The Safety of the e-cigarette

 

AcceptableChoice’s products all take off in quality oriented products from the FarEast that have been tested, controlled, analysed and again tested – in order to provide the optimal safety for the consumers.

The products consist in principle of an airflow electronic atomizing unit and a filter with substance.

 

Documentation

Potential hazardous metals in the units

We have asked our Chinese suppliers to verify which residue of metals that might be unsafe is in the units – We have received this report that clearly indicates that there are no mercury, nickel or lead in the products.

 

Note:

1.        N.D. = Not detected (<MDL        )

2.        ppm = mg/kg

3.        N.A. = Not analyzed

4.        Negative = Absence of CrVI coating, Positive=Presence Of CrVI coating. (The tested sample should be further verified by boiling-water-extraction method if the spot result cannot be confirmed)

5.        Remark (1)(2) according to the declaration from client, the source of lead in the sample could be from the copper alloy, the lead as alloying element in copper alloy till taining up to 4% lead by weight is exempted by RoHS directive 2002/95/ec of the European parliament and of the council of 27 January 2003

6.        ‘—‘ = Not applicable

7.        Test company: SGS= SGS group, ITC=ITC group

 

EMC Report for the units

Furthermore we have asked our suppliers to deliver an EMC Test Report. The conclusion from those is..

 

Rohde & Schwarz equipment has been used (ESI26, SMT03, NRVD) and the test standards are EN61000-6-3:2007(EN55022:1998+A1:2000+A2:2003), EN61000-6-2:2007(EN61000-4-2:1995+A1:1998+A2:2001) and EN61000-6-1:2007(EN61000-4-3:2002+A1:2003)

*The lower limit shall apply at the transition frequency.

*The test distance is 3cm.

    

 

 

 

 

 

Documentation

The construction of the filters AcceptableChoice is from start only offered with 0mg. Nicotine – but it is the intention at a later stage to offer the products with 4 nicotine filters for the cigarette, 4 filters for the cigar and 3 filters for the pipe – all with different concentrations of the nicotine contents. For the cigarettes and the cigars the highest dose contains the electro-thermally vaporised contents with 6% nicotine, while the lowest dose contains no nicotine. The filters come in packaging’s clearly marked with 16mg, 11mg, 6mg or 0mg (for both cigarettes and cigars) and with 30mg, 21mg or 0mg for the pipe. Furthermore the filters contain 80% to 90% of propylene glycol (1,2 propandiol). In addition, the filters also contain pharmacologically/toxicologically negligible amounts (less than 5%) of flavouring agents and antioxidants.[1] Therefore in quantitative terms, the relevant inhaled ingredients are nicotine and propylene glycol.

In China… The filter substance is mixed on a laboratory, under supervision of Yunnan Changning Dekang Biotechnology Co. Ltd. The filter substance is depending on the wanted flavour, and is delivered to the factories we use in containers. It is on our licensed manufacturers that the filters are filled with the substance. There is no process between the substance leaving the Yunnan Changning Dekang Biotechnology Co. Ltd and until it is placed in the filter containers. The working process with filling the filters are under laboratory control

 

The filters hold the following…

	Main ingredient	Manufacturers Content	Eurofins Findings	FEMA/CAS No./CoE
1	TOBACCO ESSENCIAL OIL，VIRGINIA  (flavour substance)	<5%		Natural from tobacco
2	TOBACCO ABSOLUTE，VIRGINIA (flavour substance)	<5%		Natural from tobacco
3	TOBACCO ABSOLUTE，BURLEY (flavour substance)	<5%		Natural from tobacco
4	ORIENT TOBACCO ABSOLUTE (flavour substance)	<5%		Natural from tobacco
6	2，3，5-TRIMETHYLPYRAZINE	<1%		3244/14667-55-1/CoE735
7	2，3-DIMETHYLPYRAZINE	<1%		3271/CoE11323
8	2，5-DIMETHYLPYRAZINE	<1%		3272/CoE2210
9	2-ETHYLPYRAZINE	<1%		3281/Coe2213
10	2-ACETYLPYRAZINE	<1%		3126 /22047-25-2/CoE2286
11	2，6，6-TRIMETHYLCYCLOHEX-2-BUTENE-4-ONE	<5%		3420
12	BETA-IONONE	<2%		2595/FDA172.515
13	LINAL0OL	<2%		2635/000126-90-9
14	MENTHOL	<2%	910	2665/000089-78-1
15	METHYL BUTYRIC ACID (2-)	<2%		2695/000116-53-0
16	Rose oil, bulgarian, true otto	<2%		2989/008007-01-0
17	Vanilla extract	<5%		008024-06-4
18	Octalactone (gamma-)	<1%		104-50-7
19	Undecalactone (gamma-)	<1%		104-67-6
20	PURE WATER	<20%		7732-18-5
21	PROPYLENE GLYCOL	>50%	290.000	2940/57-55-6
22	GLYCEROL	<10%	28.000	2525/000056-81-5

 

The contents have been analysed by Eurofins with a conclusion “There have been a screening of the various substances and it is only (3-(1-menthyl-2-pyrrolidnyl)-(S)-pyridine), (the nicotine contents) that we consider have a risk factor.”.

