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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2015 to February 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD 423. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.
- Cas Number:
- 61336-70-7
- Molecular formula:
- C16H25N3O8S
- IUPAC Name:
- (2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.
- Reference substance name:
- Amoxicillin trihydrate
- IUPAC Name:
- Amoxicillin trihydrate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Amoxicillin trihydrate
- Physical state: White solid powder
- Analytical purity: 98.7 %
- Purity test date: 28/10/2015
- Lot/batch No.: B334172
- Expiration date of the lot/batch: October 2020
- Storage condition of test material: Room temperature in a container made of plastic, glass or metal.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Husbandry of laboratory animals of the Experimental Medicine Centre at the Medical University in Białystok.
- Age at study initiation: 3 females at the first step were 8 weeks-old and the other 3 females were 10 week-old
- Weight at study initiation: 197.3 g (3 females first step) and 193.7 g (3 females second step)
- Fasting period before study: 19 hours
- Housing: Plastic cages (58x37x21 cm) covered with wire bar lids. Three animals per cage. UV-sterilized wood shavings were used as bedding.The environment of the animals was enriched by placing wooden blocks and nesting materials for laboratory animals in the cages.
- Diet (e.g. ad libitum): Murigran standard laboratory food ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24 ºC
- Humidity (%): 25 - 50 %
- Air changes (per hr): 16 times per hour.
- Photoperiod: 12 hours light/ 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- CMC sodium salt
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 400 mg test subtance/mL
- Amount of vehicle (if gavage): 0.5 mL/100 g b.w.
- Justification for choice of vehicle: Low water solubility, an attempt to disolve/suspend the test item in oil was conducted, solubility was weak. Carboxymthylcellulose sodium salt was used because his negligible toxicity.
DOSAGE PREPARATION
Shortly before the administration.
CLASS METHOD
- Rationale for the selection of the starting dose: Based on the bibliographic toxicity data of the test subtance. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6 in total, 3 female rats at the first step, 3 female rats at the second step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The general observation at least once a day, detailed clinical observations on the administration day, 10, 30 and 60 minutes after the administration and then at hourly intervals up to 5 hours, then once a day up to 14 days. Animals were weighed directly before the administration of the test item, on day 7 and 14 before euthanasia.
- Necropsy of survivors performed: yes, after the day 14th observation period, all surviving animals were euthanized and subjected to gross examination.
- Other examinations performed: clinical signs, body weight, gross examinations.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities were recorded.
- Clinical signs:
- other: No signs of toxicity were stated.
- Gross pathology:
- The gross examination did not reveal any pathological changes.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral-LD50 for amoxicillin trihydrate in female rats is above 2000 mg/kg bw.
- Executive summary:
An acute oral toxicity study was conducted according to the acute toxic class method (OECD 423) under GLP conditions. In a first step amoxicillin trihydrate was administered at a single dose of 2000 mg/kg bw to 3 Wistar female rats suspended in 0.5 carboxymethylcellullose sodium salt in a volume of 0.5 mL/100 g b.w. by gavage, at the second step the test item was adminstered to 3 additional female rats under the same conditions. After the administration the test animals were observed for 14 days, general and detailed clinical observations were performed on a daily basis, body weights were determined on day 0, 7 and 14. After the 14 -day observation period the animals were euthanized and subjected to detailed gross examination. All the tested animals survived the entire experiment, the examinations did not reveal any pathological change in the animals. The oral LD-50 for amoxicillin trihydrate is above 2000 mg/kg bw.
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