Dibutyl peroxydicarbonate

Endpoint summary

Description of key information

Suitable data are available to assess the acute oral toxicity of the target substance dibutyl peroxydicarbonate. In an acute oral toxicity study conducted similar to OECD 401, Wistar rats (10/sex) were orally exposed to 10 mL/kg bw test item. Based on the results, the oral LD50 can be considered to exceed 10 mL/kg bw (equals 8800 mg/kg bw).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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

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

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..

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Study conducted similar to guideline

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study technically not feasible

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study technically not feasible

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data, the target substance does not warrant classification for acute toxicity. The oral LD50 value was above the limit value of the relevant OECD guideline.