Registration Dossier

Administrative data

Description of key 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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Link to relevant study records
Reference
Endpoint:
respiratory 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
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Justification for classification or non-classification