02 Ichthyol Pale from a flask glass bearbeitet

Ichthyol® Pale

By the name of Ichthyol® Pale, Ichthyol-Gesellschaft offers pale sulfonated shale oil for use in cosmetic skin and hair care. Convince yourself of the quality and proven efficacy profile of this well-tolerated substance on the following pages.

A guarantee for good quality

Flaking scalp and skin problems as well as skin impurities are often triggered by interaction of different factors. Ichthyol® Pale provides the basis for a functionally combined approach to solving skin problems.

In cosmetics, Ichthyol® Pale is one of the well-documented substances of natural origin. The pale sulfonated shale oil is manufactured by Ichthyol-Gesellschaft according to the principles of good manufacturing practice (GMP) in consistently good quality.

Ichthyol® Pale is characterized by high purity, good tolerability, galenic preferences and versatility in the care of problem skin.

The main features at a glance

  • natural origin (from an organic matter-rich limestone)
  • high purity
  • high safety factor
  • good tolerability
  • broad spectrum of action (scientifically proven)
    • reduces dandruff
    • helps against skin impurities
    • reduces irritations
    • reduces excess sebum production
  • manufactured according to good manufacturing practice (GMP)
  • versatile formulation options (e.g. clear aqueous solutions)
Trade name Ichthyol® Pale
INCI Ictasol
Synonyms sodium shale oil sulfonate (former INCI)
Ichthyolic Acid, Sodium Salt
CAS# 1340-06-3
EC# 215-671-7
Reach Registration# 01-2120764758-36-0000
Berg 01
Fish fossil from Seefeld Paralepidotus ornatus

Manufactured from natural origin

Ichthyol® Pale has an exciting history of development. In geoscientific terms, its origin goes back to deposits of microscopic algae (phytoplankton) in a special lagoon environment of the Alpine region of the Mesozoic era. Under certain conditions, the biodegradation of marine phytoplankton by sulfate-reducing bacteria (anaerobic) allowed the formation of abundant organically bound sulfur in the biomass. In course of time, diagenetic processes formed shale-like sedimentary rocks from the periodic deposits, which today contain the marine biomass in solidified form.

At the end of geological processes qualitatively appropriate, highly sulfuric deposits of organic matter rich rock are hidden hardly accessible inside the mountains and have to be exploited in a complicated system of underground chambers.

Mine Chamber

In the dry distillation process that follows mining, the rock is gently heated in the absence of air so that the biomass it contains decomposes only to the point where it can change from a solid to a liquid form (shale oil pharma).

Manufacturing in Austria

Ichthyol® Pale is manufactured in a dedicated facility in Reith bei Seefeld, Austria. The plant operates in compliance with the requirements for active pharmaceutical ingredients in line with the guidelines of good manufacturing practice (GMP). The GMP system ensures that all Ichthyol® substances are manufactured reproducibly at the site according to the required (pharmacopoeia) quality.

The shale oil is separated into several fractions in a vacuum distillation unit. The most volatile of these fractions is used for the production of Ichthyol® Pale.

By means of sulfonation and subsequent neutralization, the oil is made water-soluble. As a result, Ichthyol® Pale is obtained as the sodium salt of a pale sulfonated shale oil.

The pale type of Ichthyol® (INCI: Ictasol) developed for the cosmetics field is characterized not only by its many beneficial properties, but also by its high purity, good tolerability and extremely pleasant applicability.

thomas henke mWk5pbVELDU unsplash

Important to know:

The production of Ichthyol® substances is not related to the exploitation of crude oil and does not have any petrochemical background. All activities concerning the production of Ichthyol® are directed towards pharmaceutical use from the very beginning.

