Mutation

Assay)

EU Method B.13/14 (Mutagenicity - Reverse Mutation

Test Using Bacteria)

mammalian cell gene mutation assay (gene mutation)

negative without metabolic activation

lymphocytes: from spleen of female balb/c mice (met.

act.: without)

negative for lymphocytes: spleen of balb/c mice(all

strains/cell types tested); met. act.: without

equivalent or similar to EU Method B.17 (Mutagenicity

- In Vitro Mammalian Cell Gene Mutation Test)
in vitro mammalian chromosome aberration test
(chromosome aberration)

lymphocytes: primary cells (met. act.: with and

without)

negative for lymphocytes: primary culture(all

strains/cell types tested); met. act.: with and without;
cytotoxicity: no

OECD Guideline 473 (In vitro Mammalian

Chromosome Aberration Test)

EU Method B.10 (Mutagenicity - In Vitro Mammalian

Chromosome Aberration Test)
chromosome aberration assay (chromosome
aberration)

hamster, Chinese male/female

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Biodiesel factory: Slivo pole 23 Bulgaria Str Rousse, Bulgaria tel: +359 (082) 817 500 fax: +359 (082) 817 517
Office: Rousse 100 Tutrakan Blvd tel/ fax: + 359 (082) 817 400/ +359 (082) 844 862
 ASTRA BIOPLANT LTD. Certificate HU09/4475

Genotoxicity: negative (male/female)

equivalent or similar to OECD Guideline 475

(Mammalian Bone Marrow Chromosome Aberration
Test)

9. Carcinogenicity: No relevance of carcinogenic effect/potential

10. Toxicity for reproduction: Low toxicological activity

rat (Sprague-Dawley) male/female

Screening

NOAEC (1000 mg/kg/day) (F1): > 1000 mg/kg bw/day

(actual dose received) (male/female) based on: test
mat.

OECD Guideline 422 (Combined Repeated Dose

Toxicity Study with the Reproduction / Developmental
Toxicity Screening Test)

12. ECOLOGICAL INFORMATION

1. Abiotic degradation: the substance is readily biodegradable.

The substance is considered stable in the

environmental range of pH. Hydrolysis happens with
the presence of strong acids or basis, with release of
methanol and the fatty acid molecule

2. Biotic degradation: 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.

3. Bioaccumulation:
Mitylus edulis BCF: ca. 3 dimensionless 2 (reliable with restrictions)
(whole body w.w.)

key study

experimental result

4. Secondary poisoning: Based on CSA, no potential for bioaccumulation is

expected

13. DISPOSAL CONSIDERATIONS

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Biodiesel factory: Slivo pole 23 Bulgaria Str Rousse, Bulgaria tel: +359 (082) 817 500 fax: +359 (082) 817 517
Office: Rousse 100 Tutrakan Blvd tel/ fax: + 359 (082) 817 400/ +359 (082) 844 862
 ASTRA BIOPLANT LTD. Certificate HU09/4475

Product

Before disposal consult producer.

Do not throw the product together with municipal wastes.
Do not throw the product in water sources.
After emptying the tanks, wash thoroughly with water.

14. TRANSPORT INFORMATION

The product is not classified as a dangerous good.
Based on its liquid physical state the product should be transported in tanks.

15. REGULATORY INFORMATION

Labelling according to EC Directives

Statutory basis/list According to Dangerous Substances Directive (67/548/EEC)

and CLP (Regulation CE 1272/2007)

The substance is not classified as dangerous according to the criteria of Dangerous

Substances
Directive (67/548/EEC) and CLP (Regulation CE 1272/2007)

S-phrase(s)

S26 In case of contact with eyes, rinse immediately with plenty of water and seek
medical advise

S28 After contact with the skink, rinse immediately with water
S64 In case of ingestion, rinse the month with water (only if conscious)
S63 In case of accidental inhalation provide fresh air to the injured and leave him
in piece
S16 Keep away from ignition sources. Do not smoke.
S29 Do not discharge in the sewage
S 3/9/14 Store in cool and well ventilated area and keep away from ignition sources.
S7 Keep container tightly closed

National legislation

Regulations on labour safety: Law on Health and Safety at work

Employment restriction: N/A

Other regulations: EU Directive 1907/2006 REACH

EU Directive 1272/2008 CLP

16. OTHER INFORMATION

This MSDS is issued on the basis of the data that our company has submitted to ECHA, based on the
obligations we have according to EU Directive 1907/2006. The information given is the same

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Biodiesel factory: Slivo pole 23 Bulgaria Str Rousse, Bulgaria tel: +359 (082) 817 500 fax: +359 (082) 817 517
Office: Rousse 100 Tutrakan Blvd tel/ fax: + 359 (082) 817 400/ +359 (082) 844 862
 ASTRA BIOPLANT LTD. Certificate HU09/4475

information our company stated in the Chemical Safety Report, which report was included in the
dossier of the substance we produce.
Since Fatty acids, C16-18 and C18-unsatd., Me esters is not a dangerous substance there are not
specific Risk Management Measures to be implemented. The Risk Management Measures listed
above are the outcome of common good practice with chemicals and are regularly implemented by the
registrant

CONTACT POINT

Disclaimer Contact: +359 82 817 505

The information above is believed to be accurate and represents the best information currently available to us.
However, we make no warranty of merchantability or any other warranty, express or implied, with respect to
such information, and we assume no liability resulting from its use. Users should make their own investigations
to determine the suitability of the information for their particular purposes. In no event shall ASTRA BIOPLANT
Ltd. be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect,
incidental, consequential or exemplary damages, howsoever arising, even if ASTRA BIOPLANT Ltd. has been
advised of the possibility of such damages.

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Biodiesel factory: Slivo pole 23 Bulgaria Str Rousse, Bulgaria tel: +359 (082) 817 500 fax: +359 (082) 817 517
Office: Rousse 100 Tutrakan Blvd tel/ fax: + 359 (082) 817 400/ +359 (082) 844 862