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Diss Factsheets
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EC number: 205-086-5 | CAS number: 132-98-9
- 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
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.
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.