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EC number: 260-086-2 | CAS number: 56271-94-4
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- At the time of issue/approval the study plan did not contain test item identification, it is however included in the final study report. This deviation was considered to have not affected the integrity or validity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- [6R-[6α,7β(Z)]]-7-[2-furyl(methoxyimino)acetamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- EC Number:
- 260-086-2
- EC Name:
- [6R-[6α,7β(Z)]]-7-[2-furyl(methoxyimino)acetamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- Cas Number:
- 56271-94-4
- Molecular formula:
- C15H15N3O7S
- IUPAC Name:
- [6R-[6α,7β(Z)]]-7-[2-furyl(methoxyimino)acetamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Identification: OK (640-2) (Furoxy Hydroxy)
Batch: G316533
Purity: 94.032% w/w
Physical state/Appearance: cream colored solid
Expiry Date: 25 March 2018
Storage Conditions: Store cold at 4° C in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animal Information
Female Wistar (RccHan™:WIST) strain rats were supplied by Envigo RMS (UK) Limited,
Oxon, UK. On receipt the animals were randomly allocated to cages. The females were
nulliparous and non-pregnant. After an acclimatization period of at least 5 days the animals
were selected at random and given a number unique within the study by indelible
ink-marking on the tail and a number written on a cage card. At the start of the study the
animals were 8 to 12 weeks of age. The body weight variation did not exceed ±20% of the
mean body weight of any previously dosed animals.
3.2.2 Animal Care and Husbandry
The animals were housed in groups of up to four in suspended solid-floor polypropylene
cages furnished with woodflakes. With the exception of an overnight fast immediately before
dosing and for approximately 3 to 4 hours after dosing, free access to mains drinking water
and food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon,
UK) was allowed throughout the study. The diet, drinking water and bedding were routinely
analyzed and were considered not to contain any contaminants that would reasonably be
expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to
70% respectively. The rate of air exchange was at least fifteen changes per hour and the
lighting was controlled by a time switch to give 12 hours continuous light and 12 hours
darkness.
The animals were provided with environmental enrichment items which were considered not
to contain any contaminant of a level that might have affected the purpose or integrity of the
study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- For the purpose of the study the test item was freshly prepared, as required, as a solution in
dimethyl sulfoxide. Dimethyl sulfoxide was used as it produced the most suitable
formulation at the required concentration. 30mg substance/Ml or 200 mg substance /ml DMSO
The test item was formulated within 2 hours of being applied to the test system. It is assumed
that the formulation was stable for this duration.
No analysis was conducted to determine the homogeneity, concentration or stability of the
test item formulation. This is an exception with regard to GLP and has been reflected in the
GLP compliance statement. - Doses:
- 300 mg/kg bw
2000 mg/kg bw - No. of animals per sex per dose:
- 1 female @ 300 mg/kg bw
5 females @ 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- In the absence of information on the toxicity of the test item, 300 mg/kg was chosen as the
starting dose; a single animal was treated.
In the absence of evident toxicity at a dose level of 300 mg/kg, an additional animal was
treated.
In the absence of toxicity at a dose level of 2000 mg/kg, an additional group of 4 animals was
treated.
A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.
All animals were dosed once only by gavage, using a metal cannula attached to a graduated
syringe. The volume administered to each animal was calculated according to the fasted
body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was
allowed between each dose group to confirm the survival of the previously dosed animals.
Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for
up to 14 days. Morbidity and mortality checks were made twice daily, early and late during
normal working days, and once daily at weekends and public holidays.
Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
At the end of the observation period the animals were killed by cervical dislocation. All
animals were subjected to gross necropsy. This consisted of an external examination and
opening of the abdominal and thoracic cavities. The appearance of any macroscopic
abnormalities was recorded. No tissues were retained. - Statistics:
- N/A
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was
estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification
System − Unclassified).
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