Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Family
- INCI Name
- Ingredient Origin
- Cosmetic Ingredients Functions
- CAS No.
- 8000-48-4
- Technologies
- Product Families
- Product formulations
Citrefine has a number of off-the-shelf formulations, using Citriodiol® as the active substance. These are available in different application types depending on your, or the market preference. These are sprays, a roll-on, a stick and a cream.
- Provides a faster route to market – no need to formulate or carry out efficacy testing
- Provides a solution for those that don’t have the expertise to formulate a product(s)
- Access to supplemental registrations in various jurisdictions – avoid the regulatory process
- Access to toll manufacturers that can produce these formulations for you – no need to find a manufacturer
- Take the formulation, brand it, sell it
Features & Benefits
- Benefit Claims
- Labeling Claims
- Features
Citriodiol® is produced from steam distilled Eucalyptus citriodora oil using a process that mimics and accelerates the aging process which naturally occurs in the leaf, by converting the citronellal content into p-menthane-3,8-diol (PMD). PMD itself is usually only present at very low levels in natural essential oils, rarely more than 1% or 2 %. This conversion process to increase the PMD content makes Citriodiol® a far more powerful repellent than the natural essential oil itself.
PMD has long been known as the active compound responsible for the repellent effect, and it is the high levels of PMD in Citriodiol® which provide its efficacy. Citriodiol® contains a minimum of 64% PMD (a mixture of the cis and trans isomers of p-menthane-3,8-diol) together with a number of minor constituents found in essential oil which enhance the efficacy further.
Citriodiol® has been notified under the European Biocidal Products Directive (BPD) 98/8/EC and is in the final stages of evaluation under the European Union’s Biocidal Products Regulation (BPR).
Unlike other essential oil based products, Citriodiol® has passed the most rigorous safety and efficacy tests. For example, it has been reviewed and met the highest standards obtaining registration and end-use product approval from the following agencies
- United States Environmental Protection Agency (US EPA)
- Australian Pesticides and Veterinary Medicines Authority (APVMA)
- Canadian Pest Management Regulatory Agency (PMRA) E
- Swedish Chemicals Agency (KEMI)
- Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb)
- Danish Environmental protection Agency (EPA)
- Finnish Safety and Chemicals Agency (TUKES)
It is often thought that insect repellents are similar to cosmetic products, such as moisturizers or face creams, in terms of the tests they have to pass to be brought to market. In fact, the tests required for insect repellents are generally much more stringent. For example, insect repellents must often pass comprehensive human health (and sometimes environmental) risk assessments by the relevant authorities, neither of which tend to be required for cosmetics.
In many countries insect repellents are classed as biocides, such as in the European Union where they are evaluated alongside insecticides under the BPR.
It is the only naturally sourced active ingredient registered for use in the USA by the EPA, and listed by the US CDC to prevent bites from mosquitoes carrying the Zika virus
- It works – despite historical misconceptions that naturally sourced insect repellents do not work, there are more than 40 studies carried out in multiple countries to prove otherwise. Furthermore, leading authorities worldwide support its efficacy against mosquitoes, ticks, midges and more. The US CDC (Centers for Disease Control and prevention) lists Citriodiol® as the only naturally sourced active ingredient to prevent bites from mosquitoes carrying the Zika virus
- It is made from sustainably sourced, ethically produced eucalyptus citriodora oil. Click here to learn more about our green sourcing and production
- It is great for all the family and our substantial dataset supports this
- It is registered in many countries including the USA (where it is known as Oil of Lemon Eucalyptus or OLE), Canada and Australia, and it is in the final stages of evaluation under the European Union’s Biocidal Products Regulation (BPR)
- This means you will be able to launch a product which meets the growing desire for ethical, sustainably sourced and environmentally friendly products. Backed by leading global authorities and vast data to support its efficacy, consumers will love Citriodiol®-based products because they work, making your route to market as smooth as possible
- Features and benefits of Citriodiol®
- summary of what insects Citriodiol® repels
- Additional Information-What else do I need to know?
