Liquid-Cigarette-Greece Safety-Report ESHTA No 02

8/12/2019 Liquid-Cigarette-Greece Safety-Report ESHTA No 02

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GroupMG Companies Murat Gkay

Division: ANASYN Biotechnology & Research

Technologiezentrum

Vor dem Kreuzberg 17

72070 Tbingen

Germany

www.groupmg.com

Characterization and Chemical Safety Assessment

of the Vapor of Electronic Cigarette Liquid

(e-Liquid)

prepared for

Hellenic Commercial Union of

Electronic Cigarettes and Vaping (ESHTA) Greece

Greece


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Technologiezentrum


72070 Tbingen

Germany

www.groupmg.com

24 August 2012

Client: Hellenic Commercial Union of Electronic

Cigarettes and Vaping (ESHTA) Greece

Requestor: Vice PresidentMr. Tasos Tsakirakis

Study: Characterization and Chemical Safety Assessment of the Vapor of

Electronic Cigarette Liquid (e-Liquid)

Sample no.: LIQUA Bright TOBACCO Italian FlavoursLOT B161

Safety report no.: 082012ECLGR02

1. Summary

The vapor of the liquid sample, used in electronic cigarettes, was analyzed by headspace gas

chromatography- mass spectrometry (HSGC-MS) to identify the ingredients in the vapor

phase and their relative concentrations.

2. Experimental

The vapor was generated by heating the liquid sample to the temperature of 65 C in a sealed

vial for 5 minutes. Afterwards 10L of the vapor were injected directly into the GC-MS

instrument.

The sample was characterized on a Hewlett Packard 6830-6890 GC-MS instrument equipped

with a DB-5MS 25m x 0,25mm, df= 0,25m capillary column. Observed peaks were

identified based on spectral matches with commercial MS libraries. Relative concentrations

were estimated from the peak areas.


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Technologiezentrum


72070 Tbingen

Germany

www.groupmg.com

3. Results & Discussion

A Total Ion Chromatogram (TIC) of 10 L of the vapor phase of the LIQUA Bright

TOBACCO Italian Flavours e-cigarette liquid is shown in Figure 1. Spectral library matches

identified two ingredients propylene glycol and nicotine with retention times of about 3.4

minutes and 17.7 minutes respectively. The signal intergral value of Propylene glycol (the

first peak) was significantly higher than the other ingredient. Table 1summarizes the

estimated relative % of each ingredient in the vapor phase, generated at 65 C, of the smoke

liquid. This analysis assumed that all components, being volatile at this temperature, were

observed in the headspace GC-MS analysis and that the sensitivity of the detector to each

compound was similar.

Chemical safety assessment was performed by considering general hazard and toxicity data

from the safety data sheets obtained from Sigma Aldrich and the safety and toxicity data

published at the online resources www.hazard.comand http://toxnet.nlm.nih.gov/index.html.


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Technologiezentrum


72070 Tbingen

Germany

www.groupmg.com

Figure 1: TIC of the e-Liquid vapor of the sample LIQUA Bright TOBACCO ItalianFlavours

Signal assignments: propylene glycol (1), nicotine (2).


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Technologiezentrum


72070 Tbingen

Germany

www.groupmg.com

The product does not need to be labeled in accordance with EC directives or respective

national laws.

Formula : C3H8O2

Molecular Weight : 76,09 g/mol

Appearance Form: liquid, clear, viscous

Colour: colourless

Melting point/freezing point-60 C

Initial boiling point and boiling range 185 - 189 C

Flash point 103 C - closed cup

Flammability (solid, gas) no data available

Upper explosion limit: 12,5 %(V)

Lower explosion limit: 2,6 %(V)

Vapour pressure 0,11 hPa at 20 C

Vapour density 2,63 - (Air = 1.0)

Relative density 1,036 g/cm3

Toxicity:

LD50 Oral - rat - 20.000 mg/kg

LD50 Dermal - rabbit - 20.800 mg/kg

LD50 Intramuscular - rat - 14 g/kg

LD50 Intravenous - dog - 26 g/kg

LD50 Intraperitoneal - rat - 6.660 mg/kg

LD50 Subcutaneous - rat - 22.500 mg/kg

LD50 Intravenous - rat - 6.423 mg/kg

LD50 Intraperitoneal - mouse - 9.718 mg/kg

Remarks: Lungs, Thorax, or Respiration:Chronic pulmonary edema. Kidney, Ureter,

Bladder:Changes in both tubules and glomeruli. Blood:Changes in spleen.

LD50 Subcutaneous - mouse - 17.370 mg/kg

Remarks: Behavioral:Change in motor activity (specific assay). Behavioral:Muscle

contraction or spasticity.Cyanosis


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Germany

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LD50 Intravenous - mouse - 6.630 mg/kg

LD50 Intravenous - rabbit - 6.500 mg/kg

Skin - Human - Mild skin irritation - 7 d

Serious eye damage/eye irritation

Eyes - rabbit - Mild eye irritation

IARC: No component of this product present at levels greater than or equal to 0.1% is

identified as probable, possible or confirmed human carcinogen by IARC.

May be harmful if inhaled. May cause respiratory tract irritation. May be harmful if

swallowed. May be harmful if absorbed through skin. May cause skin irritation. Causes eye

irritation.

Signs and Symptoms of Exposure:

Gastrointestinal disturbance, Nausea, Headache, Vomiting, Central nervous system

depression.

