Registration Dossier
Registration Dossier
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EC number: 221-111-2 | CAS number: 3006-86-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978-07-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
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 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Cyclohexylidenebis[tert-butyl] peroxide
- EC Number:
- 221-111-2
- EC Name:
- Cyclohexylidenebis[tert-butyl] peroxide
- Cas Number:
- 3006-86-8
- Molecular formula:
- C14H28O4
- IUPAC Name:
- 1,1-bis(tert-butylperoxy)cyclohexane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Industries, Inc., Indianapolis, Indiana, USA
- Weight at study initiation: 200 - 253 g
- Fasting period before study: rats were fasted overnight before dosing (ca. 18 h)
- Housing: 5 animals/sex/cage; hanging wire-mesh cages
- Diet: Purina laboratory Chow, ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
Temperature and humidity controlled quarters were used for housing.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 10 mL/kg bw (6810, 8260 mg/kg bw), 20 mL/kg bw (10000, 12100, 14700, 17800 mg/kg bw), 30 mL/kg bw (21500 mg/kg bw)
MAXIMUM DOSE VOLUME APPLIED: 30 mL/kg bw - Doses:
- 6810, 8260, 10000, 12100, 14700, 17800, 21500 mg/kg bw
- No. of animals per sex per dose:
- five rats/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 4 hours following dosing at 24 hours and daily thereafter for 14 days
- Necropsy of survivors performed: no
- Other examinations performed: body weight: recorded prior to dosing and at days 7 and 14 - Statistics:
- Statistics were performed using Thompson and Weil (1952).
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 13 342 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 10 895 - 16 338
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 21 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 16 653 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 11 912 - 23 279
- Mortality:
- No deaths occurred in dosing group 6.810 mg/kg bw. In dose group 8.260 mg/kg bw one animal died (female). 10.000 and 12.100 mg/kg bw caused a death to two out of ten animals (one male and female). In dosing group 14.700 mg/kg bw six rats died (two males, four females). The two highest dosing groups 17.800 mg/kg bw and 21.500 mg/kg bw caused the death of five animals each (one male, 4 females; two males, three females).
- Clinical signs:
- other: NA
- Body weight:
- lower than 10% body weight loss
- Remarks:
- All surviving rats gained weight during the study.
- Gross pathology:
- NA
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity study on Sprague-Dawley rats treated with 1,1-bis(tert-butylperoxy)cyclohexane resulted in a LD50 of above 2000 mg/kg bw for male and female rats.
- Executive summary:
The acute oral toxicity of 1,1-Di(t-butyl peroxy) cyclohexane was evaluated in Sprague-Dawley rats. The test material was administered orally by gavage as a solution in com oil at the following dosage levels to male and female rats: 6810, 8260, 10000, 12100, 14700, 17800 and 21500 mg/kg.The rats were observed for mortality, only, during the first four hours following dosing, at 24 hours and daily thereafter for a total of 14 days. Body weights were recorded immediately prior to dosing (control weight) and at 7 and 14 days. All surviving rats gained weight during the study. The LD50 value for male and female animals was determined to be 16653 mg/kg bw with a 95 % confidence interval of 11912 to 23279 mg/kg bw.
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