Registration Dossier

Administrative data

skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
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 Type:
other: Periodic Safety Update Report
Report date:

Materials and methods

Test guideline
according to 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
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:
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
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.