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EC number: 248-003-8 | CAS number: 26787-78-0
- 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 1 January 1991–31 December 2000.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Although no specific guideline was reported, a scientifically defensible approach was used to conduct the study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
- Endpoint addressed:
- developmental toxicity / teratogenicity
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study examined the association between amoxicillin exposure during pregnancy and birth weight, preterm delivery, congenital malformations, perinatal death, and spontaneous abortion of 401 primiparous women who filled prescriptions for amoxicillin, compared to 10237 controls who did not redeem any prescription drug from 3 months before pregnancy until the end of pregnancy.
- GLP compliance:
- no
Test material
- Reference substance name:
- Amoxicillin
- EC Number:
- 248-003-8
- EC Name:
- Amoxicillin
- Cas Number:
- 26787-78-0
- Molecular formula:
- C16H19N3O5S
- IUPAC Name:
- 6-{[amino(4-hydroxyphenyl)acetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
- Test material form:
- not specified
Constituent 1
Method
- Ethical approval:
- confirmed, but no further information available
- Remarks:
- Study carried out in accordance with the guidelines of the regional science ethics committee for use of clinical and registry data.
- Details on study design:
- The association between amoxicillin exposure and birth weight, preterm delivery, congenital malformations, and perinatal death was examined in a
cohort of primiparous women with either a live birth or a stillbirth after the 28th gestational week between 1 January 1991 and 31 December 2000. A case-control design was used to study the association between amoxicillin exposure and spontaneous abortion. - Exposure assessment:
- estimated
- Details on exposure:
- The exposed group consisted of those who redeemed a prescription for amoxicillin during pregnancy, and these women were further divided by trimester of exposure, based on prescription date recorded in the Pharmaco-Epidemiological Prescription Database and on gestational age as reported to the Danish Medical Birth Registry. Use of amoxicillin in pregnancy was determined as having redeemed a prescription for amoxicillin.
Results and discussion
- Results:
- The adjusted mean birth weight of children born to amoxicillin-exposed mothers was 57 g [95% confidence interval (CI) 9, 105] higher than that of children born to controls. No cases of perinatal death were observed in the amoxicillin-exposed women. No adverse effects were observed associated with amoxicillin exposure during pregnancy.
Any other information on results incl. tables
Table 1. Characteristics of the study cohort.
|
Exposed in the first trimester |
Exposed during pregnancy |
Controls |
No. women |
147 |
401 |
10237 |
No. prescriptions |
150 |
445 |
- |
Mean age |
27.4 |
27.0 |
26.8 |
Proportion of smokers (%) |
35.4 |
33.4 |
25.9 |
Gestational age (weeks) |
|
|
|
· ≥ 37 |
139 |
381 |
9588 |
· 34-36 |
8 |
18 |
450 |
· 28-33 |
0 |
2 |
199 |
Mean birth weight |
3518 |
3498 |
3429 |
No. low birth weight (%) |
2 |
5 |
183 |
No. preterm deliveries (%) |
9 |
20 |
649 |
No. malformations (%) |
7 |
16 |
416 |
No. prenatal deaths (%) |
0 |
0 |
60 |
Applicant's summary and conclusion
- Conclusions:
- Amoxicillin use during pregancy may cause an increased weight on babies, but does not appear to increase the risk of adverse pregnancy outcomes.
- Executive summary:
A cohort study was performed to examine the association between amoxicillin exposure during pregnancy and birth weight, preterm delivery, congenital malformations, perinatal death, and spontaneous abortion of 401 primiparous women who filled prescriptions for amoxicillin, compared to 10237 controls who did not redeem any prescription drug from 3 months before pregnancy until the end of pregnancy. Based on the observations throughout the study, amoxicillin use during pregancy may cause an increased weight on babies, but does not appear to increase the risk of adverse pregnancy outcomes.
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