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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 478-250-9 | CAS number: -
- 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)
- Rationale for reliability incl. deficiencies:
- other: Study conducted following the current relevant guideline and fully GLP compliant documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 478-250-9
- EC Name:
- -
- Cas Number:
- 62965-37-1
- Molecular formula:
- C26H42N2O4
- IUPAC Name:
- (2S)-2-{[(benzyloxy)carbonyl]amino}-3,3-dimethylbutanoic acid; N-cyclohexylcyclohexanamine
- Details on test material:
- Batch number 25557
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD (Crl:CD BR)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks (at test item administration)
- Weight at study initiation: 180-202 g
- Fasting period before study: overnight and approximately 4 hours after dosing
- Housing: 3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% w/v aqueous methylcellulose
- Details on oral exposure:
- Vehicle: 1% w/v aqueous methylcellulose
The test substance was formulated at a concentration of 30 and 200 mg/ml in the vehicle and administered at a volume of 10 ml/kg bodyweight - Doses:
- 300 and 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: at 60 min after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 8 and day 15
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy, organ weights, histopathology
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female dosed at 2000 mg/kg was found dead approximately 60 minutes after dosing. The remaining two animals dosed at 2000 mg/kg were
found dead on Day 2. Clinical signs prior to death comprised partially closed eyelids (both) and flat posture seen in all animals. In addition,
piloerection, hunched posture, underactivity, reduced body temperature, post dose salivation, abnormal gait (uncoordination), tremors,
convulsions and irregular respiration were seen in two females. Abnormal gait (unsteady), dark extremities, lacrimation and salivation were seen in
one female. These signs were first observed from approximately seventeen minutes after dosing. A loss in bodyweight was recorded for two
decedents. Macroscopic examination ofthe decedents treated at 2000 mg/kg revealed congestion (characterised by darkened tissues/organs or
blood vessels injected) of the brain, liver, stomach, duodenum, caecum, small and large intestines were found in all animals, subcutaneous tissue,
heart, lungs and spleen was seen in two animals. In addition, small (atrophy) spleen in one animal, pallor of the kidneys in two animals and white/
yellow contents of the stomach, duodenum and small intestines, seen in all animals. White/yellow contents were also observed in the large intestine in one animal - Clinical signs:
- Clinical signs of reaction to treatment in animals which were dosed at 300 mg/kg comprised hunched posture, piloerection, abnormal gait
(unsteady), seen in all six females. In addition, underactivity, poor righting reflex, fast respiration, and reduced body temperature, were seen in
four females. Fasciculation’s were seen in three females, lacrimation, tremors (tremors only during handling) and partially closed eyelids (both)
were seen in two animals, dark extremities and salivation were seen in one female. These signs were first observed approximately 30 minutes after dosing and recovery, as judged by external appearance and behaviour, by Day 2. - Body weight:
- All surviving animals were considered to have achieved satisfactory bodyweight gains throughout the study
- Gross pathology:
- No abnormalities were seen in the surviving animals at the macroscopic examination at study termination on Day 15
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of VRT-126017 dcha- was demonstrated to be between 300 and 2000 mg/kg bodyweight
- Executive summary:
Two groups of three fasted female rats received a single oral gavage dose of the test substance,
formulated in 1% w/v aqueous methylcellulose, at a dose level of 300 mg/kg bodyweight. As
results at this dose level indicated the acute lethal oral dose of the test substance to be greater
than 300 mg/kg bodyweight, in compliance with the study guidelines, a further group of
three fasted female rats was similarly dosed at 2000 mg/kg. As all three females at this dosage
died, no further animals were dosed.
The acute median lethal oral dose (LD50) to rats of Z-L-tert.-Leucine * DCHA (called VRT-126017 dcha in the respective report) was demonstrated to be between 300 and 2000 mg/kg bodyweight (included in category 4 according to GHS).
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