Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in chemico
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
All non-penicillin beta-lactams have the potential to sensitize individuals, and subsequent
exposure to penicillin may result in severe allergic reactions in some patients. Although the
frequency of hypersensitivity reactions due to cross-reactivity between beta-lactam classes can
be lower than the risk within a class, the hazard posed is present and potentially lifethreatening.
The potential health hazard of non-penicillin beta-lactams therefore is similar to that
of penicillins. Further similarities between non-penicillin beta-lactams and penicillins are as
follows:
• It is difficult to define the minimal dose below which allergic responses are unlikely to
occur in humans.
• There is a lack of suitable animal or receptor testing models that are predictive of human
sensitivity.
• The threshold dose at which allergenic response could occur is extremely low and
difficult to detect with current analytical methods.

Non-Penicillin Beta-Lactam Drugs:
A CGMP Framework for Preventing Cross Contamination: US Food and Drug Administration, April 2013

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion