Registration Dossier

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:
other: No GLP or guideline compliant study (although similar to present OECD guideline)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
NA
Body weight:
All surviving rats gained weight during the study.
Gross pathology:
NA

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.