Cyclohexylidenebis[tert-butyl] peroxide

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:

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 levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

13 342 mg/kg bw

Based on:

test mat.

95% CL:

10 895 - 16 338

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 21 500 mg/kg bw

Based on:

test mat.

Effect levels 3

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.