Registration Dossier
Registration Dossier
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EC number: 208-993-4 | CAS number: 551-16-6
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- other: Published medical opinions
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: A review article evaluating studies investigating the effects of antibiotic administration to pregnant women and their effects on the foetus.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Antibiotics in Pregnancy: Toxicity and Teratogenicity
- Author:
- Knothe H & Dette GA
- Year:
- 1 985
- Bibliographic source:
- Infection, 13(2): 49-51
Materials and methods
- Study type:
- human medical data
- Endpoint addressed:
- developmental toxicity / teratogenicity
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A review of available data on the effects of administration of a number of antibiotics to women during pregnancy and the recomended stages at which to take antibiotics.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ampicillin
- EC Number:
- 200-709-7
- EC Name:
- Ampicillin
- Cas Number:
- 69-53-4
- IUPAC Name:
- 6-{[amino(phenyl)acetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
- Reference substance name:
- Penicillin G
- IUPAC Name:
- Penicillin G
- Details on test material:
- - Name of test material : Penicillin G and Ampicillin
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Ethical approval:
- not applicable
- Details on study design:
- A discussion of the effects of various antibiotics during pregnancy and the recommended stages for use.
Results and discussion
- Results:
- Of the penicillins, the following were listed to be used at any time during pregnancy:
Ampicillin
Azlocillin
Isoxazolyl penicillins
Mezlocillin
Penicillin G
Penicillin V
Piperacillin
Ticarcillin
Applicant's summary and conclusion
- Conclusions:
- Ampicillin and penicillin G were both listed as to have never been shown to cause harmful adverse effects and can be prescribed at any time during pregnancy.
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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