“Safety Assessment Information” for Poy-Sian, Mark II.
Poy-Sian European Imports IVS have taken all general toxicological profiles of each ingredient used in our product into consideration, the chemical structure, the CIR (Cosmetic Ingredients Review) evaluation where available, the level of exposure as well as a total daily exposure has been assessed along with the margins of safety for each individual ingredient.
Further it has been taken into consideration that our product, however not in its present physical form, have been on the market in Thailand, with the same composition of ingredients from the year 1936, where Gold Mints Products Co., Ltd. was founded, as our product is based on very old and traditional use of essential oils.
The essential oil, in Poy-Sian, Mark II, can be dated back to the time before the ancient Hellas (500-900 BC) – and in China (1500 BC) – back to the time before the Shang-Dynasty, where it was known that peppermint leaves (peppermint, menthol, etc.) could be used against discomfort in the upper respiratory system, and against coughing, headache and to relieve muscle pain.
The mixing of ingredients in Poy-Sian products derives from natural plants, which in the material manufacturing process, from the supplier, has to undergo heat distillation. The distillation process produces Poy-Sian ingredients containing almost zero percent of microorganism. In addition all ingredients used in the Poy-Sian products have some degree of antimicrobial properties themselves, why the product have antiseptic property, with no need for further sterilization, preheating or fermentation processes in order to kill germs. Further our product is tested to ensure good microbiological quality.
Referring to WHO (World Health Organisation) standards for GMP (Good Manufacturing Practice), Poy-Sian manufacturing processes comply to use original packed material from the supplier in the manufacturing area. The clean room standard holds the FED STD 209E equivalent of Class 100.000 or ISO 8 (ISO 14644-1 Clean room Standards). The standard index of microbial air contamination (IMA) for the measurement of microbial air contamination has been found fully safe, based on the counting of microbial fallout onto Petri dishes when left open to the air inside the manufacturing areas.
Further Poy-Sian is found not to be carcinogenic, mutagenic or toxic for human reproduction capability, since Poy-Sian doesn’t hold any CMR substances.
As a result of our evaluation and since the fluid balm oil in our product is only intended for external use, our product have been classified as:
— NONE TOXIC AND VERY SAFE TO USE ON DAILY BASES —
Under case number 2014013437, the Danish Board of Health has approved that the menthol inhaler, Poy-Sian, Mark II, (Reg. No. G379 / 48), “2 in 1”, is not to be viewed as a pharmaceutical drug, as the product is not considered to be covered by the pharmaceutical definition of Medicines, Act § 2, no. 1a or no. 1b.
Further, under the case number MST-653-00665, the Danish Environmental Protection Agency has approved that the menthol inhaler, Poy-Sian, Mark II, (Reg. No G379 / 48), “2 in 1”, is not a cosmetic product as defined in Regulation (EC) No 1223/2009.
The Danish Environmental Protection Agency has therefore approved, that selling and marketing the menthol inhaler, Poy-Sian, Mark II, (Reg. No G379 / 48), “2 in 1”, must follow the CLP Regulation (1272/2008/EC), and therefore also the obligations stipulated under the REACH Regulation (1907/2006/EC).
The imported European edition of the menthol inhalator, Poy-Sian Mark II, (Reg. No G379 / 48), “2 in 1”, meets all these requirements, fully and completely.
RESTRICTIONS FOR CERTAIN SUBSTANCES
According to most of the regulation, of the European Parliament, REGULATION (EC) OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, you have RESTRICTIONS FOR CERTAIN SUBSTANCES, why the following statement must be made.
Restrictions for certain substances:
No such materials or substances classified in the regulations as CMR substances or classified as Nanomaterial products / substances, are being used in the production, manufacturing process or in the final, Poy-Sian, Mark II, (Reg. No G379 / 48), “2 in 1”, product.
It is also important to stipulate that according to in the regulation of the European Parliament, as an example in the REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, of 30 November 2009, On Cosmetic Products, Article 18, concerning ANIMAL TESTING, the following statement must be made.
