Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
Within a few hours after treatment all rats showed tremors. Convulsions were frequently observed.
Body weight:
No data
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.