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EC number: 951-515-0 | 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
- Study period:
- 26 Sept 2017 to 23 Jan 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- 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:
- yes
Test material
- Reference substance name:
- Co-crystal of 4-bromo-2-isopropylphenol and 1,4-diazabicyclo[2.2.2]octane (2:1)
- EC Number:
- 951-515-0
- Molecular formula:
- (C9H11BrO)2.C6H12N2
- IUPAC Name:
- Co-crystal of 4-bromo-2-isopropylphenol and 1,4-diazabicyclo[2.2.2]octane (2:1)
- Test material form:
- solid: particulate/powder
- Details on test material:
- White powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test Animals
Animals were received from Charles River, Raleigh NC and Stone Ridge, NY on 12 Sep 2017, 26 Sep 2017, 03 Oct 2017, and 26 Oct 2017. Following an acclimation period of at least five days, seven healthy, non-pregnant, nulliparous female Sprague Dawley rats were selected for dosing without conscious bias.
The animals were born on 17 Jul 2017, 31 Jul 2017, and/or 30 Aug 2017. The pre-test body weight range was 206 - 224 grams. The weight variation of the animals used did not exceed ± 20% of the mean weight of the previously dosed animals.
The animals were identified by cage notation and indelible tail marks corresponding to the numbers entered on the data collection forms. The animals were individually housed in suspended wire-bottom cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week. Fresh PMI Rat Chow (Diet No.5012) was available ad libitum except for 16-20 hours prior to dosing. Water was available ad libitum. The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Dosing
The test article was mixed with corn oil to make dosing by gavage possible. The dose was based on the dry weight of the test article. Initially, a single female Sprague Dawley rat was dosed orally by syringe and dosing needle at a dose level of 2000 mg/kg. Since the animal died, additional animals were dosed, one at a time, by a single ordered dose progression. - Doses:
- 2000mg/kg, 550mg/kg
- No. of animals per sex per dose:
- 1 per dose
- Control animals:
- no
- Details on study design:
- Type and Frequency of Observations
In Vivo - Animals were observed at 15 minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for
14 days for toxicity and pharmacological effects. Observations included, but were not limited to, evaluation
of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as
salivation, central nervous system effects including tremors and convulsions, changes in the level of activity,
gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypies or bizarre
behavior (e.g., self-mutilation, walking backwards). All animals were observed twice daily for mortality on
Day 1 to Day 14. Body weights were recorded pre-test, weekly, and at death or termination in the survivors.
Post Mortem – All animals were humanely euthanized using CO2 following study termination and
examined for gross pathology.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 0 - 20 000
- Mortality:
- 2000 mg/kg; Three female rats survived following a single oral dose of 2000 mg/kg. Two female rats died, by Day 3, following a single oral dose of 2000 mg/kg.
550 mg/kg: Two female rats survived following a single oral dose of 550 mg/kg. - Clinical signs:
- other: 2000 mg/kg; Prior to death, abnormal physical signs including diarrhea, soiling and wetness of the anogenital area, few feces, piloerection, wetness of the nose/mouth area and abdomen, ataxia, partially chewed food, and chromorhinorrhea were observed. Amo
- Gross pathology:
- 2000 mg/kg; The gross necropsy of the animals that died revealed chromodacryorrhea, wetness of the nose/mouth area, wetness and yellow staining of the anogenital area, wetness on the abdomen and abnormalities of the gastrointestinal tract. Of the surviving animals, thinning hair on the abdomen was observed on one animal and no abnormalities were observed among two animals.
550 mg/kg: The gross necropsy revealed no observable abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The estimated oral LD50 and 95% confidence limits of L-006266209-000K003 is 2000 (0 to 20,000) mg/kg of body weight in female rats.
DOT: Not poisonous, no packing group required
EPA: Category III
GHS: Category 5
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