Registration Dossier
Registration Dossier
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EC number: 218-216-0 | CAS number: 2082-79-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 18, 1981 - December 2, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline with acceptable restriction (limited reporting: purity of the test substance not reported)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- limited reporting
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- EC Number:
- 218-216-0
- EC Name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Cas Number:
- 2082-79-3
- Molecular formula:
- C35H62O3
- IUPAC Name:
- octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Details on test material:
- - Physical state: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7-8 weeks
- Mean weight at study initiation: males ca. 181±4.5 g, females ca. 165±10.6 g
- Fasting period before study: yes, overnight
- Housing: 5 per cage
- Diet (e.g. ad libitum): rat food (NAFAG No. 890, NAFAG, Gossau)
- Water (e.g. ad libitum): drinking water
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE (polyethyleneglycol 400)
- Amount of vehicle (if gavage): 20 ml/kg bw - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Immediately after administration, clinical signs were observed at hourly intervals till 5 hrs and daily thereafter. Body-weights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- no mortalities were observed
- Clinical signs:
- other: Slight sedation and exophthalmos were observed till 5 h post administration. Exophthalmos was also observed from days 8-12 post administration. Slight dyspnoea was observed till day 13 post administration. Slight to moderate ruffled fur was observed till
- Gross pathology:
- No compound related gross organ changes were observed.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The acute oral LD50 of the test material in rats of both sexes observed over a period of 14 days was found to be greater than 5000 mg/kg bw.
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