Citriodiol® is known by other names in different countries
- Citriodiol® is available to all those that require a naturally sourced active ingredient for an insect repellent product
- Citriodiol®’s main constituent is p-menthane-3,8-diol or PMD, which is naturally present in eucalyptus citriodora oil, but its levels are increased by our production process
- Citriodiol® goes by many other names. The most common ones, and the respective countries where they are used, are listed below:
- Oil of lemon Eucalyptus (OLE) – USA (EPA & CDC)
- Oil of lemon eucalyptus, hydrated, cyclized – Canada (PMRA) * see notes below
- Oil of Lemon Eucalyptus (hydrated, cyclized) – Australia (APVMA)
- Eucalyptus citriodora oil, hydrated, cyclized (abbreviated for informal use as EC Oil (H/C)) - European Union
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The characteristics of Citriodiol® - at room temperature it is a yellow liquid containing white crystals. When heated to 55°C to 60°C the crystals will melt to become homogeneous, and will be a yellow liquid. It has a strong lemon scent.
* In October 2017 the definition for Citriodiol® was changed by the Canadian authorities from p-menthane-3,8-diol and related oil of lemon eucalyptus compounds, to the name given above
- Citrefine International obtains eucalyptus citriodora oil from a handful of carefully selected sources
We work very closely with our oil producers and refiners to ensure a consistent supply of the best quality raw material for our process. We have several on-going projects to ensure supplies are maintained and the quality secure for the future, including having direct involvement with growers and plantations.
With regular visits to the plantations we are able to maintain and nurture our relationships with them, and monitor their social and environmental practices. This activity over recent years has allowed us to forge strong relationships for the future and maintain supplies of the highest quality of oil available in the world.
Applications & Uses
- Markets
- Applications
- Application Format
- Skin Care Applications
- Sustainable, ethical production
Essential oil production is an inherently green business, as the health and vitality of the soil and trees themselves play a vital role in the quality of oil produced
Steam distillation is used to extract the oil, which is an age old process using only the leaves and twigs of the trees, without harvesting the entire tree. These coppiced trees continue to grow thus becoming self-sustaining and using more carbon dioxide and producing more oxygen for the benefit of the greater environment.
Growing the trees
- Eucalyptus citriodora trees are generally grown on small plantations.
- Seedlings are planted and tended by hand by local workers.
- No synthetic fertilizers are used; the soil is simply conditioned with lime on planting and every couple of years thereafter to ensure it provides the best possible conditions for growth.
- Waste leaf from the distillation process is used to improve the soil and to help to retain moisture.
- Weeds are often controlled by running cattle in the plantation - which also fertilizes the soil.
- The trees and oil are not genetically modified.
Harvesting the leaves and managing the trees
- Leaves and branches are harvested by hand from the trees by teams of local workers including both men and women.
- Branches are cut selectively from each tree during the harvesting process so that the trees can continue to grow and produce new leaves for many years.
- Once the branches have been harvested, the twigs containing leaves are cut from the branches. The leaves and small twigs are steam distilled to produce Eucalyptus citriodora oil.
- The number of harvests each year is adjusted to ensure the on-going health of the trees.
- Once or twice during the 10-15 year life span of each tree, it will be cut to a stump and allowed to regrow.
- At the end of its life it will be cut down and a new line of trees will be planted adjacent.
- The trees which are cut down are used as fuel either on the plantation, specially treated for use as poles or sold to local businesses.
Distilling the oil
- Leaves are placed in a large vessel, compressed and then the vessel is sealed
- Steam is passed through the vessel to distill the oil from the leaves. As the steam cools the water and oil separate and the oil is captured in drums.
- A closed water system is used in which steam, passing through the leaves, distills the oil, condenses, and is re-used once the heat has been extracted from it.
- Waste leaves (known as bagasse) and/or surplus twigs are used as fuel to fire the boiler which produces the steam and the bagasse is used to maintain the soil.