(Text) Chapter V, Article 18
- Without prejudice to the general obligations deriving from Article 3, the following shall be prohibited:
The placing on the market of cosmetic products where the final formulation, in order to meet the requirements of this Regulation, has been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;
The placing on the market of cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this Regulation, have been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;
The performance within the Community of animal testing of finished cosmetic products in order to meet the requirements of this Regulation;
The performance within the Community of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Regulation, after the date on which such tests are required to be replaced by one or more validated alternative methods listed in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)(1) or in Annex VIII to this Regulation.
The product comply with the above mentioned text, as the manufacture do not conduct – nor have ever conducted any Animal Testing, as specified being prohibited by the (EC) Regulations.
This “Safety Assessment Report” is intended to provide a brief summary of our knowledge and guidance regarding the use of Poy-Sian. The information contained here has been compiled from sources considered by Poy-Sian European Imports IVS to be dependable and is accurate to the best of the Company’s knowledge. It is not meant to be an all inclusive document on “worldwide” hazard communication regulations.
This information is offered in good faith. Each user of this material needs to evaluate the conditions of use and design the appropriate protective mechanisms to prevent human exposures, property damage or release to the environment. Poy-Sian European Imports IVS assumes no responsibility for injury to the recipient or third persons – or for any damage to any property resulting from misuse of the product.
USEFUL DATA CONCERNING POY-SIAN, MARK II.
|7732-18-5||Aqua (Water) – Process Water||0.00 %|
|89-78-1||D/L – Menthol||16.50 %|
|507-70-0||Borneol (historical name Borneo Camphor)||3.00 %|
|8008-51-3||Camphor Oil||10.00 %|
|8000-48-4||Eucalyptus Oil||10.00 %|
|8016-78-2||Lavender Oil||0.50 %|
|8030-01-1||Peppermint Oil||50.00 %|
|8030-00-0||Peppermint Spirit||Quantum Satis app. 10.00 %|
|—||Chemical preservatives according to EU||NONE|
|—||Prohibited Substances according to EU||NONE|
|—||Restricted Substances according to EU||NONE|
|—||Colorants according to EU||NONE|
|—||Preservatives according to EU||NONE|
|—||UV Filters according to EU||NONE|
Estimated average exposure if Poy-Sian Mark II Inhaler is used on daily bases.
Date: 1. March 2014
Product: Poy-Sian Mark II Inhaler.
Product official Reg. No.: G 379/48
Product type: 2 in 1, Nasal inhaler and Balm Oil bottle (1 cm3.)
Product density g/cm3: 0.900 to 0.910 g/cm3
Maximum nasal exposure mg/day: Less than < 0.01 mg, even when used for 12 hours per day,
. at intervals of 15 minutes (48 times per day).
Skin surface exposure area cm2: Less than <25 cm2 surface area, less than < 0.2 mg.
Period of intensive use for Inhaler: 5 – 7 days when used for maximum nasal exposure.
Period of intensive use for Bottle: 2 – 3 days when used for maximum skin exposure.
IFRA QRA Category for Poy-Sian: 3
PAO (Period after opening): 12 month after opening.
Number of users: Product is individual, one person only in order to avoid
. transfer of bacteria and other pathogens.
Correct use: Only inhale the Poy-Sian vapor. Balm Oil is only for external
. use. Avoid contact with eyes.
CMR substances: None = (Carcinogenic, mutagenic or toxic for human
. reproduction capability).
Special information concerning: Aqua (water). Aqua 0.00%.
According to Good Manufacturing Practices as outlined in FDA’s Guidance on Cosmetic Manufacturing Practice Guidelines and in the WHO international guidelines on Good Manufacturing Practices known as ISO 22716, Gold Mints Products Co., Ltd. manufacturing processes uses no Aqua (water), as process water in Poy-Sian products.
The only water being used is water for cleaning purposes in the manufacturing areas. This water contains no unintentional substances, which in any way could harm or infect our products.
Wastewater and sewage, from the factory, is discharged under the agreed rules of the City of Bangkok, and according to the rules set by the Environmental Authorities in Thailand. In doing so, Gold Mints Products Co., Ltd. always aim to produce the Poy-Sian products with an absolute minimum environmental impact – as possible, again with due regard to GMP.