The Ichthyol® substances are derived from Jurassic limestone, which is rich in fossil organic substances. The late Kimmeridgian marine limestones of the Orbagnoux area (Rhone, France) are well known for their fish fauna. Commonly, this rock is called oil shale, although it does not meet the definition of shale rock at all. These rocks also do not contain oil. The so-called “shale oil” used for the production of the Ichthyol® substances is first extracted from the limestone by dry distillation. This shale oil is therefore fundamentally different from crude oil, which is already present in the earth in liquid form and is brought to the surface by pumping (in some cases after fracking) and subsequently used for energy generation or petrochemical purposes. A use of the highly sulfuric shale oil from the limestone deposits in the French Jura that is equivalent to crude oil is completely unthinkable. The focus is solely on pharmaceutical use, to which all production steps are adapted.

Application

Due to multifunctionality combined with natural origin and good tolerance, Ichthyol® Pale is particularly suitable for cosmetic treatment of dandruff and skin impurities.

Dandruff

Flaking skin problems in the area of the scalp are often triggered or negatively influenced by the interaction of inflammatory processes, excessive microbial colonization or even excessive secretion of sebum. An optimal solution to the irritating problem is ensured by using a combination of different active principles. Anti-dandruff shampoos therefore often contain a combination of different active ingredients that address the multifactorial nature of the problem. Ichthyol® Pale makes a significant contribution in this regard, as various active principles have been proven for this substance. Among other things, anti-inflammatory, anti-microbial and antiseborrheic properties have been described. Ichthyol® Pale therefore offers the basis for a functionally combined therapy with a single active ingredient (integrated approach).

Ichthyol® Pale in the treatment of dandruff – The benefits at a glance

  • Multifactorial:
    • anti-inflammatory
    • anti-microbial
    • anti-seborrheic

Ichthyol® Pale – Benefits in combination shampoos:

  • Provision of valuable additional active properties
  • Exceptional anti-dandruff effect
  • Faster and broader effects
  • Accompanying symptoms are successfully combated
  • Better tolerance
  • Reduction of the original concentration of the anti-dandruff active ingredient

The efficacy of Ichthyol® Pale in the treatment of dandruff has been impressively confirmed in a number of studies. It has been demonstrated that Ichthyol® Pale can be an alternative to widely obsolete anti-dandruff agents such as zinc pyrithione or coal tar. Due to the broad spectrum of action of Ichthyol® Pale, accompanying symptoms of dandruff such as reddening of the skin, itching or greasy hair can be effectively treated as well. Often, this is not possible with conventional antidandruff agents, which usually only have an antifungal effect. Ichthyol® Pale is superior to Piroctone Olamine in this respect.

In controlled studies, the efficacy of 1% Ichthyol® Pale was tested in comparison with commercially available shampoos containing zinc pyrithione and piroctone olamine.
In all treatment groups, a significant decrease in dandruff was observed at the end of the study. However, Ichthyol® Pale proved to be significantly better than the comparative substances in eliminating the accompanying symptoms such as itching and thus had an overall advantage.

Improvement of symptoms

An ideal anti-dandruff agent should be a safe and well-tolerated substance with a broad spectrum of action that eliminates dandruff while at the same time relieving accompanying secondary symptoms (e.g. skin redness). These desirable properties are combined in Ichthyol® Pale.
Unquestionably efficient, coal tar has carcinogenic properties. Even after brief hair washing, critical components of coal tar can be absorbed through the skin. For this reason, uncontrolled use of coal tar in cosmetics has been banned in Europe since the end of the 1990s.
A comparative study shows that coal tar can be substituted successfully by Ichthyol® Pale which proves superior in long-term use due to its good tolerability.

Average dandruff score

Many known anti-dandruff agents are potent antifungal agents (e.g. ketoconazole, climbazole, etc.) which, in the context of dandruff treatment, mainly target the excessive bacterial colonization of the scalp. However, for a treatment of the overall symptoms, an integrated approach should be chosen that takes into account the entire problem including inflammation, itching and skin redness.
A study was therefore conducted to investigate whether ketoconazole in combination with Ichthyol® Pale offers a broader treatment approach and thus a better prospect of treatment success.
It was concluded that the combination of 0.5% Ichthyol® Pale and 0.5% ketoconazole provided significantly faster elimination of dandruff than treatment with 1.0% ketoconazole alone. In addition, the accompanying symptoms of itching and skin redness were found to subside much more effectively when the active ingredients were combined. This means that when Ichthyol® Pale is used, the original concentration of the azole derivative, which is considered to be aggressive, can be halved with an increase in tolerability without loss of efficacy.

