Registration Dossier
Registration Dossier
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EC number: 264-513-3 | CAS number: 63843-89-0
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines/standards. Highest dose below limit dose.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- Highest dose below limit dose.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate
- EC Number:
- 264-513-3
- EC Name:
- Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate
- Cas Number:
- 63843-89-0
- Molecular formula:
- C42H72N2O5
- IUPAC Name:
- bis(1,2,2,6,6-pentamethylpiperidin-4-yl) 2-butyl-2-[(3,5-di-tert-butyl-4-hydroxyphenyl)methyl]propanedioate
- Details on test material:
- - Physical state: solid
- Lot/batch No.: EN 21175
no further details provided
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: from own premises
- Weight at study initiation: mean: female: 180g and male: 185g
- Housing: 10 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 14/10
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Method of holding animals in test chamber: rats were kept in separate PVC tubes
- System of generating particulates/aerosols: The aerosol was generated by injecting the solid test material with the help of a "Grafix Exaktomat Injector" into an air stream which was discharged into the exposure chamber through a nozzle under a pressure of 2 atm. at a rate of 20 L/min.
- Temperature, humidity: temperature: 24°C; humidity: 46 %; oxygen: 20 Vol.%
TEST ATMOSPHERE
- Brief description of analytical method used: The concentration was determined gravimetrically by sampling the test atmosphere through a selectron filter of 50 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 L/min. The size distribution of the particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell) at an air flow rate of 17.5 L/min.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: about 36.7% above 7 µm; about 34.4% 3-7 µm; about 30% 1-3 µm; about 1% 0-1 µm - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetrically
- Duration of exposure:
- 4 h
- Concentrations:
- 460 ± 70 mg/m³ air
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing: day 1 and on day 14, oberservation were done throughout the study
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 460 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: all animals survived
- Mortality:
- No animal died during the observation period.
- Clinical signs:
- other: No symptoms were seen during the exposure and observation period.
- Body weight:
- normal body weight gain
- Gross pathology:
- No substance related gross organ changes were seen.
Applicant's summary and conclusion
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information No adverse effects observed, but doses below limit dose. Criteria used for interpretation of results: EU
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