 

Propylene glycol

The bivalent alcohol propylene glycol (1,2 propandiol) is a colourless liquid. If used normally, it does not have a toxic effect. The substance is found as an inactive ingredient in many foodstuffs, beauty products, drugs and tobacco products. Canned food for small animals contains up to 13% propylene glycol. In the mentioned applications, propylene glycol acts as a stabiliser, solubiliser, emulsifying agent or humectants. As a food additive it is referred to as E1520.

Apart from allergic reactions, which can be triggered by almost any substance, as well as slight irritations of the conjunctiva, propylene glycol is toxicologically harmless. It has an LD₅₀ in rats of 20-25g/kg, corresponding to 1.5 to 1.9kg/75kg, i.e. several orders of magnitude higher than the polypropylene glycol content of the AcceptableChoice units. From today’s point of view, the addition of propylene glycol is therefore irrelevant for toxicological purposes.

 

Test on health conditions in relation to the filters

Traditional filters   A Test Centre study[2] based on the GB15193-2003 int. procedures and methods for toxicological assessment on food safety, the nicotine filters underwent acute peroral toxicity test in mice. Under the conditions of the test, the results indices: … the maximal tolerance dose of acute peroral toxicity test in Kunming mice (both sexes) to the AcceptableChoice electronic atomized cigarette fluid (spice) is higher than 10000mg/kg BW, therefore, it belongs to no toxicity level.

Acute peroral toxicity test in mice of electronic atomized cigarette fluid: Sex Dose group (mg/kg BW) Number of animals Number of Death animals Death rate (%) Female 10000 10 0 0 Male 10000 10 0 0   I. Materials and animals 1.       The sample: Electronic Atomized Cigarette Fluid (spice), light brown liquid. 10 grams of the sample was weighed and diluted with purified water to 20.0ml (500mg/mL). 2.       The experimental animals: Kunming mice were provided by Experimental Animal Centre, Kunming Medical College. The qualification number of animals: SCXK (Dian) 2005-0008. The animal feed was provided by Experimental Animal Centre, Kunming Medical College. The qualification number of animals: SCXK (Dian) 2005-0009. The animals were caged and fed according to sex. The certificate number of the experimental animal house: SYXK (Dian) 2005-0002. 3.       The environmental conditions for the test: temperature 20-25℃, relative Humidity: 40-70%. Ⅱ.Method: 1.       The test standard: GB15193-2003 Procedures and Methods for Toxicological Assessment on Food safety. 2.       The method: The maximal tolerance dose method was used. The dose was set as 10000mg/kg BW. A total of 20 mice, weighing 18.0-21.7g each, half Males and half females, were selected. The animals were fasted for 16.0 hours before intragastric infusion. The sample (0.2mL/10g BW) was administered through intragastric infusion. The observation has lasted for 14 days. The poisoning symptoms and death of the animals were recorded. Results No abnormal presentation and death was found in the animals during the experiment. No pathological change was detected following gross anatomic test.

 

Furthermore 200g of the liquid was tested, using the test standard: GB/T 5009.11,12-203 Methods of Food Hygienic Analysis-physical and chemical section and GB/T4789.2,3,4,5,10,15-2003 for food hygienic microbiology with the following test results…

-           Pathogens refer to salmonella, shigellae and staphylococcus aureus.

-           The major test facilities: Analyst 800 Atomic Absorption Spectrophotometer, AFS-830 Atomic Fluorescence Spectroscopy and Electronic Balance

-           The environmental conditions of the test: Testing Central Laboratories temperature 25-27℃, relative humidity: 46-60%

 

 

 

Documentation

Indoors Use of the electronic devices

To evaluate if an AcceptableChoice e-cigarette, e-cigar or e-pipe can be used indoor in public places or similar, there are two main parts in the evaluation of the products. First – what is left in the expiration air, and secondly – how small particles are we talking about.

The Atomizer

For an AcceptableChoice e-device to work, there need to be an atomizer to split the particles that are carrying the Aroma substances and the nicotine for full absorption in the human body. This means that the atomizing unit should be able to split the particles extremely effective and we have tested the particles after the atomization process…

The test shows that the atomizer unit is extremely effectfull. If the particles were carrying harmful substances it would have been damaging. However, the analysis report from Yunnan Tobacco in China clearly state that there in the expiration air is found 0.0 mg/unit of Tar and 0.0 mg/unit of Carbon Monoxide.

 

The residue in the air

We have asked the Yunnan Tobacco Quality Supervision, Inspection and Quarantine Organization to measure the residue in the air after smoking the e-cigarette. The test was made on 10 filters and is documented in report No. WT2008070020 of 18^th July, 2008.

YTQS/ZY-04-B-10

The conclusion

Since there are no harmful substances linked to the particles, it has no effect on pollution and in-door climate

 

Toxicological evaluation of the Products

Apart from the nicotine content, the Products are toxicologically harmless. However the products should be contraindicated for Minors and Teenagers, the non-smoking habitants and people who have allergy to nicotine, pregnant and breastfeeding women, patients who should avoid smoking like patients with cardiovascular illnesses.[3]