Special information concerning: Menthol.
According to Wikipedia, currently there has been no reported poisonous nutrient or herb interactions which involves menthol.
Ingesting pure menthol can however be poisonous, and overdose is also possible through excess consumption of menthol-containing products. According to OECD (UNEP Publications) all menthol isomers are of very low acute oral toxicity with LD50 values normally greater than 2000 mg/kg bw. The Material Safety Data Sheet from NATURAL SOURCING’tm gives the following information about toxicity to animals: Acute Oral LD50 of 3.300 mg/kg (Rats) and Handbook of Biological Active Phytochemicals & Their Activity gives LD50 to the amount of 3.180 mg/kg (Rats).
Menthol is an organic compound made synthetically or obtained from corn mint, peppermint or other mint oils. It is a waxy, crystalline substance, clear or white in color, which is solid at room temperature and melts slightly above. The main form of menthol occurring in nature is (−)-menthol, which is assigned the (1R,2S,5R) configuration. Menthol has local anesthetic and counterirritant qualities, and it is widely used to relieve minor throat irritation.
Special information concerning: Borneol.
According to Wikipedia, borneol is an eye, skin, and respiratory irritant, and it is harmful if swallowed. Toxicity studies and data concerning borneol have shown that LD50 orally in rabbits is 2.000 mg/kg (Beier).
In the United States, borneol is not approved by the Food and Drug Administration (FDA) for use in medicine, however borneol is not prohibited to use internal or oral, according to FDA, if it is as an ingredient in products labeled as “herbal supplements”, “dietary supplements” or if it is found in cosmetics, such as perfume.
Borneol is a bicyclic organic compound and a terpene, with the chemical formula C10H18O. The hydroxyl group in this compound is placed in an end position. Borneol exists as two enantiomers which have two different CAS numbers. Naturally occurring d-(+)-borneol is optically active. Borneol is easily oxidized to the ketone (camphor). One historical name for borneol is Borneo camphor which explains the name. Borneol can be synthesized by reduction of camphor by the Meerwein-Ponndorf-Verley reduction (a reversible process). Reduction of camphor with sodium borohydride (fast and irreversible) gives instead the isomer isoborneol as the kinetically controlled reaction product.
Borneol can be found in several species of Artemisia, Dipterocarpaceae, Blumea balsamifera and Kaempferia galanga. It is also one of the chemical compounds found in castoreum. This compound is gathered from the beaver plant food.
Special information concerning: Peppermint Oil.
Peppermint Oil 50.00%
According to Wikipedia, the toxicity studies of the plant have received controversial results. Some authors reported that the plant may induce hepatic diseases (liver disease), while others found that it protects against liver damage that is caused by heavy metals. In addition to that, the toxicities of the plant seem to vary from one cultivar to another and are dose dependent. This has probably attributed from the content level of pulegone.
With the limitation that the concentration of pulegone should not exceed 1%, it has been concluded that Mentha Piperita (Peppermint) Oil, Mentha Piperita (Peppermint) Extract, Mentha Piperita (Peppermint) Leaves, Mentha Piperita (Peppermint) water are safe as used in medical and cosmetic formulations.
Toxicity studies and data concerning peppermint oil have shown that LD50 orally, in fasted Wistar male rats, when using death after 24 hours as the end point, was found to be 4441 ± 653 mg/kg. After 48 hours, the oral LD50 was down to 2426 ± 329 mg/kg.
As stated, peppermint oil has a high concentration of natural pesticides, mainly pulegone (Found mainly in Mentha arvensis var. piperascens Cornmint, Field Mint, Japanese Mint and to a lesser extent-6,530 ppm in Mentha x piperita subsp. nothosubsp. piperita) and menthone.
The chemical composition of the essential oil from peppermint (Mentha x piperita L.) was analyzed by GC/FID and GC-MS. The main constituents were menthol (40.7%) and menthone (23.4%). Further components were (+/-)-menthyl acetate, 1,8-cineole, limonene, beta-pinene and beta-caryophyllene.
