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EC number: 701-059-1 | CAS number: 345217-03-0
- 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:
- November 23 to December 09, 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterize
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Remarks:
- OECD ENV/MC/CHEM(98)17
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- 2,5-anhydro-4-{[4-(4-{4-[({1-[(2S,3S)- 2-(benzyloxy)pentan-3-yl]hydrazino}carbonyl)amino]phenyl}piperazin1-yl)phenoxy]methyl}-1,3,4-trideoxy-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-
- EC Number:
- 701-059-1
- Cas Number:
- 345217-03-0
- Molecular formula:
- C43H50F2N8O4
- IUPAC Name:
- 2,5-anhydro-4-{[4-(4-{4-[({1-[(2S,3S)- 2-(benzyloxy)pentan-3-yl]hydrazino}carbonyl)amino]phenyl}piperazin1-yl)phenoxy]methyl}-1,3,4-trideoxy-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-
- Test material form:
- other: WHITE SOLID
- Details on test material:
- STORAGE AT ROOM TEMPERATURE IN THE DARK.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley CD (Crl: CD(SD) IGS BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CHARLES RIVER (UK) Ltd, Margate, Kent, UK.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 204 to 227 g- male; 200 to 220 g-females
- Fasting period before study: overnight
- Housing: 3 per same sex in solid floor polypropylene cages furnished with wood flakes stainless steel cage
- Diet: free access to Rat and Mousse Expanded diet No.1
- Water: fre access to mains drinking water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19° - 21°
- Humidity (%): 44-66
- Air changes (per hr): 15 approx
- Photoperiod (hrs dark / hrs light): 12 hrs continous light and 12 hrs dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Remarks:
- suspension
- Details on oral exposure:
- Using all available information on the toxicity of the test material, 2000 mg/kg bodyweight was chosen as the starting dose.
concentration: 200 mg/ml
Therefore, Dose volume = 10ml/kg - Doses:
- dose level: 2000 mg/kg ( males), 2000 mg/kg ( females)
- No. of animals per sex per dose:
- 3 females/males per dose
- Control animals:
- no
- Details on study design:
- All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each group to confirm the survival of the previously dosed animals. The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after the final dose and subsequently once daily for fourteen days. Individual body weights were recorded prior to dosing and seven and fourteen days after dosing. At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross pathological observations. This consisted of external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities were recorded. No tissues were retained.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Hunched posture was commonly noted. All males appeared normal two days after treatment whilst females appeared normal four to nine days after treatment.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bodyweight.
- Executive summary:
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bodyweight.
No mortalities were noted at 2000 mg/kg bodyweight.
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