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EC number: 618-844-9 | CAS number: 923604-58-4
- 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
- Study period:
- 2011-09-15 to 2010-10-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- (1R,4R,6S,7Z,15R,17R)-17-({7-methoxy-8-methyl-2-[4-(propan-2-yl)-1,3-thiazol-2-yl]quinolin-4-yl}oxy)-13-methyl-2,14-dioxo-3,13-diazatricyclo[13.3.0.0^{4,6}]octadec-7-ene-4-carboxylic acid
- EC Number:
- 618-844-9
- Cas Number:
- 923604-58-4
- Molecular formula:
- C35H42N4O6S
- IUPAC Name:
- (1R,4R,6S,7Z,15R,17R)-17-({7-methoxy-8-methyl-2-[4-(propan-2-yl)-1,3-thiazol-2-yl]quinolin-4-yl}oxy)-13-methyl-2,14-dioxo-3,13-diazatricyclo[13.3.0.0^{4,6}]octadec-7-ene-4-carboxylic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): JNJ-38940642-AAA (T003010)
- Physical state: solid
- Appearance: white powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD (Crl:CD ‘SD’)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 204-244 g
- Fasting period before study: overnight prior to and approximately four hours after dosing (with the exception of animal B1 which was fed approximately three and a half hours after dosing).
- Housing: individually, in solid bottomed polycarbonate cages with a stainless steel mesh lid, barriered rodent facility kept at a positive pressure
- Diet (e.g. ad libitum): ad libitum, standard rodent diet (Rat and Mouse No. 1 Maintenance Diet)
- Water (e.g. ad libitum): ad libitum, potable water taken from the public supply via polycarbonate bottles fitted with sipper tubes
- Acclimation period: 5-7 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 40-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: 20-09-2011 To: 18-10-2011
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: PEG 400, 1.2 eq NaOH 10N and 0.3 eq HCl 12N
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 35, 110 and 300 mg/mL (max feasible concentration)
- Amount of vehicle (if gavage): 5 mL/kg
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg
DOSAGE PREPARATION (if unusual): Formulations were stirred before and throughout the dosing procedure - Doses:
- 175, 550 and 1500 mg/kg
- No. of animals per sex per dose:
- 1 female/group (175 mg/kg, 550 mg/kg)
3 females/group (1500 mg/kg) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- mortality: cages of rats were checked at least twice daily for any mortalities
- clinical observations: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only).
- The weight of each rat was recorded on Day 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes were calculated.
- Necropsy of survivors performed: yes. all animals were humanely killed on day 15 by carbon dioxide asphyxiation
- Other examinations performed: macroscopic examinations: cranial, thoracic and abdominal cavities. - Statistics:
- No stastistical analysis was used.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: There were no clinical signs related to treatment throughout the study.
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
Any other information on results incl. tables
The 35 and 110 mg/mL test substance formulations used in this study were found to be within acceptable criteria of concentration verification.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute median lethal oral dose (LD50) of JNJ-38940642-AAA to rats was > 1500 mg/kg bodyweight. Based on this unbounded LD50 value, the test item is classified for acute toxicity category 4 according to the criteria of the CLP Regulation (EC)1272/2008 as a worst case scenario.
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