Registration Dossier
Registration Dossier
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EC number: 205-086-5 | CAS number: 132-98-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
Penicillins and related β-lactam antibiotics have a low toxicity profile for both the pregnant and non-pregnant patient when used in therapeutic doses. Only penicillin allergy may present a problem. Penicillins cross the placenta in low concentrations, and can be detected in amniotic fluid.
There is no evidence that penicillins have teratogenic or embryo/fetotoxic properties. There are no differences between the various penicillins regarding their safety in pregnancy.
Penicillins can be safely used during pregnancy in the usual doses; they are the antibiotics of choice in pregnancy (Drugs during Pregnancy and Lactation, 2007)
Penicillins and their newer derivatives are the most widely prescribed antimicrobial class during pregnancy: FDA assigned them to pregnancy category B. Potential Adverse Effects on Fetus: None known. Fetal serum levels 20%-50% of maternal. Potential Side Effects on Breast-fed Infant: Significant problems not documented, but may lead to sensitization, diarrhoea, candidiasis, or skin rash in infant. Animal studies failed to reveal evidence of fetal harm. Adverse effects have not been reported during human use. Penicillin is only recommended for use during pregnancy when benefit outweighs risk: the group of penicillins are regarded as being devoid of reprotoxic potential.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
Effects on developmental toxicity
Description of key information
Penicillins belong to the β-lactam antibiotics. They inhibit cell-wall synthesis in bacteria and have bactericidal properties. Similar metabolic pathways do not exist in mammals, and therefore penicillins and related β-lactam antibiotics have a low toxicity profile for both the pregnant and non-pregnant patient when used in therapeutic doses. Only penicillin allergy may present a problem.
Penicillins cross the placenta in low concentrations, and can be detected in amniotic fluid. Elimination of penicillins is more rapid in pregnant women, and therefore dosage or dosage intervals should be adjusted if necessary (Heikkilä 1994, Chamberlain 1993). There is no evidence that penicillins have teratogenic or embryo/fetotoxic properties (Berkovitch 2004, Jepsen 2003, Dencker 2002, Larsen 2001, 2000, Czeizel 2000A, 1998). Penicillins have been selected as the antibiotics of choice in pregnancy (Drugs during Pregnancy and Lactation, 2007).
Justification for classification or non-classification
Based upon extensive human experience, classificaiton for reproductive toxicity is not justified.
Additional information
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.
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