In general, Ichthyol® Pale can boost efficacy in combination shampoos, as synergistic effects also occur with established substances such as salicylic acid.

Please feel free to request more comprehensive information on the active profile of Ichthyol® Pale. We will be happy to provide you with literature and support you in developing your own products with Ichthyol® Pale.

Skin impurities

Skin impurities can occur during puberty but also independent of age (e.g. stress-related). Often an increased secretion of sebum in the sebaceous glands plays an important role. If a plug is formed in the excretory duct of the sebaceous glands, the accumulated sebum is an ideal nutrient medium for certain bacteria. Certain enzymes (lipases) enable the bacteria to decompose the sebum to form free fatty acids. The free fatty acids in turn penetrate into the surrounding tissue, where they provoke inflammatory phenomena such as redness and pimples.

Ichthyol® Pale for skin impurities – The advantages at a glance

  • Multifunctional
    • anti-microbial
    • anti-inflammatory
    • anti-seborrheic
  • Well tolerated
  • Natural origin

Skin blemishes are often triggered or negatively influenced by the interaction of inflammatory processes, excessive microbial colonization and excessive secretion of sebum. In the care of irritated skin, Ichthyol® Pale can make a significant contribution, as various active principles have been proven for this substance that address the overall problem outlined above. Anti-inflammatory, antimicrobial and antiseborrheic properties are described for Ichthyol® Pale. Ichthyol® Pale therefore provides the basis for a functionally combined care regimen with a single active substance.

The anti-inflammatory effect of Ichthyol® Pale was clearly demonstrated in the UVB erythema test. The skin redness of test subjects was reduced when treated with 4 % Ichthyol® Pale in a cream comparable to a 0.5 % hydrocortisone ointment.

comparison of skin color

At the cellular level, it was observed that Ichthyol® Pale inhibits the activity of enzymes that catalyze the formation of inflammation mediators. Inflammatory mediators are involved in the development of inflammation (e.g. redness). In the presence of Ichthyol® Pale, the enzyme 5-lipoxygenase, for example, is inhibited in a concentration-dependent manner, which significantly impairs the formation of the inflammatory mediator LTB4.

Ichthyol® Pale exhibits antimicrobial effects with all germs that are relevant in cosmetically significant skin problems.
In the case of skin blemishes, Propionibacterium acnes is particularly noteworthy, for which Ichthyol® Pale is highly active with a minimum inhibitory concentration (MIC) of 0.039%.

The combination of the anti-inflammatory and antimicrobial properties of Ichthyol® Pale leads to very good results in the elimination of skin impurities (pimples). This was the conclusion of a study conducted on 101 test subjects using a 1% Ichthyol® Pale formulation. After a treatment phase of six weeks, efficacy was rated as “good” or “very good” in around 76 % of cases.

Effect percent on subjects

In another study, the effectiveness of a formulation containing 1 % Ichthyol® Pale and 0.5 % salicylic acid was tested. In the course of the eight-week treatment phase, the average number of visible skin lesions was reduced from 31.4 to 6.3, corresponding to a decrease of approximately 80 %.

Number of efflorescences

In addition to the efficacy of Ichthyol® Pale, its tolerability was also rated as “good” to “very good” in both studies.

Please contact us for further information on the action profile of Ichthyol® Pale. We will be happy to support you in your development projects and provide you with framework formulations.

Product development

Product development with Ichthyol® Pale – What should be considered?

Ichthyol® Pale can generally be formulated in a wide range of concentrations (recommended 0.5 – 5%). Some raw material properties must be taken into account in order to achieve the intended results in formulations.

