Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- ICHTHAMMOL is used as an Active Pharmaceutical Ingredient (API) in registered medicinal products mainly. Most prominent finished products of this type contain ICHTHAMMOL in a concentration of 10 to 50%. In Europe registered medicinal products are subject of regular evaluation with regard to appearance of adverse/side effects. For this purpose so-called Periodic Safety Update Reports are prepared. As a side effect any occurance of skin sensitizations would be covered by a PSUR and evaluated accordingly.
A Periodic Safety Update Report is a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points post authorisation. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product taking into account new or emerging safety information in the context of cumulative information on risk and benefits.
The legal requirements for submission of PSURs are established in Regulation (EU) No 1235/2010, Directive 2010/84/EU and in Commission Implementing Regulation (EU) No 520/2012. The format of PSURs follows the structure described in the Implementing Regulation Article 35 and Module VII of the Guidelines on Good Pharmacovigilance Practices (GVP) provides guidance on the preparation, submission and assessment of PSURs.
Data source
Reference
- Reference Type:
- other: Periodic Safety Update Report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: legal requirements for submission of PSURs as established in Regulation (EU) No 1235/2010, Directive 2010/84/EU and in Commission Implementing Regulation (EU) No 520/2012
- Deviations:
- not applicable
- Principles of method if other than guideline:
- PSURs are reports providing an evaluation of the benefit-risk balance of a medicine. Marketing authorisation holders (MAHs) must submit PSURs at defined time points following a medicine’s authorisation. PSURs summarise data on the benefits and risks of a medicine and include the results of all studies carried out with this medicine, both in its authorised uses and in unauthorised uses.
The European Medicines Agency uses the information in PSURs to determine if there are new risks identified for a medicine or whether the balance of benefits and risks of a medicine has changed. It can then decide if further investigations need to be carried out or can take action to protect the public from the risks identified, such as updating the information provided for healthcare professionals and patients.
Detailed information on how to prepare PSUR can be found in EMA Human Medicines Evaluation Division document EMA/670256/2017 dated 31 October 2017 (Explanatory Note to GVP Module VII) - GLP compliance:
- no
- Remarks:
- Periodic Safety Update Reports are not subject of classification with regard to GLP compliance
- Type of study:
- other: compilation of information and their evaluation from use of an authorized medicinal product in patients (human beings)
- Justification for non-LLNA method:
- ICHTHAMMOL is used in highly concentrated (e.g. 50%) in authorized medicinal products in patients (human beings). Reported side effects from millionfold administrations on the skin of patients/human beings are recorded/put on file and evaluated in a prescribed way. From these data as well as clinical studies in human beings detailed information on tolerance can be derived (among others, skin sensitiziation). There is no need to carry out additional studies.
Test material
- Test material form:
- liquid: viscous
- Specific details on test material used for the study:
- Substance from regular production as released for use in medicinal products
Results and discussion
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The continuous recording and evaluation of adverse/side effects with regard to application/administration of registered medicinal products containing ICHTHAMMOL on the skin does not give rise to any concern about development of skin sensitisation. For a medicinal product available in Germany containing 50% of ICHTHAMMOL (Ammoniumbituminosulfonat) following information can be found concerning side effects in the Summary of Product Characteristics (Fachinformation): In rare cases (> 1/10,000, < 1/1,000) incompatibility reactions (itching, burning and/or severe redness, blistering) of the skin may occur.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.