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EC number: 229-722-6 | CAS number: 6683-19-8
Toxicological information
Acute Toxicity: inhalation
Currently viewing:
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-10-23, 1980-11-13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- 10 h light instead of 12. 2 doses only.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)
- EC Number:
- 229-722-6
- EC Name:
- Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)
- Cas Number:
- 6683-19-8
- Molecular formula:
- C73H108O12
- IUPAC Name:
- 3-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}-2,2-bis({[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}methyl)propyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
- Details on test material:
- - Physical state: Solid
- Storage condition of test material: Stable at room temperature
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred and raised on the premises
- Age at study initiation:
- Weight at study initiation: 197 - 252 g
- Fasting period before study:
- Housing: 10 animals per cage in Macrolon cages, Type 4 (Ehret, 783 Emmendingen/Germany)
- Diet (e.g. ad libitum): Ad libitum (NAFAG, Gossau/SG, Switzerland)
- Water (e.g. ad libitum): Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14/10
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Plexiglass exposure chamber
- Exposure chamber volume: 100 L
- Method of holding animals in test chamber: The rats were placed in separate PVC-tubes such that the snout and nostrils of the animals only
were exposed to the aerosol
- Source and rate of air: Air stream discharged into the exposure chamber at a rate of 10 L/min
- Method of conditioning air: Injection into an air stream
- System of generating particulates/aerosols: By introducing the solid test material with the aid of a Grafix Exaktomat Injector (Cerutti AG, Bern, Switzerland) into an air stream
- Method of particle size determination: 4 stage Cascade Impactor (C.F. Casella and Co., Ltd., Regent House, Britannia Walk, London) with Selectron filters (Schleicher and Schull AG, Feldbach, Switzerland) of 25 mm diameter and a pore size of 0.2 μm at an air flow rate of 17.5 L/min
-Pressure in air chamber: negative - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetrically by sampling the test atmosphere through a Selectron filter of 50 mm diameter and a 0.2 μm pore size
- Duration of exposure:
- 4 h
- Concentrations:
- 762 ± 41 and 1951 ± 68 mg/m3 (measured)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2 and 4 h as well as at 2 hours post-exposure and daily. Body weights were recorded immediately prior
to exposure and at day 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross examination
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1 951 mg/m³ air (analytical)
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- >= 1 951 mg/m³ air (analytical)
- Exp. duration:
- 4 h
- Mortality:
- None
- Clinical signs:
- other: AlI animals exposed to the test material recovered within 6 days. Slight dyspnoea and ruffled fur were noted in both treatment groups
- Body weight:
- not affected
- Gross pathology:
- No gross pathological changes were observed.
- Other findings:
- The particle size distribution analysis of the chamber airborne particles showed that at least 82 % were smaller than 7 µm in diameter for all exposures.
Any other information on results incl. tables
TABLE 2. PHARMACOTOXIC SIGNS
| Exposure level (mg/m3) | Pharmacotoxic sign | Observation period | ||||||||||||||||
| Hours | Day | |||||||||||||||||
| Exposure | ||||||||||||||||||
| 1 | 2 | 4 | 24 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
| 762 ± 41 | Exophthalmus | + | + | + | ||||||||||||||
| Ruffled fur | + | + | + | + | ||||||||||||||
| 1951 ± 68 | Exophthalmus | + | + | + | + | |||||||||||||
| Ruffled fur | + | + | + | + | + | |||||||||||||
Mild = +; Moderate = ++; Severe = +++
TABLE 3. MEAN BODY WEIGHT ± SD (GRAMS)
| Day | Sex | Concentration (mg/m3) | ||
| 0 (control) | 762 ± 41 | 1951 ± 68 | ||
| 1 | Male | 241 ± 9 | 252 ± 8 | 202 ± 12 |
| Female | 223 ± 6 | 224 ± 7 | 197 ± 9 | |
| 7 | Male | 291 ± 8 | 286 ± 13 | 258 ± 13 |
| Female | 232 ± 9 | 231 ± 7 | 211 ± 9 | |
| 14 | Male | 332 ± 13 | 330 ± 17 | 300 ± 15 |
| Female | 254 ± 10 | 250 ± 6 | 227 ± 10 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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