Registration Dossier
Registration Dossier
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EC number: 255-392-8 | CAS number: 41484-35-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Apr. 1, 1992 to Jun. 22, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
- EC Number:
- 253-039-2
- EC Name:
- Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
- Cas Number:
- 36443-68-2
- Molecular formula:
- C34H50O8
- IUPAC Name:
- ethane-1,2-diylbis(oxyethane-2,1-diyl) bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propanoate]
- Details on test material:
- - Physical state: Solid, White
- Storage condition of test material: Room Temperature
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
- Source: CIBA-GEIGY Limited (Animal Production) 4332 stein, Switzerland
- Weight at study initiation: 202 to 229 g
- Housing: Individually housed, in Macrolon cages type 3, with standarized soft wood bedding
- Diet (e.g. ad libitum): ad libitum, NAFAG 890 TOX
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: guaze-lined semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleaned with lukewarm water
- Time after start of exposure: 24 hour
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Constant volume or concentration used: yes (4 mL/kg body weight)
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5% carboxymethylcellulose in 0.1% aqueous polysorbate 80 - Duration of exposure:
- 24 hours
- Doses:
- 2,000 mg/kg body weight
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations and weighing on Day 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- None
Results and discussion
- Preliminary study:
- Limit Test
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: Piloerection was seen, that is a common unspecific clinical sign in acute dermal tests. The animals recovered within 2 to 3 days. At autopsy, no deviations from normal morphology were found.
- Gross pathology:
- None
- Other findings:
- Other Observations: No deviation from normal morphology were found upon necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Executive summary:
Upon an acute dermal administration of 24 hours and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined for the test item:
LD50 in male rats: greater than 2000 mg/kg body weight
LD50 in female rats: greater than 2000 mg/kg body weight
LD50 in rats of both sexes: greater than 2000 mg/kg body weight
Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 2 to 3 days. At autopsy, no deviations from normal morphology were found.
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