- No other fuel is required to run the boiler and in fact excess energy generated by the process may be used to run other equipment on the plantation.
The employees
- Workers on the plantations are nearly all local.
- Plantations provide good, stable jobs for both men and women and are important to the local economy.
Regulatory & Compliance
- Certifications & Compliance
- Regulatory support
Registering a Biocidal Product can be a daunting and lengthy process. Our dedicated regulatory team can help you to navigate this difficult stage, and offer support in many regions throughout the world. In the regions where we are not currently present, we have extensive contacts with consultants in many different countries, and can help build a picture of the requirements for each jurisdiction.
- Access to data supporting the active substance (AS)
- Access to data supporting our end use product formulations
- Support & guidance with product authorisations/registrations
- Extensive support with EU BPR (Biocidal Product Regulations)
- Assistance with classification and labeling
- Information on regulatory frameworks in countries where we operate
- Access to supplemental registrations for pre-existing formulations in various jurisdictions
- Guidance on insect repellence by species
Technical Details & Test Data
- Efficacy studies - Mosquitoes
Study 1.
Carroll (2007).
A. Test article
-
30% Citriodiol® pump spray product
B. Species tested
The following mosquito species were present at the two geographic locations tested
-
Aedes
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Anopheles
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Culex
C. Testing standards
This study was comprehensive in its testing method. It was field study (using two distinct geographic locations) and was conducted to US EPA standard OPPTS 810.3700.
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It relied on 10 volunteers testing the product in two geographically distinct locations; hence 20 replicates in total.
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Application rate much lower than the industry standard rate of 1.0ml/600cm².
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It met all applicable ethical standards by ensuring subjects were adequately warned about the potential risks of the study, women at risk or pregnancy were excluded, and the privacy of the subjects was ensured (HSRB approved).
D. Results
The 30% Citriodiol® spray formulation provided up to 8.25 hours of complete protection (CPT), a standard measuring 100% protection or repellency.
This result, which gave a median CPT of 4-6.2 hours was based on an application rate of the product that was 70% lower than industry standard. In addition, the standard of complete protection required under OPPTS 810.3700 is arguably a more rigorous standard than required by some Member States in Europe under national laws insofar as it bases its conclusion on a standard of complete protection from landings with intent to bite (time of first confirmed landing with intent to bite) whereas the "percentage protection" standard requires the often less rigorous standard of a given percentage (less than 100%) of protection from actual bites.
The US EPA determined this data supported a claim of“up to 6 hours protection from mosquitoes” based on this more conservative CPT standard.
Study 2.
Martinez de Murguia (2018)
A. Test articles:
-
30% Citriodiol® spray product(Mosi-guard Natural® Spray)
B. Species tested
-
Aedes albopictus (Stegomyia albopicta)
C. Testing standards
This study was conducted according to the WHO Guidelines for efficacy testing of mosquito repellents for human skin, Ref: WHO/CDS/NTD/WHOPES/2009.4.
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Laboratory study
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100 mosquitoes
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5 subjects /replicates
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Negative control (untreated skin)
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Application rate 1ml/600 cm2
D. Results
The 30% Citriodiol® spray formulation provided 8 hours of complete protection (CPT) and 95% repellency was maintained to 10 hours.
Study 3.
Ranzani (2018)
A. Test articles:
-
30% Citriodiol® spray product(Mosi-guard Natural® Spray)
B. Species tested
-
Anopheles Aquasalis
C. Testing standards
This study was conducted according to the WHO Guidelines for efficacy testing of mosquito repellents for human skin, Ref: WHO/CDS/NTD/WHOPES/2009.4.
-
Laboratory study
-
200 mosquitoes
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10 subjects /replicates
-
Negative control (untreated skin)
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Application rate 1g/600 cm2
D. Results
The 30% Citriodiol® spray formulation provided 6.5 hours of complete protection (CPT).
Study 4.