Further peppermint is the oldest and most popular flavour of mint-flavoured confectionery and is often used in tea and for flavouring ice cream, confectionery, chewing gum, and toothpaste. Peppermint can also be found in some shampoos, soaps and skin care products. Menthol activates cold-sensitive TRPM8 receptors in the skin and mucosal tissues, and is the primary source of the cooling sensation that follows the topical application of peppermint oil. Peppermint has a very long tradition of medicinal use, with archaeological evidence, which is placing its use at least as far back as ten thousand years.
Peppermint is commonly used to soothe or treat symptoms such as nausea, vomiting, abdominal pain, indigestion, irritable bowel, and bloating. One animal study has suggested that Peppermint may have radioprotective effects in patients undergoing cancer treatment. The aroma of peppermint has also been found to enhance memory and alertness, although other research contests this. Peppermint is also used as the main essential oil in aroma therapy.
Special information concerning: Peppermint Spirit.
Peppermint Spiritapp. qs 10.00%
Studies on toxicity suggests that one can think of peppermint spirit similar to the toxicity of peppermint oil.
Toxicity studies and data concerning peppermint oil (peppermint spirit) have shown that LD50 orally, in fasted Wistar male rats, when using death after 24 hours as the end point, was found to be 4441 ± 653 mg/kg. After 48 hours, the oral LD50 was down to 2426 ± 329 mg/kg.
Further Peppermint Spirit is a green or colorless alcoholic solution of the volatile oil produced by the peppermint leafs, and the spirit is used as a carminative and flavoring agent in the cosmetic industry.
Special information concerning: Lavender Oil.
Lavender oil 0.50%
According to known toxicity studies and data concerning Lavender oil, studies have shown that oral toxicity LD50 is 4250.00 mg/kg. Intraperitoneal injections in rats 540.00 mg/kg or intraperitoneal injections in mouse 640.00 mg/kg.
Lavender oil is an essential oil obtained by distillation from the flower spikes of certain species of lavender. Two forms are distinguished, lavender flower oil, a colorless oil, insoluble in water, having a density of 0.885 g/ml; and lavender spike oil, a distillate from the herb Lavandula latifolia, having density 0.905 g/ml.
Lavender flower oil is a designation of the National Formulary and the British Pharmacopoeia. Like all essential oils, it is not a pure compound; it is a complex mixture of naturally occurring photochemicals, including linalool and linalyl acetate.
According to advocates of alternative medicine, lavender oil can be used as an antiseptic and pain reliever to be applied to minor burns and insect bites and stings.
It is also said to treat a variety of common ailments, such as sunburn and sunstroke. It can also be used in massage oil mixtures, which may be effective in the relief of joint and muscle pain, or in chest rub mixtures for the relief of asthmatic and bronchitis spasm. It is also said to treat head lice when used in a hair rinse mixture, or on a fine comb to eliminate nits. One study suggests application of lavender essential oil instead of povidone-iodine for episiotomy wound care.
Special information concerning: Camphor Oil.
Camphor Oil 10.00%
According to Wikipedia, Camphor is poisonous in large doses. It produces symptoms of irritability, disorientation, lethargy, muscle spasms, vomiting, abdominal cramps, convulsions, and seizures. LD50 in adults is viewed in the range 50–500 mg/kg (orally). 500 reported cases of camphor intoxication in USA (Tisseran America in 1973) suggest that about 1 gram of camphor must be viewed as the lethal toxic dose to small children. Further we refer to EFSA report on camphor as flavoring in European food.
In a known CASE REPORT, a 3-year-old girl ingested 700 mg camphor from Vicks VapoRub (R). This product had been placed in her nostrils twice daily for 5 months. Grand-mal seizures occurred 2 hours after the ingestion. Coma and respiratory depression lasted 21 hours. Full recovery ensued. IPCS; Poisons Information Monograph 095: Camphor. (May 1989). Report made available from, 5 February 2004.
