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EC number: 204-092-5 | CAS number: 115-46-8
- 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: OECD, GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- This type of study is no longer part of the OECD guidelines for the Testing of Chemicals
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Azacyclonol
- EC Number:
- 204-092-5
- EC Name:
- Azacyclonol
- Cas Number:
- 115-46-8
- Molecular formula:
- C18H21NO
- IUPAC Name:
- diphenyl(piperidin-4-yl)methanol
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): Azacyclonol-Base
- Physical state: whitish granular powder
- Purity: 98.3 % (w/w)
- Impurities (identity and concentrations): included in the certificate of analysis
- Batch No.: 86000298
- Storage conditions: at +4°C and protected from Iight
- Date of receipt: 31 October 1997
- A certificate of analysis is included in the report.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Crédo, Domaine des Oncins, 69210 L’Arbresle, France
- Number and sex: Two males and two females were used for the preliminary test and three groups of five males and/or five females each for the main test.
- Age at initiation of treatment: 6 weeks
- Weight at initiation of treatment: Male: 182 ± 8 g; Female: 149 ± 10 g
- Fasting period before study: Food was withdrawn 18 hours before dosing and redistributed approximately 4 hours after administration of the test substance.
- Housing: housed in polycarbonate cages (48 cm x 27 cm x 20 cm). 4 to 7 animals of the same sex during the acclimatization period and 5 rats of the same sex during the treatment period. Each cage contained dust-free sawdust (SICSA).
- Diet (e.g. ad libitum): controlled pelleted rodent diet (AO4 C, U.A.R.) ad libitum.
- Water (e.g. ad libitum): filtered by a F.G. Millipore membrane (0.22 micron)
- Acclimatization period: 5 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 ° C
- Relative Humidity: 30 to 70%
- Ventilation: 12 cycles/hour of filtered, non-recycled air
- Light/dark cycle: 12/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% methylcellulose aqueous solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Suspension in a 0.5% methylcellulose aqueous solution
- Administration volume: 10 mL/kg - Doses:
- Preliminary study: 1000 and 2000 mg/kg
Main study: 750, 1000 and 1300 mg/kg - No. of animals per sex per dose:
- Preliminary study: 2 rats/sex/dose
Main study: 5 rats/males/dose and 5 females rats for 1000 mg/kg - Control animals:
- other: Historical controls from October 1994 to December 1996.
- Details on study design:
- - Treatment frequency: Once, a single administration on day 1 (D1)
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
= Clinical signs: daily observations
= Body weight (D1, 8, 15)
- Necropsy of survivors performed: yes at D15 - Statistics:
- The 70 to 95 % confidence interval limits were calculated statistically according to Fieller's method ( 1944).
Results and discussion
- Preliminary study:
- At the 2000 mg/kg dose-level: animals died on day 1 or 2; sedation or hypoactivity, tremors and piloerection were noted prior to death.
At the 1000 mg/kg dose-level: sedation or hypoactivity, tremors, dyspnoea and piloerection were observed in both animals on days 1 and 2. No mortality occurred. Recovery was complete on day 3.
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 984 mg/kg bw
- Based on:
- not specified
- Remarks on result:
- other: Determination of LD50 with 70% confidence interval limits
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- not specified
- Mortality:
- No mortality was recorded among the females (1000 mg/kg).
In males, mortality was 100%, 60% and 0% in the 1300, 1000 and 750 mg/kg dose-groups, respectively. Mortality occurred between day 2 and day 8. - Clinical signs:
- other: At 1300 mg/kg dose-level: hypoactivity, piloerection and tremors in all males from day 1. Dyspnoea, sedation and lateral recumbency in one animal prior to death. At 1000 mg/kg dose-level: Sedation or hypoactivity, tremors and piloerection in all animals o
- Gross pathology:
- No treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 determined experimentally was 984 mg/kg in male. Toxicity was lower in females, concentration level of 1000 mg/kg bw did not induce any adverse effects. According to the 1272/2008 CLP regulation, the substance is classified category 4 for acute oral toxicity.
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