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Diss Factsheets
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EC number: 951-814-6 | 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 July - 16 August 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure) (migrated information)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 4-(6-{3,6-diazabicyclo[3.1.1]heptan-3-yl}pyridin-3-yl)-6-(2-hydroxy-2-methylpropoxy)pyrazolo[1,5-a]pyridine-3-carbonitrile
- Molecular formula:
- C22H24N6O2.[2]H2O4S
- IUPAC Name:
- 4-(6-{3,6-diazabicyclo[3.1.1]heptan-3-yl}pyridin-3-yl)-6-(2-hydroxy-2-methylpropoxy)pyrazolo[1,5-a]pyridine-3-carbonitrile
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch (Lot) Number: 18-547.25-002
Physical Description: White powder
Storage Conditions: Kept in a room temperature area, protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Initial age at dosing: 8 weeks
- Weight range at dosing: Males: 220 g - 261g
Females: 206 g - 237 g
- Fasting period before study: not reported
- Housing: individually housed in polycarbonate cages with bedding and automatic watering valve.
- Diet (e.g. ad libitum): All animals had free access to a standard certified commerical laboratory diet.
- Water (e.g. ad libitum): Municipal tap water, after treatment by reverse osmosis and ultraviolet irradiation, was freely available to each animal via an automatic watering system, except during designated procedures.
- Acclimation period: At least 8 days were allowed between receipt of the animals and the start of treatment to accustom the animals to the laboratory environment.
ENVIRONMENTAL CONDITIONS:
- Average Temperature (°C): 21°C
- Average Humidity Range (%): 52% to 56%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: 25 Juy 2019 To: 16 August 2019
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: Reverse Osmosis Deionized (RODI) Water
- Details on dermal exposure:
- TEST SITE:
- Area of exposure: The clipped area was approximately 10% of the animal’s body surface area. The region to be dosed included the scapula to the wing of the ilium and halfway down the flank on each side of the animal. Care was taken to avoid abrading the skin during the clipping procedure.
- % coverage: 10% of the body surface area
- Type of wrap if used: The animal was inverted and the gauze dressing, which was backed by plastic wrap (occlusive binding) and an elastic wrap, was applied to the clipped area of the test animal.
REMOVAL OF TEST SUBSTANCE:
- Washing (if done): Residual test article was removed using gauze moistened with Reverse Osmosis (RO) water followed by dry gauze.
- Time after start of exposure: 24 hours
TEST MATERIAL:
- Amount(s) applied (volume or weight with unit): Group 1: 50 mg/kg, Group 2: 200 mg/kg, Group 3: 1,000 mg/kg, and Group 4: 2,000 mg/kg - Duration of exposure:
- An apporximate 24-hour exposure period
- Doses:
- Dose Level: 50 mg/kg, 200 mg/kg, 1,000 mg/kg, 2,000 mg/kg
Adjusted Dose Level:80 mg/kg, 320 mg/kg, 1,600 mg/kg, 3,200 mg/kg - No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made hourly for the first four hours after dosing and twice daily thereafter. Body weights were taken within 24 hours of receipt, just prior to dosing, and at 7 and 14 days. Individual body weights were recorded for all animals at study assignment (Day -3), prior to dosing on Day 0, and on Days 7 and 14.
- Necropsy of survivors performed: A gross-only necropsy was performed on all animals at the time of scheduled euthanasia (Day 14).
- Other examinations performed: dermal observations, mortality/moribundity checks - Statistics:
- Data were presented as individual values by animal. The individual data tables also included the means and standard deviations and were calculated separately for males and females.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study
- Clinical signs:
- other: There were no test article-related clinical observations. Incidental findings consisted of thin fur, stained fur, erected fur, increased vocalization, skin scabs, skin flaking, and pink/red skin.
- Gross pathology:
- There were no test article-related macroscopic pathology findings.
- Other findings:
- Test article-related dermal irritation was observed in males and females with dose-dependent incidence and/or severity (minimal to moderate) at ≥ 50 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, COM-1079 (Compound 3532670) was considered non-toxic at a topical dose level of 50, 200, 1000, and 2000 mg/kg. The Median Lethal Dose by the dermal route of administration was estimated to be greater than 2000 mg/kg.
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