Camphor is a waxy, flammable, white or transparent solid with a strong aromatic odor. It is a terpenoid with the chemical formula C10H16O. It is found in wood of the camphor laurel (Cinnamomum camphora), a large evergreen tree found in Asia (particularly in Sumatra, Borneo and Taiwan) and also of Dryobalanops aromatica, a giant of the Bornean forests. It also occurs in some other related trees in the laurel family, notably Ocotea usambarensis. Dried rosemary leaves (Rosmarinus officinalis), in the mint family, contain up to 20% camphor. It can also be synthetically produced from oil of turpentine. It is used for its scent, as an ingredient in cooking (mainly in India), as an embalming fluid, for medicinal purposes, and in religious ceremonies. A major source of camphor in Asia is camphor basil.
Norcamphor is a camphor derivative with the three methyl groups replaced by hydrogen.
Camphor is readily absorbed through the skin and produces a feeling of cooling similar to that of menthol, and acts as slight local anesthetic and antimicrobial substance. There are anti-itch gels and cooling gels with camphor as the active ingredient. Camphor is an active ingredient (along with menthol) in vapor-steam products, such as Vicks VapoRub, Tiger Balm and Mentholatum. Further Europe European Food Safety Authority (EFSA) approve Camphor to be an ingredient in food additives, see EFSA Journal (2008), 729 on Camphor,
Camphor may also be administered orally in small quantities (50 mg) for minor heart symptoms and fatigue. Through much of the 19th century this was sold under the trade name Musterole, however production ceased in the 1990s.
Camphor has been used in ancient Sumatra to treat sprains, swellings, and inflammation. Camphor is a component of paregoric, an opium/camphor tincture from the 18th century. Also in the 18th century, camphor was used by Auenbrugger in the treatment of mania. Based on Hahnemann’s writings, camphor (dissolved in alcohol) was also successfully used to treat the 1854-1855 cholera epidemics in Naples.
Special information concerning: Eucalyptus Oil.
Eucalyptus Oil 10.00%
Acute oral toxicity LD50 of eucalyptus oil for rats is 2.480 mg/kg. Evidence indicates the LD50 for humans is probably to be the same. Further there have been no reported human deaths worldwide, due to the ingestion of eucalyptus oil in the past 50 years.
Eucalyptus oil is the generic name for distilled oil from the leaf of Eucalyptus, a genus of the plant family Myrtaceae native to Australia and cultivated worldwide. Eucalyptus oil has a history of wide application, as a pharmaceutical, antiseptic, repellent, flavouring, fragrance and industrial uses. The leaves of selected Eucalyptus species are steam distilled to extract eucalyptus oil.
The cineole-based oil is used as component in pharmaceutical preparations to relieve the symptoms of influenza and colds, in products like cough sweets, lozenges, ointments and inhalants. Eucalyptus oil has antibacterial effects on pathogenic bacteria in the respiratory tract. Inhaled eucalyptus oil vapor is a decongestant and treatment for bronchitis. Cineole controls airway mucus hypersecretion and asthma via anti-inflammatory cytokine inhibition. Eucalyptus oil also stimulates immune system response by effects on the phagocytic ability of human monocyte derived macrophages.
Eucalyptus oil also has anti-inflammatory and analgesic qualities as a topically applied liniment ingredient.
Eucalyptus oil is also used in personal hygiene products for antimicrobial properties in dental care and soaps. It can also be applied to wounds to prevent infection.
Special information about essential oils:
*) Last but not least, there is a reference to a book describing Essential Oil Safety: A Guide for Health Care Professionals, by Robert Tisserand and Tony Balacs, where further information and properties on essential oils can be found.
**) Further the European Food Safety Authority (EFSA), Journal (2008) 729 on Camphor, in use for flavouring of food, since the Journal describes the oral intake of d-camphor as a fully approved ingredient in food additives in Europe – for flavouring purposes – as adopted by the Commission, on 22 May 2008.
Journal (2008) 729 on Camphor should be viewed in the context of approved European oral intake in foods, whereas the Poy-Sian product is only to be used externally, giving far less exposure, when the Poy-Sian product is being used according to its purpose.
