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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD 439. 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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: Amoxicillin trihydrate
- Physical state: White powder.
- Analytical purity: 98.7%
- Purity test date: 13 October 2015
- Lot/batch No.: B331003
- Expiration date of the lot/batch: September 2020
- Storage condition of test material: Controlled room temperature (15-25ºC, below 70 RH %)
Constituent 1
Constituent 2
Test animals
- Species:
- other: in-vitro
- Strain:
- other: in-vitro
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: Not required.
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg
- Concentration (if solution): As the test item was solid, first 10 µL distilled water was applied to the epidermal surface and then 20 mg of the test item.
VEHICLE
- Amount(s) applied (volume or weight with unit): 10µL.
- Concentration (if solution): 20mg/10 µL. - Duration of treatment / exposure:
- 15 minuts.
- Number of animals:
- Not applicable.
- Details on study design:
- TEST SITE
- Area of exposure: 0.38cm2.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): PBS
- Time after start of exposure: 15 min.
Results and discussion
In vivo
- Irritant / corrosive response data:
- Amoxicillin trihydrate, the results indicate that the test item is non-irritant to skin (No Category).
Any other information on results incl. tables
Substance |
Optical density (OD) |
Viability (% RV) |
||
|
Measured |
Blank corrected |
||
Negative control Phosphate buffered saline |
1 |
0.934 |
0.887 |
95.8 |
2 |
0.971 |
0.924 |
99.7 |
|
3 |
1.015 |
0.968 |
104.5 |
|
Mean |
-- |
0.927 |
100.0 |
|
Positive control 5% (w/v) SDS solution |
1 |
0.108 |
0.061 |
6.6 |
2 |
0.096 |
0.049 |
5.3 |
|
3 |
0.083 |
0.036 |
3.9 |
|
Mean |
-- |
0.049 |
5.3 |
|
Amoxicillin trihydrate |
1 |
0.847 |
0.800 |
86.3 |
2 |
0.91 |
0.864 |
93.2 |
|
3 |
0.884 |
0.837 |
90.4 |
|
Mean |
-- |
0.934 |
90.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Following an exposure to amoxicillin trihydrate the mean cell viability of the skin disks was 90% compared to the negative control. The test item was considered to be non-irritant to the skin (No category).
- Executive summary:
A in vitro skin irritation test was conducted according to the OECD guideline 439 under GLP conditions. 3 Disks of EpiSkin-SM were treated with the test subtance amoxicillin trihydrate and incubated for 15 minutes at room temperature. Exposure was terminated by rinsing with PBS, the epidermis units were then incubated at 37ºC for 42 hours. The viability of each disk was assessed through the MTT assay: tissues were incubated for 3 hours with a MTT solution at 37ºC protected from light. The precipitated formazan crystals were extracted using acidified isopropanol and were quantified spectrophotometrically. PBS and 5 % Sodium Dodecyl Sulphate (SDS) were used as negative and positive control respectively. An additional disk was used to provide and estimate of color contribution from the test item. The viability was expressed as a % relative to the negative control. Following exposure to amoxicillin trihydrate the mean cell viability was 90%, this is above the threshold of 50% adn according to OECD 439 guideline the test was considered to be non-irritant to the skin (No category). The study meet the validity criteria.
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