Ranzani (2018)
A. Test articles:
-
30% Citriodiol® spray product(Mosi-guard Natural® Spray)
B. Species tested
-
Culex quinquefasciatus
C. Testing standards
This study was conducted according to the WHO Guidelines for efficacy testing of mosquito repellents for human skin, Ref: WHO/CDS/NTD/WHOPES/2009.4.
-
Laboratory study
-
200 mosquitoes
-
10 subjects /replicates
-
Negative control (untreated skin)
-
Application rate 1g/600 cm2
D. Results
The 30% Citriodiol® spray formulation provided 6 hours of complete protection (CPT).
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- Efficacy studies -Ticks
Study 1.
Jones (2019)
A. Test articles
-
30% Citriodiol® Spray
B. Species tested
-
Ixodes scapularis (blacklegged or deer tick)
-
Amblyomma americanum (Lone Star tick)
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Rhipicephalus sanguineus (brown dog tick)
C. Testing standards
EPA Product Performance Test Guidelines (OPPTS 810.3700)
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Laboratory Study
-
25 replicates were performed for each tick species for a total of 75 individual replicates
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Negative control (untreated skin)
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Application rate of 0.714mg/600cm² (rate based upon dosimetry study to determine typical consumer dose)
D. Results
Median Complete Protection Times for each species tested were as follows:
Ixodes scapularis (blacklegged or deer tick) = 290 minutes (4 hours, 50 minutes)
Amblyomma americanum (Lone Star tick) = >600 minutes (> 10 hours)
Rhipicephalus sanguineus (brown dog tick) = 512 minutes (8 hours, 32 minutes)
Study 2.
Foltan (2016)
A. Test article
-
30% Citriodiol® spray product (Mosi-guard Natural® Spray)
B. Species tested
-
Ixodes ricinus
C. Testing standards
EPA Product Performance Test Guidelines (OPPTS 810.3700)
-
Laboratory study
-
5 ticks per exposure period
-
10 subjects
-
Negative control (untreated skin)
D. Results
Results from the study showed that 95% repellency for 5.5 hours
-
- Efficacy studies - Midges
Study 1.
Blackwell (2013)
A. Test article
-
30% Citriodiol® pump spray product (Mosi-guard Natural® Spray)
B. Species
95% of the midges observed in this trial were Culicoides spp. biting midges. This is a species commonly found in northern Europe.
B. Testing standards
-
This was a field study conducted in conformance with OPPTS 810.3700 and, where applicable WHO guidance and the TnG on PT19 efficacy testing. There is no direct guidance in this TnG on midge testing.
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It was of note that midge colonies do not typically survive for testing in laboratory conditions and hence field trials are preferred for this species.
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An application rate much lower than the industry standard of 1.0ml/600cm².
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6 human subjects.
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Negative control arms of each subject were used to establish % protection. Complete protection time was also measured.
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A positive DEET controlled was used to confirm appropriate testing conditions.
D. Results
The 30% Mosi-guard Natural® Spray provided a mean of 65% protection at 4 hours and complete protection for 2 hours. Significant decreases in protection occurred after this time, suggesting that where midges are not pathogen carriers, reapplication every 4 hours is appropriate
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- Efficacy studies - Fleas
Study 1. Fleas
Insect Services GmbH (2020)
A. Test article
-
20% Citriodiol® solution in ethanol
B. Species tested
-
Ctenocephalides felis (Cat flea)
C. Testing standards
The provisions of the European “Guidance on the biocidal Products Regulation (BPR) Volume II Efficacy – Assessment and Evaluation (Parts B&C)”; version 3.0, April 2018, ECHA.
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30 unfed male and female cat fleas between 4 and 7 days old
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Laboratory study performed with a warmed glass cylinder covered by wool fabric, to mimic a warm animal leg with fur, the surface of the fabric was sprayed with the test article and the surface temperature kept similar to the external body temperature of hosts.
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Ethanol negative control
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Application rate 1.66 μl/cm²
D. Results
Testing showed 100% repellency for the Citriodiol® solution, 100% of the fleas dropped of the fabric before reaching 10cm of walking distance, compared to 0% of fleas dropping off for the negative control.
