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EC number: 232-439-0 | CAS number: 8029-68-3 A complex product obtained by the sulfonation and ammoniation of the distillation product from bituminous schists. It may contain saturated and unsaturated hydrocarbons, nitrogen bases and thiophene derivatives.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- ongoing laboratory work for "inprocess controls" and batch release
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Generally accepted standards in this case means reference to pharmacopoeias as e.g. the European Pharmacopoeia Ph.Eur.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: company internal operation procedure with reference to official European Pharmacopeia provisions (monograph Ichthammol 0917)
- Version / remarks:
- test instructions ICHTH-Rohstoffe PA-001 version 05 dated October 13th, 2014
(with reference to European Pharmacopoeia monograph Ichthammol) - Deviations:
- not applicable
- Principles of method if other than guideline:
- company internal testing instructions based on European Pharmacopoeia requirements
monograph 0917 Ichthammol
Ichthammol
Characters
Appearance: dense, blackish-brown liquid.
Solubility: miscible with water and with glycerol, slightly soluble in ethanol (96 per cent), in fatty oils and in liquid paraffin. It forms homogeneous mixtures with wool fat and soft paraffin.
The term ‘miscible’ is used to describe a liquid that is miscible in all proportions with the stated solvent. - Other quality assurance:
- other: laboratory in a GMP certified pharmaceutical company
Test material
- Reference substance name:
- Ichthammol
- EC Number:
- 232-439-0
- EC Name:
- Ichthammol
- Cas Number:
- 8029-68-3
- Molecular formula:
- unspecified
- IUPAC Name:
- Ichthammol (UVCB substance)
- Test material form:
- liquid: viscous
- Details on test material:
- sample from a batch from regular production released for use as an active pharmaceutical ingredient in medicinal products.
1
- Specific details on test material used for the study:
- batch 0050218415Ö2/18
Results and discussion
Water solubility
- Water solubility:
- > 500 g/L
- Conc. based on:
- other: Water has to be regarded as an intrinsic part of the test substance. 500 g/L refers to the content of dry matter with reference to the total substance comprising water and dry matter (organic sulfonate salt).
- Temp.:
- 20 °C
- pH:
- >= 6 - <= 7.5
- Remarks on result:
- completely miscible
Applicant's summary and conclusion
- Conclusions:
- In the literature Sulfonated Shale Oils or bituminosulfonates (as Ichthammol or Ichthyolic Acid, Sodium Salt) are described as viscous, brown-blackish, neutral liquids of characteristic odor. Their status as liquids results from the fact that water appearing as a by-product in course of the manufacturing process (sulfonation and neutralization of a distillate resulting from destructive distillation of organic matter rich limestones) is considered an intrinsic part of the substance. It can be concluded, therefore, that there is no repulsion when bringing the substance in contact with water. Actually, sulfonated shale oils or bituminosulfonates are described in the literature as strongly polar compounds, water soluble, surface active and solubilizing. Water solubility of ICHTHYOL as trademark substance of this group of substances was described in the open literature already more than 100 years ago. In this case evidence is given about the water solubility of Ichthammol by means of an exemplary batch related certificate of analysis which is based on specifications established in the European Pharmacopoeia (monograph 0917 Ichthammol).
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