Bis(4-tert-butylcyclohexyl) peroxydicarbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: valid with restrictions; meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

- body weight was not determined; 10 animals were used per sex

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Perkadox 16

IUPAC Name:

Perkadox 16

Constituent 2

Reference substance name:

Bis(4-tert-butylcyclohexyl) peroxydicarbonate

EC Number:

239-557-1

EC Name:

Bis(4-tert-butylcyclohexyl) peroxydicarbonate

Cas Number:

15520-11-3

Molecular formula:

C22H38O6

IUPAC Name:

4-tert-butylcyclohexyl {[(4-tert-butylcyclohexyl)oxy]carbonyl}oxy carbonate

Details on test material:

- Name of test material (as cited in study report): Perkadox 16 (Bis (tert-butylcyclohexyl)peroxidicarbonate)
- Substance type: organic peroxide
- Physical state: solid, white crystalline powder
- Storage condition of test material: -20°C

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: from the Institutes colony
- Age at study initiation: young adults
- Weight at study initiation: males 243-300 g, females 135-192 g
- Fasting period before study: before dosing the animals were fasted overnight
- Housing: groups of five
- Diet (e.g. ad libitum): after dosing ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25°C

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Shellsol T

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% (w/v)
- Amount of vehicle (if gavage): 10 ml per kg body weight which is equivalent to 5 g test material per kg body weight

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: preliminary observations; LD50 of Shellsol T was stated about 8 ml/kg; no higher dose of the suspension was considered to be tolerated

Doses:

10 ml per kg body weight of a 50% (w/v) suspension of bis(4-tert-butylcyclohexyl)peroxydicarbonate in Shellsol T

No. of animals per sex per dose:

10 males and 10 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic examination

Statistics:

no statistics

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One male and five females died between 6 hours and 3 days after dosing

Clinical signs:

other: Within a few hours after treatment all rats showed tremors. Convulsions were frequently observed.

Gross pathology:

No treatment related gross alterations were examined

Other findings:

Three days after dosing the survivors recovered gradually

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

From the mortality figures (30% mortality) it can be concluded that the LD50 of bis(4-tert-butylcyclohexyl)peroxydicarbonate is higher than 5 g per kg body weight. Therefore the material can be classified as practically non-toxic.

Executive summary:

In an acute oral toxicity study similar the the OECD guideline 420 groups of 10 female and 10 male rats (Wistar) (young adults; females 135-192 g; males 243-300 g) were given a single oral dose of bis(4-tert-butylcyclohexyl)peroxydicarbonate) (50% (w/v) in Shellsol T) at doses of 10 ml/kg bw which corresponds to 5 g/kg bw bis(4-tert-butylcyclohexyl)peroxydicarbonate. Animals were then observed for 14 days. Within a few hours after treatment all rats showed tremors. Convulsions were frequently observed. One male and five females died between 6 hours and 3 days after dosing. Three days after dosing the survivors recovered gradually. A LD50 > 5 g per kg body weight was established. Bis(4-tert-butylcyclohexyl)peroxydicarbonate is therefore practically non-toxic. This acute oral study is classified as acceptable. It does satisfy the guideline requirement for an acute oral in the rat.