Note: Citriodiol® is not intended for use on cats. Despite the name, cat fleas are found on many animals. Risk assessment for different pet species was not within the scope of this test.
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- Mimicking nature’s ageing process
We convert the high citronellal content in the essential oil into the naturally occurring substance PMD (p-menthane-3,8-diol)
- In nature, as the oil found in the leaves of the Eucalyptus citriodora tree ages, the main constituent of the oil (citronellal) gradually turns into PMD (p-menthane-3,8-diol).
- Some PMD is found in the “young” oil, but only in small amounts. Because it is more difficult to distill the oil when it is more mature and because the PMD is central to the efficacy in repelling biting insects, Citrefine’s suppliers harvest the oil from leaves that are about 12-18 months old.
- This oil is supplied to Citrefine who use a simple manufacturing process to convert the citronellal to PMD.
The result is Citriodiol®, which contains a minimum of 64% PMD and only a negligible amount of citronellal. The other naturally occurring minor components in the Eucalyptus citriodora oil remain largely unaffected by this process.
In this way Citrefine is effectively mimicking nature’s own aging process.
Safety & Health
- Safety for the consumer and the environment
We have undertaken numerous field and laboratory trials to test the effect of Citriodiol® on an array of insects.
Leading authorities worldwide now recognize Citriodiol’s first-rate efficacy, making it the only plant-based repellent with this level of global accreditation. There is also a substantial body of data supporting its safety for use on human skin and in particular on young children and babies.
The toxicity profile of Citriodiol® extends to areas beyond acute toxicity assessment. For example, it has no phototoxic potential, is non-mutagenic, passes the chromosome aberration test, is negative for inducing forward mutations at the TK locus in L5178Y mouse lymphoma cells, and is negative in the in-vivo mouse micronucleus assay. In longer-term sub chronic and chronic studies, it is shown to have no adverse reproductive or dermal developmental effect.
In addition to the many toxicological studies done on Citriodiol® to ensure product safety for consumers, Citrefine has also conducted environmental testing to ensure that its products are not harmful to the environment. These tests have proven that Citriodiol® is rapidly biodegradable, so will not build up to potentially harmful levels in our soils and waterways, unlike many synthetic alternatives such as DEET. Because Citriodiol® is sourced from natural plant oil and is rapidly biodegradable it is also not toxic to birds, honey bees and other insects beneficial to the environment.
Phys/chem data including stability data is being generated on our product formulations where data gaps exist. A validated method to extract and measure the amount of PMD has been successfully developed for these products and they have proved to be stable in 2-week accelerated stability testing at 54°C.
We are keen to understand and promote the repellent properties of Citriodiol® so if you decide to conduct efficacy testing of your own, we would welcome the opportunity to review your results or even to comment on the proposed study protocol in advance.
Packaging & Availability
- Supply of Citriodiol®
As well as supplying the active ingredient, Citriodiol, we provide a range of advisory and support services to help our clients manufacture and sell insect repellents, in new and existing markets. Whether you simply want a naturally sourced active substance, require technical or regulatory support, or need access to proven and registered formulations, we are here to help. Citrefine International is a responsive, reliable and knowledgeable partner who will help you bring the best possible product to market in an efficient and effective manner.
Supply of Citriodiol®
Maybe you are looking to add a non-synthetic insect repellent to your existing product range, or have the in-house expertise to develop, register and bring a new product to market yourself. If this is the case, Citrefine can simply supply you with the Citriodiol® active substance. Our minimum order quantity (MOQ) is 25Kg, and can be shipped all over the world. Each order will be shipped with an MSDS and a Certificate of Analysis.
If you require a sample of Citriodiol® for testing purposes, we can arrange this upon request.
- Technical support
Our in-house technical team have state of the art equipment including a GC-MS and a full range of equipment to replicate our production process and formulations in the laboratory for development, analysis and quality control. We have the expertise to support you every step of the way
- Help & guidance on formulations
- Advice on analytical methods
- Assistance with classification and labeling