  • Ichthyol® Pale is a sulfonate salt of a highly volatile, extremely sulfur-rich shale oil fraction in aqueous solution. It is not an oil. The symbolized formula can be represented by R-SO3Na (R = organic fraction of phytoplanktonic origin).
  • As a sulfonate salt, Ichthyol® Pale has surfactant properties (lipophilic (R) and hydrophilic component (SO3Na) in the molecule) and is therefore surface active.
  • In principle, hydrophilic creams are formed in preference to those of lipophilic character.
  • Miscibility with oils without emulsifier is generally not possible. However, the solubility of Ichthyol® Pale in water, glycerin or alcohol-water mixtures is normally without problems.
  • In solutions, precipitation may occur when additional salts are added. Cations of higher valency and salting out must be avoided.
  • Ichthyol® Pale is stable over a wide pH range. Only strong acids cause precipitation.
  • Ichthyol® Pale has antimicrobial properties. The use of preservatives can be limited if appropriate.
  • In closed, well-filled containers, Ichthyol® Pale has a shelf life of at least 48 months, provided the storage conditions are observed.

For further information on formulating with Ichthyol® Pale, please feel free to contact us. We will be happy to provide you with detailed frame formulations for shampoos, creams, pastes, etc. on request.

Safety assessment

The good tolerability of Ichthyol® Pale has been demonstrated in a large number of toxicological studies. Ichthyol® Pale proved to be well tolerated both with short-term and long-term administration. There were no indications of teratogenic, mutagenic or carcinogenic properties.

The safety of a cosmetic raw material such as Ichthyol® Pale is best illustrated by calculating the safety factor. For both rinse-off and leave-on products, the safety factors obtained with Ichthyol® Pale in the usual use concentrations are clearly above the required minimum value of 100.

We offer our customers comprehensive documentation for the safety assessment of their cosmetics. Let us know if you need any information.

Frau mit Mikroskop im Labor

Differentiation from Tars

Since 1996, cosmetic coal tar shampoos may no longer be manufactured in the EU due to the toxicity of the tar. Ichthyol® Pale is recommended as an alternative to coal tar.

Because of their characteristic odor and related spectrum of action, sulfonated shale oils are sometimes assigned to tars. However, Ichthyol® Pale and tars differ very substantially with regard to:

Ichthyol® Pale

Origin: limestone with biomass from marine phytoplankton

Dry distillation: from approx. 300°C

Intermdiate product: Shale Oil (pharmaceutical) extremely rich in sulfur

Active Substance: sulfonated shale oil made from a refined volatile fraction of the original shale oil

• Surfactant-like organic salts based on thiophenes in an aqueous solution
• Water-soluble, hydrophilic
• Rich in organically combined sulfur

Not mutagenic

Not carcinogenic

High purity with respect to PAHs
(< 0.001 ppm benzo[a]pyrene)

Coal tar

Origin: coal from land plants

Dry distillation: at approx. 1000°C

 

Active Substance: coal tar

• Mixture of hydrocarbons and phenols
• Not water-soluble, lipophilic
• Low in sulfur

Signs of mutagenicity

Signs of carcinogenicity

Highly contaminated with PAHs
(> 5000 ppm benzo[a]pyrene)

Offers and further information

Contact us for a quotation on Ichthyol® Pale in the quantity you require. We usually deliver worldwide at short notice directly from our GMP warehouse in Hamburg in container sizes (HDPE) of 1 kg, 5 kg, 25 kg and 200 kg. Upon prior arrangement, we will be happy to provide you with samples free of charge for development work.

The use of Ichthyol® Pale is possible worldwide. For use in China, the registration code is available under the new Chinese cosmetic law since spring 2022.

For Ichthyol® Pale we offer an extensive cosmetic oriented documentation.

For regulatory and scientific questions as well as for availability of Ichthyol® Pale in a specific distribution area, please feel free to contact us.

You can find our terms and conditions here.

Your Ichthyol® Team

Phone +49 40 50714 -108 / -180 / -360 / -367
eMail rawmaterial@ichthyol.de

Ichthyol Pale drums