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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
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- other: Review
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
- Study type:
- human medical data
Test guideline
- Qualifier:
- no guideline followed
Test material
- Reference substance name:
- Phenoxymethylpenicillin potassium
- EC Number:
- 205-086-5
- EC Name:
- Phenoxymethylpenicillin potassium
- Cas Number:
- 132-98-9
- Molecular formula:
- C16H17KN2O5S
- IUPAC Name:
- potassium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-[(2-phenoxyacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
- Test material form:
- solid
1
- Specific details on test material used for the study:
- Beta-Lactams and Related Antibiotics - Penicillins
Method
- Type of population:
- other: Pregnants
- Details on study design:
- During pregnancy, untreated sexually transmitted or urinary tract infections are associated with significant morbidity, including low birth weight, preterm birth, and spontaneous abortion. Approximately one in four women will be prescribed an antibiotic during pregnancy, accounting for nearly 80% of prescription medications in pregnant women. Antibiotic exposures during pregnancy have been associated with both short-term (e.g., congenital abnormalities) and long-term effects (e.g., changes in gut microbiome, asthma, atopic dermatitis) in the newborn. However, it is estimated that only 10% of medications have sufficient data related to safe and effective use in pregnancy. Antibiotics such as beta-lactams, vancomycin, nitrofurantoin, metronidazole, clindamycin, and fosfomycin are generally
considered safe and effective in pregnancy. Physiologic changes in pregnancy lead to an increase in glomerular filtration rate, increase in total body volume, and enhanced cardiac output. These changes may lead to pharmacokinetic alterations in antibiotics that require dose adjustment or careful monitoring and assessment.
Results and discussion
- Results:
- Penicillins and their newer derivatives are the most widely prescribed antimicrobial class during pregnancy. Intravenous penicillin from the time of rupture of the placental membranes until delivery remains first-line prophylaxis if the patient is colonized with Group B Streptococcus, while ampicillin is recommended as a suitable alternative. Penicillins generally cross the placenta in high concentrations. Penicillins
with increased protein binding such as the anti-staphylococcal penicillins (except methicillin) produce lower fetal tissue concentrations compared with penicillins such as penicillin G or ampicillin that have low protein binding. Due to increased plasma volume and creatinine clearance in pregnant women, serum penicillin concentrations may be decreased by as much as 50%, which may require increased doses and/or
frequency.
Applicant's summary and conclusion
- Conclusions:
- Penicillins have a long track record of safety, with the parent compound penicillin and the aminopenicillins (ampicillin and amoxicillin) having the most robust safety data. All penicillins and their derivatives, as well as penicillin combinations with beta-lactamase inhibitors such as clavulanate or sulbactam, have been assigned a Pregnancy Category B rating.
- Executive summary:
The use of antibiotics in pregnancy requires careful assessment and a discussion of risk versus benefit to mother and fetus, both short and long term. In general, many antibiotics are considered safe in pregnancy, especially beta-lactams: Penicillins have a long track record of safety, with the parent compound penicillin and the aminopenicillins (ampicillin and amoxicillin) having the most robust safety data. All penicillins and their derivatives, as well as penicillin combinations with beta-lactamase inhibitors such as clavulanate or sulbactam, have been assigned a Pregnancy Category B rating.
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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