Ecological Information:

Toxicity to fish: mortality NOEC- Pimephales promelas (fathead minnow) - 52.930 mg/l -96h

Toxicity to daphnia and other aquatic invertebrates: mortality NOEC - Daphnia - 13.020 mg/l

- 48 h

EC50 - Daphnia magna (Water flea) - > 10.000 mg/l - 48 h

Final Toxicolgical Assessment

Propylene glycol is used as a solvent in manypharmaceuticals, including oral, injectable

and topicalformulations (notably, diazepam, which is insolublein water, uses propylene glycol

as its solvent in its clinical, injectable form). It is also used as a humectantfood additive, labeled

as E numberE1520.

Other fields of application of propylene glycol are cosmetics(as a moisturizer), food,

toothpaste, shampoo, mouth wash, hair careand tobaccoproducts.


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Technologiezentrum


72070 Tbingen

Germany

www.groupmg.com

Because of its low chronic oral toxicity, propylene glycol was classified by the U. S. Food and

Drug Administrationas "generally recognized as safe" (GRAS) for use as a direct food additive.

4.2 Nicotine

CAS-No. : 54-11-5. For this product a material safety data sheet is available. This product is

used as a laboratory chemical and for manufacturing substances.

Classification according to Regulation (EC) No 1272/2008 [EU-GHS/CLP]

Acute toxicity; Dermal (Category 1)

Acute toxicity, Oral (Category 3)

Chronic aquatic toxicity (Category 2)

Classification according to EU Directives 67/548/EEC or 1999/45/EC

Very toxic in contact with skin. Toxic if swallowed. Toxic to aquatic organisms. May cause

long-term adverse effects in the aquatic environment.Labeling according Regulation (EC) No 1272/2008 [CLP]

Pictogram :

Signal word: Danger

H301 Toxic if swallowed.

H310 Fatal in contact with skin.

H411 Toxic to aquatic life with long lasting effects.

According to European Directive 67/548/EEC as amended.

R25 Toxic if swallowed.

R27 Very toxic in contact with skin.

R51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the

aquatic environment.


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Germany

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Hazard Symbols:

Formula : C10H14N2

Molecular Weight : 162,23 g/mol

Appearance Form: clear, liquid

Colour: dark brown

pH 10,2

Melting point/range: -79 C

Initial boiling point and boiling range: 247 C at 993 hPa

Flash point: 101 C - closed cup

Vapour pressure: 0,051 hPa at 25 C

Vapour density: 5,6 - (Air = 1.0)

Relative density: 1,010 g/cm3at 20 C

completely miscible with water

Partition coefficient: n-octanol/water log Pow: 1,17

Solubility in other solvents: Ethanol 50 g/l

Toxicity:

LD50 Oral - rat - 50 mg/kg

IARC: No component of this product present at levels greater than or equal to 0.1% is

identified as probable, possible or confirmed human carcinogen by IARC.

Possible risk of congenital malformation in the fetus.

May be harmful if inhaled. May cause respiratory tract irritation. May be fatal if swallowed.

May be fatal if absorbed through skin. May cause skin irritation. May cause eye irritation.

Signs and Symptoms of Exposure prolonged or repeated exposure:

Can cause Vomiting, Diarrhoea, Convulsions, To the best of our knowledge, the chemical,

physical, and toxicological properties have not been thoroughly investigated.


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Technologiezentrum


72070 Tbingen

Germany

www.groupmg.com

Ecological Information:

Toxicity to fish: LC50 - Oncorhynchus mykiss (rainbow trout) - 4 mg/l - 96,0 h

Toxicity to daphnia and other aquatic invertebrates: EC50 - Daphnia magna (Water flea) -

0,24 mg/l - 48 h.

Very toxic to aquatic life.

Final Toxicolgical Assessment

The LD50of nicotine is 50 mg/kg for ratsand 3 mg/kg for mice. 3060 mg (0.51.0 mg/kg)

can be a lethal dosage for adult humans [1, 2]. It is unlikely that a person would overdose on

nicotine through smoking alone, although overdose can occur through combined use of

nicotine patches or nicotine gum and cigarettes at the same time [3]. In low doses (an

average cigaretteyields about 1 mg of absorbed nicotine), the substance acts as

a stimulantin mammals, while high amounts (3060 mg) can be fatal [1, 3]. This stimulant

effect is the main factor responsible for the dependence-forming properties of tobacco smoking.

Due to the low concentration of nicotine in the vapor phase of the cigarette liquid, compared

to the amount of nicotine in tobacco smoke (0.8 3.0 mg per cigarette), the inhaled

concentration can be assessed as less hazardous to health than the inhaled nicotine

concentrations in tobacco (cigarette) smoke.

References:

[1] http://www.inchem.org/documents/pims/chemical/nicotine.htm#PartTitle:7.%20TOXICOLOGY

[2] Okamoto M, Kita T, Okuda H, Tanaka T, Nakashima T (Jul 1994). "Effects of aging on acutetoxicity of nicotine in rats".Pharmacol Toxicol.75 (1): 16

[3] http://learn.genetics.utah.edu/content/addiction/drugs/overdose.html

Assessor: Dr. rer. nat. Ozan Gkay

(Chief of the Division ANASYN)

Liquid-Cigarette-Greece Safety-Report ESHTA No 02

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