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EC number: 279-482-1 | CAS number: 80480-24-6
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- January 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was not conducted under GLP as well as no guideline was cited. However, the study follows OECD TG 206 in main points with the exception of the exposure time of 2 hours, grouping of 5 rats in one chamber, no analysis of concentration of test item in air and no determination of particle size distribution.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- OECD TG 403 (adopted May 1981, updated September 2009) not available at the conduct of the study, deviations to OECD TG 403: exposure of rats 2 hours, 5 animals in a chamber, no analysis of concentration of test item, no particle size distribution
- Principles of method if other than guideline:
- 2 hours of exposure, groups of 5 males tested, treated air not analysed
- GLP compliance:
- no
- Remarks:
- GLP required 1981 in EU
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Troenan
- IUPAC Name:
- Troenan
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Troenan
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann GmbH, Borchen, Germany
- Age at study initiation: adult, age not reported
- Weight at study initiation: 185 g
- Fasting period before study: not repoeted
- Housing: not reported
- Diet: Altromin diet No. 1324
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 22 °C
- Humidity (%): approx. 50 %
- Air changes (per hr): not reported
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: during January 1981
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- other: whole body of groups of 5 test organisms
- Vehicle:
- other: ethanol
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: the test substance was dissolved in ethanol and applied within an exsiccator using a nebulizer
- Exposure chamber volume:not reported
- Method of holding animals in test chamber: not reported
- Source and rate of air: ambient air
- Method of conditioning air: not reported
- System of generating particulates/aerosols: nebulizer, not further specified
- Method of particle size determination: not conducted since obligatory guideline did not exist during the erformance of the study
- Treatment of exhaust air: measurment of output using a gas meter
- Temperature, humidity, pressure in air chamber: not reported
TEST ATMOSPHERE
- Brief description of analytical method used: no analytics conducted
- Samples taken from breathing zone: no
VEHICLE
- Composition of vehicle: 40 % ethanol
- Concentration of test material in vehicle: 1 % (w/v) solution of Troenan in solvent
- Justification of choice of vehicle: test organisms are considered to be resistent against alcohol
- Lot/batch no.: not reported
- Purity: not reported
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: not conducted since obligatory guideline did not exist during the erformance of the study
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not applicable - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 2 h
- Concentrations:
- 750 mg Troenan/m3 (calculated from 30 g Troenan as 1 % ethanol solution in 400 L air over 2 hours)
- No. of animals per sex per dose:
- 5 males per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: continous observation during inhalation, survival and symproms of toxicity at day 14, no weighing reported
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology (2 x larynx,2 x lung lobe and diaphragm lobe) - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 750 mg/m³ air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 2 h
- Mortality:
- no mortality at 750 mg Troenan/m3
- Clinical signs:
- other: Macroscopy: suspicion for pneumony, chronic pleuritis Microscopy: small to medium level subacute to chrinic laryngitis and tracheitis in larynges and trachea areas exanined in lungs medium to large level focal interstitial chronic pneumony, in rare cases
- Body weight:
- not reported
- Gross pathology:
- see at clinical signs
- Other findings:
- for histopathology see at clinical signs
Applicant's summary and conclusion
- Interpretation of results:
- sligthly toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- In a valid and reliable acute inhalation study, the test organsims were exposed to Troenan for two hours in a limit test. The LD50 was determined to be 750 mg Troenan/m3. Due to the histopathological effects, Troenen is assessed as slightly toxic regarding acute inhalation toxicity.
- Executive summary:
Testing the acute inhalation toxicity of Troenan using rats did not result in any deaths after a 2 hour exposition to an aerial concentration of 750 mg Troenan/m3 (calculated from the usage of 30 mL 1 % Troenan solution in 40 % ethaol and a through-flow of a total of 400 L air).
Under the conditions used, the LC50 -value is 750 mg/m3. Substance-specific symptoms were not observed. The experimental animals, sacrificed after the 14 day observation period, did not reveal any macroscopic or histologic changes of the respiratory passages which were substance-specific.
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