Bisdecanoyl peroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2e: study acceptable for assessment, but very few data, no Certificat of Analysis, no GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no CoA, not GLP, no individual data

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bisdecanoyl peroxide

EC Number:

212-092-1

EC Name:

Bisdecanoyl peroxide

Cas Number:

762-12-9

Molecular formula:

C20H38O4

IUPAC Name:

decanoyl decaneperoxoate

Test material form:

solid: compact

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Institute's colony
- Age at study initiation: it is indicated "young"
- Weight at study initiation: for males, weight varied from 188 g to 230 g; for females, weight varied from 104 to 138 g
- Housing: in groups of five in screen-bottomed stainless steel cages
- Diet (e.g. ad libitum): stock diet
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: no submitted
- Fasting before dosing: yes, rats were fasted overnight before dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/-1°C
- Humidity (%): no submitted
- Air changes (per hr): no submitted (but it is indicated it was "well-ventilated"
- Photoperiod (hrs dark / hrs light): no submitted

IN-LIFE DATES: no submitted

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Shellsol T : isoparaffinic hydrocarbon solvent

Details on oral exposure:

VEHICLE : Shellsol T
- Concentration in vehicle: 50 %

Doses:

single dose of 5000 mg/ kg of body weight

No. of animals per sex per dose:

10 animals per sex and per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths occured

Clinical signs:

other: Few hours after dosing, the rats showed: - sluggishness - humpback behaviour - severe diarrhoea During the first few post-treatment days: - signs of unthriftiness Then later on the rats recovered gradually and look quite healthy at the end of the observ

Gross pathology:

Macroscopic examination of the survivors ( all rats) did not reveal any treatment related gross alterations.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under experimental conditions, the oralLD 0 of didecanoyl peroxid is higher than 5000 mg/kg in rats

Executive summary:

The acute oral toxicity of didecanoyl peroxide was tested in an acute oral toxicity test, similar to OECD n°401 guideline. The substance was given by gavage as a 50 %(w/v) solution in Shellsol T to groups of Wistar rats (10 males and 10 females). The animals received 10 ml per kg, therefore 5000 mg/kg didecanoyl peroxide of body weight.

Following treatment, rats were observed frequently following hours after treatment. Thereafter, they were observed daily. The rats were weighted the day of treatment after an overnight fasting. A necropsy examination was performed at the time of scheduled euthanasia (14 days after substance test administration)

No deaths occured during the study. But within a few hours after dosing the rats showed sluggishness, humpback behaviour, and sever diarrhoea. Signs of unthriftiness were observed throughout the first few post-treatment days. Then rats recovered gradually and looked quite healthy at the end of observation period. Moreover macroscopic examination of the survivor did not reveal any treatment-related gross alterations.

Under experimental conditions, the oral LD 0 of didecanoyl peroxide is higher than 5000 mg/kg in rats