Dibutyl peroxydicarbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

- Principle of test: The test material was given by gavage to groups of ten males and ten females in one single dose of 10 mg/kg bw and were observed for signs of intoxication during a 14-day-period, after which autopsies were carried out on the survivors.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyl peroxydicarbonate

EC Number:

240-344-0

EC Name:

Dibutyl peroxydicarbonate

Cas Number:

16215-49-9

Molecular formula:

C10H18O6

IUPAC Name:

1-({[(butoxycarbonyl)peroxy]carbonyl}oxy)butane

Specific details on test material used for the study:

- Purity: 50% dilution in Shellsol T
- Product: Trigonox NBP-C 50
- Chemical name: di-N-butyl peroxydicarbonate

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: -20 °C

OTHER SPECIFICS:
- clear colourless liquid designated as Trigonox NBP-C 50, di-N-butyl peroxydicarbonate

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: Young adult
- Weight at study initiation: Males: 262 to 343 g, female: 185 to 227 g
- Fasting period before study: Animals were fasted overnight before dosing.
- Housing: Animals were housed in groups of five in screen-bottomed stainless stell cages, in a well-ventilated room
- Diet (e.g. ad libitum): stock diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitium
- Acclimation period: 14 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Shellsol T

Details on oral exposure:

DOSE VOLUME APPLIED: 10 mL/ kg body weight

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Since the LD50 of Shellsol T was stated to be about 8 mL/ kg body weight, no higher dose of the dilution was considered to be tolerated.

Doses:

10 mL/kg body weight (equals 8800 mg/kg body weight calculated with a density of 0.88 g/cm³)

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

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

Statistics:

LD50 determination by mortality rate

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 mL/kg bw

Based on:

test mat.

Mortality:

20% Mortality
1 female rat died within 24 hours,
3 male rats died on day 5, 6 and 7 after treatment

Clinical signs:

other: Within a few hours after treatment all rats showed sluggishness, humpback behaviour and severe diarrhoea. A few das after treatment the area around anus and tailroot was irritated. Most of the survivors recovered gradually, but at the end of the observati

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of Trigonox NBP-C 50 (50% dilution in Shellsol T) is higher than 10 mL/ kg bw,(equates to 8800 mg/kg) body weight. Therefore, the test material can be classified as practically non-toxic.

Executive summary:

In an acute oral toxicity study conducted similar to OECD 401, groups of overnight fasted young adult Wistar rats (10/sex) were given a single oral dose of 10 mL/kg bw of Trigonox NBP-C 50 (50% di-N-butyl peroxydicarbonate in Shellsol T) . The animals were observed afterwards for 14 days. One female and three male rats died (20% mortality). Based on the results, Trigonox NBP-C 50 can be considerd as practically non-toxic and the oral LD50 in rats is higher than 10 mL/kg bw, which equals 8800 mg/kg bw..