Registration Dossier
Registration Dossier
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EC number: 218-216-0 | CAS number: 2082-79-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Remarks:
- CIBA-GEIGY Limited, Short-term Toxicology
- 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 white
- Analytical purity: 99.9 %
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAI F (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production
- Mean weight at study initiation: males 261±10.0 g (247-274 g), females 231±13.7 g (211-244 g)
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau)
- Water (e.g. ad libitum): drinking water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on dermal exposure:
- TEST SITE
- % coverage: 10
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm water
- Time after start of exposure: 24 h
VEHICLE
- Amount(s) applied (volume or weight with unit): 4 g (corresponding approximately to 4 ml)
- Concentration (if solution): 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80 - Duration of exposure:
- 24 h
- Doses:
- 2000 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: mortality was observed twice daily and once on weekends. Signs and symptoms were observed daily. Body weight was determined immediately before application and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortalities were observed
- Clinical signs:
- other: Piloerection and hunched posture were seen, being common symptoms in acute dermal tests. The animals recovered within 2 days.
- Gross pathology:
- At autopsy, a scurfy ear was noticed in one male. No deviations from normal morphology were found in the remaining animals.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Based on the results, the test substance does not require any classification.
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