SUMMARY OF TOXICOLIGY FINDINGS
According to the regulation of the European Parliament, on Medical and Cosmetic Products, it is important to note, that the manufacture does not conduct any Animal Testing in order to determine the Poy-Sian product toxicity, as specified and prohibited by the EU Regulations.
Based on more than 100 years of experience, with the ingredients in the Poy-Sian product, first as a family owned business – then as a Company (since 1936), there is no indication that the different essential oils in the product affects one another’s toxicity. Based on our opinion and based on our experience, it is therefore safe, to make a mathematical interpolation between the essential oils, taking into account the LD50 value for each category – and put this in relation to the distribution in percent, of each ingredient in the finished Balm Oil product.
|CAS #||Ingrediens||%||LD50 mg/kg.|
|89-78-1||D/L – Menthol||16.50 %||3.180|
|507-70-0||Borneol (historical name: Borneo Camphor)||3.00 %||2.000|
|8008-51-3||Camphor Oil (lowest estimated LD50)||10.00 %||50|
|800-48-4||Eucalyptus Oil||10.00 %||2.480|
|8016-78-2||Lavender Oil||0.50 %||4.250|
|8030-01-1||Peppermint Oil (lowest estimated LD50)||50.00 %||2.097|
|8030-00-0||Pepermint Spirit (lowest estimated LD50)||QS 10.00 %||2.097|
|CAS #||Ingrediens||%||LD50 mg/kg.|
|xxxx-xx-x||Poy-Sian Balm Oil, Estimated LD50 in product.||100.00 %||2.117|
If Poy-Sian is used as described and intended, the toxicity class, according to the Hodge and Sterner Scale, when LD50 is set to 2.117 mg/kg, will be the lowest toxicity rating possible = 6. The commonly used term or description for the Poy-Sian product, due to the Hodge and Sterner Scale is = HARMLESS.
However, if Poy-Sian products are being used oral, against its description and its intended use, the toxicity class, when LD50 is set to 2.117 mg/kg, according to Gosselin, Smith and Hodge Scale, will be a toxicity rating equal to = 3, which is classified as = Moderately Toxic.
If the LD50 dose for Poy-Sian products is set equal to that of: 2.000 mg/kg or equal to 120 ml oral intake of Poy-Sian Balm Oil, for a 70 kilo (150 lbs) person.
To be lethal (LD50) to the described person (70 kilo (150 lbs)) this means that:
-With an oral intake, of Poy-Sian Balm Oil, equal to the contents of more than 60 units (5 dozen) Poy-Sian Mark II inhalers, the person is more likely to die. Chance is more than 50 %.
During a time span, of more than 100 years, the first many years as a family owned and run business – then as a registered Company (since 1936), there have been no reported accidents or incidents, where people are known to have used Poy-Sian Balm Oil in order to harm themselves, commit suicide or kill themselves.
Nor have there been any reports, which indicate accidents or incidents, where people have died due to improper handling or careless use of our Poy-Sian products. Conditions and facts, which has to be set in relation to the simple fact, that Gold Mints Products Co., Ltd. produces and sell more than 200,000 Poy-Sian Mark II inhalers, each and every day or more than 60 million unit each year.
Further the European Food Safety Authority (EFSA), Journal (2008) 729 on Camphor, in use for flavoring of food, have been taken into consideration, since it describes the oral intake of d-camphor as an approved ingredient in food additives in Europe – for flavoring purposes – as adopted by the Commission, on 22 May 2008, the most poisonous ingredient in Poy-Sian!
As a result of our evaluation and since the Poy-Sian Balm Oil found in our products are only intended for external use, our products have been recognized “Worldwide” and classified as:
— NONE TOXIC AND “VERY” SAFE TO USE ON DAILY BASES —
CLP REGULATION (EU) No 1272/2008/EC, Responsible person.
According to the regulation of the European Parliament, REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, of 16 December 2008, concerning import of Poy-Sian products – to the European Market (EU), from Gold Mints Products Co., Ltd., the responsible person will be as follows.
At all time, the CEO of Poy-Sian European Import IVS will be designated as “the responsible person”, in accordance with CLP REGULATION (EU) No 1272/2008/EC.